chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Insomnia, Malaise, Nausea
Clinical narrative: nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report from a non-contactable female consumer reported for herself (Non pregnant). A 46-year-old female patient received second dose BNT162B2 (Solution for injection, lot number was EL3246) via left arm on 24Feb2021, 10:30 AM, single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose BNT162B2 (lot number:EL3247) left arm on 03Feb2021, 10:30 AM at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. After second dose vaccination patient experienced headache, nausea, malaise, cold sweats, restlessness, unable to sleep on 24Feb2021 at 08:15 PM. The patient taking treatment 600mg ADVIL taken for all events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: nausea; Headache; malaise; Cold sweats; restlessness; unable to sleep; This is a spontaneous report from a non-contactable female consumer reported for herself (Non pregnant). A 46-year-old female patient received second dose BNT162B2 (Solution for injection, lot number was EL3246) via left arm on 24Feb2021, 10:30 AM, single dose for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose BNT162B2 (lot number:EL3247) left arm on 03Feb2021, 10:30 AM at single Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. After second dose vaccination patient experienced headache, nausea, malaise, cold sweats, restlessness, unable to sleep on 24Feb2021 at 08:15 PM. The patient taking treatment 600mg ADVIL taken for all events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain for 1 day; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the first of two reports. A 52-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation. Medical history included high blood pressure.  The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10).  The patient experienced injection site pain for 1 day (non-serious) on Feb2021. No treatment was received for the event. The outcome of the event was resolved.    No follow-up attempts are possible. No further information is expected
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Memory impairment, Panic disorder
Clinical narrative: disoriented- forgot; She was panicked; disoriented- forgot; This is a spontaneous report from a contactable consumer reported for herself.   A 77-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on 24Feb2021 11:00 AM (at the age of 77-years-old) for COVID-19 immunization. The patient was not pregnant. The patient had not medical history. the patient's concomitant medications were none. The patient waited the 17 minutes when they said to wait and then she felt to be okay at that point.  About a half hour after having gotten the vaccine, person got into her car. She went to drive home and became completely disoriented, forgot her name and where she lived. She drove to her old address. Friend called her at around 12:30 to check in on her. She was panicked, she was still disoriented, did remember her name, but had difficulty with her address and thought she had a stroke.  A friend made her pull over and asked her to call 911, but she wanted to go home. She was much better when she calmed down and the and determining that a stroke likely wasn't the case. The patient did not receive any treatment. No covid prior vaccination. Her second dose was scheduled for 18Mar2021. The outcome of the events was unknown.   Information about batch number was not available and is going to be requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Heart rate
Clinical narrative: severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat; headache; pain in the injection site; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 26Feb2021 09:30 at a single dose for COVID-19 immunisation. Medical history included allergies: dairy. Concomitant medications included ergocalciferol, retinol palmitate (VITAMINS A & D), apple cider vinegar (APPLE CIDER VINEGAR), cranberry, and allium sativum (GARLIC (DEODORIZED). Patient is not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 14:30, on the first day, patient experienced moderate headache and pain in the injection site. On 28Feb2021, the second day, patient experienced severe headache, severe body aches, slight fever, chills, severe diarrhea, dizziness almost fainted, fast heart beat. Patient is recovering from the events. No treatment was received.  Information on about lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pain, Pyrexia, Vaccination site pain
Clinical narrative: severe body aches; slight fever; chills; severe diarrhea; dizziness almost fainted; fast heart beat; headache; pain in the injection site; This is a spontaneous report from a contactable consumer (patient). This 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 26Feb2021 09:30 at a single dose for COVID-19 immunisation. Medical history included allergies: dairy. Concomitant medications included ergocalciferol, retinol palmitate (VITAMINS A & D), apple cider vinegar (APPLE CIDER VINEGAR), cranberry, and allium sativum (GARLIC (DEODORIZED). Patient is not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Feb2021 14:30, on the first day, patient experienced moderate headache and pain in the injection site. On 28Feb2021, the second day, patient experienced severe headache, severe body aches, slight fever, chills, severe diarrhea, dizziness almost fainted, fast heart beat. Patient is recovering from the events. No treatment was received.  Information on about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: didn't develop any antibodies; This is a spontaneous report from a contactable nurse, the patient. This patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2, single dose via an unknown route of administration on 07Jan2021 for COVID-19 vaccination. Medical history was unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1, single dose on an unknown date. Concomitant medications were unknown. The patient took both vaccines, last vaccine was administered on 07Jan2021 and had a significant immune response. The patient donated blood on the 24Feb2021 due to shortage in the community and just found out that "I didn't develop any antibodies." The patient was worried that the vaccine didn't work. The clinical outcome of  the event, didn't develop any antibodies was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Lymphadenopathy, Vaccination site pain
Clinical narrative: Feel an armpit swollen lymph lump; Body warmer than usual; Injection site pain; This is a spontaneous report from a non-contactable consumer reporting for herself. This is the second of two reports. A 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot En6201, via an unspecified route of administration in left arm on 23Feb2021 13:40 (at the age of 52 years) at single dose for covid-19 immunisation. The patient previously received the first dose of bnt162b2, Lot En9264, via an unspecified route of administration in left arm on 02Feb2021 13:30 (at the age of 52 years) at single dose for covid-19 immunisation and experienced injection site pain for 1 day. Medical history included high blood pressure.  The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Allergies to medications, food, or other products were none. Concomitant medication included losartan, vitamin d3, ubidecarenone (Q10).  The patient experienced injection site pain on 23Feb2021, body warmer than usual on 24Feb2021, feel an armpit swollen lymph lump on 25Feb2021. Laboratory data included body temperature 37.3C on 24Feb2021, and normal on 25Feb2021. No treatment was received for the events. The events were non serious with outcome unknown.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fatigue, Insomnia
Clinical narrative: night before (second dose) she was in atrial fibrillation; was tired but she didn't sleep the night before second dose/exhausted; was tired but she didn't sleep the night before second dose/exhausted; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), intramuscularly, administered in left arm on 29Jan2021 as single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation (has a pre existing atrial fibrillation), patient also has under active thyroid from unspecified date. The patient's concomitant medications included magnesium taken daily from an unspecified date and for unknown indication, an unspecified medication for atrial fibrillation and an unspecified low dose medicine for cholesterol. The patient previously received the second dose of unspecified shingles vaccine on an unspecified date for immunization and felt sore arm maybe a little under the weather. On 22Feb2021, the night before the second dose of vaccine, patient reported she was in atrial fibrillation, she was tired but she didn't sleep the night before second dose because she was in atrial fibrillation and was exhausted. She took extra of her atrial fibrillation medications. She does not think she took Tylenol after first one. Does not think arm was sore after the first one. The patient was vaccinated at a mass vaccination site. The events did not require emergency room or physician's office visit. The outcome of the events was unknown.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lethargy, Seizure
Clinical narrative: seizure like symptoms; Dizziness; lethargy; fatigue; This is a spontaneous report from a contactable pharmacist.  A 16-year-old male patient received first dose of intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 at 12:00 at single dose in left arm for COVID-19 immunisation at the age of 16-year-old. Lot number was EN6205. Medical history and concomitant medications were unknown. On 02Mar2021 at 12:00, the patient experienced Dizziness, seizure like symptoms, lethargy, fatigue. It was unknown if the patient was treated due to the events. The patient recovered from the events in Mar2021. It was unknown if the patient had COVID prior vaccination; it was unknown if the patient was tested for COVID post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Seizure cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pneumonia
Clinical narrative: pneumonia; Arm soreness; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (27Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (daughter) via a Pfizer Sponsored Program. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection) via an unspecified route of administration on 30Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates in Jan2021 the patient experienced pneumonia and arm soreness. It was reported that the patient had been diagnosed with pneumonia and had arm soreness after the first dose on 30Jan2021. The second dose was scheduled for today, 27Feb2021. The clinical outcomes of the events pneumonia and arm soreness were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: recently diagnosed with covid 19 despite completing the series; recently diagnosed with covid 19 despite completing the series; This is a spontaneous report received from Pfizer sponsored program via a contactable consumer.   A female patient of an unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was recently diagnosed with covid 19 despite completing the series on an unspecified date with outcome of unknown, there was no treatment received.  Information related to batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Myalgia, Vaccination site pain
Clinical narrative: Experiencing injection site (left deltoid) soreness; Muscle soreness with movement; Overal minor discomfort; This is a spontaneous report from a contactable consumer (the patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not reported) via an unspecified route of administration in left deltoid on 03Feb2021 at single dose for COVID-19 immunization. No relevant medical history. The patient's concomitant medications were not reported. The patient experienced injection site (left deltoid) soreness, muscle soreness with movement, and overall minor discomfort in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: pain on the injection site, joint, knee and ankle; pain on the injection site, joint, knee and ankle; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 06Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After taking the 1st dose in Mar2021, patient experienced pain on the injection site, joint, knee and ankle. Outcome of the events was unknown. Patient was also asking if she can take ibuprofen.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This is a spontaneous report received from Sponsored Program, via a contactable male consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date unknown) via an unspecified route of administration on 20Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID-19 last 27Feb2021. He was asking if it's okay for him to get the second vaccine on 13Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: Felt very sick; chills; This is a spontaneous report received from a Sponsored Program a contactable female consumer (patient self). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: unknown), via an unspecified route of administration on 02Mar2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced chills and felt very sick on the 3rd or 4th day after the second dose of BNT162B2. It was unknown if the patient received treatment. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered
Clinical narrative: 8 week old child received the Pentacle vaccine (both parts mixed correctly together) and then also was given another ActHIB dose separately. So, ended up with Hib from Pentacel and separately, no ae; Initial information regarding an unsolicited valid non-serious case from a other health professional via Medical Information (MI) (Reference number- 00496085) and transmitted to Sanofi on 26-Feb-2021.  This case involves a 8 weeks old female patient who was vaccinated with 0.5 ml first dose of HIB (PRP/T) VACCINE [ACT-HIB], powder and solvent for solution for injection (lot UJ354AB and expiration date : 08-JUL-2021) via intramuscular route in the left leg and a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], suspension for injection (batch number and expiration date were not reported) via unknown route in unknown administration site for prophylactic vaccination on an unknown date and reported that the patient received the pentacle vaccine (both parts mixed correctly together) and then also was given another acthib dose separately. So, ended up with hib from pentacel and separately (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.  It was a case of actual medication error due to extra dose administered (same day latency).  Also reported that after getting 2 does of ACTHIB at once and they would to know if there are any safety concerns. Caller asked what to look out for in specific if a patient got 2 doses of ActHIb on the same day? Offered to escalate, caller declined.  It was not reported whether the patient had any 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.  There will be no information available on batch number (PENTACEL) for this case.
Sex: M
Vaccine: FLUR4
Symptoms: Asthma, Condition aggravated, Laryngeal oedema
Clinical narrative: patient had laryngeal edema; Initial information received on 02-Mar-2021 regarding an unsolicited valid serious case from a physician.  This case involves male patient of unknown age who had laryngeal edema (laryngeal oedema), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  At the time of the event, the patient had ongoing Asthma.  The patient's past medical history included food allergy as reported that patient had allergy to shellfish.  The patient's past vaccination(s) included FLUZONE QUADRIVALENT with no reported adverse reactions.  The patient past medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date (two seasons ago), the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious laryngeal edema (laryngeal oedema) 20-30 minutes following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  No laboratory data reported.  The patient treatment included self-treatment of 20mg of LORATADINE (CLARITINE) (CLARITHROMYCIN) and a rescue inhaler.  The patient recovered from  the event laryngeal oedema.  Information regarding the batch number of the suspect need to be requested.; Sender's Comments: This case concerns a male patient of unknown age who presented with laryngeal oedema after vaccination with FLUBLOK QIV. The time to onset is compatible. The patient medical history included asthma, food allergy, past vaccination included FLUZONE QUADRIVALENT and treatment included CLARITINE and a rescue inhaler. There is, however, no information regarding concomitant medication, past medical treatment and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: she gave quadracel to an 8 year old by mistake, and not the prescribed TDap and Polio vaccinations with no reported adverse event; Initial information regarding this unsolicited valid non-serious case.  This case involves a 8 years old male patient who experienced she gave DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (batch number: C5763AA and expiration date: 26-Aug-2022) at a dose of 0.5 ml via intramuscular route in the left arm to the patient by mistake, and not the prescribed tdap and polio vaccinations (wrong product administered) for prophylactic vaccination.  Medical history, past medical treatments, vaccinations, concomitant medication and family history were not provided.  It was an actual medication error due to wrong drug administered (latency: same day).  At the time of reporting, the patient had no adverse event.  Disclaimer: 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, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion; This spontaneous report was received from a nurse (also reported as medical assistant) and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 21-JAN-2021, the patient was vaccinated with improperly stored doses of measles (+) mumps, (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 dose, for prophylaxis, lot # S015962, expiry date 23-MAY-2021; and varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, for prophylaxis, lot # S02560, expiry date 18-AUG-2021 (formulation, concentration, dose number, route of administration, frequency for both vaccines were not reported). Digital data logger was not involved. According to the reporter, the temperature excursion was 16.7 degrees of Fahrenheit (F) for a time frame of 1 hour on 09-NOV-2020 (reported as 09-NOV-2021), with a previous temperature excursion 11.8 degrees of Fahrenheit for a time frame of 1 hour on 06-NOV-2020 (reported as 06-NOV-2021). No additional adverse event was reported. No product quality complaint (PQC) was involved.  This is one of the reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA000100:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE information; Vaccine was going through temperature excursion/was administered to patients; Information has been received from a Nurse concerning to a patient (age and gender not reported). No medical history, concurrent condition nor concomitant medications were reported.  The nurse informed that since 01-NOV-2020 doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No.  S027465, exp. date 02-MAR-2021) went through temperature excursions and was administered to patients.  On 04-DEC-2020, the patient was vaccinated with a temperature excursion dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (product storage error). No adverse event was experienced.   Call because of data logger: Yes   Temperature excursion: -14°C for 0.25 hours
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; temperature excursions/ it was administered to patients; This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided.   On 10-FEB-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # S027465, expiration date was reported and also established as 02-MAR-2021 (strength, route of administration and anatomical location were not provided) for prophylaxis (improper storage of product in use). The nurse was unaware, that the vaccine before administration to the patient, was going through temperature excursions on an unspecified dates since 01-NOV-2020 through the end of an unknown date in February 2021, which was detected by the digital data logger. The data logger log list was provided. It was unable to assess the exact dates of excursion for the administered vaccine. The reporter was concerned about repeating the vaccination due to excursions. No additional adverse event (AE) information was reported (no adverse event).  This is one of several linked reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA000947: US-009507513-2103USA001002: US-009507513-2103USA000942:
Age: 0.08
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No other AE reported; the infant was inadvertently administered GARDASIL 9; This spontaneous report has been received from a physician referring to a 1 month old patient. The patient's medical history, concurrent condition and concomitant medication were not provided.      On 08-MAR-2021, the patient was inadvertently administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot number and expiration date were unknown) for prophylaxis (inappropriate age at vaccine administration). No other adverse event (AE) was reported. The reporter inquired if there was anything for the parents to be concerned about.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, previous drug reaction or allergy and concomitant medication was not reported.  On 09-FEB-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (1 dosage form, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot # T020652, expiration date 26-JUN-2022) for prophylaxis. The vaccine administered experienced temperature excursions of -13.9 degrees Celsius for 45 hours recorded by data logger. There was no previous temperature excursion. No additional adverse effect reported.
Age: 0.17
Sex: U
Vaccine: HEP, HEPA
Symptoms: Wrong product administered
Clinical narrative: She states that there were no witnessed adverse reactions; received a dose of VAQT A instead of the intended RECOMBIVAX HB; Patient was inadvertently administered VAQTA outside of the recommended age range.; This spontaneous report was received from a nurse and refers to a 2-month-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history proviided.  On 09-MAR-2021, the patient accidently received a dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot number: S037576, expiration date: 10-APR-2021 for prophylaxis (route of administration was not provided) instead of the intended hepatitis b vaccine (recombinant)(RECOMBIVAX HB) outside of the recommended age range. There were no witnessed adverse reactions. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S037576; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Emotional distress, Ophthalmic herpes zoster, Surgery
Clinical narrative: zoster-related eye conditions requiring surgery, severe emotional distress, and other zoster-related conditions; zoster-related eye conditions requiring surgery, severe emotional distress, and other zoster-related conditions; zoster-related eye conditions requiring surgery, severe emotional distress, and other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. Information regarding the pt's concurrent conditions, medical history and concomitant medications was not provided.     On or about 17-SEP-2007, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.         On an unknown date, subsequently to  zoster vaccine live(ZOSTAVAX) administration, the pt experienced zoster-related eye conditions requiring surgery, severe emotional distress, and other zoster-related conditions treated with different healthcare providers. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continued suffering  ongoing injuries, including but not limited to: mental, physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continued to suffer such losses, and damages in the future.  By the reporting time, the pt had not recovered form the events. The reporter considered the events to be related to zoster vaccine live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: she got the shingles; This spontaneous report was received from a currently 79 years old female patient referring to herself. The patient's concurrent conditions, concomitant medications and historical drugs were not reported.  On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, strength, route, lot# and expiration date were not reported) for prophylaxis.         On an unknown date, the patient stated she got the shingles.  The outcome of the shingles was unknown. The causality between the shingles and zoster vaccine live (manufacturer unknown) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: No further AE; an expired dose of VARIVAX was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 09-MAR-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 injection, lot# S002738 with expiration date 28-JAN-2021; strength and route of administration were not reported) for prophylaxis (expired product administered). The vaccine had no temperature excursion. Dose was supported in potency for 6 months post-expiry per memo. No further adverse event (AE), No product quality complaint (PQC) was involved in this case.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: she received two doses of GARDASIL 9, but never received her third dose; no additional AE reported; This spontaneous report was received from a consumer, a female patient of unknown age reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date (reported as approximately three years ago), the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis, but she never revived the third dose (Inappropriate schedule of vaccine administered). The patient was inquiring on the dosing schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). She preferred to contact her physician regarding this information and disconnected the call before additional information could be collected regarding this adverse event. No aditional adverse event was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: temperature excursion for PROQUAD / temperature - 10C / the vaccines were administered to patients; This spontaneous report was received from an office manager and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 16-FEB-2021, a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) 0.5 mL, lot # T027111, expiration date 07-FEB-2022 was stored improperly in a temperature of -10 degrees Celsius (C) for 1 hour 15 minutes. On 22-FEB-2021, the vaccine was administered to the patient for prophylaxis (route of administration was not reported). There was no previous temperature excursion reported. Digital data logger was not involved.  The reporter stated that their facility reported the excursion to reporting system, but was unaware they needed to report it to the Company.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Malaise, Pain in extremity, Pyrexia, Tremor
Clinical narrative: feels like when your body is telling you that you are not 100%; Anxious; Fever / Low grade fever; Shakes / shaking; Arm hurting; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hysterectomy. Previously administered products included Shingrix (1st dose received on an unknown date refer case US2021AMR011493). Concurrent medical conditions included cholesterol, vaginal dryness and thyroid activity decreased. Concomitant products included atorvastatin calcium (Lipitor) and levothyroxine sodium (Synthroid).   On 12th January 2021, the patient received the 2nd dose of Shingrix. On 12th January 2021, less than a day after receiving Shingrix, the patient experienced fever, tremor, pain in arm and anxiety. On an unknown date, the patient experienced feeling unwell. The patient was treated with ibuprofen (Advil). On 12th January 2021, the outcome of the tremor and anxiety were recovered/resolved. On 13th January 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the fever, tremor, pain in arm, feeling unwell and anxiety to be related to Shingrix.  Additional details were provided as follows: The patient received dose shingrix  experienced fever, tremor, pain in arm, feeling unwell and anxiety. The patient had mesh implants. The information regarding consent to follow up was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Had a sore arm with the second Shingles shot; This case was reported by a consumer and described the occurrence of pain in arm in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cryoablation (8 years ago). Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included atrial fibrillation (taking medication for it) and blood pressure. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season), vitamin d, metoprolol succinate (Metoprolol Succinate Er), quinapril, dabigatran etexilate mesilate (Pradaxa), hydrochlorothiazide, zinc and krill oil.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 65 or 66 year old. The patient takes the sleep thing at night, which was natural and over the counter but no product name provided. The patient take medication for blood thinner, Pradaxa (150mg) twice a day, for Blood pressure, Quinapril (40mg), Hydrochlorothiazide (25mg), Metoprolol ER succinate (25mg) and multivitamins for an unknown product indication. The patient family history includes father died of Lymphedema and his mother died at 96 years old. The patient has a sore arm with the 2nd dose Shingrix shot was 1 year prior to the date of reporting. The patient had Flu shot 2 months prior to the date of reporting. No further details provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: little soreness in my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostrix (received several years ago).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination of patient was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient had received both the doses of shingrix and experience pain in arm. The patient stated, the pain was not even enough to take ibuprofen.
Sex: F
Vaccine: VARZOS
Symptoms: Drug ineffective, Herpes simplex
Clinical narrative: After receiving / vaccine / I suffer from systematic outbreaks monthly; Acyclovir for prevention is no longer working; This case was reported by a consumer and described the occurrence of herpes simplex reactivation in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included acyclovir unknown for herpes simplex.   Previously administered products included Shingrix (1st dose received in June 2019). Concurrent medical conditions included herpes simplex (was managing it since from past 30 years).   In September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started acyclovir 400 mg once daily (400 mg daily). On an unknown date, less than a month after receiving Shingrix and not applicable after starting acyclovir, the patient experienced herpes simplex reactivation and lack of drug effect. Acyclovir was continued with no change. On an unknown date, the outcome of the herpes simplex reactivation and lack of drug effect were unknown.   It was unknown if the reporter considered the herpes simplex reactivation to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient stated, she had been taking Acyclovir (400 mg daily) for suppression or prevention of Herpes simplex for 30 years and was able to manage outbreaks to a minimum. However, after the final vaccination, she was suffering from systemic outbreaks of HSV monthly and acyclovir was no longer working. She needed to increase dosage of acyclovir. The patient asked if, the GlaxoSmithKline have any similar findings on similar situation and asked recommendations.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058851:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pain in extremity, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles sores; arm hurts ever since; rid of the pain; rid of the pain & blisters; This case was reported by a other health professional and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain in arm, pain and blister. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain in arm, pain and blister were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain in arm, pain and blister to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured as adult as per vaccine indication. The patient received a shingles vaccine in 2019. The patient's arm hurts ever since, not to mention the shingles sores were still with the patient. The patient asked what could be done to get rid of the pain and blisters. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The information regarding consent to follow up was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever, chills and general body pain. On an unknown date, the outcome of the fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. Post vaccination the patient had a week of fever, chills and body aches. The patient's provider said that because of the events, the patient might not want to get the second shot and asked about GlaxoSmithKline's advice.