chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a patient's husband referring to his 62 year old wife without drug reactions/allergies. On 23-JAN-2015 the patient was seen at her physician's office, because of pain and a rash on her back. During that visit the patient was diagnosed with hives and was given ZOSTAVAX (lot#, expiration date and dose unspecified, route was reported as "injection") and an unspecified corticosteroid. On 26-JAN-2015, the patient's pain had worsened and the patient was seen at an urgent care center where she was diagnosed with shingles. The reporter stated that the patient was prescribed morphine, lidocaine an unspecified topical formula, oxycodone, and an unspecified antiviral medicine. The reporter also stated that the patient had other unspecified pertinent medical issues. No lab diagnostics studies performed. The event outcome was not resolved. Additional information has been requested.
No menstrual period since initial vaccine. It?s now been 5 months & I am NOT pregnant. Cycles were monthly & normal the months prior to vaccine.
This is an instance of breakthrough disease after which death occurred.   The individual was vaccinated with the Pfizer COVID-19 vaccine on 03/30/2021 and 04/21/2021.   The individual became symptomatic for COVID-19 disease on 05/01/2021 and tested positive via PCR on 05/04/2021. The individual was admitted to the hospital on 05/04/2021, stabalized, and discharged 05/08/2021.  The individual was then re-admitted on  05/12/2021. An additional PCR test was positive on 05/16/2021. The individual remained hospitalized until their death on 06/02/2021. Death Certificate details are as follows: Part I: Cause of Death: A. Acute Hypoxic Respiratory Failure B. Septic Shock C. Cardiogenic Shock D. COVID-10 Part II: Other Significant Conditions: None Listed
I felt very lethargic the day after the 2nd vaccine. Now on the 2nd day after my 2nd dose, my skin is itchy (mostly on my neck, back, and chest).
I had the Shingles Shot the Second Dose made me so sick; I thought I was dying; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (experienced by both patient's father and mother).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and impending doom. On an unknown date, the outcome of the sickness and impending doom were unknown.   It was unknown if the reporter considered the sickness and impending doom to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had Shingles shot which made him/her so sick that he/she thought he/she was dying. The follow-up would not possible, as no contact details were provided. This case had been linked with US2021AMR068319 and US2021AMR068320, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR068319:same reporter (mother´s case) US-GLAXOSMITHKLINE-US2021AMR068320:same reporter (father´s case)
A little bit of trouble breathing; not breathing as I was/some problems with breathing/I need to deep breathe; Heaviness in my chest/tightness of the chest; This is a spontaneous report from a contactable consumer (Patient). A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175 and Expiry date was not reported), via an unspecified route of administration on 06Aug2021 (at the age of 60-years-old), in Arm left as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient did not receive any prior vaccination within 4 weeks. Patient received first dose of Pfizer Covid Vaccine on 06Aug2021 and since then she have heaviness in her chest and a little bit of trouble breathing. She was not breathing as well as she was just wondering if that was something that will go away within a few days or should she be concerned that this was going to be continuous. Patients weight was around 140 pounds. (Further not clarified. Hence, not captured in the tab). She had been having some problems with breathing and tightness of the chest. Patient was calling because she have been having short heaviness in her chest. She have been having some difficulties. Ever so often she need to deep breathe and have been yawning a lot. She was asking if this was normal, will it continue and how long will it last. States it started right after the shot. The patient was not received the treatment for the adverse events. The outcome for the events was not recovered.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age. It was reported doses of VARIVAX (Merck) (lot# unspecified) that were exposed to supported temperature excursions from "September 2014" and had been administered to unspecified patients on unspecified dates in 2014 since the excursion on an unspecified date in "September 2014." No adverse experience had been observed or reported. No PQC(product quality issue) involved. Action taken and outcome were not provided. Additional information has been requested.
Patient presented to office 11.27.2019; rash started 11.26.2019 at 4:00pm. Started on abdomen, arms then legs. Today (11.27.19) rash spreading to back. Red Pin point rash that is blanchable. Patient advised to watch for trouble breathing and/or swelling of lips or tongue. Rash does not seem dangerous.
got the first dose; tested positive with Covid; got the first dose; tested positive with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group for a Pfizer sponsored program. The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Lot number: FK5618) at the age of 10 years as dose 1 (tris), single 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), SARS-COV-2 TEST POSITIVE (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "got the first dose; tested positive with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, sars-cov-2 test positive. It was reported that, reporter have her kids here got the first dose on 02Dec2021 and then 2 weeks ago they are tested positive with Covid. So she was wondering if is it okay to take the second dose. Reporter stated, it was for her kids. They are all between the age of 5 and 11 all four of them. They got their COVID shot on 02Dec201 and then they were due for their second dose but then they got Covid, tested positive for Covid on 03Jan2022 (Further clarification unknown). Reporter stated patient have not got the second test for it but they were positive on the 3rd. Reporter When probed if all the four patient received any Prior vaccination (4 weeks prior), Reporter stated as No. Other Patient suffering from any other medical conditions, Reporter stated, as No and stated they are pretty healthy. Reporter stated, They did take Tylenol medication when they had Covid all of them (Further clarification unknown), There is no other specific treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200111074 same product and event, different patients
VACCINES EXPOSED TO TEMP OUT OF STORAGE RANGE.  UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.
at 8:20 pt reported swelling and tightness of face, redness to the chest and upper neck, dizzy and headache. pt denied SOB, difficulty breathing, itching of the mouth or throat. pt breathing easily and unlabored. pt skin was normal and pink warm and dry. pt refused EMT. Benadryl 25mg was given/temp 97.3, o2 99% HR 87. pt was feeling better but wanted pt be checked out by her PCP so we walked her to an exam room and had her evaluated by a provider.
Patient states she had the following: arthritis feeling, fever, felt dizzy, nauseated. Patient was not given any meds at the ER, was instructed to rest for couple days.
No additional AE; Nurse reported PROQUAD was administered after TE; see TE case 02487539. See full details below. No additional AE/no PQCs.    ?    Names of vaccines involved PROQUAD X013909 11/10/2024        ?    Temperature 8.1°F        ?    Time frame 3 hour; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 29-SEP-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X013909, expiration date: 10-NOV-2024) (strength, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 8.1 Fahrenheit (F) during 3 hours. No additional adverse event was reported.
Child developed hives within 12 hours after receiving Hib & Varivax vaccines. No respiratory distress. Hives and itching noted on tadays exam, on there face and groin, & legs. Treated with atarax PRN for itching. Continue close monitoring.
Pt recvd 2 doses of Engerix-B & devel rash & itching 48 hrs p/the 1st dose; resolved;
Dizziness; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness and pain in arm. On an unknown date, the outcome of the dizziness and pain in arm were unknown.   It was unknown if the reporter considered the dizziness and pain in arm to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's brother. The age at vaccination was not reported. The patient experienced dizziness and arm pain. The reporter declined to give further information and demographic information for the patient. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021216665:same reporter
Diarrhea; Coughing; Loss of appetite; Loss of taste and smell; Loss of taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), COUGH (Coughing), DECREASED APPETITE (Loss of appetite), AGEUSIA (Loss of taste and smell) and ANOSMIA (Loss of taste and smell) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported by reporter.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), COUGH (Coughing), DECREASED APPETITE (Loss of appetite), AGEUSIA (Loss of taste and smell) and ANOSMIA (Loss of taste and smell). At the time of the report, DIARRHOEA (Diarrhea), COUGH (Coughing), DECREASED APPETITE (Loss of appetite), AGEUSIA (Loss of taste and smell) and ANOSMIA (Loss of taste and smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: NNI follow up- called to obtain email but consumer hung up
51 years old female called to report an adverse reaction after receiving her first P-fizer vaccine on 04/15/2021 @1500. patient reported on 04/16/2021 @0800 she developed pain in bones, feet, hands, and arms, patient also reported headach, chills, fever, patient reported sulfa allergies, patient reported that she takes levothyroxine for low thyroid level and amlodipine for high blood pressure. patient was instructed to take tylenol and benadryl to help with the symptoms. patient was instructed to seek medical attention if the symptoms got worse.
approx 1 hr p/vax pt began screaming & this cont until 10PM that evening; pt held by parent & did nap for about 15 mins 2 times; no reddness or fever; given APAP;
Flare up of asthma not any worse that it usually is; Case reference number US-BN-2023-000327 is a spontaneous case report initially received from a consumer (reference number: USBAV23-0234) on 09-Feb-2023 and concerns a female patient of unknown age.  The patient's relevant medical history and concomitant medication details were not provided.  On 07-Feb-2023, the patient was vaccinated with the first dose of RabAvert (batch number not provided) at an unknown dose, site or route of administration for post exposure to rabies.   On an unspecified date, reported as two days after RabAvert dose, the patient experienced a flare up of asthma. As reported, it was not any worse than it usually was and the patient has not used any steroid at that point and could hold on for two weeks or so.  At the time of the initial report, the outcome of the event 'flare up of asthma not any worse that it usually was' was unknown.  The reporter assessed the event 'flare up of asthma not any worse that it usually was' as non-serious and as not related to RabAvert vaccine.   Additional information received from Bavarian Nordic on 10-Feb-2023 included local case ID.; Reporter's Comments: A female patient of unknown age experienced flare up of asthma, two days after she was vaccinated with the first dose of RabAvert, at an unknown dose, site or route of administration for post exposure to rabies. Reportedly, it was not any worse than it usually was and the patient has not used any steroid at that point. Asthma is unlisted according to insert for Rabipur. The outcome was unknown. Causal relationship is conservatively assessed as related to suspect product due to plausible temporal relationship however the underlying condition is strongly confounding causality assessment. The case is non-serious.; Sender's Comments: A female patient of unknown age experienced flare up of asthma, two days after she was vaccinated with the first dose of RabAvert, at an unknown dose, site or route of administration for post exposure to rabies. Reportedly, it was not any worse than it usually was and the patient has not used any steroid at that point. Asthma is unlisted according to insert for Rabipur. The outcome was unknown. Causal relationship is conservatively assessed as related to suspect product due to plausible temporal relationship however the underlying condition is strongly confounding causality assessment. The case is non-serious.
Around 5:30PM, patient had chills, fever of 100F with headache and neck pain starting around 7PM. Per patient at 12:30 that night, temp was 101.4F and went to ED. Rash noted on lateral right ankle in ED.
20 minutes after recieving covid injection Pt reported "bumps on her neck" and approx. 3hrs hives over body as of 4/26. Still has hives on Bilateral legs.
No additional AEs; Site Leader calling to report administration of expired MMR II vaccine.; This spontaneous report was received from an office manager and refers to a 49-year-old male. The patient's concurrent conditions, medical history and concomitant therapies were not provided. There was no information regarding the patient's allergies or drug reactions.  On 25-JUL-2022, the patient was vaccinated  with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (M-M-R II) injection, 0.5 milliliter, once,  lot #T016198, expiration date: 11-MAY-2022,  (strength, dose number, route and site of administration were not provided) for prophylaxis (expired product administered). No additional adverse events was reported (no adverse event).
Child was in office on February 12th for his four month well visit where he received four vaccines, PEDIARIX, PREVNAR, Hib and Rotavirus. While in office he was alert and happy, smiling, and active. Per mother he was also alert and happy at home until he was put down for tummy time by the father around 5pm. Previously child was fed by dad and layed down on his stomach on the parent's bed for tummy time, per dad. Father stepped out of the room to the living room and fell asleep. Next time child was checked on was once mom got home from work at 10:30pm and mom noticed he was blue but still breathing. Mother called 911 and once paramedics arrived he seemed to be having a seizure and was given medication. Child was rushed to hospital where he was put in NICU, and doctors stated there was nothing else that could be done. Child was disconnected the morning of Feb. 13th, 2019.
This spontaneous report as received from a pharmacist and refers to a 66 year old female patient. In 2015 the patient was vaccinated with PNEUMOVAX 23. On 06-OCT-2016 the patient was again vaccinated with PNEUMOVAX 23 lot # L026033 exp 27-MAR-2017 instead of receiving PREVNAR. No adverse event was reported. The outcome of wrong drug administered and no adverse event is unknown. Additional information has been requested.
Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code from INFLUENZA VACCINE to INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Initial unsolicited report received from a pharmacist on 17-Nov-2015. This case involves a 75-year-old female patient, who was vaccinated with first dose of 0.5 ml PREVNAR (manufacturer: Wyeth, Batch number: M06899 expiry date: Mar-2017) and first dose of Flu shot (manufacturer: Unknown, Batch number: UI491AA) both via intramuscular route in left arm on 11-Nov-2015 at 14:30. Patient had no illness at the time of vaccination. Patient denied other medications and other medical conditions. Concomitant medication was not reported. It was reported that patient had no adverse event following prior vaccination. On 11-Nov-2015, same day within five minutes after vaccination, patient developed a bump at the PREVNAR injection site which was about the size of a quarter in diameter, rose up to about 1/2 in height and stopped. Patient had also received flu shot an inch away from the PREVNAR injection site and the patient had no reaction to the flu shot injection. Laboratory investigation and corrective treatment was not reported. At the time of this report patient was recovering from the event. Documents held by sender: none. Addendum on 5-Feb-2016: Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code from 'INFLUENZA VACCINE' to 'INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE'.
Initial report was received 04 January 2012 from a health care professional. A 15-year-old male patient (age reported as 15 years of age; however, calculates to 14 years of age) had received a first dose intramuscular injection of FLUZONE (site not reported) on 31 December 2011 at 5:30 PM and within minutes of vaccination, the patient passed out after "feeling sweaty" and "staring up". The father of the patient told the reporter that the patient did not eat for 24 hours. The patient had no concurrent illness at the time of vaccination and he had not been taking any concomitant medications. The event did not require a doctor's visit. Outcome was recovered. Documents held by sender: None.
pt devel weakness of extremities p/about 2 1/2-3wk;pt started w/bell's palsy & progressed to apresis of extremities;pt got plasmapharesis @ hlth center;
Developed a bruise (after 1st shot); This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Developed a bruise (after 1st shot)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for COPD.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced CONTUSION (Developed a bruise (after 1st shot)). On 08-Apr-2021, CONTUSION (Developed a bruise (after 1st shot)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-320769, MOD-2021-320770 (Patient Link).
Left upper leg numbness and tingling and sensation of twitching intermittently since about 18 hours after the injection. Continues to be ongoing four days since the booster dose.
Under recommended age for J&J vaccine.  has been requested to enter all COVID vaccines. The teams responsible for screening and administering vaccines to the refugees.  Is assisting with entering information IN VAERS.
cough, brown sputum, positive covid test on 7/16/21; 1 yr post kidney transplant
Patient is 17 years old and received a Moderna vaccine which is only authorized for ages 18 and up.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (issues of high blood pressure, since last night his pressure has gone up, 16 for the highest and 10 for lowest.), PYREXIA (Woke up with a bit of fever) and HEADACHE (Woke up with a headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Seasonal allergy (seasonal allergies to pollen in spring). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy, LOSARTAN for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced HYPERTENSION (issues of high blood pressure, since last night his pressure has gone up, 16 for the highest and 10 for lowest.). On 20-May-2021, the patient experienced PYREXIA (Woke up with a bit of fever) and HEADACHE (Woke up with a headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Headache, at a dose of 1 dosage form. At the time of the report, HYPERTENSION (issues of high blood pressure, since last night his pressure has gone up, 16 for the highest and 10 for lowest.), PYREXIA (Woke up with a bit of fever) and HEADACHE (Woke up with a headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood pressure measurement: high (High) Blood pressure has gone up, 16 for the highest and 10 for lowest. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.