chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: knocked me out for two days, meaning I had to sleep for 2 days; injection site was sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 3 (booster), 0.3 ml single (Lot number: GJW665) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing); "Knee replacement" (unspecified if ongoing). Concomitant medication(s) included: DILAUDID taken for knee arthroplasty; MAXZIDE taken for hypertension. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot number: ER2613), administration date: 17Mar2021, when the patient was 74-year-old, for Covid-19 immunization, reaction(s): "I did have COVID"; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 immunization, reaction(s): "I did have COVID".   The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Nov2022, outcome "unknown", described as "injection site was sore"; HYPERSOMNIA (non-serious) with onset Nov2022, outcome "unknown", described as "knocked me out for two days, meaning I had to sleep for 2 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypersomnia, vaccination site pain.  Additional information: Patient had no prior vaccinations (within 4 weeks), but had COVID and waited 3 months before getting the booster. Treatment in response to adverse event was reported by the patient as 'no' and the patient just wanted to report it for keeping the data up to date.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282627 same patient different dose/drug/event;
Age: 55.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Illness, Off label use, Pain, Product use issue
Clinical narrative: I received the vaccination I also got the Flu vaccine at the same time; I received the vaccination I also got the Flu vaccine at the same time; I was horribly sick; body ache; high, high fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:40 as dose 5 (booster), single (Lot number: GJ6665, Expiration Date: 30Jun2023) at the age of 55 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 31Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: I have Asthma and I do not want to go too far on my own medical history.". The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "I was horribly sick"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "body ache"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "high, high fever"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 31Oct2022, outcome "unknown" and all described as "I received the vaccination I also got the Flu vaccine at the same time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, pain, pyrexia.  Additional information: the patient did not had any investigations in last two weeks. It was reported as I was horribly sick starting Tuesday to somewhat today but you now very, very situation better then now (at the time of report). The patient was treated with Tylenol cold and Ibuprofen. The patient I think it was my left arm, but they did one on the one side and one in the other, so I am not sure which one went where but it was top of arm." For Anatomical site of administration it was reported as I think it was my left arm, but they did one on the one side and one in the other, so I am not sure which one went where but it was top of arm.
Age: 55.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pyrexia
Clinical narrative: I received the vaccination I also got the Flu vaccine at the same time; I received the vaccination I also got the Flu vaccine at the same time; I was horribly sick; body ache; high, high fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:40 as dose 5 (booster), single (Lot number: GJ6665, Expiration Date: 30Jun2023) at the age of 55 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 31Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: I have Asthma and I do not want to go too far on my own medical history.". The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "I was horribly sick"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "body ache"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "high, high fever"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 31Oct2022, outcome "unknown" and all described as "I received the vaccination I also got the Flu vaccine at the same time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, pain, pyrexia.  Additional information: the patient did not had any investigations in last two weeks. It was reported as I was horribly sick starting Tuesday to somewhat today but you now very, very situation better then now (at the time of report). The patient was treated with Tylenol cold and Ibuprofen. The patient I think it was my left arm, but they did one on the one side and one in the other, so I am not sure which one went where but it was top of arm." For Anatomical site of administration it was reported as I think it was my left arm, but they did one on the one side and one in the other, so I am not sure which one went where but it was top of arm.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: ER2613) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DILAUDID ATROPIN taken for knee arthroplasty; MAXZIDE taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Patient had COVID and they told her she had to wait 3 months before she could get the booster. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I did have COVID.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282571 same patient different dose/drug/event;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: She has chills; Body pain; 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), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: She has allergies to some medications and some things and has strong allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Body pain"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "She has chills". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She has chills"; PAIN (non-serious), outcome "unknown", described as "Body pain". Additional Information: It was reported that she got the vaccines from Pfizer they recommended four doses but she had allergies to some medications and some things and had strong allergies and spoke with someone that Pfizer vaccines did not ask anything that she couldn't have it.  She had chills and body pains and wants to know if the 4 dose has the same things as the first 3 vaccines.  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-202201282564 Same product, patient, event and different dose;US-PFIZER INC-202201282775 Same product, patient, event and different dose;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: She has chills; Body pain; 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), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "she has allergies to some medications" (unspecified if ongoing), notes: she had allergies to some medications.; "some things and has strong allergies" (unspecified if ongoing), notes: Some things and had strong allergies. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "She has chills", "Body pain"; Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown), for Covid-19 immunization, reaction(s): "She has chills", "Body pain". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "She has chills"; PAIN (non-serious), outcome "unknown", described as "Body pain".  Additional information: Caller said she had a question and she got the three vaccines from Pfizer they recommended four doses but she had allergies to some medications and some things and had strong allergies and spoke with someone that Pfizer vaccines didn't ask anything that she couldn't have it.  She had chills and body pains and wanted to know if the 4 dose had the same things as the first 3 vaccines? The guy she talked to last time the vaccines did not have any components that mentioned all the medications  that she was allergic. Was the same components as 3 other vaccines.  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-202201282564 Same patient/product/events, different dose;US-PFIZER INC-202201282774 Same patient/product/events, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: when my wife got her shot they (Pfizer) talked to her briefly she was fine, she was nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), in 2021 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: NERVOUSNESS (non-serious) with onset 2021, outcome "unknown", described as "when my wife got her shot they (Pfizer) talked to her briefly she was fine, she was nervous".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: he got small rashes down his back/ got more on his arm a couple of days later/ rash was popping up in random areas; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 11 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: FLOVENT taken for asthma (ongoing). The following information was reported: RASH (non-serious) with onset 2022, outcome "not recovered", described as "he got small rashes down his back/ got more on his arm a couple of days later/ rash was popping up in random areas". Therapeutic measures were taken as a result of rash.  Additional information: Caller stated after her son's first vaccine, maybe not even a week later, he got small rashes down his back. Caller stated they thought it was a skin reaction so they put steroid cream on it and it calmed down. Caller stated then he got more on his arm a couple of days later so they put more steroid cream on it and they thought it went away. Caller clarified after the first vaccine the rash was popping up in random areas and the cream made it better but it didn't completely go away. The patient had medical history of asthma: when he got a cold or flu, he always got it bad in his lungs. One reason why he got the Covid 19 vaccine. There were no prior vaccinations (within 4 weeks), no family medical history relevant to Adverse Events (AEs) and no relevant tests. Other medicines Flovent: inhaler that he had always taken to make sure his asthma did not act up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received covid 19 treatment, Paxlovid, from 25Oct2022 to 29Oct2022. The patient has no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 31Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 19Jul2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 74 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Slightly elevated blood pressure" (unspecified if ongoing), notes: Rx treated. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which was Paxlovid treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201286149 Same reporter/patient, same drug, different AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (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), as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "mild asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (2022) Positive, notes: subsequently tested positive for COVID; (28Oct2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 21Oct2022 to 25Oct2022. The patient got COVID rebound after completing paxlovid treatment. Tested negative on about day 8, then began feeling symptoms again and subsequently tested positive for COVID.  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-202201282917 same patient, different drug, different event;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment drug was Paxlovid.  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: Ear disorder, Musculoskeletal stiffness, Myalgia
Clinical narrative: stiffness/ all over body stiffness; muscle pain; Son and friend had muffled ear/felt like there was water in ear but it was better within 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness/ all over body stiffness"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; EAR DISORDER (non-serious), outcome "recovered", described as "Son and friend had muffled ear/felt like there was water in ear but it was better within 24 hours".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201282842 same reporter, different dose and different event;
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Limb discomfort, Pain in extremity
Clinical narrative: he had some soreness under both arms; some soreness under both arms and going to her breast; I am feeling a lot of discomfort under both arms; Painful and uncomfortable and sore as well as in her upper back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine janssen (Caller states she had J&J last year), administration date: 2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "he had some soreness under both arms"; BREAST PAIN (non-serious), outcome "unknown", described as "some soreness under both arms and going to her breast"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I am feeling a lot of discomfort under both arms"; BACK PAIN (non-serious), outcome "unknown", described as "Painful and uncomfortable and sore as well as in her upper back".
Sex: F
Vaccine: PNC20
Symptoms: Guillain-Barre syndrome, Hypoaesthesia oral, Laboratory test, Lumbar puncture abnormal, Paraesthesia oral
Clinical narrative: she was diagnosed Guillain-Barre syndrome and stayed 28 days in the hospital before being discharged; She stated it started with numbness and tingling in the tongue and lips; She stated it started with numbness and tingling in the tongue and lips; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization), outcome "unknown", described as "she was diagnosed Guillain-Barre syndrome and stayed 28 days in the hospital before being discharged"; HYPOAESTHESIA (hospitalization), PARAESTHESIA (hospitalization), outcome "unknown" and all described as "She stated it started with numbness and tingling in the tongue and lips". The patient was hospitalized for Guillain-Barre syndrome, hypoaesthesia, paraesthesia (hospitalization duration: 28 day(s)). The patient underwent the following laboratory tests and procedures: multiple tests: 2 lumbar punctures, notes: had multiple tests including 2 lumbar punctures; Guillain-Barre syndrome, notes: several tests and trips to the hospital, she was diagnosed Guillain-Barre syndrome. The clinical course was reported as follows: she stated it started with numbness and tingling in the tongue and lips. After several tests and trips to the hospital, she was diagnosed Guillain-Barre syndrome and stayed 28 days in the hospital before being discharged. Caller mentioned she saw 25 different neurologists and had multiple tests including 2 lumbar punctures. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Wrong product administered
Clinical narrative: Nausea; dizziness; Pfizer Bivalent Dose Number: 1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 as dose 1 (bivalent), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 06Nov2022, outcome "unknown", described as "Pfizer Bivalent Dose Number: 1"; NAUSEA (non-serious) with onset 07Nov2022, outcome "not recovered"; DIZZINESS (non-serious) with onset 07Nov2022, outcome "not recovered". Therapeutic measures were not taken as a result of nausea, dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthma, Cough, Malaise, Pain in extremity, Respiratory tract irritation
Clinical narrative: lung irritation: feels like he needs to cough, like an asthma feeling; lung irritation: feels like he needs to cough, like an asthma feeling; feeling not very good; dry cough; arm soreness at the injection site; arm soreness (a little); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "unknown", described as "arm soreness (a little)"; VACCINATION SITE PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "arm soreness at the injection site"; COUGH (non-serious) with onset Oct2022, outcome "unknown", described as "dry cough"; MALAISE (non-serious) with onset Oct2022, outcome "unknown", described as "feeling not very good"; RESPIRATORY TRACT IRRITATION (non-serious), ASTHMA (non-serious) all with onset 29Oct2022, outcome "unknown" and all described as "lung irritation: feels like he needs to cough, like an asthma feeling".  Additional information: The reporter wanted to know if after receiving the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Booster dose (12 and older), have people experienced lung irritation like it feels like the patient need to cough but cannot. It was sort of like an asthma like feeling, needs to cough, dry cough. Also has arm soreness at the injection site. The patient received the booster dose on 28Oct2022 (bivalent booster) and started feeling not very good (at about 28 hours) dry cough. arm soreness (a little). The patient states the other 3 Pfizer vaccines he previously received caused him mild arm soreness. The patient has read the list of side effects before he had the vaccine and again after he had the vaccine. The patient was having a side effect but he is not sure if it is from the vaccine or maybe he caught COVID. On 29Oct2022, the next day after he received the booster, he reports lung irritation that feels like he needs to cough, like an asthma feeling. The patient has had four Pfizer COVID vaccines total and does not suspect anything was wrong with the vaccine, it could be that he has caught COVID and does not specify if he has caught COVID.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: lung irritation: feels like he needs to cough, like an asthma feeling; lung irritation: feels like he needs to cough, like an asthma feeling; feeling not very good; dry cough; arm soreness at the injection site; arm soreness (a little); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "unknown", described as "arm soreness (a little)"; VACCINATION SITE PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "arm soreness at the injection site"; COUGH (non-serious) with onset Oct2022, outcome "unknown", described as "dry cough"; MALAISE (non-serious) with onset Oct2022, outcome "unknown", described as "feeling not very good"; RESPIRATORY TRACT IRRITATION (non-serious), ASTHMA (non-serious) all with onset 29Oct2022, outcome "unknown" and all described as "lung irritation: feels like he needs to cough, like an asthma feeling".  Additional information: The reporter wanted to know if after receiving the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Booster dose (12 and older), have people experienced lung irritation like it feels like the patient need to cough but cannot. It was sort of like an asthma like feeling, needs to cough, dry cough. Also has arm soreness at the injection site. The patient received the booster dose on 28Oct2022 (bivalent booster) and started feeling not very good (at about 28 hours) dry cough. arm soreness (a little). The patient states the other 3 Pfizer vaccines he previously received caused him mild arm soreness. The patient has read the list of side effects before he had the vaccine and again after he had the vaccine. The patient was having a side effect but he is not sure if it is from the vaccine or maybe he caught COVID. On 29Oct2022, the next day after he received the booster, he reports lung irritation that feels like he needs to cough, like an asthma feeling. The patient has had four Pfizer COVID vaccines total and does not suspect anything was wrong with the vaccine, it could be that he has caught COVID and does not specify if he has caught COVID.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: lung irritation: feels like he needs to cough, like an asthma feeling; lung irritation: feels like he needs to cough, like an asthma feeling; feeling not very good; dry cough; arm soreness at the injection site; arm soreness (a little); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "mild arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2022, outcome "unknown", described as "arm soreness (a little)"; VACCINATION SITE PAIN (non-serious) with onset Oct2022, outcome "unknown", described as "arm soreness at the injection site"; COUGH (non-serious) with onset Oct2022, outcome "unknown", described as "dry cough"; MALAISE (non-serious) with onset Oct2022, outcome "unknown", described as "feeling not very good"; RESPIRATORY TRACT IRRITATION (non-serious), ASTHMA (non-serious) all with onset 29Oct2022, outcome "unknown" and all described as "lung irritation: feels like he needs to cough, like an asthma feeling".  Additional information: The reporter wanted to know if after receiving the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Booster dose (12 and older), have people experienced lung irritation like it feels like the patient need to cough but cannot. It was sort of like an asthma like feeling, needs to cough, dry cough. Also has arm soreness at the injection site. The patient received the booster dose on 28Oct2022 (bivalent booster) and started feeling not very good (at about 28 hours) dry cough. arm soreness (a little). The patient states the other 3 Pfizer vaccines he previously received caused him mild arm soreness. The patient has read the list of side effects before he had the vaccine and again after he had the vaccine. The patient was having a side effect but he is not sure if it is from the vaccine or maybe he caught COVID. On 29Oct2022, the next day after he received the booster, he reports lung irritation that feels like he needs to cough, like an asthma feeling. The patient has had four Pfizer COVID vaccines total and does not suspect anything was wrong with the vaccine, it could be that he has caught COVID and does not specify if he has caught COVID.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest X-ray, Echocardiogram, Physiotherapy, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 29Jan2021 at 15:30 as DOSE 1, SINGLE (lot number: EL9264), in the arm; on 24Feb2021 at 14:30 as DOSE 2, SINGLE (lot number: EN6198), in the arm; and on 17Nov2021 at 14:00 as DOSE 3 (BOOSTER), SINGLE (lot number: FF8839), in the arm, all intramuscular for COVID-19 immunization. The patient's relevant medical history included: "Anxiety", start date: 1998 (unspecified if ongoing); "BPPV", start date: 2005 (unspecified if ongoing); "CAD", start date: 2012 (ongoing); "Prediabetic", start date: 2012 (unspecified if ongoing); "GERD", start date: 2012 (unspecified if ongoing); "Diverticulitis", start date: 2017 (unspecified if ongoing); "Dysautonomia", start date: 2019 (ongoing). The patient's concomitant medications were not reported. Patient had no prior vaccination (within 4 weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "COVID-19." The patient underwent the following laboratory tests and procedures: Echocardiogram: (unspecified date) Ok, notes: Heart checked okay, Date: Mar/Jul; Physiotherapy: (Jun2022) Unknown results, notes: Assessed nerve muscle function; (Jul2022) Unknown results, notes: Assessed nerve muscle function; COVID-19 (SARS-CoV-2 antibody test): (12Jan2022) Unknown, notes: COVID-19 onset date: 12Jan2022; did receive antibody transfusion 13Jan2022; Lumbar X-ray (Spinal X-ray): (Jul2022) Some narrow WA LS/S1/PT; Ultrasound/Circulatory (Ultrasound scan): (Jul2022) No blockage/ No blood clots in legs; Chest X-ray: (2022) Ok, notes: Lung checked okay. Therapeutic measures were taken as a result of Vaccination failure, Covid-19; patient received antibody transfusion 13Jan2022.  Additional information: Patient age at the time of vaccination (dose number series unknown) was reported as "65 years." The patient received the 4th dose on 20May2022 (batch/lot Number: FM7553) at 15:00 via intramuscular route, administered in the arm for COVID-19 immunization. The subsequent booster doses were administered due to a weakened immune system (medical history). Specific relevant test: for thromboembolic events with thrombocytopenia was reported as "unknown."; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092813 same reporter/patient/vaccine; different dose number and events;US-PFIZER INC-202201225349 same reporter/patient/vaccine; different dose number and events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal X-ray, Ultrasound scan, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 29Jan2021 at 15:30 as DOSE 1, SINGLE (lot number: EL9264), in the arm; on 24Feb2021 at 14:30 as DOSE 2, SINGLE (lot number: EN6198), in the arm; and on 17Nov2021 at 14:00 as DOSE 3 (BOOSTER), SINGLE (lot number: FF8839), in the arm, all intramuscular for COVID-19 immunization. The patient's relevant medical history included: "Anxiety", start date: 1998 (unspecified if ongoing); "BPPV", start date: 2005 (unspecified if ongoing); "CAD", start date: 2012 (ongoing); "Prediabetic", start date: 2012 (unspecified if ongoing); "GERD", start date: 2012 (unspecified if ongoing); "Diverticulitis", start date: 2017 (unspecified if ongoing); "Dysautonomia", start date: 2019 (ongoing). The patient's concomitant medications were not reported. Patient had no prior vaccination (within 4 weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "COVID-19." The patient underwent the following laboratory tests and procedures: Echocardiogram: (unspecified date) Ok, notes: Heart checked okay, Date: Mar/Jul; Physiotherapy: (Jun2022) Unknown results, notes: Assessed nerve muscle function; (Jul2022) Unknown results, notes: Assessed nerve muscle function; COVID-19 (SARS-CoV-2 antibody test): (12Jan2022) Unknown, notes: COVID-19 onset date: 12Jan2022; did receive antibody transfusion 13Jan2022; Lumbar X-ray (Spinal X-ray): (Jul2022) Some narrow WA LS/S1/PT; Ultrasound/Circulatory (Ultrasound scan): (Jul2022) No blockage/ No blood clots in legs; Chest X-ray: (2022) Ok, notes: Lung checked okay. Therapeutic measures were taken as a result of Vaccination failure, Covid-19; patient received antibody transfusion 13Jan2022.  Additional information: Patient age at the time of vaccination (dose number series unknown) was reported as "65 years." The patient received the 4th dose on 20May2022 (batch/lot Number: FM7553) at 15:00 via intramuscular route, administered in the arm for COVID-19 immunization. The subsequent booster doses were administered due to a weakened immune system (medical history). Specific relevant test: for thromboembolic events with thrombocytopenia was reported as "unknown."; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092813 same reporter/patient/vaccine; different dose number and events;US-PFIZER INC-202201225349 same reporter/patient/vaccine; different dose number and events;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Flushing
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 29Jan2021 at 15:30 as DOSE 1, SINGLE (lot number: EL9264), in the arm; on 24Feb2021 at 14:30 as DOSE 2, SINGLE (lot number: EN6198), in the arm; and on 17Nov2021 at 14:00 as DOSE 3 (BOOSTER), SINGLE (lot number: FF8839), in the arm, all intramuscular for COVID-19 immunization. The patient's relevant medical history included: "Anxiety", start date: 1998 (unspecified if ongoing); "BPPV", start date: 2005 (unspecified if ongoing); "CAD", start date: 2012 (ongoing); "Prediabetic", start date: 2012 (unspecified if ongoing); "GERD", start date: 2012 (unspecified if ongoing); "Diverticulitis", start date: 2017 (unspecified if ongoing); "Dysautonomia", start date: 2019 (ongoing). The patient's concomitant medications were not reported. Patient had no prior vaccination (within 4 weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "COVID-19." The patient underwent the following laboratory tests and procedures: Echocardiogram: (unspecified date) Ok, notes: Heart checked okay, Date: Mar/Jul; Physiotherapy: (Jun2022) Unknown results, notes: Assessed nerve muscle function; (Jul2022) Unknown results, notes: Assessed nerve muscle function; COVID-19 (SARS-CoV-2 antibody test): (12Jan2022) Unknown, notes: COVID-19 onset date: 12Jan2022; did receive antibody transfusion 13Jan2022; Lumbar X-ray (Spinal X-ray): (Jul2022) Some narrow WA LS/S1/PT; Ultrasound/Circulatory (Ultrasound scan): (Jul2022) No blockage/ No blood clots in legs; Chest X-ray: (2022) Ok, notes: Lung checked okay. Therapeutic measures were taken as a result of Vaccination failure, Covid-19; patient received antibody transfusion 13Jan2022.  Additional information: Patient age at the time of vaccination (dose number series unknown) was reported as "65 years." The patient received the 4th dose on 20May2022 (batch/lot Number: FM7553) at 15:00 via intramuscular route, administered in the arm for COVID-19 immunization. The subsequent booster doses were administered due to a weakened immune system (medical history). Specific relevant test: for thromboembolic events with thrombocytopenia was reported as "unknown."; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092813 same reporter/patient/vaccine; different dose number and events;US-PFIZER INC-202201225349 same reporter/patient/vaccine; different dose number and events;
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Disease recurrence; Treatment of COVID-19; Treatment of COVID-19; Dose 2, 1 are Pfizer vaccine and Dose 3 are Moderna vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: EP6955), in left arm and on 13Apr2021 as dose 2, single (Lot number: ER8729) at the age of 33 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Dec2021 as dose 3 (booster), single (Lot number: 013H21B), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITIN ALLERGIC; LUTERA. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Dec2021, outcome "unknown", described as "Dose 2, 1 are Pfizer vaccine and Dose 3 are Moderna vaccine"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 05Nov2022, outcome "recovering". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: I rebounded with symptoms and tested positive a few days after finishing the Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. The patient received Paxlovid from 28Oct2022 to 02Nov2022 and she rebounded with symptoms and tested positive a few days after finishing the Paxlovid treatment on 05Nov2022; she was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Mild arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization, reaction(s): "Mild arm soreness". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Mild arm soreness".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: mild arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "mild arm soreness".  Additional information: Serious: No. Patient calling to ask if after receiving the Pfizer-BioNTech COVID-19 Vaccine, Bivalent Booster dose (12 and older), have people experienced lung irritation like it feels like I need to cough but can't. It's sort of like an asthma like feeling?" Describes dry cough. Also has arm soreness at the injection site. He received the booster dose on 28Oct2022 (bivalent booster) and started feeling not very good (at about 28 hours) dry cough. arm soreness (a little). The patient states the other 3 Pfizer vaccines he previously received caused him mild arm soreness. Patient was also the reporter. The patient reported that he was having a side effect but he was not sure if was from the vaccine or maybe he caught COVID. There was a product complaint to report. Patient states that he had four Pfizer COVID vaccines total.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.