chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: the patient had experienced any adverse issues or side effects from the administrations; a patient (15-month-old boy) who is otherwise healthy was inadvertently administered a dose of PROQUAD and VARIVAX by his medical assistant (MA) instead of a dose of MMR II and VARIVAX that was ordered and prescribed by the HCP on 01/15/2025.; a patient (15-month-old boy) who is otherwise healthy was inadvertently administered a dose of PROQUAD and VARIVAX by his medical assistant (MA) instead of a dose of MMR II and VARIVAX that was ordered and prescribed by the HCP on 01/15/2025.; This spontaneous report was received from a nurse practitioner referring to a 15-month-old male patient. The patient's medical history and concurrent conditions were not reported.  On 15-JAN-2025, the patient who was otherwise healthy was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml / once, lot #Y012594, expiration date: 14-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5ml / once, lot #Y011017, expiration date: 18-JUN-2026, administered for prophylaxis (strength, and route of administration were not provided); along with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion, lot #1973283, expiration date: 08-OCT-2026 (strength, dose, route of administration, and indication were not provided) by his medical assistant (MA) (operator of device: health professional) instead of a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (administered for prophylaxis, dose, strength, lot #, expiry date, and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) that was ordered and prescribed by the health care professional (HCP) (Wrong product administered and Accidental overdose). The HCP stated he called to check on the patient on the evening on that day after the administration who was "doing well" and the parents did not report the patient had experienced any adverse issues or side effects from the administrations (No adverse event). No other information provided during the call.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Additional AE; a patient received their initial dose of ROTATEQ at 5 months old.; This spontaneous report was received from an Other Health Professional and refers to a 5-month-old male patient. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On an unknown date in 2024, at the age of 5 months old, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (2 ml, lot #y003754 has been verified to be a valid lot number, expiration date not reported but upon internal validation established as 25-OCT-2025) orally for prophylaxis (strength was not provided) (inappropriate schedule of product administration). No additional doses have been given at this time. No additional adverse event (no adverse event) was reported.
Sex: M
Vaccine: SMALLMNK
Symptoms: Autoimmune disorder
Clinical narrative: Autoimmune disorder; Case reference number US-BN-2025-000136 is a spontaneous case initially received from consumer via Communication (reference number: USBAV25-0136) on 17-Jan-2025 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date in Sep-2022, the patient received the first dose of Jynneos vaccine (batch number: unknown), at unknown dose, route or site of administration for unknown indication.  On an unspecified date in Oct-2022, for unknown of time from the first dose, the patient received the second dose of Jynneos vaccine (batch number: unknown), at unknown dose, route or site of administration.  On an unspecified date, unknown of time after vaccination with Jynneos, reported as in the last 24 hours, the patient got diagnosed with autoimmune disorder.   At the time of initial report, it was unknown if the patient recovered from the event of autoimmune disorder.  The reporter assessed the event of autoimmune disorder as serious due to criteria of disability and medical significance and possible related to Jynneos.  No further information was provided.; Reporter's Comments: A male patient received two doses of the Jynneos vaccine in Sep and Oct 2022. Recently, he was diagnosed with an autoimmune disorder. Recovery status is unknown. The patient's medical history and concomitant medication details were not provided. The reported event autoimmune disorder is considered unlisted as per RA v7.0 and RA. The causality is assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product cannot be excluded. The case is serious due to disability and medical significance.; Sender's Comments: A male patient received two doses of the Jynneos vaccine in Sep and Oct 2022. Recently, he was diagnosed with an autoimmune disorder. Recovery status is unknown. The patient's medical history and concomitant medication details were not provided. The reported event autoimmune disorder is considered unlisted as per RA v7.0 and RA. The causality was assessed as related due to lack of alternative explanation at this point, and since contributory role of suspect product and a plausible mechanism of action cannot be excluded. The case is serious due to disability and medical significance.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Swelling
Clinical narrative: induration erythema; swelling; warmth; This serious case was reported by a other health professional via sales rep and described the occurrence of induration erythema in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 07-JAN-2025, an unknown time after receiving Shingrix, the patient experienced induration erythema (Verbatim: induration erythema) (serious criteria GSK medically significant), swelling (Verbatim: swelling) and feeling of warmth (Verbatim: warmth). The outcome of the induration erythema, swelling and feeling of warmth were resolved.   The reporter considered the induration erythema, swelling and feeling of warmth to be related to Shingrix.     The company considered the induration erythema to be unrelated to Shingrix. The company considered the swelling and feeling of warmth to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JAN-2025 The reporter reported that the patient received a first dose of Shingrix and had induration erythema, swelling, and warmth.; Sender's Comments: Erythema induratum is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: They hurt like hell.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 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 shingles (Verbatim: They hurt like hell.). The patient was treated with diethylamine salicylate, methyl nicotinate (Aspercreme). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient had 1st dose was going to get the 2nd and it hit god people get the vaccine, it hurt like hell. Patient have it right at time of reporting. Almost finish, patient physician recommended asper cream  5 percent, it numbs the pain for a while.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the Shingrix vaccine back on 10th March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-DEC-2024 Pharmacy Manager reported that the patient never got the second dose of it. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination..
Sex: F
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: she accidently removed flip cap from shingrix antigen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in drug usage process in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong technique in drug usage process (Verbatim: she accidently removed flip cap from shingrix antigen). The outcome of the wrong technique in drug usage process was unknown.   Additional Information: GSK Receipt Date: 27-DEC-2024 The healthcare professional was the reporter. The reporter stated that she accidently removed flip cap from Shingrix antigen and was unsure when the antigen vial will be used. No further information was known. The adverse event filed after call disconnected. Minimal information obtained to file adverse event.
Age: 24.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Expired Dose Administered/6 days over the exp date; Extra dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA993A, expiry date 31-DEC-2024) for prophylaxis.   Previously administered products included Menveo (received first dose of Menveo on an unknown date).   On 06-JAN-2025, the patient received the 2nd dose of Menveo. On 06-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered/6 days over the exp date) and extra dose administered (Verbatim: Extra dose administered). The outcome of the expired vaccine used and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 06-JAN-2025  The other health professional reported that an expired dose of Menveo was administered to a patient on the morning of the reporting day.  The lyophilized component was 6 days over the expiration date which led to expired vaccine used, the liquid conjugate was still within the expiration date.  The other health professional stated there were no adverse reactions after the administration.  The patient received 2nd dose of Menveo which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Upset stomach; Nauseousness; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (The most recent was 4 months ago, and still has a little bit of pain from the Shingles.).   In JAN-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced upset stomach (Verbatim: Upset stomach) and nausea (Verbatim: Nauseousness). The outcome of the upset stomach and nausea were not resolved.   It was unknown if the reporter considered the upset stomach and nausea to be related to Shingrix.     It was unknown if the company considered the upset stomach and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JAN-2025 The reporter was the patient. About 3 days ago, the patient received the first dose of Shingrix. Ever since, the patient had been experiencing nauseousness and an upset stomach. The patient had developed Shingles 3 times in the past. The most recent was 4 months ago, and still had a little bit of pain from the Shingles
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Syncope
Clinical narrative: fainted; feeling dizzy; Shortness of breath; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in OCT-2024).   On 03-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid). On 05-JAN-2025, 2 days after receiving Shingrix, the patient experienced fainting (Verbatim: fainted) (serious criteria GSK medically significant and other: serious as per reporter), dizziness (Verbatim: feeling dizzy) (serious criteria other: serious as per reporter) and shortness of breath (Verbatim: Shortness of breath) (serious criteria other: serious as per reporter). On 07-JAN-2025, the outcome of the fainting and dizziness were resolved (duration 2 days). The outcome of the shortness of breath was not resolved.   It was unknown if the reporter considered the fainting, dizziness and shortness of breath to be related to Shingrix.     The company considered the fainting, dizziness and shortness of breath to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JAN-2025 The patient spouse reported that a patient receiving his 2nd Shingrix vaccine, had no symptoms after the 1st vaccine, however, he did have symptoms after the 2nd vaccine. 48 hours receiving the 2nd vaccine the patient started feeling dizzy, short of breath and fainted.  The ambulance was called, and the patient stayed for 12 hours at the hospital, then he was discharged home.  The patient continues to have some shortness of breath, but the dizziness and the fainting has subsided. ER (emergency room) visit required.; Sender's Comments: Syncope, Dizziness and Dyspnoea are unlisted events which, due to the following criteria (strong temporal association) are considered related to GSK vaccine Shingrix.
Age: 45.0
Sex: M
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: administration of Infanrix instead of Boostrix to an adult patient; the administration of Infanrix instead of Boostrix to an adult patient; the administration of Infanrix instead of Boostrix to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 45-year-old male patient who received DTPa (Infanrix) (batch number Y7JC3, expiry date 07-SEP-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 13-JAN-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 13-JAN-2025, immediately after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: administration of Infanrix instead of Boostrix to an adult patient), adult use of a child product (Verbatim: the administration of Infanrix instead of Boostrix to an adult patient) and underdose (Verbatim: the administration of Infanrix instead of Boostrix to an adult patient). The outcome of the wrong vaccine administered, adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JAN-2025 The medical assistance reported that the administration of Infanrix instead of Boostrix to an adult patient which led to wrong vaccine administered, adult use of a child product and underdose.
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early dose/received it twice, 26 days apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 16-year-old patient who received Men B NVS (Bexsero) (batch number 4L274, expiry date 30-SEP-2024) for prophylaxis.   Concomitant products included Meningococcal vaccine B rfHbp/NadA/NHBA OMV (Bexsero).   On 08-FEB-2024, the patient received the 2nd dose of Bexsero. On 08-FEB-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Early dose/received it twice, 26 days apart). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JAN-2025 The other health professional had a question about somebody who received the Bexsero vaccine.  The other health professional reported that it was a meningitis b Bexsero vaccine, and then there was a question about, he/she know that it was recently updated, the guidance was recently updated for the first and second dose being 6 months but last in January and February of 2024 a patient received it twice, 26 days apart. The other health professional just wanted to know does the patient need to be revaccinated or what was recommended. The patient received second dose of Bexsero shorter than the recommended interval which led to shortening of vaccination schedule.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis; This is a spontaneous report received from a Nurse.  A 45-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: comirnaty (Dose 1; lot: EL9262), administration date: 21Jan2021, when the patient was 45-year-old, for COVID-19 immunization; comirnaty (Dose 2; lot: EM9809), administration date: 11Feb2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: PSORIASIS (non-serious) with onset Aug2021, outcome "unknown".  Additional information: The patient called because she developed psoriasis after she took Pfizer COVID-19 Vaccine. Patient confirmed that she does not have psoriasis before she took it and then after she took the Pfizer Covid vaccine, she developed it.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Feeling abnormal
Clinical narrative: Patient ran a temperature; exhausted; felt really bad; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 07Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Patient ran a temperature"; FATIGUE (non-serious), outcome "unknown", described as "exhausted"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt really bad".  Additional information: Caller calling in regards to the covid vaccine this year. The caller mentions that the callers daughter gotten sick with the vaccine and stated both of them, yes referring to the patients vaccines. Daughter had the vaccine at the same time as granddaughter and no reactions it just made her sick. Patient ran a temperature and felt really bad and had to stay in bed. Was exhausted and felt bad. This is the fist time had a reaction. Never had a reaction except this year. Stated we have never had a reaction to it except this year, Caller mentioned that everyone she talked thats received the Pfizer vaccine this year has gotten ill. Caller has no details to provide, No lot numbers to provide for any other patient.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had 4 Pfizer covid vaccinations I had Covid 4 times.; I had 4 Pfizer covid vaccinations I had Covid 4 times.; This is a spontaneous report received from an Other HCP.  A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had 4 Pfizer covid vaccinations I had Covid 4 times.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Only treated with Paxlovid this last diagnosis-first time very sick with no Paxlovid Rx.  The information on the batch/lot number for BNT162b2 omicron (kp.2) has been requested and will be 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 lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded.
Sex: M
Vaccine: COVID19
Symptoms: Infertility male
Clinical narrative: he is trying to be a father again, after the vaccines it was not successful; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1, lot number unknown), for COVID-19 immunisation; Pfizer covid vaccine (Dose 2, lot number unknown), for COVID-19 immunisation. The following information was reported: INFERTILITY MALE (non-serious), outcome "not recovered", described as "he is trying to be a father again, after the vaccines it was not successful".  Additional information: Patient used Pfizer Covid vaccine. After they give him 3 applications, he is trying to be a father again, after the vaccines it was not successful. He is very worried about it and he need to know if he can count on Pfizer's help to solve this problem that is serious. The patient is the father of 3 beautiful children and he has never had this problem, after the vaccine, there was no result until currently.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Cardiac failure congestive, Pain
Clinical narrative: an auto immune disease; pain is unreal some days; congestive heart failure; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 45-year-old female patient received BNT162b2 (BNT162B2), in 2020 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: CARDIAC FAILURE CONGESTIVE (medically significant) with onset 2024, outcome "unknown", described as "congestive heart failure"; AUTOIMMUNE DISORDER (medically significant), 6 months after the suspect product(s) administration, outcome "unknown", described as "an auto immune disease"; PAIN (non-serious), outcome "unknown", described as "pain is unreal some days". The event "an auto immune disease" required physician office visit. Clinical details: Fast forward to 10 months ago the patient was diagnosed with congestive heart failure. Not 1 case of any kind of heart disease anywhere in either side of her family. The patient is a married woman, with 4 kids, and just had her 1st grandbaby. Before she had the shot in 2020, she was healthy, played softball as adult, very on the go with kids and work, never slowed down. 6 months after Pfizer's covid vaccine, she is finding that she has an auto immune disease that most likely would have laid dormant rest of her life if she wouldn't have had. 7 different dermatology confirmed. Pain is unreal some days. Her girls have to brush her hair after.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: data logger usually logs the temperature twice a day but for some reason, on 23dec2024, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes with no reported ae; Initial information received on 14-Jan-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 due to data logger usually logs the temperature twice a day but for some reason, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes 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; Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap) for Immunisation; Influenza vaccine (Influenza) for Immunisation; and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 09-Jan-2025, the patient received 0.5 ml of dose 2 of IPV (VERO) Suspension for injection (strength- standard, expiry date- 31-Oct-2026 and lot X1C891M) once via intramuscular route in the right deltoid as Immunization which was exposed to temperature excursion due to data logger usually logs the temperature twice a day but for some reason, it did not pick up on the temperature excursion at 46.5 degrees f for 15 minutes with no reported adverse event (Poor quality product administered) (latency- same day).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient got a dose of RSV vaccine in 2023. Patient got 2nd dose on 01-21-25 when not indicated. No adverse event reported from the patient at this time.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Hypersomnia, Limb mass
Clinical narrative: Vaccinated Friday 1/10/25, starting Saturday morning 1/11/25 headache, temperature 103.0, pain in all joints, exhaustion (slept 16 hrs). L arm sore starting then with a lump but not red or hot.  Continued headache, joint pain, fatigue but not fever thru 1/13/25, felt better 1/14/15, return of symptoms 1/15/25 which is when pt reported it.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Vaccinated Friday 1/10/25, starting Saturday morning 1/11/25 headache, temperature 103.0, pain in all joints, exhaustion (slept 16 hrs). L arm sore starting then with a lump but not red or hot.  Continued headache, joint pain, fatigue but not fever thru 1/13/25, felt better 1/14/15, return of symptoms 1/15/25 which is when pt reported it.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain in extremity
Clinical narrative: Pt reported bruise below the deltoid and a sore arm. Pt did not seek treatment. Time of course not specified.
Age: 84.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events were reported from patient. The pharmacy was alerted by our clinicial team via email that this patient recieved a 2nd dose of RSV. (1st dose was 1/11/2024 and 2nd dose was 1/21/2025) Patient did not need a 2nd dose of RSV Arexvy vaccine.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Caesarean section, Cholestasis, Exposure during pregnancy, Infertility female, Labour induction
Clinical narrative: Due date was November 9th, ended up with Preeclampsia, cholestasis, and needing induction/c section. Now struggle with PCOS, menstruation changes, and conceiving. Child has stomach issues, behavioral concerns, and eye issues that do not run in family
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Polycystic ovarian syndrome, Pre-eclampsia
Clinical narrative: Due date was November 9th, ended up with Preeclampsia, cholestasis, and needing induction/c section. Now struggle with PCOS, menstruation changes, and conceiving. Child has stomach issues, behavioral concerns, and eye issues that do not run in family
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already received a dose of Arexvy on 10/11/23 and was unaware that he didn't need another dose. Patient is not claiming any injury.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Pt had already received doses of Shingrix from MD office 2018 - reported at wellness exam on 1/21/25 that she had her 2nd dose of Shingrix (2nd series) and had headache, chills and fatigue following dose on 1/17/25. MD reports at wellness visit on 1/21/25 no fever and no other issues.
Age: 3.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given by mistake the HPV vaccine on 01/16/2025. When we realized the error on 01/17/2025 the provider called the parents to check in on the patient and reassured there would not be adverse reaction to vaccine. All questions were answered by provider and parent had no further questions.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Chills, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Response lasted 9 days this time - severe headache beginning within 15 mins of vaccine , lasted 4 days then followed with a medium headache lasting an additioal 5 days- Fevers plus fevers w/ chills by that evening and lasting 4 days - joint inflamation beging at same time as fever and lasting 4 days - muscle stiffness started same time as fevers and lasted  9 days -swelling in nose and sinuses that was felt around day 3 and lasted  for 5 days - had to mouth breathe for 2-3 days injection site swelled and redness to about the size of my fist. Arm was sore for almost 2 weeks After very first dose my response same as above except facial swelling lasted 3-4 days,  With each continuing year my reaction lasted longer and longer. With the addition of facial swelling that interferred with my breathing I will  no longer get vaccinated and take my chances with the perscribed medication . I am someone who seldom is sickened by viruses or colds. This latest response is not acceptable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth breathing, Musculoskeletal stiffness, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: Response lasted 9 days this time - severe headache beginning within 15 mins of vaccine , lasted 4 days then followed with a medium headache lasting an additioal 5 days- Fevers plus fevers w/ chills by that evening and lasting 4 days - joint inflamation beging at same time as fever and lasting 4 days - muscle stiffness started same time as fevers and lasted  9 days -swelling in nose and sinuses that was felt around day 3 and lasted  for 5 days - had to mouth breathe for 2-3 days injection site swelled and redness to about the size of my fist. Arm was sore for almost 2 weeks After very first dose my response same as above except facial swelling lasted 3-4 days,  With each continuing year my reaction lasted longer and longer. With the addition of facial swelling that interferred with my breathing I will  no longer get vaccinated and take my chances with the perscribed medication . I am someone who seldom is sickened by viruses or colds. This latest response is not acceptable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: Response lasted 9 days this time - severe headache beginning within 15 mins of vaccine , lasted 4 days then followed with a medium headache lasting an additioal 5 days- Fevers plus fevers w/ chills by that evening and lasting 4 days - joint inflamation beging at same time as fever and lasting 4 days - muscle stiffness started same time as fevers and lasted  9 days -swelling in nose and sinuses that was felt around day 3 and lasted  for 5 days - had to mouth breathe for 2-3 days injection site swelled and redness to about the size of my fist. Arm was sore for almost 2 weeks After very first dose my response same as above except facial swelling lasted 3-4 days,  With each continuing year my reaction lasted longer and longer. With the addition of facial swelling that interferred with my breathing I will  no longer get vaccinated and take my chances with the perscribed medication . I am someone who seldom is sickened by viruses or colds. This latest response is not acceptable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Night sweats, Pain in extremity, Pyrexia
Clinical narrative: (Please note that I also received a flu vaccine in the left arm on the same day at the same pharmacy.) I developed first chills (8pm to midnight), then a low fever (1.5 degrees F), and spent a pretty miserable night waking up sweating and miserable. I got up at 9 the next morning and took 400 mg ibuprofen. Within a couple of hours my fever was gone. My left arm was sore but nothing out of the norm for having received a vaccine. I gradually started feeling better over the next two days (Jan. 19 and 20). However: I also developed an intermittent hand tremor that lasted for the same two days. It was almost gone on Jan. 21 and is now gone completely. I just thought it was worth reporting. I had Covid in September of 2024 and at that time developed a sensation of internal tremors. Which was very weird. It lasted about 1 week after I stopped testing positive and has not returned.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tremor
Clinical narrative: (Please note that I also received a flu vaccine in the left arm on the same day at the same pharmacy.) I developed first chills (8pm to midnight), then a low fever (1.5 degrees F), and spent a pretty miserable night waking up sweating and miserable. I got up at 9 the next morning and took 400 mg ibuprofen. Within a couple of hours my fever was gone. My left arm was sore but nothing out of the norm for having received a vaccine. I gradually started feeling better over the next two days (Jan. 19 and 20). However: I also developed an intermittent hand tremor that lasted for the same two days. It was almost gone on Jan. 21 and is now gone completely. I just thought it was worth reporting. I had Covid in September of 2024 and at that time developed a sensation of internal tremors. Which was very weird. It lasted about 1 week after I stopped testing positive and has not returned.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Hypersensitivity, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, swelling, warm to the touch, tender to the touch, itchy around the injection site, streaky erythema.  Antibiotics given told it was cellulitis and an allergic reaction.  Could not tolerate antibiotics given 4 shots of clindamycin over a few days period.  Then given an antibiotic ointment. Redness has lasted for 15 days. 1/07/2025-1/22/2025
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm to the touch, tender to the touch, itchy around the injection site, streaky erythema.  Antibiotics given told it was cellulitis and an allergic reaction.  Could not tolerate antibiotics given 4 shots of clindamycin over a few days period.  Then given an antibiotic ointment. Redness has lasted for 15 days. 1/07/2025-1/22/2025
Age: 76.0
Sex: F
Vaccine: PNC21
Symptoms: Back pain
Clinical narrative: Patient started to have strong lower back pain 4 hours after receiving the vaccine and it stays. She has gone to a chiropractor and got treatment for 5 times.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt reported red patch and pain, hot to touch, at injection area
Age: 25.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Immunoglobulin therapy, Increased tendency to bruise, Petechiae, Platelet count decreased
Clinical narrative: Patient is a 25-year-old G4P2103 with EDD 2/17/25, who was admitted to the hospital on 1/20/25 at 36w0d due to 1-week of petechiae and easy bleeding/bruising. She was found to have new profound thrombocytopenia on admission, with platelet count of 5k. The presumed diagnosis is ITP, either as a primary autoimmune condition or as a vaccine adverse event. She remains admitted today (1/22/25) and work-up for alternative causes of thrombocytopenia, but no other cause has been identified thus far. She is receiving steroids and IVIg with the goal to improve her platelet count prior to delivery.
Age: 25.0
Sex: F
Vaccine: RSV
Symptoms: Thrombocytopenia
Clinical narrative: Patient is a 25-year-old G4P2103 with EDD 2/17/25, who was admitted to the hospital on 1/20/25 at 36w0d due to 1-week of petechiae and easy bleeding/bruising. She was found to have new profound thrombocytopenia on admission, with platelet count of 5k. The presumed diagnosis is ITP, either as a primary autoimmune condition or as a vaccine adverse event. She remains admitted today (1/22/25) and work-up for alternative causes of thrombocytopenia, but no other cause has been identified thus far. She is receiving steroids and IVIg with the goal to improve her platelet count prior to delivery.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: 7 days after the injection husband noticed a red patch on pts arm.  The next day seen at the clinic with a rash below the injection site, red, warm, indurated, 6 x 4 cm,  and tender to touch.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: 7 days after the injection husband noticed a red patch on pts arm.  The next day seen at the clinic with a rash below the injection site, red, warm, indurated, 6 x 4 cm,  and tender to touch.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Cellulitis, Peripheral swelling, Pruritus, Skin irritation
Clinical narrative: I was told he would have no reaction as this is his 3rd time getting the vaccine have waited two years to get this vaccine since the last one he had he got a staff infection as well. His shot was January 17th he had itched at it for 3 days the night on January 20th it started to appear extremely swollen and by the morning of January 21st his arm was 5x the size I called office to be seen the refused to see him so that?s when I rushed to the emergency room where they gave him his first round a Benadryl and perscribed him cephalexin he has currently had 3 doses of if and the swelling and irritation has not reduced at all
Age: 32.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Epistaxis, Exposure during pregnancy, Haematuria, Platelet count decreased, Thrombosis with thrombocytopenia syndrome
Clinical narrative: Severe thrombocytopenia approximately one week after receiving vaccine / Platelet level was 0; This is a spontaneous report received from a Physician.  A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Jan2025 as dose number unknown, single (Lot number: LN5464) at the age of 32 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Pregnancy was previously uncomplicated" (unspecified if ongoing), notes: Prior pregnancy was uncomplicated. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Mar2025. The patient's concomitant medications were not reported. The following information was reported: THROMBOCYTOPENIA (hospitalization, life threatening) with onset 18Jan2025, outcome "not recovered", described as "Severe thrombocytopenia approximately one week after receiving vaccine / Platelet level was 0". The patient underwent the following laboratory tests and procedures: Platelet count: 0. Therapeutic measures were taken as a result of thrombocytopenia. The patient developed severe thrombocytopenia approximately one week after receiving vaccine. Platelet level was 0 and not responsive to IVIG. Pregnancy was previously uncomplicated and prior pregnancy was uncomplicated.; Sender's Comments: Severe thrombocytopenia approximately one week after receiving ABRYSVO.  A possibly contributory role of the vaccine in triggering the event onset might not be fully ruled out, considering the temporal relationship.  However, more workups would be needed to explore all possible etiologies. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Age: 32.0
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Immunoglobulin therapy, Platelet count decreased, Thrombocytopenia
Clinical narrative: Severe thrombocytopenia approximately one week after receiving vaccine / Platelet level was 0; This is a spontaneous report received from a Physician.  A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 09Jan2025 as dose number unknown, single (Lot number: LN5464) at the age of 32 years intramuscular, in left deltoid for immunisation. The patient's relevant medical history included: "Pregnancy was previously uncomplicated" (unspecified if ongoing), notes: Prior pregnancy was uncomplicated. The patient was 33 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 05Mar2025. The patient's concomitant medications were not reported. The following information was reported: THROMBOCYTOPENIA (hospitalization, life threatening) with onset 18Jan2025, outcome "not recovered", described as "Severe thrombocytopenia approximately one week after receiving vaccine / Platelet level was 0". The patient underwent the following laboratory tests and procedures: Platelet count: 0. Therapeutic measures were taken as a result of thrombocytopenia. The patient developed severe thrombocytopenia approximately one week after receiving vaccine. Platelet level was 0 and not responsive to IVIG. Pregnancy was previously uncomplicated and prior pregnancy was uncomplicated.; Sender's Comments: Severe thrombocytopenia approximately one week after receiving ABRYSVO.  A possibly contributory role of the vaccine in triggering the event onset might not be fully ruled out, considering the temporal relationship.  However, more workups would be needed to explore all possible etiologies. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, SARS-CoV-2 test, Vaccination failure
Clinical narrative: patient had pneumonia, then a couple days later tested positive for Covid-19; patient had pneumonia, then a couple days later tested positive for Covid-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 74-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Oct2024 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 (primary immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "not recovered" and all described as "patient had pneumonia, then a couple days later tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (08Jan2025) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 pneumonia.  Clinical course: Patient had booster shot 25Oct2024, plus all of past Covid shots. Patient asked why he/she now have Covid-19 at 74 years of age. The patient had pneumonia, then a couple days later tested positive for Covid-19. Patient have been in the hospital several times and given IV antibiotics and now he/she is on bed rest at home hoping he/she can beat this. Patient was tested 08Jan2025 and still positive today. Just wanted to share his/her fears.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.