chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergic reaction to the Prevnar vaccine a couple of years ago; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the experienced allergic reaction to the Prevnar vaccine a couple of years ago. The outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.
Within 10 hours of getting the Janssen covid vaccine, I had suddent and severe joint pain in multiple joints, severe body chills, fatigue. I was shivering and felt unable to get warm despite truck temperature at 90 degrees along with a blanket and seat warmers on. Took 1000mg of Tylenol and symptoms mostly resolved with some minor joint pain and fatigue but had to continue the tylenol every 8-10 hours for the next 2 days or the symptoms returned in the severe state. Site of injection has also been swore with touch still at day 9. No redness or swelling at injection site. Also had 2xepisodes of random severe fatigue which is not normal and it lasted about 1-2 hours.
Patient states that at 1130pm the night of 2/26/21 he had a "convulsion" that lasted 4-5 seconds.  He did not lose consciousness and does not know if it was a seizure.  Afterwards he felt like he had a fever, increased heart rate, and confusion.  Today, 2/27/21, he feels weak and slightly feverish.  I advised him to follow up with his primary care provider Monday, but to go to the emergency room if his symptoms became worse.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 20-JUN-2015, the patient was inadvertently vaccinated with a dose of ZOSTAVAX lot # K010630, expiration date reported as 30-OCT-2015 (dose, route and site of administration were not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected, because there was no consent to contact the pharmacist.
Information has been received from a pharmacist concerning a female patient who was vaccinated with two doses of rubella virus vaccine live (Wistar RA 27/3). A titer determination study was performed and the titer was negative. Unspecified medical attention was sought and it was reported by the pharmacist that the patient had not recovered. A product quality complaint was not involved. No further information is available.
acute wheezing 1/2 hrs p/vax; facial flushed hot, hrs p/vax;
Patient reported severe joint/muscle pain and headache that prevented her from sleeping or even being able to do normal daily activities. Patient is OTC pain medication to treat but its effectiveness has been limited.
Dizziness and slight queasiness late in day on day given.  Chills and sweats during that night. Did not sleep well.   Next morning, extreme pain in joints and muscles.  It was hard to walk and painful, with swelling in joints of knees, feet, lower back, fingers.  Slight dizziness continued with exhaustion.  Muscle and joint pain continued throughout day.   Midday developed upset stomach and loose stools.  By afternoon had a headache and ran a fever of  100.4 degrees.  Site of injection red, hard, hot, itchy, painful and swollen of about 3-4 inches diameter.  Overall, felt much better the following day.  Arm still itchy, swollen and painful 2 days later.   Upset stomach lingered, arthritis swelling lingered several days.   A week later feel back to normal except for joints still more sore than usual.
This spontaneous report was received from a licensed practical nurse and refers to an 11-year-old female patient. The patient's medical history included Kawasaki disease. The patient had an allergy to unspecified penicillin. On 31-JUL-2012, the patient was vaccinated with a first and only dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported). The vaccine was reconstituted with sterile diluent. On an unknown date (when the patient was 12 years old), the patient experienced vesicoureteric reflux. She was hospitalized and received a DEFLUX implant as a treatment. She had unspecified lab studies completed in hospital. The patient recovered from the event on an unknown date. At the time of reporting, she was doing fine. The relatedness between the event and VARIVAX and sterile diluent was not reported. On 12-DEC-2018, the patient was seen in the office for an additional dose of VARIVAX. Upon internal review, the event of vesicoureteric reflux was considered to be medically significant, as the patient underwent vesicoureteral reflux surgery.
Sometime after 8 am on 18Apr2021, more than 13 hrs after receiving the Pfizer vaccine, the patient fainted in her bathroom and hurt her forehead; hurt her forehead; This is a spontaneous report from a contactable consumer.  A 33-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: ER8731), via an unspecified route of administration, on 17Apr2021 at 16:15 (at the age of 33-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included contraception from an unknown date and unknown if ongoing. The patient has no known allergies.The patient was not pregnant at the time of vaccination. Prior to vaccination the patient had not been diagnosed with COVID-19. Concomitant medication included desogestrel, ethinylestradiol (RECLIPSEN) taken for contraception, start and stop date were not reported. On 18Apr2021 at 08:15,  more than 13 hours after receiving the Pfizer vaccine, the patient fainted in her bathroom and hurt her forehead. Treatment for the event fainted included wetting the patient's face as well as the application of a cold towel to the patient's forehead.  Since the vaccination the patient has not tested positive for COVID-19. The clinical outcome of syncope was reported as recovering. The clinical outcome of injury was not provided.
Patient received mRNA mixed vaccine series. Patient received first dose Moderna at outside facility and second dose as Pfizer. Manager notified of Pfizer vaccination. Patient information obtained, will f/up as needed. 30 minute obs completed. No reaction documented at this time.
The next day she felt fevered and was having difficulty breathing.  She was hospitalized for 3 days.
Patient called pharmacy on 5/6/16 at 11:00 AM reported rash developed on 5/5/16 at injection site and got worse with arm swelling and fever of 101.1 on 5/6/16.
Anterior right thigh with induration diffusely surrounding DTap, IPV, (Quadracel) vaccine injection site 12 cm x 12 cm erythema on 8/22/2019 swelling and erythema started late 8/20/19 per father the patient was seen at hospital 8/21/2019.
Sustained hyperglycemia outside of my usual excursions for 48-60 hours, onset about 32 hours after the vaccination. Range 180-300. No ketones noted. Treated with oral hydration, every 1-4 hour blood glucose checks, additional insulin boluses. No change in baseline insulin pump settings was made. Return to baseline blood glucose by 76 hours after vaccination.  Only  soreness in right arm , mild fatigue on day 2 noted, without fever, redness or swelling
pt recv vax 7FEB97 & presented 12MAY99 w/severe case of varicella;
Bell's Palsy, left side of face, gradual onset starting afternoon May 16. Visited Hospital emergency room on May 16 late night. Recurrent dry/burning eyes sensation (both eyes). Lime disease test was negative. Emergency room doctor prescribed  (I'm still taking) Valacyclovir HCL 1 gram tablet  (3 times a day) and Prednisone 20mg tablet (once a day). Symptoms seem to be getting slightly better. Waiting for an appointment with a general practitioner now.  (Note: I have no evidence that my health issue is a vaccine side effect, but I was advised to report - I value your work).
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 85-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included unspecified Flu vaccine. On 28th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 2nd October 2018, 4 days after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 84 or 85 years old. The patient received the dose of the SHINGRIX in the left deltoid at 3 pm. The patient reported that the injected arm was sore when he raised his arm. This symptom did not start until, the date of reporting. The patient was aware that this was a possible side effect but stated that he was surprised that it was starting 4 days after he received the SHINGRIX. The patient was referred to his healthcare professional. The patient had denied permission to contact their physician. This case was linked with US2018179229, reported by the same reporter.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2015, the patient was vaccinated with the involved in the temperature excursion dose of VAQTA (lot # K012457, expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 08-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # J000443 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Swelling; Itching; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: el9264) dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 08:45(age at vaccination:40 Years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, Patient had received other medications Nifedipine, Xolair, Symbicort, Flonase, Vitamin D within 2weeks of vaccination. Medical history included asthma from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, food allergy (sea food) from an unknown date and unknown if ongoing, food allergy (shellfish) from an unknown date and unknown if ongoing, food allergy (peanuts, tree nuts) from an unknown date and unknown if ongoing, anaphylactic shock from an unknown date and unknown if ongoing. Concomitant medications included nifedipine (NIFEDIPINE) taken for an unspecified indication, start and stop date were not reported; omalizumab (XOLAIR) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; cholecalciferol (VITAMINE D) taken for an unspecified indication, start and stop date were not reported. Patient didn't had covid prior to vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: el3248) via unspecified route of administration in Arm right on 28Jan2021 14:30(age at vaccination:40 years) as DOSE 1, SINGLE for covid-19 immunisation. No Therapeutic measures were taken for the events. Patient was not tested for covid to post vaccination. On 19Feb2021 the patient experienced swelling, itching. The outcome of the events swelling pruritus was recovering.  Follow-up attempts completed. No further information expected.
Sick; Cough; Runny nose; Classic cold; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 39 year-old male patient received bnt162b2 (BNT162B2), administration date 30Nov2021 (Lot number: FF2589) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 24Feb2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 03Feb2021, when the patient was 37 years old, for COVID-19 Immunization.  The following information was reported: ILLNESS (non-serious) with onset 28Mar2022, outcome "unknown", described as "Sick"; COUGH (non-serious) with onset 28Mar2022, outcome "unknown", described as "Cough"; RHINORRHOEA (non-serious) with onset 28Mar2022, outcome "unknown", described as "Runny nose"; NASOPHARYNGITIS (non-serious) with onset 28Mar2022, outcome "unknown", described as "Classic cold"; PYREXIA (non-serious) with onset 28Mar2022, outcome "unknown", described as "Fever". The events "sick", "cough", "runny nose", "classic cold" and "fever" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
At 12:30am on 11/10/2021, I woke up and tried to get out of bed. However, as soon as I moved my muscles started contracting and spasming uncontrollably. My full body.  I wasn?t able to sit up myself and they we constant for about 72 hours straight. If I managed to lay for an extended period of time (1 hour) they would subside as long as I didn?t move at all. If I moved even a finger, they would start up again. They subsided around 72 hours after onset. For 2.5 months following, I had a slight tremor in my left arm if I wasn?t moving and occasional full body spasms if I stood up too quickly that subsided after about 20-30 seconds. On 1/30/2022, I had and orgasm and  immediately following it, and for a week after, I had the full body muscle spasms/tremors. They were better if I moved about or engaged my muscles, but at rest were very present. I saw my PCP and that started lab work and she ordered a Brain MRI and I was referred to a Neurologist who I am working with. However, overall the spasms/tremors only happen occasionally now. Mainly, if I move quickly and then stop, but still tremors in my left arm when just sitting.
Sore raised red area at injection site. Site is hot, with 2 inch circumference of raised redness. Low grade fever, 100.0 F
Injection site painful, swollen, itching, red, burning, hard, spreading to underarm, continuing through 09/07/2015, the date of report.
This case was reported by a pharmacist via a sales representative and described the occurrence of discomfort at time of injection in an unspecified number of subjects of unspecified age and gender who was vaccinated with ENGERIX B. On an unspecified date the subject received unspecified dose of ENGERIX B (20 mcg, unknown) and experienced discomfort at the time of injection. At the time of reporting the outcome of the event was unspecified. It was also reported that the site had observed increased reports of discomfort with injection of ENGERIX B since they had switched from the competitor product.
Felt sick; have cold and he think it is a severe cold; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (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: MALAISE (non-serious), outcome "unknown", described as "Felt sick"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "have cold and he think it is a severe cold". Additional information: Patient was trying to get his second dose and was asking if he can get his second dose from his local pharmacy. He got his first dose on 24Mar2021, and was scheduled for his second dose last 21Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Felt drained; Low grade fever; Extreme headache; Body aches; Felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Felt drained), PYREXIA (Low grade fever), HEADACHE (Extreme headache), MYALGIA (Body aches) and FATIGUE (Felt fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 -101.9 (High) 99.9 -101.9 F.         No relevant concomitant medications were reported.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A12A) for COVID-19 vaccination.     No medical history was provided.     On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Fever; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included paracetamol (TYNELOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever on an unspecified date with outcome of recovering. Reporter seriousness for Fever was unspecified. The reporter stated, "I am calling someone else (consumer). They have a fever after taking this shot, the Covid shot first one, yesterday and they have a fever but I put a cold "wet" (not clarified) on and the fever went down a little bit. Can they take a Tylenol or they cannot take one." In response, reporter stated, "Do we need to go to the Hospital or talk to them first?"   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PAIN; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included upadacitinib for moderate to severe rheumatoid arthritis. On an unspecified date, the patient experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain. This report was non-serious.
I received my vaccine, I was monitored for 15 min with no effects.  I walked outside to my truck when I got in I could  not breathe, I was gasping for air. I am on 02 for my Copd and had to turn it up and sit for 30 minutes until I could drive because I could not catch my breathe.  I lost my voice it is raspy and have had a COPD exacerbation  since my vaccination. I have been hospitalized  twice since receiving the vaccine, and still have no voice. No treatments are working.
Low grade fever presented about two hours after vaccination (99.7- 100.3) Fever went away by next morning, but by noon (15 hours after vaccine) pain in the low back started. No fever but intense pain in back. We believe the vaccine may have triggered a sickle cell crisis.
Narrative:  55 YO F with PMH of chronic pain (including right shoulder joint,  neck, limb, back) reported pain at injection site and swelling in axillary following Dose #1 on 2/15/21. Dose #2 administered on 3/8/21, patient endorsed pain under  her right arm on 3/30/21.