chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: ANTH
Symptoms: Peroneal nerve palsy, Spinal osteoarthritis, X-ray
Clinical narrative: Increased Migraines, extreme burning sensation left side, loss of left leg use (zero muscle resistance when asked to push, foot drop/drag, trouble walking), extreme leg cramps, left side face numbness, chest pain, ....years later bilateral leg pain, degenerative arthritis in joints (back, hands, elbows, wrists, ankles, ect..), dercums disease, shooting bouts of all over pain, headaches
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Area where shots were received was swollen and bright red, about 4 inches wide. Hard knot noted behind it.  Sore and itchy. Patient's parent put ice on area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Area where shots were received was swollen and bright red, about 4 inches wide. Hard knot noted behind it.  Sore and itchy. Patient's parent put ice on area.
Age: 54.0
Sex: M
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: Patient who is planning to travel with this family and friends made an appointment to  receive multiple vaccines.   Patient was given the vaccine. Later, while having discussion about other family members,  it was discovered that the patient had entered son's information on the website, who has the same date of birth and name.  patient is 54 y/o and the vaccine is not recommended for his age group.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Arthralgia, Arthritis, Balance disorder, Blood test
Clinical narrative: Severe joint pain and inflammation, dizziness, mobility, balance, tremors , brain fog short and long term memory loss.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Magnetic resonance imaging, Mobility decreased, Tremor
Clinical narrative: Severe joint pain and inflammation, dizziness, mobility, balance, tremors , brain fog short and long term memory loss.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pt reported swelling / itching  near to/below injection site
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Contusion, Rash, Rash pruritic
Clinical narrative: Rash to bilateral legs, arms, chest, and back. Mild bruising to left arm and right leg, but may be from scratching hard. Treating today following recommendation of Dr., Zyrtec PO BID for 10 Days and Benadryl nightly for max 10 days.
Age: 29.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: No adverse event reported by the patient. I am reporting because vaccine was given outside of Guidelines. The guidelines state Abrysvo should only be administered to pregnant women between September 1 and January 31. This vaccine was administered on February 14.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received duplicate vaccination. Received a dose on 10/30/2023 and accidentally received a duplicate dose on 4/20/2024. Patient is tolerating well and having no adverse effects at this time.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient is 31 years old and she received high dose inadvertently.   No reaction
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event reported - submitting because vaccine was given outside of guidelines. Per guidelines, 32-36 week pregnant patients should receive the vaccine only between September 1 and January 31, but this vaccine was given on April 3.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Patient contacted the pharmacy on 04/21/24 to state they she was having injection site reaction to the vaccine. Stated injection area was red with a rash, painful and a knot.
Age: 72.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Urticaria
Clinical narrative: Patient came home after getting vaccine and broke out in hives. Called his doctor at clinic and they told him to take benadryl, as far as I know that was helping.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram abdomen abnormal, Diarrhoea, Diverticulitis, Scan with contrast abnormal
Clinical narrative: Got my second dose of the year of Spikevax on Apr 9, 2024, diarrhea started Apr 15, 2024.  ER visit on Apr 18, 2024, diagnosed with diverticulitis after CT scan with contrast.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right deltoid swelling with mild redness.  She came to my office 2 days after it happened and it was already decreasing. Advised motrin and ice and to use MENACTRA brand when she is 16 yrs old.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Patient reported she has a rash 4 weeks after the injections, mainly on her forehead.
Age: 65.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: PT HAD BOTH SHINGRIX AND PREVNAR IN SAME ARM ON SAME DAY, SHE CALLED ME TODAY (4/21) STATING SHE HAS HAD SOME REDNESS, ITCHING, AND SWELLING.  FROM HER DESCRIPTION IT DOES NOT SOUND LIKE AN ALLERGIC REACTION, BUT DOES SOUND LIKE TYPICAL INJECTION SITE REACTION.  ADVISED TO TAKE SOME IBU AND BENADRYL TO HELP WITH SYMPTOMS. She states her symptoms are dissipating already.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersomnia, Muscle contractions involuntary, Pain
Clinical narrative: Donor had full body pain, contraction of hands and finger curling. Excess lathery slept off and on 36 hours. Donor had a similar reaction to HEP b series.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Pt report that tendered, reddened , itching , after received the vaccine.
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Death, Diarrhoea, Dysphagia, Eyelid ptosis, Guillain-Barre syndrome
Clinical narrative: Patient showed signs of Guillain barre syndrome (GBS).
Age: 81.0
Sex: M
Vaccine: RSV
Symptoms: Intensive care, Lumbar puncture, Mobility decreased, Respiratory disorder
Clinical narrative: Patient showed signs of Guillain barre syndrome (GBS).
Age: 1.67
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Balanoposthitis, Injection site swelling, Penile erythema, Penile pain, Penile swelling
Clinical narrative: He got some leg swelling at site of vaccines a few days after the vaccines. Then, 6 days after receiving Proquad and DTaP, he got redness and swelling and pain of his penis that required being seen in the ER. He was diagnosed with Balanitis and  he was put on oral antibiotics (cephalexin) and topcial mupirocin ointment.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Axillary pain, Back pain, Neuralgia, Neuritis
Clinical narrative: Within a week of vaccination, patient began experiencing "shooting, burning pain" under left arm around to left side of back.  Approximately 3-4 days later, patient also began experiencing same pain under right arm around to right side of back.  Approximately 3-4 days prior to coming into PCP office on 4/19/24, patient had same pain in epigstric area.  Pt was seen in office on 3/15/24 for upper respiratory illness symptoms and was experiencing the nerve pain in the bilateral axilla/flank area at that time.  Upon office visit on 4/19/2024, pt still experiencing neuritis in bilateral axilla/flank and epigastric area. No rash or other abnormal physical findings.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Respiratory symptom, Vitamin B12 normal
Clinical narrative: Within a week of vaccination, patient began experiencing "shooting, burning pain" under left arm around to left side of back.  Approximately 3-4 days later, patient also began experiencing same pain under right arm around to right side of back.  Approximately 3-4 days prior to coming into PCP office on 4/19/24, patient had same pain in epigstric area.  Pt was seen in office on 3/15/24 for upper respiratory illness symptoms and was experiencing the nerve pain in the bilateral axilla/flank area at that time.  Upon office visit on 4/19/2024, pt still experiencing neuritis in bilateral axilla/flank and epigastric area. No rash or other abnormal physical findings.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Arterial rupture, Atrial fibrillation, Balance disorder, Basilar artery thrombosis
Clinical narrative: Had a mild case of Covid in Jan. 2021, no fever, just lose of smell & taste.  2nd vacine 4/10/2022.  In May & maybe June 2022, felt some AFib symptoms.  9/9/2022 had a cerebral infarction (stroke) due to thrombosis of basilar artery, a brain stem stroke and 2 other arteries in brain closed, one ruptured the other was cleared. Hemiplegia of the dominant right side and hemiparesis of the left. Dysarthria - not able to swallow or talk. Some cognitive deficit.  Disabled, but had just retired as a teacher, so not paid into for disability.  Was not expected to survive the first night after the craniectomy, due to the pressure of the  bleeding in the brain and thought he would have a heart attack. Pacemaker implanted 9/29/22 (Heart rate regulator in brain stem affected).  Decannulation of the tracheostomy on 12/16/22.  Was in the ICU for 3 weeks at hospital, then transferred to a long term acute care hospital for 3 weeks, then to third facility for 9 1/2 weeks.  As of today, in a wheelchair, cannot walk, talk , sit, or eat (feeding tube). and incontinent.  Balance in sitting is very difficutl.  Continuing with therapy, OT/PT and Speech as insurance and savings permit. Patient had retired from teaching.  He was still going to coach and drive the school bus.  He had a bus driving physical 8/4/22.  He was driving a route bus everyday of the week in the AM and working with/coaching athletes during school 3-4 days a week.  He was active, walking and swimming (in our swim spa) - some type of exercise daily.  Actually went to the walk in medical clinic in July 2022 for water in his ear/swimming.  He had his annual physical scheduled for 10/19/22 and was going to check with the doctor on the AFib symptoms he thought he might be having.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain stem stroke, Cardiac pacemaker insertion, Cerebral artery occlusion, Cerebral haemorrhage, Cerebral infarction
Clinical narrative: Had a mild case of Covid in Jan. 2021, no fever, just lose of smell & taste.  2nd vacine 4/10/2022.  In May & maybe June 2022, felt some AFib symptoms.  9/9/2022 had a cerebral infarction (stroke) due to thrombosis of basilar artery, a brain stem stroke and 2 other arteries in brain closed, one ruptured the other was cleared. Hemiplegia of the dominant right side and hemiparesis of the left. Dysarthria - not able to swallow or talk. Some cognitive deficit.  Disabled, but had just retired as a teacher, so not paid into for disability.  Was not expected to survive the first night after the craniectomy, due to the pressure of the  bleeding in the brain and thought he would have a heart attack. Pacemaker implanted 9/29/22 (Heart rate regulator in brain stem affected).  Decannulation of the tracheostomy on 12/16/22.  Was in the ICU for 3 weeks at hospital, then transferred to a long term acute care hospital for 3 weeks, then to third facility for 9 1/2 weeks.  As of today, in a wheelchair, cannot walk, talk , sit, or eat (feeding tube). and incontinent.  Balance in sitting is very difficutl.  Continuing with therapy, OT/PT and Speech as insurance and savings permit. Patient had retired from teaching.  He was still going to coach and drive the school bus.  He had a bus driving physical 8/4/22.  He was driving a route bus everyday of the week in the AM and working with/coaching athletes during school 3-4 days a week.  He was active, walking and swimming (in our swim spa) - some type of exercise daily.  Actually went to the walk in medical clinic in July 2022 for water in his ear/swimming.  He had his annual physical scheduled for 10/19/22 and was going to check with the doctor on the AFib symptoms he thought he might be having.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Cognitive disorder, Craniectomy, Disability, Dysarthria
Clinical narrative: Had a mild case of Covid in Jan. 2021, no fever, just lose of smell & taste.  2nd vacine 4/10/2022.  In May & maybe June 2022, felt some AFib symptoms.  9/9/2022 had a cerebral infarction (stroke) due to thrombosis of basilar artery, a brain stem stroke and 2 other arteries in brain closed, one ruptured the other was cleared. Hemiplegia of the dominant right side and hemiparesis of the left. Dysarthria - not able to swallow or talk. Some cognitive deficit.  Disabled, but had just retired as a teacher, so not paid into for disability.  Was not expected to survive the first night after the craniectomy, due to the pressure of the  bleeding in the brain and thought he would have a heart attack. Pacemaker implanted 9/29/22 (Heart rate regulator in brain stem affected).  Decannulation of the tracheostomy on 12/16/22.  Was in the ICU for 3 weeks at hospital, then transferred to a long term acute care hospital for 3 weeks, then to third facility for 9 1/2 weeks.  As of today, in a wheelchair, cannot walk, talk , sit, or eat (feeding tube). and incontinent.  Balance in sitting is very difficutl.  Continuing with therapy, OT/PT and Speech as insurance and savings permit. Patient had retired from teaching.  He was still going to coach and drive the school bus.  He had a bus driving physical 8/4/22.  He was driving a route bus everyday of the week in the AM and working with/coaching athletes during school 3-4 days a week.  He was active, walking and swimming (in our swim spa) - some type of exercise daily.  Actually went to the walk in medical clinic in July 2022 for water in his ear/swimming.  He had his annual physical scheduled for 10/19/22 and was going to check with the doctor on the AFib symptoms he thought he might be having.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Feeding disorder, Gait inability, Gastrointestinal tube insertion, Heart rate abnormal
Clinical narrative: Had a mild case of Covid in Jan. 2021, no fever, just lose of smell & taste.  2nd vacine 4/10/2022.  In May & maybe June 2022, felt some AFib symptoms.  9/9/2022 had a cerebral infarction (stroke) due to thrombosis of basilar artery, a brain stem stroke and 2 other arteries in brain closed, one ruptured the other was cleared. Hemiplegia of the dominant right side and hemiparesis of the left. Dysarthria - not able to swallow or talk. Some cognitive deficit.  Disabled, but had just retired as a teacher, so not paid into for disability.  Was not expected to survive the first night after the craniectomy, due to the pressure of the  bleeding in the brain and thought he would have a heart attack. Pacemaker implanted 9/29/22 (Heart rate regulator in brain stem affected).  Decannulation of the tracheostomy on 12/16/22.  Was in the ICU for 3 weeks at hospital, then transferred to a long term acute care hospital for 3 weeks, then to third facility for 9 1/2 weeks.  As of today, in a wheelchair, cannot walk, talk , sit, or eat (feeding tube). and incontinent.  Balance in sitting is very difficutl.  Continuing with therapy, OT/PT and Speech as insurance and savings permit. Patient had retired from teaching.  He was still going to coach and drive the school bus.  He had a bus driving physical 8/4/22.  He was driving a route bus everyday of the week in the AM and working with/coaching athletes during school 3-4 days a week.  He was active, walking and swimming (in our swim spa) - some type of exercise daily.  Actually went to the walk in medical clinic in July 2022 for water in his ear/swimming.  He had his annual physical scheduled for 10/19/22 and was going to check with the doctor on the AFib symptoms he thought he might be having.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Hemiplegia, Impaired driving ability, Impaired work ability, Incontinence
Clinical narrative: Had a mild case of Covid in Jan. 2021, no fever, just lose of smell & taste.  2nd vacine 4/10/2022.  In May & maybe June 2022, felt some AFib symptoms.  9/9/2022 had a cerebral infarction (stroke) due to thrombosis of basilar artery, a brain stem stroke and 2 other arteries in brain closed, one ruptured the other was cleared. Hemiplegia of the dominant right side and hemiparesis of the left. Dysarthria - not able to swallow or talk. Some cognitive deficit.  Disabled, but had just retired as a teacher, so not paid into for disability.  Was not expected to survive the first night after the craniectomy, due to the pressure of the  bleeding in the brain and thought he would have a heart attack. Pacemaker implanted 9/29/22 (Heart rate regulator in brain stem affected).  Decannulation of the tracheostomy on 12/16/22.  Was in the ICU for 3 weeks at hospital, then transferred to a long term acute care hospital for 3 weeks, then to third facility for 9 1/2 weeks.  As of today, in a wheelchair, cannot walk, talk , sit, or eat (feeding tube). and incontinent.  Balance in sitting is very difficutl.  Continuing with therapy, OT/PT and Speech as insurance and savings permit. Patient had retired from teaching.  He was still going to coach and drive the school bus.  He had a bus driving physical 8/4/22.  He was driving a route bus everyday of the week in the AM and working with/coaching athletes during school 3-4 days a week.  He was active, walking and swimming (in our swim spa) - some type of exercise daily.  Actually went to the walk in medical clinic in July 2022 for water in his ear/swimming.  He had his annual physical scheduled for 10/19/22 and was going to check with the doctor on the AFib symptoms he thought he might be having.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Intracranial pressure increased, Mobility decreased, Terminal state, Tracheostomy
Clinical narrative: Had a mild case of Covid in Jan. 2021, no fever, just lose of smell & taste.  2nd vacine 4/10/2022.  In May & maybe June 2022, felt some AFib symptoms.  9/9/2022 had a cerebral infarction (stroke) due to thrombosis of basilar artery, a brain stem stroke and 2 other arteries in brain closed, one ruptured the other was cleared. Hemiplegia of the dominant right side and hemiparesis of the left. Dysarthria - not able to swallow or talk. Some cognitive deficit.  Disabled, but had just retired as a teacher, so not paid into for disability.  Was not expected to survive the first night after the craniectomy, due to the pressure of the  bleeding in the brain and thought he would have a heart attack. Pacemaker implanted 9/29/22 (Heart rate regulator in brain stem affected).  Decannulation of the tracheostomy on 12/16/22.  Was in the ICU for 3 weeks at hospital, then transferred to a long term acute care hospital for 3 weeks, then to third facility for 9 1/2 weeks.  As of today, in a wheelchair, cannot walk, talk , sit, or eat (feeding tube). and incontinent.  Balance in sitting is very difficutl.  Continuing with therapy, OT/PT and Speech as insurance and savings permit. Patient had retired from teaching.  He was still going to coach and drive the school bus.  He had a bus driving physical 8/4/22.  He was driving a route bus everyday of the week in the AM and working with/coaching athletes during school 3-4 days a week.  He was active, walking and swimming (in our swim spa) - some type of exercise daily.  Actually went to the walk in medical clinic in July 2022 for water in his ear/swimming.  He had his annual physical scheduled for 10/19/22 and was going to check with the doctor on the AFib symptoms he thought he might be having.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tracheostomy tube removal, Wheelchair user
Clinical narrative: Had a mild case of Covid in Jan. 2021, no fever, just lose of smell & taste.  2nd vacine 4/10/2022.  In May & maybe June 2022, felt some AFib symptoms.  9/9/2022 had a cerebral infarction (stroke) due to thrombosis of basilar artery, a brain stem stroke and 2 other arteries in brain closed, one ruptured the other was cleared. Hemiplegia of the dominant right side and hemiparesis of the left. Dysarthria - not able to swallow or talk. Some cognitive deficit.  Disabled, but had just retired as a teacher, so not paid into for disability.  Was not expected to survive the first night after the craniectomy, due to the pressure of the  bleeding in the brain and thought he would have a heart attack. Pacemaker implanted 9/29/22 (Heart rate regulator in brain stem affected).  Decannulation of the tracheostomy on 12/16/22.  Was in the ICU for 3 weeks at hospital, then transferred to a long term acute care hospital for 3 weeks, then to third facility for 9 1/2 weeks.  As of today, in a wheelchair, cannot walk, talk , sit, or eat (feeding tube). and incontinent.  Balance in sitting is very difficutl.  Continuing with therapy, OT/PT and Speech as insurance and savings permit. Patient had retired from teaching.  He was still going to coach and drive the school bus.  He had a bus driving physical 8/4/22.  He was driving a route bus everyday of the week in the AM and working with/coaching athletes during school 3-4 days a week.  He was active, walking and swimming (in our swim spa) - some type of exercise daily.  Actually went to the walk in medical clinic in July 2022 for water in his ear/swimming.  He had his annual physical scheduled for 10/19/22 and was going to check with the doctor on the AFib symptoms he thought he might be having.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, COVID-19, Drug ineffective
Clinical narrative: Allergic to Pfizer Covid vaccine; covid-19; covid-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "covid-19"; ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergic to Pfizer Covid vaccine". The event "covid-19" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Allergic to pfizer covid vaccine-received 1 dose on 30Mar2020 (pending query). Taken to ER. Patient was treated with Paxlovid.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 90.0
Sex: M
Vaccine: FLUA4
Symptoms: Death
Clinical narrative: Passed; This spontaneous case was retrieved on 02-Oct-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2682408-1), reported by other healthcare professional and concerned a 90-year-old, male patient.  The patient's concurrent conditions included atrial fibrillation, acute respiratory failure with hypoxia, pneumonia, hypertensive heart disease with heart failure, muscle weakness, age-related osteoporosis, benign prostatic hyperplasia, retention of urine, hyperlipidemia, long-term use of aspirin and congestive heart failure. The patient's procedures included joint replacement surgery. The patient's concomitant medications included albuterol for wheezing, and aspirin, atorvastatin, celecoxib, finasteride, latanoprost, metoprolol and omeprazole, and all used for unreported indications. The patient had aftercare following joint replacement surgery. The patient had no known drug allergies.  On 13-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one', route of administration: intramuscular, anatomical location: right arm, indication: not reported). The batch number reported was 370678.  On 14-Sep-2023, the following day after receiving Fluad Quadrivalent the patient passed. The patient had gone to Happy hour, had a margarita, went to bed around 8:00pm and was found by assisted living staff at around 9:00 pm.  The cause of death was not reported. It was unknown whether an autopsy was performed.   The reporter did not provide a causality assessment.  The event of 'death' was assessed as serious due to fatal outcome. Additionally, the event was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Follow-up information was received on: 22-APR-2024 Nullification Reason: Determined to be a duplicate of case 202304215, which remains the case of record.; Reporter's Comments: A 90-year-old, male patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient passed. The cause of death was not reported, and it was not reported if an autopsy was performed. The patient's advanced age and concurrent conditions of atrial fibrillation, acute respiratory failure with hypoxia, pneumonia, hypertensive heart disease with heart failure, hyperlipidemia and congestive heart failure, may have contributed to the development of the event. Causal role of the suspect vaccine is unassessable for the event death, due to lack of additional information provided.; Reported Cause(s) of Death: Unknown couse of death
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: bad rash on my arms and upper body; swelling; Hives; This non-serious case was reported by a consumer and described the occurrence of rash in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-APR-2024, the patient received the 1st dose of Shingrix (left arm). On 08-APR-2024, 7 days after receiving Shingrix, the patient experienced rash (Verbatim: bad rash on my arms and upper body), swelling (Verbatim: swelling) and hives (Verbatim: Hives). The outcome of the rash was resolving and the outcome of the swelling and hives were not reported.   It was unknown if the reporter considered the rash, swelling and hives to be related to Shingrix.     It was unknown if the company considered the rash, swelling and hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2024 and 11-APR-2024 The patient self-reported this case. The patient had Shingrix vaccine on Monday and exactly one week later, on next Monday, he got a bad rash on his arms and upper body. There was swelling, too hives. The patient went to the ER (emergency room) that same evening and was treated with IV (intravenous) infusion of antihistamine and steroid. That cured the rash right away. But it came back the next evening (on 09-APR-2024), so now (on the day of reporting) patient taking oral medications to suppressed it again (which seemed to be working). Patient's PCP (primary care physician) was recommending to him that to do not take a second shot of Shingrix. Patient asked GlaxoSmithKline if that was the right advice. However, since the rash did not appear until a full week after the first shot, so the reporter thought and asked GSK was it likely that the rash was caused by something else, rather than Shingrix and could Shingrix caused a rash to appear as long as a week after the shot, rather than right away. The reporter could send a photo of the rash that was taken on Monday before he went to the emergency room.
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: bad rash on my arms and upper body; swelling; Hives; This non-serious case was reported by a consumer and described the occurrence of rash in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-APR-2024, the patient received the 1st dose of Shingrix (left arm). On 08-APR-2024, 7 days after receiving Shingrix, the patient experienced rash (Verbatim: bad rash on my arms and upper body), swelling (Verbatim: swelling) and hives (Verbatim: Hives). The outcome of the rash was resolving and the outcome of the swelling and hives were not reported.   It was unknown if the reporter considered the rash, swelling and hives to be related to Shingrix.     It was unknown if the company considered the rash, swelling and hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2024 and 11-APR-2024 The patient self-reported this case. The patient had Shingrix vaccine on Monday and exactly one week later, on next Monday, he got a bad rash on his arms and upper body. There was swelling, too hives. The patient went to the ER (emergency room) that same evening and was treated with IV (intravenous) infusion of antihistamine and steroid. That cured the rash right away. But it came back the next evening (on 09-APR-2024), so now (on the day of reporting) patient taking oral medications to suppressed it again (which seemed to be working). Patient's PCP (primary care physician) was recommending to him that to do not take a second shot of Shingrix. Patient asked GlaxoSmithKline if that was the right advice. However, since the rash did not appear until a full week after the first shot, so the reporter thought and asked GSK was it likely that the rash was caused by something else, rather than Shingrix and could Shingrix caused a rash to appear as long as a week after the shot, rather than right away. The reporter could send a photo of the rash that was taken on Monday before he went to the emergency room.
Age: 26.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Gastrointestinal disorder, Guillain-Barre syndrome, Nausea, Vomiting
Clinical narrative: Patient reported to ER three (3) different times (First Hospital and 2X to Second Hospital) for unknown conditions of nausea, vomiting, and body pain.  On third ER visit March 12, 2024, patient was completely paralyzed, droop lip and based on criticalness of condition, was admitted to Second Hospital.  Same week patient received Intravenous Immunoglobulin Therapy (IVIG) treatment for four(4) days after Lumbar Spinal tap provided the final diagnosis on what was going on.  Patient was admitted to Accute Skilled Facility for physical and occupational therapy.  Current insurance is not cooperate in continued treatment and will be sent home April 23rd for home care which includes nurse visits and general physical therapy.   Current Doctor at the Accute Facility does not agree with patient being sent home and conducted "peer to peer" and insurance allowed one (1) week extension.   Patient needs continued full time PT for complete recovery.
Age: 26.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Blood test, Computerised tomogram, Facial paralysis, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: Patient reported to ER three (3) different times (First Hospital and 2X to Second Hospital) for unknown conditions of nausea, vomiting, and body pain.  On third ER visit March 12, 2024, patient was completely paralyzed, droop lip and based on criticalness of condition, was admitted to Second Hospital.  Same week patient received Intravenous Immunoglobulin Therapy (IVIG) treatment for four(4) days after Lumbar Spinal tap provided the final diagnosis on what was going on.  Patient was admitted to Accute Skilled Facility for physical and occupational therapy.  Current insurance is not cooperate in continued treatment and will be sent home April 23rd for home care which includes nurse visits and general physical therapy.   Current Doctor at the Accute Facility does not agree with patient being sent home and conducted "peer to peer" and insurance allowed one (1) week extension.   Patient needs continued full time PT for complete recovery.
Age: 26.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Immunoglobulin therapy, Insurance issue, Loss of personal independence in daily activities, Lumbar puncture abnormal, Muscle spasms
Clinical narrative: Patient reported to ER three (3) different times (First Hospital and 2X to Second Hospital) for unknown conditions of nausea, vomiting, and body pain.  On third ER visit March 12, 2024, patient was completely paralyzed, droop lip and based on criticalness of condition, was admitted to Second Hospital.  Same week patient received Intravenous Immunoglobulin Therapy (IVIG) treatment for four(4) days after Lumbar Spinal tap provided the final diagnosis on what was going on.  Patient was admitted to Accute Skilled Facility for physical and occupational therapy.  Current insurance is not cooperate in continued treatment and will be sent home April 23rd for home care which includes nurse visits and general physical therapy.   Current Doctor at the Accute Facility does not agree with patient being sent home and conducted "peer to peer" and insurance allowed one (1) week extension.   Patient needs continued full time PT for complete recovery.
Age: 26.0
Sex: F
Vaccine: FLUA4, FLU4
Symptoms: Nausea, Pain, Paralysis, Vomiting
Clinical narrative: Patient reported to ER three (3) different times (First Hospital and 2X to Second Hospital) for unknown conditions of nausea, vomiting, and body pain.  On third ER visit March 12, 2024, patient was completely paralyzed, droop lip and based on criticalness of condition, was admitted to Second Hospital.  Same week patient received Intravenous Immunoglobulin Therapy (IVIG) treatment for four(4) days after Lumbar Spinal tap provided the final diagnosis on what was going on.  Patient was admitted to Accute Skilled Facility for physical and occupational therapy.  Current insurance is not cooperate in continued treatment and will be sent home April 23rd for home care which includes nurse visits and general physical therapy.   Current Doctor at the Accute Facility does not agree with patient being sent home and conducted "peer to peer" and insurance allowed one (1) week extension.   Patient needs continued full time PT for complete recovery.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Flushing, Headache, Hypoaesthesia
Clinical narrative: Pt noticed a red area below the injection site the day after the vaccine. On 4/16/24, the area became raised and painful to the touch. She also had some stomach bug type issues (was around a child who had a stomach bug so it could have been from that). Pt came to the pharmacy on 4/17/24 to let us know what was going on. She said it felt like shingles. It looked very similar to what a shingles outbreak looks like. I recommended she go to the dr and she stated she already had an appointment the following day. I asked her to let us know what the physician said. The following day, she came into the pharmacy and said she was diagnosed with shingles.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Malaise, Pain
Clinical narrative: Pt noticed a red area below the injection site the day after the vaccine. On 4/16/24, the area became raised and painful to the touch. She also had some stomach bug type issues (was around a child who had a stomach bug so it could have been from that). Pt came to the pharmacy on 4/17/24 to let us know what was going on. She said it felt like shingles. It looked very similar to what a shingles outbreak looks like. I recommended she go to the dr and she stated she already had an appointment the following day. I asked her to let us know what the physician said. The following day, she came into the pharmacy and said she was diagnosed with shingles.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pyrexia, Rash, Vomiting
Clinical narrative: Pt noticed a red area below the injection site the day after the vaccine. On 4/16/24, the area became raised and painful to the touch. She also had some stomach bug type issues (was around a child who had a stomach bug so it could have been from that). Pt came to the pharmacy on 4/17/24 to let us know what was going on. She said it felt like shingles. It looked very similar to what a shingles outbreak looks like. I recommended she go to the dr and she stated she already had an appointment the following day. I asked her to let us know what the physician said. The following day, she came into the pharmacy and said she was diagnosed with shingles.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Gastroenteritis viral, Herpes zoster, Swelling, Tenderness
Clinical narrative: Pt noticed a red area below the injection site the day after the vaccine. On 4/16/24, the area became raised and painful to the touch. She also had some stomach bug type issues (was around a child who had a stomach bug so it could have been from that). Pt came to the pharmacy on 4/17/24 to let us know what was going on. She said it felt like shingles. It looked very similar to what a shingles outbreak looks like. I recommended she go to the dr and she stated she already had an appointment the following day. I asked her to let us know what the physician said. The following day, she came into the pharmacy and said she was diagnosed with shingles.
Sex: F
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Inbound call from nurse calling to report temperature excursions that occurred for VAXNEUVANCE.  Vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023.; This spontaneous report was received from a nurse and refers to a 68-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with an improperly storage dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #W036242, which had verified to be a valid lot number expiration date reported and confirmed as 01-OCT-2024, administered for prophylaxis (strength, dose, route of administration, and anatomical location were not provided). It was reported that the suspect vaccine had multiple excursions from the time period of 07-JUN-2023 to 09-DEC-2023 as following: 07-JUN-2023: 33 degrees Fahrenheit (F) for 3 hours 0 minutes 0 seconds; 13-JUN-2023: 60F for 4 hours 30 minutes 0 seconds; 13-JUN-2023: 34.10F for 240 hours 0 minutes; 30-NOV-2023: 52F for 5 hours 45 minutes; and from 01-DEC-2023 to 09-DEC-2023: 51.78F for 192 hours (product storage error). Previous temperature excursion was reported (details not provided) and no data logger was involved. In addition, it was confirmed no symptomatic adverse events were reported (no adverse event). Operator of device was a health care professional. No additional information provided.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic adverse events were reported; temperature excursions that occurred for GARDASIL-9; This spontaneous report was received from a registered nurse referring to a currently 13-year-old patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: W010663, expiration date: 11-MAR-2024; strength, dose, and route of administration were not reported) by healthcare professional for prophylaxis. The administered vaccine experienced multiple temperature excursion from 07-JUN-2023 to 09-DEC-2023 (07-JUN-2023: 33F for 3 hours; 31-JUN-2023: 60F for 4 hours 30 minutes and 34.10F for 240 hours; 30-NOV-2023: 52F for 5 hours 45 minutes; 01-DEC-2023 to 09-DEC-2023: 51.78F for 192 hours) (product storage error). This medication error was first identified on 13-JUL-2023 and was not caused by a data logger. No symptomatic adverse events were reported.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Injection site pain, Myalgia
Clinical narrative: site pain; fatigue; joint and muscle pain; joint and muscle pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: site pain), fatigue (Verbatim: fatigue), joint pain (Verbatim: joint and muscle pain) and muscle pain (Verbatim: joint and muscle pain). The outcome of the injection site pain, fatigue, joint pain and muscle pain were not reported.   It was unknown if the reporter considered the injection site pain, fatigue, joint pain and muscle pain to be related to Arexvy.     It was unknown if the company considered the injection site pain, fatigue, joint pain and muscle pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media. The reporter reported that, he/she felt site pain, fatigue, joint and muscle pain.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue
Clinical narrative: very tired; Chills; upset stomach; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced tiredness (Verbatim: very tired), chills (Verbatim: Chills) and upset stomach (Verbatim: upset stomach). The outcome of the tiredness, chills and upset stomach were not reported.   It was unknown if the reporter considered the tiredness, chills and upset stomach to be related to Shingles vaccine.     It was unknown if the company considered the tiredness, chills and upset stomach to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2024 This case was reported by patient via interactive digital media. The patient reported that he or she did not like side effects. He/she was very tired, had chills and upset stomach. The patient knew that was nothing compared to the shingles.
Sex: U
Vaccine: RSV
Symptoms: Cough
Clinical narrative: still has a bad cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: still has a bad cough). The outcome of the cough was not resolved.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-APR-2024 The case was received from the consumer via (Open field AE monitoring) interactive digital media.   The reporter stated that his/her (illegible text) had it badly and still he/she had a bad cough.
Sex: M
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: I had a syringe malfunction where the solution drew out of the syringe and didn't go into the muscle, so I had a lot of solution lost that did not go into the patient's arm."; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a male patient who received Herpes zoster (Shingrix) (batch number G2XE5, expiry date 10-FEB-2026) for prophylaxis.   On 03-APR-2024, the patient received Shingrix. On 03-APR-2024, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: I had a syringe malfunction where the solution drew out of the syringe and didn't go into the muscle, so I had a lot of solution lost that did not go into the patient's arm."). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 09-APR-2024 The pharmacist called to inform the following about Shingrix, that had administered a shingles vaccine, and what happened was, while injecting it I had a syringe malfunction where the solution drew out of the syringe and didn't go into the muscle, so I had a lot of solution lost that did not go into the patient's arm, which led to incomplete dose administered. The Vaccine Administration Facility was the same as Primary Reporter,
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: shingrix reconstituted with sterile water, instead of the  supplied diluents, was administered in error; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-APR-2024, the patient received Shingrix. On 09-APR-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: shingrix reconstituted with sterile water, instead of the  supplied diluents, was administered in error). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 10-APR-2024 The pharmacist called to know if a dose should be repeated if Shingrix was reconstituted with sterile water instead of provided diluent which led to, wrong solution used in drug reconstitution. The pharmacist stated that there was no information available about the patient or the vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent the follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who got 2 doses, they are very very far apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 54ld5, expiry date 27-SEP-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th November 2021).   On 17-OCT-2023, the patient received the 2nd dose of Shingrix. On 17-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient who got 2 doses, they are very very far apart). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-APR-2024 The reporter called about the Shingrix vaccine that they had a patient who got 2 doses and they were very very far apart. The reporter wanted to know if patient needed a 3rd one because it was very spread apart The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she received first dose of vaccine series 20th November 2021 and second dose 25th January 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 20th November 2021).   On 25-JAN-2024, the patient received the 2nd dose of Shingrix. On 25-JAN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: she received first dose of vaccine series 20th November 2021 and second dose 25th January 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 10-APR-2024 The reporter was the patient. The reporter stated the patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. As per product information a first dose at Month 0 followed by a second dose administered 2 to 6 months later. The reporter consented to follow up.