chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 17:00 as dose 1, single (Lot number: HD9876) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL0142, Anatomical location: Arm Left), administration date: 04Jan2021, for COVID-19 Immunization; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL3247, Anatomical location: Arm Left), administration date: 25Jan2021, for COVID-19 Immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FK9894, Anatomical location: Arm Left), administration date: 01Apr2022, for COVID-19 Immunization; bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: CRJ2524, Anatomical location: Arm Left), administration date: 30Sep2022, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (16Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Negative; (18Oct2023) Negative. Therapeutic measures (Paxlovid therapy start date: 12Oct2023, stop date: 16Oct2023) were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event vaccination failure and COVID 19 cannot be ruled out.    ,Linked Report(s) : US-PFIZER INC-202300335901 same patient, different drug and event;
Age: 51.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Slight sore arm and tiredness beginning 24 hrs after vaccination; Slight sore arm and tiredness beginning 24 hrs after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 19Oct2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 19Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunization; Covid-19 vaccine (DOSE 2), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER)), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious) all with onset 20Oct2023 at 16:30, outcome "recovered" and all described as "Slight sore arm and tiredness beginning 24 hrs after vaccination". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information: the patient had no known allergies. The patient was not covid tested post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I then tested positive 2 days later; 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 female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 11:00 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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 (Booster), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 4 (Booster), Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 5 (Booster), Manufacturer unknown), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious) with onset 12Oct2023, outcome "recovered" (Oct2023), described as "I then tested positive 2 days later". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient's husband tested negative on 10Oct. Patient was negative and went to get the COVID vaccine, the first date that it was available, which was weird. Patient then tested positive 2 days later, and then took paxlovid. 5 days later and tested negative. Patient had paxlovid treatment from 12Oct2023 to 16Oct2023. Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335918 same patient, different drug and event;
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 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 71-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Oct2023 at 12:00 as dose 1, single (Lot number: HF9275) at the age of 71 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset Oct2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19 as Paxlovid from 11Oct2023 to 16Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336156 same patient, different drug and event;
Sex: U
Vaccine: COVID19
Symptoms: Brain oedema, Fatigue, Hypersomnia
Clinical narrative: I experienced the symptoms of brain swelling; Very little, very minor, just tiredness until that time/ Extreme tiredness; I slept for almost 24 hours on and off; 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 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 17Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 17Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; barbital (BARBITAL), from 17Oct2023 (Batch/Lot number: unknown) to 17Oct2023 at single (dose number unknown, single). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN OEDEMA (medically significant), outcome "unknown", described as "I experienced the symptoms of brain swelling"; FATIGUE (non-serious), outcome "unknown", described as "Very little, very minor, just tiredness until that time/ Extreme tiredness"; HYPERSOMNIA (non-serious), outcome "unknown", described as "I slept for almost 24 hours on and off". Clinical course: Patient only got that reaction with that (Barbital) thing. Patient took three vaccinations all at the same time; took Shingrix, Pfizer COVID Vaccine and also took the flu (Unspecified Flu Vaccine); Another one was Comirnaty. Patient wanted to know if there was any barbital in the ingredients whether it was in the actual medicine, vaccine or in the push system and does it had a push system. Patient did not had any flu reaction at all. What they had was like an allergic reaction to a histamine or barbital ingredient and it caused brain swelling and they had a pretty severe reaction (Intent: History). So, wanted to know was there any barbital in the medication for the push system. Patient's current vaccination was on Tuesday. Took barbital, there were everything from caffeine to morphine. So, they had to be very careful but did not expected it in the vaccination. But they thought there was one, because they only got that reaction with that (Barbital) thing. And was trying to find what it was. So, didn't take it again. Patient experienced very little, very minor, just tiredness until that time. Extreme tiredness, slept for almost 24 hours on and off and experienced the symptoms of brain swelling. And was just trying to figure out. was that because they took three at the same time. which they have not done before.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: injection site pain; Muscle Pain; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 at 11:45 as dose 1, single (Lot number: HF9275) at the age of 57 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 20Oct2023 at 05:00, outcome "not recovered"; MYALGIA (non-serious) with onset 20Oct2023 at 05:00, outcome "not recovered", described as "Muscle Pain"; VACCINATION SITE PAIN (non-serious) with onset 20Oct2023 at 05:00, outcome "not recovered", described as "injection site pain". Therapeutic measures were taken as a result of vaccination site pain, myalgia, headache with Advil.  Additional information: Patient got vaccine at Workplace clinic. Patient did not have other vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested COVID post vaccination. Patient had no known allergies.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: covid-19; covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Mar2023 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE, start date: 01Sep2021. Past drug history included: Minocycline, reaction(s): "Known allergies: Minocycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 10Oct2023 to 14Oct2023 as treatment of COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 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 43-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. 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 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious), outcome "unknown", described as "COVID 19 Treatment". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19.  Additional information: Patient also received treatment with Paxlovid from 07Oct2023 to 11Oct2023 for Covid-19.  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-202300336347 Same patient, different product, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: covid-19; covid-19; Vaccine Brand: Pfizer / BioNTech, Vaccine Administration date: 09Oct2022, Vaccine Dose number: 5, Vaccine Brand: Moderna,Vaccine Administration date: 19May2023; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 71-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Oct2022 as dose 5 (booster), single (Lot number: GJ6739), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2023 as dose 6 (booster), single (Lot number: AS718QB), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19May2023, outcome "recovered", described as "Vaccine Brand: Pfizer / BioNTech, Vaccine Administration date: 09Oct2022, Vaccine Dose number: 5, Vaccine Brand: Moderna,Vaccine Administration date: 19May2023"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (16Oct2023) and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Oct2023) Negative; (21Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid as treatment from 09Oct2023 to 14Oct2023.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: I have a little red mark on the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset Oct2023, outcome "not recovered", described as "I have a little red mark on the injection site". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: patient was tested for COVID and the result came back positive. However the lab made a mistake as it was not the patient's result. She was given the PAXLOVID medication, but the patient didn't take it or open the box as her HCP told her not to take it because of the lab error. The patient had the Pfizer COVID-19 vaccine formula 2023-2024 three weeks ago. (Oct2023). She had a little red mark on the injection site. It had been about little less than three weeks maybe 2 and half weeks, the small red dot was still there. The patient thought it's a size of a dime.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Weight, Weight decreased
Clinical narrative: husband has acid reflux; He has lost 103lbs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 62-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 as dose 3 (booster), single (Lot number: CSJ6738) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes", start date: 1999 (ongoing), notes: Type 2 diabetes diagnosed about 24 years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "not recovered", described as "husband has acid reflux"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "He has lost 103lbs". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastrooesophageal reflux disease.  Additional information: Wife's patient reported "acid reflux after all previous Covid shots" and "He had no other problems with the vaccine". His acid reflux has been off and on. Exact start date unknown. He usually took tums, but is on medication now. Acid reflux is consistent at the time of the report, but he watched what he eats.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: heart attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division.  A female patient received bnt162b2 (BNT162B2), on 19Nov2021 as dose number unknown, signle (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid issue" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death) with onset 21Nov2021, outcome "fatal", described as "heart attack". The patient date of death was 21Nov2021. Reported cause of death: "heart attack". It was not reported if an autopsy was performed. Additional information: Reporter lost mom (death) due to a covid vaccine she was given on 19Nov2021 and died 21Nov2021. Patient was mostly healthy woman with thyroid issue minimal high cholesterol etc. Patient suffered a heart attack caused by a pfizer vaccine she received states that on her death certificate.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: heart attack
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Malaise
Clinical narrative: heart attack; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division.  A female patient received bnt162b2 (BNT162B2), on 19Nov2021 as dose number unknown, signle (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thyroid issue" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death) with onset 21Nov2021, outcome "fatal", described as "heart attack". The patient date of death was 21Nov2021. Reported cause of death: "heart attack". It was not reported if an autopsy was performed. Additional information: Reporter lost mom (death) due to a covid vaccine she was given on 19Nov2021 and died 21Nov2021. Patient was mostly healthy woman with thyroid issue minimal high cholesterol etc. Patient suffered a heart attack caused by a pfizer vaccine she received states that on her death certificate.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: heart attack
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea, Somnolence
Clinical narrative: runny nose and sore throat like a cold; runny nose; sore throat; tired; sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Oct2023 as dose 1, single (Lot number: HF9275) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 12Sep2022, for COVID-19 immunization, reaction(s): "no reactions"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 11Oct2021, for COVID-19 immunization, reaction(s): "no reactions"; bnt162b2 (DOSE 2, SINGLE), administration date: 05Mar2021, for COVID-19 immunization, reaction(s): "no reactions"; bnt162b2 (DOSE 1, SINGLE), administration date: 12Feb2021, for COVID-19 immunization, reaction(s): "no reactions". The following information was reported: RHINORRHOEA (non-serious) with onset 21Oct2023, outcome "unknown", described as "runny nose"; NASOPHARYNGITIS (non-serious) with onset 21Oct2023, outcome "unknown", described as "runny nose and sore throat like a cold"; SOMNOLENCE (non-serious) with onset 21Oct2023, outcome "unknown", described as "sleeping"; OROPHARYNGEAL PAIN (non-serious) with onset 21Oct2023, outcome "unknown", described as "sore throat"; FATIGUE (non-serious) with onset 21Oct2023, outcome "unknown", described as "tired". Additional information: The patient got vaccination on Thursday, 19Oct2023, and it says on the vaccination card: "Pfizer Comirnaty HF9275".  The patient has had four Pfizer COVID 19 vaccines previously with no reactions, until this most recent one on 19Oct2023. She got this dose 5 on 19Oct2023 of "Pfizer Comirnaty HF9275" and have developed symptoms of runny nose and sore throat like a cold, which she usually didn't get and was not normal for her. The patient stated that she just tired, sleeping and runny nose. She got these symptoms 2 days after vaccination.  She confirmed she is an adult patient.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: muscle weakness in her left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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: MUSCULAR WEAKNESS (non-serious) with onset 2023, outcome "unknown", described as "muscle weakness in her left leg". Therapeutic measures were taken as a result of muscular weakness.  Additional Information: She had muscle weakness in her left leg and she was wondering if it's going to get any better. Patient added that it does not hurt but she had to use a walker. She's already seen 2 doctors and they don't have a clue.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: extremely ill/horribly ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: Having covid three times. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 Immunization, reaction(s): "Illness"; Bnt162b2 (Dose 2), for Covid-19 Immunization, reaction(s): "Illness". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "extremely ill/horribly ill". Additional information: Event Description: How sick the covid vaccine and booster made me. Having covid three times was a better reaction than I had to having the covid vaccine times two and one booster. Made me extremely ill and I am having long-term covid effects. The covid vaccine times two and the booster times one made me horribly ill.   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-PV202300175426 same patient, drug and event with different dose;
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2 NOS), in Apr2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if 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 Oct2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Influenza like illness, Malaise, Rash, Vaccination site inflammation
Clinical narrative: I have been feeling really bad; large rash all the way around; I have flu like symptom; area is red and inflamed and it feels heat. The whole area feels hot and red/arm where I got the injection is swallowing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 12:00 as dose 1, 0.3 ml single (Lot number: HG9498) at the age of 76 years intramuscular, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 21Oct2023, outcome "unknown", described as "I have been feeling really bad"; INFLUENZA LIKE ILLNESS (non-serious) with onset 21Oct2023, outcome "unknown", described as "I have flu like symptom"; VACCINATION SITE INFLAMMATION (non-serious) with onset 21Oct2023, outcome "unknown", described as "area is red and inflamed and it feels heat. The whole area feels hot and red/arm where I got the injection is swallowing"; RASH (non-serious) with onset 21Oct2023, outcome "unknown", described as "large rash all the way around". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site inflammation. The patient was treating it with Aloe. Additional information: Consumer stated, "I got the Pfizer vaccine on Friday and for the past three days I have been feeling really bad. My arm where I got the injection was swelling with a large rash all the way around; The area is red and inflamed and it feels heat. The whole area feels hot and red. I have flu like symptom for the last three days." The patient was wondering if this was normal and if that will continue to happen. The patient just treated it with like Aloe because it's, the area was red and inflamed and it felt heat. The whole area felt hot and red.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Vaccination site pain, Vaccination site reaction
Clinical narrative: Took the same Pfizer COVID shot also was down for 3 days with fever; Arm soreness and little stiffness; Arm soreness and little stiffness; Chills; little pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Took the same Pfizer COVID shot also was down for 3 days with fever"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE REACTION (non-serious), outcome "unknown" and all described as "Arm soreness and little stiffness"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "little pain".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300340866 Same reporter and drug, similar events, different patient;
Sex: U
Vaccine: RSV
Symptoms: Erythema, Feeling abnormal, Peripheral swelling
Clinical narrative: Whew big red egg on arm; Whew big red egg on arm; feel punk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "Whew big red egg on arm"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feel punk". The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Somnolence
Clinical narrative: tired; groggy; under the weather/Feeling abnormal; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2023US136607.  A 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 19Oct2023, outcome "unknown", described as "groggy"; FATIGUE (non-serious) with onset 19Oct2023, outcome "unknown", described as "tired"; FEELING ABNORMAL (non-serious) with onset 19Oct2023, outcome "unknown", described as "under the weather/Feeling abnormal".  Additional information: Stated had Covid vaccine yesterday, today was under the weather, groggy, tired.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I have gotten the Pfizer vaccine and still ended up with COVID so I'm not the biggest fan of it.; I have gotten the Pfizer vaccine and still ended up with COVID so I'm not the biggest fan of it.; 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 adult female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 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) all with onset 2023, outcome "unknown" and all described as "I have gotten the Pfizer vaccine and still ended up with COVID so I'm not the biggest fan of it.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: severe itching; severe case of hives/urticaria; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001260 (Novavax).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Lot number: GH9694) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, SINGLE), for COVID-19 immunization; Comirnaty (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "recovered", described as "severe case of hives/urticaria"; PRURITUS (non-serious), outcome "unknown", described as "severe itching". Therapeutic measures were taken as a result of urticaria.  Additional information: The patient had a severe case of hives that lasted 2 days with an unspecified antihistamine treatment.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: extremely ill/horribly ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: Having Covid three times. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "extremely ill/horribly ill".  Additional information: Having covid three times was a better reaction than she had to having the covid vaccine times two and one booster. Made her extremely ill and she was having long-term covid effects. The covid vaccine times two and the booster times one made her horribly ill.   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-202300340351 same patient, drug and event with different dose;US-PFIZER INC-202300340350 same patient, drug and event with different dose;
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My father died due to your mRNA vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: DEATH (death), outcome "fatal", described as "My father died due to your mRNA vaccination". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: My father died due to your mRNA vaccination
Age: 66.0
Sex: F
Vaccine: FLUX, RVX
Symptoms: Cough, Wheezing
Clinical narrative: coughing; wheezing; Initial information was received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 66 years old female patient who experienced coughing and wheezing after receiving influenza vaccine, RSV vaccine and treprostinil sodium.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included Tadalafil.  On an unknown date in Apr-2021, the patient started taking treprostinil sodium at a dose of 0.05 ug/kg via intravenous not other specified (nos) (form, strength, frequency, lot number, expiration date: unknown) for Pulmonary arterial hypertension.  On 26-Sep-2023, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer and unknown dose of suspect RSV vaccine not produced by Sanofi Pasteur (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization. The information on the batch number was requested.  On an unknown date in Sep-2023 the patient had coughing (cough) and wheezing (unknown latency) following the administration of influenza vaccine, RSV vaccine and treprostinil sodium.  No action was taken with treprostinil sodium and action taken with influenza vaccine and RSV vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (coughing, wheezing).  At time of reporting, the outcome was Unknown for the events.
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vaccines were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine with no reported adverse event; vaccines were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 90 years old male patient and reporter reported Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received 0.7 ml of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot number: U8162BA) (Expiry date: 30-Jun-2024) (Strength: High dose) (Frequency: once) (with an unknown formulation) via intramuscular route in the right deltoid for prophylactic vaccination (Immunisation).  On 16-Oct-2023, reporter reported Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine with no reported adverse event (product storage error, latency: unknown) (poor quality product administered, latency: same day).  It was reported, Supervisor called in because they received a shipment of FLUZONE HIGH DOSE QUADRIVALENT on 16Oct2023 that was shipped out on 12Oct2023, and the facility received a notice from VAXSERVE that the vaccines were out of the stability range and to not use any of the vaccine, but at the time the clinic already had given 4 doses of the vaccine out of stability. Caller was asking about what to do next if the vaccines should be repeated. This inquiry was submitted to PV since it was not supported by the extended stability information post excursion and the dose was given to a patient.  Action taken: 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 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: 1.75
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient being administered a vaccine post-excursion with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case is linked to case 2023SA322119(CLUSTER).  This case involves a 21 months old male patient who was administered a IPV (VERO) (IPOL) vaccine post-excursion (with no reported adverse event).  The patient's past vaccination(s) included PENTACEL. The patient's past medical history, medical treatment(s), and family history were not provided.  On an unknown date, the patient received dose 1 of 0.5 ml of suspect IPV (VERO) Suspension for injection (Batch number: W1A101M, expiry date: unknown strength: standard) via intramuscular route in the left thigh as Immunization  On an unknown date, the patient was administered a vaccine post-excursion (with no reported adverse event) (poor quality product administered) (Latency: same day)  It was reported" A doctor is reporting a temperature excursion that occurred one month ago and was advised to call us to determine if the vaccines are still viable for use. He also stated that the vaccines were used for three patients after the temperature excursion. Product/s: IPOL was Opened products and the reason: unknown Max temperature reached: 47.1°F Duration out of labelled range: 15 minutes Human error was unknown. The extended stability data did not cover the excursion. 3 patients were involved. Previous excursion: None. The patients were fine, and the reporter did not report any side effects."  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 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: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: product was given to a patient after it had expired with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves an unknown age and unknown gender patient who experienced product was given to a patient after it had expired with no reported adverse event, after receiving vaccine Hib (Prp/T) Vaccine [Act-Hib].  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 Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (strength: unknown) (lot number, expiry date: not reported) via unknown route in unknown administration site for immunization.  On an unknown date the product was given to a patient after it had expired, with no reported adverse event (expired product administered) (latency: same day) following the administration of Hib (Prp/T) Vaccine.  Action taken: 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 Directive and Regulatory Authority 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: 5.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: she administered pentacel to a patient instead of the scheduled Daptacel today with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 5 years old female patient who was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient instead of the scheduled Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] today 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 Poliomyelitis vaccine (inactivated) (ipol) for Immunisation.   On 18-Oct-2023, the patient received 0.5 ml (Dose 1) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ957AB) (strength: standard) (Frequency: once) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation).  On 18-Oct-2023, the patient was administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] to a patient instead of the scheduled Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] today with no reported adverse event (wrong product administered) (latency: same day).  It was reported, Nurse called to notify that she administered PENTACEL to a patient instead of the scheduled Daptacel today, 18Oct2023. Nurse said that patient received Ipol today as well so they're wondering if there are recommendations that can be e-mailed when patients receive an extra IPV dose! Outbound  This situation is reported as an off-label use as per local labelling due to administering PENTACEL to a 5-year-old patient. This situation is reported as a medication error due to administering PENTACEL to a patient who was supposed to receive Daptacel.  Action taken: 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 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.