chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: headache; Queasy stomach; vomiting; diarrhea (loose, then changed to runny); severe chills; slight fever at 99.6 degrees F; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jun2023 at 11:00 as dose 1, single (Lot number: GK1337) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Celiac sprue" (unspecified if ongoing); "GERD" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Known allergies: Gluten (celiac sprue)" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; GLUCOSAMINE; TYLENOL; VIT D [VITAMIN D NOS]; OMEGA 3 [FISH OIL]. Past drug history included: Tramadol, reaction(s): "Known allergies: Tramadol"; Ibuprofen, reaction(s): "Known allergies: Ibuprofen". The following information was reported: NAUSEA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "Queasy stomach"; DIARRHOEA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "diarrhea (loose, then changed to runny)"; CHILLS (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "severe chills"; PYREXIA (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered", described as "slight fever at 99.6 degrees F"; VOMITING (non-serious) with onset 20Jun2023 at 19:00, outcome "recovered"; HEADACHE (non-serious) with onset 21Jun2023 at 01:30, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, vomiting, diarrhoea, chills, pyrexia, headache.  Additional information: No other vaccine administered in four weeks. Other medications in two weeks: Levothyroxine/glucosamine/Tylenol/Vit D/omega 3. No Covid prior to vaccination and Not tested for Covid post vaccination. At 7 pm: Queasy stomach, then vomiting and diarrhea (loose, then changed to runny) for approx 30-40 minutes; went to bed with severe chills & slight fever at 99.6 degrees F. Woke up at 1:30 am w/headache.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: Area around the left arm pit swollen it was bland and it presented as a slight discomfort; Area around the left arm pit swollen it was bland and it presented as a slight discomfort; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Jun2023 as dose 3 (booster), single (Lot number: GJ3270) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "covid prior vaccination" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN PROTECT; VITAMIN D [ERGOCALCIFEROL]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EW8736, Location of injection: Arm Left), administration date: 22Apr2021, when the patient was 41-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EE0178, Location of injection: Arm Left), administration date: 20May2021, when the patient was 41-year-old, for Covid-19 immunization. The following information was reported: SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 19Jun2023 at 10:00, outcome "not recovered" and all described as "Area around the left arm pit swollen it was bland and it presented as a slight discomfort". Therapeutic measures were taken as a result of swelling, axillary pain.  Additional Information: The day after the vaccine the patient had the area around the left arm pit swollen it was bland and it presented as a slight discomfort. He took some ibuprofen for 2 days to see if the swelling reduces but changed to an anti-inflammatory and 3 days later it still was swollen.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: it felt like she was punched in her arm for a couple days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 14Mar2021 as dose 1, single (Lot number: ER6208) at the age of 60 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "it felt like she was punched in her arm for a couple days".  Additional information: It was reported that patient first dose of the two parter was on 14Mar2021, her vaccine card just has a sticker on the card and she can kind of barely read it, it says E something, she needs a magnifying glass. She had the vaccine card in her pocket for a while and now the sticker was hard to read. It said E then the next two are hard to read and then it said 6208. EXP wasn't provided on vaccine card. Second letter might be R. She was pretty sure the site for the injection was her arm because it felt like she was punched in her arm for a couple days. Her doses were probably given in her right arm, she doesn't remember and it was not written down, she was left handed so she wouldn't probably get it in that arm, she would get them in the other arm. Her second dose also has just a sticker on vaccine card. She got her initial shots, then two boosters, and then the bivalent . Patient did not received Prior Vaccinations within 4 weeks. No relevant test was reported. No Other Conditions and Investigations was reported.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Umbilical hernia
Clinical narrative: umbilical hernia; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A child patient received BNT162b2 (BNT162B2), on 27Jul2022 at 17:11 as dose 2 (maroon cap), single (Lot number: FT9142) intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history included: "Hx of SARS-CoV2", start date: 18May2022 (unspecified if ongoing); "Constipation", start date: 12May2022 (unspecified if ongoing), notes: Pertinent details: Referred to GI. Concomitant medication(s) included: DTAP intramuscular taken for immunisation, on 30Mar2023 as dose 4, single; INFLUENZA intramuscular taken for immunisation, on 30Mar2023 as dose 2, single. Vaccination history included: BNT162b2 (Dose 1, Single, Time: 17:06, Anatomical site of injection: Right Thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142), administration date: 06Jul2022, for COVID-19 Immunization; Dtap (Manufacturer: Sanofi; No. of previous doses: 3), for Immunization; Influenza (Manufacturer: Sanofi; No. of previous doses: 1), for Immunization. The following information was reported: UMBILICAL HERNIA (non-serious) with onset 30Mar2023, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Specific Relevant Test for thromboembolic events with thrombocytopenia were none.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Nov2022 as dose 7 (booster), single (Batch/Lot number: unknown) at the age of 47 years 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), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recently had a lumpectomy to remove breast cancer" (unspecified if ongoing); "Recently had a lumpectomy to remove breast cancer", start date: Apr2023, stop date: Apr2023; "Allergy to pine nuts" (unspecified if ongoing); "breast infection in mid May", start date: May2023 (unspecified if ongoing); "Allergy to morphine" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 06Jun2023 to 11Jun2023. Clinical course included: She assumed she had a lower immune system right then due to her surgery.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300229398 same patient, different drug, different event.;US-PFIZER INC-202300229412 Same patient and drug, different events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: We recently had COVID Again; We recently had COVID Again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Suspected COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "We recently had COVID Again". Clinical course: The patient had received all shots for Covid, had Covid again.  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: Linked Report(s) : US-PFIZER INC-PV202300110818 same reporter/drug and different patient/events.;
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: severe headache; spike in blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Jun2023 at 14:45 as dose 4 (booster), single (Lot number: G12042) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "fast heartbeat" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication(s) included: ALLOPURINOL. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 22Jun2023 at 02:00, outcome "recovered" (Jun2023), described as "severe headache"; BLOOD PRESSURE INCREASED (non-serious) with onset 22Jun2023 at 02:00, outcome "recovered" (Jun2023), described as "spike in blood pressure". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, blood pressure increased. Additional information: the patient experienced severe headache and spike in blood pressure 30 to 36 hours after vaccination. AE treatment: Ibuprofen, extra dose Losartan.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: test positive; test positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Apr2023, outcome "not recovered" and all described as "test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Apr2023) Positive, notes: When we got home we both tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Reporter stated that her husband and she were fully vaxxed and double booster with Pfizer products. On 20Feb reporter and her husband flew to (PRIVACY) visited (PRIVACY). 30Apr, the day they were flying home, they both woke up sick. When they got home they both tested positive. 01May they started Paxlovid and finished that 5 days later. On 08May, reporter recovered and her husband did not. Despite vaccines, they both were very sick although they did not required hospitalization. She had fever (moderate) for 4 days. Her husband had fever less than 2 days. Her relapse was like having a severe head cold. No fever.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300191485 same reporter/drug /event different patient;
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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 (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease".  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.
Sex: U
Vaccine: COVID19
Symptoms: Blood disorder, Illness, Infection, Renal failure
Clinical narrative: 5 days later I was in kidney failure; Started getting sick that night; Many other infections and blood disorders.; Many other infections and blood disorders.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had covid in Nov2020", start date: Nov2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "Started getting sick that night"; RENAL FAILURE (hospitalization) with onset 2021, outcome "not recovered", described as "5 days later I was in kidney failure"; INFECTION (non-serious), BLOOD DISORDER (non-serious) all with onset 2021, outcome "not recovered" and all described as "Many other infections and blood disorders.". The events "5 days later i was in kidney failure", "started getting sick that night" and "many other infections and blood disorders." required physician office visit. Therapeutic measures were taken as a result of renal failure. Clinical course as: In Mar2021 patent had first Pfizer vaccine. Started getting sick that night and 5 days later patient was in kidney failure. Patient had been hospitalized 6 times and had dialysis twice. Many other infections and blood disorders, always recover but comes back. Patient have been to numerous doctors and didn't know where to turn to. Patient was a healthy person of 67.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Drug ineffective, Suspected COVID-19
Clinical narrative: We recently had COVID Again; We recently had COVID Again; I have lost my sense of taste/ smell, for the 2nd time; I have lost my sense of taste/ smell, for the 2nd time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Suspected COVID-19" (unspecified if ongoing); "I have lost my sense of taste/ smell" (unspecified if ongoing); "I have lost my sense of taste/ smell" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 2023, outcome "unknown" and all described as "I have lost my sense of taste/ smell, for the 2nd time"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "We recently had COVID Again". Clinical course: The patient and her husband had received all shots for Covid, had Covid again and patient had lost all her senses of taste/smell for 2nd time.  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: Linked Report(s) : US-PFIZER INC-202300229697 same reporter/drug and different patient/events.;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in May2023 as dose 5 (booster), single (Batch/Lot number: unknown) 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: "Asthmatic" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Jun2023, outcome "unknown" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2023) Negative, notes: By Sunday, the symptoms were gone, and I tested negative in an antigen test; (13Jun2023) Positive, notes: On 13Jun2023 I tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: To finish patient's previous message-it was apparent that the new COVID strains were immune to the bivalent vaccine. By the way, patient did not have a fever last week or in patient's current Rebound COVID. Patient just thought they should know. In May2023 patient received fifth Pfizer COVID vaccine, the second bivalent. On 13Jun2023 patient tested positive for COVID and received a course of Paxlovid because patient was 69 and asthmatic. By Sunday, the symptoms were gone, and patient tested negative in an antigen test.  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: Linked Report(s) : US-PFIZER INC-PV202300111277 same patient, different drug/event;
Sex: U
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: This is the patient I had that developed PMR with a few days after a Pfizer COVID immunization; This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "This is the patient I had that developed PMR with a few days after a Pfizer COVID immunization".  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 the temporal relation, the association between the event POLYMYALGIA RHEUMATICA  and the suspect product cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-202300206787 Same reporter/drug, different patient;
Age: 75.0
Sex: F
Vaccine: TYP
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: slight leakage from typhoid vaccine from syringe with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 75 years old female patient who had slight leakage from Typhoid Vi Polysaccharide Vaccine [Typhim Vi] from syringe, with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect Typhoid Vi Polysaccharide Vaccine, Solution for injection (lot: V2A451M, strength,  Expiry date: Not reported) via intramuscular route in unknown administration site for optional travel vaccine (immunization).  On 07-JUN-2023 the patient had slight leakage from typhoid vaccine from syringe with no reported adverse event (incorrect dose administered) (latency: same day).  There were no lab data/results available  Action taken with Typhoid Vaccine was not applicable.  At time of reporting, the outcome was Unknown for the 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: 1.67
Sex: F
Vaccine: MEN
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: menquadfi to a patient under 2 years of age with no reported adverse event; Initial information received on 16-Jun-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 20 months old female patient who was under 2 years of age was administered Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history included Cancer with patient who had cancer and was successfully treated and cleared and Acute myeloid leukaemia in remission. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis A Vaccine (Hepatitis A) and Hepatitis B Vaccine (Hepatitis B Vaccine) in the left leg for Prophylactic vaccination.  On 24-May-2023, the patient received a dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection (lot: U7576AD) with unknown strength & expiry date via intramuscular route into the right quadriceps muscle for Immunization with no reported adverse event (product use issue) (latency: same day).  Action taken: not applicable.  At time of reporting, the 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 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.
Sex: U
Vaccine: FLUR4
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired Flublok was administered to a patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient, expired influenza quadrivalent recombinant vaccine [Flublok QIV] was administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 19-Jun-2023, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine (form, strength, lot number: unknown) (expiry date: 14-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested  On 19-Jun-2023 the patient had a non-serious event of expired flublok was administered to a patient with no reported adverse event (expired product administered) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  It was unknown if any lab data/tests available.  Action taken with quadrivalent recombinant influenza vaccine (Flublok QIV) was not applicable.  Outcome: 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 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.
Sex: U
Vaccine: IPV, PNC13
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: nurse accidentally gave Ipol to patient instead of Prevnar with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid  non-serious case received from a Non-health professional.  This case involves an unknown age and unknown gender patient and is reported patient were given IPV (VERO) [IPOL] instead of pneumococcal vaccine CONJ 13V (CRM197) [prevnar 13] 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 received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site  On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) instead of PREVNAR 13 (wrong product administered) latency on the same day. Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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: 1.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered expired pentacel with no reported adverse event; Initial information received on 21-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 year old female patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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 hepatitis B vaccine for Prophylactic vaccination (immunization).  On 20-Jun-2023, the patient received an expired 0.5 mL dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/ HIB(PRP/T) vaccine, suspension for injection (batch number: UJ671AA; Expiry date: 13-May-2023) via unknown route in the left vastus lateralis for immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event administered expired pentacel 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: 1.25
Sex: U
Vaccine: IPV, PNC13
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: patient were given IPOL instead of Prevnar 13 with no reported adverse event; Initial information received on 22-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old and unknown gender patient and is reported patient were given IPV (VERO) [IPOL] instead of pneumococcal vaccine CONJ 13V (CRM197) [prevnar 13] 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 received a dose of suspect PREVNAR 13 not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site  On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection strength, dose, expiry date, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) instead of PREVNAR 13 (wrong product administered) latency on the same day.Information on the batch number was requested.  Reportedly The patient is 15 months old and they were given IPOL instead of Prevnar 13. The patient previously received 3 doses of IPOL at 2, 5, and 7 months.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event patient were given ipol instead of prevnar 13/incorrectly administered ipol to a patient, 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: MEN, MNQ
Symptoms: Injection site pain, Vaccination site pain
Clinical narrative: burning sensation on the injection site; Initial information was received on 22-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced burning sensation on the injection site after receiving meningococcal a-c-y-w135 (d conj) vaccine [Menactra] and 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.  On an unknown date, the patient received a unknown dose of suspect meningococcal a-c-y-w135 (t conj) (Solution for injection) for immunization and meningococcal a-c-y-w135 (d conj) vaccine (Solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was unknown at this time.  On an unknown date the patient developed a non-serious event of burning sensation on the injection site (vaccination site pain) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine and (unknown latency) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  Action taken with meningococcal vaccine (Menquadfi) and meningococcal vaccine (Menactra) was not applicable.  It was not reported if the patient received a corrective treatment for the event (burning sensation on the injection site).  At time of reporting, the outcome was Unknown for the event burning sensation on the injection site.
Age: 0.33
Sex: F
Vaccine: IPV
Symptoms: Rash
Clinical narrative: had a reaction that involved a rash/rash was worse after the 6 month dose; Initial information received on 22-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old female patient who had a reaction that involved a rash at 4 month and rash was worse after the 6 month dose while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number, strength, dose, expiry date not reported) via unknown route in unknown administration site as immunization.  On an unknown date the patient had a reaction that involved a rash at 4 months and rash was worse after the 6 month dose (rash) (unknown latency) following the administration of IPV (VERO).  It was reported "After that the patient did not receive any further vaccines. Now, the patient is going to an allergist and the allergist is requesting that the nurse send a dose of IPOL in a syringe out of the IPOL MDV so he can inject the patient with IPOL and then Boosterix to determine what the patient is allergic too and assess the reaction. The nurse asks if it is safe to send IPOL in a syringe to the Allergist's office."  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: today a child received an expired Daptacel vaccine, with no reported adverse event; Initial information was received on 23-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Child male patient who reported that today a child received an expired diphtheria-15/tetanus/5 ac pertussis vaccine (daptacel) 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 hepatitis b vaccine for Prophylactic vaccination.  On 23-Jun-2023, the patient received a dose of 0.5 ml of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (strength, expiry date reported) (lot C5893AA) via intramuscular route in unknown administration site for Immunization.  On 23-Jun-2023 the patient developed a non-serious event of today a child received an expired daptacel vaccine, with no reported adverse event (expired product administered) (latency : same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Daptacel) was not applicable.  At time of reporting, the outcome was Unknown for the event today a child received an expired daptacel 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness; Slight swelling; Itching; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: Redness), swelling (Verbatim: Slight swelling) and pruritus (Verbatim: Itching). The outcome of the erythema, swelling and pruritus were resolved (duration 1 month).   It was unknown if the reporter considered the erythema, swelling and pruritus to be related to Shingrix.     It was unknown if the company considered the erythema, swelling and pruritus to be related to Shingrix.   Additional Information: GSK Receipt date: 20-JUN-2023 The patient complaints of redness, slight swelling, and itching for approximately 1 month after vaccine administration. The reporter agreed to follow up from GSK.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Vaccinated SHINGRIX patient who recently had Shingles/ Suspected vaccination failure; Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Vaccinated SHINGRIX patient who recently had Shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2023 The physician had vaccinated Shingrix patient who recently had Shingles. The reporter asked question that should the patient be vaccinated again and if so, how long should she wait to receive the vaccine after contracting shingles. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details confirming shingles were unknown at a time of reporting.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered a dose of Boostrix on 21Jun2023 from lot number 4M2EZ, which had an expiration date of 03Jun2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4M2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 21-JUN-2023, the patient received Boostrix. On 21-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Boostrix on 21Jun2023 from lot number 4M2EZ, which had an expiration date of 03Jun2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-Jun-2023 The pharmacist reported that an patient was administered with a dose of Boostrix The vaccine administration facility was the same as Primary Reporter Patient received a dose of Boostrix on June 21, 2023, which was expired on June 03, 2023, which led to expired vaccine used. The reporter consented to follow up.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: might have been given intradermally around one-tenth of a milliliter, with no reported adverse event; Initial information was received on 22-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (Patient).  This case involves 40 years old male patient who have been influenza quadrival a-b intradermal vaccine [Fluzone] taken intradermally around one-tenth of a milliliter with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient might have been received a dose around one-tenth of a milliliter suspect influenza quadrival A-B intradermal vaccine Solution for injection in pre-filled syringe (lot number: UT5570BA, strength, administrative site, expiration date: Unknown) via intradermal route for Immunization (immunisation) with no reported adverse event (incorrect dose administered) (latency: same day)  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event might have been given intradermally around one-tenth of a milliliter, 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 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: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: I contracted shingles, zoster virus. I've read that the vaccine can reactivate this chickenpox virus, which usually affects older people. I state that I am a sportsman and the virus hit me during a period of high sporting stress. But I doubted, being young that there could also be a correlation with the vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Myocarditis
Clinical narrative: MYOCARDITIS HYPOXIA
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Muscle twitching
Clinical narrative: Muscle twitching in both arms, legs and torse. for 5 days.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received both vaccines on 6-23-23. 2 days later leg became red & swollen and warm to touch. Pt being treated with Keflex due to cellulitis. Pt has not had any fever.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Reported Symptoms:  10024264:LETHARGY; Narrative:  At the time of the reported ADR an 89yo patient with a historical ADR of Moderna Covid - 19 vaccine induced Lethargy which was reported by a staff Nurse on November 29, 2022.  The report didn't include when and where the Moderna-covid 19 vaccine was administered or by who. However the patient's vaccine record showed he had received Pfizer Mrna.
Sex: F
Vaccine: COVID19
Symptoms: Injection site indentation, Injection site muscle atrophy, Skin atrophy
Clinical narrative: Following the COVID-19 Pfizer vaccine, I noticed the dent in my left shoulder at the injection site, which has become significantly larger and appears to be muscular atrophy. I have been advised that the skin and fat at the site have died in that caused the dented region.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Adverse food reaction, Vomiting
Clinical narrative: After receiving the first covid vaccine I started having terrible stomach pain after eating certain foods and violent vomiting. The stomach pain felt as strong as appendicitis. After several bouts of this I did a good elimination process and found that I could no longer tolerate stabilizers or thickener additives such as xantham gum, guar gum, carrageenan etc.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Kinrix vaccine given in error instead of DTAP.  Error noted during monthly inventory county.  Attempted to contact parent.  Phone number no longer working. Alert put in child's chart.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Cellulitis, Feeling hot, Peripheral swelling
Clinical narrative: Swelling of left thigh and warm to touch noted by patient's parent on the evening of the vaccination. Diagnosed with cellulitis two days after vaccination. Patient treated with cephalexin (weight-based dosing) by mouth every 8 hours for 5 days.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient had no reactions to vaccine