chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Body height, COVID-19, SARS-CoV-2 test, Vaccination failure, Weight
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Lot number: FF8841, Expiration Date: Dec2021) at the age of 65 years as dose 3 (booster), single, administration date 03Mar2021 (Lot number: EN6203) as dose 2, single and administration date 10Feb2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 06Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "hypothyroid", start date: 2015 (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hypothyroidism. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Adds she had the booster in October and then had omicron in December". The event "adds she had the booster in October and then had omicron in December" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body height: (unspecified date) 156, notes: (cm); (unspecified date) 5'1.5"; sars-cov-2 test: (03Jan2022) positive, notes: (omicron). Covid test was done in Dec2021, then resulted on 03Jan2022; weight: (unspecified date) 47.63 kg; weight: (unspecified date) 105 lbs. Therapeutic measures were taken as a result of Covid-19. Clinical course: She had the booster in Oct and then had omicron in Dec, she did not get the results because of the holiday was impossible to get a hold of them. Clarifies that the Covid test was done in Dec2021, then resulted on 03Jan2022. Facility where the most recent COVID-19 vaccine was administered was Withheld facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Military facility: There were soldiers there when she got the vaccine. it was a vaccination site. Emergency Room not required. Product complaint to report was Yes. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200474011 same reporter, drug, different event.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonitis aspiration
Clinical narrative: Pt hospitalized see VAERS e-report # 822130  Patient with out of hospital arrest. diffuse bilateral infiltrates in the lungs COVID 19 positive
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Lung infiltration, SARS-CoV-2 test positive
Clinical narrative: Pt hospitalized see VAERS e-report # 822130  Patient with out of hospital arrest. diffuse bilateral infiltrates in the lungs COVID 19 positive
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: the vials expired on 17Mar2022 for the 10 weeks in refrigerator storage; the vials expired on 17Mar2022 for the 10 weeks in refrigerator storage; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 26 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Mar2022 (Lot number: FK9729, Expiration Date: 31May2022) at the age of 26 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose Pfizer covid vaccine: 21Aug2021, Lot/Exp/NDC: unknown), administration date: 21Aug2021, when the patient was 25 years old, for Covid-19 immunization; Bnt162b2 (Second dose Pfizer covid vaccine: 13Sep2021, Lot/Exp/NDC: unknown), administration date: 13Sep2021, when the patient was 25 years old, for Covid-19 immunization. The following information was reported: PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 24Mar2022, outcome "unknown" and all described as "the vials expired on 17Mar2022 for the 10 weeks in refrigerator storage". No follow-up attempts are possible. No further information is expected.  Additional Information:  The pharmacist reported that she was told by the health department that the vials expired on 17Mar2022 for the 10 weeks in refrigerator storage. She reported that there were 2 patients who received the vaccine on 19Mar2022. She wanted a confirmation on the 2 days extension and patient recommendation for the male patient.  Follow-up (30Mar2022): This is a follow up spontaneous report from a contactable Pharmacist. This Pharmacist reported for a patient that: Update Information Included: Patient Full Name, Historical Vaccine, Dosage regimen.  She reported that she was not the one that administered it, the pharmacist that was working at the time was confused as to when it was received and when it was expired. The health department told her that they heard of another pharmacy and if it was administered up to two days past the expiration date that is is ok. She reported that the patients that received the vaccine on 19Mar2022 were ok. But she thought there may be an issue with the patient that was administered his third dose of the vaccine on 24Mar 022. She was told it would be ok so she prefered to file a report for the one patient administered the vaccine on 24Mar2022. She needed to file a VAERS report. Informed her that we are separate from VAERS. Seriousness: Unknown since she knows Pfizer has extended their expiration date on so many things, multiple times.   Follow-up (01Apr2022): Follow-up attempts are completed. No further information is expected
Age: 26.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: the vials expired on 17Mar2022 for the 10 weeks in refrigerator storage; the vials expired on 17Mar2022 for the 10 weeks in refrigerator storage; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 26 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Mar2022 (Lot number: FK9729, Expiration Date: 31May2022) at the age of 26 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose Pfizer covid vaccine: 21Aug2021, Lot/Exp/NDC: unknown), administration date: 21Aug2021, when the patient was 25 years old, for Covid-19 immunization; Bnt162b2 (Second dose Pfizer covid vaccine: 13Sep2021, Lot/Exp/NDC: unknown), administration date: 13Sep2021, when the patient was 25 years old, for Covid-19 immunization. The following information was reported: PRODUCT STORAGE ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 24Mar2022, outcome "unknown" and all described as "the vials expired on 17Mar2022 for the 10 weeks in refrigerator storage". No follow-up attempts are possible. No further information is expected.  Additional Information:  The pharmacist reported that she was told by the health department that the vials expired on 17Mar2022 for the 10 weeks in refrigerator storage. She reported that there were 2 patients who received the vaccine on 19Mar2022. She wanted a confirmation on the 2 days extension and patient recommendation for the male patient.  Follow-up (30Mar2022): This is a follow up spontaneous report from a contactable Pharmacist. This Pharmacist reported for a patient that: Update Information Included: Patient Full Name, Historical Vaccine, Dosage regimen.  She reported that she was not the one that administered it, the pharmacist that was working at the time was confused as to when it was received and when it was expired. The health department told her that they heard of another pharmacy and if it was administered up to two days past the expiration date that is is ok. She reported that the patients that received the vaccine on 19Mar2022 were ok. But she thought there may be an issue with the patient that was administered his third dose of the vaccine on 24Mar 022. She was told it would be ok so she prefered to file a report for the one patient administered the vaccine on 24Mar2022. She needed to file a VAERS report. Informed her that we are separate from VAERS. Seriousness: Unknown since she knows Pfizer has extended their expiration date on so many things, multiple times.   Follow-up (01Apr2022): Follow-up attempts are completed. No further information is expected
Age: 0.17
Sex: F
Vaccine: RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired dose of RotaTeq. Vaccine expired on 03/24/22, given on 03/28/22. It was inside a non expired RotaTeq box. Patient did not experience any side effects.  Incident reported to Merck.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: 10 days after first shot, in the middle of night, the headache came back on the same location but severe headache this time; she had a mild headache on the left side of neck, ear area and the head for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (she had a mild headache on the left side of neck, ear area and the head for 2 days) and HEADACHE (10 days after first shot, in the middle of night, the headache came back on the same location but severe headache this time) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Patient reported seasonal migraine on & off & triggered by Florescent light and changes in weather. She stated that she does not take maintenance Migraine medication and she does not have Migraine disease).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (she had a mild headache on the left side of neck, ear area and the head for 2 days). On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (10 days after first shot, in the middle of night, the headache came back on the same location but severe headache this time). On 26-Mar-2021, HEADACHE (she had a mild headache on the left side of neck, ear area and the head for 2 days) had resolved. On 05-Apr-2021, HEADACHE (10 days after first shot, in the middle of night, the headache came back on the same location but severe headache this time) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Patient reported that she did not took medications, it went away by itself.   This case was linked to MOD-2022-530741, MOD-2022-530742 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: 10 days after first shot, in the middle of night, the headache came back on the same location but severe headache this time; she had a mild headache on the left side of neck, ear area and the head for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (she had a mild headache on the left side of neck, ear area and the head for 2 days) and HEADACHE (10 days after first shot, in the middle of night, the headache came back on the same location but severe headache this time) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Migraine (Patient reported seasonal migraine on & off & triggered by Florescent light and changes in weather. She stated that she does not take maintenance Migraine medication and she does not have Migraine disease).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (she had a mild headache on the left side of neck, ear area and the head for 2 days). On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (10 days after first shot, in the middle of night, the headache came back on the same location but severe headache this time). On 26-Mar-2021, HEADACHE (she had a mild headache on the left side of neck, ear area and the head for 2 days) had resolved. On 05-Apr-2021, HEADACHE (10 days after first shot, in the middle of night, the headache came back on the same location but severe headache this time) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. Patient reported that she did not took medications, it went away by itself.   This case was linked to MOD-2022-530741, MOD-2022-530742 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Developed some side effects after receiving the Moderna vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines). At the time of the report, VACCINATION COMPLICATION (Developed some side effects after receiving the Moderna vaccines) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.   Reporter reported that she developed some side effects after receiving the Moderna vaccines and that she would like to receive the booster but she was nervous about it. She stated she had reported this in the past but didn't finish the process and that she would like to follow up on that.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes virus infection, Hidradenitis
Clinical narrative: Developed Herepes and Hidradenitis
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chronic spontaneous urticaria
Clinical narrative: Angeo Adema, chronic idiopathic uticaria (both still active as of today, 4/4/22)
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient was administered expired ROTATEQ.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not provided.  On 16-MAR-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, lot #1707460, expiration date: 14-MAR-2022, route of administration defaulted to oral, for prophylaxis (expired product administered). The vaccine did not have any prior temperature excursions. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: No additional AE details or PQC; 6 months old was administered a dose of ROTATEQ after 2 doses of Rotatrix series; This spontaneous report as received from a consumer refers to a 6 month old patient (gender unknown).   The patient's concurrent conditions, medical history or concomitant medications were not provided.     On unspecified dates, the patient received the first and second dose of rotavirus vaccine live oral 1v(ROTARIX) (dose regimen details, lot #, expiration date and indication were not provided).  On 22-MAR-2022 the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral for prophylaxis (interchange of vaccine products).  No additional adverse events were reported.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No other adverse events reported; The patient received GARDASIL 9 in Jan 2021 and Mar 2021 and had yet to receive third dose; This spontaneous report has been received from a pharmacist referring to a 21 years old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.     On an unknown date in January 2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. Then, on an unknown date in March 2021, she was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis. At the time of reporting, the patient had yet not received the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). The reporter stated the patient's other information was unknown, as she had not come in yet. There were no other adverse events reported.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received his second dose of GARDASIL 9 five years ago and has not yet completed the series; No additional AE reported; This spontaneous report was received from a pharmacist referring to a currently 26-year-old male patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   On approximately 2017, reported as five years ago, the patient received his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).   Reporter stated the patient had not yet completed the series (inappropriate schedule of product administration). No additional AE reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Inbound call from HCP stating a dose of PROQUAD was inadvertently administered to a patient over 13 years of age. No additional AE details or PQC.; This spontaneous report was received from a pharmacist referring to a 13-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 28-FEB-2022, reported as about a month ago, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot # U030591, expiration date 29-MAR-2023 (route of administration not reported) for prophylaxis (product administered to patient of inappropriate age). The vaccine was reconstitued with sterile diluent, lot number T0143000, expiration date 12-MAR-2022. No adverse event was reported.  Lot number T0143000 is an invalid lot number for sterile diluent. Lot number T0143000 does not match any Company product as confirmed by Lot Verification team.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reporting a patient was administered VARIVAX after a temperature excursion. No additional information provided. Additional AE cases: 02138009, 02138049, 02138054, 02138052, 02138050, 02138056, 02138057 field. No additional AE reported. No PQC r; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 11-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number U019904, expiration date 24-JUN-2023 (route of administration not reported)  for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 12.4 degrees Farhrenheit (°F) for 20 Minutes. Also, the vaccine had undergone a previous temperature excursion from 6°F to 14°F (11.6°F) for 25 Minutes.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional information provided; Nurse reporting a patient was administered VARIVAX after a temperature excursion.; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 11-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number U019904, expiration date 24-JUN-2023 (route of administration not reported)  for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 12.4 degrees Farhrenheit (°F) for 20 Minutes. Also, the vaccine had undergone a previous temperature excursion from 6°F to 14°F (11.6°F) for 25 Minutes.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reporting a patient was administered VARIVAX after a temperature excursion.; This spontaneous report as received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 13-JAN-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number U019904, expiration date 24-JUN-2023 (route of administration not reported)  for prophylaxis (product storage error). No adverse event was reported.  The vaccine underwent a temperature excursion of 12.4 degrees Farhrenheit (°F) for 20 Minutes. Also, the vaccine had undergone a previous temperature excursion from 6°F to 14°F (11.6°F) for 25 Minutes.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a patient was administered VARIVAX after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, and concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JAN-2022, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #U019904, expiration date: 24-JUN-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided) which was administered after temperature excursion of 12.4 Fahrenheit (°F) during a time frame of 0 hours, 20 minutes and 0 seconds. Previous temperature excursion of 6°F to 14°F (11.6F) for 0 hours 25 minutes and 0 seconds  No additional additional adverse events were reported.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: two-part shot, still break out with them/suspected vaccination failure; still break out with them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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, 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 Information: GSK Receipt Date: 26-Mar-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The reporter stated, it did not matter if you get the two-part shot, the patients still broke out with shingles. Additional Supportive Information: This case described the occurrence of suspected  vaccination failure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible, as no contact details were available. This case had been linked to US2022AMR056641, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR056641:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Eye swelling, Herpes zoster
Clinical narrative: She has a terrible case of shingles on her face; Her eye is all swollen shut. It looks like a big red strawberry!; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles and eye swelling. On an unknown date, the outcome of the shingles and eye swelling were not recovered/not resolved.   It was unknown if the reporter considered the shingles and eye swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: This case was reported by a consumer via Interactive digital media. The case was reported by the patient's friend. The patient never had shingles and was told by her doctor that because of her age she needed the vaccine. A week later, she had a terrible case of shingles all over her face and her eye was all swollen shut.  It looked like a big red strawberry. The reporter said that all vaccines were not good. Additional Supportive Information: Follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Generalised tonic-clonic seizure, Headache
Clinical narrative: Grand Mal seizure; headache; This case was reported by a consumer and described the occurrence of grand mal seizure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th March 2022, the patient received Shingles vaccine. On 25th March 2022, 1 days after receiving Shingles vaccine, the patient experienced grand mal seizure (serious criteria GSK medically significant) and headache. The patient was treated with antiepileptics nos (Seizure Medication). On an unknown date, the outcome of the grand mal seizure was unknown and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the grand mal seizure and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-MAR-2022 Reporter's Comments:  The patient was given the vaccine last Thursday afternoon.  The next day, in the evening, the patient had a grand mal seizure.  The patient had headaches ever since then.  The patient had a doctor's appointment on the reporting day and some tests were ordered.  The patient was on seizure medication and reported that on the questionnaire, but no one discussed the potential side effects with him/her. The reporter consented to follow up.
Age: 89.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue
Clinical narrative: Fatigue; Shivers; Weakness, lack of energy; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 89-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (on 21st October 2021, received 1st dose).   On 26th March 2022, the patient received the 2nd dose of Shingrix. In March 2022, less than a day after receiving Shingrix, the patient experienced shivers and weakness. On 27th March 2022, the patient experienced fatigue. On an unknown date, the outcome of the shivers, weakness and fatigue were unknown.   The reporter considered the shivers, weakness and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: This case was reported by the is the patient's daughter.  The patient received Shingrix in the morning and felt fine during the day but at night he experienced shivers and weakness. One day after receiving Shingrix, the patient experienced fatigue or lack of energy or weakness. It was unknown how he was feeling on the date of reporting. The reporter did not live with her father and thus did not have any paperwork which would have the lot number of the Shingrix but she did provide the pharmacy's information who should have the lot number on file.
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose to adult patient; Pediatric dose to adult patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 29-year-old female patient who received HAV (Havrix 720) (batch number yg7yg, expiry date 3rd February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th March 2022, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 14th March 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: Medical assistant reported that the patient received a pediatric dose of Havrix. The consent to follow up was given. Additional Supportive Information: The adult patient received pediatric dose of Havrix which led to, underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: developed urticaria and the local site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site urticaria in a 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 injection site urticaria. On an unknown date, the outcome of the injection site urticaria was unknown.   It was unknown if the reporter considered the injection site urticaria to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Pharmacist reported on behalf of a staff member at the hospital where he worked.  The patient received Shingrix vaccine at the hospital and developed urticaria at the local site of injection.  Pharmacist did not had any additional information and any patient demographic information. Pharmacist enquired if the 2nd dose of Shingrix could be given and what the effectiveness was after 1 dose of Shingrix. The representative spoke from content and package insert(PI) and gave medical disclaimer and referred to health care professional (HCP).  Reporter was also given medical information telephone number for future reference and warm transferred call to Medical Information (MI). The consent obtained to contact pharmacist for follow-up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: inadvertently administered a third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA638A, expiry date 30th November 2022) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 15th August 2017). Concomitant products included MENVEO.   On 28th March 2022, the patient received the 3rd dose of Menveo. On 28th March 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Medical Assistant reported that a patient received first dose of Menveo (lot number and expiration date unavailable as it was administered at a different facility) and was given a booster dose. The patient was then inadvertently administered a third dose. Health care professional (HCP) gave permission for follow-up. The reporter consented to follow up. Additional Supportive Information : As the patient received a third dose of Menveo, which led to extra dose administered.
Age: 20.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Registered pharmacist reported that on the day of reporting, a patient received an expired dose of Twinrix . The reporter consented to follow up. Additional Supportive Information On 29th March 2022, patient received dose of Twinrix that was already got expired on 8th February 2022, which led to expired vaccine used.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 11-year-old patient received a dose of Infanrix; received Infanrix instead of a Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number LS444, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Medical assistant reported that the patient received a dose of Infanrix instead of a Boostrix. The consent to follow up was given. Additional Supportive Information: The patient received Infanrix instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month old received fluarix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 52SA4, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comment: Medical assistant reported that a 2 months year old patient received Fluarix Quadrivalent and wanted to know if there was any safety information or how to proceed. The reporter consented to follow-up. Additional supportive information:  The 2 month old patient received dose of Fluarix Quadrivalent, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received by error 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose recieved on an unknown date).   On 30th March 2022, the patient received the 3rd dose of Shingrix. On 30th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-Mar-2022 Reporter's comment: The patient received Shingrix third dose by error. The consent to follow up was given. No information available on patient´s details and lot number of the vaccine. Additional Supportive Information: The patient received 3rd dose of Shingrix in error which led to, extra dose administered.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSY; This spontaneous report received from a patient via a company representative and concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had bells palsy (Dose number in series 2). It was reported that shot was not tested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220400821-covid-19 vaccine ad26.cov2.s-Bell's palsy. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Systemic lupus erythematosus
Clinical narrative: LUPUS SYNDROME; SICKNESS; This spontaneous report received from a patient via another manufacturer concerned a 6 decade old female unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported,1 total, administered on 25-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled syringe, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. On an unknown date, patient had rash from Humira shot on stomach (injection site rash). The patient was recovering from injection site rash. No concomitant medications were reported.  On an unspecified date in 2021, patient had sickness and on an unspecified date patient had lupus syndrome. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from sickness and the outcome of lupus syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220401951- covid-19 vaccine ad26.cov2.s-Lupus Syndrome. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Application site nerve damage, Dizziness, Headache, Magnetic resonance imaging, Pain in extremity
Clinical narrative: DIZZINESS; WRONG NEEDLE WAS USED WHICH THEN HIT THE NERVE; ARM PAIN; HEADACHE; WRONG INJECTION TECHNIQUE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 40 kilograms, and height was not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient experienced dizziness, wrong needle was used which then hit the nerve, arm pain, headache, and wrong injection technique. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) negative, and MRI (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, headache, dizziness, wrong injection technique and wrong needle was used which then hit the nerve was not reported. This report was non-serious. This report was associated with product quality complaint: 90000224405.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Wrong technique in product usage process
Clinical narrative: DIZZINESS; WRONG NEEDLE WAS USED WHICH THEN HIT THE NERVE; ARM PAIN; HEADACHE; WRONG INJECTION TECHNIQUE; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight was 40 kilograms, and height was not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient experienced dizziness, wrong needle was used which then hit the nerve, arm pain, headache, and wrong injection technique. Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) negative, and MRI (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm pain, headache, dizziness, wrong injection technique and wrong needle was used which then hit the nerve was not reported. This report was non-serious. This report was associated with product quality complaint: 90000224405.