chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient reports a large nodule at the injection site that is painful, red, and swollen. She has not tried any medications yet at this time. Informed patient to monitor and call us back or go to emergency room if needed.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: administered flublok and prevnar into right arm - developed rash about 3 inches BELOW vaccination site and to elbow. not around injection sites. minor bruise to injection site appears to be unrelated but still submitting report
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Abdominal distension, Abdominal pain, Cleft lip repair, Clostridium difficile infection, Clostridium test positive
Clinical narrative: Unclear if related. Patient got Rotarix #2 without issue on 2/18. Got a mouth surgery on 2/25. 2/26 had fever, abd pain, lethargy, abdominal bloating, and rust-colored heme-positive stool. Needed an orogastric tube, NPO. Needed broad-spectrum antibiotics. Oral vancomycin for presumed C difficile. Unclear whether rotavirus is at all related. VAERs filed due to it being detectable in a stool PCR panel (but rotavirus Antigen was negative in stool workup).
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Faeces discoloured, Gastrointestinal tube insertion, Laboratory test, Lethargy, Nucleic acid test
Clinical narrative: Unclear if related. Patient got Rotarix #2 without issue on 2/18. Got a mouth surgery on 2/25. 2/26 had fever, abd pain, lethargy, abdominal bloating, and rust-colored heme-positive stool. Needed an orogastric tube, NPO. Needed broad-spectrum antibiotics. Oral vancomycin for presumed C difficile. Unclear whether rotavirus is at all related. VAERs filed due to it being detectable in a stool PCR panel (but rotavirus Antigen was negative in stool workup).
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Occult blood positive, Pyrexia, Rotavirus test positive, Urinary system X-ray, X-ray gastrointestinal tract
Clinical narrative: Unclear if related. Patient got Rotarix #2 without issue on 2/18. Got a mouth surgery on 2/25. 2/26 had fever, abd pain, lethargy, abdominal bloating, and rust-colored heme-positive stool. Needed an orogastric tube, NPO. Needed broad-spectrum antibiotics. Oral vancomycin for presumed C difficile. Unclear whether rotavirus is at all related. VAERs filed due to it being detectable in a stool PCR panel (but rotavirus Antigen was negative in stool workup).
Age: 19.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Nausea, Oropharyngeal pain, Urticaria
Clinical narrative: Hives on both arms, fatigue,  sore throat, nausea
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Depressed level of consciousness, Seizure like phenomena
Clinical narrative: seizure-like adverse reaction, partial loss of consciousness
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Asthenia, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: sinusitis (chronic congestion) came back, weakness and intermittent fever.  Treated with a course of antibiotics but congestion hasn't resolved 2+ months after vaccination
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: Sinus congestion, Sinusitis
Clinical narrative: sinusitis (chronic congestion) came back, weakness and intermittent fever.  Treated with a course of antibiotics but congestion hasn't resolved 2+ months after vaccination
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Pain
Clinical narrative: Extreme pain at injection site approximately 12 hours after injection. It was MUCH more sore than that of any other vaccine I have had. It hurt to move the arm and it was even more painful if someone or something applied pressure to the arm. This lasted for about 24 hours. About one week later, a rash occurred on the affected arm. It went from just below the shoulder to just above the elbow and lasted for about 48 hours.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: 6-7 hours after injection flu like symptoms began and continued for the next 24 hours. Symptoms included fever, chills, joint pain, fatigue,  and headache. It felt just as if I had the flu.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 6-7 hours after injection flu like symptoms began and continued for the next 24 hours. Symptoms included fever, chills, joint pain, fatigue,  and headache. It felt just as if I had the flu.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Breast tenderness, Chills, Dysmenorrhoea, Fatigue
Clinical narrative: This was my booster. I started experiencing flu like symptoms 6-7 hours after the injection. Symptoms included, fever, chills, joint pain, fatigue and headache. This lasted for approximately 24 hours after onset of symptoms. My next menstrual period after this booster was effected as well. I experienced EXTREME breast tenderness, increase in menstrual flow, increased intensity of menstrual headaches, increased intensity of menstrual cramps, and increased duration of menstruation.  This was all very odd because I normally have mild to no menstrual symptoms due to having Mirena IUD. Periods returned to normal after this event.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Menstrual disorder, Menstrual headache, Oligomenorrhoea
Clinical narrative: This was my booster. I started experiencing flu like symptoms 6-7 hours after the injection. Symptoms included, fever, chills, joint pain, fatigue and headache. This lasted for approximately 24 hours after onset of symptoms. My next menstrual period after this booster was effected as well. I experienced EXTREME breast tenderness, increase in menstrual flow, increased intensity of menstrual headaches, increased intensity of menstrual cramps, and increased duration of menstruation.  This was all very odd because I normally have mild to no menstrual symptoms due to having Mirena IUD. Periods returned to normal after this event.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This was my booster. I started experiencing flu like symptoms 6-7 hours after the injection. Symptoms included, fever, chills, joint pain, fatigue and headache. This lasted for approximately 24 hours after onset of symptoms. My next menstrual period after this booster was effected as well. I experienced EXTREME breast tenderness, increase in menstrual flow, increased intensity of menstrual headaches, increased intensity of menstrual cramps, and increased duration of menstruation.  This was all very odd because I normally have mild to no menstrual symptoms due to having Mirena IUD. Periods returned to normal after this event.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Pain, Rash, Skin warm
Clinical narrative: Swollen deltoid, rash, warm to touch, and pain.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Death, Lethargy, Malaise, Mobility decreased
Clinical narrative: Mom fell ill almost immediately, but symptoms became worse the next day on the 20th she could not get out of bed ,went to check on her she died that next morning( lathargic, muscle pain in arm, and chest pains)
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Mom fell ill almost immediately, but symptoms became worse the next day on the 20th she could not get out of bed ,went to check on her she died that next morning( lathargic, muscle pain in arm, and chest pains)
Age: 1.5
Sex: F
Vaccine: DTPPVHBHPB, MMR, VARCEL, DTPPVHBHPB, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Decreased appetite, Extra dose administered, Inappropriate schedule of product administration, Injection site rash, Irritability
Clinical narrative: Fever of 103+, rash, and lethargy starting the day after and lasting about 2 days. Physical exam conducted by DO in office 4 days after the vaccinations. Appt was concluded with normal neuro exam, normal motor functions, regular cardiovascular findings, and good general appearance.
Age: 1.5
Sex: F
Vaccine: DTPPVHBHPB, MMR, VARCEL, DTPPVHBHPB, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Malaise, Pyrexia, Rash, Vomiting
Clinical narrative: Fever of 103+, rash, and lethargy starting the day after and lasting about 2 days. Physical exam conducted by DO in office 4 days after the vaccinations. Appt was concluded with normal neuro exam, normal motor functions, regular cardiovascular findings, and good general appearance.
Age: 1.5
Sex: F
Vaccine: DTPPVHBHPB, MMR, VARCEL, DTPPVHBHPB, MMR, PNC13, VARCEL, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 103+, rash, and lethargy starting the day after and lasting about 2 days. Physical exam conducted by DO in office 4 days after the vaccinations. Appt was concluded with normal neuro exam, normal motor functions, regular cardiovascular findings, and good general appearance.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MMRV, UNK
Symptoms: Product storage error
Clinical narrative: No adverse effects; "was stored in the refrigerator for months; This spontaneous report was received from a Nurse and refers to a 9-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included (Gardasil 9) Human Papillomavirus 9-valent Vaccine, Recombinant,  Havrix (Hepatitis a vaccine inact), Fluarix quadrivalent (Influenza vaccine inact split 4v), IPOL (inactivated polio virus), Engerix b (Hepatitis b vaccine rHBsAg (yeast)), Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) .  On 01-Oct-2024, the facility receievd a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. A document was found on the FD website with title "Package insert refrigerator stable formulation Proquad". Unware that there were two Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) products licensed by the FDA, it was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be refrigerated and both state and priavte Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenhelt) until administration. On 13-Nov-2024, the dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the patient arrived to the facility and was refrigerated until administration day.   On 06-Jan-2025, the patient was vaccinated with the first dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013579 has been verified to be a valid lot number, expiration date: 03-Feb-2026; dose and strength were not provided) by Subcutaneous route in right arm for prophylaxis (product storage error). No adverse effects (no adverse event) were reported.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MMRV, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; "was stored in the refrigerator for months; This spontaneous report was received from a Nurse and refers to a 9-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included (Gardasil 9) Human Papillomavirus 9-valent Vaccine, Recombinant,  Havrix (Hepatitis a vaccine inact), Fluarix quadrivalent (Influenza vaccine inact split 4v), IPOL (inactivated polio virus), Engerix b (Hepatitis b vaccine rHBsAg (yeast)), Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) .  On 01-Oct-2024, the facility receievd a shipment of COVID vaccine that needed to be stored in the freezer. There was no room in the freezer to accommodate the shipment. A document was found on the FD website with title "Package insert refrigerator stable formulation Proquad". Unware that there were two Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) products licensed by the FDA, it was assumed that the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) received could be refrigerated and both state and priavte Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were moved to the refrigerators where they remained within normal refrigerated temperature range (36 to 46 degrees Fahrenhelt) until administration. On 13-Nov-2024, the dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) administered to the patient arrived to the facility and was refrigerated until administration day.   On 06-Jan-2025, the patient was vaccinated with the first dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013579 has been verified to be a valid lot number, expiration date: 03-Feb-2026; dose and strength were not provided) by Subcutaneous route in right arm for prophylaxis (product storage error). No adverse effects (no adverse event) were reported.
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No reported signs/symptoms of adverse events.; second dose in the vaccination series on 10/07/2019 and the expiration date of VARIVAX was n022977 / 08/23/2019, post expiry date; Information has been received from Business Partner/CRO on 11-Feb-2025.  This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-Oct-2019, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), (lot #N022977, expiration date: 23-Aug-2019) (2nd dose),. On 07-Oct-2019, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), for the treatment of Prophylaxis.  On 07-Oct-2019, the patient experienced second dose in the vaccination series on 10/07/2019 and the expiration date of VARIVAX was n022977 / 08/23/2019, post expiry date. On an unknown date, the patient experienced No reported signs/symptoms of adverse events..   At the reporting time, the outcome of second dose in the vaccination series on 10/07/2019 and the expiration date of VARIVAX was n022977 / 08/23/2019, post expiry date and No reported signs/symptoms of adverse events. was unknown.   The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.
Sex: F
Vaccine: VARZOS
Symptoms: Dacryostenosis acquired, Ophthalmic herpes zoster, Pain
Clinical narrative: tear duct a non-functioning; and got shingles in my left eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a 83-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced ophthalmic herpes zoster (Verbatim: and got shingles in my left eye) (serious criteria GSK medically significant) and blocked tear duct (excl congenital) (Verbatim: tear duct a non-functioning). The outcome of the ophthalmic herpes zoster was resolved (duration 4 months) and the outcome of the blocked tear duct (excl congenital) was not reported.   The reporter considered the ophthalmic herpes zoster and blocked tear duct (excl congenital) to be related to Shingles vaccine.     The company considered the ophthalmic herpes zoster and blocked tear duct (excl congenital) to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAR-2025 The patient was 83 years old. The reporter reported that definitely get the shot which was done in 2 sessions. The patient got the first one when it was not that affective and got shingles in his/her left eye. It was extremely painful. It took 4 months to clear up plus left his/her tear duct a non-functioning mess. The patient got the current one because if someone has had shingles, there was a good possibility of getting it again when older.; Sender's Comments: Ophthalmic herpes zoster and Dacryostenosis acquired are unlisted events which are considered unrelated to GSK Shingles vaccine.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Day after second shot she experienced fever; She also experienced arm pain for first 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 40-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2024). Concurrent medical conditions included systemic lupus erythematosus, asthma and cytomegalovirus infection (Chronic). Concomitant products included hydroxychloroquine, azathioprine and valaciclovir (Valacyclovir).   On 06-FEB-2025, the patient received the 2nd dose of Shingrix (right deltoid). On 07-FEB-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Day after second shot she experienced fever). In FEB-2025, the patient experienced pain in arm (Verbatim: She also experienced arm pain for first 2 days). In FEB-2025, the outcome of the pain in arm was resolved (duration 2 days). The outcome of the fever was not resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.     It was unknown if the company considered the fever and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2025 The patient received Shingrix and the day after second shot she experienced fever which was still present.  She also experienced arm pain for first 2 days.  No other details were provided.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nausea
Clinical narrative: Shivers; Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of shivers in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included evolocumab (Repatha), glipizide and benazepril.   On 28-FEB-2025, the patient received the 1st dose of Shingrix. On 05-MAR-2025, 5 days after receiving Shingrix, the patient experienced shivers (Verbatim: Shivers) and nausea (Verbatim: Nausea). The outcome of the shivers and nausea were unknown.   It was unknown if the reporter considered the shivers and nausea to be related to Shingrix.     It was unknown if the company considered the shivers and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date : 05-MAR-2025. The reporter is the patient.  The patient received the first dose of SHINGRIX last Friday at a local pharmacy.  About 2 hours ago 3pm ET , on the day of reporting , the patient was began experienced shivers and nausea.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia
Clinical narrative: numbness in the pinky finger, ring finger of left hand /pad area of the hand, up to the tip of both fingers; This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in fingers in a 61-year-old female patient who received Flu unspecified (Influenza 2024-2025 Vaccine) for prophylaxis.   On 17-JAN-2025, the patient received Influenza 2024-2025 Vaccine (intercostal, left arm). On 18-JAN-2025, 1 days after receiving Influenza 2024-2025 Vaccine, the patient experienced numbness in fingers (Verbatim: numbness in the pinky finger, ring finger of left hand /pad area of the hand, up to the tip of both fingers). The outcome of the numbness in fingers was not resolved.   It was unknown if the reporter considered the numbness in fingers to be related to Influenza 2024-2025 Vaccine.     It was unknown if the company considered the numbness in fingers to be related to Influenza 2024-2025 Vaccine.   Additional Information: GSK Receipt Date: 06-FEB-2025 The reporter was a female patient that received a GSK Flu vaccine (Influenza 2024-2025 Vaccine).  The patient was administered flu vaccine and it was administered in the left arm. The reporter does not know the name of the vaccine or have information of Lot/Exp.  The patient was only informed that it is a GSK brand.  The patient reported having side effects of numbness. The patient noticed it the following morning after the vaccination day.  The patient stated, she have numbness in the pinky finger, ring finger left hand. The patient stated that the numbness was started from the pad area of the hand, up to the tip of both fingers. The patient stated it was not resolved.  The patient reported, they never had a symptom prior to this with any vaccine, this was the first time she experienced such events after post vaccination.  No additional events were reported.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: A 26 years old female patient received a dose of Priorix via IM instead of SC.; dose of Priorix via IM instead of SC; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 26-year-old female patient who received MMR (Priorix) (batch number XX9N4, expiry date 01-JUN-2026) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 26 years old female patient received a dose of Priorix via IM instead of SC.) and subcutaneous injection formulation administered by other route (Verbatim: dose of Priorix via IM instead of SC). The outcome of the inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route were not applicable.   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-FEB-2025 A pharmacist called to report that a 26 years old female patient received a dose of Priorix via intramuscular instead of Subcutaneous which led to Subcutaneous injection formulation administered by other route. Should the patient be revaccinated. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Interchange of vaccine products
Clinical narrative: they administered a dose of Kinrix to a 3 years 7 months old patient; Different products for primary series; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3RT93) for prophylaxis.   Previously administered products included Vaxelis (received 1st dose on 20th April 2023) and Pediarix (received 2nd dose on 11th November 2024).   On 25-FEB-2025, the patient received the 3rd dose of Kinrix. On 25-FEB-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: they administered a dose of Kinrix to a 3 years 7 months old patient) and inappropriate schedule of vaccine administered (Verbatim: Different products for primary series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were not applicable.   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-FEB-2025 The reporter contacted to request information about how to proceed after a three-year 7 month old patient accidentally received a dose of Kinrix, which led to inappropriate age at vaccine administration. They mentioned that the patient received doses of DtAP and Polio previously, with the first dose being on 20th April 2023, the second dose being on 7th November 2024 and the third dose being the one administered on 25th February 2025, which led to inappropriate schedule of vaccine administered. During the phone call they also requested information about how to space out the different components of Kinrix, and the information was read after letting the health care professional know that this information was in a standard response letter for Pediarix.  The reporter asked if there were any grace period or the dose was count as valid. The Vaccine Administration Facility was the same as Primary Reporter. They mentioned that they consented to receive follow up.
Age: 1.17
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Bexsero dose was given to a 14-month-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-month-old female patient who received Men B NVS (Bexsero) (batch number Xx33p, expiry date 31-JAN-2026) for prophylaxis.   On 03-MAR-2025, the patient received Bexsero. On 03-MAR-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero dose was given to a 14-month-old patient). The outcome of the inappropriate age at vaccine administration was not applicable.   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-MAR-2025 Medical assistant calls to reporta Bexsero dose was given to a 14-month-old patient, which led to Inappropriate age at vaccine administration. The reporter consented to follow up via email.
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Feeling abnormal
Clinical narrative: I will never be the same after the different shots; Revaccination with different covid-19 vaccine; This spontaneous report received from a patient by a business partner (Pfizer Inc.) on 05-Feb-2025 was received by Johnson and Johnson Innovative Medicine on 05-Feb-2025 and concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient was previously treated with bnt162b2 and experienced feeling abnormal.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose number series 2, for covid-19 prophylaxis.The batch number was not reported. The company is unable to perform follow-up to request for batch or lot number.  No concomitant medications were reported.  On an unspecified date, the patient experienced i will never be the same after the different shots and revaccination with different covid-19 vaccine. (dose number series 2). Patient reported that they got that shot and the jj before the 2nd shots and will never be the same after the different shots The action taken with janssen covid-19 vaccine was not applicable.  The outcome of i will never be the same after the different shots and revaccination with different covid-19 vaccine was not reported.  This report was non-serious.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Only Time I had flu was after I got the flu shot; Initial information received on 27-Feb-2025 regarding an unsolicited valid non-serious case received from social media.  This case involves Adult male patient who had flu after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer, Solution for Injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation).  There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date, the patient experienced flu was after he got the flu shot (influenza) (unknown latency).  Reportedly, Patient had flu was after he got the flu shot, and he also stated that first shingles shot almost killed him.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Had my regular flu shot and still got the flu!; Initial information received on 01-Mar-2025 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional.  This case involves Adult female patient who had got the flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient developed had my regular flu shot and still got the flu! (influenza) (unknown latency) following the administration of influenza vaccine.  Information on the batch number could not be requested corresponding to the one at time of event occurrence  Reportedly, reporter stated that, had my regular flu shot and still got flu.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 20.0
Sex: M
Vaccine: COVID19, HPV9, MEN, VARCEL
Symptoms: Urticaria
Clinical narrative: He developed hives on his right thigh and lower le; Initial information received on 28-Feb-2025 regarding an unsolicited valid  non-serious Courtesy case received from a consumer/non-health care professional.  This case involves a 20 years adult male patient who had developed hives on his right thigh and lower leg after receiving Varivax (Varicella zoster vaccine live (Oka/Merck)), Gardasil 9 (HPV vaccine VLP rL1 9v (yeast)), Novavax COVID-19 Vaccine(COVID-19 vaccine prot. subunit (NVX CoV 2373)) and Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  The patient's past medical history included Headache. The patient's past medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided.   On 26-Nov-2024, the patient received a dose 2 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (Solution for injection) lot U8370AA via intramuscular route in unknown administration site, a dose 3  of suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur Injection lot 6024MF016A via intramuscular route in unknown administration site for COVID-19 Vaccination, a dose 1  of suspect Varivax not produced by Sanofi Pasteur Injection  lot Y005919 via intramuscular route in unknown administration site, a dose 1 of suspect Gardasil 9 not produced by Sanofi Pasteur  Injection lot 1957404 via intramuscular route in unknown administration site and On 07-Jan-2025 he also received a dose 1 of vaccine 1957404 via intramuscular route in unknown administration site for all Prophylactic vaccination (Immunization) (strength, expiry date was unknown for all the suspects).  On 26-NOV-2024 the patient developed hives on his right thigh and lower leg (urticaria) (latency : same day) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine, Novavax COVID-19 Vaccine, Gardasil 9 and Varivax.  Action taken was not applicable.  The patient was treated with Cetirizine hydrochloride (Zyrtec) for Urticaria.  At time of reporting, the outcome was Recovered / Resolved on 26-Nov-2024 for the event he developed hives on his right thigh and lower le.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administration of pentacel with only the dtap-IPV component with no reported adverse event; Initial information received on 27-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 19 months old female patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIBPRP/T) vaccine [Pentacel (Vero)] with only the dtap-ipv component 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 pneumococcal vaccine Conj 15V (CRM197) [Prevnar 15]; varivax; and measles vaccine, mumps vaccine, rubella vaccine [MMR] all for Immunisation.  On 26-Feb-2025, the patient received 0.5 mL (dose 3) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIBPRP/T) vaccine with only the DTaP-IPV component, Suspension for injection, (unknown Strength),expiry date 31-Aug-2025, lot UK110AA via intramuscular route in unknown administration site for immunization (Single component of a two-component product administered) (Latency Same day).  Reportedly, She stated that the ACTHIB was left out of the refrigerator overnight, approximately 16 hours and is at room temperature at around 68°F to 77°F.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient receives two high dose flu vaccines (Fluzone Hd) in one day with no reported adverse event; Initial information received on 27-Feb-2025 (with live follow up process together with CSD: 27-Feb-2025) regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age and gender patient who receives two high dose flu vaccines (fluzone hd) in one day with no reported adverse event after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine; Suspension for injection in pre-filled syringe (lot UT8470AA with expiry date 30-Jun-2025) via unknown route in unknown administration site for Immunization (Immunisation), patient receives two high dose flu vaccines (fluzone hd) in one day with no reported adverse event (extra dose administered).  Reportedly: nurse inquired what happens when a patient receives two high dose flu vaccines (Fluzone Hd) in one day. She confirmed that this happened to a patient. Administration of extra doses of tetanus toxoid containing vaccines earlier than the recommend interval can increase the risk for hypersensitivity reactions. - Informed caller that this will be escalated to the business hours team who may contact her for further assistance.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  No follow-up is possible as Reporter cannot be contacted by Sanofi.  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: 45.0
Sex: F
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: Yf-Vax was reconstituted with sterile water instead of supplied diluent with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 45 years old female patient and reporter stated that yellow fever vaccine - US [YF-VAX] was reconstituted with sterile water instead of supplied diluent 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 typhoid vaccine (typhoid vaccine) and influenza vaccine (influenza), both for Immunisation.  On 13-Nov-2024, the patient received standard dose of 0.5 ml of suspect yellow fever vaccine - US Solution for injection lot UK118AA and expiry date 30-Sep-2025 via unknown route in unknown administration site for Immunisation that was reconstituted with sterile water instead of supplied diluent with no reported adverse event (product preparation error) (Latency same day).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion of ipol; max/low temperature reached: 47.1°f duration: 10 mins with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid  non-serious case received from a other health professional.   This case involves a 10 years old female patient who received IPV (VERO) [IPOL] which was exposed to temperature excursion and max/low temperature reached: 47.1°f duration: 10 mins 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 measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation; Varicella zoster vaccine (Varicella vaccine) for Immunisation; Hepatitis B vaccine for Immunisation; and Hepatitis A Vaccine for Immunisation.  On 25-Feb-2025, the patient received 0.5 ml of dose 2 of IPV (VERO) Suspension for injection with standard strength (expiry date- 08-Sep-2025 and lot W1B511M) once via intramuscular route in the left deltoid for Immunization which was exposed to temperature excursion and max/low temperature reached: 47.1°f duration: 10 mins with no reported adverse event (product storage error) (latency- same day).   Reportedly, reporter said that they were transferring the vaccines from their AccuVax to their fridge that was 10 feet away. There was no previous excursion. Human error was involved.   Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACT-HIB given to a patient with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid  non-serious case received from a other healthcare professional.  This case involves a 1 years old female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] given to a patient 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 (VAQTA), hepatitis A vaccine (hepatitis A), measles vaccine live (ENDERS-EDMONSTON), mumps vaccine live (JERYL LYNN), rubella vaccine live (WISTAR RA 27/3), varicella zoster vaccine live (OKA/MERCK) (proquad) and pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20), all for Immunisation.  On 03-Mar-2025, the patient received standard dose 4 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection with lot UK010AA and expiry date 28-Feb-2025  via unknown route in unknown administration site for Immunization (expired product administered) (Latency same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered a dose of ACTHIB too early/underaged patient (7-days-old) with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case linked to US-SA-2025SA067436.  This case involves a 7 days old female patient who experienced inappropriate use as patient being administered a dose of acthib too early/underaged, was administered act-hib and daptacel with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation.  On 02-Mar-2025, the patient received a dose 1 (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection with standard strength (lot UK148AA with expiry date 30-Sep-2025) via intramuscular route in the left thigh for Immunization (Immunisation) and patient administered a dose of acthib too early/underaged patient (7-days-old) with no reported adverse event (product administered to patient of inappropriate age).(latency: same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA067436:ACT-HIB
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered a dose of DAPTACEL too early to underaged patient (7-days-old) with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to US-SA-2025SA067387.  This case involves a 7 days old female patient who was administered with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at underage with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB Vaccine Conj (Tet Tox) (ACT-HIB) for Immunisation.  On 02-Mar-2025 the patient was administered 0.5ml (once) dose 1 of diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection, Standard strength, Expiry date 31-Dec-2025 and lot 3CA11C1 via intramuscular route in the left thigh for immunization too early at underage (7-days-old) with no reported adverse event (product administered to patient of inappropriate age) (Latency same day)  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA067387:ACT-HIB
Age: 1.25
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: a patient was administered an expired ACTHIB with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid  non-serious case received from a Other Health Care Professional.  This case involves a 15 months old with  unknown gender patient who administered an expired  Hib (PRP/T) Vaccine [Act-Hib] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other List of comcomitants vaccines is mentioned   On 03-Mar-2025, the patient administered an expired 0.5 ml  dose of suspect  Hib (PRP/T) Vaccine,Powder and solvent for solution for injection, lot UJ995AA, expiry date: 28-feb-2025,via intramuscular route in the left vastus lateralis for Immunization.with no reported adverse event (expired product administered) (latency: same day).  Reportedly,Caller inquired if the vaccine shot was valid after administering an expired ACTHIB. Call was disconnected.  Action taken  was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.