chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Bradycardia, Cold sweat, Dizziness, Injection site pain, Pallor
Clinical narrative: 7/27/2024 @ 1512 central time. LPN called into this providers room as the pt felt dizzy and wanted to lay down. Pt was sitting up after receiving 2nd dose of Meningitis ACYW and 1st dose of Trumenba. This provider went into the pts room to assess the situation. The patient never lost consciousness. Pt was lying down and vitals were being done by LPN. Pt was clammy, pale, alert and oriented x 3. Heart rate was bradycardia, regular rhythm (50s). Lung sounds were clear. No swelling of the tongue, pharynx, lips, face. No rash noted. Pt has a hx of passing out with lab draws, some vaccines, and even after being stung by a bee in the past. Patient stated "just thinking about the stinger in me made me pass out". Both father and sister do the same thing with lab draws and vaccines. Mother and pt denied any anaphylaxis with medications or vaccinations in the past. He already received 1 dose of the Meningitis ACYW back in 2018 and tolerated it well. Pt was continuously monitored (assessed/vitals) by LPN and this provider. Pt was feeling better. Color improved, not clammy. Once pt stood up he felt dizzy so he laid back down. He got pale and clammy again. We continued to monitor him with his mother and father in the room. He drank some water and Gatorade. At 1551 the pt stood up for a couple minutes and stated "I feel much better". He denied dizziness, his color was pink, he was not clammy, and vital signs were stable. HEENT, cardiac, pulmonary physical exam was all normal. No tongue, pharynx, mouth, face swelling, heart-RRR, lung sounds clear, no rashes. Pt was alert and oriented x 3. Pt states "I feel fine now I am ready to go". His mother and father were both given the visit summary, vaccine forms and VIS forms to take home with strict instructions to dial EMS if symptoms or new symptoms return. Mother drove pt home. Pt, mother, and father all communicated understanding and agreed with plan of care. Pt call back in place to follow up. Notified VAERS since Trumenba was the first time he ever received vaccine and vagal response lasted longer than mother or pt remembers in the past. Attempted to submit report on 07/27/2024 twice but kept getting logged out. Called the pt on 07/28/2024 and pt doing well with no complaints. He has some mild tenderness at each site.
Age: 1.17
Sex: F
Vaccine: MMRV
Symptoms: Irritability, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Fever of 102 for three days, broke out in a rash (red bumps that look just like measles) all over body (face, legs, stomach, back). Irritable and fussy.  The fever began first and lasted for about 3 days. The rash started on day two and lasted 3.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Arachnoiditis, Biopsy, Lichenoid keratosis, Sleep disorder
Clinical narrative: I ended up getting COVID; I ended up getting COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150) intramuscular, in left arm, on 04May2021 as dose 2, single (Lot number: EW0173), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8841) and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 29Dec2023 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; FLUTICASONE PROPIONATE nasal taken for seasonal allergy; CLARITIN [LORATADINE] taken for seasonal allergy. Vaccination history included: Flu shot (I got the flu shot (Name could not be specified)), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I ended up getting COVID".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400222927 same patient, different dose/event;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Systemic scleroderma
Clinical narrative: I ended up getting COVID; I ended up getting COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150) intramuscular, in left arm, on 04May2021 as dose 2, single (Lot number: EW0173), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8841) and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 29Dec2023 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; FLUTICASONE PROPIONATE nasal taken for seasonal allergy; CLARITIN [LORATADINE] taken for seasonal allergy. Vaccination history included: Flu shot (I got the flu shot (Name could not be specified)), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I ended up getting COVID".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400222927 same patient, different dose/event;
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I ended up getting COVID; I ended up getting COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 67-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0150) intramuscular, in left arm, on 04May2021 as dose 2, single (Lot number: EW0173), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8841) and on 22Apr2022 as dose 4 (booster), single (Lot number: FJ4989) for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 29Dec2023 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; FLUTICASONE PROPIONATE nasal taken for seasonal allergy; CLARITIN [LORATADINE] taken for seasonal allergy. Vaccination history included: Flu shot (I got the flu shot (Name could not be specified)), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I ended up getting COVID".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400222927 same patient, different dose/event;
Age: 0.17
Sex: U
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: No additional AE; HCP called to report a 2 month old accidentally received VAQTA, MMRII, and VARIVAX as the provider read the wrong order. No symptoms or side effects noted, all vaccines administered today, 7/3/2024. No additional AE/no PQC.; This spontaneous report was received from a nurse and refers to a 9-week-old (also reported as 2-month-old) patient of unknown gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.   On 03-JUL-2024, the patient was accidentally vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #x028613, expiration date: 13-DEC-2025; hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #x025484, expiration date: 13-MAY-2025; and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHa), (M-M-R II) injection, 0.5 milliliter, lot #X019104, expiration date: 16-JUL-2025, administered for prophylaxis, as the provider read the wrong order (Wrong patient received product). Strength, route of administration and anatomical site f vaccination for all suspected vaccine were not provided. No additional adverse event (AE) was reported (no adverse event).
Age: 0.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional Ae/PQC reported; This father states that at 2:45 to 3:30 pm he went to the hospital inadvertently gave his 2-month-old son Merck Hepatitis A vaccine, Merck MMR vaccine, Merck Varicella vaccine which were intended for a 2-year-old and not a 2-month-old.; the hospital inadvertently gave his 2-month-old son Merck Hepatitis A vaccine, Merck MMR vaccine, Merck Varicella vaccine which were intended for a 2-year-old and not a 2-month-old.; This spontaneous report was received from Consumer and refers to a 2-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  It was reported that on 03-JUL-2024 from 14:45 to 15:30, he went to the hospital to give his 2-month-old son his vaccines but the hospital inadvertently gave his 2-month-old son hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided); and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided), which were intended for a 2-year-old and not a 2 month-old (wrong product administered and product administered to patient of inappropriate age). The baby was fine at this time as it was only about an hour ago that the vaccines were given.  No additional adverse event (AE) was reported.  Lot # are being requested and will be submitted if received.
Age: 6.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse side effects were reported.; MMR II vaccine that expired 6/20/2024 and was administered to a patient on 7/8/2024; .This spontaneous report was received from patients mom and refers to a 6-year-old (conflicting information, also reported as 5-year-old) female patient. The patient's concurrent conditions, medical history were not provided. Concomitant medications included diphtheria vaccine toxoid (+) hepatitis b vaccine rhbsag (yeast) (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (PEDIARIX) and sterile diluent.    On 08-JUL-2024,  the patient was vaccinated with the second dose of an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, lot number W019423, with expiration date 20-JUN-2024, that has been verified to be valid administered subcutaneously of left thigh for prophylaxis (strength and vaccination scheme were not provided) (expired product administered). No previous temperature Excursion. No adverse effects reported. No other information provided. No additional adverse event. No PQC. At time of reporting, patient was doing fine.  Safe guard actions have been putted ono place, placed expiation dates on the front of the vaccine refrigerator for vaccines close to expiring so they can be noted and removed promptly. Patients mom stated that as the vaccine was expired it did not count and her daughter will have to went back in one month for another measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). .
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Otitis media, Otitis media acute, Product storage error
Clinical narrative: Otitis media acute; adminstered after being exposed to multiple temperature excursions; This spontaneous report was received from medical assistant and refers to a 5-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided.  On 20-MAY-2024, the patient was vaccinated with improperly stored vaccines in a private doctor's office/hospital: with a measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHa) (M-M-R II) injection, in the right arm (RA), lot #W035041, expiration date: 24-MAY-2024; with  a hepatitis a vaccine, inactivated (VAQTA), intramuscular injection, in the left arm (LA) , lot #X015939, expiration date: 05-DEC-2024; with a varicella virus vaccine live (oka/merck) (VARIVAX) injection, in the right arm (RA), lot #X018954, expiration date: 13-JUL-2025; and with a diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), in the left arm (LA) lot# 5AY23, and expiration date 13-JUL-2025, for prophylaxis (Product storage error). Strength, route of administration, were not provided for all suspect vaccines. It was reported that the vaccines were administered following as temperature excursion (temperature and previous temperature excursions were not reported. It was also reported that: vaccine/vaccine device were available for return/evaluation; the vaccine/vaccine device were used according to the instruction leaflet; operator of device was healthcare professional; and the operator was trained.   On 20-MAY-2024, the patient experienced , acute bilateral otitis media. On the same day, due to the event the patient received amoxicillin as a treatment. At the time of reporting, the outcome of the event of otitis media acute was not provided.  The causal relationship between otitis media acute and all the suspect vaccines was not provided.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: the HCP reported receiving PCV13 and then subsequently PNEUMOVAX23 years ago in residency and experienced "big swollen red hot arm".; the HCP reported receiving PCV13 and then subsequently PNEUMOVAX23 years ago in residency and experienced "big swollen red hot arm".; the HCP reported receiving PCV13 and then subsequently PNEUMOVAX23 years ago in residency and experienced "big swollen red hot arm".; This spontaneous report was received from a field based employee (FBE) and refers to a female patient of unknown age. The patient's concurrent conditions included: asthma. Historical drugs included: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) (reported as PCV 13). Her concomitant therapies, medical history and drug reaction were not reported.  On an unknown day, the patient was vaccinated with a pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, (strength, dose, dose#, lot #, expiry date, route of administration, and anatomical site of vaccination were not provided) for prophylaxis.  On an unknown date, the patient experienced big swollen red hot arm. Due to the event, she received ibuprofen (ADVIL). At the time of reporting, the outcome of the even was unknown.  The causal relationship between the event and the suspect vaccine was not provided.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Medical assistant reported that a patient received an expired PROQUAD.  The diluent that was mixed with PROQUAD was not expired.  No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT). The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 19-JUL-2024, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, at a dose of 1 dosage form (strength, vaccination scheme, anatomical site of vaccination and route of administration were not reported; lot number x011437, expiration date was reported and validated as 18-JUL-2024) as prophylaxis (expired product administered). The diluent that was mixed with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not expired. No additional AEs were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report an expired dose of VARIVAX was administered to a patient on 07/18/2024. Caller reported the expiration date of the product was 07/10/2024.; This spontaneous report was received from a nurse and a physician regarding to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 18-JUL-2024, the patient was vaccinated with 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot number W021740 (lot number W021740 had been verified to be valid lot number for varicella virus vaccine live [Oka/Merck] [VARIVAX]), expiration date 10-JUL-2024 (strength, dose, frequency, route of administration and anatomical injection site were not provided) for prophylaxis, in combination with sterile diluent (STERILE DILUENT) (also reported as "DILUENT MRK INJ") solution for injection/infusion (strength, dose, lot number and expiration date were not provided).  On the same date (conflicting information also reported as 22-JUL-2024), expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to the patient. Caller confirmed the product has never had a temperature excursion. No additional information provided. No additional adverse evento (AE). No producto quality complaint (PQC).
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no side effects; Nurse called to report an MMRII that expired on 6/18/2023, was administered to a 34 year old patient on 7/23/2024; This spontaneous report was received from a nurse regarding to a currently 34-year-old male patient. The patient's pertinent medical history, previous drug reactions or allergies were not provided. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On 23-JUL-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, at a dose of 0.5 milliliter (mL), once, lot number U019290 (lot number U019290 had been verified to be valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [M-M-R II]), expiration date 18-JUN-2023 (route of administration and anatomical injection site were not provided) for prophylaxis (expired product administered).  The reporter confirmed no temperature excursions on measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Confirmed no side effects for this adult patient. Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) dose was not supported by post expiry memo vaccines and biologics administered, read not supported disclaimer to nurse. Nurse inquired about further recommendations. No additional adverse event (AE)/no product quality complaint (PQC).
Age: 1.17
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called to report administration of expired MMRII to a patient. Provider confirmed vaccine did not experience any temperature excursions.  No symptoms reported.  Consent to correspond was provided.  No additional AE/No PQC.; This spontaneous report was received from a physician regarding to a currently 14-month-old patient of unspecified gender. The patient's pertinent medical history, previous drug reactions or allergies were not provided.  On 23-JUL-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, at a dose of 0.5 milliliter (mL), lot number X012185 (lot number X012185 had been verified to be valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [M-M-R II]), expiration date 03-JUN-2024 (route of administration and anatomical injection site were not provided) for prophylaxis (expired product administered), in combination with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion (strength, dose, lot number and expiration date were not provided).  Provider confirmed vaccine did not experience any temperature excursions. No symptoms reported. Consent to correspond was provided. No additional adverse event (AE)/no product quality complaint (PQC).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Physician stated that a patient was administered an expired dose of MMR II on 7/15/2024 which had a labeled expiration date of 6/20/2024.; This spontaneous report was received from a physician regarding to a patient of unspecified age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.  On 15-JUL-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, at a dose of 0.5 milliliter (mL), two dose series, lot number W019422 (lot number W019422 had been verified to be valid lot number for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live [M-M-R II]), expiration date 20-JUN-2024 (route of administration and anatomical injection site were not provided) for prophylaxis (expired product administered).  Physician confirmed that the patient involved did not experience any medical concerns or symptoms after the administration of the expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Consent granted for correspondence. No additional information provided. Case number provided. No additional adverse event (AE)/product quality complaint (PQC) reported.
Sex: U
Vaccine: RSV
Symptoms: Nodule, Rash macular, Swelling
Clinical narrative: knot; swollen and a big spot; big spot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mass in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced mass (Verbatim: knot), swelling (Verbatim: swollen and a big spot) and spot-like rash (Verbatim: big spot). The outcome of the mass, swelling and spot-like rash were not reported.   It was unknown if the reporter considered the mass, swelling and spot-like rash to be related to Arexvy.     It was unknown if the company considered the mass, swelling and spot-like rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-JUL-2024 The case was received from the patient via (Open field AE monitoring) interactive digital media. The patient received Arexvy. The patient had the 1st four side affects plus a knot, swollen and a big spot.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: patient was accidentally given a dose of prior Rex with the lot number M79YM that had expired on June 1st 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received MMR (Priorix) (batch number M79YM, expiry date 01-JUN-2024) for prophylaxis.   On 15-JUL-2024, the patient received the 1st dose of Priorix. On 15-JUL-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: patient was accidentally given a dose of prior Rex with the lot number M79YM that had expired on June 1st 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: 15-JUL-2024 The nurse reported that, a one year old patient was accidentally given a dose of Priorix that was expired which led to expired vaccine used.  The nurse wanted to know how to proceed.  The nurse provided information about the vaccine, event and patient.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: numbness right index finger side closest to the thumb; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of numbness in fingers in a 36-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9935H, expiry date 03-JUL-2026) for prophylaxis.   Concomitant products included HPV vaccine VLP rL1 4v (yeast) (Gardasil).   On 09-JUL-2024, the patient received Boostrix (right arm). On 09-JUL-2024, less than a day after receiving Boostrix, the patient experienced numbness in fingers (Verbatim: numbness right index finger side closest to the thumb). The outcome of the numbness in fingers was unknown.   It was unknown if the reporter considered the numbness in fingers to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the numbness in fingers to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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: 16-JUL-2024 Pharmacist was going to end up reporting it as a VAERS but wanted to run it that a patient who got a Boostrix shot last week. He got the shot on July 9, 2024 on his right arm and on the same day he got, HPV, Gardisil, in his left arm. On his right arm, he said it was later that evening, it was really just isolated to his right index finger, basically the side of it that was closest to his thumb, he was just having a lot of numbness that would not go away. When he first reported it, the pharmacist thought that could be normal, it was in the arm where he got the Boostrix. The pharmacist said give it another day or two and if it gets worse or it did not get better, notify your doctor and then he came back in and it has been a few days and he said it just had not gotten any better, so, the pharmacist said see if that was something, kind of see paresthesia listed post marketing.  The pharmacist did not know if that was still being a nerve issue if that was something that needed to be reported. The pharmacist actually got that from Facts and Comparisons post marketing data and it was listed under nervous system, so did not know how that compares.
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Unevaluable event
Clinical narrative: Menveo + interchangeability with Menactra; This non-serious case was reported by a other health professional via call center representative and described the occurrence of interchange of vaccine products in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (dip tox) (Menactra) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo and Menactra. On an unknown date, an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: Menveo + interchangeability with Menactra). The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2024 Medical assistant reported that a patient received a first dose of Menveo in and at age 13 received a dose of Menactra, which led to interchange of vaccine products. No other information was provided.
Age: 39.0
Sex: M
Vaccine: MEN
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: the menquadfi was administered subcutaneously instead of intramuscularly with no reported adverse event; Initial information received on 18-Jul-2024 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 39 years old male patient where the Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] was administered subcutaneously instead of intramuscularly 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 b vaccine (hepatitis b vaccine) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (tdap) for Prophylactic vaccination.  On 12-Jul-2024, the patient received 0.5 ml (Total) dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (strength- standard) Solution for injection lot number not reported via subcutaneous route in unknown administration site (lot/batch number and expiration date: not provided) for Immunisation (incorrect route of product administration) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Existing tinnitus got worse, and continues to worsen.
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Crying, Decreased appetite, Feeling abnormal, Insomnia, Pain
Clinical narrative: Sore, out of it, unable to stay asleep, fever of 100.9 (up and down) vomit after bottle, whimpering and crying. Loss of appetite
Age: 0.25
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Sore, out of it, unable to stay asleep, fever of 100.9 (up and down) vomit after bottle, whimpering and crying. Loss of appetite
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Received First and Second Dose, and Labs Show Negative Titer; Initial report received on 17-Jun-2024.  A non-significant follow-up report received on 21-Jun-2024 that included the QA investigation results of the mixed product quality complaint: the investigation did not identify a potential lot-related issue.  No potential impact to the lot was identified.     A pharmacist in the reported that a 47-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient's titer came back negative.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unknown date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and site not reported) at the physician's office.  On 12-Feb-2024, the patient received the second dose of HEPLISAV-B (Lot #943187, expiration date 30-Nov-2025, NDC # 43528-003-05) intramuscularly in the right arm at the pharmacy.  On an unknown date, after completing the HEPLISAV-B series in Feb-2024, labs were drawn, and the titer came back negative.  No adverse reactions for the injection were reported to the reporter's knowledge.  No additional information was provided.   Company Comment: The company assessed the event as non-serious and not immunologically confirmed as the dosing schedule and serological marker testing after the second dose is unknown.; Sender's Comments: The company assessed the event as non-serious and not immunologically confirmed as the dosing schedule and serological marker testing after the second dose is unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Mechanical urticaria, Urticaria
Clinical narrative: hives; chest pain; dermatographia; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives), CHEST PAIN (chest pain) and MECHANICAL URTICARIA (dermatographia) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant) and MECHANICAL URTICARIA (dermatographia) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral use) at a dose of 50 milligram every four hours. At the time of the report, URTICARIA (hives), CHEST PAIN (chest pain) and MECHANICAL URTICARIA (dermatographia) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient had hives, chest pain, dermatographia post 12 days. It was unknown if the patient experienced any additional symptoms/events.  Company comment-This spontaneous case concerns a male patient of an unknown age, with no medical history reported who experienced serious (due to medically significant) unexpected events of urticaria, chest pain and mechanical urticaria after a dose of SPIKEVAX 2023-2024  (dose number, dates for vaccination and onset dates were not provided; hence, latency could not be estimated). It was reported that post 12 days the patient experienced hives, chest pain, dermatographia. No further details about the clinical course, diagnostic procedures and treatments were provided. The outcome of the events was reported as not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal distension, Abdominal pain, Anal incontinence, Cataract, Colon cancer stage I
Clinical narrative: I got my colon cancer diagnosis April 12, 2024. I also developed cataracts.  As soon as I got the 1st vaccine, immediatelly, my left eye turned  blood red.  With the 2nd vaccine, 5 to 10 minutes after the shot, I had to run to the toilet as I immediately developed severe diarrhea.   I had developed symptoms 2021 after the vaccines from colon cancer.  I started having bloating and passing gas non-stop.  2022, I had bloody stools.  Then I would defecate loose stools shortly after eating something and I would go 5 to 6 times a day. Then I would have leakage from my anus. Then I started to have abdominsl.pain
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Flatulence, Haematochezia, Immediate post-injection reaction, Ocular hyperaemia
Clinical narrative: I got my colon cancer diagnosis April 12, 2024. I also developed cataracts.  As soon as I got the 1st vaccine, immediatelly, my left eye turned  blood red.  With the 2nd vaccine, 5 to 10 minutes after the shot, I had to run to the toilet as I immediately developed severe diarrhea.   I had developed symptoms 2021 after the vaccines from colon cancer.  I started having bloating and passing gas non-stop.  2022, I had bloody stools.  Then I would defecate loose stools shortly after eating something and I would go 5 to 6 times a day. Then I would have leakage from my anus. Then I started to have abdominsl.pain
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a medical assistant, referring to a 5-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 13-JUN-2024, the patient was vaccinated with improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot # X015245, expiration date: 22-NOV-2024, administered orally for prophylaxis (dose and strength not provided) by a health professional (product storage error). It was reported that the vaccine was exposed to a temperature excursion on 30-APR-2024 (temperature: 74.4 degrees Fahrenheit [F]; time frame: 72 hours [also reported as excursion for 3 days plus 23 hours; min: 39.02 F, max: 74.84 F]). There was no previous temperature excursion. It was reported that the call was done because of a "data logger". It was confirmed that there were no symptomatic adverse events (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA013125: US-009507513-2407USA013127:
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Blood test, Dehydration, Infant irritability, Intussusception, Poor feeding infant
Clinical narrative: Infant received her vaccines at her routine 4 month old well child check on 7/24/24. She was mildly fussy at the time of the appointment but was able to console by her mom. The next morning, she was much more fussy than typical. Mom gave her Tylenol, warm bath, without significant improvement. Fussiness continued throughout the day with decreased feedings, minimal to no relief with interventions. Mom called around 9:30 pm on 7/25/24 to after hours line for advice, was advised to go to the local emergency department for additional evaluation as the infant's symptoms seemed outside of the typical for vaccine related fussiness. Infant was evaluated in the emergency department at Mission Hospital and was diagnosed with intussusception, which spontaneously resolved.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Ultrasound scan
Clinical narrative: Infant received her vaccines at her routine 4 month old well child check on 7/24/24. She was mildly fussy at the time of the appointment but was able to console by her mom. The next morning, she was much more fussy than typical. Mom gave her Tylenol, warm bath, without significant improvement. Fussiness continued throughout the day with decreased feedings, minimal to no relief with interventions. Mom called around 9:30 pm on 7/25/24 to after hours line for advice, was advised to go to the local emergency department for additional evaluation as the infant's symptoms seemed outside of the typical for vaccine related fussiness. Infant was evaluated in the emergency department at Mission Hospital and was diagnosed with intussusception, which spontaneously resolved.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pruritus
Clinical narrative: Patient describes general flu like symptoms, and itching in the left underarm. Resolved after 2 days.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Ear pain, Fatigue, Leukocytosis
Clinical narrative: Hospitalized 3/14/23-3/17/23 Fatigue, earache, decreased appetite, cough, mastoiditis, sinusitis, otitis media, leukocytosis,
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Mastoiditis, Otitis media, Sinusitis
Clinical narrative: Hospitalized 3/14/23-3/17/23 Fatigue, earache, decreased appetite, cough, mastoiditis, sinusitis, otitis media, leukocytosis,
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough infection
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, painful, warm to touch.  Redness, swelling is distal to injection site.  Started on cephalexin.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to touch and sore.  The size is between a tennis ball and softball.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia
Clinical narrative: She got her vaccine, about 4 days later she started having slight muscle pain in the bicep.  Then she had it around the elbow area, and the nit was in the muscle in her shoulder also.  It just fluctuates where it is at different times.  It is a mild pain though.  She still continues to have the pain.  She does not have insurance and has not seen a doctor for it, and not taken anything for it.  It comes and goes and it is not persistent and it is not killing her.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tenitus
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: No energy, tired. Explosive diarrhea during day. Headache, and strangely  days afterwards, itching at injection site. Like a severe case of the flu, but I know it was not the flu.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: No energy, tired. Explosive diarrhea during day. Headache, and strangely  days afterwards, itching at injection site. Like a severe case of the flu, but I know it was not the flu.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Bradycardia, Bronchitis, Cough, Hypotension
Clinical narrative: Hospitalized 3/16/23-3/27/23 Fall, cough, fever with chills, hypotension, bronchitis, a-fib, elevated troponin, bradycardia,
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Troponin increased
Clinical narrative: Hospitalized 3/16/23-3/27/23 Fall, cough, fever with chills, hypotension, bronchitis, a-fib, elevated troponin, bradycardia,
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Injection site pain, Paraesthesia, Tinnitus
Clinical narrative: Pt experienced ringing in ears, soreness at the injection site, joint pain, and paresthesias in injection arm within a few minutes of the injection.  These symptoms have persisted but have improved over the past 5 days. Pt was treated with ibuprofen and ice with mild relief felt.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Atrial flutter, Cardiac ablation, Cardiomyopathy, Detoxification
Clinical narrative: MODERNA #1 12/21/2021  MODERNA #2 2/2/2022, DEVELOPED VACCINE INDUCED MYOPERICARDITIS MANIFESTED BY ATRIAL FLUTTER REQUIRING ABLATION AND NONISCHEMIC CARDIOMYOPATHY LOWEST LVEF 15% WITH MILD PERICARDIAL EFFUSION.  TREATED WITH CARVEDILOL, ENTRESTO, SPIRONOLACTONE, ELIQUIS, COLCHICINE, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Ejection fraction decreased, Electrocardiogram, Laboratory test, Myopericarditis
Clinical narrative: MODERNA #1 12/21/2021  MODERNA #2 2/2/2022, DEVELOPED VACCINE INDUCED MYOPERICARDITIS MANIFESTED BY ATRIAL FLUTTER REQUIRING ABLATION AND NONISCHEMIC CARDIOMYOPATHY LOWEST LVEF 15% WITH MILD PERICARDIAL EFFUSION.  TREATED WITH CARVEDILOL, ENTRESTO, SPIRONOLACTONE, ELIQUIS, COLCHICINE, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericardial effusion
Clinical narrative: MODERNA #1 12/21/2021  MODERNA #2 2/2/2022, DEVELOPED VACCINE INDUCED MYOPERICARDITIS MANIFESTED BY ATRIAL FLUTTER REQUIRING ABLATION AND NONISCHEMIC CARDIOMYOPATHY LOWEST LVEF 15% WITH MILD PERICARDIAL EFFUSION.  TREATED WITH CARVEDILOL, ENTRESTO, SPIRONOLACTONE, ELIQUIS, COLCHICINE, AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Cellulitis, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt reported redness, swelling, and itching on R arm about 36 hours after receiving Varivax and MenQuad in R deltiod. Received HPV in R gluteal per parents. Pt was seen 48 hours after vaccine administration in the same clinic, and was treated for cellulitis with Keflex and Zyrtec.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: 22 hours after injections, hives began around the Varicella (Varivax) injection site as well as on belly. As the day went on, the hives got much worse extending to entire body.  Given 2mL zyrtec by doctor.  The following day (48 hours after injection), hives had diminished on belly, neck & arms, but had spread at the injection site to cover entire left thigh.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Crying, Headache, Malaise, Somnolence
Clinical narrative: Patient woke up the next day following the vaccine with a 9/10 headache and elevated temperature in the 99-100 degree range, never a fever.  Patient, that is normally very resilient, was crying because she felt so terrible. Throughout that day she experienced chills and headache that would go down in severity but never would go away with tylenol and Ibuprofen.  In particular she experienced worse headache when looking out the corners of her eyes to the left or right.  At 36 hours after vaccination she threw up and still had the headache and chills.  She slept off and on all day. During the 36-48 hours mark the other symptoms resolved except the headache.  It did lessen in severity and remained at a 3 or 4 until the 108 hours post administration mark, when the headache finally resolved.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Patient woke up the next day following the vaccine with a 9/10 headache and elevated temperature in the 99-100 degree range, never a fever.  Patient, that is normally very resilient, was crying because she felt so terrible. Throughout that day she experienced chills and headache that would go down in severity but never would go away with tylenol and Ibuprofen.  In particular she experienced worse headache when looking out the corners of her eyes to the left or right.  At 36 hours after vaccination she threw up and still had the headache and chills.  She slept off and on all day. During the 36-48 hours mark the other symptoms resolved except the headache.  It did lessen in severity and remained at a 3 or 4 until the 108 hours post administration mark, when the headache finally resolved.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: severe arm pain. Patient required subsequent visit with provider and was Rx'd steroid to help with severe arm pain.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Area surrounding injection became red, raised and painful starting in 7/4/2024. Pt. was seen and treated at Urgent care with steroids and zyrtec on 7/5/2024. Pt. completely recovered from injection reaction.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Neck pain
Clinical narrative: Patient was given Adacel injection and called to report that he has been having pain in the neck since he got the injection
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Hallucination, Myalgia, Pain, Pyrexia
Clinical narrative: 101 F fever 32 hours post shot. Shivering. Hallucinations, body ache, muscle ache lasting for 5 days post shot.