chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately  3 - 5 minutes after the vaccine I got a very hot feeling in my chest.  I then started to feel lightheaded and just weird.  I was taken to lay down.  My blood pressure was taken and it was elevated.  I don't recall the exact numbers.  I then began to develop hives on my chest and neck and a few minutes later I began coughing.  An ambulance was already on site.  They took me in the ambulance and gave me 25 mg of Benadryl and a dose of epi.  The coughing subsided for about 10 minutes then began again.  I was given another 25 mg of Benadryl.  At the hospital I was observed.  At approximately 5:30 I began to cough again.  It was decided that I needed steroids and was given steroids in my IV.  Once I stopped coughing  I was discharged and sent home with a prescription for steroids and an Epi-pen
(L) arm pain, burning, indurated, red with streaks shortness of breath, wheeze, palpitation.
a side effect of itching, itching all over; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient received BNT162B2 yesterday and had a side effect of itching, itching all over. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Vaccine administration at 1522, at 1533 patient states not feeling well. Took to Emergency Department.  Flushing, hives, shortness of breath, throat swelling, tachycardia, dizziness.
No other AE; Temperature excursion; This spontaneous report was received from a nurse referring to a 6-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 16-DEC-2020, the patient was vaccinated with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) 1 dosage form, lot number T021638, expiration date 21-DEC-2021 (route of administration not provided) for prophylaxis. No other adverse event details were reported.  The vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for 4 hours and 15 minutes. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several reports reported by the same nurse.; Sender's Comments:  US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013533: US-009507513-2012USA013539: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013601: US-009507513-2012USA013603:
Within 10 minutes of getting the vaccine I started having hay fever- like symptoms.  Sinus drainage, itchy, burning eyes, runny nose, scratchy throat, hoarse voice. This lasted for several hours. It again worsened during the night and next day I had bouts of nausea and some head ache.
This medically confirmed spontaneous report (initial receipt: 25-Oct-2012) concerns a 94-year-old female patient. On 25-Oct-2012 the patient received AFLURIA MDV (batch number: 06549211A) at a dose of 0.5 mL intramuscularly in right deltoid. When the pharmacist administering the AFLURIA dose, part of the dose came out from around the injection site. No adverse effect had been observed or reported. The event outcome was not reported.
She got her vaccine, her arm was sore, had a really bad headache, a little bit sick to her stomach and her heart was beating rapidly and she was flushed.  Has a history of AFib.  She has medicine that she takes for her A-fib and took that, and continued to take a 3rd dose which resolved it.  All of the time that she has been on that medicine as needed she has only had to take it in that way once in 15 years.  This has happened a couple of times since taking the booster shot, but does resolve with medication.  These have been lasting longer in duration since the vaccine.  She has been to her cardiologist and had testing.
pt recvd vax lt arm area became red, warm to touch & hives on chest, arms, & back; pt given DPH;
36 hours after vaccines had an event that may have been a seizure. He had 10 cycles lasting approximately 3 seconds of whole body stiffening including extension of limbs.
Pt standing with mother in hallway of office after receiving DtaP #5, IPV #4, and MMR #2. Pt had syncope episode and hit occiput on wood floor. Pt then had tightening of arms and eyes rolled back in head.  Pt carried to exam table where vitals were pulse ox 98%, HR- 93 bpm, BP- 109/64. "Seizure- like activity" lasted approximately 2 minutes and then patient opened eyes and was responsive. Pt continued to be sleepy. Sent pt to ER with mom via personal car.
first shot about a year ago, never got second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got first Shingrix shot about a year ago (would be confirmed) but definitely more than 6 months).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-MAY-2022 Reporter's Comment: The patient never got his/her second shot of Shingrix.  The reporter wanted to know how did they go about getting this finished. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:  01/04/2021,Pfizer Lot#EJ1685 2nd dose: 01/25/21,Pfizer Lot# EL3249 Diagnosed covid positive:03/22/21 Exposure:Home Symptoms:Headahe,fatigue,muscle aches
Rheumatoid arthritis flare up; This is a solicited report based on information received by Pfizer (Mfr. Control No.: 21K-163-4090213-00) received from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 intramuscular on 08Mar2021 (at the age of 70 years old, Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen) subcutaneous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for moderate to severe rheumatoid arthritis. Medical history included rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 intramuscular on 15Feb2021 (Batch/Lot number was not reported) for covid-19 immunisation. Patient with an event of non-serious Rheumatoid arthritis flare up after the second Covid shot with Humira (Adalimumab). The patient experienced rheumatoid arthritis flare up in 2021 with outcome of recovered in 2021. In 2021, the patient experienced Rheumatoid arthritis flare up after the second Covid shot. In 2021, the Rheumatoid arthritis flare up after the second Covid shot resolved. Pfizer BionTech COVID-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the event for adalimumab was unknown. The reporter's causality for the event of rheumatoid arthritis flare up and BNT162B2 as possible and not provided for adalimumab.  No follow-up attempts are needed. Information about lot/batch number cannot been obtained. No further information is expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported event.  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
headache; sore throat; sore arm/ arm hurts; nausea; 108 temp; chills; body ache; This is a spontaneous report from a Pfizer-sponsored report from a contactable consumer (reported for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 16Mar2021 at 10:00 as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Patient had COVID one year ago). The patient previously received aspirin [ACETYLSALICYLIC ACID] and experienced drug hypersensitivity. The patient experienced headache, sore throat, sore arm/ arm hurts on 16Mar2021 and 108 temp, chills, body ache, nausea on an unspecified date in Mar2021. The clinical course was as follows: After the first dose and patient is experiencing headache, sore throat, and sore arm. Patient was seeking information if she can take Motrin 400mg for pain. Patient allergic to a lot of medication. Reporter want to know if she can continue taking her medication. Patient allergic to aspirin. Reporter want to know if she can take Motrin, allergy pills, folic acid, b12, thiamine, metoprolol, Protonix for nausea. Reporter takes an over-the-counter allergy medicine which she knows is an antihistamine. The caller takes a lot of medications and has a lot of allergies to medications, so she has a few questions about that and is concerned now. The patient underwent lab tests and procedures which included body temperature: 108 and body temperature: 100.8 Fahrenheit on an unspecified date in Mar2021 (highest temperature was 100.8F). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient called 6/17/19 complaining that she was still experiencing a very sore arm at the injection site. Recommended heating pad and icing the area and following up with Dr. for further evaluation.
Pt first leaned forward and then leaned back in chair. Unresponsive.  Moved pt to the floor and applied cold compress to forehead.  Pulse was 60.  Pt responded to verbal stimuli after lying on the floor.  Was drowsy and oriented.  After 5 minutes assisted pt to sit up on floor. Pt tolerated well.  8:35 am pt walked out of office without ill effect.
Initial solicited report received on 17 April 2015 and follow up information received on 17 April 2015 from an investigator participating in a study.  A 10-year-old male subject was diagnosed with atypical erythema multiforme on 04 March 2015 i.e. 84 days after receiving a first dose of study vaccine MENVEO on 10 December 2014 (site of administration, route of administration and batch number was not reported).  The event appeared after visit 2. The subject had no relevant medical history. The subject had concomitant therapies with dose 1 ADVIL 2 tablets orally for abdominal pain on 01 March 2015 and "1" PAIN-AID orally for fever on 02 March 2015. The cause of erythema multiforme minor was unknown. The subject was hospitalized on 07 March 2015. There were no lab investigations performed. The subject was treated with Anti-itch medicine, cold compresses and BENADRYL PRN. The subject was discharged from the hospital on 08 March 2015. The event of atypical erythema multiforme was resolved on 30 March 2015. According to the investigator, the event was not related to the concomitant medications. According to the investigator, the event was not related to the study vaccine or to the trial procedures. Relationship to investigational product according to Company: not associated. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 28 April 2015: It was reported that on 01 March 2015 subject had complaining of abdominal pain, he took two ADVIL and symptoms resolved. The next day the subject was sent home from school with fever of 101.0 for which he took PAIN-AID, and the fever resolved. On 03 March 2015 subject complained minor abdominal pain, but it resolved on its own. No further fever or abdominal pain for 48 hours. On 04 March 2015 subject woke up with a rash on his upper thighs and by last night it had spread down his legs. The subject mother gave him 2 BENADRYL. On 05 March 2015 rash spread to rest of his body. Itch was minor but not painful with contact. On 06 March 2015 subject was admitted to hospital for worsening rash with fever and vomiting. As a corrective treatment the subject received two capsule of Diphenhydramine orally every 6 hourly for itching. Follow up information received on 08 May 2015. The PAIN-AID concomitant medication were updated as subject received Aspirin tablet of 162 mg, PARACETAMOL 110 mg and 32.4 g of caffeine. Follow up information received on 14 May 2015 and 15 May 2015: The investigator reported that there was no skin biopsy performed and also there were no lesions. It was reported that investigations for infectious etiology were performed. Follow up information received on 6 June 2015 (PV query): The investigator confirmed that the subject was seen by a dermatologist however infectious etiology was not performed.
This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a infant patient who received ROTARIX oral suspension. On 26th May 2017, the patient received ROTARIX oral suspension (oral). On an unknown date, less than a month after receiving ROTARIX oral suspension, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to ROTARIX oral suspension. Additional details were received as follows: The age at vaccination was not reported. The patient experienced an unspecified adverse reaction after vaccination with a dose of ROTARIX. The reporter's call was disconnected and the reporter was unable to be contacted for full details as their office message indicated that it was closed for lunch with no opportunity to leave a voice mail message.
Patient received a vaccine that had exceeded the 12 hour temperature limit. We have attempted to contact the patient and notify her but she hasn't returned our call.
Patient showed a red swollen arm. Patient reports that on 06 27 took some ADVIL to relieve pain but arm was very stiff and sore.
Redness and induration at local site of injection 6 cm in diameter resolving on examination at 48 hrs.
Came to ER with SOBx1 month worse around midnight, cough x 1 month.
Rheumatoid arthritis flare up; Ill feeling; Generalized aching; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), MALAISE (Ill feeling), PAIN (Generalized aching) and FATIGUE (Fatigue). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved, MALAISE (Ill feeling) outcome was unknown and PAIN (Generalized aching) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Physician discontinued Humira /thought another therapy would work controlling patients pain and rheumatoid arthritis flare ups. Concomitant medications were not reported. No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning an adult male patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult male patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up), after receiving the first dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and further treatment details were not provided in the case. The event had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Took complaint from Nanwalek CMP-reports skin rash that started at 48 hour of last set of immunizations on 4/26/06. Has been under care for bronchitis/upper respiratory infection since 4/3/06. On 5/10/06 Mother reported to CHP with baby with symptoms of upper respiratory infection, skin rash. Temp 101F, P -158, RR40. Runny nose, cough, red, raised, pin-point rash on legs, arms, back, face and arms. Mom reported rash started on 4/28/06. CHP reports no pattern to rash, some old, some new rash areas. No open ones, itching, appetite good, playful, breastfeeding well, elim normal. CHP plans to report to primary medical doctor.  No signs or symptoms of infection on skin.
redness; covid arm; hypersensitivity reaction; itching all day; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (hypersensitivity reaction), PRURITUS (itching all day), ERYTHEMA (redness) and VACCINATION SITE REACTION (covid arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012l20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity reaction (hypersensitivity reactions to vaccine - small pox ( 1976) it was itchy on the left arm for 12 months.) and Hypersensitivity reaction (hypersensitivity reactions to medications -penicillin ( rash after 10 days )). Concurrent medical conditions included Hypersensitivity reaction (codeine ( red cheeks )), Hives and Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL], MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and TIOTROPIUM BROMIDE (SPIRIVA) for Asthma, ATORVASTATIN CALCIUM (LIPITOR) for Blood cholesterol abnormal, DENOSUMAB (PROLIA) for an unknown indication.   On 19-Jan-2021 at 6:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 6:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced HYPERSENSITIVITY (hypersensitivity reaction). 28-Jan-2021, the patient experienced PRURITUS (itching all day) and VACCINATION SITE REACTION (covid arm). On an unknown date, the patient experienced ERYTHEMA (redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) on 28-Jan-2021 for Hypersensitivity reaction, at a dose of 10 mg once a day and CLOBETASOL PROPIONATE (CLOBETASOL 0.05%) (topical) from 28-Jan-2021 to 05-Feb-2021 for Hypersensitivity reaction, at a dose of UNK dosage form. On 02-May-2021, HYPERSENSITIVITY (hypersensitivity reaction) had resolved. At the time of the report, PRURITUS (itching all day) and VACCINATION SITE REACTION (covid arm) had resolved and ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-041232 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Added vaccines' batch numbers, patient demographics, medical history, concomitant drug indications and dosage information and treatment drugs.
injection site soreness; tightness/soreness in his back and shoulder blade; tightness/soreness in his back and shoulder blade; tightness/soreness in his back and shoulder blade; This spontaneous report was received from a 59 years old male patient referring to himself. The patient's concurrent condition included diabetes. The patient was allergic to penicillin (unspecified). The patient's concomitant therapy was not provided.  On 27-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) booster shot (0.5 milliliter; strength, frequency, lot # and expiration date were unknown) intramuscularly for prophylaxis.        On the same date, the patient started experiencing injection site soreness and tightness/soreness in his back and shoulder blade. The patient didn't seek medical attention. The outcome of the events was not recovered. The causality assessments between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported.
This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, fever, nausea and injection site swelling. On an unknown date, the outcome of the injection site erythema, fever, nausea and injection site swelling were recovered/resolved. It was unknown if the reporter considered the injection site erythema, fever, nausea and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had fever, nausea and redness and swelling at the injection site that lasted for 1 week. No further information was provided. Sales representative did not have any additional details.