chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report inadvertent administration of expired MMR-II to a patient.; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2024, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant human albumin) injection, valid lot #W035040, expiration date: 10-MAY-2024, administered for prophylaxis (dose, strength, and route of administration were not provided) (expired product administered). No additional adverse event (AE) was reported.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no symptomatic adverse events were reported; Inbound call from HCP calling to report administration of an expired dose of MMR-II to a patient.; This spontaneous report was received from a medical assistant and referred to a 4-year-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 22-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA]) (M-M-R II) injection, 0.5 ml /once, lot #U039910, expiration date: 16-DEC-2023, administered for prophylaxis (strength, anatomical site of administration and route of administration were not provided) by a health care professional (HCP). HCP stated the physician assistant who administered the dose did not know it was expired. Confirmed no symptomatic adverse events were reported. Confirmed product had no temperature excursions during its lifetime. No additional information at this time (no adverse event, expired product administered).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical Assistant calling to report adverse event regarding the administration of an expired dose of MMR II.  Medical Assistant stated that the MMR II dose had a labeled expiration date of 6/2/2024, and the dose of MMR II was administered on 6/3/2024; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditionsand concomitant therapies were not reported.  On 03-JUN-2024, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #W039972, expiration date: 02-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The pharmacist is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX x026790   11/14/2025 Temperature and Time frame:; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 31-MAY-2024 the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X026790 and expiration date 14-NOV-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided). The temperature excursion lates for 2 hours 0 Minutes 0 Seconds in temperature of 6 degrees Fahrenheit (F) up to 14 F and 1 hours 30 minutes 0 Seconds in temperature of 14 F up to 46 F (product storage error and no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events were reported; HCP called to report a Temperature Excursion in case number 02613481 (supported).; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 03-JUN-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml/ series, lot #y000202, expiration date: 03-JAN-2026, administered for prophylaxis (strength, frequency, route of administration, and anatomical location were not provided).  The varicella virus vaccine live (oka/merck) (VARIVAX) vaccine underwent a temperature excursion at a temperature of -12.4 degrees Celsius, for the time frame of 42 minutes. There was a previous temperature excursion of -14 degrees Celsius to -10 degrees Celsius (-11.6 C) for 29 minutes.  No symptomatic adverse events were reported.  This is one of two cases from the same reporter.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient receive a dose of Engerix-B vaccination that expired on 3/29/2024; 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 male patient who received HBV (Engerix B) (expiry date 29-MAR-2024) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient receive a dose of Engerix-B vaccination that expired on 3/29/2024). The outcome of the expired vaccine used 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: 27-MAY-2024 The patient received the Engerix B vaccine that was already expired. The reporter asked, was the dose given still effective since they were still within 2 months of the expiration date or would he need a new dose. The vaccination was stored in refrigerator, not at room temperature.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Incorrect product administration duration
Clinical narrative: takes their 2nd dose for 4 months after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too long in a 61-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix vaccine in 26th October 2023).   On 24-FEB-2024, the patient received the 2nd dose of Twinrix. On 24-FEB-2024, an unknown time after receiving Twinrix, the patient experienced drug administration duration too long (Verbatim: takes their 2nd dose for 4 months after the first dose). The outcome of the drug administration duration too long 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: 28-MAY-2024 The pharmacist reported he/she had a question on the schedule its 0, 1 and 6 Months, the situation before the 2nd dose way later than the 1 month. Question was someone takes their 2nd dose for 4 Months after the first dose, how long they have to wait between the 2nd dose to get the 3rd dose? The 2nd dose received by the patient longer than the recommended interval which led to lengthening of vaccination schedule. The reporter consented to follow up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient received Bexsero vaccine twice today by mistake; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 03-JUN-2024, the patient received the 2nd dose of Bexsero. On 03-JUN-2024, an unknown time after receiving Bexsero, the patient experienced overdose (Verbatim: patient received Bexsero vaccine twice today by mistake). The outcome of the overdose 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: 03-JUN-2024 A nurse reported that a patient received Bexsero vaccine twice today by mistake which led to overdose. The patient was doing fine.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Possible administration of expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received MMR (Priorix) (batch number ep99z, expiry date 13-MAY-2024) for prophylaxis.   On 14-MAY-2024, the patient received Priorix. On 14-MAY-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Possible administration of expired dose). The outcome of the expired vaccine used 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: 03-June-2024 Office manager/nurse called stating they were unsure if incident happened but a patient may had received an expired dose of Priorix by 1 day which led to expired vaccine used. The Healthcare professional who administered it was not available to confirm whether this happened or not. Healthcare professional had no patient details.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Dysphonia, Eye pruritus, Inappropriate schedule of product administration
Clinical narrative: itching eyes; hoarse voice; the vaccine he started having diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of eye pruritus in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-OCT-2023, the patient received the 1st dose of Shingrix. On 11-OCT-2023, 1 days after receiving Shingrix, the patient experienced eye pruritus (Verbatim: itching eyes) and hoarseness (Verbatim: hoarse voice). In OCT-2023, the patient experienced diarrhea (Verbatim: the vaccine he started having diarrhea). The outcome of the eye pruritus, hoarseness and diarrhea were not resolved.   It was unknown if the reporter considered the eye pruritus, hoarseness and diarrhea to be related to Shingrix.     It was unknown if the company considered the eye pruritus, hoarseness and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-June-2024 Patient reported that he got his first dose of Shingrix vaccine at a local pharmacy on October 10th 2023. Patient reported that the day after the vaccine he started having diarrhea and hoarse voice. Patient reported that a few days after the itching eyes started. Patient had diarrhea twice a day every day during the morning since then. Patient reported that he had never these symptoms before. Patient reported he had not taken the 2nd dose of Shingrix due to these reactions. Patient was vaccinated with Shingrix but never completed the series (AE: Inappropriate schedule of vaccine). No additional information was reported. Not all information is available. Lot and Expiry date were unknown. Patient consent to follow up with Healthcare professional but this information was not available at the moment of the call.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Palpitations, SARS-CoV-2 test
Clinical narrative: fever, sore throat, tired, chills and tested positive for covid; heart palpitations; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (fever, sore throat, tired, chills and tested positive for covid) and PALPITATIONS (heart palpitations) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. NDC 80777-0102-93) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose: 1 Batch/Lot number: EN6207 Route of administration: Intramuscular Anatomical site of injection: Right arm) on 09-Mar-2021, Pfizer / BioNTech (Dose: 2 Batch/Lot number: EP7533 NDC:59267-0304-07  LOT 653275 Route of administration: Intramuscular Anatomical site of injection: Right arm) on 30-Mar-2021, Pfizer / BioNTech (Dose: 3 Batch/Lot number: FH8028 Route of administration: Intramuscular Anatomical site of injection: Right arm) on 01-Dec-2021, PFIZER BIONTECH COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/5) (Dose: 4 Batch/Lot number: NDC 54267-0304-07 Route of administration: Intramuscular Anatomical site of injection: Right arm) on 04-Nov-2022. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5), Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concomitant products included UBROGEPANT (UBRELVY) for Migraine, IPRATROPIUM from 26-Jan-2024 to 15-Feb-2024 for Rhinorrhea, LORAZEPAM for Sleep disorder NOS.    On 26-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 15-Feb-2024, the patient experienced COVID-19 (fever, sore throat, tired, chills and tested positive for covid) and PALPITATIONS (heart palpitations). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 15-Feb-2024 for COVID-19 treatment, at a dose of taken consistent to schedule, 2 times a day till medication used up. On 16-Feb-2024, PALPITATIONS (heart palpitations) had resolved. At the time of the report, COVID-19 (fever, sore throat, tired, chills and tested positive for covid) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2024, SARS-CoV-2 test: Positive. On 22-Feb-2024, SARS-CoV-2 test: Negative. On 26-Feb-2024, SARS-CoV-2 test: Positive.         It was reported that patient started having sore throat on 14-Feb-2024. On 16-Feb-2024, fever and heart palpitations were ceased, on 18-Feb-2024 all other symptoms ended and patient felt normal. 0n 22-Feb-2024, patient was tested negative and felt normal for four days. On 03-Mar-2024, Patient felt normal again and resumed normal activities.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Nerve injury
Clinical narrative: Small fiber nerve damage; This spontaneous case was reported by a patient and describes the occurrence of NERVE INJURY (Small fiber nerve damage) in a 53-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Spinal tap. Concurrent medical conditions included Diabetes, Autoimmune disorder NOS and MS.    In 2022, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced NERVE INJURY (Small fiber nerve damage). At the time of the report, NERVE INJURY (Small fiber nerve damage) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: Negative. On an unknown date, Magnetic resonance imaging: Negative.         No concomitant medication was reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient developed neuropathy after having received the Covid vaccine and some boosters. Patient received 2 Moderna vaccines followed by 2 boosters with the most recent one received in the Spring of 2022. In the Fall of 2022, patient developed tingling, burning and numbness from bilateral knees to the waist. The first neurologist diagnosed patient with small fiber nerve damage. At the time of reporting patient still had symptoms which have worsened over time. Patient reported burning and numbness mainly in both legs from just above the knees up to the waist but, then including burning in the bottoms of both feet as well as numbness now in the face. No treatment medication was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy liver, Blood alkaline phosphatase, Computerised tomogram, Metastatic neoplasm, Positron emission tomogram
Clinical narrative: sarcoidosis; metastatic disease; This spontaneous case was reported by a patient and describes the occurrence of SARCOIDOSIS (sarcoidosis) and METASTATIC NEOPLASM (metastatic disease) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 007M20A and 011F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient experienced SARCOIDOSIS (sarcoidosis) (seriousness criterion medically significant) and METASTATIC NEOPLASM (metastatic disease) (seriousness criterion medically significant). At the time of the report, SARCOIDOSIS (sarcoidosis) and METASTATIC NEOPLASM (metastatic disease) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy liver: read as sarcoidosis. On an unknown date, Blood alkaline phosphatase: abnormal. On an unknown date, Computerised tomogram: my abdomen and pelvis, which showed lesions in my liver and spleen. lesions on my spine. On an unknown date, Positron emission tomogram: All of my scans mention this can be metastatic disease.         No Concomitant medication was reported.  Patient had had 2 PET Scans, and endoscopic ultrasound. She has seen a liver specialist, was currently being seen at the sarcoidosis center. All of her scans mention this can be metastatic disease. she has next be scheduled for a bone Biopsy, to determine if this was metastatic disease or sarcoidosis. This all happened to her following the covid vaccines. It was unknown if the patient experienced any additional symptoms/events.   No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 68-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Sarcoidosis and Metastatic neoplasm, which occurred after the first 3 doses of mRNA-1273 vaccine. As reported, the patient had an abnormal alkaline phosphatase blood test after receiving the vaccines. This led to more testing. She had a CT scan of her abdomen and pelvis, which showed lesions in liver and spleen. 2 liver biopsies were performed, which were read as sarcoidosis. Patient also has lesions on her spine. She have had 2 PET scans and an endoscopic ultrasound. All of the scans mention this can be metastatic disease. Patient will next be scheduled for a bone biopsy, to determine if this is metastatic disease or sarcoidosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: sarcoidosis; metastatic disease; This spontaneous case was reported by a patient and describes the occurrence of SARCOIDOSIS (sarcoidosis) and METASTATIC NEOPLASM (metastatic disease) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 007M20A and 011F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient experienced SARCOIDOSIS (sarcoidosis) (seriousness criterion medically significant) and METASTATIC NEOPLASM (metastatic disease) (seriousness criterion medically significant). At the time of the report, SARCOIDOSIS (sarcoidosis) and METASTATIC NEOPLASM (metastatic disease) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy liver: read as sarcoidosis. On an unknown date, Blood alkaline phosphatase: abnormal. On an unknown date, Computerised tomogram: my abdomen and pelvis, which showed lesions in my liver and spleen. lesions on my spine. On an unknown date, Positron emission tomogram: All of my scans mention this can be metastatic disease.         No Concomitant medication was reported.  Patient had had 2 PET Scans, and endoscopic ultrasound. She has seen a liver specialist, was currently being seen at the sarcoidosis center. All of her scans mention this can be metastatic disease. she has next be scheduled for a bone Biopsy, to determine if this was metastatic disease or sarcoidosis. This all happened to her following the covid vaccines. It was unknown if the patient experienced any additional symptoms/events.   No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 68-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Sarcoidosis and Metastatic neoplasm, which occurred after the first 3 doses of mRNA-1273 vaccine. As reported, the patient had an abnormal alkaline phosphatase blood test after receiving the vaccines. This led to more testing. She had a CT scan of her abdomen and pelvis, which showed lesions in liver and spleen. 2 liver biopsies were performed, which were read as sarcoidosis. Patient also has lesions on her spine. She have had 2 PET scans and an endoscopic ultrasound. All of the scans mention this can be metastatic disease. Patient will next be scheduled for a bone biopsy, to determine if this is metastatic disease or sarcoidosis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination Failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Cholecystectomy" (not ongoing); "Thyroid Cancer" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: COZAAR; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "recovered" (24May2024); VACCINATION FAILURE (medically significant) with onset May2024, outcome "recovered" (24May2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24May2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 22May2024 to 27May2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: cramps; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 93-year-old 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: MUSCLE SPASMS (non-serious), outcome "unknown", described as "cramps".  Additional information: The patient mentioned that she will fly to another state in early July for two weeks and she needed to know if she needs to get another Pfizer covid-19 vaccine or should she wait. Upon further discussion, when asked, caller stated that she was 93 years of age. The patient mentioned that she became aware of a new variant of the COVID-19 virus, recently identified as "FLiRT" (upper case and lower-case letters were determined during post-call documentation, consulting the world wide web/internet). The patient was interested in any information available regarding guidelines as to whether she should be vaccinated to be better protected against new variant. The patient inquired as to how long she is protected against COVID-19 after vaccination. The patient added that she had received the vaccine in mid-October of 2023. The patient expressed that she had experienced cramps prior to administration of the most recent dose of the vaccine and the finality of her question was not necessarily related to the reporting of adverse events, but rather merely informative. The patient was unsure if she had mentioned experiencing side effects to HCP (physician).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, HEP
Symptoms: Condition aggravated, Decreased immune responsiveness, Fatigue, Mobility decreased, Pyrexia
Clinical narrative: fever; feels to have her immunity diminished; feels to have her immunity diminished; redness on the injection site and muscle soar/roughness on the injection site and muscle sore; redness on the injection site and muscle soar/roughness on the injection site and muscle sore; having difficulties even to lift her arm; tiredness; sleepiness; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; hepatitis B vaccine (HEPATITIS B VACCINE) for immunisation. The patient's relevant medical history included: "radiation" (ongoing); "immunity has been diminished" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; DECREASED IMMUNE RESPONSIVENESS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "feels to have her immunity diminished"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovering" and all described as "redness on the injection site and muscle soar/roughness on the injection site and muscle sore"; MOBILITY DECREASED (non-serious), outcome "recovering", described as "having difficulties even to lift her arm"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: A Patient calls for information about the Comirnaty vaccine, specifically about if she would need to be administered with the vaccine with more than one dose. The Patient reports that she is being through treatment with radiation and her immunity has been diminished, also she has been prescribed with multiple vaccinations, including the Comirnaty vaccine.  The Patient reports that she was administered with a Hep B vaccine and the Comirnaty vaccine on Thursday of the last week and she experienced fever from Thursday to Sunday, she feels to have her immunity diminished, redness on the injection site and muscle soar (roughness on the injection site and muscle sore), having difficulties even to lift her arm, The patient also reported to be experiencing tiredness and sleepiness.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19, HEP
Symptoms: Somnolence, Vaccination site erythema, Vaccination site pain
Clinical narrative: fever; feels to have her immunity diminished; feels to have her immunity diminished; redness on the injection site and muscle soar/roughness on the injection site and muscle sore; redness on the injection site and muscle soar/roughness on the injection site and muscle sore; having difficulties even to lift her arm; tiredness; sleepiness; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; hepatitis B vaccine (HEPATITIS B VACCINE) for immunisation. The patient's relevant medical history included: "radiation" (ongoing); "immunity has been diminished" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; DECREASED IMMUNE RESPONSIVENESS (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "feels to have her immunity diminished"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovering" and all described as "redness on the injection site and muscle soar/roughness on the injection site and muscle sore"; MOBILITY DECREASED (non-serious), outcome "recovering", described as "having difficulties even to lift her arm"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: A Patient calls for information about the Comirnaty vaccine, specifically about if she would need to be administered with the vaccine with more than one dose. The Patient reports that she is being through treatment with radiation and her immunity has been diminished, also she has been prescribed with multiple vaccinations, including the Comirnaty vaccine.  The Patient reports that she was administered with a Hep B vaccine and the Comirnaty vaccine on Thursday of the last week and she experienced fever from Thursday to Sunday, she feels to have her immunity diminished, redness on the injection site and muscle soar (roughness on the injection site and muscle sore), having difficulties even to lift her arm, The patient also reported to be experiencing tiredness and sleepiness.  Batch/lot number is not provided, and it cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies" (unspecified if ongoing); "High HDL" (unspecified if ongoing); "hypertension" (unspecified if ongoing), notes: well controlled with meds. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "recovered" (May2024); VACCINATION FAILURE (medically significant) with onset May2024, outcome "recovered" (May2024). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 25May2024 to 30May2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: 15 blood clots in her lungs; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "15 blood clots in her lungs".  Clinical course: The reporter mentioned that she needs to get the whole list of ingredients for the Pfizer Covid Vaccine. She informed that her daughter has 15 blood clots in her lungs and her daughter's doctor was asking for the ingredients since they did not get informed consent, they got a blank piece of paper. They need the ingredients to know how to treat her daughter.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400187516 same reporter/product/events, different patient;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contacted COVID after Pfizer Covid-19 vaccine; Contacted COVID after Pfizer Covid-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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 "Contacted COVID after Pfizer Covid-19 vaccine". Clinical course: Reporter consider event not caused by suspect product.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by varied factors; however, a contributory role of the suspect product to the reported events Drug ineffective  and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a sore spot on her right arm due to the vaccine; lasted weeks; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 65-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "a sore spot on her right arm due to the vaccine; lasted weeks".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Extra dose administered, Medication error, No adverse event
Clinical narrative: patient was given an extra dose of acthib with no reported adverse event; Initial information received on 31-May-2024 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 1-year-old male patient was given an extra dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); pneumococcal vaccine CONJ 20V (CRM197) (PREVNAR 20) and hepatitis A vaccine for Prophylactic vaccination.  On 15-Sep-2023, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown) (lot: UJ964AA, expiry date: 11-Aug-2024) via intramuscular route in the right thigh for Prophylactic Vaccination (immunization) and patient was given an extra dose of acthib with no reported adverse event (extra dose administered) (latency: same day).  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: 17.0
Sex: M
Vaccine: HEP, HIBV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: reported that the consumer was prescribed hepatitis b vaccine but was accidently given the acthib by a nurse with no reported adverse event; Initial information received on 31-May-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 17 years old male patient who was prescribed Hepatitis B Vaccine but was accidently given the HIB (PRP/T) Vaccine [ACT-HIB] by a nurse with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-May-2024, the patient accidently received a 0.5 ml dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot UK025AA, Expiry: 31-Mar-2025, with unknown strength) via unknown route in the left deltoid as Immunization but was prescribed Hepatitis B Vaccine produced by unknown manufacturer with no reported adverse event (wrong product administered) (Latency: Same day).   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: 19.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of ipol was administered to a patient with no reported adverse event; Initial information received on 03-Jun-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 19 years old female patient where patient got administered expired dose of IPV (VERO) [IPOL] 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 hepatitis a vaccine inact, hepatitis b vaccine rhbsag (yeast) (twinrix); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (tdap) and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 03-Jun-2024, the patient received 0.5 ml dose of suspect IPV (VERO) Suspension for injection (lot- V1B891M and expiration date- 01-Jun-2024) via intramuscular route in the left deltoid (expired product administered) (latency- same day).  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 and Regulatory Authority 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: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Patient received 1st dose in Left Deltoid muscle parallel to the armpit.  Patient had usual soreness but on 3rd day after vaccination patient reports that the pain increased.  She describes pain spikes within deltoid and limited range of motion of only up to about 90 degrees, moving to the side or back is more painful, that driving with left hand on steering wheel is very bothersome.  She states that this pain is similar to when she experienced frozen shoulder many years prior.  She states that the pain is not improving even with use of ibuprofen and her continued stretching exercises.
Age: 85.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site reaction, Mobility decreased, Muscular weakness
Clinical narrative: PATIENT'S WIFE DESCRIBED THAT PATIENT HAD WHOLE BODY MUSCLES WEAKNESS AND HE WAS UNABLE TO MOVE AND ALSO REDNESS AT THE INJECTION SITE AS WELL.  PATIENT HAD TO GO TO THE ER FOR TREATMENT.  HE IS DOING BETTER NOW
Age: 61.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Erythema, Inflammation, Skin warm
Clinical narrative: Patient reported after receiving vaccine she had a reaction between the time of 4:00pm-5:00pm. Patient reported arm inflaming, red, and hot to the touch.  She also reported difficulty breathing and had to go to the hospital.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Irritability, Sleep disorder
Clinical narrative: After vaccine administration, it was discovered that there were Vaxelis syringes in the tray where sterile water (diluent) is stored and there was concern that patient's vaccinations had been prepared with Vaxelis and not diluent.  Overnight, patient was very irritable and spiking fevers. Parents gave anti-pyretics and she was able to fall back to sleep. This morning there is swelling and redness on her thighs at both injection sites. Golf-ball sized area of induration and erythema on right thigh. Quarter-sized area of erythema and induration on left thigh.    Evident localized reaction to intramuscular immunizations given yesterday. Advised to apply ice or cool compresses to the affected areas, Tylenol/Motrin    The sterile water available for dilution was in a PFS instead of a vial that it historically came in, which looks a lot like the Vaxelis PFS.  It was found that the Vaxelis had been placed in the container bin in the fridge labeled as sterile water by mistake, which was partially a cause of the Vaxelis being used to dilute the MMR and Varicella rather than sterile water.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen, redness and  itching at the site injection
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Neuralgia, Pain
Clinical narrative: Two days after receiving the vaccine, I began feeling a prickly nerve pain on my left torso. Pain worsened over the next few days. Red rash appeared on 4/28/24. Throughout the week patches of blisters appeared on the left side of my abdomen, side, and back. Made an appointment with Dr. on 4/29/24 @ 10:00 am. She confirmed this was Shingles and agreed that it was caused by the vaccine. Prescribed anti-viral and pain meds. Blisters all healed but still have residual red patches that are slowly fading. The nerve pain, however, continues. Most of the time the pain is prickly but occasionally I get very sharp stabbing pains.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Two days after receiving the vaccine, I began feeling a prickly nerve pain on my left torso. Pain worsened over the next few days. Red rash appeared on 4/28/24. Throughout the week patches of blisters appeared on the left side of my abdomen, side, and back. Made an appointment with Dr. on 4/29/24 @ 10:00 am. She confirmed this was Shingles and agreed that it was caused by the vaccine. Prescribed anti-viral and pain meds. Blisters all healed but still have residual red patches that are slowly fading. The nerve pain, however, continues. Most of the time the pain is prickly but occasionally I get very sharp stabbing pains.
Age: 70.0
Sex: M
Vaccine: RSV, TDAP
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Patient came pharmacy today reporting potential adverse reaction to a vaccine he received yesterday. He described a temporary muscle spasm that happened today at the injection site of the Tdap vaccine. The spasm has passed. He suggested it might be from the vaccine or from an insect sting. No wheal was present at the site.
Age: 1.33
Sex: M
Vaccine: DTAP, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, Redness, swelling to left thigh
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Patient woke up at 4 am on May 30th, 2024 due to chest pain, warmth, nausea, sweats and extreme discomfort level near chest and called 911. Patient was sent to ER and hospitalized.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient is a 3 year and 10 mo female who received Dtap-IPV (Kinrix) 2 months early due to a mistake over the patient's age.  The error was discussed with the parent of the patient in the office once the error was noted.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Due to charting error, second Tdap inadvertently given 2 weeks after initial dose for routine prenatal care. No known adverse effects.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Patient's entire left arm went numb about an hour after receiving the shot and then resolved a short time later. She woke up around 8am on 05/30/24 with it numb again and it remained numb until around 3pm.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Muscle contractions involuntary, Pallor, Syncope
Clinical narrative: After administration of HPV vaccine- patient experienced symptoms of vasovagal syncope with fainting, with UE muscle contraction and becoming pale. Brief LOC but regained consciousness in under 20 seconds. Ice used behind neck and patient reclined on bed. Salty snacks and water provided and patient was monitored for approx. 20 minutes. Discussed etiology and presentation of vasovagal syncope. Discussed that this can occur with HPV vaccines- can proceed with caution with HPV #2 in 6 months if pt and mom agreeable, can discuss risks vs. benefits when due. Pt and pt mom left at 3:17 PM in stable condition. Advised to monitor for symptoms and ED warning signs advised.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Headache
Clinical narrative: One week after the vaccine patient felt in the right eye and the top of her head. 3 days after she couldn't tolerate the pain anymore she went to the ER. That's when the doctor said she has the shingles. They gave her medicines for the shingles and eye drop.