chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild
Parents noticed large, hot, red, lump at site of DTaP injection apprxoimately 36 hours after injection given. Seen by PCP approx 48 hrs post injection and started on Keflex 250/5 3/4 tsp. tid x 7 days for suspected cellulitis.
Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Tachycardia-Mild, Additional Details: about 10 minutes after patient got the vaccine. she fainted in the chair. her head swung back and she was shaking. she woke soon afterwards. she became increasingly pale and reported feeling palpitations with some blurred vision. nurse checked EKG with normal results. normal blood glucose readings. EMS was called for evaluation then medic transport to nearby hospital
Jansen COVID-19 Vaccine EUA The first side effect began at 4/10/21 ~9:00 PM, approximately 6 hours after injection.  The very first noticeable symptom was chills. As the night progressed, chills came in cycles while headache and an abnormal sensation in the head became apparent. Throughout the night, there was also a feverish feeling, body aches, periodical sweating, and sore arm at injection site. I?ve experienced all these symptoms (except the sore arm and sweating) while being sick with Covid-19 approximately over a week prior to the vaccination. Symptoms continued until the next day, 4/11/21, and they gradually went away as the day progressed and after taking doses of acetaminophen and ibuprofen. Symptoms completely dissapeared by the evening of 4/11/21.
Notice high grade fever 102.4 after several hours of rec'd. shot, went to ER also due to nausea, vomiting then whole week redness of arm about 2/3 of arm-left  arm.
maladministration of havrix (exp date 24-JAN-2022); This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HAV (Havrix) (batch number 299X2, expiry date 24th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 22nd March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, a maladministration of expired havrix into a patient, which led to expired vaccine used. The reporter consented to follow up.
Patient presented to the ED and was subsequently hospitalized for opiate overdose, accidental, within 6 weeks of receiving COVID vaccination.
After injection, c/o increased tightness in throat. PE nl rd, O2 SATS 99% RA. Objective: nl exam.
Woke up at 4:30am with intense pain in the arm where I received the injection in the shoulder area. Pain would not resolve with ibuprofen and lasted until about 3:30pm that day when it suddenly disappeared.
Within minutes of receiving the vaccine, patient reported not feeling well. Upset stomach, coughing and color going from face. Patient sat down and proceeded to lose consciousness briefly and possible have a seizure. Patient came back to consciousness in seconds and was able to converse as pharmacist was on call with 911/EMS. Patient improved in condition to the point of conversating with parents and reported feeling much better. EMS came and assessed the patient reported to believe it was a syncope episode, offered ambulance to ER but declined by parents. Will call patient tomorrow Sunday to see if anything else progressed/treatment was performed.
Patient presented at the pharmacy on March 29, 2022 complaining that her arm was still sore from Moderna vaccine administered Jan 2022. She showed my tech and me the site which was slightly swollen. There was a darkened area representative of a scar or prior irritation. The site was "high" on the right arm. On that that the patient was picking up a prescription for her husband for Ibuprofen 800mg and stated she had been taking Ibuprofen 800mg, and had also previously used Salonpas  patches as  well. She also stated on March 29, that she had receive a cortisone shot 2 weeks prior and the area felt better but began hurting again 2 months prior.  Patient returned to pharmacy on April 1, 2022 and stated she had been back to the doctor and received another cortisone shot. Also stated that the orthopedic dr stated that the vaccine had been administerd in the bursa. Patient said the doctor did not want to put her on more meds because she was already taking quite a few, but that ongoing therapy was a possible option
OFF BALANCE WITH EVERY HEAD TURN; SLIGHT HEAD TURN MADE ME DIZZY; RAPID HEARTBEAT; DROWSINESS; VERY TIRED; WEAK; MILD MUSCLE ACHES; NO APPETITE; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 64 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid, and mild blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) .5 ml, administered on 05-MAR-2021 09:08 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced rapid heartbeat. On 05-MAR-2021, the subject experienced drowsiness. On 05-MAR-2021, the subject experienced very tired. On 05-MAR-2021, the subject experienced weak. On 05-MAR-2021, the subject experienced mild muscle aches. On 05-MAR-2021, the subject experienced no appetite. On 05-MAR-2021, the subject experienced low grade fever. On 06-MAR-2021, the subject experienced off balance with every head turn. On 06-MAR-2021, the subject experienced slight head turn made me dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from off balance with every head turn, and slight head turn made me dizzy on 07-MAR-2021 02:00, and the outcome of drowsiness, rapid heartbeat, mild muscle aches, low grade fever, no appetite, very tired and weak was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) 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) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MOD-2021-395985 (Patient Link).
heart flutters; This is a spontaneous report from a Pfizer Sponsored, a contactable Nurse. A male patient of an unspecified age receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Feb2021 at SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  Historical vaccine information included BNT162B2 on 03Feb2021 was the first dose. The patient experienced heart flutters, several times a day from an unspecified date. She is wondering if this is a normal reaction and what she should do about it. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
On 05/06/2002 mother stated that when the pt received her immunization on 03/04/2002 she develoed a temp of 104 deg. F, rolled her eyes back several times. Mother reported baby's condition to the doctor and was instructed to give her Tylenol and Advil. Temperature lasted for about one hour.
Headache, Myalgia, Fever, NauseaVomiting, Chills, pain @ injection site Narrative:  Seen in EH clinic- fever, nausea, chills, body aches, HA, pain @ injection site  Other Relevant History:
No reaction at actual site of injection, but whole side (inside) of upper arm very red, swollen, itchy and painful.
Dizziness, Headache, Myalgia, Fever, NauseaVomiting, malaise Narrative:  Other Relevant History:
Pt was given influenza vaccine with preservative in it - box mislabeled by the manufacturer.
face turned really red; lightheadedness on rising; see stars on rising; I had severe tremors; fatigue; A spontaneous report was received from a nurse concerning a 58-year-old, female patient who experienced the events of my face turned really red, fatigue, tremor, and lightheadedness on rising, I see stars on rising.   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Details of first dose of mRNA vaccine was not reported.  On 28 Jan 2021, the patient experienced the events erythema, fatigue, dizziness, and tremor.   The patient reported that her face and cheeks turned red, felt fatigue, felt lightheadedness on rising and had severe tremors in the night for 2 hours.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events erythema, fatigue, dizziness, and tremor was resolved.; 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.
on 05/28/2021 at 0815 patient experienced tonic-clonic grand mal seizure lasting approximately 1 minute. A second tonic-clonic grand mal seizure lasting approx 1 minute was also experienced and witnessed in pt's home on 06/02/2021. Second grand mal resulted in hospitalization of pt overnight and adjustment of AED's was made. Prior to these seizures pt had been seizure free for 3 months.
This spontaneous report as received from a pharmacist refers to a 66 years old female patient with asthma, diabetes and chronic obstructive pulmonary disease (COPD). On 26-OCT-2012, the patient was vaccinated subcutaneously in the left arm with a dose of 0.65 ml of ZOSTAVAX (lot# reported as H013017, expiry 09-OCT-2013). Patient received unspecified concomitant medications. On 02-Nov-2012, the patient called the pharmacy and stated that she has itchy rash at injection site. No treatment was given. The patient sought medical attention (called the pharmacy on 02-NOV-2012). The outcome of itchy rash at injection site was reported as not recovered. The pharmacist stated he would have the patient follow-up with her health provider if needed. Additional information is not expected.
Initial report received 31 January 2008 from a health care professional.  A 13-year-old female patient with no pre-existing medical conditions, had received an intramuscular left deltoid injection of Menactra, lot number U2326AA, and an intramuscular left deltoid injection of Varicella, lot number 1576U (manufacturer Merck), and an intramuscular left deltoid injection of Hepatitis A, lot number 6510/AHAVB225BB (manufacturer GSK), and an Aplisol test (route, site, manufacturer not reported), and within minutes, she fainted in the elevator.  The patient's blood pressure was stable and no other symptoms were observed.  The patient had no concurrent illness, no concomitant medications and she had not experienced any adverse events following prior vaccinations.  The patient had recovered from the event and no further information was provided.
Developed bloody/mucousy stools 6 days after Rotavirus vaccine. Lasted for approximately 12 hrs has labs, AXR and stool studies, trial of hypoallergenic formula - symptoms resolved.
Numbness on tongue, tingling on face.  Reported same symptoms as allergic reaction to shellfish.   Observed and symptoms resolved within 30 minutes. Released home
Shot was given on above date, woke up next morning with severe pain in my feet, could not walk. Got second dose and things got worse. Finally after six months began seeing posturists.  no so;lution. Finally saw doctor. He is an allergy doctor who describes it as an adverse effect to the vaccine.
pain in left arm lasting for about 24 hours; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Apr2021 18:30 (Lot Number: EW0161), at the age of 45-year-old, as single dose for COVID-19 immunisation. The medical history included multiple chemical sensitivities and polyneuropathy. The concomitant medication was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After Vaccine #1 the patient experienced pain in his left arm lasting for about 24 hours in Apr2021. The outcome of the event was recovered in Apr2021.
Reported to vaccinating pharmacist by patient via phone on 2/23/2021 of dizziness shortly after the vaccine that lasted intermittently x 3 weeks, felt like had a fever (temperature not checked) x 3 weeks, swelling of face about 2 weeks after vaccine which was also directly after a massage (had botox "not long ago in the past"), swelling of the lymph glands, headaches and migraines started.  Went to the hospital on 2/19/2021 via ambulance due to migraine.  At the hospital patient was treated with anti-emetic, fentanyl, and other unknown medications that included benadryl.  Was discharged same day. Continued to have a migraine next two days.
p/vax pt devel diarrhea. dx was exacerbation of pt ulcerative colitis. treated w/prednisone.
pt recv vax 13JAN99 & w/in 48hr devel hives;
This case received from Regulatory Authority via a consumer concerning a 78 year old, male subject, who had been receiving nasal influenza and INDACATEROL, 150.0 micrograms, every day for COPD. The patient's medical history included asthma and intervertebral disc prolapse. Concomitant medications included unspecified and oxycodone hydrochloride for back pain. Influenza virus vaccine started during 2012 and INDACATEROL started on 09-Nov-2012 for COPD. The patient experienced severe headache which started on 13-Nov-2012 and ONBREZ used to treat suspected COPD, with underlying condition asthma. At the time of reporting, the event of severe headache was improving and the outcome of the event of ONBREZ used to treat suspected COPD, with underlying condition asthma is unknown. The report was considered to be non-serious. Corrected report 03-May-2013: Initial unit was changed from AstraZeneca to MedImmune and key ingredient was also changed from influenza virus vaccine polyvalent to FLUMIST.
This spontaneous report as received from a 54 year old female patient reporting on herself. The patient had no pertinent medical history and drug reactions or allergies. On 17-JAN-2017, the patient was vaccinated with one dose of ZOSTAVAX injection (lot#, expiration date, dose and route of administration were not reported) for prevention of shingles. Concomitant therapies included SYNTHROID. On 18-JAN-2017, the patient noticed little bump on her arm after receiving ZOSTAVAX, at the same location. On 19-JAN-2017 (reported as "the next day"), her arm was stiff, there was redness and the bump became hard. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality between the events and ZOSTAVAX was not reported. No laboratory diagnostics tests were performed. The patient did not seek medical attention. Product quality complaint was not involved. Additional information has been requested.
A non-serious spontaneous report of fever, cough, sore throat and feeling exhausted has been received from a consumer concerning a 47-year-old male subsequent to H1N1, Intranasal vaccination. Neither relevant medical history nor concomitant medications have been reported. On 18-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. On 19-Dec-2009, 24 hour after vaccination the patient developed symptoms of fever, cough, sore throat and felt exhausted. The symptoms were present at the time of report. The outcome of reported events was not resolved.
Unable to get out of bed next day, body aches, low grade fever. Severe joint pain in knees, hips, shoulders. Buildup of synovial fluid, unable to bend right knee or completely straighten.  Fatigue has continued over months, interfering with work and daily activities. Unable to sleep due to pain.
Severe Left deltoid pain: throbbing, achy, constant pain without much swelling. Severe tenderness to palpation, limiting range of motion of L arm. Had same reaction within 6 hours following the first dose in the series and pain lasted for 3 days.
While receiving  second dose the vaccinator inserted what appeared to be an empty syringe. The vaccinstor stated "oops" and withdrew the needle. The vaccinator then filled a second syringe and and re-injected patient.  The issue is the person being vaccinated is concerned that he may have had air injected into the deltoid muscle and/or may have been over vaccinated. He reported to the Pod Commander and his supervisor at work.
8 days post shot patient experienced multiple episodes of vertigo and has a golf ball size lymphnode in armpit region of shot arm.
Hot to touch; itchy rash; Itchy rash/small rash spread and cover almost all the upper arm; A little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little sore arm), VACCINATION SITE WARMTH (Hot to touch), RASH PRURITIC (itchy rash) and VACCINATION SITE RASH (Itchy rash/small rash spread and cover almost all the upper arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergic to sulfa basic medication.). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN), VITAMIN B COMPLEX and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (A little sore arm). On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch), RASH PRURITIC (itchy rash) and VACCINATION SITE RASH (Itchy rash/small rash spread and cover almost all the upper arm). At the time of the report, PAIN IN EXTREMITY (A little sore arm) had resolved and VACCINATION SITE WARMTH (Hot to touch), RASH PRURITIC (itchy rash) and VACCINATION SITE RASH (Itchy rash/small rash spread and cover almost all the upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .The patient HCP told her to take OTC Benadryl for allergic or if painful take OTC ibuprofen or Tylenol. and put cold compress on it to make it feel better.    Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Added Patient demographic details .( Race information is added.)
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reaction or allergies were not reported. On 13-AUG-206, the patient was vaccinated twice with PNEUMOVAX 23 (lot number, expiration date, dose and route of administration were not reported) due to a human error. Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
never got the shingles until a short time after he got the "vaccination/suspected vaccination failure; never got the shingles until a short time after he got the "vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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. 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 reported as follows: This case was reported by the patients friend. The age at vaccination was not reported. The patient never got the shingles until a short time after he got the vaccination. The reporter asked if it was a coincidence. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were not provided. The follow up would not possible as contact information was not available.
Pt. was vaccinated and being monitored, 15 minutes after vaccination. Pt was injected @ the R DT. Pt reported pain to R side of neck, dizziness, and weakness. Pt's vitals were obtained all were WNLs, breathing was normal and unlabored. S/S  subsided, pt denied any further issues. Pt was released to spouse.
Fevers at 103.5, muscle aches, extreme coughing later resulting in coughing up blood, my mouth and tongue became numb for 8 hours. sweating, chills, lungs hurt for 3 days.
Pneumo immunization given 12/2/02 and client complained of soreness all day. Red, swollen, painful medial aspect of upper left arm noticed on 12/3/02 in evening. Reported to health dept 12/4/02 in morning. Arm still red, swollen and painful. Client states pain has resolved somewhat.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient got the first shingles vaccine shot (1st of 2) and immediately got shingles before she ever could get the second shot. The follow-up could not be possible as no contact details were available.