chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Body temperature increased, Hypoaesthesia, Swelling, Urticaria
Clinical narrative: At about 02:38pm, Employee reported to medical staff that she was experiencing hives, swelling in finger tips,  and also complained of severe itching, vaccine was administered one hour prior to event, Employee was evaluated by medical staff denied any swelling in her throat area, or difficulty swallowing, alert and oriented, EMTs was recommended due to the severity of the reaction and symptoms appeared to worsen, EMTs were called at about 02:40pm, EMTs arrived and instructed employee to take over the counter Benadryl that employee had purchased, Employee left with EMTs to be evaluated at hospital.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: Patient experienced Very red, hot, blotchy circle the size of a small adult hand to the area were the immunization was administered. It began about 18 -24 hours post administration and continued for approximately 3 - 4 days. No fever or other symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia areata
Clinical narrative: alopecia areata
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Chills, Lymphadenopathy, Pyrexia
Clinical narrative: She states she is received for previous vaccinations initially on day 0, day 3, day 6, and day 9.  After the day 9 vaccine she had fever, chills, lymphadenopathy, and weakness that lasted for 3 days then resolved.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient broke out in hives and had rash over large area
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Facial paralysis, Hypoaesthesia
Clinical narrative: Pt called. Rt facial drooping after shot, felt numb. No breathing issues, no problem  wth speech, swallowing. Not affecting upper part of face. Could drive, walk well  Brought to office. Has rt side drooping when showing teeth. Otherwise neuro intact. No EOM abnormality, equal frowns on forehead, can close lids tight.  UE, LE, cerebellar normal
Age: 18.0
Sex: F
Vaccine: HEP, HIBV, HPV9, MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: None were reported by the mother or patient.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccination
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Rash, Urticaria
Clinical narrative: Patient received vaccines in clinic during. Upon getting home, parent noticed a rash with hives extending from groin to chest.  No other symptoms noted.  Rash/hives went away a few hours later. No other issues after that.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dtap (daptacel) was given early due to mistake in planning by RN. Child had no reaction and parent informed about mistake and need ot repeat dose at 4-6 years of age.
Age: 32.0
Sex: F
Vaccine: HEPAB, PNC20, TDAP
Symptoms: Chest pain, Pain
Clinical narrative: patient received vaccinations at approximately 12:30pm on 7/15/124 and on 7/16/24 she reports feeling a lot of body aches, but she also developed a sharp pain in her sternum ( NO shortness of breath or difficulty breathing) at approximately 2:30pm on 7/16/24.  Patient states the pain is very uncomfortable and she took 2 extra-strength Tylenol and did not provide any relief.
Age: 2.0
Sex: F
Vaccine: HEPA, IPV
Symptoms: Injection site rash, Malaise, Pruritus
Clinical narrative: Patient developed a rash on her right upper thigh two days after receiving vaccines. Per parent, patient felt a little sick and had a lot of itching.
Age: 1.17
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; administered MMR II on May 31, 2024, and VARIVAX was administered today, June 17, 2024. VARIVAX was an invalid dose according to the spacing of live vaccine guidelines, which dictates a minimum of 28 day i; This spontaneous report was received from nurse and refers to a 14-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 17-JUN-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #x023717, expiration date: 26-SEP-2025, administered for prophylaxis (strength, and route of administration were not provided).The interwal between those vaccines should be minimum of 28 days (Inappropriate schedule of product administration). No additional adverse event was reported.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE; Caller reporting that a dose of VAQTA was administered "early." First dose was given on 1/29/2024 and second dose was given on 6/18/2024. No additional information reported, no additional AE, no PQC. No additional information.; This spontaneous report was received from medical assistant and refers to a 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 29-JAN-2024, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (1st dose, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On 18-JUN-2024, the patient was vaccinated with second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (0.5 milliliter, lot #X025484 was valid for formulation pre-filled syringe, expiration date: 13-MAY-2025, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate schedule of product administration). No additional information reported, no additional adverse event (AE), no product quality complaint (PQC) (No adverse event). No additional information.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects noted; HCP reports patient received improperly stored PEDVAXHIB.  No adverse effects noted. No other information provided.  No PQC.   PEDVAXHIB LOT X017447  Exp 3/11/2026 82 Hours 50 Minutes 34.5 F No Previous TE; This spontaneous report was received from medical assistant and refers to a 2-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2024, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, single dose, lot #X017447, expiration date: 11-MAR-2026, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 34.5 Farenheit for 82 hours and 50 minutes (Product storage error). No additional adverse event was reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additiinal adverse event; HCP called to report VARIVAX was administered to a patient after experiencing a T/E.  No symptoms reported.  HCP provided consent to contact.  No additional AE/PQC reported.; This spontaneous report was received from nurse and refers to a 15-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAR-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X021930, expiration date: 29-AUG-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion (Product storage error). No additional adverse evenet was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE for VARIVAX that occurred on 06/12/24. HCP informed the VARIVAX was inadvertently administered to patient on 07/05/24 at 6:00pm, following the TE. No further details provided. Permission was given to contact HCP. See additiona; This spontaneous report was received from Other and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-JUL-2024 18:00:00, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, unk, lot #X026326, expiration date: 07-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). The vaccine underwent temperature excursion in 30 Farenheit for 1 hour 45 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Vaccine coordinator reported that a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report was received from a consumer referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.  On 10-JUL-2024, the patient was vaccinated with a dose of improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection, lot #X011112, expiration date: 18-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). The vaccine had been exposed to 47 degrees Fahrenheit (F) to 77 F (49.2 F) for 3 hours 48 minutes; 14 F to 46 F for 8 hours; 6 F to 14 F for 1 hour 42 minutes. There was no previous temperature excursion. The patient and patient's family have not reported any other AEs since the administration (no adverse event).
Sex: F
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient was vaccinated with the second dose of Jynneos 32 days after the first dose; Case reference number US-BN-2024-002097 is a spontaneous case initially received from a nurse via Communications (reference number: USBAV24-1420) on 19-Jun-2024 and concerns a 35-year-old female patient.  The patient's medical history and concomitant medication details are not provided.  On 14-May-2024, the subject was vaccinated with the first dose of Jynneos (batch number: FDP00015), at an unknown dose, route, or site of administration for smallpox immunization/monkeypox immunization.  On 15-Jun-2024, 32 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00015), at an unknown dose, route, or site of administration. As reported, on Saturday, the nurse took some vaccines out and put them in a cooler, the vaccine was frozen and put on some ice packs. The nurse stated that the vaccines remained frozen and provided that the cooler reached up to 31.6 Fahrenheit. The maximum temperature according to the log was 42.6 Fahrenheit. As reported, 12 doses were affected. The doses were put into a cooler at 10:40 AM and returned to the freezer at 4 PM (explicitly coded as 'Inappropriate schedule of vaccine administered').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Jynneos vaccine.  No further information was provided.; Reporter's Comments: A 35-year-old female patient was vaccinated with two doses of Jynneos, 32 days apart, which is considered inappropriate schedule of vaccine administered. No associated adverse events were reported. The inappropriate schedule of vaccine administered is considered listed per company convention. The patient's medical history and concomitant medication details are not provided. Inappropriate schedule of vaccine administered is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A 35-year-old female patient was vaccinated with two doses of Jynneos, 32 days apart, which is considered inappropriate schedule of vaccine administered. No associated adverse events were reported. The inappropriate schedule of vaccine administered is considered listed per company convention. The patient's medical history and concomitant medication details are not provided. Inappropriate schedule of vaccine administered is considered not related to Jynneos, but to human error. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of Jynneos on day 21; Patient received second dose of Jynneos intradermally; Case reference number US-BN-2024-002090 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV24-1470) on 24-Jun-2024 and concerns a *60-year-old male patient*.  The patient's medical history and concomitant medication were not provided.  *On 20-Aug-2022*, the patient was vaccinated with the first dose of Jynneos (*batch number: FDP00013*) at an unknown dose, *subcutaneously in left arm for mpox pre-exposure prophylaxis.*  *On 08-Sep-2022, 21 days after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00013) at an unknown dose, intradermally in left forearm (explicitly coded as 'inappropriate schedule of vaccine administered' and 'intradermal injection').*  *At the time of follow up report, the patient did not experience any adverse event due to Jynneos.*  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a pharmacist on 05-Jul-2024: New information included patient demographic details (initials, gender and age) and Jynneos dosage information.; Reporter's Comments: A 60-year-old male patient was vaccinated with the second dose of Jynneos, 21 days after the first dose, at an unknown dose, intradermally in left forearm which is considered as inappropriate schedule of vaccine administered and intradermal injection. It was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and injection are both considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 60-year-old male patient was vaccinated with the second dose of Jynneos, 21 days after the first dose, at an unknown dose, intradermally in left forearm which is considered as inappropriate schedule of vaccine administered and intradermal injection. It was unknown if the patient experienced any adverse event due to Jynneos. Inappropriate schedule of product administration and injection are both considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Patient received Jynneos vaccine intradermally; Case reference number US-BN-2024-002131 is a spontaneous case initially received from a nurse via Communication (reference number: USBAV24-1563) on 03-Jul-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication were not provided.  On an unspecified date, the patient was vaccinated with the dose of Jynneos (batch number: unknown) intradermally, at an unknown dose and site of administration for unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the dose of Jynneos intradermally, for unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with the dose of Jynneos intradermally, for unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose, and Has Not Received Second Dose She is Pregnant; Was Pregnant; Initial report received on 10-Jun-2024.  A pharmacist reported that a 35-year-old pregnant female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but did not receive the second dose as she is pregnant.  Medical history and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.   The last menstrual period date, pregnancy history, pregnancy risk factors, and estimated date of delivery were not reported.   On 11-Mar-2024, the patient received her first dose of HEPLISAV-B (Lot number 943192, expiration date 08 Mar-2026; NDC number unknown) intramuscularly in the left deltoid. The patient needed a second dose but was pregnant (number of weeks gestation was not reported). No side effects have been reported by the patient.   No further information was available.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: bad i felt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: bad i felt). The outcome of the feeling bad was resolved (duration 10 days).   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-JUL-2024 The case was received from the patient via interactive digital media. The patient received second dose of Shingles vaccine and felt bad. The patient looked like an inflatable doll when they disconnect it from the light, that was how his/her body felt. The patient lasted about ten days like that.
Sex: U
Vaccine: RVX
Symptoms: Oral administration complication, Vomiting
Clinical narrative: when got home was fed and threw up his feed, about one hour after receiving rotatrix; Regurgitation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of vomiting in a patient who received Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received Rotavirus vaccine. On an unknown date, 1 hr after receiving Rotavirus vaccine, the patient experienced vomiting (Verbatim: when got home was fed and threw up his feed, about one hour after receiving rotatrix) and regurgitation (Verbatim: Regurgitation). The outcome of the vomiting was not reported and the outcome of the regurgitation was unknown.   It was unknown if the reporter considered the vomiting and regurgitation to be related to Rotavirus vaccine.     It was unknown if the company considered the vomiting and regurgitation to be related to Rotavirus vaccine.   Additional Information: GSK Receipt date: 11-JUL-2024 A reporter reported that the patient parent asking whether a repeat dose was necessary for rotatrix, the patient received rotatrix tolerated well and when got home was fed and threw up his feed, about one hour after receiving rotatrix. Parents concerned that he did not receive full dose.  The reporter did he need another dose of rotatrix. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient via J an J managed social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced stroke (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Cerebrovascular accident. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Blood oestrogen, Blood oestrogen increased, Hormone analysis, Hormone level abnormal, Invasive ductal breast carcinoma
Clinical narrative: INVASIVE DUCTAL CARCINOMA; NEUROPATHY; HORMONE CHANGES; ESTROGEN LEVELS HIGH; This spontaneous report received from a patient via J and J managed social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that the patient had covid vaccine on MAR-2021. She had other side effects such as hormone changes (dose series 1) but didn't pay much attention. The patient was curious to check for hormones in blood work, because of her age she didn't check. She also had mild issues, but couldn't connect anything. The patient started to use hormone cream few months ago for several weeks. She was panicked and she checked carefully, no lumps were present till past MAY and later found to have invasive ductal carcinoma (dose series 1), which was possibly there for several weeks. The patient's estrogen levels were high (dose series 1) and she believed her vaccine shot triggered it. She got neuropathy (dose series 1) after the shot, which was said to be pretty much consumed her life. She was trying to make sense of these events and was wandering about if shot could trigger hormone changes and if other women had the similar experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hormone changes, invasive ductal carcinoma, estrogen levels high and neuropathy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Invasive ductal breast carcinoma, Neuropathy peripheral. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: INVASIVE DUCTAL CARCINOMA; NEUROPATHY; HORMONE CHANGES; ESTROGEN LEVELS HIGH; This spontaneous report received from a patient via J and J managed social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that the patient had covid vaccine on MAR-2021. She had other side effects such as hormone changes (dose series 1) but didn't pay much attention. The patient was curious to check for hormones in blood work, because of her age she didn't check. She also had mild issues, but couldn't connect anything. The patient started to use hormone cream few months ago for several weeks. She was panicked and she checked carefully, no lumps were present till past MAY and later found to have invasive ductal carcinoma (dose series 1), which was possibly there for several weeks. The patient's estrogen levels were high (dose series 1) and she believed her vaccine shot triggered it. She got neuropathy (dose series 1) after the shot, which was said to be pretty much consumed her life. She was trying to make sense of these events and was wandering about if shot could trigger hormone changes and if other women had the similar experience. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hormone changes, invasive ductal carcinoma, estrogen levels high and neuropathy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Invasive ductal breast carcinoma, Neuropathy peripheral. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Polymyalgia rheumatica, Vasculitis
Clinical narrative: Polymyalgia rheumatica; She had some problems with vasculitis; She had an increase in her migraines (starting with the 1st dose and subsequent doses of Moderna)/ Increased migraines; This spontaneous case was reported by a physician and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2020, the patient experienced MIGRAINE (She had an increase in her migraines (starting with the 1st dose and subsequent doses of Moderna)/ Increased migraines). On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant) and VASCULITIS (She had some problems with vasculitis). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) and VASCULITIS (She had some problems with vasculitis) outcome was unknown and MIGRAINE (She had an increase in her migraines (starting with the 1st dose and subsequent doses of Moderna)/ Increased migraines) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient got the Moderna mRNA vaccine starting in 2020 with primary series when it first came out. She had some problems with vasculitis and an increase in her migraines starting with first dose of Moderna and developed polymyalgia rheumatica. Reporter mentioned that after each Moderna dose, her migraines increased. Before the doses she would get 1 to 3 migraines per year and after Moderna she would get 10 migraines per year, Treatment information was not reported.  Company Comment: This is a spontaneous case concerning a 70-year-old, female patient with a relevant medical history of migraines, who experienced the serious (due to medically significant) unexpected event of Polymyalgia rheumatica, among other non-serious events of Vasculitis and Migraine. The events occurred on an unknown date after a dose of mRNA-1273 vaccine (dose number and onset dates were not provided; hence, latency could not be estimated). It was reported that the patient had primary series and 3 Moderna boosters and a Novavax booster, on an unknown date. Clinical course, supportive diagnostic procedures and treatment, were not provided. The outcome of the events Polymyalgia rheumatica and Vasculitis was not provided, and for the event Migraine, was unknown. Underlying current condition of Migraines is a contributor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-771203 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Polymyalgia rheumatica, Vasculitis
Clinical narrative: polymyalgia rheumatica; After each Moderna dose, (the) migraines increased; problems with vasculitis; This spontaneous case was reported by a physician and describes the occurrence of POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine.   On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) (seriousness criterion medically significant), MIGRAINE (After each Moderna dose, (the) migraines increased) and VASCULITIS (problems with vasculitis). At the time of the report, POLYMYALGIA RHEUMATICA (polymyalgia rheumatica) and VASCULITIS (problems with vasculitis) outcome was unknown and MIGRAINE (After each Moderna dose, (the) migraines increased) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had received primary series of Moderna vaccine.  Patient had some problems with vasculitis. Patient had an increase migraine (starting with the 1st dose and subsequent doses of Moderna) and developed polymyalgia rheumatica. After each Moderna dose, (the) migraines increased. Before the doses patient would get 1 to 3 migraines per year and after Moderna doses would get 10 migraines per year. The 6th dose was the Novavax vaccine booster. After the Novavax vaccine patient had 1 to 2 migraines per year.   Treatment medication was not reported.  Company Comment: This is a spontaneous case concerning a 70-year-old, female patient with a relevant medical history of migraine, who experienced the serious (due to medically significant) unexpected event of Polymyalgia rheumatica among other non-serious events of Vasculitis and Migraine. The events occurred on an unknown date after a dose of SPIKEVAX COVID-19 VACCINE NOS (onset dates were not provided; hence, latency could not be estimated). It was reported that the patient had primary series and 3 Moderna boosters and a Novavax booster, on an unknown date. Clinical course, supportive diagnostic procedures and treatment, were not provided. The outcome of the events Polymyalgia rheumatica and Vasculitis was not provided, and for the event Migraine, was unknown. Underlying current condition of Migraines is a contributor. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.   This case was linked to MOD-2024-770836 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had Covid 3 times; had Covid 3 times; had Covid 3 times; The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 12Jul2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 84-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "had Covid 3 times". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: was having issues with test. Clinical course: Patient verbally stated that she was having issues with test and has had Covid 3 times and had it for at least 5 months.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I even got covid after the shot; I even got covid after the shot; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I even got covid after the shot".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400091534 Same patient/same product, different dose/event;
Sex: M
Vaccine: COVID19, RSV
Symptoms: COVID-19, Drug ineffective, Respiratory syncytial virus infection, Weight
Clinical narrative: worried that he may have either RSV or the newest covid; worried that he may have either RSV or the newest covid; worried that he may have either RSV or the newest covid; This is a spontaneous report received from a Physician.  A 69-year-old male patient received rsv vaccine prot.subunit pref 2v (RSV VACCINE PROT.SUBUNIT PREF 2V), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (ongoing), notes: mild case; did not have any asthma until he had covid; "sick" (unspecified if ongoing), notes: began probably 5 years ago; "Covid" (unspecified if ongoing), notes: lost 55 pounds from the first round of covid; "other bad virus" (unspecified if ongoing), notes: in his 30s. The patient informed that he has a mild case of asthma that usually did not present itself unless he got sick, and it began probably 5 years ago when he got sick; did not have any asthma until he had covid. There were no concomitant medications. The reporter was calling because he was worried that he may have either RSV or the newest covid vaccine and he has been fully vaccinated up until this new variant and he was wondering what he should do in terms of vaccination or if his vaccination was standard up to this point. He needed some kind of treatment to eliminate or reduce the symptoms. The patient stated he's not great right now. The reporter informed that he missed when the vaccine came out when got sick and lost 55 pounds from the first round of covid. The initial event of being diagnosed with covid stated that was early on when the vaccines first came out and was somewhere around that era and it was prior to the vaccines he had at that time. The reporter informed that this current issue has not had an official diagnosis so far for covid or RSV and just has the symptoms. The reporter stated that the reported event was probably in the middle of that range and he would say medically significant but not to point where it required hospitalization or was life threatening. He just felt terrible. The reporter informed that no treatment was required for the reported events as of yet.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (respiratory syncytial virus infection) with the suspect product RSV VACCINE PROT.SUBUNIT PREF 2V cannot be fully excluded. Based on known disease pathophysiology, the event CoVID-19 is assessed as not related to the suspect drug, and more likely an intercurrent medical condition.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Drug ineffective, Rash erythematous
Clinical narrative: diagnosed with COVID; diagnosed with COVID; red dot rash on both my knees; some chest congestion; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 73-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "diagnosed with COVID"; RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "red dot rash on both my knees"; CHEST DISCOMFORT (non-serious), outcome "not recovered", described as "some chest congestion". Therapeutic measures were taken as a result of drug ineffective.  Clinical course: The patient reported that "I was diagnosed with COVID today and think I got covid from the doctor's office.  I had a red dot rash on both my knees and went to the doctor to check it out and think I got COVID during that visit (date of previous visit was not provided); I was prescribed some cream for it and a pill that I take every 12 hours. I started feeling bad starting on Tuesday night (09Jul2024); body feeling real run down, laying in bed and drinking lots of fluids.  I had a light fever and chills for one day and was sick for a few days total.  I am better now and felt normal after about 3 days but still had some chest congestion so went to the doctor today and they prescribed me Paxlovid saying I needed to take it."    Batch/lot number is not provided, and it cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; TE where product was administered to a patient; This spontaneous report was received from a medical assistant and refers to an 11-year-old female patient.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 27-JUN-2024, the patient was vaccinated by a health professional with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, involved lot # was 1965079, expiration date: 01-FEB-2026 (verified to be valid), administered as prophylaxis (strength, and route of administration were not provided). Temperature excursion was 47.6 degrees Fahrenheit (F) for 0 hours 54 minutes 0 seconds. There was no previous temperature excursion, neither a report of adverse event or product quality complaint involved.   This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2407USA001278: US-009507513-2407USA001395: US-009507513-2407USA001484: US-009507513-2407USA001660:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Pharmacy Tech called to report TE for VARIVAX that occurred on 06/12/24. HCP informed the VARIVAX was inadvertently administered to patient on 06/29/24 at 3:30pm, following the TE. No further details provided. Permission was given to contact HCP. See; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 12-JUN-2024, a dose of varicella virus vaccine live (oka/merck)(VARIVAX) had a temperature excursión as: 30°F with time frame: 1 Hour 45 Minutes 0 Seconds, however on 29-JUN-2024, at 03:30 pm the patient received the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X026326, expiration date: 07-NOV-2025 (strength, dose, dose number, route, and anatomical location were not provided) for prophylaxis. It was reported that there was no previous temperature excursión.  No adverse event reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: received all of my Covid vaccines by Pfizer and I did contract it a couple times later, my symptoms were way less severe each time; received all of my Covid vaccines by Pfizer and I did contract it a couple times later, my symptoms were way less severe each time; received all of my Covid vaccines by Pfizer and I did contract it a couple times later, my symptoms were way less severe each time; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "received all of my Covid vaccines by Pfizer and I did contract it a couple times later, my symptoms were way less severe each time".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Malaise, Nausea, Vomiting projectile
Clinical narrative: severe dizzines with projectile vomiting; general weakness; severe dizzines; nausea; Initial information received on 09-Jul-2024 with live follow up information received on same day and processed together regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves a 64 years old female patient  who experienced severe dizzines with projectile vomiting, general weakness, severe dizzines and nausea after receiving Rabies (HDC) Vaccine [Imovax Rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Jul-2024, the patient received dose 1 of suspect Rabies (HDC) Vaccine (Powder and solvent for suspension for injection) (lot number, expiry date and strength not reported) and on 05-Jul-2024 , dose 2 were administered via unknown route in unknown administration site for Immunisation. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  on unknown date In Jul-2024, the patient developed severe dizzines with projectile vomiting (vomiting projectile), general weakness (asthenia), dizzines (dizziness) and nausea (latency: unknown).  Reportedly, patient is supposed to get her third dose today, but she is really sick and patients who received this vaccine may experience pain, swelling or itching at the injection site, headache, nausea, abdominal pain, muscles aches, and dizziness.  Action taken: Not applicable.  It was not reported that the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.
Age: 11.0
Sex: U
Vaccine: MEN, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 11-year-old patient received an adolescent dose of menquadfi and supposed to receive the MenB vaccine but received menquadfi instead with no reported adverse event.; 11-year-old patient received an adolescent dose of menquadfi and supposed to receive the MenB vaccine but received menquadfi instead with no reported adverse event.; Initial information received on 11-Jul-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 11 years old unknown gender patient who received an adolescent dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] a year ago and supposed to receive the Meningococcal Vaccine B [MENB] vaccine but received menquadfi instead with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot number, expiry date and strength not reported) a year ago and supposed to receive the Meningococcal Vaccine B [MENB] vaccine but received menquadfi instead with no reported adverse event (product administered to patient of inappropriate age), (wrong product administered) (latency: same day) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  Reportedly, the pharmacist mentioned that the HCP was made aware of the event and they are monitoring the patient for potential side effects.  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.