chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hypersensitivity, Nausea, Pain
Clinical narrative: Nausea; Dizziness; Pain; Allergy; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-JAN-2025, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), dizziness (Verbatim: Dizziness), pain (Verbatim: Pain) and allergy (Verbatim: Allergy). The outcome of the nausea and dizziness were not resolved and the outcome of the pain and allergy were unknown.   It was unknown if the reporter considered the nausea, dizziness, pain and allergy to be related to Shingrix.     It was unknown if the company considered the nausea, dizziness, pain and allergy to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-FEB-2025 The patient self-reported this case. The patient received her second dose of Shingrix and was still having dizziness and nausea today (on the reporting day). It was not provided when the dizziness or nausea started and she read to take Tylenol and Advil and that these did not help with pain involved with the shot or after effects (no further information provided). It was not clear if the patient took either Tylenol or Advil (unknown product information).  The patient reported that her physician told her to come in to note an allergy in her chart after receiving the second dose of Shingrix, but no further information was provided about the potential allergy.
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was administered to a 6-month-old patient; Kinrix dose was the second dose overall of Dtap and IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 06-FEB-2025, the patient received Kinrix. On 06-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix was administered to a 6-month-old patient) and inappropriate schedule of vaccine administered (Verbatim: Kinrix dose was the second dose overall of Dtap and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-FEB-2025 A nurse called to report Kinrix was administered to a 6-month-old patient. This Kinrix dose was the second dose overall of Dtap and IPV for the patient which led to Inappropriate schedule of vaccine administered. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site pain, Rash erythematous, Rash pruritic
Clinical narrative: itchy red spots; pain at injection site; Bruised arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G5T3, expiry date 20-JUL-2026) for prophylaxis.   The patient's past medical history included kidney transplant (The patient reports she did receive a kidney transplant 6 years ago and is on anti-rejection medication).   On 19-NOV-2024, the patient received the 2nd dose of Shingrix (intramuscular, right arm) .5 ml. On 19-NOV-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site) and bruising of arm (Verbatim: Bruised arm). On 24-NOV-2024, the patient experienced itchy rash (Verbatim: itchy red spots). The outcome of the injection site pain was resolved and the outcome of the bruising of arm and itchy rash were not resolved.   It was unknown if the reporter considered the injection site pain, bruising of arm and itchy rash to be related to Shingrix.     It was unknown if the company considered the injection site pain, bruising of arm and itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-FEB-2025 Caller was the patient and  reported she received her second Shingrix vaccine in her right arm on November 19. 2024.  The pharmacist injected it very low on her upper arm, about 4 "above her elbow, the bruise is still there.  Patient reported there was pain at the injection site that has been resolved.  Caller reported less than a week after the Shingrix injection she began experiencing an itchy spot mainly from her shoulders up to her head.  The red itchy spots are the size of a dime, some a pencil eraser size and one was the size of a 50-cent piece.  The Patient reported she went to the health care professional on 12-Apr-2024 and the HCP gave her a steroid cream for the itching. The caller went back to the HCP and the HCP took a biopsy of 50 percent piece size spot on 05-Feb-2025 and the results will take a week. Caller describes the red itchy spots as coming and going but they never resolve. She also had  a spot near her panty line. Caller does had pictures to share if needed.  The patient reported she did receive a kidney transplant 6 years ago and is on anti-rejection medication.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the second dose of Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose during April 2024 in left arm).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not received the second dose of Shingrix vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2025 The patient received the 1st dose of Shingrix at a local pharmacy,the lot and expiry were unknown.  The patient reports he has not received the second dose of Shingrix vaccine, which led incomplete course of vaccination.  It was unknown why the patient did not get the vaccine between 2 to 6 months after the 1st dose. The reporter did not consent to follow-up.
Age: 29.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: A 29 years old pregnant woman received a dose of Arexvy; A 29 years old pregnant woman received a dose of Arexvy; A 29 years old pregnant woman received a dose of Arexvy instead of a dose of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 54A7M, expiry date 30-OCT-2025) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On an unknown date, the patient received Arexvy and did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A 29 years old pregnant woman received a dose of Arexvy), drug use in unapproved population (Verbatim: A 29 years old pregnant woman received a dose of Arexvy) and wrong vaccine administered (Verbatim: A 29 years old pregnant woman received a dose of Arexvy instead of a dose of Abrysvo). The outcome of the vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-FEB-2025 Pharmacist called to report that they administered a dose of Arexvy instead of a dose of Abrysvo to a 29 years old pregnant patient, which led to Drug use in unapproved population, Wrong vaccine administered and Vaccine exposure during pregnancy.
Age: 29.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Device use issue, Exposure during pregnancy, No adverse event
Clinical narrative: A 29 years old pregnant woman received a dose of Arexvy; A 29 years old pregnant woman received a dose of Arexvy; A 29 years old pregnant woman received a dose of Arexvy instead of a dose of Abrysvo; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a 29-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 54A7M, expiry date 30-OCT-2025) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On an unknown date, the patient received Arexvy and did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: A 29 years old pregnant woman received a dose of Arexvy), drug use in unapproved population (Verbatim: A 29 years old pregnant woman received a dose of Arexvy) and wrong vaccine administered (Verbatim: A 29 years old pregnant woman received a dose of Arexvy instead of a dose of Abrysvo). The outcome of the vaccine exposure during pregnancy, drug use in unapproved population and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 10-FEB-2025 Pharmacist called to report that they administered a dose of Arexvy instead of a dose of Abrysvo to a 29 years old pregnant patient, which led to Drug use in unapproved population, Wrong vaccine administered and Vaccine exposure during pregnancy.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Fluarix vaccine fridge temperatures Total time at 47.5F x 37 days and it was 51.1 for 1 hour at one point as well; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis.   On an unknown date, the patients received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Fluarix vaccine fridge temperatures Total time at 47.5F x 37 days and it was 51.1 for 1 hour at one point as well). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-FEB-2025 The reporter reported that the storage fridge temperatures had been ranging 44 to 50 for months and asked was fluarix still good. The fridge temperature for the last 37 days had been 47 to 48 degrees Fahrenheit and the total time at 47.5 Fahrenheit for 37 days and found a graph and it was 51.1 for 1 hour at one point as well and these vaccines (Fluarix vaccines) were used in patients, which led to incorrect storage of drug.
Sex: F
Vaccine: COVID19
Symptoms: Scan, Vision blurred
Clinical narrative: blurry vision; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VISION BLURRED (blurry vision) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan: eye problems.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient had blurry vision and patient did not had covid-19 before receiving the Moderna covid-19. The scan shows the eye problems and she had thousands of tests because of this and blood work and she was never sick before.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-782161 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-782161:Patient's father
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder, Throat tightness
Clinical narrative: throat almost seized up completely; strange taste in my mouth; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Jan2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hypogammaglobulonemia" (unspecified if ongoing); "light-chain disease" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: several plants" (unspecified if ongoing); "Known allergies: oral allergy syndrome for related foods" (unspecified if ongoing), notes: Known allergies: oral allergy syndrome for related foods; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; DOXYCYCLINE. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Levaquin, reaction(s): "Known allergies: levaquin". Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN; LOT NUMBER UNKNOWN), for COVID-19 immunization, reaction(s): "strange taste in my mouth", "throat feeling a little tight". The following information was reported: TASTE DISORDER (life threatening) with onset 11Jan2025, outcome "recovered" (11Jan2025), described as "strange taste in my mouth"; THROAT TIGHTNESS (life threatening) with onset 11Jan2025, outcome "recovered" (11Jan2025), described as "throat almost seized up completely". Therapeutic measures were taken as a result of throat tightness, taste disorder. Patient reported that she have previously reacted to this vaccine with her  throat feeling a little tight from the moment of injection. She got a strange taste in her mouth immediately and then an uncomfortable tightness that relaxes after about 15 minutes but remains for a few hours to a lesser degree. During this last dose, her throat almost seized up completely. She always carry extra strength Benadryl and an epinephrine auto-injector, which no doubt saved her life that day, but she was writing to try and discover what in this vaccine was causing her to react this way. She was immunocompromised and an asthmatic who would greatly benefit by continuing to take it, but at this point, the reactions have become too dangerous to risk. Patient also mentioned that she have never had COVID before despite being around infected people.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Throat tightness
Clinical narrative: throat almost seized up completely; strange taste in my mouth; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Jan2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 41 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hypogammaglobulonemia" (unspecified if ongoing); "light-chain disease" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: several plants" (unspecified if ongoing); "Known allergies: oral allergy syndrome for related foods" (unspecified if ongoing), notes: Known allergies: oral allergy syndrome for related foods; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT; DOXYCYCLINE. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Levaquin, reaction(s): "Known allergies: levaquin". Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN; LOT NUMBER UNKNOWN), for COVID-19 immunization, reaction(s): "strange taste in my mouth", "throat feeling a little tight". The following information was reported: TASTE DISORDER (life threatening) with onset 11Jan2025, outcome "recovered" (11Jan2025), described as "strange taste in my mouth"; THROAT TIGHTNESS (life threatening) with onset 11Jan2025, outcome "recovered" (11Jan2025), described as "throat almost seized up completely". Therapeutic measures were taken as a result of throat tightness, taste disorder. Patient reported that she have previously reacted to this vaccine with her  throat feeling a little tight from the moment of injection. She got a strange taste in her mouth immediately and then an uncomfortable tightness that relaxes after about 15 minutes but remains for a few hours to a lesser degree. During this last dose, her throat almost seized up completely. She always carry extra strength Benadryl and an epinephrine auto-injector, which no doubt saved her life that day, but she was writing to try and discover what in this vaccine was causing her to react this way. She was immunocompromised and an asthmatic who would greatly benefit by continuing to take it, but at this point, the reactions have become too dangerous to risk. Patient also mentioned that she have never had COVID before despite being around infected people.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder, Throat tightness
Clinical narrative: I have previously reacted to this vaccine with my throat feeling a little tight from the moment of injection; a strange taste in my mouth immediately; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hypogammaglobulonemia" (unspecified if ongoing); "light-chain disease" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: several plants" (unspecified if ongoing); "Known allergies: oral allergy syndrome for related foods" (unspecified if ongoing), notes: Known allergies: oral allergy syndrome for related foods; "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Levaquin, reaction(s): "Known allergies: levaquin". The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "I have previously reacted to this vaccine with my throat feeling a little tight from the moment of injection"; DYSGEUSIA (non-serious), outcome "unknown", described as "a strange taste in my mouth immediately". Therapeutic measures were taken as a result of throat tightness, dysgeusia.  Clinical course: The patient have previously reacted to this vaccine with her throat feeling a little tight from the moment of injection. She got a strange taste in her mouth immediately and then an uncomfortable tightness that relaxed after about 15 minutes but remained for a few hours to a lesser degree. During this last dose, her throat almost seized up completely. She was always carrying an extra strength Benadryl and an epinephrine auto-injector, which no doubt saved her life that day. She was writing to try and discover what in this vaccine was causing her to react this way. She was immunocompromised and an asthmatic who would greatly benefit by continuing to take it, but at this point, the reactions have become too dangerous to risk. She never had COVID before despite being around infected people.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500029326 same patient/product/events; different dose;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Throat tightness
Clinical narrative: I have previously reacted to this vaccine with my throat feeling a little tight from the moment of injection; a strange taste in my mouth immediately; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "hypogammaglobulonemia" (unspecified if ongoing); "light-chain disease" (unspecified if ongoing); "hemochromatosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: several plants" (unspecified if ongoing); "Known allergies: oral allergy syndrome for related foods" (unspecified if ongoing), notes: Known allergies: oral allergy syndrome for related foods; "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: codeine"; Levaquin, reaction(s): "Known allergies: levaquin". The following information was reported: THROAT TIGHTNESS (non-serious), outcome "unknown", described as "I have previously reacted to this vaccine with my throat feeling a little tight from the moment of injection"; DYSGEUSIA (non-serious), outcome "unknown", described as "a strange taste in my mouth immediately". Therapeutic measures were taken as a result of throat tightness, dysgeusia.  Clinical course: The patient have previously reacted to this vaccine with her throat feeling a little tight from the moment of injection. She got a strange taste in her mouth immediately and then an uncomfortable tightness that relaxed after about 15 minutes but remained for a few hours to a lesser degree. During this last dose, her throat almost seized up completely. She was always carrying an extra strength Benadryl and an epinephrine auto-injector, which no doubt saved her life that day. She was writing to try and discover what in this vaccine was causing her to react this way. She was immunocompromised and an asthmatic who would greatly benefit by continuing to take it, but at this point, the reactions have become too dangerous to risk. She never had COVID before despite being around infected people.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500029326 same patient/product/events; different dose;
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report received from a Consumer or other non HCP.  A 42-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Feb2025 at 07:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing); "Drug allergy" (unspecified if ongoing), notes: Name of Drug as Reported: No. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "recovering". Therapeutic measures were not taken as a result of rash.  Additional information: The patient did not received any other vaccines on the same date as the vaccine(s) for which they were reporting. The patient did not received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which they were reporting. The patient was not taking any other medications within 2 weeks of the event starting. Patient had recently seen a rash.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hypothyroidism
Clinical narrative: hypothyroid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient in her 50's received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, 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 1), for Covid-19 Immunization; Bnt162b2 (DOSE 2), for Covid-19 Immunization. The following information was reported: HYPOTHYROIDISM (medically significant), outcome "unknown", described as "hypothyroid". Therapeutic measures were taken as a result of hypothyroidism. The patient must take medicines for life now.  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-PV202500016654 Same reporter and product; different patient and events;
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After getting Pfizer Covid Shot Psoriasis was better; This is a spontaneous report received from a Consumer or other non HCP.  A 68-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 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: "Psoriasis" (unspecified if ongoing); "arthritis in the spine" (unspecified if ongoing), notes: takes medicine for this; "low thyroid" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM oral taken for spinal osteoarthritis (ongoing); SYNTHROID oral taken for hypothyroidism (ongoing). The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "After getting Pfizer Covid Shot Psoriasis was better". Additional information: She clarified the positive feedback as she has and suffered from Psoriasis. When she first got the COVID shots it was the two shots, it was the original one and the one afterwards. She later clarified and confirmed, this report as regarding her as the patient. She is the one with Psoriasis and have the positive feedback. She explained she had Psoriasis and after getting the first shot it was 10-15 percent better. Then got the second shot and it was 30 percent better. She later got the first booster, and it got better. She went recently and got the last booster in November and now cannot tell where she had it on her arm. No one else can see it. Whatever we put in it is working for her psoriasis. She is not on any other medication for psoriasis. She did not see a dermatologist about it. When she got the vaccine, she noticed a big difference with the psoriasis. She got the first shot in 2021. After getting the first one, she did not really notice a difference a whole lot. She was thinking it was due to less stress initially. This comes and goes. The second one, she noticed the benefit more. It was sometime in May 2021 when she got the second shot and noticed this.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: MYOCARDITIS (medically significant), outcome "unknown".  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-PV202500017159 Same reporter and product; different patient and events;US-PFIZER INC-202500033364 Same reporter, product and event; different patient;
Sex: U
Vaccine: COVID19
Symptoms: Diagnostic procedure, Dyspnoea, Electrocardiogram, Hypertrophic cardiomyopathy
Clinical narrative: Hypertrophic cardiomyopathy; shortness of breath; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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 1), for covid-19 immunization. The following information was reported: HYPERTROPHIC CARDIOMYOPATHY (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". The patient underwent the following laboratory tests and procedures: Diagnostic procedure: (unspecified date) Unknown results; (Jul2023) confirmed shortness of breath; Electrocardiogram: (unspecified date) Unknown results; (unspecified date) Unknown results, notes: 2nd EC. Clinical course: During COVID-19, the patient had to get vaccinated because [City] required doses for almost everything. However, the patient did it because of work. The patient had to be vaccinated to attend the patient's players' hockey games. Following COVID-19, when the patient resumed training, the patient felt a slight difference in breathing, not alarming but the patient could see that there was a difference. It was getting worse and worse, but the patient did not pay much attention to it. In Aug2022 the patient left to register the patient's company. Having an apartment in [City], continuing to have a "pied-a-terre" in the city, and continuing training in the patient's daily life. In July2023, doin tests in the city so as not have any problems back since the patient cannot have an insurance policy for protection. At that time, they came back to the patient and confirmed shortness of breath, at the same time they asked the patient to check everything. The patient met a cardiologist and a family doctor in City luckily because they also found this shortness of breath intriguing. The patient had tests and an EC cardiogram, the cardiologist wanted to have the patient have an EC cardiogram every year. So it was at the patient's 2nd EC cardiogram that the patient was screened for this rare disease, Hypertrophic Cardiomyopathy. Breathing was increasingly difficult and above all, the obligation to no longer do high-intensity exercise. The patient stated that all this started from the results of the vaccine, before all that, the patient had no problems. The patient was taking the time to write before starting the procedures because the patient was officially 200% certain that this was caused by the 2 vaccines.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; This is a spontaneous report received from a Consumer or other non HCP, Program ID: .  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 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: POLYMYALGIA RHEUMATICA (medically significant) with onset 2021, 1 week after the suspect product(s) administration, outcome "unknown". The event "polymyalgia rheumatica" required physician office visit. The patient underwent the following laboratory tests and procedures: tested: (2021) Polymyalgia rheumatica. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: the patient developed severe hip and shoulder 1 week after Covid shot. Later that year the patient was tested, diagnosed and treated by a Rheumatologist for polymyalgia rheumatica. The patient was still taking prednisone as a treatment.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: My 1st son; 8 months died after vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 8-month-old male patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), 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: DEATH (death, medically significant), outcome "fatal", described as "My 1st son; 8 months died after vaccine". The date and cause of death for the patient were unknown.  Clinical course: The reporter stated that My 1st son; 8 months died after vaccine. I did get all 3 COVID vaccines (Pfizer) & became hypothyroid & must take meds. for life now.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: passed away from pneumonia due to COVID-19; passed away from pneumonia due to COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Nov2024 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 (death), COVID-19 PNEUMONIA (death) all with onset Nov2024, outcome "fatal" and all described as "passed away from pneumonia due to COVID-19". The patient date of death was 26Nov2024. Reported cause of death: "passed away from pneumonia due to COVID-19", "pneumonia". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162B2 OMICRON (KP.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: passed away from pneumonia due to COVID-19; passed away from pneumonia due to COVID-19; pneumonia
Sex: F
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Vaccination site pain
Clinical narrative: In the same arm and It hurts for a while; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 62-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), in arm for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), in arm for immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "In the same arm and It hurts for a while".  Additional Information: She made her remember when she got the COVID; Shingles and Flu vaccines at the same time and in the same arm. It hurts for a while. It was unknown whether the reporter consider event as caused by suspect product.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Overdose
Clinical narrative: She reacted poorly to have two on the same day; She reacted poorly to have two on the same day; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An elderly female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: FEELING ABNORMAL (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "She reacted poorly to have two on the same day".  Additional information: It was reported that she still was not sure about so many vaccines she reacted poorly to have two on the same day. It was unknown whether the reporter consider event as caused by suspect product.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder
Clinical narrative: GI issues; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: GASTROINTESTINAL DISORDER (non-serious), outcome "unknown", described as "GI issues".  Additional information: Patient was forced to get the Pfizer Covid vaccine in order to resume normal living. Everyone in my household who got it has had GI issues since. Those who got a different vaccine haven't had GI issues. Patient think the vaccine's side effects hadn't been determined and now  don't trust Pfizer any longer.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had taken several Pfizer vacs, but still got Covid / reactions had varied; Had taken several Pfizer vacs, but still got Covid / reactions had varied; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult female 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had taken several Pfizer vacs, but still got Covid / reactions had varied". Reporter considered event as caused by suspect product(s).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu while being vaccinated; This spontaneous case, initially received on 04-Feb-2025, was reported by a non health professional and concerns a patient of unknown age/gender.  Administration of company suspect drug: On an unknown date, the patient received INN Flu Vaccine Seasonal for indication not reported, dose, route of administration and anatomical location: not reported. Lot number: No batch number available but will be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Flu while being vaccinated (Medically Significant, outcome: Not Reported).  It was reported that, the patient got flu while being vaccinated. It was unknown which influenza vaccine the patient received.  INN Flu Vaccine Seasonal action taken: Not Applicable  Reporter assessment: the reporter did not provide seriousness and causality assessment for the event.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Furthermore, due to lack of more detailed information (e.g. temporal relationship, patients risk factors, diagnostic reports and brand name of vaccine) causality cannot be excluded.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Skin erosion, Vaccination site discomfort, Vaccination site erythema, Vaccination site reaction, Vaccination site scab
Clinical narrative: Patient complaint of reaction post vaccination. Patient scheduled with provider visit on 02-04-2025, patient reports she believes staff caused lesion and per patient reports she noted day 1 post vaccination area appeared swollen, beefy raw and reported discomfort. Patient denies previous allergic reaction to vaccines. Upon assessment of affected area, area appeared swollen, moderate erythema surrounding affected area and wound bed appeared discolored/ dry blood (scab like), patient denied fever or drainage to wound and wound measured 1,5inx1.5in. Assessed patient for allergic reaction: high persistent fever, angioedema, pruritus, SOB, hives , swelling or redness to injection site, patient reported only discomfort/ swelling and redness. Wound assessed by provider per provider wound care done, applied triple antibiotic and instructed patient to cover wound. Affected area marked and informed patient if erythema surpasses line, patient to go to ER. Patient verbalized understanding. Patient has been visiting nursing for wound care and monitoring of wound. Wound appears to be healing with 80% improvement, measuring 0.5inx0.5in, no erythema or swelling to affected site and healthy granulation tissue present with no drainage to area at this time. Patient scheduled for wound check in one week with nursing per provider.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site swelling, Wound
Clinical narrative: Patient complaint of reaction post vaccination. Patient scheduled with provider visit on 02-04-2025, patient reports she believes staff caused lesion and per patient reports she noted day 1 post vaccination area appeared swollen, beefy raw and reported discomfort. Patient denies previous allergic reaction to vaccines. Upon assessment of affected area, area appeared swollen, moderate erythema surrounding affected area and wound bed appeared discolored/ dry blood (scab like), patient denied fever or drainage to wound and wound measured 1,5inx1.5in. Assessed patient for allergic reaction: high persistent fever, angioedema, pruritus, SOB, hives , swelling or redness to injection site, patient reported only discomfort/ swelling and redness. Wound assessed by provider per provider wound care done, applied triple antibiotic and instructed patient to cover wound. Affected area marked and informed patient if erythema surpasses line, patient to go to ER. Patient verbalized understanding. Patient has been visiting nursing for wound care and monitoring of wound. Wound appears to be healing with 80% improvement, measuring 0.5inx0.5in, no erythema or swelling to affected site and healthy granulation tissue present with no drainage to area at this time. Patient scheduled for wound check in one week with nursing per provider.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody increased, Antinuclear antibody positive, Balance disorder, Bile duct stone, Biliary dilatation
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy oesophagus normal, Blood pressure increased, C-reactive protein normal, Carbohydrate antigen 19-9 increased, Carcinoembryonic antigen normal
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac stress test normal, Chest X-ray normal, Chest pain, Cholelithiasis, Condition aggravated
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Echocardiogram normal, Endoscopic retrograde cholangiopancreatography abnormal, Endoscopic ultrasound abnormal, Endoscopy upper gastrointestinal tract abnormal
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus antibody negative, Epstein-Barr virus antibody positive, Full blood count normal, Gastritis, Helicobacter test negative
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hiatus hernia, Impaired work ability, Lipids normal, Loss of personal independence in daily activities, Magnetic resonance cholangiopancreatography
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging abdominal abnormal, Malaise, Mass, Metabolic function test normal, Musculoskeletal chest pain
Clinical narrative: Day of Shot - Loss of balance, dizziness. Continued for several days and worsened. Day 3-4 started with PVCs and nausea. BP elevated 200+/100+.   Admitted to hospital on 2/25 with chest pain, PVCs, very high blood pressure. It has been almost 1 year of doctor appointments and tests since that shot. I still am not well and have not been able to work or manage my home.