chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe migraine; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "severe migraine". Therapeutic measures were taken as a result of migraine.  Additional information: Consumer would like to know how to get Paxlovid. After a month She received the two doses of the Pfizer COVID-19 vaccine she experienced severe migraine and exacerbation. She never got the booster due to that. She also mentioned that she is taking carbamazepine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax;hives,itching,burning of entire body;face,eyes swollen;took Nyquil & returned to bed;in am,redness,hives dec;to er;feet,hands,face,eyes extremely swollen;said throat felt thick,breathing sounded raspy;adrenaline,solumedrol give
Patient was not over the age of 18 at time of vaccination.  No adverse reaction.  Vaccinator missed this patient was a minor.  Howeve,r parental consent was given.
Migraine.  Fever(101). Chills.  Aching joints. Fatigue. Length of event - 20 hours.
devel fine morbilliform type rash around sites of inject in anterior thighs; DTP on rt sl larger than HIB on lt only about 6-7cm across; no induration warmth or drainage; seen 48 hrs p/inject;
Red streaks running from shoulder to injection site. Liquid Diphenhydramine administered. 25mg PO.
Nausea, deep harsh dry cough, HA, burning and tightness across shoulder blades. Arm very sore the next morning
On 03 July she developed redness, swelling, itching and discomfort to upper arm where she received AVA and typhoid. Area the size of her palm going around the arm. No swelling to elbow. This was AVA number 5. No problems with previous immz. July, in addition to above symptoms she also report flu like symptoms, headache and joint pain. Denies fever. Follow up on 06 July and reported improvement of symptoms Follow up 09 July and she reports that symptoms have almost fully resolved and she is feeling much better. Continues with some soreness to her arms and localized itching.
No Adverse Event; The patient was administered with first dose on 02-Feb-2023 and second dose on 20-Mar-2023; They accidently administered a monovalent vaccine that expired 12-Feb-2023 on 20-Mar-2023; The vaccine got expired on 12-Feb-2023 and was initially stored in refrigerator on 20-Mar-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient was administered with first dose on 02-Feb-2023 and second dose on 20-Mar-2023), EXPIRED PRODUCT ADMINISTERED (They accidently administered a monovalent vaccine that expired 12-Feb-2023 on 20-Mar-2023), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Feb-2023 and was initially stored in refrigerator on 20-Mar-2023) and NO ADVERSE EVENT (No Adverse Event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 02-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient was administered with first dose on 02-Feb-2023 and second dose on 20-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (They accidently administered a monovalent vaccine that expired 12-Feb-2023 on 20-Mar-2023). 20-Mar-2023, the patient experienced PRODUCT STORAGE ERROR (The vaccine got expired on 12-Feb-2023 and was initially stored in refrigerator on 20-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient was administered with first dose on 02-Feb-2023 and second dose on 20-Mar-2023), EXPIRED PRODUCT ADMINISTERED (They accidently administered a monovalent vaccine that expired 12-Feb-2023 on 20-Mar-2023), PRODUCT STORAGE ERROR (The vaccine got expired on 12-Feb-2023 and was initially stored in refrigerator on 20-Mar-2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient was administered with first dose on 02-Feb-2023 and second dose on 20-Mar-2023), EXPIRED PRODUCT ADMINISTERED (They accidently administered a monovalent vaccine that expired 12-Feb-2023 on 20-Mar-2023) and PRODUCT STORAGE ERROR (The vaccine got expired on 12-Feb-2023 and was initially stored in refrigerator on 20-Mar-2023).    No concomitant medications were provided. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Mar-2023. The vial did not undergo any temperature excursion. No treatment medication was provided.
Headaches, bodyaches, severe chills, injection site pain, fatigue for 48 hours.
Developed T,convuls&pneumonia.Hospitalized w/ septic shock, renal failure & disseminated intravascular coagulation.Develop rash&tracheitis.Culture-Staph aureus.Exp multiple system failure-renal/respiratory/metabolic/cardivascul.Died 11Jan91
VACCINE GIVEN IN ERROR. PATIENT IS ONLY 34 AND IS NOT IMMUNOCOMPROMISED BUT WAS GIVEN THE 2ND BOOSTER BY MISTAKE. PATIENT WAS INFORMED OF THIS MISTAKE AND IS AWARE OF IT. CONSULTED TO KEEP AN EYE OUT FOR ANY SIDE EFFECTS AND TO CONTACT US WITH ANY QUESTIONS.
pt says she got very woozy and waited 15 minutes before leaving after taking the vax.  She ran errands and then went home but still felt woozy.  She took an aspirin and went to bed.  She woke up with pain in her bones.  She said the pain from her neck down to her feet.  She had pain her her right arm, nauseated, head pressure, still neck, light headed, and cold.  She took aspirin for her symptoms that lasted for 5 days.  On the 6th day her neck was still stiff so she took aspirin and went back to work.   Her symptoms have since subsided.
Product storage error; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 17-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
could not lift their arm after the second dose; felt a little off for a day and a half,; headache; achy joints, not bad,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT, FEELING ABNORMAL, HEADACHE, and ARTHRALGIA in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A, 939905, and 029L20A) for COVID-19 vaccination.     Concomitant products included EXCEDRIN ASPIRIN FREE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT, FEELING ABNORMAL, HEADACHE, and ARTHRALGIA. The patient was treated with TYLENOL 8 HOUR for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT, FEELING ABNORMAL, HEADACHE, and ARTHRALGIA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Vaccination Site Movement Impairment, and expected events of Headache and Arthralgia. The events on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since events on second dose did not happen on the first dose. The events headache and arthralgia is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-380153, MOD-2021-378552 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 12th June 2018 14:15, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain and itchy rash. The patient was treated with hydrocortisone and BENADRYL. On an unknown date, the outcome of the injection site pain and itchy rash were recovering/resolving. The reporter considered the injection site pain to be probably related to SHINGRIX. The reporter considered the itchy rash to be unrelated to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the right deltoid. The health care professional reported that the patient developed an itchy rash on the abdomen, under the bra area, and groin area the day after receiving the SHINGRIX vaccine. The patient also experienced soreness at the injection site. The health care professional does not believe rash was caused by the SHINGRIX. The health care professional recommended the patient to use hydrocortisone cream and BENADRYL on the rash.
hard bump and soreness, and itchyness at site of injection and also small cold sore like bumps around mouth
Body is achy; Started sweating it out; Still sick to my stomach; Nauseous; A pounding head ache; Temperature was like a 101°F/between 99°F and 100°F during the day/100.2°F/moderate fever/low grade fever 99.5°F; I had the chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN, HYPERHIDROSIS, ABDOMINAL DISCOMFORT, NAUSEA, and HEADACHE in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 038K20A, and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced PAIN, HYPERHIDROSIS, ABDOMINAL DISCOMFORT, NAUSEA, HEADACHE, PYREXIA, and CHILLS. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, PAIN and NAUSEA had not resolved and HYPERHIDROSIS, ABDOMINAL DISCOMFORT, HEADACHE, PYREXIA, and CHILLS outcome was unknown.            No Concomitant medication was reported.   This case was linked to MOD-2021-366173 (Patient Link).
Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:18 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 63.23  Concomitant products were not provided.  On 03-Apr-2021 vials were moved to clinic. On 30-Mar-2021 the vaccines were moved to fridge. On 03-Apr-2021, the vial underwent the excursion on the following timings: at 09 AM temperature was 34.  The vaccine beyond use date was reported as 29-Apr-2021.  Vial was stored in cooler 1, on 03-Apr-2021, temperature excursion at 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41 and 1 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
01/18/22 presents to ED for "weakness, chills, and back pain". PMHx of "ESRD on hemodialysis, T2DM, D-CHF, and recent AV fistula repair"
Patient received the vaccine yesterday and a few hours later she started having generalized body aches and pain/swelling at vaccine area. She took TYLENOL and THERAFLU, but could not sleep all night due to aches.
Developed RSV typical runny nose, sore arm, then 2 days after developed Covid symptoms and positive Covid self test.  Had no abnormal health issues before RSV injection
patient was feeling dizzy and then collapsed on her back at 11:20am. patient was rushed back to the pharmacy where she was administered 0.15mg of epipen and then held in the little clinic until paramedics arrived
PATIENT REPORTED NAUSEA AND LIGHTHEADEDNESS ABOUT 5 MINUTES AFTER VACCINE. VOMITED AND PARAMEDICS WERE CALLED. PATIENT STARTED FEELING BETTER AFTER VOMITING. PER PARAMEDICS, VITAL SIGNS WERE WITHIN NORMAL LIMITS. PATIENT WILL FOLLOW UP WITH PRIMARY CARE PHYSICIAN
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics.  On an unknown date in 2013 the patient was vaccinated with RECOMBIVAX HB. The medical assistant reported that, multiple unspecified patients were administered with RECOMBIVAX HB that was exposed to unspecified temperature excursions from January 2013 to the present. No adverse effects were reported. This case is linked to 1401USA000054, 1401USA000056, 1312USA012478 (same reporter). Additional information has been requested.
Patient reported feeling dizzy and hot immediately after receiving vaccine. Patient also reported a sensation of liquid going down their spine, lower back pain, and salivation. patient was given water to drink, and 911 was called. Patient was observed for additional  20 minutes and she reported symptoms had alleviated. Patient then requested to go outside for fresh air before leaving.
mom reports that when woke from nap was shaky & had a blue color & was cold; t98.6 R; 12MN temp 102.3; rash; seen by MD dx roseola;
Seconds after receiving Pfizer covid 19, pt had a vasovagal episode with stiffening and jerking movements of  extremities.  Few second duration.  Father stated upon arrival that Pt's mother had a "Bad reaction to Moderna" (seizure).  She also has these reactions frequently and with botox injections.  Pt "ate very little for breakfast. He was given water to drink.  He drank 2 bottles.  Vital signs x2 and walked in clinic without difficulty.
2/5: Headache a few hours post injection. Pain at site 2/6: Exhaustion, extrem tiredness. Headache in morning. Pain at site. 2/7: approximately 1.5 inch radius firmness area from injection site (3 inch) diameter. Tiredness continues. Pain at firmness site. 2/8: rash over firmness area unchanged in size, area was also hot and itchy. Chills on and off throughout day. Tiredness continues. Pain at firmness site. 2/9: rash slightly still present, itchiness continued on-off through out the day. Chills thought day and more present in the evening. Pain still at firmness site. 2/10: Firmness goes away. Chills continue and tiredness continues. Itchiness continues on and off. 2/11: Itchiness continues on and off. Tiredness continues. Chills continue on and off, more present in the evening.  site now sore (no longer pain) to pressure. 2/12: Itchiness continues on and off. Tiredness continues. Chills continue on and off, more in the evening. Site still sore to pressure 2/13:  Itchiness continues on and off. Site still sore to pressure. 2/12:
Mother called 6/17/08 1-5:00pm.  She reported that patient had following signs and symptoms:  Redness on top of ears, rash.  She also said now after out in sun, he broke out with red rash, small spots on back.  Not raised and big patch on arm.  No temperature.  She questioned if this could be from the shots.  Onset - noted 6/16/08 4PM when she picked him up from sitters.  Was playing outside. 0/20 mother recieved call form grandmother on 6/19. She reported that she took child to see family doctor 6/19 after she was seen @ family health ctr on 6/18. Dr told her he has itonibtes & said that he did nto believe the rash was related to shots.
40 yo presented to Emergency Room with tetanus vaccine ADR. Inflammatory response due to tetanus vaccine: Received tetanus vax in Rt shoulder 4 days ago - on 10/6/2011 - 3 days - 10/7/2011 - ago developed pain, swelling, redness near immunization site along with chills and nausea. Discharged from ED with rxs for cephalexin and prednisone.
Fever over 104, large lump on thigh where shot was given.  Lump increased in size. Fever lasted several days which required trip to ER.
Pneumovax given lft deltoid, pt stated "by that evening my arm was red down to my elbow slightly swollen, hot to the touch.  Next day arm was itchy.  Sx resolved within 48 hr.  No tx given.
Could not move arm after covid-19 vaccination; fever; This spontaneous case was reported by a consumer and describes the occurrence of JOINT RANGE OF MOTION DECREASED (Could not move arm after covid-19 vaccination) and PYREXIA (fever) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML, Citrate free. In September 2022, the patient experienced JOINT RANGE OF MOTION DECREASED (Could not move arm after covid-19 vaccination) and PYREXIA (fever). At the time of the report, JOINT RANGE OF MOTION DECREASED (Could not move arm after covid-19 vaccination) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103. Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Treatment medications were not reported.
Patient received her 3rd dose of Pfizer COVID vaccine on 9/25/21 (dose 1 was on 2/19/21 and dose 2 was on 3/12/21). On 9/28/21,  patient was brought to the ED after having multiple falls at home. She reported not eating or drinking well after her booster shot. Patient was found to be dehydrated and COVID (+). Patient was initially hypoxic in the ED at 88% on room air and was started on remdesivir and dexamethasone. The following day, pt was no longer requiring supplemental O2. Pt was discharged after spending 4 days in the hospital.
This spontaneous report was received from a pharmacist refers to a 62 years old female patient. The patient received an unspecified inactivated flu vaccine in mid-October 2012. The patient was vaccinated subcutaneously with lot # (H013023), exp. date: 09-OCT-2013, 0.65 ml ZOSTAVAX on 01-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient developed an unspecified rash after receiving ZOSTAVAX and the time of the report had a scar from the rash. No treatment information was reported. The patient was unspecified dermatologist. The outcome of the event was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
pain at injection site on left shoulder persisted for 24 weeks after injection. Also myalgia radiating from injection site,
On 5/15/00, had increased redness, induration and warm to touch. On 5/17/00, induration 9 cm in diameter. No fever or vomiting.