chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough infection - tested positive via Rapid on Monday, started quarantine.  PCR test done Monday, results Tuesday - Positive.; Breakthrough infection - tested positive via Rapid on Monday, started quarantine.  PCR test done Monday, results Tuesday - Positive.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from product quality group.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection), intramuscular, administered in arm left, administration date 05Nov2021 13:00 (Lot number: 301358A) at the age of 40 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 24Feb2021 04:15 (Lot number: EN5318) as dose 2, single and intramuscular, administered in arm left, administration date 02Feb2021 04:45 (Lot number: EN5318) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: XELJANZ; LEVOXYL. The following information was reported: VACCINATION FAILURE (medically significant) with onset 06Dec2021, outcome unknown, COVID-19 (medically significant) with onset 06Dec2021, outcome recovering, and all described as Breakthrough infection - tested positive via Rapid on Monday, started quarantine. PCR test done Monday, results Tuesday  Positive; IMMUNISATION (medically significant) with onset 05Nov2021 13:00, outcome unknown, described as booster. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (06Dec2021) positive, notes: Nasal Swab; sars-cov-2 test: (07Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with Covid-19 Prior to vaccination. The patient has the patient been tested for COVID-19, since the vaccination. Patient did not have any known allergies.  No follow-up attempts are possible. No further information is expected.
PASSED OUT DURING NITE WHEN UP TO GO TO BATHROOM--WAS ON FLOOR TILL 10:00AM NEXT AM..WAS NOT ALERT-TALKING SENSE-WAS ABULANCED TO HOSPITAL AND THERE 5 DAYS--TESTED FOR EVERY THING AND FOUND ADRENAL GLANDS NOT PUMPING REGULARLY--NOTHING ELSE FOUND.
Patient received Shingrix on 6/13/19 she stated that 8 days later a rash appeared  now is beginning to self resolve.
A non-serious spontaneous report of 56-year-old received FLUMIST was received from a health professional concerning a 56-year-old male. Neither relevant medical history nor concomitant medications were reported. On 08-Sep-2011, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
expired vaccine administered to 5 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 5 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 5 patients). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received, includes no new information. On 01-Oct-2021: Follow-up received, includes no new information.
Fever,to 102,body aches, severe chills, extreme fatigue,sweats pain in hands and feet
This case was reported by a other health professional via call center representative and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 6 hrs after receiving SHINGRIX, the patient experienced fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired. On an unknown date, the outcome of the fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the fever, nausea, gastrointestinal upset, injection site pain, myalgia and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that starting 6 to 8 hours after receiving the 1st dose of SHINGRIX, the patient reported fairly serious adverse events including a fever of 101 degrees F, myalgia, Gastrointestinal upset, and nausea as well as pain at the injection site. These events resulted in 1 missed day of work, which was the day after vaccination.  On day 2 after vaccination, the patient felt ok, but not great and by day 3 after vaccination felt back to normal.
Immediate burning sensation, within 2 hours severe pain with decrease range of motion.  Lodine 400mg BID since 10/6/2021 Medrol, Flexeril, Lidocaine patches 10/2021 Physical therapy 11/2021 to 1/2022 with improvement but not resolved Physical therapy with dry needling started 3/30/22 Neurology referral pending 4/2022 continue to shoulder/arm pain, decreased range of motion
fever; soreness in her arm; diarrhea; she vomits when she does eat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in her arm"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "recovered", described as "she vomits when she does eat".  Additional Information: Reporter was calling about the BioNTech Covid 19 Vaccine. Reporter said that her daughter just had appointment with her doctor on 19Jan2022 and at the end of her appointment she got her 1st dose of the Covid 19 vaccine. Ever since then she hasn't been eating, she vomits when she does eat, has diarrhea, and a fever. She doesn't know what she should she do about it. States that she has the paper with the list of common side effects and some of these are listed on the paper, but some of them are not, so she just wants to make sure that these are all side effects from the vaccine. States that she spoke to her daughter this morning and she is not doing any more vomiting, but she still has diarrhea, and now she has a headache, and her fever keeps going up. Her daughter is 14. While reporting on her daughter, Reporter states that her mother in law had the Pfizer shot and she had the same symptoms, a fever, soreness in her arm and diarrhea. Then she had the 2nd shot and she was fine. Her mother in law said that the 2nd dose made her like speedy; clarified that made her really energetic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
eye was "really swollen on the bottom" and it "looked like a sty"; eye was "really swollen on the bottom" and it "looked like a sty"; "hurt to blink", and the inner corner of eye start to hurt; "hurt to blink", and the inner corner of eye start to hurt; felt pressure and headache at the left upper side of the face or head area; felt pressure and headache at the left upper side of the face or head area; This is a spontaneous report received from a contactable consumer (reporting on herself). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration on 14Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Apr2021, patient received the first dose of the BNT162B2. By the evening, patient reported to have felt pressure and headache at the left upper side of the face or head area. When patient woke up on 15Apr2021, her eye was really swollen on the bottom and it looks like a sty. Eventually, patient mentioned that it hurts to blink, and the inner corner of eye start to hurts. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt has inflammation and erythema 2 inches in diameter. + tenderness and pruritus.
No other AE's.; Medical assistant calling to report that a patient received an expired dose of MMRII.; This spontaneous report was received from a medical assistant and referred to a patient of unknown age or gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 17-NOV-2022, the patient received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T031436, expiration date: 15-SEP-2022 for prophylaxis (strength, dose, frequency, route of administration were not provided) (expired product administered). No other adverse event. No other issues or concerns noted. No temperature excursion.
Erythema Multiforme 8 days after receiving Fluvax and Hep A brother also ill at the time with presumed 5th disease.
postherpetic neuralgia; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events multiple outbreaks of herpes zoster and postherpetic neuralgia was considered to be not recovered and causal relationship was assessed as related.     The lawyer considered the events multiple outbreaks of herpes zoster and postherpetic neuralgia to be disability.
On Day 5 I started having localized pain in my right calf, similar to a knot in my muscle. On Day 6 the pain had moved to a new location in my right calf. Again on Day 8 and 9, the pain moved. Day 10 was a similar location to Day 8. On Day 11 my calf was so sore (felt bruised) that I couldn't rest my leg on the recliner. Day 12 started the cycle all over again, so I went to the doctor.
Had pain on the Left arm Sunday morning and wake up Monday with pain on my chest and sharp pain on my back.
Client received YF, IPV and oral Ty vax on 5/3/06. Had a dizzy disoriented episode 3 days later that lasted 12 hrs. Went to hospital and had neg head CT scan. Symptoms resolved after 12 hrs. 7/3/06 Received medical records from hospital which reveal patient admitted 5/6/06 w/diagnosis of disorientation, dysarthria & slurred speech.  Admitted to having 3 glasses of wine night before, attended conference following day w/o symptoms until after lunch.  Had hallucinations while in ER & became somnolent.  Had been seen in ER 1 week prior for similar s/s.
Case number PHEH2013US017159 is an initial spontaneous report from pharmacist on 09 Aug 2013. This report refers to 43 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: X11041) intramuscular on 02 Aug 2013. On 08 Aug 2013, the patient noticed a red, itchy rash in the area where the vaccine was administered. Outcome of the events was ongoing. Seriousness an causality assessment was not reported.
does not feel a bit good; actually feels dizzy; sick at stomach; had a big case of diarrhea; sick and is you know hurting a little bit in chest; sick and is you know hurting a little bit in chest; has got an extreme headache; no energy, no energy; Arm every you know every couple of days or few days or something like that gets a real soreness in that arm and can feel it; Arm every you know every couple of days or few days or something like that gets a real soreness in that arm and can feel it; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: not provided) (age at the time of vaccination was 66 years) via unspecified route of administration on 06Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: not provided) via unspecified route of administration on 16Mar2021 as DOSE 1, SINGLE for COVID-19 immunisation. It was reported that on an unknown date the patient does not feel a bit good, actually feels dizzy, sick at stomach, had a big case of diarrhea, sick and is you know hurting a little bit in chest, has got an extreme headache, no energy, no energy. Does not feel a bit good: began right after took that shot, within a week of the second shot. she explains she was worsened. Arm every you know every couple of days or few days or something like that gets a real soreness in that arm and can feel it: What caller was going to tell agent was that the arm caller took vaccine in, caller was told by person's up there at Rite Aid, where the vaccine was administered what they think it is.  Caller's arm every you know every couple of days or few days or something like that gets a real soreness in that arm and can feel it. Actually, feels dizzy: Caller states this began the first week after receiving the second dose Pfizer Covid Vaccine. Caller was still dizzy. Caller just walked in a room to get vaccination card and is now laying down.  Caller is laying down now and does not feel like agent knows. Caller states it was the same as it has been the last two or three days.  Caller was still dizzy and still does not not have energy and caller begins to mention something about her stomach but stops and says it has been probably been 45 minutes to an hour and caller does not feel like too much more talking. The outcome of the events does not feel a bit good and actually feels dizzy was not recovered and unknown for other events.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
High fever to 102.4 rectally on 1-31-07 (one week after immunization).  Also irritability and fatigue
Body aches, headache, nausea, vomiting, chills, fatigue, arm tenderness
Information has been received from a physician concerning a 26 year old female who on 18-MAY-2007 was vaccinated with the first dose of Gardasil (lot # 657736/0389U) at 11:25 and experienced numbness in her arm for the rest of that day.  The patient did not seek medical attention.  There was no illness reported at the time of vaccination.  The physician did not learn of this until the patient came in for the second dose of Gardasil which was administered.  On 19-MAY-2007, the patient recovered from numbness in her arm.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/27/2007. Initial and follow-up information has been received from a physician concerning a 26 year old female with an occupation in data entry, who on 18-MAY-2007 was vaccinated intramuscularly in left deltoid with the second (previously reported as the first) dose of GARDASIL (lot # lot # 657736/0389U) at 11:25. Concomitant therapy included medroxyprogesterone acetate. Subsequently, the patient experienced numbness in her arm for the rest of that day. Also on 14-AUG-2007 the patient experienced numbness in her arm for the rest of that day. Also on 14-AUG-2007 the patient experienced left arm numbness throughout the day. The patient did not seek medical attention. There was no illness reported at the time of vaccination. The physician did not learn of this until the patient came in for the second dose of GARDASIL which was administered. On 19-MAY-2007 and 15-AUG-2007m the patient recovered from numbness in her arm. Additional information is not expected.
menstrual cycle started 12 days early after the first vaccine and is heavier and longer than usual
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored VAQTA (lot # R013858, expiration date: 12-JUN-2019, strength, dose, frequency and route were unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. The case was one of the cases received from the same reporter. Sender's Comments: US-009507513-1901USA004786.
Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 18 years old female patient who received partial 0.5 ml dose as the syringe malfunctioned during injection, and some went in and some squirted out, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Nov-2018, the patient received a partial 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA, expiry date - 30-Jun-2019 via intramuscular route in the left arm. It was also a case of actual medication error due to vaccine underdose. It was also a case of syringe issue. The patient outcome is reported as Not Applicable for received partial 0.5 ml dose and as Not Applicable for the syringe malfunctioned during injection, and some went in and some squirted out. 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 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.
The infant received Pediarix, ActHIB, PCV13 and Rotarix on 5/4/2015 at 3:35pm. No immediate issues post-vaccination in the clinic. The infant was found deceased the next morning, 5/5/2015. The coroner reported onset of rigor mortis upon arrival to pick infant up and approximate time of death 4-6 hours previously. The infant was sent to the Medical Examiner for autotopsy. The parents reported the infant had mild irritability/fussiness about 72 hours prior to death but no fever, diarrhea, oral intolerance, flaccidity or seizures. No history of seizures. The autopsy was essentially normal with no findings that would explain an acute death. The Medical Examiner did report that the child was co-sleeping between the two parents with heavy adult sized bedding.
Pharmacist has no further information on AE; HCP called to reports that a patient received the first dose of GARDASIL 9 on 3/30/2023, the second dose on 5/30/2023 according to the prescribing information. However, the third dose was given today 8/4/2023. Only 9 weeks and 3 days after the 2nd do; This spontaneous report was received from a pharmacist and refers to a 25-year-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.   On 30-MAR-2023 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 30-MAY-2023 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 30-MAR-2023 the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided).  On 04-AUG-2023 the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis, lot number W030851 and expiration date 08-JAN-2025, 0.5 milliliters (route and site of administration were not provided) (inappropriate schedule of product administration and no adverse event).
No additional adverse effects reported; a patient was administered improperly stored PEDVAXHIB and ROTATEQ; Information has been received from a licensed practical nurse referring to a 4 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 13-FEB-2020, the patient was administered improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were unknown; lot # R027329 and expiration date 12-JUL-2021) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were unknown; oral, lot # R033251 and expiration date 29-JUN-2020) for prophylaxis. The vaccines were exposed to temperature excursion below 2 degrees Celsius (0.3 degrees Celsius) multiple for 45 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No adverse effects were reported.