chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Headache
Clinical narrative: Bad headache; Dizzy; bone pain; This is a spontaneous report received from contactable reporter (Consumer or other non-HCP) from the Medical Information Team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as DOSE 1, SINGLE (lot number: EL3246) at the age of 74 years old, administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Knows that she has a lot of sensitivities to medications" (unspecified if ongoing); "Has a lot of allergic reactions" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 21Jan2021, outcome "recovered" (22Jan2021), described as "Bad headache"; DIZZINESS (non-serious) with onset 21Jan2021, outcome "recovered" (22Jan2021), described as "Dizzy"; BONE PAIN (non-serious) with onset 21Jan2021, outcome "recovered" (22Jan2021). Therapeutic measures were taken as a result of headache, dizziness, bone pain.  Additional information: Regarding Covid vaccines, caller states she feels very protected. Knows that she has a lot of sensitivities to mediations. Was pretty worried there would be some reaction. It was pretty strong so, she just blocked out a couple of days each time to get over it. Caller was very pleased with the vaccine. Knew there was going to be side effects. She is so sensitive to medications. Has a lot of allergic reactions, blocks out a couple of days each time for it. Patient had the very first vaccine 21Jan2021. That reaction was a really bad headache and, felt like her head was going to implode. It ached terribly, felt like her bones were breaking. She remembers talking to her husband and crying because one of her really good friend had just died from Covid. All she could think of was, is this what it felt like for her for those 2 weeks, this pain. She took Tylenol. Her daughter is a nurse, told her to take Tylenol and go to sleep. Woke up, still had headache and ached all over but, not as bad. Took more Tylenol and think, the next day, in the afternoon, it just sort of magically went away. The bad headache, being dizzy, the tremendous bone pain, was gone. Clarified that by the next day, 22Jan2021, those symptoms were gone. That next day, she was still going down and out and had kind of a headache but by the end of the day, it all went away. Patient had no prior vaccinations (within 4 weeks). Patient takes medication for diabetes and blood pressure. Sender's Comments: Linked Report(s): US-PFIZER INC-202300077975 same patient and product, different vaccine doses and events;US-PFIZER INC-202300077978 same patient and product, different vaccine doses and events;US-PFIZER INC-202300077976 same patient and product, different vaccine doses and events;US-PFIZER INC-202300077977 same patient and product, different vaccine doses and events;
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 17:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 45 years, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive for covid after 3 days of negatives following paxlovid dosing; Positive, notes: Tested positive for covid after 3 days of negatives following paxlovid dosing; Negative, notes: Tested positive for covid after 3 days of negatives following paxlovid dosing; Negative, notes: Tested positive for covid after 3 days of negatives following paxlovid dosing. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 13Feb2023 to 17Feb2023.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 18Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hemochromatosis" (unspecified if ongoing); "HBP(controlled and stable)" (unspecified if ongoing); "Known allergies: sulfite preservatives" (unspecified if ongoing). Concomitant medication(s) included: MELATONIN; DULOXETINE; TELMISARTAN. Past drug history included: Known allergies: sulfites, reaction(s): "Known allergies: Sulfites". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks. COVID 19 Treatment with Paxlovid from 19Feb2023 to 21Feb2023, lot number: gf8462.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number 1, 2 ; Moderna, Dose Number: 3, 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 10:30 as dose 1, single (Lot number: EN6204), in right arm and on 07Apr2021 at 09:30 as dose 2, single (Lot number: ER8732), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Dec2021 at 12:00 as dose 3 (booster), single (Lot number: 031H21A), in right arm and on 19Nov2022 at 19:00 as dose 4 (booster), single (Lot number: as7166B) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "obese" (unspecified if ongoing), notes: obese; "thyroid disease" (unspecified if ongoing), notes: thyroid disease. Concomitant medication(s) included: LEVOTHYROXINE, start date: Mar2007, stop date: 09Feb2023. Past drug history included: Codeine, reaction(s): "known allergies codeine", notes: known allergies codeine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11Dec2021, outcome "unknown", described as "Pfizer / BioNTech, Dose Number 1, 2 ; Moderna, Dose Number: 3, 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Course of events: Patient received COVID-19 anti-viral treatment with Paxlovid from 09Feb2023 to 15Feb2023,
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she got Covid; she got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EL3246) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she got Covid".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300077893 same reporter and patient, different AE;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Vaccine Brand Other=Moderna/Vaccine Administration Date=22Nov2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 4 (booster), single (Lot number: GJ6665), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20Jan2021 as dose 1, single (Lot number: 011C20A), in right arm, on 17Feb2021 as dose 2, single (Lot number: 030M20A), in left arm and on 22Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL SULFATE] resp inhalation, start date: 01Nov2021; ASMANEX resp inhalation, start date: 01Nov2021; SINGULAIR, start date: 01Feb2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Nov2021. Past drug history included: Codeine, reaction(s): "Known allregies: codeine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Oct2022, outcome "unknown", described as "Vaccine Brand Other=Moderna/Vaccine Administration Date=22Nov2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: Patient received anti-viral treatment with Paxlovid from 11Feb2023 to 16Feb2023.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 at 15:45 as dose 1, single (Lot number: EK9231), in left arm and on 25Feb2021 at 15:45 as dose 2, single (Lot number: EL8982) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2022 at 15:45 as dose 3 (booster), single (Lot number: 022T21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Sinus allergies: pollen" (unspecified if ongoing); "Sinus allergies: dust mites" (unspecified if ongoing); "Sinus allergies:pet dander" (unspecified if ongoing); "knonwn allergies:Sulpha Drugs" (unspecified if ongoing); "knonwn allergies: penicillin" (unspecified if ongoing); "knonwn allergies: eggs" (unspecified if ongoing); "knonwn allergies: soy" (unspecified if ongoing); "known allergies: dairy" (unspecified if ongoing); "knonwn allergies: cinna" (unspecified if ongoing); "known allergies narcotic drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "known allergies Augmentin"; Codeine, reaction(s): "known allergies codeine"; Morphine, reaction(s): "known allergies morphine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Jan2022 at 15:45, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 17Feb2023 to 21Feb2023.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand: Moderna, Vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 20Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: EW0191), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); " Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL, start date: Jan2012; OMEPRAZOLE, start date: Jan2012; LIPITOR, start date: Jan2016; NATROL, start date: Jan2018; CENTRUM WOMEN, start date: Jan2016; D3, start date: Jan2012; SUPER B COMPL, start date: Jan2012. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Vaccine brand: Moderna, Vaccine dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Feb2023) Negative, notes: Negative test 20Feb in a.m; (21Feb2023) Positive, notes: Positive test. Therapeutic measures were taken as a result of vaccination failure, COVID-19: the patient received Paxlovid from 13Feb2023 to 17Feb2023 for COVID-19 treatment.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: COVID-19, Insomnia, SARS-CoV-2 test positive
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand: Moderna, Vaccine dose number: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Lot number: 066K21A), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 20Feb2021 as dose 2, single (Lot number: EN6198), in left arm and on 24Sep2021 as dose 3 (booster), single (Lot number: EW0191), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); " Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION HCL, start date: Jan2012; OMEPRAZOLE, start date: Jan2012; LIPITOR, start date: Jan2016; NATROL, start date: Jan2018; CENTRUM WOMEN, start date: Jan2016; D3, start date: Jan2012; SUPER B COMPL, start date: Jan2012. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Apr2022, outcome "unknown", described as "Vaccine brand: Moderna, Vaccine dose number: 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Feb2023) Negative, notes: Negative test 20Feb in a.m; (21Feb2023) Positive, notes: Positive test. Therapeutic measures were taken as a result of vaccination failure, COVID-19: the patient received Paxlovid from 13Feb2023 to 17Feb2023 for COVID-19 treatment.
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Investigation, Lymphadenopathy, Pathology test, Positron emission tomogram
Clinical narrative: 4 foci of avidity (SUVmax, 3.2) in the left axilla localizing to mildly enlarged; This is a literature report for the following literature source(s).  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery for prostate cancer" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant), outcome "unknown", described as "4 foci of avidity (SUVmax, 3.2) in the left axilla localizing to mildly enlarged". The patient underwent the following laboratory tests and procedures: Computerised tomogram: images show avidity localizing 4 mildly enlarged, notes: but morphologically normal lymph nodes (arrows). Remaining images (not shown) confirmed no other sites of potentially pathologic radiotracer avidity; SUV mean: 3.2; 3.5; Negative; Pathology test: revealed a Gleason score of 7 (3 1 4) with, notes: evidence of perineural invasion and 1 of 5 local lymph nodes positive for spread; Positron emission tomogram: it is to be expected that, as with 18F-FDG,, notes: low-grade avidity by axillary nodes will be a potential finding, after COVID-19 vaccination; examination revealed 4 foci of avidity (SUVmax,, notes: 3.2) in the left axilla localizing to mildly enlarged but morphologically normal lymph nodes; Prostatic specific antigen: 1.0 ng/ml; undetectable, notes: at 6 mo, confirming the benign nature of the uptake and the absence of residual malignancy; undetectable, notes: at 9 mo, confirming the benign nature of the uptake and the absence of residual malignancy.; Sender's Comments: Based on the temporal relation, the association between the event of lymphadenopathy and the suspect product cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen
Clinical narrative: 4 foci of avidity (SUVmax, 3.2) in the left axilla localizing to mildly enlarged; This is a literature report for the following literature source(s).  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "surgery for prostate cancer" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (medically significant), outcome "unknown", described as "4 foci of avidity (SUVmax, 3.2) in the left axilla localizing to mildly enlarged". The patient underwent the following laboratory tests and procedures: Computerised tomogram: images show avidity localizing 4 mildly enlarged, notes: but morphologically normal lymph nodes (arrows). Remaining images (not shown) confirmed no other sites of potentially pathologic radiotracer avidity; SUV mean: 3.2; 3.5; Negative; Pathology test: revealed a Gleason score of 7 (3 1 4) with, notes: evidence of perineural invasion and 1 of 5 local lymph nodes positive for spread; Positron emission tomogram: it is to be expected that, as with 18F-FDG,, notes: low-grade avidity by axillary nodes will be a potential finding, after COVID-19 vaccination; examination revealed 4 foci of avidity (SUVmax,, notes: 3.2) in the left axilla localizing to mildly enlarged but morphologically normal lymph nodes; Prostatic specific antigen: 1.0 ng/ml; undetectable, notes: at 6 mo, confirming the benign nature of the uptake and the absence of residual malignancy; undetectable, notes: at 9 mo, confirming the benign nature of the uptake and the absence of residual malignancy.; Sender's Comments: Based on the temporal relation, the association between the event of lymphadenopathy and the suspect product cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Interchange of vaccine products, Throat irritation, Throat tightness, Tongue pruritus
Clinical narrative: Interchange of vaccine products; Anaphylaxis reaction; Throat and tongue started feeling itchy; Throat and tongue started feeling itchy; Felt like throat was closing up; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 2023NVX-US-000000157 (Novavax).  A 54-year-old female patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen COVID-19 vaccine (dose number unknown, single), administration date: 27Mar2021, when the patient was 54-year-old, for COVID-19 immunization. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset 30Nov2021, outcome "unknown", described as "Anaphylaxis reaction"; THROAT TIGHTNESS (medically significant) with onset 30Nov2021, outcome "unknown", described as "Felt like throat was closing up"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Nov2021, outcome "unknown"; THROAT IRRITATION (medically significant), TONGUE PRURITUS (medically significant) all with onset 30Nov2021, outcome "unknown" and all described as "Throat and tongue started feeling itchy".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the ears; This is a spontaneous report received from contactable reporter(s) (Pharmacist). Other Case identifier(s):   A 59-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 2022, outcome "unknown", described as "ringing in the ears".  Additional information: It was reported the patient experienced a severe reaction; the only specific symptom they described was ringing in the ears.   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
Clinical narrative: Tired; Sore; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Tired"; PAIN (non-serious), outcome "unknown", described as "Sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: fluzone administered to adult patient after product experienced an excursion with no reported adverse events; fluzone administered to adult patient after product experienced an excursion with no reported adverse events; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] was administered after product experienced an excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (dose, strength: not reported; lot UT7683NA; UT7683NA: expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization after product experienced an excursion with no reported adverse events (product storage error) (poor quality product administered) (unknown latency).  Action taken : not applicable.  Outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA057309:01495347 US-SA-2023SA055890:01495388
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, Product administered to patient of inappropriate age
Clinical narrative: 4 years had not elapsed between the last meningococcal vaccine with no reported adverse event; Initial information received on 21-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who reported  4 years had not elapsed between the last meningococcal vaccine with no reported adverse event after receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 9V (YEAST) (GARDASIL 9) for Immunisation.  On 20-Feb-2023, the patient received  0.25 mL to 2 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE solution  for injection( lot number U7449AA ) and(  expiry 24-Sep-2023) via intramuscular route in the right arm for Immunization  On 20-FEB-2023 the patient had a non-serious event " 4 years had not elapsed between the last meningococcal vaccine with no reported adverse event" (product administered to patient of inappropriate age) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE ( latency : same day )   No lab data included  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  At time of reporting, the outcome was Unknown for the event 4 years had not elapsed between the last meningococcal vaccine with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, Medication error
Clinical narrative: blister; Received expired dose of tenivac; Initial information was received on 21-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves 77 years old male patient who had blister and received expired dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Feb-2023, the patient received a standard dose (booster) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5 mL total (lot U6922AA, expiry date- 22-Jan-2023) via intramuscular route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of blister (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  On 21-Feb-2023 the patient developed a non-serious event of expired dose was received for diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (expired product administered) (latency- same day).   It was reported, patient received and expired dose of TENIVAC. The patient had a blister on his finder. The caller is wanting to know if the patient needs to be revaccinated. No further information provided by reporter. Still using product : No  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (blister).  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion due to a malfunction with the refrigerator,excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit,with no reported adverse event; vaccine was given post excursion to two patients, with no reported adverse event; Initial information received on 21-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA060514(CLUSTER).  This case involves a 11 years old male patient whose reported stated vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] exposed to temperature excursion due to a malfunction with the refrigerator, excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit and vaccine was given post excursion to two patients, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ALTHAEA OFFICINALIS ROOT, CINNAMOMUM CAMPHORA ESSENTIAL OIL, CITRUS AURANTIUM OIL, EUCALYPTUS GLOBULUS LEAF ESSENTIAL OIL, MENTHA X PIPERITA ESSENTIAL OIL (GARDISIL); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation.  On 20-Feb-2023, the patient received a 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test-0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, solution for injection (lot: U7048AA, expiry date: 28-Feb-2024) via intramuscular route in right arm site ( strength: standard) as Immunization or TB skin test.  On an unknown date the vaccine was exposed to temperature excursion due to a malfunction with the refrigerator,excursion lasted for 69 days 1041 hours and 56.0-63.0 degrees Fahrenheit (product storage error) and On 20-Feb-2023, the vaccine was given post excursion to two patients, with no reported adverse event (poor quality product administered)  (latency: same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  First time product used : Yes Still using product : No  Action taken with MENINGOCOCCAL VACCINE was not applicable.  At time of reporting, the outcome was Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Tinnitus - ringing in the ear(s) of a high pitched sound. Was the most prominent during sleep and woke me up numerous times. Can still be heard when very quiet also.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia areata, Depression, Stress
Clinical narrative: Major non-scarring hair loss (Alopecia Areata). Loss of over 50% of hair to create in two large bald patches on top of head - resulting in high levels of stress and depression.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE or PQC reported; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report has been received from a registered nurse referring an patient of unknown age and gender. The patients pertinent medical history, drug reactions, allergies and concomitant medications were not reported.    On 01-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W018836 that had been verified to be a valid number with expiration date 14-JUN-2024 (strength, specific dosage, vaccination scheme, route of administration, anatomical site of application, lot number and expiration date were not provided) (product storage error)  The administered dose of the vaccine experienced a temperature excursion of 12.7 degrees Celsius (C). It was reported that a previous temperature excursion happened. Time frame unknown. There was no additional adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash pruritic
Clinical narrative: red rash at injection site; itchy rash, believes it is bed bugs; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2023, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd February 2023, 2 days after receiving Shingrix, the patient experienced injection site rash. In February 2023, the patient experienced itchy rash. On an unknown date, the outcome of the injection site rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site rash and itchy rash to be related to Shingrix.     Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: The reporter was the patient. The reporter reported that she received her second Shingrix vaccine in the left deltoid.  The patient reported that 2 days later she developed a red rash at the injection site. The patient still had the rash, and it was getting itchy during the past 2 weeks.  The patient believes it was bed bugs that caused the rash. The patient did not provide date of birth. The reporter did not consent to follow up.
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB, HIBV, DTPPVHBHPB, HIBV
Symptoms: Accidental overdose, Wrong product administered
Clinical narrative: Vaxelis and Hiberix given on same day; Hiberix given by mistake instead of PCV vaccine; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a 2-year-old male patient who received Hib (Hiberix) (batch number EK5Y2, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included VAXELIS for prophylaxis.   On 8th February 2023, the patient received Hiberix and VAXELIS. On 8th February 2023, unknown after receiving Hiberix, the patient experienced accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment:  The reporter reported that the patient was almost 3 years old and received Vaxelis and Hiberix vaccine. The reporter stated that the patient was supposed to receive Vaxelis and PCV vaccine but received Hiberix vaccine by mistake.  The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The reporter reported that, they were intending to administered PCV vaccine and inadvertently administered Hiberix instead of PCV vaccine, which led to wrong vaccine administered. The patient received Vaxelis and Hiberix vaccine on same day, which led to accidental overdose.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Jun2022, did not complete the series; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received HAB (Twinrix) 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.   Previously administered products included Twinrix (received 1st dose on 22nd June 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 16-FEB-2023 Reporter's Comment: The certified pharmacy technician reported that the patient did not return for the rest of the series of the Twinrix. The reporter consented to follow up by postal. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination. This case was linked with US2023026721 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023026721:Same reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Chest pain, Computerised tomogram, Constipation, Diarrhoea
Clinical narrative: Transported by ambulance to ER, Memorial Hospital Treated by Internal Medicine MD, Pulmonologist, and Cardiologist.  Treated for Thrombosis, Tachycardia, Difficulty breathing, chest pains and black outs dizzyness gastrointestinal issues bloating cramping, constipation and diarrea umbilical hernia.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Echocardiogram, Full blood count, Gastrointestinal disorder
Clinical narrative: Transported by ambulance to ER, Memorial Hospital Treated by Internal Medicine MD, Pulmonologist, and Cardiologist.  Treated for Thrombosis, Tachycardia, Difficulty breathing, chest pains and black outs dizzyness gastrointestinal issues bloating cramping, constipation and diarrea umbilical hernia.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Muscle spasms, Tachycardia, Thrombosis, Ultrasound scan
Clinical narrative: Transported by ambulance to ER, Memorial Hospital Treated by Internal Medicine MD, Pulmonologist, and Cardiologist.  Treated for Thrombosis, Tachycardia, Difficulty breathing, chest pains and black outs dizzyness gastrointestinal issues bloating cramping, constipation and diarrea umbilical hernia.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Umbilical hernia
Clinical narrative: Transported by ambulance to ER, Memorial Hospital Treated by Internal Medicine MD, Pulmonologist, and Cardiologist.  Treated for Thrombosis, Tachycardia, Difficulty breathing, chest pains and black outs dizzyness gastrointestinal issues bloating cramping, constipation and diarrea umbilical hernia.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Paraesthesia
Clinical narrative: Client call me today saying" I had those side effects again as last time but seems worse" client states he started to notice it wednesday morning, a constant and slow progression, when doing normal ADL/activities  he feels he exacerbates these symptoms. He explains that his first shot, it was about a month later before he had any tingling or numbness in his right arm. This time he wanted his shot in his left arm and now this symptoms began alot sooner and seem to be worse. He will seek medical attention as soon as he is able.
Age: 11.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Gave patient the Covid 19 Bivalent Booster and she should have received the 5-11 dose
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dyspnoea, Fatigue, Headache, Pharyngeal swelling, Pyrexia
Clinical narrative: My breathing got worse within 5 minutes,  though didn't get to the point of having to have emergency services.  within a few hours I had constantly runny nose, headache, fever and swollen throat, exhaustion
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rhinorrhoea
Clinical narrative: My breathing got worse within 5 minutes,  though didn't get to the point of having to have emergency services.  within a few hours I had constantly runny nose, headache, fever and swollen throat, exhaustion
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: HSOPITALIZATION
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: He did not have an adverse reaction to the vaccine. He started having congestion about one day prior to testing. He tested positive for COVID-19 in 02/2023. Several days into the infection, he had a deeper cough, so we got him to the doctor to check for other illnesses and he was fine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: Chills started in the middle of the night around 1:30 am and did not resolve until almost lunchtime. The chills were not reduced with clothing, blankets, or heat. By 9:00 am I felt achy and had a headache and very fatigued. I could not work, and I could not even telework I felt so bad. These symptoms ended aroound midnight with the exception of fatigue. Additionally, every time I took a sip of water or tea or tried to eat anything throughout the day, no matter how little, I felt like vomiting. Yesterday I ate 1 piece of toast, 3 crackers, and just 24 oz of liquid (ginger tea, ginger ale) These symptoms have reduced a bit where I don't feel like vomiting, but still feel slightly nauseous when I eat or drink.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Chills started in the middle of the night around 1:30 am and did not resolve until almost lunchtime. The chills were not reduced with clothing, blankets, or heat. By 9:00 am I felt achy and had a headache and very fatigued. I could not work, and I could not even telework I felt so bad. These symptoms ended aroound midnight with the exception of fatigue. Additionally, every time I took a sip of water or tea or tried to eat anything throughout the day, no matter how little, I felt like vomiting. Yesterday I ate 1 piece of toast, 3 crackers, and just 24 oz of liquid (ginger tea, ginger ale) These symptoms have reduced a bit where I don't feel like vomiting, but still feel slightly nauseous when I eat or drink.
Age: 83.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Covid vaccine not viable due to improper temperature storage.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata, Alopecia universalis
Clinical narrative: After receiving the Covid vaccines in Spring 21,  I started experiencing late onset alopecia areata,  I have never had this in the past.  I experienced approx 30% hair loss.  8 weeks after receiving the booster (Pfizer) I went through profuse shedding for approx 4 months which has resulted in a diagnosis of Alopecia universalis.  I have no hair anywhere on my body, including in my nose.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered was expired. Expired on 02/11/2023
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Hospitalization for COPD exacerbation and COVID-19 on dates 1/19/2023- 1/26/2023. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cellulitis, SARS-CoV-2 test positive, Suicidal ideation
Clinical narrative: Hospitalization for suicidal ideation, cellulitis, COVID-19 positive on dates 1/20/2023-1/23/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Age: 76.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Medication error, Product storage error
Clinical narrative: Medication error. Vaccine not viable due to improper temperature storage.