chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Dysarthria, Muscle rigidity, Muscle spasms, Muscle twitching
Clinical narrative: garbled speech; spasms; Mouth/lips twitching/twitching; arms rigid up toward face; lips blue; rapid breathing; deep sleep after; glazed look; not responding; bite tongue; This is a spontaneous report received from a contactable healthcare professional also reported as a nurse. A 93-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN5318) intramuscular, administered in Arm Left on 28Feb2021 at 14:30  as SINGLE DOSE for covid-19 immunisation  Facility where the most recent COVID-19 vaccine was administered was a Home/Facility. Medical history included cerebrovascular accident 'CVA 8 months ago' from Jul2020 to an unknown date , atrial fibrillation from an unknown date and unknown if ongoing. The patient has no known allergies. Historical Vaccine included BNT162B2 Dose 1, Lot number EL9621, Administration date 07Feb2021 at 14:00, Intramuscular, in the Left arm for Covid-19 immunization. Concomitant medication included asa (ASA); levothyroxine (LEVOTHYROXINE);metoprolol (METOPROLOL); bupropion (BUPROPION); docusate sodium (COLACE); apixaban (ELIQUIS); iron (IRON); latanoprost (LATANOPROST); omeprazole (PROTONIX [OMEPRAZOLE]); timolol (TIMOLOL); paracetamol (TYLENOL). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 2021, The patient experienced spasms,  mouth/lips twitching/twitching,arms rigid up toward face, lips blue, rapid breathing, deep sleep after, glazed look, not responding,  bite tongue and on Mar2021 garbled speech. on Mar2021. The events Mouth/lips twitching,arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, garbled speech was considered Disabling/Incapacitating. Clinical course was reported as follows  Mouth/lips twitching, arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, same repeated 4 hours later and then again 1 hour after that. next day garbled speech, not exhausted and stayed in bed 4 days. It was unknown if treatment was give for the events.  The clinical outcome of the events was recovered with sequelae.     .
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Respiratory rate increased, Somnolence, Tongue biting, Unresponsive to stimuli
Clinical narrative: garbled speech; spasms; Mouth/lips twitching/twitching; arms rigid up toward face; lips blue; rapid breathing; deep sleep after; glazed look; not responding; bite tongue; This is a spontaneous report received from a contactable healthcare professional also reported as a nurse. A 93-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN5318) intramuscular, administered in Arm Left on 28Feb2021 at 14:30  as SINGLE DOSE for covid-19 immunisation  Facility where the most recent COVID-19 vaccine was administered was a Home/Facility. Medical history included cerebrovascular accident 'CVA 8 months ago' from Jul2020 to an unknown date , atrial fibrillation from an unknown date and unknown if ongoing. The patient has no known allergies. Historical Vaccine included BNT162B2 Dose 1, Lot number EL9621, Administration date 07Feb2021 at 14:00, Intramuscular, in the Left arm for Covid-19 immunization. Concomitant medication included asa (ASA); levothyroxine (LEVOTHYROXINE);metoprolol (METOPROLOL); bupropion (BUPROPION); docusate sodium (COLACE); apixaban (ELIQUIS); iron (IRON); latanoprost (LATANOPROST); omeprazole (PROTONIX [OMEPRAZOLE]); timolol (TIMOLOL); paracetamol (TYLENOL). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 2021, The patient experienced spasms,  mouth/lips twitching/twitching,arms rigid up toward face, lips blue, rapid breathing, deep sleep after, glazed look, not responding,  bite tongue and on Mar2021 garbled speech. on Mar2021. The events Mouth/lips twitching,arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, garbled speech was considered Disabling/Incapacitating. Clinical course was reported as follows  Mouth/lips twitching, arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, same repeated 4 hours later and then again 1 hour after that. next day garbled speech, not exhausted and stayed in bed 4 days. It was unknown if treatment was give for the events.  The clinical outcome of the events was recovered with sequelae.     .
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Nausea, Palpitations
Clinical narrative: my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontaneous report received from a contactable consumer reported (patient herself). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6205), via an unspecified route of administration on 28Feb2021 11:30 in left arm at single dose for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), migraine, and allergies: codeine, mushrooms, shrimp. Pregnant at the time of vaccination was no. Concomitant medication within 2 weeks of vaccination included atenolol; ergocalciferol (CALCIFEROL VIT D); esomeprazole magnesium (NEXIUM 24HR); methylcellulose (CITRUCEL); paracetamol (TYLENOL); atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (lot number: EL9264) on 07Feb2021 at 09:00 AM in right arm for covid-19 immunization. About ten hours after injection (28Feb2021 21:30), her started pounding, rate was 130-140, BP (blood pressure) went to about 180/110 and she became nauseated. This happened as she was sitting quietly watching TV.  After about 15 minutes she called 911 and was taken to hospital.  All events were reported as serious and resulted in emergency room/department or urgent care, hospitalization on 28Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for events included Telemetry, ondansetron hydrochloride (ZOFRAN), prochlorperazine edisylate (COMPAZINE). Outcome of events were recovered in 2021.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Smear test
Clinical narrative: my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontaneous report received from a contactable consumer reported (patient herself). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6205), via an unspecified route of administration on 28Feb2021 11:30 in left arm at single dose for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), migraine, and allergies: codeine, mushrooms, shrimp. Pregnant at the time of vaccination was no. Concomitant medication within 2 weeks of vaccination included atenolol; ergocalciferol (CALCIFEROL VIT D); esomeprazole magnesium (NEXIUM 24HR); methylcellulose (CITRUCEL); paracetamol (TYLENOL); atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (lot number: EL9264) on 07Feb2021 at 09:00 AM in right arm for covid-19 immunization. About ten hours after injection (28Feb2021 21:30), her started pounding, rate was 130-140, BP (blood pressure) went to about 180/110 and she became nauseated. This happened as she was sitting quietly watching TV.  After about 15 minutes she called 911 and was taken to hospital.  All events were reported as serious and resulted in emergency room/department or urgent care, hospitalization on 28Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for events included Telemetry, ondansetron hydrochloride (ZOFRAN), prochlorperazine edisylate (COMPAZINE). Outcome of events were recovered in 2021.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Discomfort, Echocardiogram, Electrocardiogram, Heart rate increased
Clinical narrative: my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontaneous report received from a contactable consumer reported (patient herself). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6205), via an unspecified route of administration on 28Feb2021 11:30 in left arm at single dose for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), migraine, and allergies: codeine, mushrooms, shrimp. Pregnant at the time of vaccination was no. Concomitant medication within 2 weeks of vaccination included atenolol; ergocalciferol (CALCIFEROL VIT D); esomeprazole magnesium (NEXIUM 24HR); methylcellulose (CITRUCEL); paracetamol (TYLENOL); atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (lot number: EL9264) on 07Feb2021 at 09:00 AM in right arm for covid-19 immunization. About ten hours after injection (28Feb2021 21:30), her started pounding, rate was 130-140, BP (blood pressure) went to about 180/110 and she became nauseated. This happened as she was sitting quietly watching TV.  After about 15 minutes she called 911 and was taken to hospital.  All events were reported as serious and resulted in emergency room/department or urgent care, hospitalization on 28Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for events included Telemetry, ondansetron hydrochloride (ZOFRAN), prochlorperazine edisylate (COMPAZINE). Outcome of events were recovered in 2021.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Nausea, Troponin increased
Clinical narrative: my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontaneous report received from a contactable consumer reported (patient herself). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6205), via an unspecified route of administration on 28Feb2021 11:30 in left arm at single dose for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), migraine, and allergies: codeine, mushrooms, shrimp. Pregnant at the time of vaccination was no. Concomitant medication within 2 weeks of vaccination included atenolol; ergocalciferol (CALCIFEROL VIT D); esomeprazole magnesium (NEXIUM 24HR); methylcellulose (CITRUCEL); paracetamol (TYLENOL); atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (lot number: EL9264) on 07Feb2021 at 09:00 AM in right arm for covid-19 immunization. About ten hours after injection (28Feb2021 21:30), her started pounding, rate was 130-140, BP (blood pressure) went to about 180/110 and she became nauseated. This happened as she was sitting quietly watching TV.  After about 15 minutes she called 911 and was taken to hospital.  All events were reported as serious and resulted in emergency room/department or urgent care, hospitalization on 28Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for events included Telemetry, ondansetron hydrochloride (ZOFRAN), prochlorperazine edisylate (COMPAZINE). Outcome of events were recovered in 2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Ear disorder, Erythema, Flushing, Nasal congestion
Clinical narrative: my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started feeling stuffy; felt flushed; my face was red; what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain; what feels like my heart quivering for several seconds; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at left arm on 08Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included gastroesophageal reflux disease, osteoarthritis, nodules on thyroids and allergy to Aspartsme. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took Sulfanomide (Sulfa drugs) and had allergy (swelling), codeine and had allergy (nausea). The symptom that has made patient concerned enough to report the possibility of a side effect is: she had her shot this morning and between about 8:55 and 9:15 this evening she had 9 or 10 episodes of what feels like her heart quivering for several seconds followed 3 or 4 times by very slight pain, just below her right breast, she has never experienced such a thing before. (she took baby aspirin around 9:20 in case she was having some kind of heart thing). It's 9:45 pm, and the quivering episodes haven't happened for the last 30 minutes, so maybe they're all cleared up. Earlier, within 30 min of getting the vaccine, her ears started feeling like they were stopped up and her nose started feeling stuffy. Then as she was driving home she felt flushed and looked in the mirror and her face was red, she took one Sudafed in case it was allergies, and those symptoms improved quite a lot. Adverse event start date was 08Mar2021 10:00 AM. Since the vaccination, the patient has not been tested for COVID-19. Unknown if treatment received for ears started feeling like they were stopped up and nose started feeling stuffy. Outcome of what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain was recovered. Outcome of felt flushed and face was red was recovering and outcome of other events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: my ears started feeling like they were stopped up and my nose started feeling stuffy.; nose started feeling stuffy; felt flushed; my face was red; what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain; what feels like my heart quivering for several seconds; This is a spontaneous report received from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at left arm on 08Mar2021 09:30 AM at single dose for COVID-19 immunization. Medical history included gastroesophageal reflux disease, osteoarthritis, nodules on thyroids and allergy to Aspartsme. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. Concomitant medication included pantoprazole sodium sesquihydrate (PANTOPRAZOLE 40). the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took Sulfanomide (Sulfa drugs) and had allergy (swelling), codeine and had allergy (nausea). The symptom that has made patient concerned enough to report the possibility of a side effect is: she had her shot this morning and between about 8:55 and 9:15 this evening she had 9 or 10 episodes of what feels like her heart quivering for several seconds followed 3 or 4 times by very slight pain, just below her right breast, she has never experienced such a thing before. (she took baby aspirin around 9:20 in case she was having some kind of heart thing). It's 9:45 pm, and the quivering episodes haven't happened for the last 30 minutes, so maybe they're all cleared up. Earlier, within 30 min of getting the vaccine, her ears started feeling like they were stopped up and her nose started feeling stuffy. Then as she was driving home she felt flushed and looked in the mirror and her face was red, she took one Sudafed in case it was allergies, and those symptoms improved quite a lot. Adverse event start date was 08Mar2021 10:00 AM. Since the vaccination, the patient has not been tested for COVID-19. Unknown if treatment received for ears started feeling like they were stopped up and nose started feeling stuffy. Outcome of what feels like my heart quivering for several seconds followed 3 or 4 times by very slight pain was recovered. Outcome of felt flushed and face was red was recovering and outcome of other events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Pharmacist via Agency (Reference number- 00521572) and transmitted to Sanofi on 16-MAR-2021.  This case involves a patient (unknown age and gender) who was administered an expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] (lot U6214AA, expiry date: 14-Mar-2021) via unknown route in the unknown site for prophylactic vaccination on 16-Mar-2021(expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (latency same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; A patient was administered an expired MMR II.; This spontaneous report was received from a nurse manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not reported.      On 22-FEB-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Albumin status: recombinant human albumin (rHA)) (strength, dose and route were not reported; lot# was S005248 and expiration date was 20-FEB-2021) for prophylaxis (expired product administered). No additional adverse event (AE) was reported. The vaccine never had a prior temperature excursion.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; posible given after temperature excursion 55 F; This spontaneous reported was received from a pharmacist and pharmacy technician, and refers to a patient of an unknown age and gander. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # S039310 was confirmed to be valid, expiration date was not reported but upon internal validation was established as 04-DEC-2021, 0.5 milliliter (route and site of administration were not reported) for prophylaxis. The administered dose was exposed to the temperature of 55 degrees Fahrenheit for 5 hours. There was no previous temperature excursion. The call was because of a digital data logger. There was no additional adverse event reported.
Sex: M
Vaccine: MMR
Symptoms: Hypersensitivity, Pyrexia, Rash
Clinical narrative: an allergic reaction/ high fever and a rash.; an allergic reaction/ high fever and a rash.; This spontaneous report was received from a male patient of unknown age, who was referring to himself. No information regarding his pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date (reported as the patient was a kid), the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unknown date in 1986, the patient had an allergic reaction. It was reported that he experienced high fever and rash. The outcome of the events was not reported.  The relatedness between the events and the suspect vaccine was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; Caller reported that VARlVAX that experienced a temperature excursion was administered (minus 10 C to 8C (minus 3.7C) for 22 hours ).; This spontaneous report was received from another health professional (nurse) referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Lot # T022315, expiration date 30-JUN-22) for prophylaxis (dose and route of administration were not provided).    On 17-FEB-2021, the suspect vaccine underwent a temperature excursion of -10-degree Celsius (C) to 8 C (average of 3.7 C) for a period of 22 hours. The vaccine did not undergo a previous temperature excursion. The excursion was called by a digital data logger. The patient did not experience any adverse event.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient was administered a dose of improperly stored PROQUAD; 15 year old patient was vaccinated with PROQUAD; This spontaneous report as received from an office manager refers to a 15 year old patient. On 23-FEB-2021, the patient was vaccinated with an improperly stored 0.5 mL dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027111 exp date 07-FEB-2022). The vaccines were through the temperature excursion on 16-FEB-2021. There was no data logger issue. The temperature of excursion was -10 °C for a time frame of 1 hour 15 minutes.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: patient was inavertently administered with am expired dose of M-M-R II; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 11-MAR-2021, the patient was vaccinated with an expired 0.5 mL dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S006646 exp date 05-MAR-2021) (route not reported). It was reported that the product had never had a temperature excursion and was supported per the post-expiry memo.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no additional AE; patient received a dose of MMRlI on 3/11/2021 that was reconstituted with a vial of STERILE DILUENT which was improperly stored; This spontaneous report refers to a 37-year-old female patient. There was no information about her concurrent conditions, concomitant therapies or medical history provided.  On 11-MAR-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) lot # T000890, expiration date: 08-JAN-2022, 0.5 milliliter (strength and route of administration were not reported) which was reconstituted in a vial of improperly stored sterile diluent, lot # T013005, expiration date: 20-OCT-2022, 0.5 milliliter (strength and route of administration were not reported), both for prophylaxis. On an unknown date, the dose of sterile diluent was exposed to temperature excursion at - 7.5 Fahrenheit degrees (F) for 2,160 hours. There was no previous temperature excursion reported. The call was not due to digital data logger. No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; Patient was administered improperly stored VARlVAX on 03/15/2021.; This spontaneous report was received from a healthcare professional referring to a 4-year-old patient of unknown gender.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 15-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T010315 with an expiration date on 24-MAR-2022) for prophylaxis (strength, dose, anatomical location, and route of administration were not reported).        Administered dose of vaccine experienced a temperature excursion of -13 degrees Celcius (°C) for 2 hours and 19 minutes on unspecified dates. A data logger was involved. There were no previous excursions reported.  No adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Cardiac disorder, Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; arrhythmia; cardiac issues; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided. On an unknown date, 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 was diagnosed herpes zoster, post herpetic neuralgia, an arrhythmia and cardiac issues. 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).
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling in to report adverse event involving vaccines MMR II (stored in freezer) and VARIVAX, temperature excursion case number 01892408; This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 17-MAR-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # S039319 with expiration date 04-DEC-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# T025945 has been verified to be valid, expiration date reported as 30-JUL-2022) for prophylaxis (dose number, exact dose and route of administration were not provided) (product storage error).  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) experienced the temperature excursion from -50 to 8 degrees Celsius (-1.6 degrees Celsius) for 1 hour 36 minutes 0 second. Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion from -10 to 8 degrees Celsius (-1.6 degrees Celsius) for 1 hour 36 minutes 0 second. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse event or product quality complaint was reported at this time.
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: left arm stiffness, back stiffness, neck stiffness; decreased mobility in all four of his extremities; This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 4Z43X, expiry date unknown) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) (batch number DJ7721, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal stiffness (1st dose received on 16th September 2020, refer case US2021062762).   On 28th November 2020, the patient received the 2nd dose of Shingrix and PREVNAR 13. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced stiff neck and mobility decreased. Rechallenge with Shingrix was positive. On 1st March 2021, the outcome of the stiff neck and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the stiff neck and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in left deltoid and Prevenar in right deltoid and experienced injection site discomfort, mobility decreased. Neck, back and arm stiffness. The reporter stated that, mobility decreased improved on  27th February 2021 and 3rd March 2021. The reporter stated that, the events were resolved. The reporter consented to follow up. It was unknown if the reporter considered the injection site discomfort, stiff neck and mobility decreased to be related to Prevenar.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062762:same reporter
Age: 68.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: left arm stiffness, back stiffness, neck stiffness; decreased mobility in all four of his extremities; This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 4Z43X, expiry date unknown) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) (batch number DJ7721, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of musculoskeletal stiffness (1st dose received on 16th September 2020, refer case US2021062762).   On 28th November 2020, the patient received the 2nd dose of Shingrix and PREVNAR 13. On 5th December 2020, less than a day after receiving Shingrix, the patient experienced stiff neck and mobility decreased. Rechallenge with Shingrix was positive. On 1st March 2021, the outcome of the stiff neck and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the stiff neck and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix in left deltoid and Prevenar in right deltoid and experienced injection site discomfort, mobility decreased. Neck, back and arm stiffness. The reporter stated that, mobility decreased improved on  27th February 2021 and 3rd March 2021. The reporter stated that, the events were resolved. The reporter consented to follow up. It was unknown if the reporter considered the injection site discomfort, stiff neck and mobility decreased to be related to Prevenar.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021062762:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported, but was selected as an adult as per vaccine indication. The patient had first shot of Shingrix and felt bad for a day. For tolerance of second dose refer case ID US2021AMR064388.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064388:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Shot was very painful; Arm very sore; Couldnt move it; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (also experienced sore arm after receiving 1st dose on an unknown date, refer case US2021AMR064333).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain, pain in arm and mobility decreased. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site pain, pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm and mobility decreased to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient herself/himself. 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 2nd dose of Shingles vaccine and stated shot was very painful and made his/her arm very sore to where he/she could not move it. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064333:same report, same patient, different dose (2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: mild case of shingles; painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  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 stated that he/she just got over a mild case of shingles and it was painful too. The patient would get another dose in 3 months. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: headache; low grade fever; This case was reported by a nurse via sales rep and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and fever. On an unknown date, the outcome of the headache and fever were unknown.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had headache and low grade fever.  The reporter said that the patient would welcome GlaxoSmithKline to follow up if more information was needed. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache; achiness; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were unknown.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but was selected as an adult as per vaccine indication. The patient had received shingrix and experienced headache and achiness. Patient had questioned to take Tylenol after the 2nd vaccine. No other information was reported.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever of 103 degrees / after 3 days the fever came down to 99 degrees; This case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose on 13th September 2020 and experienced sore arm, refer case US2021066283).   On 13th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 13th March 2021, less than a day after receiving Shingrix, the patient experienced fever. The patient was treated with paracetamol (Acetaminophen). On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received dose 2 and on same evening, the patient experienced fever of 103 degrees Fahrenheit. The fever lasted several days, but after 3 days the fever came down to 99 degrees Fahrenheit with acetaminophen therapy. The patient did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021066283:same patient (2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: contract shingles after the first dose; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but was selected an adult as per vaccine indication. The patient had received first dose of Shingrix and experienced Shingles. The reporter was wondering what the recommendation was on receiving dose 2 if contracted shingles after the first dose. No other information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: My arm was very stiff; This case was reported by a consumer via other manufacturer and described the occurrence of limbs stiffness in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced limbs stiffness. On an unknown date, the outcome of the limbs stiffness was unknown.   It was unknown if the reporter considered the limbs stiffness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination not reported. The patent stated that Shingles shot was horrible as her arm was very stiff after receiving shingles vaccine. The reporter's and healthcare professional s consent to follow-up was reported as not applicable. For tolerance of 2nd dose refer case US2021AMR067301; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR067301:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: chills with 2nd shot.; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date, refer case US2021AMR067988).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had chills with 2nd shot of Shingles vaccine. The patient was glad to get the vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Feeling abnormal, Illness
Clinical narrative: I had the Shingles Shot the Second Dose made me so sick; I thought I was dying; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (experienced by both patient's father and mother).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and impending doom. On an unknown date, the outcome of the sickness and impending doom were unknown.   It was unknown if the reporter considered the sickness and impending doom to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had Shingles shot which made him/her so sick that he/she thought he/she was dying. The follow-up would not possible, as no contact details were provided. This case had been linked with US2021AMR068319 and US2021AMR068320, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR068319:same reporter (mother´s case) US-GLAXOSMITHKLINE-US2021AMR068320:same reporter (father´s case)
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Dizziness, Malaise
Clinical narrative: felt faint; felt faint and ill; This case was reported by a consumer via call center representative and described the occurrence of felt faint in a 61-year-old female patient who received HAB (Twinrix) (batch number 3Y7NL, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th March 2021, the patient received Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. On 10th March 2021, less than a day after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced felt faint (serious criteria GSK medically significant) and feeling unwell. On an unknown date, the outcome of the felt faint and feeling unwell were recovered/resolved.   It was unknown if the reporter considered the felt faint and feeling unwell to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. After being vaccinated the patient felt faint and ill. The patient was transported to the emergency department (ED). Symptoms have since resolved. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19 infection, and wanted to receive the second dose of Shignrix; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19. The patient was treated with immunoglobulins nos (Immunoglobulin). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.   Additional details provided as follows: The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The pharmacist reported that the patient recently received an immunoglobulin as a therapy for Covid-19 infection. The patient wanted to receive the 2nd dose of Shignrix. No further information available. The reporter consented to follow up via email. Note: This case was conservatively considered valid as it was unknown if Shingrix 1st dose was administered before or after Covid-19 infection.