chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not yet received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12-OCT-2023 with batch number 9T2L9 and lot expiry 28-MAY-2024).   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: not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2025 The pharmacist reported that a patient received only one dose of Shingrix and had not yet received the second dose. The patient was in the pharmacy now, but at the time of reporting, a second dose has not yet been administered. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: they got their first injection, and missed the second one in the 2-6 month window; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: they got their first injection, and missed the second one in the 2-6 month window). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-JAN-2025 The physician started that the patient got their first injection, and missed the second one in the 2-6 month window and were now here a year later. The reporter clarified they did not had any additional details apart from these. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: a  patient was given a prescription for Shingrix by his doctor/The patient has not received the vaccine at the time of the call; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 43-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles in the past).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced intercepted drug prescribing error (Verbatim: a  patient was given a prescription for Shingrix by his doctor/The patient has not received the vaccine at the time of the call). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK receipt date: 15-JAN-2025 The pharmacist reported that a patient was given a prescription for Shingrix by his doctor which led to, intercepted drug prescribing error. The patient was under 50 years of age and was not immunocompromised. The reason for the prescription for Shingrix was that the patient had Shingles in the past. The reporter stated that only the prescription was written. The patient had not received the vaccine at the time of the call.
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: second dose of Arexvy was administered; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of extra dose administered in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in 2023). Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On an unknown date, the patient received the 2nd dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: second dose of Arexvy was administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 15-JAN-2025 The reporter reported that the patient received second dose of Arexvy which led to, extra dose administered. The patient was vaccinated with Shingrix at the same time as the second dose of Arexvy was administered.  No further information was known including dates of administration for both doses of Arexvy and the dose of Shingrix or patient demographics. This case is linked with US2025005048, reported by the same reporter.; Sender's Comments:  US-GSK-US2025005048:Same reporter/Different Patient
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous report received from a consumer concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up. No concomitant medications were reported.  On an unspecified date, the patient experienced death. (dose series 1). The action taken with janssen covid-19 vaccine was not applicable.  It was unknown if an autopsy was performed.  Reported cause of death was unknown cause of death.  The patient died on an unspecified date.  This report was serious (death).; Sender's Comments: V0: Death. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: unknown cause of death
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Mood swings, Nausea, Vertigo
Clinical narrative: she started having 'intermittent instability'; weak; vertigo; extreme dizziness; nausea; vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness) and NAUSEA (nausea) in an 85-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In January 2025, the patient experienced MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness), NAUSEA (nausea) and VOMITING (vomiting) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient husband reported that a couple days later (unsure if it was the 27, 28, 29 of Jan) she had intermittent instability, nausea, extreme dizziness, weak, and vertigo. He stated that she was fine for two days and then it 'repeated again', that its not like her, she's very healthy. The wife came on the phone for a second and said she's had vomiting as well, she still had symptoms.  No treatment medications were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she started having 'intermittent instability'; weak; vertigo; extreme dizziness; nausea; vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness) and NAUSEA (nausea) in an 85-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In January 2025, the patient experienced MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MOOD SWINGS (she started having 'intermittent instability'), ASTHENIA (weak), VERTIGO (vertigo), DIZZINESS (extreme dizziness), NAUSEA (nausea) and VOMITING (vomiting) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown) was unknown.   For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient husband reported that a couple days later (unsure if it was the 27, 28, 29 of Jan) she had intermittent instability, nausea, extreme dizziness, weak, and vertigo. He stated that she was fine for two days and then it 'repeated again', that its not like her, she's very healthy. The wife came on the phone for a second and said she's had vomiting as well, she still had symptoms.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he had not been healthy since and it is just getting worse. caller states "I had been sick in the past by 4 weeks.'; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Lot number: SC3180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Lot number: EW0198)), administration date: 2021, for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he had not been healthy since and it is just getting worse. caller states "I had been sick in the past by 4 weeks.'".  Additional information: The patient was hoping to get the information as to what the Pfizer COVID vaccine he took in 2021. The patient stated that after receiving the vaccine, he had not been healthy since and it was just getting worse. The patient stated, "I had been sick in the past by 4 weeks."  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chromaturia, Eye disorder, Illness, Macular degeneration
Clinical narrative: macular degeneration; eye surgery; my eyes turned yellow; my urine dark brown; sick; skin itchy; stomach pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 82-year-old 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. Past drug history included: Vitamin d3. The following information was reported: MACULAR DEGENERATION (medically significant), outcome "unknown"; EYE DISORDER (medically significant), outcome "unknown", described as "eye surgery"; OCULAR ICTERUS (non-serious), outcome "unknown", described as "my eyes turned yellow"; CHROMATURIA (non-serious), outcome "unknown", described as "my urine dark brown"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PRURITUS (non-serious), outcome "unknown", described as "skin itchy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pain". Therapeutic measures were taken as a result of macular degeneration, eye disorder.  Clinical course: The patient only used pfizer covid 19 vaccines and shortly after around same time she had an eye surgery and she started taking a vitamin for macular degeneration and, her white of her eyes turned yellow  and her urine dark brown, skin itchy, stomach pain. She just thought that she was getting sick and then she was cleaning up her files and she found this  symptoms related to Paxlovid. She asked why did she got this this time and when she should worry about her health, what the outcome of this she had never had a problem till this last dose, very itchy skin ishemade an appointment with the dermatologist but she had to wait weeks and she did not know what was going on. She could not stop scratching  her legs and arms her stomach, so tell me what's happening. She is taking PreserVision 2  vitamin. She confirmed it was  the vaccine she thought it was because of the vitamins the yellowing of her eyes. She had an appointment with the retina doctor in 2 weeks, but now that she found this she thought it is due to the Pfizer vaccine.  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: Ocular icterus, Pruritus
Clinical narrative: macular degeneration; eye surgery; my eyes turned yellow; my urine dark brown; sick; skin itchy; stomach pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 82-year-old 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. Past drug history included: Vitamin d3. The following information was reported: MACULAR DEGENERATION (medically significant), outcome "unknown"; EYE DISORDER (medically significant), outcome "unknown", described as "eye surgery"; OCULAR ICTERUS (non-serious), outcome "unknown", described as "my eyes turned yellow"; CHROMATURIA (non-serious), outcome "unknown", described as "my urine dark brown"; ILLNESS (non-serious), outcome "unknown", described as "sick"; PRURITUS (non-serious), outcome "unknown", described as "skin itchy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach pain". Therapeutic measures were taken as a result of macular degeneration, eye disorder.  Clinical course: The patient only used pfizer covid 19 vaccines and shortly after around same time she had an eye surgery and she started taking a vitamin for macular degeneration and, her white of her eyes turned yellow  and her urine dark brown, skin itchy, stomach pain. She just thought that she was getting sick and then she was cleaning up her files and she found this  symptoms related to Paxlovid. She asked why did she got this this time and when she should worry about her health, what the outcome of this she had never had a problem till this last dose, very itchy skin ishemade an appointment with the dermatologist but she had to wait weeks and she did not know what was going on. She could not stop scratching  her legs and arms her stomach, so tell me what's happening. She is taking PreserVision 2  vitamin. She confirmed it was  the vaccine she thought it was because of the vitamins the yellowing of her eyes. She had an appointment with the retina doctor in 2 weeks, but now that she found this she thought it is due to the Pfizer vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear of injection, Investigation, Lumbar puncture, Magnetic resonance imaging, Malaise
Clinical narrative: blood clotting; never been feeling good or like herself; is terrified of any shots; Multiple sclerosis (MS); This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01May2021 as dose 2, single (Lot number: EW0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EW0161, Administration site: left arm), administration date: 10Apr2021, when the patient was 60-year-old, for Covid-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant) with onset 2023, outcome "unknown", described as "Multiple sclerosis (MS)"; THROMBOSIS (medically significant), outcome "not recovered", described as "blood clotting"; MALAISE (non-serious), outcome "unknown", described as "never been feeling good or like herself"; FEAR OF INJECTION (non-serious), outcome "unknown", described as "is terrified of any shots". The patient underwent the following laboratory tests and procedures: Test: (28Jan2024) has the blood clotting issues now; Lumbar puncture: (unspecified date) diagnosed with MS; Magnetic resonance imaging: (unspecified date) diagnosed with MS. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: She is calling about the covid vaccine, she only took the first two doses so she could get the vaccine card. She only took the first two doses since she had something going on. She was given a list of stuff to watch out for but what she was having was not what she was told to look out for. She is calling to report that she is now on the infusion Ocrevus since she was  diagnosed with Multiple sclerosis (MS) in the beginning of 2023. Confirms she was diagnosed with MS after receiving the covid vaccine, states it took a while to get diagnosed. She is seeing another doctor besides her neurologist that is helping her with long covid. She has the blood clotting issues now, she just got those test results back yesterday. She has never been feeling good or like herself. She waited too late to get help to pay for things, states all of this is expensive. States it is the MRNA that is the problem, now she is terrified of any shots. She had to go through a lot of MRIs and a spinal tap to be diagnosed with MS. She just wanted it out there that MRNA is not a great thing.  .; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021985 same patient, different doses/events;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multiple sclerosis, Thrombosis
Clinical narrative: blood clotting; never been feeling good or like herself; is terrified of any shots; Multiple sclerosis (MS); This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01May2021 as dose 2, single (Lot number: EW0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EW0161, Administration site: left arm), administration date: 10Apr2021, when the patient was 60-year-old, for Covid-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant) with onset 2023, outcome "unknown", described as "Multiple sclerosis (MS)"; THROMBOSIS (medically significant), outcome "not recovered", described as "blood clotting"; MALAISE (non-serious), outcome "unknown", described as "never been feeling good or like herself"; FEAR OF INJECTION (non-serious), outcome "unknown", described as "is terrified of any shots". The patient underwent the following laboratory tests and procedures: Test: (28Jan2024) has the blood clotting issues now; Lumbar puncture: (unspecified date) diagnosed with MS; Magnetic resonance imaging: (unspecified date) diagnosed with MS. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: She is calling about the covid vaccine, she only took the first two doses so she could get the vaccine card. She only took the first two doses since she had something going on. She was given a list of stuff to watch out for but what she was having was not what she was told to look out for. She is calling to report that she is now on the infusion Ocrevus since she was  diagnosed with Multiple sclerosis (MS) in the beginning of 2023. Confirms she was diagnosed with MS after receiving the covid vaccine, states it took a while to get diagnosed. She is seeing another doctor besides her neurologist that is helping her with long covid. She has the blood clotting issues now, she just got those test results back yesterday. She has never been feeling good or like herself. She waited too late to get help to pay for things, states all of this is expensive. States it is the MRNA that is the problem, now she is terrified of any shots. She had to go through a lot of MRIs and a spinal tap to be diagnosed with MS. She just wanted it out there that MRNA is not a great thing.  .; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021985 same patient, different doses/events;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Post-acute COVID-19 syndrome
Clinical narrative: blood clotting; never been feeling good or like herself; is terrified of any shots; Multiple sclerosis (MS); This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 01May2021 as dose 2, single (Lot number: EW0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, single, Lot number: EW0161, Administration site: left arm), administration date: 10Apr2021, when the patient was 60-year-old, for Covid-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant) with onset 2023, outcome "unknown", described as "Multiple sclerosis (MS)"; THROMBOSIS (medically significant), outcome "not recovered", described as "blood clotting"; MALAISE (non-serious), outcome "unknown", described as "never been feeling good or like herself"; FEAR OF INJECTION (non-serious), outcome "unknown", described as "is terrified of any shots". The patient underwent the following laboratory tests and procedures: Test: (28Jan2024) has the blood clotting issues now; Lumbar puncture: (unspecified date) diagnosed with MS; Magnetic resonance imaging: (unspecified date) diagnosed with MS. Therapeutic measures were taken as a result of multiple sclerosis. Clinical course: She is calling about the covid vaccine, she only took the first two doses so she could get the vaccine card. She only took the first two doses since she had something going on. She was given a list of stuff to watch out for but what she was having was not what she was told to look out for. She is calling to report that she is now on the infusion Ocrevus since she was  diagnosed with Multiple sclerosis (MS) in the beginning of 2023. Confirms she was diagnosed with MS after receiving the covid vaccine, states it took a while to get diagnosed. She is seeing another doctor besides her neurologist that is helping her with long covid. She has the blood clotting issues now, she just got those test results back yesterday. She has never been feeling good or like herself. She waited too late to get help to pay for things, states all of this is expensive. States it is the MRNA that is the problem, now she is terrified of any shots. She had to go through a lot of MRIs and a spinal tap to be diagnosed with MS. She just wanted it out there that MRNA is not a great thing.  .; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021985 same patient, different doses/events;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fear of injection, Investigation, Lumbar puncture, Magnetic resonance imaging, Malaise
Clinical narrative: long covid; long covid; long covid; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0161), in left arm and on 01May2021 as dose 2, single (Lot number: EW0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown" and all described as "long covid". The event "long covid" required physician office visit. The patient was calling about the covid vaccine, she only took the first two doses so she could get the white vaccine card. The second Pfizer covid vaccine dose was considered as given in the left arm, but it was not sure. She is seeing another doctor besides her neurologist that is helping her with long covid. States it is the mRNA that is the problem, now she is terrified of any shots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021953 same patient, different doses/events;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Multiple sclerosis, Thrombosis
Clinical narrative: long covid; long covid; long covid; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0161), in left arm and on 01May2021 as dose 2, single (Lot number: EW0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown" and all described as "long covid". The event "long covid" required physician office visit. The patient was calling about the covid vaccine, she only took the first two doses so she could get the white vaccine card. The second Pfizer covid vaccine dose was considered as given in the left arm, but it was not sure. She is seeing another doctor besides her neurologist that is helping her with long covid. States it is the mRNA that is the problem, now she is terrified of any shots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021953 same patient, different doses/events;
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Post-acute COVID-19 syndrome
Clinical narrative: long covid; long covid; long covid; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0161), in left arm and on 01May2021 as dose 2, single (Lot number: EW0173) at the age of 60 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown" and all described as "long covid". The event "long covid" required physician office visit. The patient was calling about the covid vaccine, she only took the first two doses so she could get the white vaccine card. The second Pfizer covid vaccine dose was considered as given in the left arm, but it was not sure. She is seeing another doctor besides her neurologist that is helping her with long covid. States it is the mRNA that is the problem, now she is terrified of any shots.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021953 same patient, different doses/events;
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: Real bad pain/Hurting all over; Short of breath; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) 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: PAIN (non-serious), outcome "unknown", described as "Real bad pain/Hurting all over"; DYSPNOEA (non-serious), outcome "unknown", described as "Short of breath".  Additional information: The patient was calling to see what was this Pfizer deals about on these shots, what was the side effects. The COVID shots, clarified as Pfizer COVID-19 Vaccine. The patient did not know if it was cause of the shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: diagnosed with COVID/tested positive for COVID; diagnosed with COVID/tested positive for COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The patient informed that there were no any other vaccinations within four weeks prior to the first administration date of Pfizer COVID Vaccine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jan2025, outcome "unknown" and all described as "diagnosed with COVID/tested positive for COVID". The event "diagnosed with covid/tested positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jan2025) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The consumer informed that he obtained COVID on Wednesday, 29Jan, he was diagnosed with COVID. He informed that on Wednesday, he went to the doctor's and was tested, and he was tested positive for COVID, so that would be 29Jan (clarified as 29Jan2025). The patient informed that he just had a COVID vaccination done in Oct onsite in our (name withheld), (name withheld) building. The vaccination facility name was Pfizer, it was the working building, they have the infirmary with a nurse inside work building. He got the vaccination at work. The Pfizer has work building in (name withheld), (name withheld). The patient had it done at Pfizer by there on staff nurse." The consumer stated, "I have no idea what, it's the latest vaccine that has come out by Pfizer, that is why I have gotten it." The patient was yearly getting the Pfizer, he was getting the new strain every, he was going to get it every fall because Pfizer provided it. It was to prevent him from getting sick. The patient informed that no treatment for COVID, he has not. He just took like the 'regular'.  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: Pain in extremity
Clinical narrative: arm was "very sore"; This is a spontaneous report received from a Consumer or other non HCP.  A 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was "very sore"". Additional information: The reporter stated that her arm was "very sore" after she received her COVID-19 vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: now I have COVID. I just tested positive; now I have COVID. I just tested positive; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 86-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "now I have COVID. I just tested positive". The event "now i have covid. i just tested positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2025) Positive. Additional information: During an inbound call for financial support for Paxlovid, the caller (patient) stated, "I was part of your clinical trial for the Covid vaccine back 5 years ago. Well, it's taken me 5 years to get the Covid. Now I have Covid. I just tested positive." The patient hasn't had a current prescription, called the doctor today.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Non-small cell lung cancer stage III, Respiratory disorder
Clinical narrative: non-small cell lung cancer stage 3A; health problems especially respiratory; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult male patient received BNT162b2 omicron (kp.2) (BNT162B2 OMICRON (KP.2)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "smoker" (unspecified if ongoing), notes: 1 to 2 packs of cigarettes a day for 30 years; "COPD" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "cervical and lumbar spinal injuries" (unspecified if ongoing); "cervical and lumbar spinal injuries" (unspecified if ongoing); "heart problems" (unspecified if ongoing); "hooked on heroin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna vaccine (dose number unknown), for COVID-19 immunization; Comirnaty (dose number unknown), for COVID-19 immunization, reaction(s): "6 shots of the vaccine/covid-19 Vaccine 7 times in a span of 2 months/9 vaccine shots for COVID-19/9 vaccine shots for COVID-19/at least 20 covid 19 Pfizer shot's". In (place name) they were paying people to get the shot's and we did like at least 20 covid 19 Pfizer shot's in a time period of one to two months, we have all of our prepaid credit cards, and the "vacation card" with the information on each one we used different names now. The following information was reported: NON-SMALL CELL LUNG CANCER STAGE III (medically significant), outcome "unknown", described as "non-small cell lung cancer stage 3A"; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "health problems especially respiratory".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101198847 same patient/reporter, different drug dose/events;
Age: 0.5
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered the patient with ADACEL instead of DTAP (Infanrix) with no reported adverse event; Initial information received on 29-Jan-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old male patient to whom administered diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] instead of dtap (Infanrix) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB vaccine; Pneumococcal vaccine conj (Pneumococcal conjugate vaccine) and Rotavirus vaccine (Rotavirus vaccine) all for Prophylactic Vaccination (Immunisation).  On 29-Jan-2025, the patient received 0.5 mL dose 3 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (frequency: once) (strength: standard) (lot U8231AA and expiry date: May-2026) via intramuscular route in the right thigh for Immunization instead of dtap (Infanrix) not produced by Sanofi Pasteur (lot number and expiry date not reported) with no reported adverse event (wrong product administered) (Latency: same day).  Reportedly, No Adverse Event, patient did not even cry.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: another nurse administered the diluent of the ACTHIB, and not the vaccine itself with no reported adverse event; Initial information received on 29-Jan-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 months old male patient and it was reported another nurse administered the diluent of the HIB (PRP/T) vaccine [ACT-HIB], and not the vaccine itself with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Jan-2025, another nurse administered the diluent of the HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot: UK021AA; expiry date: 28-Feb-2025), and not the vaccine itself with no reported adverse event (product preparation error) (latency: same day) via unknown route in unknown administration site for Immunization.  Reportedly, the medication itself was still in the fridge.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: DTAP, DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: accidentally given Dtap instead of Tdap with no reported adverse event; Initial information received on 30-Jan-2025 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 25 years old female patient where patient was accidentally given diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] instead of diphtheria, tetanus and acellular pertussis vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot 3CA25C1 via intramuscular route in the right arm (dose, frequency, route, strength and expiration date: not provided) for Immunisation and patient received a dose of suspect diphtheria, tetanus and acellular pertussis vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, frequency, route, strength and expiration date: not provided) for Immunisation and accidentally given dtap instead of tdap with no reported adverse event (wrong product administered) (latency- same day).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Coccydynia, Dyspnoea, Fear
Clinical narrative: The incident scared me to death; Excruciating pain in my back (spine) running from shoulders to tailbone; Difficulty breathing; Could not move; This spontaneous case, initially received on 23-Jan-2025, was reported by a non health professional and concerns an elderly female patient.  No medical history and allergy information were reported. Concomitant medication: refer to appropriate report section.  There was no product complaint associated with this case.  Administration of company suspect drug: On 27-Dec-2024, the patient received Fluad (TIV) for unknown indication, Dose regimen and route of administration: not reported, Anatomical location: left arm. Lot number: No batch number available but would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 27-Dec-2024, the patient experienced Excruciating pain in my back (spine) running from shoulders to tailbone (outcome: Recovered / Resolved, stop date: 27-Dec-2024), Difficulty breathing (outcome: Unknown), Could not move (outcome: Unknown). On an unknown date, the patient experienced The incident scared me to death (outcome: Unknown).  The patient wrote to report an adverse reaction to the vaccine she received. She received her vaccine at a pharmacy  on 27-Dec-2024. She walked to her car after received her injection in the left arm. When she got to her car she had excruciating pain in her back (spine) running from her shoulders to her tailbone. It was so intense she could not move and had difficulty breathing. Then after a few minutes She started having periods of relief. After about 5-10 minutes all of the pain had subsided. She had waited now several weeks to see if she would have any other symptoms. She had not had any further symptoms. She had not had an adverse reaction to any previous vaccines in her life. The incident scared her to death. Now she did not know if she could take a vaccination. She would not want anything worse than what she experienced to happen.  Fluad (TIV) action taken: Not Applicable  Reporter assessment:  The reporter assessed the events as non serious and did not provide a causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes in view of close temporal association (while walking back to car after vaccination).
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Spinal pain
Clinical narrative: The incident scared me to death; Excruciating pain in my back (spine) running from shoulders to tailbone; Difficulty breathing; Could not move; This spontaneous case, initially received on 23-Jan-2025, was reported by a non health professional and concerns an elderly female patient.  No medical history and allergy information were reported. Concomitant medication: refer to appropriate report section.  There was no product complaint associated with this case.  Administration of company suspect drug: On 27-Dec-2024, the patient received Fluad (TIV) for unknown indication, Dose regimen and route of administration: not reported, Anatomical location: left arm. Lot number: No batch number available but would be requested upon follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 27-Dec-2024, the patient experienced Excruciating pain in my back (spine) running from shoulders to tailbone (outcome: Recovered / Resolved, stop date: 27-Dec-2024), Difficulty breathing (outcome: Unknown), Could not move (outcome: Unknown). On an unknown date, the patient experienced The incident scared me to death (outcome: Unknown).  The patient wrote to report an adverse reaction to the vaccine she received. She received her vaccine at a pharmacy  on 27-Dec-2024. She walked to her car after received her injection in the left arm. When she got to her car she had excruciating pain in her back (spine) running from her shoulders to her tailbone. It was so intense she could not move and had difficulty breathing. Then after a few minutes She started having periods of relief. After about 5-10 minutes all of the pain had subsided. She had waited now several weeks to see if she would have any other symptoms. She had not had any further symptoms. She had not had an adverse reaction to any previous vaccines in her life. The incident scared her to death. Now she did not know if she could take a vaccination. She would not want anything worse than what she experienced to happen.  Fluad (TIV) action taken: Not Applicable  Reporter assessment:  The reporter assessed the events as non serious and did not provide a causality assessment.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes in view of close temporal association (while walking back to car after vaccination).
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs were reported; Nurse reported that a patient received MMR II and VARIVAX on 12/2/2024 and received PROQUAD on 1/30/2025; This spontaneous report was received from a nurse regarding a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant medications, past drug reactions and allergies were not reported.   On 02-DEC-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection; and with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection; both administered for prophylaxis (dose, lot number, expiration date, anatomical site of injection and route of administration were not provided for any of the mentioned doses). On 30-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, 1 dosage form, administered for prophylaxis (lot number Y012074 has been verified to be a valid number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live [PROQUAD], expiration date 05-JAN-2026; exact dose, anatomical site of injection and route of administration were not provided) (Extra dose administered). No additional adverse events (AEs) were reported for the patient (No adverse event). No further information was provided.