chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: She has experienced long COVID herself; This spontaneous case was reported by a patient and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (She has experienced long COVID herself) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (She has experienced long COVID herself). At the time of the report, POST-ACUTE COVID-19 SYNDROME (She has experienced long COVID herself) outcome was unknown.            No concomitant medications were reported.  The patient had experienced long COVID herself and noted that there was no test available to diagnose it. She wanted to know if there were any specific studies for a long COVID because nobody seemed to have any idea what to do with long COVID.  She had not switched companies at any point. She had consistently received the same Moderna vaccine over the past couple of years. Also, she mentioned it was not anyone's fault.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.   Reporter did not allow further contact
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: the diabetes was diagnosed after the covid vaccine; This spontaneous case was reported by a patient and describes the occurrence of DIABETES MELLITUS (the diabetes was diagnosed after the covid vaccine) in a 77-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Ulcerative colitis.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DIABETES MELLITUS (the diabetes was diagnosed after the covid vaccine) (seriousness criterion medically significant). At the time of the report, DIABETES MELLITUS (the diabetes was diagnosed after the covid vaccine) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. No treatment medications were reported.   Reporter did not allow further contact; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Migraine
Clinical narrative: I couldn't work so I filled for disability; Chronic Intractable Migraine. Extremely painful migraines that lasted for days; This spontaneous case was reported by a patient and describes the occurrence of IMPAIRED WORK ABILITY (I couldn't work so I filled for disability) and MIGRAINE (Chronic Intractable Migraine. Extremely painful migraines that lasted for days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A/048B21A/029H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In May 2021, the patient experienced IMPAIRED WORK ABILITY (I couldn't work so I filled for disability) and MIGRAINE (Chronic Intractable Migraine. Extremely painful migraines that lasted for days). At the time of the report, IMPAIRED WORK ABILITY (I couldn't work so I filled for disability) had not resolved and MIGRAINE (Chronic Intractable Migraine. Extremely painful migraines that lasted for days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported the patient missed children's wedding, graduation, birthdays, holidays, vacations. Patient can't go out because, afraid of something will trigger a migraine. It was unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Food allergy
Clinical narrative: I have acquired anemia; I´m allergic to foods; This spontaneous case was reported by a patient and describes the occurrence of ANAEMIA (I have acquired anemia) and FOOD ALLERGY (I´m allergic to foods) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Soy allergy (Have a soy sensitivity too, and that was great when she took the pneumonia vaccine).  On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ANAEMIA (I have acquired anemia) and FOOD ALLERGY (I´m allergic to foods). The patient was treated with Cyanocobalamin (B12) for Anemia, at a dose of 1 milliliter. At the time of the report, ANAEMIA (I have acquired anemia) had not resolved and FOOD ALLERGY (I´m allergic to foods) outcome was unknown.      For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant product information was not provided by the reporter.  Since patient had taken the COVID vaccines and they were all from Moderna, patient had acquired anemia. That was the first thing. But at the time of reporting patient noticed that she was allergic to foods. Foods that she was never been allergic to. It was an additive in the food. It was not the food itself. So, one of them was sodium tripolyphosphate, the other one was sodium phosphate. Regarding management of her anemia, reporter stated, that she takes B12 shots and had left everything else and she had gotten it to just above normal.   Patient was never allergic to these foods before, these additives. Now cannot eat, like it was weird. Patient cannot eat half the foods she used to eat because they all contain sodium phosphate. It was all, it was preservative. Sodium tripolyphosphate was a neuro, a neurotoxin, but they put that in fish.   This case was linked to MOD-2022-672563 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: When I received the vaccine my arm was red and swollen for over a week; When I received the vaccine my arm was red and swollen for over a week; I still have pain; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (When I received the vaccine my arm was red and swollen for over a week), PERIPHERAL SWELLING (When I received the vaccine my arm was red and swollen for over a week) and PAIN IN EXTREMITY (I still have pain) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080803) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 50 microgram. On an unknown date, the patient experienced ERYTHEMA (When I received the vaccine my arm was red and swollen for over a week), PERIPHERAL SWELLING (When I received the vaccine my arm was red and swollen for over a week) and PAIN IN EXTREMITY (I still have pain). At the time of the report, ERYTHEMA (When I received the vaccine my arm was red and swollen for over a week) and PERIPHERAL SWELLING (When I received the vaccine my arm was red and swollen for over a week) had resolved and PAIN IN EXTREMITY (I still have pain) had not resolved.            No concomitant medications were reported.  The patient received the vaccine, and her arm was red and swollen for over a week, went away but it had been over a month and still had pain.  It was unknown if the patient experienced any additional symptoms or events.   No treatment medications were reported.
Age: 90.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Malaise
Clinical narrative: extreme weakness; Covid like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (extreme weakness) and SUSPECTED COVID-19 (Covid like symptoms) in a 90-year-old male patient who received mRNA-1345 (mRESVIA) for Lower respiratory tract infection.     The patient's past medical history included Long COVID. Concurrent medical conditions included Respiratory disorder NOS since 2022.    On 25-Mar-2025, the patient received dose of mRNA-1345 (mRESVIA) (Intramuscular use) .5 milliliter. On 26-Mar-2025, the patient experienced ASTHENIA (extreme weakness) and SUSPECTED COVID-19 (Covid like symptoms). On 26-Mar-2025, ASTHENIA (extreme weakness) and SUSPECTED COVID-19 (Covid like symptoms) had resolved.            No concomitant medications were reported. The patient did not experience any additional symptoms or events.  No treatment medications were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Incomplete course of vaccination, Renal impairment, SARS-CoV-2 test
Clinical narrative: Started losing weight about 4-5 months later; My kidneys declined; Had Covid again in 2023; I got a Novavax in 2022; This non-serious, initial spontaneous safety was reported by a Consumer or other non-health professional via the Novavax Medical Information (MI no. NOV25-00120) and concerns a 76-year-old Male who "received Novavax in 2021 only" on an unspecified date in 2021, and "had Covid again in 2023" on an unspecified date in 2023 after receiving Novavax COVID-19 Vaccine, Adjuvanted on an unspecified date in 2021.   At the time of the report, the outcome of COVID-19 was Unknown and Incomplete course of vaccination was Recovered/Resolved.  On 18-Apr-2025, significant information was received from a consumer via contact center (MI No. NOV25-00214) - This case was upgraded from non-serious to serious. Patient and primary reporter details were updated, a third reporter was added, "hernia repair" was added to the patient's medical history, added 04-Apr-2025 dose to patient's past therapy, updated therapy start and end date from --2021 to -Oct-2022, updated the event verbatim "Received Novavax in 2021 only" (Incomplete course of vaccination) to "I got a Novavax in 2022", added two new events: "My kidneys declined" (Renal impairment) (Seriousness criteria: Other medically important condition) and Started losing weight about 4-5 months later (Weight decreased), and added new lab data "I got a blood draw" done on an unknown date in 2023 with the result of "my kidneys declined". The outcome of the events renal impairment and weight decreased were unknown.; Sender's Comments: This 77-year-old Male experienced Renal impairment, Incomplete course of vaccination, COVID-19, and Weight decreased after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (1).  The event Renal impairment was reported as serious.   The events Incomplete course of vaccination, COVID-19, and Weight decreased were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Renal impairment, Incomplete course of vaccination, COVID-19, and Weight decreased is considered Possible.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: Started losing weight about 4-5 months later; My kidneys declined; Had Covid again in 2023; I got a Novavax in 2022; This non-serious, initial spontaneous safety was reported by a Consumer or other non-health professional via the Novavax Medical Information (MI no. NOV25-00120) and concerns a 76-year-old Male who "received Novavax in 2021 only" on an unspecified date in 2021, and "had Covid again in 2023" on an unspecified date in 2023 after receiving Novavax COVID-19 Vaccine, Adjuvanted on an unspecified date in 2021.   At the time of the report, the outcome of COVID-19 was Unknown and Incomplete course of vaccination was Recovered/Resolved.  On 18-Apr-2025, significant information was received from a consumer via contact center (MI No. NOV25-00214) - This case was upgraded from non-serious to serious. Patient and primary reporter details were updated, a third reporter was added, "hernia repair" was added to the patient's medical history, added 04-Apr-2025 dose to patient's past therapy, updated therapy start and end date from --2021 to -Oct-2022, updated the event verbatim "Received Novavax in 2021 only" (Incomplete course of vaccination) to "I got a Novavax in 2022", added two new events: "My kidneys declined" (Renal impairment) (Seriousness criteria: Other medically important condition) and Started losing weight about 4-5 months later (Weight decreased), and added new lab data "I got a blood draw" done on an unknown date in 2023 with the result of "my kidneys declined". The outcome of the events renal impairment and weight decreased were unknown.; Sender's Comments: This 77-year-old Male experienced Renal impairment, Incomplete course of vaccination, COVID-19, and Weight decreased after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (1).  The event Renal impairment was reported as serious.   The events Incomplete course of vaccination, COVID-19, and Weight decreased were reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted and Renal impairment, Incomplete course of vaccination, COVID-19, and Weight decreased is considered Possible.
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Sleep disorder
Clinical narrative: Extreme injection site pain and swelling; Extreme injection site pain and swelling; extreme itchiness; Unable to sleep at night because of the pain; This is a spontaneous report received from a Nurse from a sales representative.  A 64-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 17Mar2025 at 11:45 as dose 1, single (Lot number: LK6655), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 20Mar2025, outcome "recovered" (26Mar2025) and all described as "Extreme injection site pain and swelling"; SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (non-serious) with onset 20Mar2025, outcome "recovered" (26Mar2025), described as "Unable to sleep at night because of the pain"; VACCINATION SITE PRURITUS (non-serious) with onset 20Mar2025, outcome "recovered" (26Mar2025), described as "extreme itchiness". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site pruritus, sleep disorder due to general medical condition, insomnia type. Additional information: Extreme injection site pain and swelling. Along with extreme itchiness. Unable to sleep at night because of the pain. The patient did not receive any other vaccines on the same date as the PREVNAR 20.
Sex: F
Vaccine: COVID19
Symptoms: Micturition urgency, Nocturia, Pollakiuria
Clinical narrative: overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident; It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night; Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours; This is a spontaneous report received from a Consumer or other non HCP.  A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Jan2024; LOSARTAN/HYDROCHLOROTHIAZIDE, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Urgency urination", "Nocturia", "Increased urinary frequency". The following information was reported: MICTURITION URGENCY (non-serious), outcome "recovered", described as "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident"; NOCTURIA (non-serious), outcome "recovered", described as "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; POLLAKIURIA (non-serious), outcome "recovered", described as "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours". Therapeutic measures were not taken as a result of micturition urgency, nocturia, pollakiuria. Additional information: Patient managed hypertension effectively with medication. Since receiving the initial COVID-19 vaccination in February 2021, she has had seven booster shots. After each Pfizer vaccination, patient experienced an intense and unusual side effect starting about 6-8 hours post-injection. She developed an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night. Despite trying to rest, she found it impossible due to the frequency and urgency of these episodes. Notably, after her first injection, this cycle lasted between 12-14 hours. These symptoms only occur following the vaccine.   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-202500067929 same patient/event, different dose;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: latex-like reaction/ with in 2 days feel hot, prickly "on fire" shot area around right arm; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 0.3 ml single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, single, manufacturer unknown), for Covid-19 immunization, reaction(s): "no adverse event"; Flu vaccine (Dose number unknown, single), for Immunization, reaction(s): "no adverse event". The following information was reported: VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "latex-like reaction/ with in 2 days feel hot, prickly "on fire" shot area around right arm".  Additional information: Patient never had reaction to either the flu or covid shots in the past and these were much like latex reactions.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in her forehead; forehead numb; This is a spontaneous report received from a consumer from medical information team, Program ID.  A 50-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Apr2024 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Little bit fat" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE 2), for COVID-19 immunization, reaction(s): "Joint pain". The following information was reported: HYPOAESTHESIA (non-serious) with onset Apr2024, 20 min after the suspect product(s) administration, outcome "recovered" (Apr2024), described as "Numbness in her forehead; forehead numb". Therapeutic measures were not taken as a result of hypoaesthesia.  Additional Information: The patient had no other conditions, other products, or investigations. The patient has no significant health conditions other than being a little bit fat. When the patient received her last booster in Apr2024 (to stay current and was going to a group setting), she experienced numbness in her forehead about 20 minutes after she received the vaccine (made her forehead numb), but it went away (recovered completely). It only lasted for less than 5 minutes and went away. No treatment was received for the event. The patient wanted to know if she should be concerned about getting another vaccine booster and if the forehead numbness could be a buildup of too much of the spike proteins. Her pharmacist said not to worry about the forehead numbness as they had heard about this before. The patient doesn't understand how the vaccine works and why there is a new one seemingly every year that patients need to get. The patient would like to know if she can get booster again with her children with the 2024 formulation in Oct2025.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500069247 Same patient and product; different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Renal function test
Clinical narrative: she was diagnosed with acute kidney injury; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  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: ACUTE KIDNEY INJURY (medically significant), outcome "unknown", described as "she was diagnosed with acute kidney injury". The patient underwent the following laboratory tests and procedures: Renal function test: (Feb2024) 71 %. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Vaccine does not work; Have had COVID three times; Vaccine does not work; Have had COVID three times; Vaccine does not work; Have had COVID three times; 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. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), administration date: Jan2021, for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE (BOOSTER)), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4, SINGLE (BOOSTER)), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5, SINGLE (BOOSTER)), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Vaccine does not work; Have had COVID three times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: have had COVID three times. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence.  Clinical course: The patient had all the boosters, and they all are Pfizer COVID-19 vaccines (1, 2, 3, 4, 5, and 6 vaccines), and got COVID three times. Vaccine does not work. Prescribed Paxlovid after getting COVID at the beginning; He has been prescribed Paxlovid to treat COVID again.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea
Clinical narrative: shortness of breath; reduced energy; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jul2021 as dose 1, single (Lot number: EW0198) at the age of 56 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: May2017; HYDROCHLOROTHIAZIDE, start date: Jan2020; LOSARTAN, start date: Sep2020. Past drug history included: Lisinopril, reaction(s): "allergy". The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; ASTHENIA (non-serious), outcome "unknown", described as "reduced energy". Additional information: Not long after taking the vaccines, the patient had shortness of breath and reduced energy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500084622 Same patient/drug; different dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Parkinson's disease
Clinical narrative: After taking the Pfizer booster shot, I was diagnosed with Parkinson's; This is a spontaneous report received from a Consumer or other non HCP.  A 79-year-old female patient (not pregnant) 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: "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Vascular Disease" (unspecified if ongoing); "Dementia" (unspecified if ongoing); "Alzheimer's" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LANTUS; ATORVASTATIN; LISINOPRIL. Vaccination history included: Covid-19 vaccine (Primary immunisaton completed; Manufacturer unknown), for COVID-19 immunisation. The following information was reported: PARKINSON'S DISEASE (disability, medically significant), outcome "not recovered", described as "After taking the Pfizer booster shot, I was diagnosed with Parkinson's". Therapeutic measures were taken as a result of parkinson's disease.  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: Our daughter got the Pfizer ones and wound up getting Covid 5 times; Our daughter got the Pfizer ones and wound up getting Covid 5 times; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A child 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 "Our daughter got the Pfizer ones and wound up getting Covid 5 times".  Clinical course: The consumer's child received the Comirnaty COVID-19 Vaccine; they wrote: ''Our daughter got the Pfizer ones and wound up getting Covid 5 times. No other details are known.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: patient's 3rd time having Covid; patient's 3rd time having Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 28-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Dec2024 as dose 1, single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: The last time he had COVID, he was hospitalized for 3 days/he's had COVID twice; "sick" (unspecified if ongoing), notes: It was awful he was so sick; "hospitalized" (not ongoing), notes: The last time he had COVID, he was hospitalized for 3 days. The patient's concomitant medications were not reported. Past drug history included: Monoclonal antibodies, notes: he had to get the monoclonal antibodies that was before the meds were out; a year half ago. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient's 3rd time having Covid". Clinical details: The patient had COVID twice. The first time, way back in the day, he had to get the monoclonal antibodies that was before the meds were out; a year half ago, he was- his glucose shot up, his stats were in the low 80s. He had to hospitalized for 3 days. It was just a nightmare. It was awful he was so sick, so that's how much it means to his family. The last time he had COVID, he was hospitalized for 3 days, he tested positive for COVID. He has a prescription with the pharmacy. This was the patient's 3rd time having Covid. He has had his shot preventative and it was Pfizer, he got the recent one back in December. That was the most recent 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: Blood pressure measurement, Brain fog, COVID-19, Cardiac disorder, Drug ineffective
Clinical narrative: Covid; Covid; Long Covid; cardiac issues; blood pressure when she lay down went really low like 60/40; internal vibrations and tremors; fatigue; brain fog; This is a spontaneous report received from a Nurse, Program ID.  A 78-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 included: "breast cancer" (unspecified if ongoing); "pancreatic tumor" (unspecified if ongoing); "whipple operation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac issues"; HYPOTENSION (non-serious), outcome "unknown", described as "blood pressure when she lay down went really low like 60/40 "; TREMOR (non-serious), outcome "unknown", described as "internal vibrations and tremors"; FATIGUE (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 60/40, notes: go really low. The clinical course was reported as follows: Patient's husband was going to be 84 and they both have had cancer, he had cancer now, he had menthenmathoma. Patient also had Long Covid and she was no longer allowed to take the vaccines, which she had been taking for Covid. Her husband took nirmatrelvir, ritonavir and he did very well on it. The patient and her husband had a prescription for nirmatrelvir, ritonavir, but did not have Covid at this time. They were so ill before, her husband had cancer and they were going to take a trip, so they would like to have nirmatrelvir, ritonavir with him, if they should get it. Patient was in really bad shape with the Covid, with all sorts of all sorts of issues, and was in bed for long long time and had cardiac issues. Her blood pressure when she lay down went really low like 60/40 and then she had internal vibrations and tremors and incredible fatigue for so so long. Patient still was not where she was, but she was a whole lot better. She also had brain fog.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with Comirnaty (2024-2025 Formula) can not be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypotension, Post-acute COVID-19 syndrome, Tremor
Clinical narrative: Covid; Covid; Long Covid; cardiac issues; blood pressure when she lay down went really low like 60/40; internal vibrations and tremors; fatigue; brain fog; This is a spontaneous report received from a Nurse, Program ID.  A 78-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 included: "breast cancer" (unspecified if ongoing); "pancreatic tumor" (unspecified if ongoing); "whipple operation" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "Long Covid"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "cardiac issues"; HYPOTENSION (non-serious), outcome "unknown", described as "blood pressure when she lay down went really low like 60/40 "; TREMOR (non-serious), outcome "unknown", described as "internal vibrations and tremors"; FATIGUE (non-serious), outcome "unknown"; BRAIN FOG (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: 60/40, notes: go really low. The clinical course was reported as follows: Patient's husband was going to be 84 and they both have had cancer, he had cancer now, he had menthenmathoma. Patient also had Long Covid and she was no longer allowed to take the vaccines, which she had been taking for Covid. Her husband took nirmatrelvir, ritonavir and he did very well on it. The patient and her husband had a prescription for nirmatrelvir, ritonavir, but did not have Covid at this time. They were so ill before, her husband had cancer and they were going to take a trip, so they would like to have nirmatrelvir, ritonavir with him, if they should get it. Patient was in really bad shape with the Covid, with all sorts of all sorts of issues, and was in bed for long long time and had cardiac issues. Her blood pressure when she lay down went really low like 60/40 and then she had internal vibrations and tremors and incredible fatigue for so so long. Patient still was not where she was, but she was a whole lot better. She also had brain fog.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with Comirnaty (2024-2025 Formula) can not be fully excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Balance disorder
Clinical narrative: She said that she had no smell, no taste, and no balance after taking them; She said that she had no smell, no taste, and no balance after taking them; She said that she had no smell, no taste, and no balance after taking them; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing); "cholesterol abnormal" (unspecified if ongoing). Concomitant medication(s) included: COLESTID taken for blood cholesterol abnormal. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "She said that she had no smell, no taste, and no balance after taking them".  Additional information: She was taking Colestid which was a medication for cholesterol. She took 2 packets of it every day then she was made to take these huge pills that she really has trouble swallowing. She also wanted to know if Pfizer had a program for Eliquis and Gemtesa where she could get them at a cheaper price. She further stated that she has multiple sclerosis, and she had to take three shots of the Pfizer COVID vaccine because she was in the (PRIVACY) and she could not get them to check her blood thinner without taking the shots. She said that she had no smell, no taste, and no balance after taking the Pfizer COVID vaccine.  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: the patient had COVID; the patient had COVID; 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)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patient had COVID". Clinical course: This is the second time patient got Covid. Last time, when she was prescribed Paxlovid, she didn't have any issue getting the medication, but right now, when she went to the pharmacy, and the pharmacist told her that she needs the billing information, so she kind of worried because she didn't have this experience before and she's is sick. She need assistance on how to taken care of it, like, you know, getting the medication for the Paxlovid". The reason for the call was because the patient had Covid for a second time, took Paxlovid previously, and needed assistance.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Balance disorder, Brain fog, Deafness unilateral, Dizziness, Memory impairment
Clinical narrative: left ear deafness; tinnitus 24/7; Balance Problems; vertifo; nystagmus; dizziness; memory problems; brain fog; 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 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: DEAFNESS UNILATERAL (medically significant), outcome "not recovered", described as "left ear deafness"; TINNITUS (non-serious), outcome "not recovered", described as "tinnitus 24/7"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Balance Problems"; VERTIGO (non-serious), outcome "not recovered", described as "vertifo"; NYSTAGMUS (non-serious), outcome "not recovered"; DIZZINESS (non-serious), outcome "not recovered"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "memory problems"; BRAIN FOG (non-serious), outcome "not recovered".  Clinical course: The patient was reporting side effects and health problems from the COVID vaccinations and boosters. Patient was required to get them for work as a health professional. Has left ear deafness, tinnitus, nystagmus, balance problems, memory loss, brain fog, vertigo and dizziness. Has never ever called in sick for work and can now barely function. Patient states that" It is easy to say that you all are too busy, but my life is awful now. I will never get my life back.". Received 5 vaccinations/boosters
Vaccine: COVID19
Symptoms: Nystagmus, Tinnitus, Vertigo
Clinical narrative: left ear deafness; tinnitus 24/7; Balance Problems; vertifo; nystagmus; dizziness; memory problems; brain fog; 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 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: DEAFNESS UNILATERAL (medically significant), outcome "not recovered", described as "left ear deafness"; TINNITUS (non-serious), outcome "not recovered", described as "tinnitus 24/7"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "Balance Problems"; VERTIGO (non-serious), outcome "not recovered", described as "vertifo"; NYSTAGMUS (non-serious), outcome "not recovered"; DIZZINESS (non-serious), outcome "not recovered"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "memory problems"; BRAIN FOG (non-serious), outcome "not recovered".  Clinical course: The patient was reporting side effects and health problems from the COVID vaccinations and boosters. Patient was required to get them for work as a health professional. Has left ear deafness, tinnitus, nystagmus, balance problems, memory loss, brain fog, vertigo and dizziness. Has never ever called in sick for work and can now barely function. Patient states that" It is easy to say that you all are too busy, but my life is awful now. I will never get my life back.". Received 5 vaccinations/boosters
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: lost all of my hair Alopecia areata totals; 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 NOS), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA AREATA (non-serious), outcome "unknown", described as "lost all of my hair Alopecia areata totals".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: DTAPIPV
Symptoms: No adverse event, Underdose
Clinical narrative: Needle slipped and incomplete dose given with no reported adverse event; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) [Quadracel] whose needle slipped, and incomplete dose given 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 in 2025, the patient received a 0.5ml dose of suspect Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) vaccine Suspension for injection (lot number, expiry date-unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) and needle slipped and incomplete dose given with no reported adverse event (incorrect dose administered) (latency- 1 day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.  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: 79.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Eye swelling
Clinical narrative: Eye swelling; Initial information received on 31-Mar-2025 regarding an unsolicited valid  non-serious courtesy case received from a consumer/non-hcp (non-healthcare professional).  This case involves a 79 years old female patient who experienced eye swelling after receiving Influenza USP Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose] and COVID-19 vaccine prot. subunit (NVX CoV 2373) [Novavax COVID-19 Vaccine].  No concomitants used/reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Dec-2024, the patient received an unknown dose (dose 1) of suspect COVID-19 vaccine prot. subunit (NVX CoV 2373), Injection not produced by Sanofi Pasteur (lot 6024MF020, strength 0.5mL; strength not reported) via intramuscular route in unknown administration site for COVID-19 immunization.  On an unknown date, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot UT8454EA, strength 0.5mL; expiry date not reported) via intramuscular route in unknown administration site for Drug Use for Unknown Indication (Product used for unknown indication).   On 13-Dec-2024, the patient developed eye swelling (latency 1 day) following the administration of COVID-19 vaccine prot. subunit (NVX CoV 2373) and (latency unknown) Influenza USP Trival A-B High Dose Subvirion Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.  Sender's comment - This 79-year-old Female experienced Eye swelling after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The event Eye swelling was reported as non-serious.Based on the spontaneous nature of the report, the causal relationship between the vaccine and the event is considered Possible.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation issue
Clinical narrative: medication error due to administration of incorrect reconstitution of ACTHIB with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 2 months old female patient who received HIB (PRP/T) vaccine [ACT-HIB] incorrectly reconstituted 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 rotavirus vaccine, pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20) and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (pediarix), all for Immunisation.  On 19-Mar-2025, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength with lot UK107AB and expiry date 30-Sep-2025 via intramuscular route in the left thigh for Immunization that was incorrectly reconstituted with no reported adverse event (product preparation error) (Latency same day)  Reportedly, Reporter stated that, administered ACTHIB that was reconstituted with sterile water  Action taken was not applicable.   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.