chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in for Janssen COVID vaccine that was scheduled electronically online.  All appropriate prescreening was done and patient had no previous allergies or issues.  Patient was instructed to sit in one of the chairs designated for post vaccine observation for 15 minutes after her vaccine.  Within a minute or so  patient felt light headed and like she might pass out. She notified the technician who was right there and he notified me.  I assisted her to a sitting position on the floor from her chair and I was able to ease her back to a lying down position from there with her head on the floor and feet elevated above heart on a chair.  Patient was able to talk the whole time.  She told us at that point when she was younger she was scared of shots and had fainted when having them, but thought she was past that and did not mention it during screening. She said she was surprised to feel this way because she was so excited about getting her COVID vaccine.  She had not eaten much today (a small snack) and had rushed here for her appointment without getting food. I checked her blood pressure while she was lying down and it was 94/63 and pulse of 75.  She said she normally had lower end of normal blood pressure.   She was pale when I started checking her, but her color began to return to normal within minutes. After 5 minutes she felt well enough to sit up and we got her a granola bar and water.  She remained this way for 5 minutes and felt good, so we moved her to sitting in a chair and got her a pepperoni and cheese snack tray from the cafe.  She ate this and waited for 10minutes and felt good. We walked her to her car and she felt fine.  I called to verify she got home fine and she did.
Angular blepharitis; Itching; Fatigue intermittent; Light headedness and dizziness; Sleepiness; Swelling at the injection site; He got the shot on Tuesday (Dec 29) and it is still sore today; Headache; A spontaneous report was received from consumer concerning a 52 years old male patient, who received Moderna's COVID-19 vaccine and experienced lightheadedness, dizziness, sleepiness, headache, sore injection site area, swelling at injection site, Angular blepharitis, Itching and Fatigue intermittent.  The patient's medical history, as provided by the reporter, included temporomandibular joint (TMJ) and allergies. No relevant concomitant medications were reported.  On 29 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient experienced headache, swelling and soreness in the site of vaccination, fatigue intermittent. He also experienced lightheadedness, dizziness and sleepiness the same day as vaccination. The patient developed itching from 1 Jan 2021. The patient experienced Angular blepharitis since 04 Jan 2021.  The patient is unsure if his headache is due to the vaccine or his TMJ.  Treatment information included Claiiten once a day and Pepcid both since 13 Jan 2021 till 15 Jan 2021 for an unknown indication. Lab details were not reported.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, swelling, lightheadedness, dizziness, sleepiness, sore injection site area and swelling at injection site, angular blepharitis, itching and fatigue intermittent were considered as unknown. The outcome of the event headache was resolved on 15 Jan 2021.  The reporter's assessment of causality for the events was not provided.  Follow up: Follow-up received on 15 Jan 2021 included Batch number of the vaccine, treatment details and event headache details including start date and stop date. Other events were also reported included, angular blepharitis, itching and fatigue intermittent.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The patient's medical history of allergies and TMJ syndrome is a risk factor for headache and pruritus.
In ED on 3/11 0246 with the following Chief complaint - I got the johnson and johnson covid vaccine 3/10 at 4pm and now I can't stop throwing up"  c/o emesis, fever, body aches.  HR 140s. pt is A/O x3. + nasuea, chills fever 101.2. denies throat swelling or SOB. pt presents with swelling at vaccine site and rash to both shoulder blades She does feel lightheaded and dizzy.  Denies any recent illnesses.  Denies any prior intolerance to vaccines. Fever 101.7F Patient has low-grade fever but nontoxic-appearing.   Blood work shows mild leukocytosis with left shift likely reactive otherwise within normal limits.   After 3 L of IV fluids she remains persistently tachycardic in the high 130s to 140s. Additional information for Item 18:  She states she was feeling fine prior to her vaccine, denies any recent illness, sick contacts, recent travel, CP, SOB, abd pain, dysuria. After eating and drinking patient states she feels a little nauseous and having some indigestion so was given some more Zofran and Maalox.   She continues to be presenting tachycardic in the 130s.   Given the rest of the reassuring ED work-up I think this is likely autoimmune response to the vaccine however given her current heart rate I cannot discharge her safely.   Will admit her to medicine team for observation.   SIRS, likely 2/2 vaccine - hold off on antibiotics for now without clear source of infection, procalcitonin negative - tylenol prn for fever   Principal Problem:   SIRS (systemic inflammatory response syndrome) Active Problems:   Tachycardia   Asthma  3/12 discharge summary She was given 3L IVF bolus in the ED -- still tachycardic in the 110s, fever has improved.  There was concern for adverse reaction to vaccine and she was given prednisone 60 mg x 1 in the ED.  Her symptoms have improved and she is able to tolerate PO without vomiting.  Of note, she says her entire family had a respiratory viral illness approx 1 year ago which her PCP suspected was COVID 19, but were unable to be tested at the time.     Fever has resolved, has been afebrile x24 hours, leukocytosis has resolved   tachycardia has improved although still HR in the 110's with ambulation, ordered an echo however patient did not want to stay wanted to follow-up with PCP and have this done there.   Vital signs have been stable, patient states back to her baseline and feeling great.  Would like to go home.
On day 3 my arm at the injection sight swelled and became very hot and a rash former in a large circle around the injection sight.  My lymph nodes swelled under that arm and also under right arm,
suspected vaccination failure; have them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (twice).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with Shingles vaccine was unknown. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles again twice. The patient was sure, Shingles shot helped but did not prevent from getting them again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Had a fever in 12 hours; temperature: 98F to 100F; Tiredness; Muscle pain; This is a spontaneous report from a non-contactable consumer. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on 17Apr2021 at 11:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 17Apr2021, the patient had a fever in 12 hours, temperature 98F to 100F, which lasted for 12 hours and was fully recovered after 36 hours. On an unknown date in Apr2021, the patient experienced tiredness and muscle pain. On 17Apr2021, the patient underwent body temperature and the result was 98 to 100 Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever was resolved on an unknown date in Apr2021 (also reported duration of 36 hours) and for the events tiredness and muscle pain were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Sterile abscess on L thigh. Four months immunizations given on 10/23/02. Most likely from DTaP or Comvax. Puriulent drainage noted around injection site. Evaluated by MD no further treatment.
Roughly 1-2 hrs after injection pt felt - disoriented - chills - dizzy - fainted. Pt was then taken to the ER.
Immunization Administration Error: Pt. was given a Dtap instead of a Tdap. No adverse reaction occured.
I evaluated the patient in an outpatient dermatology clinic. She received her 2nd moderna vaccine 3/29 and 3 days later started getting urticarial eruption. This had improved by the time I saw her 1 month later.
(Privacy) hospitalized after the moderna COVID-19 vaccine , Diagnosed with perimyocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Privacy) hospitalized after the moderna COVID-19 vaccine , Diagnosed with perimyocarditis) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS ((Privacy) hospitalized after the moderna COVID-19 vaccine , Diagnosed with perimyocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS ((Privacy) hospitalized after the moderna COVID-19 vaccine , Diagnosed with perimyocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported No treatment medication information was reported  Company comment: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the expected serious (hospitalization and medically significant) event/AESI of Myocarditis after a dose of mRNA- 1273 vaccine. Temporal association was not disclosed. No further information is available regarding clinical manifestations, diagnostic work-up and treatment provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no medical history reported, who experienced the expected serious (hospitalization and medically significant) event/AESI of Myocarditis after a dose of mRNA- 1273 vaccine. Temporal association was not disclosed. No further information is available regarding clinical manifestations, diagnostic work-up and treatment provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
C/O dizziness. HR 80. Resp. 20. Resp - even and unlabored. Skin not dry. Color pink.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red circle), PRURITUS (itchiness) and VACCINATION SITE RASH (Covid arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. No medical history was provided by the reported.  Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced ERYTHEMA (red circle), PRURITUS (itchiness) and VACCINATION SITE RASH (Covid arm). On 30-Mar-2021, PRURITUS (itchiness) outcome was unknown. On 01-Apr-2021, ERYTHEMA (red circle) and VACCINATION SITE RASH (Covid arm) outcome was unknown. 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. No treatment information were reported.
Received pneumonia shot on 11/09/04 that evening arm swelled up so much she went to ER, Cold packs for treatment.
Information has been received from an office manager and a consumer concerning her 5 year old son who on approximately October 2006, 06-JAN-2011 and 24-FEB-2011 was vaccinated respectively with the first, second and third (0.5ml) doses of VARIVAX (Merck) (lot numbers not provided). The consumer reported that on 24-FEB-2011 the patient received 3 vaccinations the day the third dose of VARIVAX (Merck) was administered (two in one arm and one in the other arm) and the patient developed a red ring at the injection site on one arm. The red ring was described as 2 inches around. It was unknown which vaccines were administered at the injection site that developed the red ring. The names of the other vaccines were unspecified. It was unspecified if the patient sought medical attention, if any lab diagnostic studies were performed or if any treatment was given for the adverse event. It was reported that the red ring cleared up after a couple of days. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent condition was provided. From 02-DEC-2015 to the time of this report, unspecified number of improperly stored doses of GARDASIL 9 (route, lot # and expiration date were not provided) were administered to unspecified number of patients. No adverse effects were reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
24 hour later temp102-103 degrees, seen by MD on 11/21/2009, Dx "viral". No meds Rx. Child returned to school 11/24/09.
Redness and inflammation - 33.5cm width, 13 cm length distal to the injection site.
Severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Severe allergic reaction) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Severe allergic reaction). At the time of the report, ALLERGY TO VACCINE (Severe allergic reaction) had not resolved.            Concomitant medications were not reported. Treatment details were not provided.
tested positive after receiving the vaccine; tested positive after receiving the vaccine; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst; This is a spontaneous report from a contactable consumer (patient herself).  A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, batch/lot no. EH9899 and expiry date Mar2021), via an unspecified route of administration on 05Jan2021 on her left arm at a single dose for covid-19 immunization. Medical history included leg pain. There was no reported concomitant medications. On an unspecified date, patient received COVID vaccine. She stated that she was symptomatic during the vaccine and somewhere after confirmed that she was COVID-positive. She wanted to know if there are any health concerns with getting the vaccine while COVID positive. She added that this was her first dose. she did not think symptoms were related to COVID like leg pain. She noticed that it was a lot worst but did not think that it was a symptom. She stated that she does not recall the first time ever that she had leg pain but stated that the leg pain was really bad the night before the vaccine. She added that she was isolated until 14Jan2021. Outcome of the events drug ineffective, COVID-19 virus test positive and leg pain were unknown.; Sender's Comments: Leg pain is considered intercurrent and unrelated to suspect BNT162B2.
extremely severe fatigue; feeling terrible; arm pain; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 23Mar2021 09:30 (at the age of 31 years) (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunization. Medical history included blood thyroid stimulating hormone high, NSAID allergies, and Hashimoto's. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Concomitant medications (other medications in two weeks) included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL). On 24Mar2021, the next morning, the patient could not get out of bed. She had extremely severe fatigue and missed class that whole week. The fatigue has not gone away or gotten much better and she was very concerned about getting dose 2. This is concerning because she was feeling fine and had tons of energy before the vaccine. The patient that this caused an autoimmune response as she felt like she did when her TSH was high years ago. The patient stated that it was not normal to be in bed for weeks feeling terrible after a vaccine. She went to a clinic to get an IV with vitamins on Friday, 26Mar2021 (cocktail and zinc) and felt mildly better but still not close to being better. Patient also had the normal arm pain but that resolved in 48 hours. Treatment received included: IV vitamins and saline. Outcome of the event arm pain was recovered on 26Mar2021 and of the other events was not recovered.
SHORTNESS OF BREATH AND LABOURED BREATHING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-APR-2021, the subject experienced shortness of breath and laboured breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shortness of breath and laboured breathing was not reported. This report was non-serious.
mom reported very high temp & 3 hrs of screaming day of DTP; did not have thermometer & did not take to MD or Hosp;
My mood dropped considerably.  I had been full of energy and very upbeat that evening.  It was a bit sudden.  I am sad and do not have the energy to smile - low depressive episode. It has continued to be very low, as I am writing this on 11/12/2013 at 5:00 PM  I know it will pass, but it was a peculiar onset.
Vaccine received on October 25, 2002 in the AM at 1600 was chilling, had severe aches, very tired, felt Ice Cold (did not take a temp)  Felt better by the evening of the 27th.
Day after Tdap vaccination, patient presents to clinic with complaints of pain, redness, warmth and swelling to left deltoid.  No other complaints.  Received Td 8/6/07 and Td 10/10/07 with no known prior tetanus vaccination as adult or child.  Patient born non-US.
Initial unsolicited report received from a pharmacist (Director of Pharmacy)on 12 October 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, 2016SA189841, 2016SA189842, 2016SA189843, 2016SA189844, 2016SA189845, 2016SA189846, 2016SA189847, 2016SA189848. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE (batch number: UI669AA, expiration date: 30 June 2017) via intramuscular route (dose in series, dose and site of administration was not reported), on 04 October 2016. Patient's medical history and concomitant medication were not reported. On an unspecified date,(It was reported as Over the past month ) following the vaccination, the patient had experienced arm swelling (size of baseball), real itchy, hot to touch at site, headache and nausea for 32 hours. Relevant laboratory data was not reported. Ongoing Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as unknown. Corrective treatment was not reported. On an unspecified date the patient was recovered from the event nausea and the outcome for other event was unknown. List of documents held by sender: none.
The patient experience throat tightness and trouble swallowing.  The issue resolved and the patient left on their own accord.
This spontaneous report as received from a physician via company representative refers to a female patient in her "Mid" 60 years old. In approximately February 2012 ("1-2 years prior"), the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry date, dose, strength and route not reported). Concomitant therapies included TYLENOL. The physician reported that the patient developed a shingles outbreak in the "last two weeks" (on approximately 24-JAN-2014). The physician stated that the patient developed dermatomes on her "right side mid line to mid line from T5-T8 or 9". The patient was seen by the physician on an unspecified date. At the time of reporting, the outcome of the event was recovering. Additional information is not expected.