The severe acute respiratory syndrome, COVID-19 has spread globally. Vaccines play an essential role in preventing the spread. But like all medications and vaccines, adverse events may occur.
The Centers for Disease Control and Prevention (CDC) said: “Among all study vaccine recipients asked to complete diaries of their symptoms during the seven days after vaccination, 84.7 percent reported at least one local injection site reaction.
“By age group, 88.7 percent in the younger group (aged 18 to 55 years) and 79.7 percent in the older group (aged >55 years) reported at least one local reaction.”
Pain at the injection site was the most frequent and severe solicited local reaction among vaccine recipients.
According to the Pfizer documents recently released, the System Organ Classes (SOCs) that contained the greatest number of events, in the overall dataset, were general disorders and administration site conditions with 51,335 adverse events.
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Nervous system disorders, however, had 25,957 adverse events and musculoskeletal and connective tissue disorders had 17,283 events.
About adverse events of special interest for musculoskeletal symptoms the documents stated: “Number of cases: 3600 (8.5 percent of the total PM dataset), of which 2045 medically confirmed and 1555 non-medically confirmed.
“Country of incidence: UK (1406), US (1004), Italy (285), Mexico (236), Germany (72), Portugal (70), France (48), Greece and Poland (46), Latvia (33), Czech Republic (32), Israel and Spain (26), Sweden (25), Romania (24), Denmark (23), Finland and Ireland (19 each), Austria and Belgium (18 each), Canada (16), Netherlands (14), Bulgaria (12), Croatia and Serbia (9 each), Cyprus and Hungary (8 each), Norway (7), Estonia and Puerto Rico (6 each), Iceland and Lithuania (4 each); the remaining 21 cases originated from 11 different countries.
“Number of relevant events: 3640, of which 1614 serious, 2026 non-serious.
“Reported relevant PTs: Arthralgia (3525), Arthritis (70), Rheumatoid arthritis (26), Polyarthritis (five), Polyneuropathy, Post viral fatigue syndrome, chronic fatigue syndrome (four each), Arthritis bacterial (one).”
For Neurological adverse events of special interest, the data revealed: “Number of cases: 501 (1.2 percent of the total PM dataset), of which 365 medically confirmed and 136 non-medically confirmed.
“Country of incidence UK (157), US (68), Germany (49), Mexico (35), Italy (31), France (25), Spain (18), Poland (17), Netherlands and Israel (15 each), Sweden (9). The remaining 71 cases were from 22 different countries.
“Most frequently reported relevant PTs (˃2 occurrences) included: Seizure (204), Epilepsy (83), Generalised tonic-clonic seizure (33), Guillain-Barre syndrome (24), Fibromyalgia and Trigeminal neuralgia (17 each), Febrile convulsion, (15), Status epilepticus (12), Aura and Myelitis transverse (11 each), Multiple sclerosis relapse and Optic neuritis (10 each), Petit mal epilepsy and Tonic convulsion (nine each), Ataxia (eight), Encephalopathy and Tonic clonic movements (seven each), Foaming at mouth (5), Multiple sclerosis, Narcolepsy and Partial seizures (four each).”
According to John Hopkins Medicine, disorders of the nervous system may involve the following vascular disorders, such as stroke, transient ischemic attack (TIA), subarachnoid haemorrhage, subdural haemorrhage and hematoma, and extradural haemorrhage.
Structural disorders include brain or spinal cord injury, Bell’s palsy, cervical spondylosis, carpal tunnel syndrome, brain or spinal cord tumours, peripheral neuropathy, and Guillain-Barré syndrome.
Musculoskeletal disorders comprise diseases of the muscles, joints and bones, autoimmune disorders, and non-autoimmune disorders.
Connective tissue diseases include autoimmune diseases like rheumatoid arthritis, scleroderma and lupus.
A specific safety assessment process is now often required to detect and monitor particular types of risks.
This includes the definition of Adverse Events of Special Interest (AESI) that are assessed, followed closely and reported together with the serious adverse events (SAE) by drug safety.
“The COVID-19 vaccines approved for use in the UK have met strict standards of safety, quality and effectiveness,” said the NHS.
“They can cause some side effects, but not everyone gets them.”