chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Jul2021 15:00 (Lot number: EW0164) at the age of 57 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing), notes: she has allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose#1 Pfizer Covid 19 vaccine on 20Jun2021 in her right arm likely, around 3pm. lot EW0172, Route of administration: intramuscular), administration date: 20Jun2021, when the patient was 56 years old, for Covid-19 immunization, reaction(s): "weird feeling in my mouth"; Flu shot (I got flu shot in Nov2020), administration date: Nov2020. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles"; CONTUSION (non-serious) with onset Jul2021, outcome "unknown", described as "I had bruising on top of both feet"; BACK PAIN (non-serious), BURNING SENSATION (non-serious) all with onset 06Jan2022, outcome "recovering" and all described as "My R side upper back hurt & burned"; PYREXIA (non-serious) with onset 06Jan2022, outcome "recovered" (Jan2022), described as "Had a fever 101.00 for a day & half"; DYSPHONIA (non-serious) with onset Jan2022, outcome "recovered" (Jan2022), described as "Then my voice was slow losing". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of herpes zoster, back pain, burning sensation, dysphonia. Additional information: Caller states she has the Pfizer Covid-19 vaccine done at the hospital because she has allergies and her doctor said to go to the hospital and ended up with internal shingles 3 weeks ago. No prior vaccinations. (06Jan2022) My R side upper back hurt & burned. There was no bumps. Had a fever 101.00 for a day & half. The pain was ongoing. Then my voice was slow losing. Then I went to an urgent care on (10Jan2022). The Dr. diagnosed me with internal shingles. Dr. treated me with prednisone 20 and valacyclovir 1gm #21. After taking the meds for 2 days my voice came back. My pain in my back was going away slowly. Now I still have pain but not all the time. I think the shingles did nerve damage. I looked online and saw articles that people were getting shingles from getting the Covid shot. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Ear discomfort, Hypoacusis, Lymphadenopathy, Scab
Clinical narrative: After  I received my booster, my lymph nodes on the left side (same side I received my injection) were very swollen and remained so for weeks.  Three weeks after receiving it, I had a substantial allergic reaction (hives, oozing, scabbing, swelling) to the same hair dye I?ve been using for a long time.  I can no longer dye my hair, and my lymph nodes swelled up again so much that my ear feels clogged.  My ear is also ringing, and I?m struggling to hear properly.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Skin weeping, Swelling, Tinnitus, Urticaria
Clinical narrative: After  I received my booster, my lymph nodes on the left side (same side I received my injection) were very swollen and remained so for weeks.  Three weeks after receiving it, I had a substantial allergic reaction (hives, oozing, scabbing, swelling) to the same hair dye I?ve been using for a long time.  I can no longer dye my hair, and my lymph nodes swelled up again so much that my ear feels clogged.  My ear is also ringing, and I?m struggling to hear properly.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test positive, Rash, Rash pruritic, Urticaria
Clinical narrative: I began to experience rashes all over my body on 12/4/22.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood immunoglobulin M, Influenza B virus test, Investigation, Nucleic acid test
Clinical narrative: Pain in administration area(left arm); weakness; Pain and inflammation of the administration area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 14:00 (Lot number: EP7534) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 21Mar2018 (ongoing), notes: continuous medicines (prescribed drugs). Concomitant medication(s) included: MONTELUKAST taken for asthma, start date: 21Mar2018 (ongoing); CETIRIZINE [CETIRIZINE HYDROCHLORIDE] taken for asthma, start date: 21Mar2018 (ongoing); DYMISTA taken for asthma, start date: 21Mar2018 (ongoing); BREO ELLIPTA taken for asthma, start date: 21Mar2018 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Pain in administration area(left arm)"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered", described as "weakness"; VACCINATION SITE INFLAMMATION (non-serious) with onset Mar2021, outcome "recovered", described as "Pain and inflammation of the administration area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported, the patient received dose 2 intramuscular on 04Apr2021 14:00 (Lot number: EP6955) and dose 3 intramuscularly on 18Dec2021 15:00 (Lot: 33025BD). Reportedly, the patient had side effect described as follow. 1st dose: Pain and inflammation of the administration area (left arm) and weakness. The effects disappeared after 2 days.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia mycoplasmal, Polymerase chain reaction, SARS-CoV-2 RNA, SARS-CoV-2 test, Vaccination site inflammation
Clinical narrative: Pain in administration area(left arm); weakness; Pain and inflammation of the administration area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 14:00 (Lot number: EP7534) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 21Mar2018 (ongoing), notes: continuous medicines (prescribed drugs). Concomitant medication(s) included: MONTELUKAST taken for asthma, start date: 21Mar2018 (ongoing); CETIRIZINE [CETIRIZINE HYDROCHLORIDE] taken for asthma, start date: 21Mar2018 (ongoing); DYMISTA taken for asthma, start date: 21Mar2018 (ongoing); BREO ELLIPTA taken for asthma, start date: 21Mar2018 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Pain in administration area(left arm)"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered", described as "weakness"; VACCINATION SITE INFLAMMATION (non-serious) with onset Mar2021, outcome "recovered", described as "Pain and inflammation of the administration area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported, the patient received dose 2 intramuscular on 04Apr2021 14:00 (Lot number: EP6955) and dose 3 intramuscularly on 18Dec2021 15:00 (Lot: 33025BD). Reportedly, the patient had side effect described as follow. 1st dose: Pain and inflammation of the administration area (left arm) and weakness. The effects disappeared after 2 days.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in administration area(left arm); weakness; Pain and inflammation of the administration area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 21Mar2021 14:00 (Lot number: EP7534) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 21Mar2018 (ongoing), notes: continuous medicines (prescribed drugs). Concomitant medication(s) included: MONTELUKAST taken for asthma, start date: 21Mar2018 (ongoing); CETIRIZINE [CETIRIZINE HYDROCHLORIDE] taken for asthma, start date: 21Mar2018 (ongoing); DYMISTA taken for asthma, start date: 21Mar2018 (ongoing); BREO ELLIPTA taken for asthma, start date: 21Mar2018 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "Pain in administration area(left arm)"; ASTHENIA (non-serious) with onset Mar2021, outcome "recovered", described as "weakness"; VACCINATION SITE INFLAMMATION (non-serious) with onset Mar2021, outcome "recovered", described as "Pain and inflammation of the administration area". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported, the patient received dose 2 intramuscular on 04Apr2021 14:00 (Lot number: EP6955) and dose 3 intramuscularly on 18Dec2021 15:00 (Lot: 33025BD). Reportedly, the patient had side effect described as follow. 1st dose: Pain and inflammation of the administration area (left arm) and weakness. The effects disappeared after 2 days.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Influenza A virus test, Influenza B virus test, Pain, Pneumonia mycoplasmal
Clinical narrative: Pain in body; Weakness; Pain in administration area (Right arm); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Apr2021 14:00 (Lot number: EP6955) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 21Mar2018 (ongoing), notes: Pertinent details: Continuous use medication (Prescribed drugs). Concomitant medication(s) included: MONTELUKAST taken for asthma, start date: 21Mar2018 (ongoing); CETIRIZINE taken for asthma, start date: 21Mar2018 (ongoing); DYMISTA taken for asthma, start date: 21Mar2018 (ongoing); BREO ELLIPTA taken for asthma, start date: 21Mar2018 (ongoing). Vaccination history included: Bnt162b2 (Lot/Batch number: EP7534, Route of administration: Intramuscular, Time of vaccination: 14:00, Dose no: 1), administration date: 21Mar2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "Pain and inflammation of the administration area (left arm)", "Pain and inflammation of the administration area (left arm)", "weakness". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in body"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Weakness"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in administration area (Right arm)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information:2nd dose: Pain in body and weakness. Pain in administration area (right arm). The effects disappear after 3 days.   Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 RNA, SARS-CoV-2 test, Serology test, Vaccination site pain
Clinical narrative: Pain in body; Weakness; Pain in administration area (Right arm); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Apr2021 14:00 (Lot number: EP6955) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 21Mar2018 (ongoing), notes: Pertinent details: Continuous use medication (Prescribed drugs). Concomitant medication(s) included: MONTELUKAST taken for asthma, start date: 21Mar2018 (ongoing); CETIRIZINE taken for asthma, start date: 21Mar2018 (ongoing); DYMISTA taken for asthma, start date: 21Mar2018 (ongoing); BREO ELLIPTA taken for asthma, start date: 21Mar2018 (ongoing). Vaccination history included: Bnt162b2 (Lot/Batch number: EP7534, Route of administration: Intramuscular, Time of vaccination: 14:00, Dose no: 1), administration date: 21Mar2021, when the patient was 40 years old, for COVID-19 immunization, reaction(s): "Pain and inflammation of the administration area (left arm)", "Pain and inflammation of the administration area (left arm)", "weakness". The following information was reported: PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in body"; ASTHENIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Weakness"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain in administration area (Right arm)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information:2nd dose: Pain in body and weakness. Pain in administration area (right arm). The effects disappear after 3 days.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: pain on hips really bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis, start date: 07Aug2021. Past drug history included: Enbrel for Rheumatoid arthritis, reaction(s): "Device issue", notes: Enbrel (Unit=Cartridge). Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "pain on hips really bad". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Pain in extremity, Rhinorrhoea
Clinical narrative: she started experiencing an ache/heaviness in her arm / I have a pain in my bicep when I try and pick up a cup of coffee; she started experiencing an ache/heaviness in her arm; a "drippy nose."; the needle punctured a nerve in her arm; This spontaneous report was received from a 71-year-old female patient who referred to herself and a licensed practical nurse (LPN). She had no concomitant medication and no pertinent medical history. Her historical drugs included levofloxacin (LEVAQUIN), to which she reported allergy. Her historical vaccines included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) and pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The patient reported to have contracted pneumonia after being vaccinated with unspecified pneumonia vaccine (captured in case 2202USA004709).  On 14-JAN-2022, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection (site of administration, lot# and expiry date were not provided) intramuscularly for pneumonia prevention.   On 21-JAN-2022, the patient experienced ache and heaviness in her arm, and a drippy nose. She stated she had pain in her bicep when she tried and picked up a cup of coffee. The patient was informed by a pharmacist the pain she was experiencing could have been caused if the needle punctured a nerve in her arm, however it was unconfirmed. The patient was treated with ibuprofen (ADVIL) for events (also reported as "for inflammation"). The LPN advised she did not have additional information regarding the reported adverse events post the vaccine administration, as the patient was not vaccinated at their's office. The patient sought medical attention form a healthcare professional. The outcome of events was reported as not recovered.  The causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA004709:
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: No additional AEs reported; administration of vaccines involved in a temperature excursion; This spontaneous report was received from a medical assistant referring to a 1-year-old female patient.  Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 16-FEB-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U024090, expiration date 28-OCT-2023, intramuscular in the left arm for prophylaxis (dose and vaccination scheme frequency were reported as "1") (product storage error).         The vaccine was stored in a temperature of 1.35 degree Celsius for1 hour as recorded by a data logger. There was no previous temperature excursion reported.  This is one of three reports received from the same reporter.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional information; Dose of MMR II that was administered 1 day after expiration; This spontaneous report was received from registered nurse referring to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies.  On 28-FEB-2022, the patient was vaccinated one day after expiration of measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) (Expired product administered) (lot # T007234 was a valid lot number, expiration date was reported as 27-FEB-2022; dose, frequency, vaccination scheme, route of administration and anatomical site of vaccination were not reported) for prophylaxis. The vaccine had not gone any temperature excursions.   No PQC. No additional information was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no adverse event; patient received a 2nd dose of VARlVAX on day 26 instead of day 28; This spontaneous report was received from a pharmacist and refers to a 59-year-old patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On approximately 08-NOV-2021 (26 days before 04-DEC-2021), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot #, expiration date, route of administration and dose were not reported) for prophylaxis.  On 04-DEC-2021, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # T010309 and expiration date: 24-MAR-2022 (route of administration and dose were not reported) for prophylaxis. It took place on day 26 after first dose, instead on day 28 (inappropriate schedule of product administration).
Age: 24.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; PROQUAD administered to a 24 year old; This spontaneous information has been received referring to a 24-year-old patient of unknown gender. Information regarding the patient' medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   On 04-MAR-2022, at the age of 24 years old, the patient was vaccinated with with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, lot #U026799, expiration date: 26-FEB-2023, administered subcutaneously for prophylaxis (product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; dose of expired MMRlI was administered; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender.There was no information regarding patient's medical history, concurrent conditions or concomitant therapies provided.  On 08-MAR-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) 0.5 ml, lot #: T007235, expiration date 27-FEB-2022 (expired product administered) (formulation and route of administration were not reported) for prophylaxis. No additional adverse events reported (no adverse event). No product quality complaints reported.
Sex: U
Vaccine: RV5, UNK
Symptoms: Product storage error
Clinical narrative: No addittional adverse events reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.       On 05-FEB-2022, both rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot #1741817, expiration date 30-JUL-2022) and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) (lot #U7124AA, expiration date 13-JUL-2024) had occurred a temperature excursion in 0.8 degree Celsius for 35 minutes. And on 09-FEB-2022, the patient was vaccinated with both improperly stored vaccines (strength, dose and route of administration were not provided) for prophylaxis (product storage error). There was no previous temperature excursion. No additional adverse event (AE) reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  USA-009507513-2203USA003814: USA-009507513-2203USA003938: USA-009507513-2203USA003853: USA-009507513-2203USA003841: USA-009507513-2203USA003951: USA-009507513-2203USA003955:
Age: 1.25
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; A 15 month old infant was administered GARDASIL 9; This spontaneous report has been received from a nurse, concerning a 15-month-old patient of unknown gender. Information regarding the patient's concurrent conditions, medical history, and concomitant therapies was not reported.  On 10-MAR-2022 (reported as "today"), the patient was vaccinated by mistake with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #1775808, expiration date: 20-AUG-2023 (strength, and route of administration were not provided) as prophylaxis (Product administered to patient of inappropriate age). No additional adverse events were reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had no reported side effects; expired dose of ROTATEQ was administered; This spontaneous report was received from a nurse referring to a 6 month old patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 11-MAR-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), for prophylaxis, a dose of 2 milliliter, orally, lot # P028132, which expired on 22-FEB-2022 (expired product administered). The vaccine had had no known temperature excursions.  The patient had no reported side effects.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: varicella rash; This spontaneous report was received from a physician and refers to a 20-month-old female patient. The patient had no pertinent medical history, drug reactions or allergies and concomitant medications.  On approximately May 2021 (reported as about 8 months ago), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (exact dose, dose number, vaccination site, route of administration, lot # and expiration date were not provided).  On an unknown date, the patient developed a varicella rash. On 19-JAN-2022, the patient was seen in an emergency department (ED) for the rash. The action taken with suspect vaccine and outcome of the event were unknown.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further adverse events; administration of expired doses of MMR-II and VARIVAX to the same patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 15-MAR-2022, the patient was vaccinated with expired doses of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # T006346 with expiration date 20-FEB-2022; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA) 1 (units not provided), lot # T007235 with expiration date 27-FEB-2022; both for prophylaxis (strength, route of administration and anatomical location were not reported for the suspect vaccines). No further adverse events were reported.
Sex: U
Vaccine: HEP
Symptoms: COVID-19, Cerebral haemorrhage, Feeling abnormal, Hepatic encephalopathy, Incoherent
Clinical narrative: Unresponsive; Brain Bleed; Hepatic Encephalopathy; Tested Positive for Covid-19; Initial Report Received on 08-Mar-2022  A nurse reported that a 68 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history was reported as cirrhosis of liver, liver transplant (21 years ago), diabetes type II (no medication at this time), hypertension (no medication at this time). The patient had received two doses of Engerix in the past and was reported to be a non-responder. Allergy history included unknown reaction to lactose.  Medications at the time of vaccination were reported as Bumex (bumetanide), mycophenolate, tacrolimus, Viread (tenofovir disoproxil fumarate), and antiviral therapeutics.   On 08-Feb-2022, the patient received a dose of HEPLISAV-B (Lot # 935848, expiration date 22-Feb-2022 and NDC # 43528-003-05) through an unknown route and site.   On 10-Feb-2022, 3 days after having been vaccinated with HEPLISAV-B, the patient's wife found him unresponsive and called 911. The patient was then hospitalized for brain bleed and hepatic encephalopathy. The patient was ventilated at this time.   On 27-Feb-2022, the patient was to be discharged to a rehabilitation facility. However, he tested positive for COVID. The patient was reported to have brain fog and was not making sense. He walked out of the hospital against medical advice. On the same day, the patient's wife returned him to the hospital where he was readmitted to the COVID unit. The patient was reported to be mentally "not right", but with lactulose, he was fine most days.   No additional information was reported.   Company Comment: The company assessed the events of unresponsive to stimuli, cerebral haemorrhage and hepatic encephalopathy as serious and SARS-CoV-2 test positive as non-serious. The events are considered unrelated to HEPLISAV-B. Risk factors include hypertension, diabetes and liver cirrhosis. The events are unlisted per HEPLISAV-B IB, USPI and SmPC.; Sender's Comments: The company assessed the events of unresponsive to stimuli, cerebral haemorrhage and hepatic encephalopathy as serious and SARS-CoV-2 test positive as non-serious. The events are considered unrelated to HEPLISAV-B. Risk factors include hypertension, diabetes and liver cirrhosis. The events are unlisted per HEPLISAV-B IB, USPI and SmPC.
Sex: U
Vaccine: HEP
Symptoms: Mechanical ventilation, Mental disorder, SARS-CoV-2 test positive, Treatment noncompliance, Unresponsive to stimuli
Clinical narrative: Unresponsive; Brain Bleed; Hepatic Encephalopathy; Tested Positive for Covid-19; Initial Report Received on 08-Mar-2022  A nurse reported that a 68 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history was reported as cirrhosis of liver, liver transplant (21 years ago), diabetes type II (no medication at this time), hypertension (no medication at this time). The patient had received two doses of Engerix in the past and was reported to be a non-responder. Allergy history included unknown reaction to lactose.  Medications at the time of vaccination were reported as Bumex (bumetanide), mycophenolate, tacrolimus, Viread (tenofovir disoproxil fumarate), and antiviral therapeutics.   On 08-Feb-2022, the patient received a dose of HEPLISAV-B (Lot # 935848, expiration date 22-Feb-2022 and NDC # 43528-003-05) through an unknown route and site.   On 10-Feb-2022, 3 days after having been vaccinated with HEPLISAV-B, the patient's wife found him unresponsive and called 911. The patient was then hospitalized for brain bleed and hepatic encephalopathy. The patient was ventilated at this time.   On 27-Feb-2022, the patient was to be discharged to a rehabilitation facility. However, he tested positive for COVID. The patient was reported to have brain fog and was not making sense. He walked out of the hospital against medical advice. On the same day, the patient's wife returned him to the hospital where he was readmitted to the COVID unit. The patient was reported to be mentally "not right", but with lactulose, he was fine most days.   No additional information was reported.   Company Comment: The company assessed the events of unresponsive to stimuli, cerebral haemorrhage and hepatic encephalopathy as serious and SARS-CoV-2 test positive as non-serious. The events are considered unrelated to HEPLISAV-B. Risk factors include hypertension, diabetes and liver cirrhosis. The events are unlisted per HEPLISAV-B IB, USPI and SmPC.; Sender's Comments: The company assessed the events of unresponsive to stimuli, cerebral haemorrhage and hepatic encephalopathy as serious and SARS-CoV-2 test positive as non-serious. The events are considered unrelated to HEPLISAV-B. Risk factors include hypertension, diabetes and liver cirrhosis. The events are unlisted per HEPLISAV-B IB, USPI and SmPC.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: What if I missed the 6 months for second dose?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter asked what if the patient missed the 6 months for Shingrix. Ii was unknown if the patient received 2nd dose till the time of reporting, which led to incomplete course of vaccination. The follow up would not possible since the no contact details were provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inability to afford medication, Vaccination failure
Clinical narrative: I got the 2 shots but I still have flare ups/Suspected vaccination failure; I still have flare ups; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 (got shingles in forehead, scalp, nose, all on the left side). Concurrent medical conditions included ophthalmic herpes zoster, scar (lots of scar tissue in left eye, flare ups) and post herpetic neuralgia (aggravates the nerves that were damaged).   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 patient self-reported this case.                                        The age at vaccination was not reported. The patient  tried numerous times to get a shingles shot years ago from the date of reporting but even though he/she had insurance it was costing him/her 375.00 of his/her portion, needless to say, patient could not afford that amount. The patient would stop by the pharmacy now and then because was afraid to had get shingles and his/her portion way too high for a long time. Unfortunately, patient got shingles in eye, forehead, scalp and nose, all on the left side and at the time of reporting the patient was living with all the damage to his/her eye and nerves that it did, had lots of scar tissue in his/her left eye and flared ups. The patient had to pull his/her hair off face because it aggravated the nerves that were damaged. The patient had been on an anti-viral pill since he/she got it several years ago and the physician thought that patient might be on them the rest of life. The vaccine came available at prices that were miniscule and patient got the 2 Shingles shots so he/she could not get shingles again but still had flare ups. The patient advised to get the shots and stated that the damage shingles could do was not pleasant. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Had us down; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The shot had put down the patient for 12 hours.  The patient was fine now. The follow up would not possible as no contact details were available. The case had been linked to US2022AMR046615, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046615:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccination, 6 months later got shingles/Suspected vaccination failure; Got shingles, was brutal; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving 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.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the vaccination and 6 months later got shingles.  It was brutal. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness unilateral, Labyrinthitis, Varicella
Clinical narrative: Lost hearing in one ear due to labyrinthitis.; Labyrinthitis; Virus probably chickenpox/infection; This case was reported by a consumer via interactive digital media and described the occurrence of hearing loss unilateral in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hearing loss unilateral (serious criteria GSK medically significant), labyrinthitis and chickenpox. On an unknown date, the outcome of the hearing loss unilateral, labyrinthitis and chickenpox were unknown.   It was unknown if the reporter considered the hearing loss unilateral, labyrinthitis and chickenpox to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the Shingrix vaccination and 6 months later had the chickenpox infection. The patient stated that he/she did not have shingles rash, but lost hearing in one ear due to labyrinthitis caused by a virus probably chickenpox virus harbored in his/her body. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm hurt for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that his/her arm hurt for a few days. No other side effects. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles 2 months after my second shingles shot/Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine and unknown after receiving 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 case was reported by the patient. The age at vaccination was not reported. The patient got shingles 2 months after second shingles shot. The vaccination didn't work for the patient. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Tinnitus
Clinical narrative: Left ear has rung, ear ringing; felt much worse after Shingles shot vs the Covid shots; This case was reported by a consumer via interactive digital media and described the occurrence of ringing in ears in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of feeling abnormal (got all 3 Covid vaccines and felt much worse after the Shingles shot versus the Covid shots.).   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 ringing in ears and feeling bad. On an unknown date, the outcome of the ringing in ears was not recovered/not resolved and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the ringing in ears and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case.                                        The age at vaccination was not reported. The patient got all 3 Covid vaccines and went for first Shingles shot and ever since then his/her left ear had rung. The patient questioned to get the second shot, as he/she did not wanted both ears ringing.  The patient felt much worse after the Shingles shot versus the Covid shots.  The patient enquired if anyone else had their ears ringing as a side effect and it was not fun. The follow-up would not possible as no contact details were available
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Malaise
Clinical narrative: Injection site was hard; redness at the injection site; pain at injection site; Headache; Malaise; This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site induration, injection site redness, injection site pain, headache and malaise. On an unknown date, the outcome of the injection site induration, injection site redness, injection site pain, headache and malaise were recovered/resolved.   It was unknown if the reporter considered the injection site induration, injection site redness, injection site pain, headache and malaise to be related to Shingrix.     Linked case(s) involving the same patient:  US2022046162  Additional details were provided as follows: The patient self-reported this case. The patient received 1st dose of Shingrix vaccine and she noticed the injection site was hard, redness at the injection site, pain at injection site, headache and malaise. The patient was referred to HCP (health care professional) and provided medical advice disclaimer. Offered PI (package insert). The reporter consented to follow-up and permission to contact health care professional. This case was linked to US2022046162 for same patient second dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022046162:Same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt all over; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a 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 general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and it hurt him/her all over for about 12 hours. Well worth not getting Shingles. The follow-up would not possible as no contact details were available. For tolerance to the 2nd dose of Shingles vaccine, refer case US2022AMR046835.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046835:Same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Somnolence
Clinical narrative: sore at injection site; sleepy; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, refer case US2022AMR046830).   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 injection site pain and sleepiness. On an unknown date, the outcome of the injection site pain and sleepiness were unknown.   It was unknown if the reporter considered the injection site pain and sleepiness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR046830  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine and experienced sore at injection site and felt sleepy. The patient stated it was well worth not getting shingles. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR046830:Same patient, different dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had the first shingles vaccination, still got the disease; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details reported were as follows: The age at vaccination was not reported. The patient received 1st Shingles vaccine and still got shingles. The patient advised others to take vaccination if not received yet. Follow up would not be possible no contact details provided.