chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: Expired Product Used/patient received Hiberix which was expired on 09th Jan; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received Hib (Hiberix) (batch number 3G57J, expiry date 09-JAN-2025) for prophylaxis.   On 13-JAN-2025, the patient received Hiberix. On 13-JAN-2025, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Expired Product Used/patient received Hiberix which was expired on 09th Jan). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 16-DEC-2024 Other HCP reported that 12 month old male patient was administered a dose of Hiberix 13th JAN, 2025, which had an expiration date of 09th JAN, 2025, which led to expired vaccine used. At the time of reporting, no additional doses had been administered.
Age: 80.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Medication error; he was given another RSV shot by mistake; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 80-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Pneumococcal vaccine for prophylaxis.   Previously administered products included Arexvy (received an RSV vaccination 6 months ago).   On 10-JAN-2025, the patient received the 2nd dose of Arexvy. On an unknown date, the patient received Pneumococcal vaccine. On 10-JAN-2025, an unknown time after receiving Arexvy, the patient experienced wrong vaccine administered (Verbatim: Medication error) and extra dose administered (Verbatim: he was given another RSV shot by mistake). The outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 14-JAN-2025 The patient reported that he received an RSV vaccination 6 months ago at a pharmacy. The patient reported that his physician office called a few days ago and asked him to come in to receive a pneumonia shot and was later informed that he was given another RSV shot by mistake which led to wrong vaccine administered and extra dose administered.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received second dose of Arexvy; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 77-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (Patient received first dose one year ago).   On 13-JAN-2025, the patient received the 2nd dose of Arexvy (intramuscular, right deltoid). On 13-JAN-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received second dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-JAN-2025 The patient reported that she received Arexvy vaccine twice, which led to extra dose administered.
Sex: U
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 7 patients received a second dose of Arexvy; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in an specified number of patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   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: 7 patients received a second dose of Arexvy). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-JAN-2025 Reporter stated that 7 patients received a second dose of Arexvy, which led to extra dose administered. The patients were fine and no more specific information of the patients or the lot numbers and expiration dates of the vaccines were provided.
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix was mistakenly given in the deltoid muscle rather than subcutaneously; This non-serious case was reported by a nurse via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 18-year-old male patient who received MMR (Priorix) (batch number 342RC, expiry date 01-MAY-2025) for prophylaxis.   On 15-JAN-2025, the patient received Priorix (intramuscular, unknown deltoid). On 15-JAN-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was mistakenly given in the deltoid muscle rather than subcutaneously). The outcome of the subcutaneous injection formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-JAN-2025 The reporter was the Healthcare Professional. Priorix was mistakenly given in the deltoid muscle rather than subcutaneously which led to Subcutaneous injection formulation administered by other route. Nothing else was reported.
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: a second dose was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 84-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255T2, expiry date 05-DEC-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose a year ago).   On 21-JAN-2025, the patient received the 2nd dose of Arexvy. On 21-JAN-2025, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a second dose was administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-JAN-2025 The pharmacist reported that a patient received a first dose of Arexvy last year and a second dose was administered which led to extra dose administered. The pharmacist asked for potential adverse effects.
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: experienced soreness at the injection site; a small bump at the injection site; itching at the injection site; large red area surrounding the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 255T2, expiry date 05-DEC-2025) for prophylaxis.   On 09-JAN-2025, the patient received Arexvy (intramuscular). On 09-JAN-2025, less than a day after receiving Arexvy, the patient experienced injection site erythema (Verbatim: large red area surrounding the injection site) and injection site itching (Verbatim: itching at the injection site). On 10-JAN-2025, the patient experienced injection site pain (Verbatim: experienced soreness at the injection site) and injection site mass (Verbatim: a small bump at the injection site). The outcome of the injection site erythema and injection site itching were not resolved and the outcome of the injection site pain and injection site mass were resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site mass and injection site itching to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site pain, injection site mass and injection site itching to be related to Arexvy.   Additional Information: GSK Receipt Date: 24-JAN-2025 The reporter reported that she received her Arexvy vaccine on 9th January 2025.  Later the day of reporting she noticed a large red area surrounding the injection site that had faded somewhat but was still visible. She also experienced soreness, a small bump and itching at the injection site.  The itching was milder but still present.  The bump and soreness had resolved.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned an elderly female patient via social media. 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, intramuscular, 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 to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced death. (dose series 1). It was unknown if an autopsy was performed. The action taken with janssen covid-19 vaccine was not applicable.   Reported cause of death was unknown cause of death.  The patient died on an unspecified date.  The reporter considered the causality between janssen covid-19 vaccine and death as related. Company causality between janssen covid-19 vaccine and death as possible.  This report was serious (death).; Sender's Comments: V0; Death; The event 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. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: unknown cause of death
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rotator cuff syndrome
Clinical narrative: rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pain in the other arm (left) while still having mild pain in the right; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pain in the other arm (left) while still having mild pain in the right) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In November 2024, the patient experienced ROTATOR CUFF SYNDROME (rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pain in the other arm (left) while still having mild pain in the right). At the time of the report, ROTATOR CUFF SYNDROME (rotator cuff issue / Severe arm pain / trouble moving the arm in which I had the vaccine (right)/pain in the other arm (left) while still having mild pain in the right) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  Patient had severe arm pain and trouble moving the arm in which she had the vaccine (right). After a week, she experienced pain in the other arm (left) while still having mild pain in the right. As of now (28 January 2025) she had still pain in the left arm which has been diagnosed as a rotator cuff issue. It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: I have been experiencing higher than normal blood pressure over the last 2 years; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (I have been experiencing higher than normal blood pressure over the last 2 years) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028k21a and 053e21a) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 15-Dec-2020. Concurrent medical conditions included ADHD and Osteoarthritis.   On 22-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 15-Jun-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERTENSION (I have been experiencing higher than normal blood pressure over the last 2 years). At the time of the report, HYPERTENSION (I have been experiencing higher than normal blood pressure over the last 2 years) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Blood pressure measurement: higher than normal blood pressure over the last 2 years.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: She is very dizzy/dizziness/has to hold onto walls to walk; she feels like vomiting/she has thrown up many times; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (She is very dizzy/dizziness/has to hold onto walls to walk) and VOMITING (she feels like vomiting/she has thrown up many times) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. UNKNOWN) for COVID-19 prophylaxis.     No Medical History information was reported.    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 DIZZINESS (She is very dizzy/dizziness/has to hold onto walls to walk) and VOMITING (she feels like vomiting/she has thrown up many times). At the time of the report, DIZZINESS (She is very dizzy/dizziness/has to hold onto walls to walk) and VOMITING (she feels like vomiting/she has thrown up many times) had not resolved.            No concomitant medications were reported.  The patient was very dizzy/dizziness/had to hold onto walls to walk and she felt like vomiting/she had thrown up many times and sick from the shot, she had it 10 days ago. She was very dizzy and felt like vomiting. Her husband who was a doctor called in and got nothing from people.   The patient holds onto walls to walk, and she had thrown up many times.   No treatment medications were reported.
Age: 22.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Pain
Clinical narrative: chills; body aches; temperature 99.6 F/100F; Thought they had given an HPV Vaccine, but instead they had given Abrysvo; This is a spontaneous report received from a Pharmacist, Program ID.  A 22-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Nov2024 as dose 1, single (Lot number: LN5502, Expiration Date: 10Jan2025) at the age of 22 years intramuscular, in right deltoid for immunisation. The patient didn't receive hpv vaccine (HPV VACCINE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 11Nov2024, outcome "unknown", described as "Thought they had given an HPV Vaccine, but instead they had given Abrysvo"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "temperature 99.6 F/100F". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Abryvso vaccine was given to the wrong patient. The patient is post-partum. They thought they had given an HPV Vaccine, but instead they had given Abrysvo. The patient did not receive any other vaccine on the same day as the Pfizer vaccine. The patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient did not previously receive the Pfizer suspect vaccine. The patient was not allergic to ang previous vaccinations, medications, food or other products. There was no any other diagnosed illness/medical history/chronic health conditions. The event did not require a visit to the emergency room or physician's office. Treatment was not received for the adverse event. There was no adverse events following this vaccination.   Amendment: This follow-up report is being submitted to amend previously reported information: suspect vaccine Indication was updated from "Maternal exposure timing unspecified" to "Immunization". Follow-up (16Jan2025): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.  Follow-up (29Jan2025): This is a spontaneous follow-up report received from a Pharmacist in response to follow-up letter.  Updated information: patient's details (name, date or birth, age, weight, height) added, product details (vaccination date, anatomical location, route, dose number, lot number, expiration date), event details (onset date), removed event Drug use in unapproved population, new event chills, General body pain, fever added, additional information added.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling hot, Hypersomnia
Clinical narrative: clammy; overheated ,hot and clammy; severe exhaustion/tired all the time; she sleeps 10 to 12 hours; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: F00809), in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Surgery for lung cancer", start date: 2017, stop date: 2017, notes: It was removed & has not reoccurred. No test results to include, everything seems back to normal; "Lung cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Mumps and measles vaccines (dose number unknown, manufacturer unknown; received as a kid), for Immunisation; Flu vaccine (over the years got the annual flu vaccine), for Immunisation. The following information was reported: COLD SWEAT (non-serious), outcome "not recovered", described as "clammy"; FEELING HOT (non-serious), outcome "not recovered", described as "overheated ,hot and clammy"; FATIGUE (non-serious), outcome "unknown", described as "severe exhaustion/tired all the time"; HYPERSOMNIA (non-serious), outcome "unknown", described as "she sleeps 10 to 12 hours".  Additional information: The patient got her vaccine in 2021 since then and with time she was more warm and she had to find ways to keep cool, she was wearing shorts during winter and it was to a point where  it was  becoming ridiculous. She also had severe exhaustion, she sleeps 10 to 12 hours, and was tired all of the time, and if years later this could be related to the vaccine. How long would this last. The patient complained about feeling overheated, hot, and clammy. As stated, the patient got the vaccines a few years ago and it started since got them and continued till today and wondering if was a side effect.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021957 same reporter/vaccine/patient, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Condition aggravated, Feeling hot, Inappropriate schedule of product administration
Clinical narrative: feeling hot; feeling hot and each year it seems to be getting worse; clammy; 1st covid vaccine given 09Sep2021; 2nd covid vaccine given on 21Sep2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 2, single (Lot number: 301358A) for covid-19 immunisation. The patient's relevant medical history included: "lung cancer" (unspecified if ongoing), notes: It was removed & has not reoccurred. No test results to include, everything seems back to normal; "lung cancer surgery", start date: 2017, stop date: 2017. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, lot number: F00809), administration date: 09Sep2021, for COVID-19 immunisation, reaction(s): "feeling hot", "severe exhaustion/tired all the time", "sleeps 10 to 12 hours", "clammy"; Mumps vaccine (dose number unknown, manufacturer unknown, as a kid), for immunisation; Measles vaccine (dose number unknown, manufacturer unknown, as a kid), for immunisation; Flu vaccine (annually, over the years), for immunisation. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Sep2021, outcome "unknown", described as "1st covid vaccine given 09Sep2021; 2nd covid vaccine given on 21Sep2021"; FEELING HOT (non-serious), outcome "not recovered"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "feeling hot and each year it seems to be getting worse"; COLD SWEAT (non-serious), outcome "unknown", described as "clammy". Additional information: Patient was employed. She received the vaccine in the left shoulder. Patient has no prior vaccinations (within 4 weeks). Patient was feeling hot. Each year, it seems to be getting worse. It will be 50 something degrees. Patient will be feeling hot and clammy. Inside the house, the temperature will be 62 degrees. During the summer, patient was very concerned because when it does get hot inside, she continues to get hotter. Patient was fine on the other medications taking before. She feels like it's the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500021408 same patient/drug, different event/dose;
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pyrexia, Vomiting
Clinical narrative: got very hot and feverish; threw up; sweaty; nausea; headache; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-781244 (Moderna).  A male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 2, single (Lot number: ER8734) 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: EN6207), administration date: 17Mar2021, for COVID-19 immunization, reaction(s): "got very hot and feverish". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "got very hot and feverish"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021); NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021); HYPERHIDROSIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "sweaty"; VOMITING (non-serious) with onset 2021, outcome "recovered" (2021), described as "threw up". Additional information: Patient was curious about getting an update on his COVID-19 shots, had 3 shots back in 2021 and they were all Pfizer shots. Patient was asking if it matter if the patient update the shots with the Moderna vaccine and was planning on getting his shot. Patient expects to get mild symptoms, is pretty healthy, the last time had a shot, had a different reaction on all 3 different shots, pretty sick. Patient did not have the expiration date or the dose volume of the 3 shots written on his vaccination card. Patient clarified also got very hot and feverish for all 3 doses. One of them had a pretty bad headache too, probably with the second dose. Patient noted the second dose was the most traumatic since experienced the most, all of it, the hot and throwing up and the headache. Patient experienced really high temperature, got really-everything got really hot and sweaty, experienced nausea and throwing up on his second dose. On the 3rd dose, got really hot, but doesn't know if it would be considered a high fever, sweaty stuff. The symptoms came and went pretty quick. It all came and went pretty quick as far as the patient can remember, within the next day was doing better. Patient later mentioned being older, got to be more of at risk (referring to his risk of COVID-19).  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500022036 Same patient/vaccine, different dose/AE;US-PFIZER INC-PV202500012460 Same patient/vaccine, different dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: got very hot and feverish; Sweaty stuff; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-781244 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "got very hot and feverish"; HYPERHIDROSIS (non-serious), outcome "recovered", described as "Sweaty stuff".  Additional information: Patient was curious about getting an update on his COVID-19 shots, had 3 shots back in 2021 and they were all Pfizer shots. Patient was asking if it matter if the patient update the shots with the Moderna vaccine and was planning on getting his shot. Patient expects to get mild symptoms, is pretty healthy, the last time had a shot, had a different reaction on all 3 different shots, pretty sick. Patient did not have the expiration date or the dose volume of the 3 shots written on his vaccination card. Patient clarified also got very hot and feverish for all 3 doses. One of them had a pretty bad headache too, probably with the second dose. Patient noted the second dose was the most traumatic since experienced the most, all of it, the hot and throwing up and the headache. Patient experienced really high temperature, got really-everything got really hot and sweaty, experienced nausea and throwing up on his second dose. On the 3rd dose, got really hot, but doesn't know if it would be considered a high fever, sweaty stuff. The symptoms came and went pretty quick. It all came and went pretty quick as far as the patient can remember, within the next day was doing better. Patient later mentioned being older, got to be more of at risk (referring to his risk of COVID-19).  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500012460 Same patient/vaccine, different dose/AE;US-PFIZER INC-202500022035 Same patient/vaccine, different dose/AE;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 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: CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever".  Additional information: Patient mentioned the she have had COVID vaccinations, and she got a reaction to that. She got a fever and chills, It last for a day and it's gone. (...) These were the things not made in public, she did read the information when the pharmacist told her what she was going to give her. She did read it thoroughly because again, COVID knocked her sideways but they seem to be okay. But had she known there were some instances of extreme fatigue, systemic muscle pain, she would have drawn another one.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Cachexia, Chest pain, Fatigue, Illness
Clinical narrative: Cachexia; body pain; sick; tired; abdominal pain; chest pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CACHEXIA (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body pain"; ILLNESS (non-serious), outcome "unknown", described as "sick"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ABDOMINAL PAIN (non-serious), outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown". The patient stated, "What should I do now that I am dying almost 4 years after getting the Pfizer vaccine 2021? I have been diagnosed with Cachexia." Since getting the vaccine, the patient had been so weak, sick and tired with many any visits to the ER for abdominal pain. Patient had had chest pain and body pain since receiving the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Cachexia; body pain; sick; tired; abdominal pain; chest pain; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Lot number: FE3592) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CACHEXIA (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body pain"; ILLNESS (non-serious), outcome "unknown", described as "sick"; FATIGUE (non-serious), outcome "unknown", described as "tired"; ABDOMINAL PAIN (non-serious), outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown". The patient stated, "What should I do now that I am dying almost 4 years after getting the Pfizer vaccine 2021? I have been diagnosed with Cachexia." Since getting the vaccine, the patient had been so weak, sick and tired with many any visits to the ER for abdominal pain. Patient had had chest pain and body pain since receiving the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: got very hot and feverish; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-781244 (Moderna).  A male patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6207) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "got very hot and feverish". Additional information: Patient was curious about getting an update on his COVID-19 shots, had 3 shots back in 2021 and they were all Pfizer shots. Patient was asking if it matter if the patient update the shots with the Moderna vaccine and was planning on getting his shot. Patient expects to get mild symptoms, is pretty healthy, the last time had a shot, had a different reaction on all 3 different shots, pretty sick. Patient did not have the expiration date or the dose volume of the 3 shots written on his vaccination card. Patient clarified also got very hot and feverish for all 3 doses. The symptoms came and went pretty quick. It all came and went pretty quick as far as the patient can remember, within the next day was doing better. Patient later mentioned being older, got to be more of at risk (referring to his risk of COVID-19).  No follow-up attempts are possible.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500022035 Same patient/vaccine, different dose/AE;US-PFIZER INC-202500022036 Same patient/vaccine, different dose/AE;
Sex: F
Vaccine: PNC20
Symptoms: Condition aggravated, Fatigue, Inflammation, Pain
Clinical narrative: She is still exhausted until now; inflammation response; severe pain flare-up/developed a tremendous pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A 72-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 07Jan2025 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Pain" (unspecified if ongoing), notes: pain management patient. Concomitant medication(s) included: NOVOCAIN. The following information was reported: PAIN (medically significant) with onset 08Jan2025, outcome "recovering", described as "severe pain flare-up/developed a tremendous pain"; FATIGUE (non-serious), outcome "not recovered", described as "She is still exhausted until now"; INFLAMMATION (non-serious), outcome "unknown", described as "inflammation response". The event "severe pain flare-up/developed a tremendous pain" required physician office visit. Therapeutic measures were taken as a result of pain. Clinical course: On 29Jan2025, it was reported that the patient received the Prevnar 20 vaccine. The patient is a pain management patient and get biweekly trigger point injections to manage her pain. The day after the vaccine, she started to have a severe pain flare up that even additional trigger point injections didn't help. Her doctor said that she was having an inflammation response. The patient was still in pain and it's three weeks later. On 30Jan2025, additional context was reported:  She is on pain management, and she has been getting biweekly trigger point injections to manage her pain which she was getting these trigger point injections prior to the administration of Prevnar 20. She mentioned that the trigger point injections include Novocain. Three days after receiving the Prevnar 20 vaccine, she developed a tremendous pain. She is still exhausted until now, and the pain is starting to decline in the past three days. The pain she experienced is enough to seek medical attention and agent stated she did seek medical attention.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Hypertension, Nervous system disorder
Clinical narrative: stroke; It affected patient's whole body especially nervous system; High blood pressure; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "It affected patient's whole body especially nervous system"; HYPERTENSION (non-serious), outcome "unknown", described as "High blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high. Clinical details: The patient had a severe reaction to the Pfizer vaccine. The first shot and only one. Dr's told the patient never to get another vaccine. It affected patient's whole body especially nervous system. High blood pressure along with having a stroke.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 41.0
Sex: U
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site erythema; Injection site warmth; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from Health Authorities via Nurse.  This case involves a 41 years old and unknown gender patient who experienced injection site erythema and injection site warmth after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  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 0.5 ml dose once of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number, strength and expiry not reported) via intramuscular route in unknown administration site as Immunisation. There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date the patient developed injection site erythema and injection site warmth (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received 2 doses of ACT-HIB with no reported adverse event; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced patient received 2 doses of ACT-HIB with no reported adverse event after receiving HIB (PRP/T) Vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Nov-2024, the patient received 2DF (dosage form) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization.  Information on the batch number was requested corresponding to the one at time of event occurrence.  On 18-Nov-2024, the patient developed patient received 2 doses of ACT-HIB with no reported adverse event (latency same day) following the administration of HIB (PRP/T) Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: had an anaphylactic reaction to the tetanus vaccine, ADACEL; Initial information received on 31-Jan-2025 regarding an unsolicited valid serious case received from a Nurse.  This case involves an unknown age and unknown gender patient had an anaphylactic reaction to the tetanus vaccine, diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot number, expiry date and strength: not reported) via unknown route in unknown administration site for Immunization   Information on batch number and expiry date corresponding to the one at time of event occurrence was requested  On an unknown date the patient had an anaphylactic reaction to the tetanus vaccine, ADACEL (anaphylactic reaction) (latency unknown)  Reportedly, the reporter do not know what component of ADACEL the patient reacted to. She asked if there were any components in TYHPHIM VI that are the same as ADACEL  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (anaphylactic reaction).  At time of reporting, the outcome was Unknown for the event anaphylactic reaction.  Seriousness Criteria: Medically significant for the event anaphylactic reaction; Sender's Comments: Sanofi Company Comment dated on 04-Feb-2025: Based on the information available, the role of the vaccine cannot be established. Further information regarding concurrent condition during vaccination, previous reaction to the vaccination or similar vaccine, tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the individual role of the suspect vaccine cannot be assessed.
Sex: F
Vaccine: UNK
Symptoms: Cough, Fatigue, Influenza, Pyrexia, Respiratory tract congestion
Clinical narrative: Diagnosed with Influenza A; Fatigue; Fever; Coughing; Congestion; This spontaneous case, initially received on 21-Jan-2025, was reported by a non health professional and concerns a female patient with unknown age.  No medical history or concomitant medications were reported.  Administration of company suspect drug: On 24-Oct-2024, the patient received Flucelvax (TIV) for Active immunization for the prevention of influenza disease, dose, route of administration and route of administration: not reported,  Lot number: not reported and wont be requested due to no follow-up consent.   No additional suspect drugs.  Adverse reactions/events and outcomes: On 19-Jan-2025, the patient experienced Diagnosed with Influenza A (Medically Significant, outcome: Unknown). Associated symptoms included: Standard symptoms of the flu - Fatigue, Fever, Coughing, Congestion.  The patient reported that wanted to report an adverse event, with a special situation. She was vaccinated with Flucelvax on 24-Oct-2024. She was diagnosed with Influenza A on 19-Jan-2025 at Urgent Care,  The patient was experiencing standard symptoms of the flu, including fatigue, fever, coughing, congestion etc. The patient has no other medical conditions.  Non-drug treatment/Other action taken:  Flucelvax (TIV) action taken: Not Applicable  Reporter assessment: the reporter did not provide a seriousness and causality assessment for the event; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. Of note, Influenza A occurred 2 months and 27 days post vaccination with Flucelvax. But, there is limited information regarding the laboratory tests for the confirmation of Influenza A.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Clinic coordinator calling to report an expired dose of GARDASIL 9 was inadvertently administered to a patient.; This spontaneous report was received from a clinic coordinator and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-JAN-2025, the patient was inadvertently vaccinated with an expired dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, (lot #W026152 was verified to be a valid number, expiration date: 29-JAN-2025), administered for prophylaxis (dose, vaccination scheme, injection, strength, and route of administration were not provided) (expired product administered). The product did not undergo any temperature excursions and was supported per Post Expiry Memo. No additional adverse event was reported.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE; On 22Jan2025 received SHINGRIX. On 03Feb2025 patient came in an they administered the VARIVAX.; On 22Jan2025 she was scheduled to get VARIVAX/ instead inadvertently received SHINGRIX; This spontaneous report has been received from a nurse concerning to a 33-year-old female patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  It was reported that the patient needed to get varicella virus vaccine live (Oka/Merck) (VARIVAX) for her nursing school. On 22-JAN-2025, she was scheduled to get varicella virus vaccine live (Oka/Merck) (VARIVAX) but instead inadvertently received varicella zoster vaccine rge (cho) (SHINGRIX) as prophylaxis (formulation, strength, dose, route and anatomical location of administration, lot #, and expiration date were not provided) (wrong product administered). Later, on 03-FEB-2025 (reported as today) the patient was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (strength, dose, route and anatomical location of administration, lot #, and expiration date were not provided) as prophylaxis (extra dose administered). No other information was known or reported. No side effects and no additional adverse event (AE) were reported.  Lot # is being requested and will be submitted if received.
Age: 1.25
Sex: F
Vaccine: RV5
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: No adverse effects were reported.; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; HCP called to report that a healthy 15 month old female was given a 4th (extra) dose of ROTATEQ today (2/3/2025), above the maximum age limit for administration of ROTATEQ, even though it wasn't ordered for this specific patient. (It was stated that; This spontaneous report was received from a physician regarding a 15-month-old female.  The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported.  On 03-FEB-2025, the patient received a fourth (4th) an extra dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (formulation also reported as vial 2), 2 mL, administered orally for prophylaxis (strength, lot #, and expiry date were not provided), above the maximum age limit for administration of this vaccine, even though it had not been ordered her specifically (It was stated that it was not product confusion, but possibly given to the wrong patient) (Extra dose administered) (Product administered to patient of inappropriate age) (Wrong patient received product). However, No adverse effects were reported. No other information was provided at the time of the call.   Additional information was not expected.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or symptoms reported; Nurse called to report GARDASIL 9 that expired 1/20/2025 was given to a patient today, 2/3/2025. No side effects or symptoms reported. No temperature excursion on this product. Product supported  by post expiry memo. No additional AE/no PQC.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.     On 03-FEB-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, 0.5 milliliter (mL) once lot number W015894, expiration date 20-JAN-20225, as prophylaxis (expired product administered). No adverse event was reported.