chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 09-NOV-2015 the patient was vaccinated with ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
patient said it hurt immediately and continued to hurt. It did not improve and continued to hurt over the period of time when she followed up with me twice. (12/27/19 11:45am and 1/17 11:40am).  Description included stiff in the morning and hurt while reaching for things and was a dull achy feel.  It only hurts pin-point where the shot was given. I advised her each time that she should try ibuprofen for inflammation and may add Tylenol for pain as needed. I advised to alternate between heat and ice as needed for pain/inflammation as well. Following up the second time, patient had not done what I had advised. She seemed to understand that it may improve it instead of just waiting. She also lifts heavy items for her occupation which may contribute to the inability to heal if there is inflammation.
pt. vax'd w/ 3 doses of Hepatitis B vaccine in approx OCT86 following vax developed Guillian Barre synd.
Patient was given the pfizer primary series for age 4 years old when patient had already turned 5 years of age prior to third dose. No side effects were noted. No complaints from patient.
Headache, muscle pain, nausea Woke with a headache and a sore neck (history of previous injury, so the location is not significant and I only include to show that it was not full-body muscle pain). Pain decreased with the administration of excedrin. Nausea began around 7:30am, no treatment administered.
developed shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 86-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 5 (booster), 30 ug single (Batch/Lot number: unknown) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 4), for COVID-19 immunization; Bnt162b2 (DOSE: 3, Route of Administration: Intramuscular), for COVID-19 immunization; Bnt162b2 (DOSE: 2, Route of Administration: Intramuscular), for COVID-19 immunization; Bnt162b2 (DOSE: 1, Route of Administration: Intramuscular), for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious), 7 days after the suspect product(s) administration, outcome "unknown", described as "developed shingles". The event "developed shingles" required physician office visit.  Additional information: The patient received Comirnaty Bivalent COVID-19 Vaccine Booster. She received the 2 dose primary series and boosted, and this was her 5th dose. The patient received Comirnaty Bivalent COVID-19 Vaccine Booster a week and a half to 2 weeks ago and 7 days after the vaccine developed shingles and was diagnosed by her PCP. Patient did not receive any prior vaccinations (within 4 weeks).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
ARM FELT SWOLLEN; REDNESS ALL OVER; HEADACHE; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, vaccinated on left deltoid, once a total administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced arm felt swollen. On 26-MAR-2021, the subject experienced redness all over. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt swollen on MAR-2021, and had not recovered from headache, fever, and redness all over. This report was non-serious.
10 minutes after receiving reported tingling around lips & arms with heaviness in chest. Sent via 911 to hospital. Told reaction to preservative in vaccine most likely cause.
Ulcerated lesion over R deltoid in area where vaccine was administered.  Note:  Patient also had UTI at the time of the event and led to hospitalization.
4 mo shot, given & explanation of possible Rx.  Took infant home & 2 hours post shots started crying almost non stop.  Brought back to clinic & right leg red Dr recommended to try MOTRIN & cool compress.  2 hours post seen & given MOTRIN infant fine & leg no longer red.
Patient presented to the ED on 3/3/2021 and was subsequently hospitalized. After 4 days he was transferred to Clinic on 3/7/2021 for another 10 days.
Fever and chills for 24 hours and swollen lymph node under left arm for 3/4 days
No additional AE/no PQC.; HCP reporting that VARIVAX was administered after it experienced a supported temperature excursion. No side effects were reported. No additional information provided. No additional AE/no PQC.         ?    Names of vaccines involved (including lot/e; This spontaneous report was received from Other Health Professional and refers to a 17-year-old patient of unknown gender,   The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 11-OCT-2023, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 ml, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided).  On 11-OCT-2023, HCP reported that VARIVAX was administered after it experienced a supported temperature excursion (Temperature: -9 C for 4 hours, 30 minutes). No side effects were reported. No additional information provided. No additional AE/no PQC.
Did not give her the second covid-19 vaccine; Severe hives for 3 weeks; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of URTICARIA (Severe hives for 3 weeks) and INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (Severe hives for 3 weeks). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine). At the time of the report, URTICARIA (Severe hives for 3 weeks) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not give her the second covid-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication including thyroid meds was reported Treatment using diphenhydramine was reported  Reporter did not want to share email, does not have any other patient info   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter stated intentional omission of second dose, event updated
pt recv vax 19SEP96 & awoke the next morning w/lt nipple red, inflamed & swollen;seen in ER thought it was an infect but could not rule out a rxn to vax;all sx were resolved w/in 3 days of starting the  ATB;
This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, approximately in 2015, the patient was vaccinated with improperly stored RECOMBIVAX HB INJ 2.5/0.5, lot # K010535; expiration date 27-AUG-2016, 0.5 ml/once, intramuscular. No adverse effects were reported. There was no additional information to report. Follow up information was received from healthcare worker on 18-JUN-2015 who reported that the patient received subsequent dose of RECOMBIVAX HB on an unknown date. The reporter stated that they received letter but had no further information to provide. Additional information is not expected as the reporter requested no further contact regarding the case. General, Products and Narrative were updated.
Case previously recorded as MA2009-3284. Initial case report received from a newspaper article via MedCom, on 27 OCT 2009. A patient, between 6 months to 9 years old (no further identifier), was vaccinated i.m. with S-OIV FLUVIRIN (batch no. unknown) in 2009. The patient received twice the normal dose for a child, six other children ages 6 months to 9 years were also double dosed, maybe due to similar packaging between the vaccines for adults and children. No adverse event was reported. Addendum 02 NOV 2009: Despite request there is no further information available. The cases MA2009-3285 to MA2009-3289 have been combined under case number MA2009-3284 (the events could not attach to the patients). No change in assessment. Reference no.: NA09-007089.
Fever of 103.8, body aches, chills, head ache, sweats, diarrhea, vomiting, nausea
My upper left arm where pneumonia shot was given hurt for 15 days, it turned real red and was very warm to the touch. It's still a little discolored on inside of arm.
Swelling radiating down arm away from injection site, warmth on touch, slight itching.
On Jan 8 - To urgent care - on Jan 9- admitted to Medical Center for extensive blood clots in my left leg- disch on Jan 16 - readmitted on Jan 13 -Pr increase blood clots in my (L) leg and abdominal clots - thrombectomy was done - removed many of the clots - disch on Sat - Jan 15 on Eliquis - I am still on Eliquis. No family Hx- no fall - Doctors unable to pinpoint cause-
Report received from a physician on 03-OCT-2008.  An 88 year-old patient received AFLURIA (batch unknown) on 30-Sep-2008 and experienced a fever of about 103F within 2 days of administration (02-Oct-2008).  The fever resolved (date unknown).  Awaiting further information.  Serious criteria: None; Causality: The company assessed this case as possibly related.  Information derived from this AE report does not change the current safety profile of the product.
patient is over a year past due for dose two of Shingrix; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix. (1st dose received on an unknown date).   On an unknown date, the patient received 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 details were provided as follows:  The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist reports the patient was over a year past due for dose two of Shingrix. The healthcare professional did not provide any patient demographics, lot number, expiration date, or exact date of 1st dose of Shingrix. The reporter did not consent to follow up.
Chest pressure, Malaise x 24 hours  DX. Pericarditis
I received my first vaccine February 16th, 2022. The next day I called the on call nurse due to mucus plug pieces coming out. Eventually it had stopped. My second vaccine was given March 9th, 2022. The next day my hips were very sore, I had to call off work for the 11th. I went to work on the 12th and the next day on the 13th around 6pm my water broke. I am now in the hospital receiving treatment. My due date is July 9th, 2022. I am currently only 23 weeks and 2 days pregnant. There were no complications with this pregnancy before this experience or worries at any of my appointments.
Headache within a few hours of the vaccination and lasted 10 hrs. Vomiting 9hrs after the vaccination.
Uncontrollable shakes, chills, nausea, body aches,  headache, onset in middle of night suddenly. Treatment with rest and hydration. Body aches and headaches and fatigue lasted all next day. Uncomplicated pregnancy. Edd 10/31/2021.
Arm pain; Pain all over my body; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) and MYALGIA (Pain all over my body) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2021321A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Arm pain) and MYALGIA (Pain all over my body). At the time of the report, VACCINATION SITE PAIN (Arm pain) and MYALGIA (Pain all over my body) had resolved.            No relevant concomitant medications were reported.   Treatment information was not provided.  On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form." to "On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.", as the dose was not changed.  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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Action taken changed to not applicable; coding of both events changed; listedness changed accordingly; narrative updated accordingly.; Sender'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.
I had a UTI 2 days after each dose of the vaccine; This is a spontaneous report from a contactable pharmacist (patient). A  patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: En5318), dose 2 via an unspecified route of administration, in Left Arm on 25Feb2021 as 2nd dose, single for Covid-19 immunisation. The patient medical history included allergic to sulfonamide. The patient did not receive any other vaccine in four weeks of vaccination. Patient was not diagnosed to COVID, prior vaccination. Patient did not test for COVID, post vaccination. The patient had received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: En5318) via an unspecified route of administration, in Left Arm on 04Feb2021  as 1st dose, single for Covid-19 immunisation. The patient concomitant medications were not reported. The patient had experienced a UTI 2 days after each dose of the vaccine" on 27Feb2021. The event led the patient to doctor or other healthcare professional office/clinic visit. Patient received the treatment as ciprofloxacin for the events. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Symptoms Patient received Men B vaccine on 7/10 -- and then had hives on 7/14/2023 after going out to dinner.  Mother gave patient allegra on the 7/14 -- then benedryl the next day and had about 75 % resolution of hives.  Mother has added some pepcid as well.  Patient did have swollen lips about 2 days after the initial hives, but no swelling inside of mouth/throat.  Patient has been taking benedryl about every 6 hours.  Last benedryl was at about 8:30 a.m. today.  Mother had a similar reaction to the covid vaccine.  This patient and her sister did not have any issues with covid vaccines.  Patient hasn't had any new products or foods prior to the hives.  No fever, cough, congestion, emesis, diarrhea..
The patient stated that her right arm has been tender and sore to the touch between the elbow and shoulder joints. She said this developed over a few days after receiving the flu shot and has not improved since then. The immunization was administered on 9-23-2017 and she reported the problem to us on 10-25-2017. The patient is currently taking several pain medications as previously listed, but is still experiencing pain and some weakness at the site.
08/24/21, 4:20 PM,, sore throat and cough started today, last shifts worked 08/23 and 08/20, she states that her manger told her she was exposed at work on 08/19, has no record of that exposure, COVID test ordered to be done per her request.
Headache within 15 min. of getting the shot.  not feeling well and my whole left arm hurting  about 120 min. of getting the shot.   dizziness, chills, nausea and cold sweat lasting for another 120min.  headache lasted longer
Pt. c/o low grade fever and injection site was red, swollen, and painful to touch for 4 days after injection.
Hives without other symptoms.  Treated with Benadryl and then Zyrtec.
VOMITING, CONGESTION, MUSCLE ACHES AND FATIGUE, HEADACHE, NAUSEA, MALAISE, BLACK SPOTS IN LINE OF VISION
PT in 2nd week of smallpox vax when bandage fell off in left axilla region. Increased pain increased vesicles (3) increased erythema. Pain 2/10 no fever. PT feels fine. Auto inoculation? (reporter put question mark)
Tightness on chest would come and go for 3 days Tightness on rear of neck would come and go for 2 days Inflammed Liver for a week
Wheezing, gasping for air.  Went to local Emergency Room and treated with IV Prednisone and nebulizer treatment
This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included fish oil. On 2nd July 2018, the patient received the 1st dose of SHINGRIX. On 3rd July 2018, 1 days after receiving SHINGRIX, the patient experienced headache and light headedness. On an unknown date, the outcome of the headache and light headedness were recovered/resolved. It was unknown if the reporter considered the headache and light headedness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient received SHINGRIX in the left arm. The events lasted for 24 hours. The contact details of the physician was provided. For tolerance to next dose, refer case US2018164489.
Hives over entire body; muffled hearing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives over entire body) and HYPOACUSIS (muffled hearing) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016MZ0A and 032M20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, RIVAROXABAN (XARELTO), CARVEDILOL, METFORMIN, ALOPURINOL, SEMAGLUTIDE (OZEMPIC), EVOLOCUMAB (REPATHA) and COLCHICINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced URTICARIA (Hives over entire body) and HYPOACUSIS (muffled hearing). At the time of the report, URTICARIA (Hives over entire body) and HYPOACUSIS (muffled hearing) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient went to emergency department due to symptoms. Treatment information was provided as Antibiotic, Steroid Shot in Knee, diphenhydramine hydrochloride Cream, Prednisone Cream.
Complex febrile seizure (history of same in past) eventual admission to hospital, of course unclear if related time course wise to immunizations.
Not known adverse effects; an administered dose of M-M-R II underwent a temperature excursion prior to being administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications were not provided.  It was reported that an administered dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) by subcutaneous route, for prophylaxis, lot number R014689 and expiration date 23-MAY-2020, underwent a temperature excursion prior to be administered (product storage error). The temperature excursion started on the evening of 09-JUL-2019 and finished on the morning of 10-JUL-2019, it was reported as 12.4 Celsius degrees during a time frame of 19 hours. Data logger was involved.  On 10-JUL-2019, the patient was vaccinated with the improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II), after the temperature excursion had concluded. No adverse effects were reported. ; Sender's Comments:  US-009507513-1907USA008694:
Fell to floor - pale, fainted.  V/S taken 430p 94/68 P 64 R 18. 435p 98/70 64 - 18.
Pt recvd dose of Engerix-B approx 3 mins p/inject devel nausea & vomiting; tx DPH; became drowsy, lt work early to go home to sleep; missed next work day; said was still tired & tongue felt raw;
Vaccine leaked out at the syringe and hub connection. 2nd vaccine administered Needle-25Gx1m Lot 4155460 vaccine syringe- Lot UT7317JA
5/9: presented with chest pain and found to have elevated troponin T concerning for myocarditis. He was taken to the ED with chest pain and tightness while playing computer games associated with palpitations Thursday night, 5/8. Mother reports that he received his COVID-19 vaccine the second dose on 5/5/21. She denies any fevers or other associated symptoms. Patient mentions that his chest pain was 7-8/10 at the presentation. He had labs done at the outside ED and found to have abnormal EKG with mild ST elevation and elevated troponin T.  5/10: Cardiac MRI confirmed myocarditis. S/P IVIG and aspirin. Troponin trending up to 1.13. echo continued to show normal function.  5/11 No acute hemodynamic issues overnight. Lactate trending down to 0.83.  discharged home with instructions to follow-up with cardiology.
Initial report was received on 03 January 2013 from a non-healthcare professional. A 42 year-old male patient who had no illness at the time of vaccination, had received on 03 December 2012 an intramuscular left deltoid injection of ADACEL, lot number C4181AA and immediately after vaccination, experienced neuropathic pain and weakness in the left arm. As of 03 January 2013, the patient continued to have the neuropathic pain and weakness in the left arm. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
14 x 16cm area circumferential redness, induration area inj site; severe local rxn lt arm
Rash on face, lower face on chin, chin line and around mouth. Rash also on different parts of body including chest, back, inner thighs and scalp.