chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; chills; fever; muscle aches; This is a spontaneous report from a contactable consumer. A 50-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318), via an unspecified route of administration at arm right on 04Feb2021 11:30 at age of 50-years-old at single dose for COVID-19 immunization. The patient medical history was not reported, no known allergies. The concomitant medications in two weeks included vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included 1st dose of BNT162B2 on 15Jan2021 at age of 50-years-old for COVID-19 immunization. The patient experienced headache, chills, fever, muscle aches started at 05Feb2021 20:00 and resolved within 24 hours. Reported now feeling fine on 06Feb2021, symptoms resolved. No treatment was received for the adverse events. The events outcome was recovered on 06Feb2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th January 2022) for prophylaxis.   On 11th January 2023, the patient received Havrix. On 11th January 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-Jan-2023  Reporter's Comments: The clinical coordinator reported that an expired dose of Havrix was inadvertently administered to a patient.  The reporter consented to follow up. The healthcare professional could not provide patient demographics. Additional supportive information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Pain in shot site, flu like symptoms for 3 days then very tired for the last week.
Patient reported feeling tingling sensation in mouth and mouth "feeling swollen". approx 228  No observed swelling or difficulty with breathing.  Also reported flushed feeling  BP 140/82.  Reported Had hx of allergic reaction to lisinipril in past 4 years ago and was hospitalized and was in ICU.  Afebrile. Also reported having an unpleasant bad taste in mouth.  Bendadryl 25mg po given 228 pm.  reported feeling a  little better within 15 minutes.  Water given.  Approx 3:00 pm reported having another episode of flushed feeling and just not feeling right.  Denied the need for epi-pen.  Reported normally takes 50mg of bendaryl.  Additional dose of bendadryl  25mg oral given 3:05.   Requested client to contact family member fort transportation. Spoke with Daughter.  Clients sister came to clinic that was held at college.  Client remained alert and oriented.  Contacted case's primary care provider's office, provider Doctor not available, but covering provider will return call to her. Reported she could not be seen in office today.  Requested refill for epipen to be provided to case by doctor.  Case denied the need for epipen at center and any further medical care or call to 9ll for emergency care.  Case was advised to be monitored throughout with another family member.  Lives alone, will be staying with daughter or sister. Verbalized to call 911 if any difficulty with breathing or worsening of symptoms.  Dr.'s office reported they would follow up with client today after patients are seen.
Pt. states after getting injection she became very tired, sore and sick to stomach. Next day she had rapid heart rate, migraine and vomiting. C/O aching all over and just not feeling right. Feels better at present.
Facial Numbness Sensation  started approximately 20 minutes after vaccination , improved with time and mostly resolved 2 weeks after injection.  injection site  tenderness, still continuing at 3 weeks out after vaccination.  Chills  started approximately 3 hours after vaccination and resolved  within 12 hours.  Minor headache/forehead tension/brain fog  started  a couple of hours after vaccination and  not fully resolved.
Initial case received from a healthcare professional on 26 July 2011. A 17-year-old female patient, with a history of asthma and ovarian cysts, received intramuscular right deltoid injections of MENACTRA (lot number U3844AA) and PNEUMOVAX (Merck, lot number 056AA) on 25 July 2011. The evening of vaccination, she complained of neck and shoulder pain on the right side. The pain was reported as constant, and was ongoing at the time of the report. The patient was seen by her physician due to the event. Concomitant vaccination included SINGULAIR, methotrexate, folic acid, "Apprgy" birth control, and ondansetron. The patient was not ill at the time of vaccination.
The patient has been c/o right arm pain since receiving the MenQuadfi vaccine on 05/26/23, x 5 days, noted pain in right arm the day after immunization, felt nausea/dizziness in the evening after immunization, used Motrin for arm pain for few days after inmmunizations, no redness noted at injection site, pain constant in right upper arm, pain scale 1-2/10, pain most noticeable when moves and used right arm, pain scale 4-6/10, no numbness or tingling of right arm, denies weakness, lifting back pack causes pain or getting dressed and undressed, painful if lies on right side for sleep, c/o sharp shooting pain down right arm this afternoon, resolved on its own and not precipitated by anything in particular. No rash noted, no itching
Narrative: PT ARRIVES TO ED W/REPORT OF SHINGLES RT MID BACK. PT STATES NOTICED IT 6/20 WITH PAIN 8/10. Treated with gabapentin and Valtrex.
AFTER RECEIVING VACCINATION PATIENT BECAME DIZZY AND EXPERIENCED AN EPISODE OF SYNCOPE. PATIENT APPEARED TO BE DIAPHORETIC, PALE AND COOL TO THE TOUCH. PATIENTS PUPILS WERE DILATED AND SLUGGISH UPON ASSESMENT. PATIENT RECOVERED UNDER SUPERVISION, PARAMEDICS WERE CALLED AS A PRECAUTION. PATIENT STATED THEY "FELT FINE" AND DID NOT NEED TO GO TO THE HOSPITAL, PATIENT WAS ASSESED BY EMS.
Extreme Migraine and Nausea for about a 24 hour time period.  Tylenol. Symptoms did not start for approx 12 hours from getting vaccine.  After 28 hours from getting vaccine, symptoms have become less extreme, but still feeling quite ill.
Initial unsolicited report received from a pharmacist on 12 Oct 2016. THIS CASE IS LINKED WITH 2016SA189772, 2016SA189781, 2016SA189791, 2016SA189792, 2016SA189793, 2016SA189794, 2016SA189795, 2016SA189796, 2016SA189797, 2016SA189798, 2016SA189799, 2016SA189800, 2016SA189801, 2016SA189802, 2016SA189803, 2016SA189804, 2016SA189805, 2016SA189806, 2016SA189807, 2016SA189808, 2016SA189809, 2016SA189810, 2016SA189811, 2016SA189812, 2016SA189813, 2016SA189814, 2016SA189815, 2016SA189816, 2016SA189817, 2016SA189818, 2016SA189819, 2016SA189820, 2016SA189821, 2016SA189822, 2016SA189823, 2016SA189824, 2016SA189825, 2016SA189826, 2016SA189827, 2016SA189828, 2016SA189829, 2016SA189830, 2016SA189831, 2016SA189832, 2016SA189833, 2016SA189834, 2016SA189835, 2016SA189836, 2016SA189837, 2016SA189838, 2016SA189839, 2016SA189840, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189846, 2016SA189847, 2016SA189848 (same lot number). This case involves a patient (gender and age not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (batch number: UI669AA, expiry date: 30 June 2017, dose, dose in series, route and site of administration were not reported) intramuscularly on 03 Oct 2016 (over the past month). Illness at the time of vaccination was reported as and pre-existing physician diagnosed allergies, birth defects, medical conditions was unknown. Concomitant medications were not reported. On an unknown date (over the past month), following the vaccination, the patient had developed headache, nausea, body weakness and fatigue (systemic reaction). The patient's laboratory data was not reported. The patient required ER visit. The patient did not take any treatment. The outcome of events was unknown. List of documents held by sender: none.
Tinnitus began 3 d day after receiving 1st dose of vaccine.  Continuing through today when I received 2d dose of vaccine, and continues.
pain in her arm where the vaccine was injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in her arm where the vaccine was injected) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in her arm where the vaccine was injected). At the time of the report, VACCINATION SITE PAIN (pain in her arm where the vaccine was injected) had resolved.            No concomitant medications were provided  No treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow-up received document Addition of second dose information added , outcome of event Vaccination site pain is changes from unknown to recovered, No further follow-up required.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 02-APR-2013 the patient was vaccinated with an expired dose of ROTATEQ (lot# 1346AA, expiration date 27-OCT-2012). It was not known which of the three doses in the ROTATEQ vaccination series this dose was. No adverse effect reported. No patient contact details available. Additional information has been requested.
Urticaria (hives) with itchiness over the whole body.  Went to urgent care and was prescribed prednisone  and cetirizine hydrochloride. Prednisone was taken for 2 weeks and cetirizine hydrochloride (10mg) has been taken daily for 9 + weeks.  Urticaria has persisted for 9+ weeks. The severity of symptoms have dimensioned somewhat since the onset but still persist.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 14-MAY-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance the intended purpose of the long-term prevention of shingles and zoster related injuries (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 06-MAR-2017, the patient was treated for herpes zoster or shingles. On or about 11-JUL-2012, the patient sought subsequent treatment for continuing pain and was diagnosed with postherpetic neuralgia. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Since I have dysautonomia there was a chance that I was going to have a flareup of my postural orthostatic tachycardia syndrome. However, I have lost out almost a week of work due to the effects of the vaccination triggering my postural orthostatic tachycardia syndrome along with my Ehlers-Danlos syndrome which is a connective tissue disorder. This does not mean that a person should not be vaccinated that has my conditions; but it does mean that there needs to be more research done on people like me and others so we can make an educated guess about what to do
Fever; Achy; Stomach hurts; Nauseous; Lymph nodes under the armpit where he got got the shot is swollen; This is a spontaneous report from a contactable consumer (patient mother). A 15-years-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiration date was not reported), via an unspecified route of administration on 09Jun2021, as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Patient previously received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as 1st dose, single dose for COVID-19 immunization. Reporter was calling about the covid shot. Her son (patient) got his second dose yesterday (09Jun2021) and he woke up this morning (on10Jun2021) with a fever, achy, his stomach hurts and he's nauseous. His lymph nodes under the arm-pit where he got got the shot was swollen and she (reporter) has been reading through the information and its common to have these side effects she just would like to confirm and he was 15. Asking if have any advise for the next little bit or does it last longer than 24 hours. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Patient presented to clinic relating that she has a known PEG allergy and received covid vaccine on Saturday 1/09/2021. Patient took one benadryl before covid vaccine and a few hours later. Did not disclose PEG allergy at time of vaccination. Patient stated that no immediate reaction post vaccine Saturday or Sunday, has a rash all over body today as well as joint pain.   Patient sent to Emergency Department for further evaluation and treatement.
Pt recvd 1 dose of Recombivax & 2 doses of Engerix-B & did not respond;
Patient came today 12/13/21 to let me know he received his first Shingrix shot on 10/10/21 and since then he still reports a sore area in the deltoid muscle where he received his Shingrix shot. He reminded me he also received other shots from a different provider, a week before receiving the Shingrix shot. (He said that the week before 10/10, he received a tetanus shot in the same (left) arm, in a slightly different area of the deltoid muscle). He said he has pain in the muscle when he moves his arm. He did not experience any redness, swelling or lump at any point after his Shingrix shot, or after his (previous) tetanus shot. The only reaction he had was the site pain, and it is persisting since 10/10/21. It is not severe, but he feels it when he is moving his arm. I advised him to consult his doctor for further investigation. He said he will see his PCP in a week. In the meantime, I advised him to take some Ibuprofen OTC as needed, after checking his medication history for any interactions. He said he will try ibuprofen and thanked me for the advice.
Redness around injection site about quarter size, came back 10/04 size had grown to 2x3 inches.
sustained a fall injury; Got a fever within 24 hours; Patient was diagnosed with strep pneumonia meningitis; Patient was diagnosed with strep pneumonia meningitis; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A 7-year-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient sustained a fall injury and got a fever within 24 hours. Patient was sent to the hospital. Once at the hospital, patient was diagnosed with strep pneumonia meningitis. Titers showed only significant antibodies were 6B and 18C. All other 21 strains tested, including 9 Prevnar 13 serotypes in the panel, were low or absent. Physician recommended booster of PCV13 and PPSV. Lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Fall represents an accidental injury unrelated to vaccine use.  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.
Tested positive for COVID-19; A spontaneous report was received from a consumer, concerning a patient of unspecified age, who received Moderna's COVID-19 vaccine and tested positive for COVID-19.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 23-DEC-2020, prior to the onset of event, the patient received dose of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 28-Dec-2020, after getting dose of mRNA-1273 vaccine, the patient was tested positive for COVID-19 . No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, COVID-19 was not reported.  Follow-up received on 16 Mar 2021 included no new information.; Reporter's Comments: Based on the mechanism of action of mRNA-1273, the event of COVID-19 is assessed as unlikely related to mRNA-1273. Very limited information regarding the symptoms has been provided at this time. Further information has been requested.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 65-year-old female patient of unspecified race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced redness at the injection site 6 months to a year before report with outcome of unknown.
administration of the Moderna COVID-19 vaccine past the published expiry; The vaccine was thawed before the administration throughout the end of March to the beginning of April. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of the Moderna COVID-19 vaccine past the published expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.) in a 37-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of the Moderna COVID-19 vaccine past the published expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of the Moderna COVID-19 vaccine past the published expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   HCP reported administration of the Moderna COVID-19 vaccine past the published expiry to 19 patients. The vaccine was thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April. The vial was initially stored in the refrigerator on 01Apr2022/thawed on the day of use. 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.
tingling; cold sensation in feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in feet) and PERIPHERAL COLDNESS (cold sensation in feet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in feet) and PERIPHERAL COLDNESS (cold sensation in feet). At the time of the report, PARAESTHESIA (tingling in feet) and PERIPHERAL COLDNESS (cold sensation in feet) had not resolved.            No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Missed my period for the first time in 5 years despite being on birth control and never missing it before.  I was not and am not pregnant.
Information has been received from a medical assistant concerning 2 patients who on unknown dates, were vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). It was reported that on unknown dates, 2 patients might have developed a rash but medical assistant could not be sure of this. Patients sought unspecified medical attention. Patients' outcomes were unknown at the time of report. This is one of two reports from the same source. Follow up information has been received from the physician refers to a 77 years old female patient with no known drug allergy, Gastrooesophageal reflux disease (GERD) and Hypertension (HTN). The patient was vaccinated with first dose PNEUMOVAX 23 (lot number 672781/1706AA; expire date 03-OCT-2012) intramuscularly at left deltoid at 10:01 am on 16-MAY-2012. No other co-suspects were reported. Concomitant medications included famotidine (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On 16-MAY-2012 at 3:00 pm the patient experienced site of injection felt itchy night of injection then swelled the next day in 17-MAY-2012 with mild pain and no fever. In May 2012, exam showed erythema surrounding injection site about 6cm diameters with mild waterish or swelling. The patient was treated with AVELOX. The outcome of the event had been resolved by 21-MAY-2012. This is one of two reports from the same source. Additional information is not expected.