chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Influenza like illness
Clinical narrative: Field based employee is reporting an adverse event on behalf of a nurse. Caller states the nurse (name, demographic information not provided) reported her 13 year old son received the first dose GARDASIL 9 on an unspecified date experienced flu-like; This spontaneous report was received from a nurse, referring to her son, a 13-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, 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, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown date, the patient experienced flu-like symptoms (influenza like illness) and would not be receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The outcome of influenza like illness and the causal relationship between the event and the suspect therapy were not reported.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: temperature excursion; route of administration:IM; This spontaneous report was received from another health professional and referred to a 13-month-old male. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, with a reported valid lot #W006412, and a validated expiration date of 23-FEB-2024, administered intramuscularly (Incorrect route of product administration) into the right thigh for prophylaxis (strength was not provided). The vaccine had a temperature excursion (unspecified) and the temperature change was detected with a data logger.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Product use issue
Clinical narrative: a 18 years old patient received an adult dose of RECOMBIVAX; This spontaneous report was received from another health professional and referred to an 18-year-old. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 1 ml, with a reported and validated: lot #U019139, and expiration date of 11-JUN-2023, administered for prophylaxis (strength, and route of administration were not provided). However, the 18 years old patient received an adult dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (Drug use in unapproved age group).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional AE's were reported; The HCP reports that an adult patient was administered a dose of PROQUAD; This spontaneous report has been received from a physician concerning an adult patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On 21-APR-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, administered subcutaneously (lot # W028568, expiration date 06-MAR-2024) (anatomical location was not provided) for prophylaxis (product administered to patient of inappropriate age). No additional events were reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Refusal of vaccination
Clinical narrative: Patient was anxious and declined to have their third dose of GARDASIL 9; This spontaneous report was received from a Registered Nurse and refers to an adult female in her mid-twenties (reported as believed to be 25 or 26 years old).  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On unknown dates, the patient was vaccinated with first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, lot #, expiry date, and route of administration were not provided).  The reporter informed that the patient was scheduled to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 22-APR-2023, but that she was anxious and declined to have her third dose of the mentioned vaccine on that date (Anxiety). The reporter was unable to provide any additional details regarding this event as it was unknown. No additional adverse events were reported and there were no product quality complaints. No further information was provided. At the time of this report, the outcome of anxiety was unknown.  Action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding anxiety was not applicable.  The causal relationship between anxiety and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported (unknown).
Sex: F
Vaccine: HPV4
Symptoms: Wrong technique in product usage process
Clinical narrative: unfortunately we were supposed to inject the GARDASIL 4 vaccine by ourselves and we weren't alert about shaking it before; This spontaneous report was received from a 27-year-old female patient reporting on herself. The patient's concurrent conditions, medical history and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (lot#, expiry date, dose and route of administration were not provided).  The reporter stated that she and her sister were supposed to inject the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine by themselves and they were not alert about shaking it before the injection (wrong technique in product usage process). It was reported that they were concerned of what would happen and what should they do.  This is one of two reports received from the same reporter.
Sex: F
Vaccine: HPV4
Symptoms: Wrong technique in product usage process
Clinical narrative: unfortunately we were supposed to inject the GARDASIL 4 vaccine by ourselves and we weren't alert about shaking it before; This spontaneous report was received from a consumer reporting on behalf of her sister a 21-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported.  On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prophylaxis (lot#, expiry date, dose and route of administration were not provided).  The reporter stated that she and her sister were supposed to inject the quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine by themselves and they were not alert about shaking it before the injection (wrong technique in product usage process). It was reported that they were concerned of what would happen and what should they do.  This is one of two reports received from the same reporter.
Sex: U
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness Under the Site of Injection; Warm; Very Itchy; Initial Report Received on 23-Feb-2023.  A registered pharmacist reported to a sales representative that she, the patient (age, race, and ethnicity unknown), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced redness, warmth, and itching.  Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On an unknown date, the patient received a dose of HEPLISAV-B vaccine (details not reported). The patient experienced redness slightly below the injection site (not the actual injection site), warmth, and increased itching. The patient stated that it was "not a large area."  No further information was provided. Additional information was requested.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product leakage, Underdose
Clinical narrative: Leak Between Needle And Vial of Heplisav-B, Only Received Half The Dose; Initial Report Received on 24-Feb-2023.  A non-significant follow-up report received on 29-Mar-2023 that included the QA investigation results of the mixed product quality complaint:  the investigation did not identify a potential lot-related issue, there was no trend, this was the first AE associated with HEPLISAV-B Lots 941061, no potential impact to the lot was identified, no CAPA was recommended, and the case was closed on 29-Mar-2023.  A pharmacist in the reported that a 34-year-old female patient (race and ethnicity unknown) received a half a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization because there was a leak between the needle and the vial of HEPLISAV-B.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.   On 24-Feb-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 941061, expiration date 10 Dec-2024, NDC # 43528-0003-05; and route not reported) in the left deltoid. There was a leak between the needle and the vial of HEPLISAV-B and the patient only received about half of the dose. The needle went into the vial as usual. The vial and needle were not retained by the reporter as they were thrown away in the sharps container. No adverse effects were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Given an Injection of Heplisav-B Which Had Been Out of Temperature Range for Greater Than 8 Hours; Initial Report Received on 27-Feb-2023.  A registered nurse reported that a 41-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was out of temperature range for greater than eight hours.  Medical history was unknown and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On 08-Feb-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 937228, expiration date 30 Aug-2023, NDC # 43528-0003-05) intramuscularly in the left deltoid. The HEPLISAV-B dose that the patient received had been out of temperature range for greater than eight hours. No adverse effects were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Given an Injection of Heplisav-B Which Had Been Out of Temperature Range for Greater Than 8 Hours; Initial Report Received on 27-Feb-2023.  A registered nurse reported that a 35-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was out of temperature range for greater than eight hours.  Medical history was unknown and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On 06-Feb-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 937228, expiration date 30 Aug-2023, NDC # 43528-0003-05) intramuscularly in the left deltoid. The HEPLISAV-B dose that the patient received had been out of temperature range for greater than eight hours. No adverse effects were reported.  No further information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received Two Doses of Heplisav-B At The Same Time; Initial Report Received on 28-Feb-2023  A registered pharmacist in the reported that a 34-year-old patient (gender, race, and ethnicity unknown) received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization at the same time in a combined dose.  Medical history was unknown and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On an unknown date, the patient received two doses of HEPLISAV-B vaccine (Lot # 937230, expiration date Sep-2023, NDC # 4352800305) at the same time in a combined dose intramuscularly (injection site unknown). The person administering the vaccines misread the prescription and combined two doses of HEPLISAV-B into one prefilled syringe and administered them to the patient. No adverse reactions were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Immunodeficiency, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received 2 Doses of Heplisav-B Out of Schedule; Initial Report Received on 06-Mar-2023.  A licensed practical nurse reported that a 43-year-old female patient (race and ethnicity unknown) received two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was out of schedule.   Medical history and allergies were not reported at the time of vaccination. The patient was not on any concomitant medications and was not pregnant.  On 30-Dec-2022, the patient received the first dose of HEPLISAV-B vaccine (no details were reported).  On 24-Feb-2023, 57 days after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B vaccine (Lot # 941060, expiration date 02-Dec-2024, NDC # 43528-003-01) intramuscularly in the left deltoid. The second dose of HEPLISAV-B was given out of schedule. The provider wanted to give a third dose of HEPLISAV-B because the patient was immunocompromised and requested more information. No adverse effects were experienced by patient.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 43.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received Moderna Bivalent vaccine that was past it's use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine that was past it's use by date).    No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Case  (MOD-2023-720844) found duplicate of case (MOD-2023-720842) hence all source documents are copied from case (deletion case: MOD-2023-720844) and appended into case (retained case:MOD-2023-720842). Case  (retained case: MOD-2023-720842) will retain for further follow up and case ID MOD-2023-720844  needs to be deleted. On 21-Apr-2023: Live follow-up : DOB updated
Sex: M
Vaccine: COVID19-2
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: When vaccination provider was administering the vaccine some of the liquid leaked out.; No adverse event; Patient received his 6th Moderna shot on 23-APR-2023, but when vaccination provider was administering the vaccine some of the liquid leaked out.; This spontaneous case was reported by a patient and describes the occurrence of UNDERDOSE (Patient received his 6th Moderna shot on 23-APR-2023, but when vaccination provider was administering the vaccine some of the liquid leaked out.), DEVICE CONNECTION ISSUE (When vaccination provider was administering the vaccine some of the liquid leaked out.) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, allergy, concomitant diseases, risk factor and unknown if received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 23-Apr-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced UNDERDOSE (Patient received his 6th Moderna shot on 23-APR-2023, but when vaccination provider was administering the vaccine some of the liquid leaked out.). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (When vaccination provider was administering the vaccine some of the liquid leaked out.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received his 6th Moderna shot on 23-APR-2023, but when vaccination provider was administering the vaccine some of the liquid leaked out.), DEVICE CONNECTION ISSUE (When vaccination provider was administering the vaccine some of the liquid leaked out.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (Patient received his 6th Moderna shot on 23-APR-2023, but when vaccination provider was administering the vaccine some of the liquid leaked out.) and DEVICE CONNECTION ISSUE (When vaccination provider was administering the vaccine some of the liquid leaked out.).    No concomitant information was reported. It was reported that patient had no adverse events with previous vaccines or the last one so far. Suspect product dosage text was reported as additional booster. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator 20-MAR-2023, administration of vaccine 21-APR-2023; No adverse event; Vaccine expired on 19-APR-2023 and was used for vaccinations on 21-APR-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-APR-2023 and was used for vaccinations on 21-APR-2023), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 20-MAR-2023, administration of vaccine 21-APR-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-APR-2023 and was used for vaccinations on 21-APR-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 20-MAR-2023, administration of vaccine 21-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-APR-2023 and was used for vaccinations on 21-APR-2023), PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator 20-MAR-2023, administration of vaccine 21-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication were reported. Vaccine expired on 19-APR-2023. Individual vials with vial size of 2.5 ml. The vial was initially stored in the refrigerator 20-MAR-2023. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721047 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721047:2nd patient case.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received dose from a vial with a BUD 23-Apr-2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial with a BUD 23-Apr-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial with a BUD 23-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial with a BUD 23-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose from a vial with a BUD 23-Apr-2023).    No concomitant medications were reported. Vaccine Manufactured date was reported as 26-Sep-2022. No treatment information was provided.  This case contains information for the 1st of 2nd adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721018 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721018:Patient 2
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. as7180b) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (12 patients received the Moderna Covid-19 vaccine after the April 6, 2023 use by Date).    No concomitant medications were reported.  No other adverse events had been reported. Date(s) of administration of vaccine on 22-Apr-2023 (3 patients), 21-Apr-2023 (5 patients), 20-Apr-2023 (2 patients), 16-Apr-2023 (1 patient) and 12-Apr-2023 (1 patient).  The patients involved were all over the age of 65.   No treatment medications were reported.  This case contains information for the 3rd out of 12th elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721060 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721060:Patient 1
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram abnormal, Headache
Clinical narrative: Extreme headache; got the results of a CT scan and there is something wrong; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 90-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Mar2023 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 4, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 3, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 2, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose number: 1, Unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset Mar2023, outcome "unknown", described as "Extreme headache"; COMPUTERISED TOMOGRAM ABNORMAL (non-serious) with onset Mar2023, outcome "unknown", described as "got the results of a CT scan and there is something wrong". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient had a Pfizer 5th shot (Confirmed as COVID-19 vaccine) the last week of Mar and had extreme headache and yesterday (unspecified date) got the results of a CT scan and there was something wrong that is definitely from the Pfizer COVID shot and wanted to find out what to do for it. Extreme headache; gone for 4 weeks; still had the headache. Reported that, by 24 hours had an extreme headache. The headache was gone on for 4 weeks, this week and had CT scan everything was correct but still had the headache and told that Pfizer recommends a product called Zavzpret but noticed that it was like 500 dollars. Patient called in seeking assistance with the medication Zavzpret. Patient doctor said it was a rebound from the Pfizer. And told that Pfizer recommends that Zavzpret shot. Note: The patient's date of birth and address was not provided during the call. Patient mentioned that she had her fifth COVID shot last week of Mar and immediately had headaches. She mentioned that she had a CT Scan to make sure that there were not any other problems and that now she was going to be recommended to take Zavzpret. She mentioned that Zavzpret is very expensive and that she cannot afford it. Caller wanted to get some recommendations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: fatigue; injection site soreness in the arm soreness; injection site soreness in the arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2021 as dose 2, single (Lot number: EN6204) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6204), administration date: 18Mar2021, for COVID-19 immunisation, reaction(s): "Fatigue"; BNT162b2 (DOSE 1, SINGLE, Lot: EN6204), administration date: 18Mar2021, for COVID-19 Immunization, reaction(s): "injection site soreness in the arm soreness", "injection site soreness in the arm soreness". The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "injection site soreness in the arm soreness".  Additional information: It was reported that, the patient got 4 covid vaccines, primary dose, 2 boosters, and bivalent booster, all of them from Pfizer. He mentioned that he usually felt fatigue and arm soreness for a while. Caller also added that his primary care physician says that the only important vaccines are the 2 primary better, which was the reason why he also believes they could ware off. He finally added that he had no regrets with the first shots, but that he's regretting to get this new one, that he's not happy, and now he's nervous of how long the side effects could last, so he doesn't think he made the right decision. He also stated that He had previously taken his original Pfizer Covid vaccinations when they first came out. He got the first two vaccines 2 weeks apart. Then, in 6-8 months he got his first booster. Then, 6-8 months later her got a second booster. He had relatively the same side effects for those. His side effects were common and expected. They all cleared up by the following evening by the most part. All the other shots, they asked him to sit for 10 minutes before he left, and each time everything was okay. Typically, with the other injections, a few hours later, he started feeling fatigue and then later in the evening injection site soreness in the arm soreness. He had a soreness in his arm that wasn't soreness anymore it was hurting. Sender's Comments: Linked Report(s): US-PFIZER INC-202300163844 same patient/event, different vaccine dose.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: cut the muscle at my face it actually caused an indentation so a piece of my face was taken out and now I've got swelling in that side and you can't see the indentation anymore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing), notes: I have had migraines; "brain tumor" (unspecified if ongoing), notes: I have had brain tumor; "brain surgery" (unspecified if ongoing), notes: I had to get brain surgery 2 time in my brain; "neurological problems" (unspecified if ongoing), notes: I've had neurological problems; "Tumor" (unspecified if ongoing), notes: I had a tumor when I was 18 years old; "seizures" (unspecified if ongoing), notes: suffered with seizures 8 years after that for a period of 12 years; "allergies to medicine" (unspecified if ongoing), notes: I had a lot of allergies to medicine; "arm pain" (unspecified if ongoing), notes: wake up with arm pain; "upset stomach" (unspecified if ongoing), notes: possibly an upset stomach. The patient's concomitant medications were not reported. The following information was reported: SWELLING FACE (non-serious) with onset 2023, outcome "unknown", described as "cut the muscle at my face it actually caused an indentation so a piece of my face was taken out and now I've got swelling in that side and you can't see the indentation anymore".  Additional information: Caller reports that she had vaccine for covid 4 weeks ago as of tomorrow, used to suffer with migraines, wake up with arm pain, possibly an upset stomach, have had migraines it came and gone, have had brain tumor, had to get brain surgery 2 time in her brain and She is just concerned about having the second vaccine, she never meant to have it because she don't wanna have a stroke or anything bad to happen because of the vaccine. She had neurological problems, had 2 brain operations, had a tumor when she was 18 years old and suffered with seizures 8 years after that for a period of 12 years. She had a lot of allergies to medicine. She was just concerned because it cut a muscle at my face and when they cut the muscle at her face it actually caused an indentation so a piece of her face was taken out and now she got swelling in that side and you can't see the indentation anymore. They started out really intense and for a solid week it was didn't leave and they are coming and going like when she was a child cause she suffered with them for 5 years till they found out she had a tumor and there is scar tissue in the area where the tumor was."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: losing patches of hair due to alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL3249) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; WIXELA INHUB; SAM-E. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3246, Location of injection: Arm Left, Vaccine Administration Time: 12:00), administration date: 13Jan2021, when the patient was 43-year-old, for Covid-19 immunization. The following information was reported: ALOPECIA (medically significant) with onset 01Mar2021 at 12:00, outcome "not recovered", described as "losing patches of hair due to alopecia". The event "losing patches of hair due to alopecia" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of alopecia.  Clinical course: "Soon after getting vaccinated I started losing patches of hair due to alopecia. I had to shave my head due to it after a few months". Ae treatment with Steroid Shots and topical medications. Patient had no covid prior vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: losing patches of hair due to alopecia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL3249) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; WIXELA INHUB; SAM-E. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3246, Location of injection: Arm Left, Vaccine Administration Time: 12:00), administration date: 13Jan2021, when the patient was 43-year-old, for Covid-19 immunization. The following information was reported: ALOPECIA (medically significant) with onset 01Mar2021 at 12:00, outcome "not recovered", described as "losing patches of hair due to alopecia". The event "losing patches of hair due to alopecia" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of alopecia.  Clinical course: "Soon after getting vaccinated I started losing patches of hair due to alopecia. I had to shave my head due to it after a few months". Ae treatment with Steroid Shots and topical medications. Patient had no covid prior vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes/Positive; Since the vaccination, has the patient been tested for COVID-19?:Yes/Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 12:00 as dose 1, single (Lot number: EL3246), in left arm and on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL3249) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; WIXELA INHUB taken for asthma; SAM-E. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes/Positive". The event "since the vaccination, has the patient been tested for covid-19?:yes/positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. Clinical course: No other vaccine was taken in four weeks. There was no covid prior vaccination and patient was covid tested post vaccination.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes/Positive; Since the vaccination, has the patient been tested for COVID-19?:Yes/Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 13Jan2021 at 12:00 as dose 1, single (Lot number: EL3246), in left arm and on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL3249) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; WIXELA INHUB taken for asthma; SAM-E. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes/Positive". The event "since the vaccination, has the patient been tested for covid-19?:yes/positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab. Clinical course: No other vaccine was taken in four weeks. There was no covid prior vaccination and patient was covid tested post vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles about 2 months after injection; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: "nuts" (unspecified if ongoing), notes: mouth swelling. The patient took concomitant medications. Past drug history included: Propofol, reaction(s): "Hives". Vaccination history included: Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 10Dec2022, outcome "recovered", described as "Shingles about 2 months after injection". The event "shingles about 2 months after injection" required physician office visit. Therapeutic measures were taken as a result of herpes zoster.  Additional Information: The patient received Multivitamin during two weeks of vaccination. The patient received Valacyclovir as treatment for Shingles. There was no covid prior vaccination and no covid tested post vaccination.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Degen. disc dis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies"; Ketoconazole, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2023) Positive; (unspecified date) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 07Apr2023 to 11Apr2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 at 17:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 16Mar2021 at 14:15 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 at 13:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 16Oct2021 at 10:30 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11Apr2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid treatment from 12Apr2023 to 17Apr2023 . The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Mar2023 at 11:00 as dose 6 (booster), single (Lot number: GL0447) at the age of 52 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes, Other medical history: yes. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for "Positive for COVID-19 on a home test three days after receiving the Pfizer COVID-19 booster on 19Jan2023." of "PFIZERBIONTECH COVID-19 VACCINE INJECTABLE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot "GL0447". A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. (site name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Clinical course: Patient received other medications in two weeks; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and COVID-19 cannot be ruled out.