chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash developed within 48 hrs of second dose; The rash is slightly itchy; Fever; Chills; Body aches; Headache; Pain in the arm the injection; This is a spontaneous report from a contactable Other HCP (patient). A 42-years-old non-pregnant female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 07Feb2021 09:15 (at the age of 42-years-old) as single for COVID-19 immunization and was administered at Hospital. The patient's Other medical history was reported as no. The patient's concomitant medications included Ibuprofen taken for unspecified indication start date and stop date was not provided. (other medications in two weeks). The patient previously took amoxicillin, biaxin, cefzil flagyl [metronidazole benzoate] and Flourescene Dye and experienced drug allergy. No oher vaccine was given in four weeks. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL0142), via an unspecified route of administration, administered in Arm Left on 17Jan2021 10:45 (at the age of 42-years-old) as single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 09Feb2021 at 06:00 (48 hrs of second dose), the patient developed rash as she woken up with the rash. Rash stated on arms then spread to chest, legs and face. The rash was slightly itchy. Prior to development, other symptoms included: fever, chills, body aches, headache and pain in the arm the injection was received. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was unknown.    Follow-up attempts completed. No further information expected.
CHILLS; 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. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Vaccinated pt admitted and tested positive for covid. NO VACCINE INFO AVAILABLE including dose, manufacturer, location, date, etc.
Presumed Bell's Palsy. Tearing of eye started 1/21/21, and produced R facial hemi-paresis 1/22/21.
6 weeks after flu vaccine, profound fever and leg weakness and paresthesia.  Recovered in about 6 more weeks, absent reflexes and ability to recover from stooping all returned. Information from Medical records state pneumonia, cough, sinusitis, chills, nausea, spots in eyes. msv
(REPORTED BY PATIENT'S HUSBAND, WHO WAS PICKING UP PRESCRIPTIONS FOR HER FROM URGENT CARE.) FULL BODY MUSCLE ACHES AND PAINS STARTING THE DAY AFTER THE VACCINATION. PAINS WERE MOST SEVERE IN NECK, WORSENING TODAY (2 DAYS POST VACCINATION). PATIENT PRESENTED TO URGENT CARE DUE TO SEVERITY OF MUSCLE PAIN/SPASM. WAS PRESCRIBED HYDROCODONE 5/325 AND TIZANIDINE 4MG.
Patient due for HPV immunization. HIB vaccine accidently given instead of HPV. Vaccine checked by 2 people prior to administration of vaccine but mistake was not caught prior to administration. Parent told of incident at time. Nurse Practitioner denied possible adverse reactions from wrong vaccine. Patient and parent denied adverse reactions at time of administration.
Pt experienced a fever of 102, axillary on 3/21/00 in the evening. A fever of 104.4 the following day 3/22/00. Saw an MD on the next day 3/23/00. Diagnosed with ear infection. Pt experienced a runny nose on 3/24/00. Physician told parents symptom were from MMR.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 77-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that vials had not undergone any temperature excursion. Total of 173 doses/vials were given from LOT 070H21A. Date the vial was initially stored in the refrigerator was reported as unknown. No treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received and included no significant information.
Patient reported to pharmacy day after receiving vaccine. She said her arm was ok but starting to get a little red and sore the evening after receiving vaccine. The next morning, her arm was considerably red  (hive-like) and swollen. She reported to the pharmacy with a red, hive like reaction on her entire upper arm with a large skin irritation at injection site. She had not tried any treatments, but since it was getting worse was going to report to the ER. She was not having any difficulty breathing or swelling or hives any other locations. Tried to call this evening for follow up but was unable to reach patient.
Immediately after the booster I developed a strong immune response (nausea, chills, fever, headaches, exhaustion, etc).  The headaches persisted for several months and was consistent with occipital neuralgia.  One month later, I developed moderate/severe tinnitus which appears to be a symptom of inflammation associated with occipital neuralgia.  I have been refractory to steroid treatments (prednisone, nerve block) and acupuncture.  The headaches have mostly subsided, but the tinnitus has not and seems to be getting a bit worse.
pt recvd vax & c/o rt hip pain & upper leg pain 6NOV95;exp numbness in lips& eyes bilat w/inability to focus on 10NOV95;pt hosp for bifacial paralysis & lower extremity weakness;GBS dx;c/o dysuria;22NOV95 mild lt peripheral facial weakness
Within a couple of hours of administration, patient's arm swelled up and got red within a couple of hours. Patient took shirt off at home and RXN had progressed and was hot to touch that evening. Patient ran temp of 101.4. Patient saw Dr. the next day (Friday) and who diagnosed the patient with cellulitis, started cephalexin 500 QID. Arm was red and warm to touch from shoulder to elbow. By Sunday, redness was going away and continued to decrease.
THE NEXT DAY AFTER VACCINATION THE AREA OF INJECTION OF ZOSTAVAX PATIENT DESCRIBED IT WAS SWELL, RED, ITCHINGAND HAD PAIN IN HER ARM. THEN SHE COMES AT THE PHARMACY IN 01/28/2018 DESCRIBING THE SAME SYMPTOMS IN THE AREA OF INJECTION OF PREVNAR. SHE DESCRIBED SYMPTOMS IN THE AREA OF INJECTION OF ZOSTAVAX HAVE IMPROVE WITH SOM HARDNESS STILL IN THE AREA.
Patient developed initial swelling, redness and pain around injection site. Reaction extended to rest of upper arm. Patient is receiving doses of diphenhydramine.
Pt presented and clinic with red maculo papular rash over body with some involvement and face. No dyspnea or airway involvement treated with prednisone, 20mg bid x 4d and OTC Benadryl. Child had no previous allergies but had also eaten peanuts on 7/26/05.
terrible rash/the rash got worse; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, Solution for injection; Lot Number: FA7484), via an unspecified route of administration, administered in left arm (left shoulder) on 03Aug2021 at 14:23 (at the age of 78-years-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. Patient did not get any other vaccines the same day or 4 weeks prior to vaccination. No problems with vaccines in past. No illness prior to getting the vaccine. On an unspecified date in Aug2021, patient experienced terrible rash probably started at least a week later of vaccination, and the week after getting the vaccine, the rash got worse and she went back to the pharmacist and showed them her arm and was told it was a rash and to have her doctor look at it. It was reported that, this was just not her saying she had a rash. Patient Stated it was getting better because she was putting on Cortisone 10 on it to control it. Therapeutic measures were taken as a result of terrible rash or the rash got worse with Cortisone 10. Adverse event not resulted in Emergency Room or Physician Office. At the time of this report, the outcome of event was recovering.  Follow-up attempts are completed. No further information is expected
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID taken from 27Dec2022 to 02Jan2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Patient arrived for second dose of Pfizer vaccine. Made provider aware that she has a history of syncopal episodes. Vaccine given. Patient sat in waiting area and began to faint. Provider alerted. Ammonia was broken and cold towel was placed on forehead. Patient came to and was given water and snacks. Mother was present. Observed patient for thirty minutes and she left with mother.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX and then developed shingles two weeks later. Further patient identifiers, lot number, expiry date or any further details regarding event were unknown.
Patient received a booster dose on 10/5 and the product expired on9/30/2022
Member complains of malaise and lymphinopathy in the armpit region of the arm that the member received the immunizations.
Patient received MMR and Varicella vaccine on 1/30/06. Present in out office on 2/20/06 with varicella. Hive rash and symptoms. Diagnosis: Varicella
3/3/07 Fever (102.4), leg pain, cannot walk or stand, unable to urinate, cannot sit on toilet, left-side abdominal pain, pain with palpation of thigh muscles, no erythema. (DTaP on 3/2/07 left thigh) complained of leg pain as soon as got home.  Did not want to walk. 3/6/07 diagnosed Influenza B.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovered with sequelae" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (24Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This was my booster shot after an April, 2021J&J vaccine. I did have an annual flu vaccine in my right arm. I have never had an adverse reaction to my annual flu vaccine whatsoever. I had an almost exactly the same reaction to the J&J dose in April but I did not report that reaction.  The following applies to both the reaction I had this week, as well as the April J&J.  I had a positive covid test in February, 2021. My symptoms were VERY mild.  I went to sleep comfortably at around 11pm after the 1:30pm vaccination. I felt fine. Approximately 12 hours after the injection I woke up with a fever (101.5), chills and severe pain all over my body.  Other than these 2 vaccinations, the only thing I can compare this to was a 2018 (breakthrough) influenza.  My entire body hurt. Movement of any type made it worse. I was sensitive to even the slightest touch. The weight of my body against my bed was painful.  Fatigue In both cases this year, the pain began early Saturday morning after the friday afternoon shot. In both cases the pain became less severe by Monday morning. and was almost completely gone by Tuesday night. It is now Wednesday night and there is only mild discomfort/stiffness on my head/scalp, neck, shoulders and middle back. (none of which have ever been sensitive until now). I am still feeling low energy. In the first instance, It took over a week to get my full energy back.  I got mild pain relief from tylenol.
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer and an 85-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the ZOSTAVAX by a healthcare provider (not further specified) at a clinic (lot number, dosage and route of administration not provided). On or about 28-FEB-2017, the patient was treated by a physician at a medical office for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claims damages including: injury to himself and economic losses. The outcome of Shingles was unknown. Causality assessment for shingles was considered as related to ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a registered nurse (R.N.) refers to unspecified number of infants of unknown gender. On an unknown date, the patients were vaccinated with ROTATEQ (orally, dose, frequency, lot# and expiration date were not reported). It was stated that the nurse was administering ROTATEQ daily to infants and most of them could drink from dispenser great, but some had unspecified issues on an unknown date. The outcome of adverse event was reported. Causality assessment was not provided. Additional information has been requested.
I received the injection at aprox 1:40 pm. After midnight while I was attempting to fall asleep I began itching, especially the tops of my feet. I found a raised welt on my breast the size of a quarter. I got up at 1:30 am to take an antihistamine pill as the itching had worsened. Shortly thereafter I broke out in hives. They covered my arms, hands, back of thighs, and legs. About 45 minutes after taking a single 10 mg pill of Loratadine, the hives and itching subsided.
Patient received the Yellow Fever Vaccine on 8/24/07.  On the way home, she started feeling bad, like she was getting the flu.  She had mucus in her respiratory tract and chest tightness. An hour and a half after the Yellow Fever Vaccine, she started wheezing, coughing and sweating.  On 8/26/07 she went to Urgent Care and the doctor gave her a breathing treatment and a prescription for doxycycline 100 mg bid and Prednisone 10 mg, six tablets and then decrease by one every other day.  And he ordered an albuterol inhaler. On 8/27/07 she saw Dr.; he diagnosed her with bronchospasm and some concomitant bronchitis.  He had her continue the doxycycline 100 mg but increase prednisone to 20 mg 3 tablets tid, then 2 tablets tid and then 1 tid after which she was to restart Prednisone 10 mg qd after finishing previous prednisone prescription.  He added Advair 250/50 one puff every 12 hours.
Dizzy, low pulse, low heart rate, low blood pressure, Light headed. Felt like she was going to pass out.
A spontaneous report was received from a consumer concerning a 90-year-old-female patient who while receiving COVID-19 Vaccine injection a lot ran out down arm. The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.  The patient received their first of two planned doses of  Batch number 027L20a on 20-Jan-2021 intramuscularly for prophylaxis of COVID-19 infection.  Action taken with   response to the event(s) was not provided. The event when given injection a lot ran out down arm and incomplete dose administered, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of device connection issue and vaccine under dose, lot # 027L20a with no associated AEs.
The patient presents with generalized weakness and fever.  She has been feeling weak in general for past 2 days.  She developed fever (103F) today.  She also has a decrease appetite.  She does not have any pain.  She denies any chest pain, headache, sore throat, abdominal pain.  She denies any cough, shortness of breath, vomiting, diarrhea, or dysuria.  She does not have any sick contact.  She received Pfizer COVID-19 vaccination about a week ago.  Since then, she has been feeling slightly weak and fatigued..   Given fluids and discharged to home stable.
C/O minor dizziness, tingling in bilateral hands, fingers 4 and 5. Pt states she is very anxious about getting her vaccine, and in the past she had epinephrine for a procedure and it had the same results of dizziness, tingling bilateral hands. -Monitored, released from OBS area in 30 minutes
Case number PHEH2014US017806, is an initial spontaneous report from a nurse received on 04 Sep 2014. This report refers to patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with MENVEO (batch number: not reported) intramuscularly on 04 Sep 2014. It was reported that MENVEO was exposed to temperatures down to 34 F overnight. No adverse reaction was reported since the maladministration (incorrect storage of drug).
pt c/o of bad pains & hurting in arms & legs;woke next morning w/t103, rash (face, neck, hands, elbows, side back, legs, lethargic, having does not feel good, stomachache
Patient started with a rash on the dordum of the hands and the distal legs on 1/27/04.  By the morning of 1/28/04, the rashhad spread to the entire body sparing the plantar surfaces of the hands, feet and the face.  The rash is a macular papular rash on most of the body.  On the distal legs, the rash is a large erythematous, indurated placque.  The rash is pruritic.  The patient has been afebrile.  The expiration date of the yllow fever vaccine is 2/17/04.
MMR vaccinated on 11/22/2005. Developed a few discrete circular eruptions on face and trunk on 11/30/2005. I developed further macular and multiform erythema eruption generalized to trunk, neck and extremities, without much constitutional SX.
Breakthrough case admission after 3 vaccines Moderna 6/13/21 lot# 047C21A;  Moderna 7/11/21 lot# 053C21A;  Moderna 2/16/22 Lot# 042J21A
Pt. called to discuss 2/5/14 PNEUMOVAX. Took call on 2/6/14 at 3:40 PM. Pt c/o painful left deltoid, red, hot, swollen and (L) axillary pain. Chills, feels shaky.
Break through COVID infection lasting 4-5 days. Significant fever and muscle aches for the duration.
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.