chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Developed tinnitus in left ear(same side as shot) on day 5 and had plugged ear. Have never had tinnitus in the past. Blood pressure went up by 30 points. Have generally not felt well since vaccine. Doctors called it an adverse immune reaction. Week 3-thyroid swelled and am now dealing with that. Went for ultrasound today
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Chills, Computerised tomogram head abnormal, Death, Disorientation
Clinical narrative: Monday night pt. became ill, threw up and had a fever.  He went to bed, but around 11 pm he woke up disoriented, unable to walk.  Was helped to the bathroom, but was unable to get back to bed on his own.  Fell on his bottom.  I had to call our son to come pick him up and help him back to bed, unable to hold his own weight..  Had trouble sleeping.  Abt 1 pm needed help getting up again, same disorientation, also fell off the toilet and needed help getting back to the bed, unable to hold his own weight.  Finally fell asleep.  Next day seemed fine enough. Tuesday night, became ill again, went to bed.  Got up to go to the bathroom, was wobbly, but able to make it.  Was helped back, wobbly but able to walk. Trouble falling asleep, fever, chills.  Finally fell asleep at 3 am Wed morning.  I had to go to the doctor early, so left him sleeping in bed.  When I came back around 11 am, he was still sleeping, snoring loudly.  Became concerned.  Wouldn't wake up.  Called Paramedics.  CT scan at the hospital revealed a brain bleed.  Transported to hospital. Put on support for almost 2 weeks.  No progress, no response.  Finally support was discontinued and he died April 19th at 7:52 pm.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Electroencephalogram, Fall, Gait disturbance, Gait inability, Illness
Clinical narrative: Monday night pt. became ill, threw up and had a fever.  He went to bed, but around 11 pm he woke up disoriented, unable to walk.  Was helped to the bathroom, but was unable to get back to bed on his own.  Fell on his bottom.  I had to call our son to come pick him up and help him back to bed, unable to hold his own weight..  Had trouble sleeping.  Abt 1 pm needed help getting up again, same disorientation, also fell off the toilet and needed help getting back to the bed, unable to hold his own weight.  Finally fell asleep.  Next day seemed fine enough. Tuesday night, became ill again, went to bed.  Got up to go to the bathroom, was wobbly, but able to make it.  Was helped back, wobbly but able to walk. Trouble falling asleep, fever, chills.  Finally fell asleep at 3 am Wed morning.  I had to go to the doctor early, so left him sleeping in bed.  When I came back around 11 am, he was still sleeping, snoring loudly.  Became concerned.  Wouldn't wake up.  Called Paramedics.  CT scan at the hospital revealed a brain bleed.  Transported to hospital. Put on support for almost 2 weeks.  No progress, no response.  Finally support was discontinued and he died April 19th at 7:52 pm.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Initial insomnia, Laboratory test, Magnetic resonance imaging, Mobility decreased, Pyrexia
Clinical narrative: Monday night pt. became ill, threw up and had a fever.  He went to bed, but around 11 pm he woke up disoriented, unable to walk.  Was helped to the bathroom, but was unable to get back to bed on his own.  Fell on his bottom.  I had to call our son to come pick him up and help him back to bed, unable to hold his own weight..  Had trouble sleeping.  Abt 1 pm needed help getting up again, same disorientation, also fell off the toilet and needed help getting back to the bed, unable to hold his own weight.  Finally fell asleep.  Next day seemed fine enough. Tuesday night, became ill again, went to bed.  Got up to go to the bathroom, was wobbly, but able to make it.  Was helped back, wobbly but able to walk. Trouble falling asleep, fever, chills.  Finally fell asleep at 3 am Wed morning.  I had to go to the doctor early, so left him sleeping in bed.  When I came back around 11 am, he was still sleeping, snoring loudly.  Became concerned.  Wouldn't wake up.  Called Paramedics.  CT scan at the hospital revealed a brain bleed.  Transported to hospital. Put on support for almost 2 weeks.  No progress, no response.  Finally support was discontinued and he died April 19th at 7:52 pm.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Snoring, Vomiting, Weight bearing difficulty, Withdrawal of life support
Clinical narrative: Monday night pt. became ill, threw up and had a fever.  He went to bed, but around 11 pm he woke up disoriented, unable to walk.  Was helped to the bathroom, but was unable to get back to bed on his own.  Fell on his bottom.  I had to call our son to come pick him up and help him back to bed, unable to hold his own weight..  Had trouble sleeping.  Abt 1 pm needed help getting up again, same disorientation, also fell off the toilet and needed help getting back to the bed, unable to hold his own weight.  Finally fell asleep.  Next day seemed fine enough. Tuesday night, became ill again, went to bed.  Got up to go to the bathroom, was wobbly, but able to make it.  Was helped back, wobbly but able to walk. Trouble falling asleep, fever, chills.  Finally fell asleep at 3 am Wed morning.  I had to go to the doctor early, so left him sleeping in bed.  When I came back around 11 am, he was still sleeping, snoring loudly.  Became concerned.  Wouldn't wake up.  Called Paramedics.  CT scan at the hospital revealed a brain bleed.  Transported to hospital. Put on support for almost 2 weeks.  No progress, no response.  Finally support was discontinued and he died April 19th at 7:52 pm.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Oedema peripheral, Pyrexia
Clinical narrative: Adverse events: Chills, fever, and swelling under left arm Outcome: all better after 24 hours
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Got 2nd dose vaccine on  4/15/21.  I  started to have menstrual bleeding  on 4/18/21. My last period JUST ended on 4/10/21. I NEVER had bleeding during ovulation in my entire life.  Today is 4/21/21, it is getting heavier than beginning.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Extremely heavy/irregular menstrual cycle shortly after receiving vaccine
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Symptoms started with a light headache a few hours after the injection and slight arm pain at the site of the injection.  Nothing serious until I fell asleep, which is when I developed a fever, uncontrollable chills, and aches all over my body, so much that I could not sleep until I took some ibuprofen. In the morning, the chills were gone, but a slight fever and body aches remained all day. They were gone by the next day.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Symptoms started with a light headache a few hours after the injection and slight arm pain at the site of the injection.  Nothing serious until I fell asleep, which is when I developed a fever, uncontrollable chills, and aches all over my body, so much that I could not sleep until I took some ibuprofen. In the morning, the chills were gone, but a slight fever and body aches remained all day. They were gone by the next day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Diarrhoea, Dyspnoea
Clinical narrative: Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest.  My chest was tight.  It hurt in my neck and shoulder and chest to take a deep breath.  Shortly after, I felt jittery inside & started getting chills.  The backs of my legs were quaking against the chair and I got really cold.  My blood pressure went up to 149/78.  I also had one bout of diarrhea.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Feeling jittery, Hypertension, Neck pain, Pain in extremity
Clinical narrative: Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest.  My chest was tight.  It hurt in my neck and shoulder and chest to take a deep breath.  Shortly after, I felt jittery inside & started getting chills.  The backs of my legs were quaking against the chair and I got really cold.  My blood pressure went up to 149/78.  I also had one bout of diarrhea.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest.  My chest was tight.  It hurt in my neck and shoulder and chest to take a deep breath.  Shortly after, I felt jittery inside & started getting chills.  The backs of my legs were quaking against the chair and I got really cold.  My blood pressure went up to 149/78.  I also had one bout of diarrhea.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Moderna COVID-19 Vaccine EUA On my  2nd shot of the vaccine on April 8, I had a mild fever of 99.7 which steadily increased to 100.7 for four (4) days.  My second symptoms was having rashes since last Wednesday, April 14 that spread throughout my body, primarily on my arms, armpit, legs, buttocks, and back until today, April 21.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Neck pain
Clinical narrative: HEADACHE NECK PAIN ELEVATED HEARTBEAT
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Rash, Skin discolouration
Clinical narrative: 1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs.  2) Sharp breast pain,  on the left breast,
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Hypoaesthesia, Pigmentation disorder, SARS-CoV-2 test, Swelling
Clinical narrative: 1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs.  2) Sharp breast pain,  on the left breast,
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Eye swelling, Feeling hot, Pruritus, Tachycardia
Clinical narrative: throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5  during the 24 hours prior to my vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5  during the 24 hours prior to my vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Pruritus, Throat irritation, Throat tightness
Clinical narrative: throat constriction, dryness, scratcy/itchy. facial itiching, head, arm, back itching, eye swelling, overheating, tachycardic. epinephrine administered, 911 called, ambulance taken across the street to ER for observation. steroids given. further benadryl taken at home. symptoms started 10-15 minutes post injection. I am allergic to PEG, my allergist put me on a pre dose of anthystamines & steroids to lessen or prevent reaction so overall reaction was fairly mild but epi was the only thing left to give as I had already had 400mg hydroxyzine, 40 mg pepcid x3, 28mg medrol x5  during the 24 hours prior to my vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: CHILLS; This spontaneous report received from a patient concerned a 50 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in both feet with onset 12 days after vaccination.; This is a spontaneous report from a contactable other HCP (herself). A 31-year-old female (Non pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9265, Expiry date: unknown), via an unspecified route of administration in left arm on 05Feb2021, at 09:30 AM, as single dose for COVID-19 immunisation. The patient medical history included Hashimoto thyroiditis. Patient concomitant medication included Synthroid (LEVOTHYROXINE SODIUM). The patient experienced numbness in both feet with onset 12 days after vaccination on 10Feb2021. Patient visited at physician's office. Patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 0.33
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE was reported; Improperly stored vaccine(s) were administered; This spontaneous report as received from a registered nurse refers to a 4-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 30-MAR-2021, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: 1691299, expiration date: 25-DEC-2021, dose and route of administration not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot number: T020616, expiration date: 16-MAR-2023, dose and route of administration not provided). The vaccines were stored in temperature 50.7 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-2104USA000392:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; patient on a 3-dose schedule of GARDASIL 9 received the 2nd dose 3 weeks after the 1st dose; This spontaneous report was received from a pharmacist referring to a patient to unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On approximately 12-FEB-2021 (reported as 3 weeks before of second dose), the patient was vaccinated with first dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration, anatomical location lot number and expiration date were not reported).   Then on 05-MAR-2021 3 weeks after the first dose, the patient was vaccinated with second dose of hpv rL1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, dosage, route of administration and anatomical location were not reported; lot number T008152 and expiration date 21-JUN-2022) (inappropriate schedule of product administration). No adverse event was reported.  This is one of two reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008152; expirationdate: 21-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA001750:
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient did not experience any side effects and no other AE occurred; The customer reported they have a patient who received PEDV AX HIB and ROT ATEQ after the products we improperly stored.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender.  No information regarding concurrent conditions, medical history or concomitant medications was provided.  On 08-APR-2021, the patient was administered 1 dose of improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot 1684166 and expiration date 27-JUN-2021 and 1 improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot T020615 and expiration date:13-MAR-2023 for prophylaxis (dose, dose number and vaccination schemes frequency were not reported). The involved vaccine underwent a temperature excursion of 51.4 degrees Fahrenheit for 30 minutes. No Data Logger was involved. No previous temperature excursions were reported.   At the time of the report no adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: multiple outbreaks of herpes zoster; Information has been received regarding a case in litigation from a lawyer regarding a patient of unknown gender and age. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 18-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, as the result of the use of zoster vaccine live (ZOSTAVAX), the patient presented multiple outbreaks of herpes zoster for which the patient was treated. The patient claimed damages, including injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the event was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: herpes zoster/blisters on left side of torso, back and spine; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 09-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, subsequently after receiving zoster vaccine live (ZOSTAVAX), the patient suffered blisters on left side of torso, back and spine and was diagnosed with Herpes Zoster. As a result of these symptoms, the patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations were not present prior to using zoster vaccine live (ZOSTAVAX) vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX) vaccine, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered serious, progressive, permanent, and incurable injuries. The outcome of the event of shingles was considered as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of shingles was considered to be disabling event.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARlVAX that underwent a temperature excursion was administered; No additional adverse effect reported; This spontaneous report as received from a licenced practical nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 31-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T027302, expiration date: 12-AUG-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine underwent the temperature excursion: from -15 to -10 degrees Celsius for 2 hours and 30 minutes. Digital data logger was involved. There were no previous excursions.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Adverse reactions or side effects experienced: N/A; Vaccine administered on 22-NOV-2009 and then on 17-MAR-2011; This spontaneous report has been received from a lawyer, from a case in litigation for Zoster Vaccine Live (ZOSTAVAX) (MARRS# 1806USA003285), concerning a 60-year-old female patient. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 22-NOV-2009, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and on 17-MAR-2011, she received another dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (Inappropriate schedule of product administration), both administered as prophylaxis (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported for both doses). No adverse effects were reported.; Sender's Comments:  US-009507513-1806USA003285:
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Visual impairment
Clinical narrative: vision and balance issues; vision and balance issues; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. On or about 05-DEC-2012, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), patient suffered vision and balance issues. As a result of these symptoms, patient was seen and treated by medical providers. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, patient have suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.Outcome of the events was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: consumer received the first dose of Gardasil 9 vaccine at 11 yeras old and now is 14 years old and has not received a second dose of the vaccine; no additional adverse event reported; This spontaneous report was received from a pharmacist via  employee and refers to a reporter's son 14-year-old male patient. His pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On an unknown date, when the patient was 11-year-old, he was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (lot #, expiration date, exact dose, strength, route of administration and anatomical location were not reported). At the time of this report, he had not received a second dose of the vaccine yet. No additional adverse event reported.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Asthma, Electrocardiogram, Fatigue, Hypersensitivity
Clinical narrative: shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare; shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare; overwhelming fatigue; This is a spontaneous report from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASP2021052927), license party for etanercept (ENBREL).  This non-serious spontaneous report (USASP2021052927) was reported on 06/APR/2021 by a consumer and involves a 29 year old female patient who experienced had shortness of breath/ chest pain/ burning throat and SOB/ diagnosed as allergic reaction or possible asthma flare [PT: hypersensitivity] while receiving Enbrel with Single Dose Prefilled Syringe and Aimovig with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included psoriatic arthritis, migraine, and asthma. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine. The patient began Aimovig with Single Dose Prefilled Autoinjector on an unknown date in JUL/2018. The patient started taking Enbrel with Single Dose Prefilled Syringe on an unknown date in 2020. On 15/MAR/2021, the patient received her first Pfizer COVID-19 vaccination. On 25/MAR/2021, the patient took her latest Enbrel injection. On 27/MAR/2021, the patient took her latest Aimovig injection. On 28/MAR/2021, Sunday, the patient started experiencing shortness of breath (SOB) and chest pain which lead her to see her physician the following Monday. On 29/MAR/2021, the patient performed electrocardiogram (ECG) at the physician's office which was normal. On 29/MAR/2021, on Monday night, the patient went to the emergency room with a burning throat and SOB and the patient was diagnosed with an allergic reaction or possible asthma flare, and she was prescribed a prednisone taper which she did not take and baclofen. The patient had been taking the baclofen and using her Xopenex (levosalbutamol hydrochloride) rescue inhaler as needed for SOB. The patient also reported that the SOB and chest pain was getting better but still had issues. On an unknown date in 2021, the patient also reported that she had been experiencing overwhelming fatigue and was scheduled to receive her second Pfizer COVID-19 vaccination on 09/APR/2021. The outcome of the events hypersensitivity was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Syringe was reported as unknown for the events hypersensitivity. Action taken with Aimovig with Single Dose Prefilled Autoinjector was reported as unknown for the events hypersensitivity. The causal relationship between the events hypersensitivity, and Enbrel with Single Dose Prefilled Syringe was not provided by the consumer. The causal relationship between the events hypersensitivity and Aimovig with Single Dose Prefilled Autoinjector was not provided by the consumer. Follow up is not required.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: given SQ; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number LT533, expiry date 11th May 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The healthcare professional reported that the patient possibly received a Shingrix subcutaneously, which led to incorrect route of vaccination. No further information was reported.   Follow up information received from nurse on 13th April 2021: The new reporter contact details were added. The reporter stated that she just received the letter and she did not remember anything from 3 years ago and would not send the return letter. The reporter requested no further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Apathy, Fatigue, Feeling abnormal, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Spent 2 days in bed with a 100.5 fever ( normal is 97.6); Extreme fatigue / my fatigue was more than normal for me; Developed pronounced brain fog which was previously not pronounced; Very apathetic/ il motivated; Experience a sore / arm for 5 days; Experience a / swollen arm for 5 days; Spent 2 days in bed; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, swelling arm, activities of daily living impaired, fever, fatigue, foggy feeling in head and apathy. On an unknown date, the outcome of the pain in arm, swelling arm and activities of daily living impaired were recovered/resolved and the outcome of the fever and apathy were unknown and the outcome of the fatigue and foggy feeling in head were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, swelling arm, activities of daily living impaired, fever, fatigue, foggy feeling in head and apathy to be related to Shingrix.   Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received both doses of Shingrix and experienced a sore and swollen arm for 5 days and spent 2 days in bed with a 100.5 degree F fever and had extreme fatigue for 4 days. The patient stated that he/she had fibromyalgia, so every side effect and symptom was magnified and lasts longer, so his/her fatigue was more than normal for him/her and on the scale of 1 to 10, 10 being extreme, the patient went from 4 to 8 and the patient also developed pronounced brain fog which was previously not pronounced and on same 1 to 10 scale, the patient went from a 2 to 8. The patient stated that all of this pronounced fatigue and brain fog lasted about 10 days and though the levels dropped, 3 plus weeks later, his/her fatigue and brain fog level was about 5. The patient noticed that he/she was suddenly very apathetic and in motivated. The patient asked if there had been any other reports with similar effects. The patient stated that he/she trying to resolve his/her extra fatigue and brain fog, apathy and lack of motivation and was looking for answers.  The patient had no other illness, clinical depression and any issues with his/her family.   Error correction was performed on 8th April 2021: Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028980:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Spent 2 days in bed with a 100.5 fever ( normal is 97.6); Extreme fatigue / my fatigue was more than normal for me; Developed pronounced brain fog which was previously not pronounced; Very apathetic/ il motivated; Experience a sore / arm for 5 days; Experience a / swollen arm for 5 days; Spent 2 days in bed; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, swelling arm, activities of daily living impaired, fever, fatigue, foggy feeling in head and apathy. On an unknown date, the outcome of the pain in arm, swelling arm and activities of daily living impaired were recovered/resolved and the outcome of the fever and apathy were unknown and the outcome of the fatigue and foggy feeling in head were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, swelling arm, activities of daily living impaired, fever, fatigue, foggy feeling in head and apathy to be related to Shingrix.   Additional details were provided as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received both doses of Shingrix and experienced a sore and swollen arm for 5 days and spent 2 days in bed with a 100.5 degree F fever and had extreme fatigue for 4 days. The patient stated that he/she had fibromyalgia, so every side effect and symptom was magnified and lasts longer, so his/her fatigue was more than normal for him/her and on the scale of 1 to 10, 10 being extreme, the patient went from 4 to 8 and the patient also developed pronounced brain fog which was previously not pronounced and on same 1 to 10 scale, the patient went from a 2 to 8. The patient stated that all of this pronounced fatigue and brain fog lasted about 10 days and though the levels dropped, 3 plus weeks later, his/her fatigue and brain fog level was about 5. The patient noticed that he/she was suddenly very apathetic and in motivated. The patient asked if there had been any other reports with similar effects. The patient stated that he/she trying to resolve his/her extra fatigue and brain fog, apathy and lack of motivation and was looking for answers.  The patient had no other illness, clinical depression and any issues with his/her family.   Error correction was performed on 8th April 2021: Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028980:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Scar, Vaccination failure
Clinical narrative: took 2 shots / so bad then shingles 4 years ago; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (experienced shingles 4 years ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not  reported. This case was reported by patient herself. The patient took the shot and would not wish them on his or her worse friend, they were terrible and did leave scars just like chicken pox do. This case was considered as suspected vaccination failure as details regarding  time to onset for target disease (shingles) and laboratory confirmation were unknown at the time of reporting. The reporter stated that 2 of his or her sister's did not take them but 1 and he or she, did an slept in the same bed till mamma had to make him or her a bed in a chair away from the other kids. The patient had them so bad than the shingles 4 years ago. The patient received the 2 doses of shingrix and experienced shingles and suspected vaccination failure. This case was likned with case US2021AMR077290 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR077290:same reporter US-GLAXOSMITHKLINE-US2021AMR077311:same patient
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Migraine
Clinical narrative: had a 3 day migraine; This case was reported by a consumer via licensee and described the occurrence of migraine in a 53-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   The patient's past medical history included blood pressure high, hypothyroidism, anxiety and depression. Concurrent medical conditions included diabetes. Concomitant products included lamotrigine (Lamictal), levothyroxine sodium (Synthroid), duloxetine, methylpropylpropanediol dinitrate, acetylsalicylic acid (Aspirin), gabapentin, colecalciferol (Vitamin D3), cyanocobalamin (Vitamin B12), lisinopril, metformin hydrochloride, insulin detemir (Levemir), melatonin, memantine hydrochloride (Namenda), black cohash extract/herbals/green tea extract/minerals/phytoestrogens/vitamins/, docusate sodium (Colace), paracetamol (Tylenol) and ibuprofen.   On 12th August 2020, the patient received Tdap Vaccine. On an unknown date, less than 9 months after receiving Tdap Vaccine and an unknown time after starting Lamictal, the patient experienced migraine. On an unknown date, the outcome of the migraine was recovered/resolved.   It was unknown if the reporter considered the migraine to be related to Tdap Vaccine.  Additional details were provided as follows: The patient's ethnicity reported The patient had medical history such as diabetes form 2016, blood pressure high, hypothyroidism, anxiety and depression. On 12th August 2020, the patient received Tdap Vaccine. On an unknown date, less than 9 months after receiving Tdap Vaccine , the patient experienced migraine. On an unknown date, the outcome of the migraine was recovered/resolved. The patient received concomitant medications such as lamotrigine (Lamictal) 100mg once a day, levothyroxine sodium (Synthroid) 75 mg once a day for hypothyroidism, duloxetine 120 mg once a day for depression, methylpropylpropanediol dinitrate 15mg once daily for depression, acetylsalicylic acid (Aspirin) 81 mg on Monday , Wednesday and Friday for pain , gabapentin 200mg once a day for diabetes, colecalciferol (Vitamin D3) 5000IU Tuesday , cyanocobalamin (Vitamin B12) 1000mcg tuesday, lisinopril for high blood pressure, metformin hydrochloride 500mg in morning and 100 mg in evening for diabetes, insulin detemir (Levemir) 28 unit at bedtime for diabetes, melatonin 0.5mg-1.5mg , memantine hydrochloride (Namenda) 10mg tablet twice daily, black cohash extract/herbals/green tea extract/minerals/phytoestrogens/vitamins/ 500mg once a day, docusate sodium (Colace), paracetamol (Tylenol)  for pain,azo capsule and ibuprofen. On 07th April 2021 patient took covid-19 vaccine and experienced events. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Laboratory test, Neuralgia, Post herpetic neuralgia
Clinical narrative: He is in excruciating nerve pain; Blisters have gone / didn't have much problem with blisters; Second shingles vaccine about 3 months ago / March 17, 2021 he got shingles/suspected vaccination failure; Second shingles vaccine about 3 months ago / March 17, 2021 he got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In January 2021, the patient received the 2nd dose of Shingles vaccine. On 17th March 2021, unknown after receiving Shingles vaccine and between 1 and 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia and blister. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the post herpetic neuralgia and blister to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported for both 1st and 2nd dose of Shingrix. The patient received 2nd dose of Shingles vaccine about 3 months before day of reporting and he got shingles on his right chest wrapping under his armpit and into his back. Less than 3 months after receiving Shingles vaccine, the patient had blisters that had gone but he was in excruciating nerve pain. The patient did not have much problem with blisters. The reporter stated that they were praying for some relief soon. The follow up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: He is in excruciating nerve pain; Blisters have gone / didn't have much problem with blisters; Second shingles vaccine about 3 months ago / March 17, 2021 he got shingles/suspected vaccination failure; Second shingles vaccine about 3 months ago / March 17, 2021 he got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In January 2021, the patient received the 2nd dose of Shingles vaccine. On 17th March 2021, unknown after receiving Shingles vaccine and between 1 and 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia and blister. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. It was unknown if the reporter considered the post herpetic neuralgia and blister to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported for both 1st and 2nd dose of Shingrix. The patient received 2nd dose of Shingles vaccine about 3 months before day of reporting and he got shingles on his right chest wrapping under his armpit and into his back. Less than 3 months after receiving Shingles vaccine, the patient had blisters that had gone but he was in excruciating nerve pain. The patient did not have much problem with blisters. The reporter stated that they were praying for some relief soon. The follow up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pharyngeal swelling, Rash
Clinical narrative: Allergic reaction; rash on stomach; throat swelling; This case was reported by a nurse via sales rep and described the occurrence of hypersensitivity in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 14th April 2021, the patient received the 2nd dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced hypersensitivity, rash and throat swelling. The patient was treated with epinephrine (Epi Pen). On an unknown date, the outcome of the hypersensitivity, rash and throat swelling were unknown.   It was unknown if the reporter considered the hypersensitivity, rash and throat swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not reported.   The patient reported rash on stomach and throat swelling. Emergency room (ER) visit was required and epi pen was given to the patient.  ER physician did not think this allergic reaction was shingles.  The patient released same day from ER
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given their second shots 2 WEEKS after their first; This case was reported by a consumer and described the occurrence of drug dose administration interval too short in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient was reporter sister's husband. The age at vaccination was not reported. The patient had taken second shot two weeks after first shot and not properly immunized, which led to which led to shortening of vaccination schedule. No further information was provided. This case has been linked with case US2021AMR087434 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR087434:same reporter