chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   In July 2022, the patient received the 2nd dose of Shingles vaccine. In July 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced flu symptoms. On an unknown date, the outcome of the flu symptoms was recovered/resolved.   It was unknown if the reporter considered the flu symptoms to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR112016   Additional Information: GSK Receipt Date: 25-Jul-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The patient just got the 2nd vaccine shot last week. It was reported as give yourself a few days to recover from it.  The patient had flu symptoms for a couple days. It was well worth it though if it kept him/her from getting shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR112016:1st dose case same patient (deletion case)
Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Respiratory tightness around 16:00, "hard to breathe in-felt need to breathe out with fatigue. Around 20:00, awoke from nap with cough, lungs felt on fire. In the AM, lungs felt irritated, throat felt irritated, and had cough. No self treatment. On 10/26/00, at 14:00, given Zyrtec.
2/1/07 Mother reported arm red, hot and swollen at injection site warm compresses applied, office visit-script for Amoxil given.  2/2/07 Office visit for recheck-Benadryl taken. 2/2/07-evening-ER visit-Augmentin and Prednisone started. 2/3/07-Office visit-improvement noted
By 10:00pm on 2/6/21 I started running a fever of 101 degrees and up to 102.5 degrees the next day on 2/7/21. The site of the injection on my left arm hurt so bad I couldn?t touch or move it.  I had the chills and was sweating badly. By Monday 2/8/21 my fever was gone but I was now nauseous and had the chills plus sweating anytime I got up to move around. By the evening on 2/8/21 I was vomiting.  I was  basically incapacitated for three days.
Patient received 1st dose of Moderna at approximately 12:30pm on 3/18/21. He did not stay the recommended 15 minutes on site for observation. He drove himself back to vaccination clinic parking lot at approximately 1:40pm and got out of his car hurriedly to get his mask from the trunk before speaking with EMS on site. He then reported to EMS his wife witnessed him have a seizure (eyes rolled back, unresponsive, stiffening of arms and legs) for 2-3 min approximately 1 hour after receiving his shot. He reported when he regained responsiveness he asked his wife what had happened as he reportedly had no recollection of the seizure, they decided to call the patient's sister and she directed them to return to site of vaccination to report his seizure.  EMS who evaluated patient reported he denied (and was not exhibiting) postictal signs/symptoms when he arrived back in parking lot at vaccination site. He denied having a history of seizures or any medical conditions. EMS also reported that neither the patient nor his wife called 911 after the seizure. Patient declined any further medical evaluation/follow up. EMS urged him to call 911 if he had anymore seizure activity to which he replied he thought if he just rested Friday and through the weekend, he'd be fine to return to work on Monday.
no adverse events, the patient received a Pfizer booster and had the  moderna vaccine in the original series.
Site: Pain at Injection Site-Mild, Systemic: extreme thirst and dehydration-Severe, Systemic: Headache-Mild, Additional Details: extreme thirst for first 48 hours then thirst for 6 days after
expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported by the reporter. No concomitants medicines were reported.
presents with critical COVID-19 infection requiring emergent intubation in the setting of immunosuppressed state secondary to active sigmoid cancer undergoing chemotherapy and status post sigmoidectomy, morbid obesity and triple vaccinated.
EYES BECAME VERY IRRITATED AND EVENTUALLY BECAME VERY SWOLLEN AND SHUT, ALSO WATERY.
Patient recieved Pfizer on 8/26/2021 and then recieved Moderna on 9-16-2021    Patient was informed.
NEW Years Eve LAST YEAR went into the hospital WITH PNEUMONIA; This spontaneous report has been received from a patient via Pfizer, referring to himself/herself, a patient of unknown age and gender. The patient got the influenza virus vaccine inactivated (unspecified) (reported as "flu shot") every year and this year it was a high dose one. The patient got flu big time at the year he/she did not got the flu vaccine. Information about concurrent conditions, concomitant therapies and drug allergies was not provided.     On unknown dates prior to last year, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, route and dose details were unknown) and pneumococcal 13v conj vaccine (crm197) (manufacturer unknown) (lot #, expiration date, route and dose details were unknown) for prophylaxis.      On approximately 31-DEC-2019 (reported as New Year's Eve last year), the patient went into the hospital with pneumonia (the actual event start date was not reported), which caused the patient hospitalized.      The outcome of the event was unknown. The causality assessment between the suspect products and the event was not provided.  Upon internal review, pneumonia was determined to be medically significant.
had a high fever 103 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a high fever 103 degrees F) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (had a high fever 103 degrees F). At the time of the report, PYREXIA (had a high fever 103 degrees F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-023079 (Patient Link).
Only felt tired and then a slight headache several hours after vaccination. Next morning, still had headache, but feeling nauseous. Just sipped water occasionally for a few hours. Just sat on couch for little while. When I started feeling a stronger nausea, I went to kitchen sink. I soon felt dizzy, next thing, I woke up on the kitchen floor with a bruise on my head! This has never happened to me in all of my life! By lunchtime (11:00 a.m.), ate some plain yogurt, 20 min. later I threw it up. I sat down for a while, then laid down for an hour. Just sipped water all day and evening. Nauseous headache continued. Feeling a little better Thursday morning.
5/8/06 pt here for redness and swelling around face and right leg, had vaccines 1 hr prior to this reaction. Gave Epinephrine 1:1000 solution 0.2mg (.2ml) SQ, SIG clearing after 5 mins, after 10 mins only had mild edema of lip. HR 88
This spontaneous report as received from a registered nurse (R.N.) refers to a 18 year old female patient. On an unknown date the patient was vaccinated with the second dose of GARDASIL (lot # not reported) (dose not reported, route reported as injection). Concomitant therapy was not reported. On an unspecified date the patient experienced swelling of the throat after receiving her second dose of GARDASIL. The patient went to see the doctor. At the time of the report the patient' outcome was recovering. Additional information is not expected.
Pt. fainted after receiving 2nd vaccine in office, MA took her BP 112/69 and pulse was 55; Pt c/o HA and was given adult dose of MOTRIN.
GI symptoms; This is a spontaneous report from a contactable consumer (patient's sister). A female patient of an unspecified age bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated while reporting on herself she mentioned another sister who also had GI symptoms after the COVID vaccine. She felt like got off easy by not having their symptoms. Caller mentioned the sister did a vsafe report and declined to go through a report. Did not clarify what GI symptoms occurred. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever ranged from 100 to 102.9 degree Fahrenheit/ still had a fever of 100.7 at 2 am in morning of reporting date; Had nausea when her fever was high; Loss of appetite when her fever was high; Chills /chills would also happen when her fever was high; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th November 2020, less than a day after receiving Shingrix, the patient experienced chills. On 14th November 2020 11:00, the patient experienced fever, nausea and appetite lost. The patient was treated with paracetamol (Tylenol). In November 2020, the outcome of the chills and nausea were recovered/resolved. On 18th November 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the appetite lost was not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, nausea and appetite lost to be related to Shingrix.  Additional details were provided as follows: The patient had fever on morning of next day after vaccination. The fever had ranged from 100 to 102.9 degree Fahrenheit. The patient did had a fever of 100.7 degree Fahrenheit at 2:00 am on reporting date and took Tylenol and the fever had resolved at the time of reporting. On the same night of vaccination, the patient also had chills and the chills also had happened when her fever was high.  She also had nausea and loss of appetite when her fever was high and did not have an appetite till the time of reporting. Patient did not have lot number or expiration date information to provide.  The reporter consented to follow-up and also gave consent to follow-up with health care professional.
1 of 3 pts (of the first 5 doses of Tetramune administered from vial) who devel an inject site react of induration, erythema & warm to touch w/in 24 hrs; react approx the size of a fifty cent piece; no treatmnet initiated;
Experienced sever burning and rash on the left side of my chest that extended to the left part of my upper back near the shoulder blades.  Upon seeking medical care, I was informed that I had shingles.
SWELLING AND TENDERNESS IN LYMPH NODES UNDERARM LEFT SIDE ONLY. RESOLVED IN 5 DAYS.
Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump  is sore and itches, trouble breathing, body aches
Blister-like lesion to left buttock then spread of lesions to entire buttock, trunk, and upper extremity bilaterally approximately one week later.
Headache, Full body hives, itching, mouth numbness with top lip swelling.  Hives still present as of this date 08/21/21. Lip swelling resolved with Benadryl.  Urgent care visit- recommended Benadryl every 4 hrs, go directly to ED if mouth numbness or lip swelling occur again.
The patient experienced a rash on the left arm a little below the injection site starting on 09/30/2020 in the morning . It was red and sore to touch. It got better after taking antihistamines and applying cortisone cream. The rash cleared up as on 10/01/2020 evening.
Received vaccine and then 4 hours later arm started hurting and that night she had night sweats and chills, Sunday she had severe fatigue and slight headache. That night same thing-night chills and sweats alternating. Monday fatigue and nothing else. Then the arm was red and the pain in the arm went away. Tuesday and yesterday afternoon she noticed the redness hot gotten bigger. Started taking Ibuprofen again. She reports this morning not as red, but it is still hot and did not spread. The redness has spread to about there, now warm to the touch, but not as hot.
Soreness in arms; Very little reactions; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in arms) and ADVERSE REACTION (Very little reactions) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in arms) and ADVERSE REACTION (Very little reactions). At the time of the report, PAIN IN EXTREMITY (Soreness in arms) and ADVERSE REACTION (Very little reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-033403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow up received on 20-JUL-2021. patient demographics were updated.
It was reported that a 2 month old male pt received an IPOL (lot TDT32-2) on 4/26/01. Reportedly, on 5/1/01, the pt developed hypotonia, laryngeal edema, vomiting, retching, drowsiness and lethargy. The pt was hospitalized. Further information is requested. From telephone contact on 1/21/02, it was reported that the pt received Infanrix, Engerix and Pedivax-Hib in addition to the IPOL. No lot number information was provided. The pt was released from the hospital the afternoon following administration. His mother subsequently, reported the infant was "back to normal". Note that the lot number (TDT32-2) provided for the IPOL product is not an Aventis Pasteur lot number. Further efforts for clarification will be made.
Adverse event: swelling, erythema, pruritis and increased heat around the injection site which has become progressively worse over 3 days since injection Treatment: Tylenol, cold compresses, xyzal twice a day
psoriatic arthritis flare up; achy; chills; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4271535-00 (AbbVie).  A 44 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 04Mar2021 (Batch/Lot number: unknown) at the age of 44 years as dose 1, single and intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1155994) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "not recovered", described as "psoriatic arthritis flare up"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "achy"; CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills". The action taken for adalimumab was dosage not changed.  The reporter's causality for the event(s) of Psoriatic arthritis flare up with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of Achy due to covid vaccine and Chills due to covid vaccine with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter's causality for the event(s) of Psoriatic arthritis flare up, Achy due to covid vaccine and Chills due to covid vaccine due to covid vaccine with bnt162b2 (BNT162B2) was not related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The evening after the vaccine administration, patient started to develop redness at the injection site. The redness spread throughout the entire upper arm, and part of the shoulder. Patient states reaction site was hot to the touch, and developed a fever of 103 degrees F. Patient reported to the pharmacy 2 days after the vaccine was given, stating she thought she had an allergic reaction to one of the vaccines she was given. Fever subsided overnight the day the vaccine was given, but 2 days later arm is still warm to the touch and redness still remains. Recommended that patient could take BENADRYL for the reaction, but had not previously taken.
24hours after immunization patient experienced dyspnea - called office 3-8-21 - referred for CTA chest given symptoms + for bilateral pulmonary emboli, NO history of such and NO obvious predisposing risk
Pt recv vax on 9/10/98; on 9/24/98 pt exp local rx w/ swelling & vesicles; 9/25/98 pt exp fever, chills, fatigue, pustular lesions & pruritus
AFTER PATIENT GOT FLUARIX VACCINATED, SHE DEVELOPED AN INLAMMATION AT THE AREA OF UPPER ARM, SHE WENT TO SEE HER DOCTOR WHO FOUND OUT SHE HAS AN INFECTION THAT REQUIRED AN ANTIBIOTIC (DOXYCYCLINE )SHE WENT TO PHARMACY THE NEXT DAY TO TELL ME WHAT HAPPENED TO HER AND PICKED UP HER DOXYCYCLINE PRESCRIPTION
Loss of smell; lost her taste; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in left arm on 15Mar2021 at 10:00 hours as 1st dose, single dose (at the age of 61-year-old) for COVID-19 immunisation. Patient had no medical history (including any illness at time of vaccination). Patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 15Mar2021 at night, patient lost her taste and smell and had diarrhea. Patient stated that diarrhea stopped at night only and got her taste and smell back today (16Mar2021). Patient declined any treatment for the events. Patient did not get any blood work or diagnostic testing done. Patient had no emergency room and physician office visit. Patient asked if a person was supposed to had side effects after receiving the COVID-19 Vaccine and stated she was scheduled for her second COVID-19 vaccine on 05Apr2021. The outcome of diarrhea was recovered on 15Mar2021 and recovered for rest both the events on 16Mar2021.  No follow up attempts are possible. No further information is expected.
Headache, Fever, L DELTOID SWOLLEN, LOWER BACK PAIN Narrative:
Pt complained of tenderness left neck base and tenderness chest wall lateral to left breast. No visible palpable changes at the injection site. Pt treated with Darvocet.
On 3/1, patient called to report a rx she was having to the Td vaccine given on 2/21.  She said she felt it was something to do with the nerve in her left are where the vaccine was given.  She plans to see her Dr. on 3/2. On 3/7 patient said the Dr. said the nerve was inflammed, ordered Relafen to be started on 3/7 and told her it might take a while to heal - maybe as long as a month. She said she felt a burning sharp pain shoot down her arm when the nurse put the needle in her arm on 2/21 when she got the vaccine.  The sensation calmed down by the time she stopped to check out of the clinic.  There was muscle soreness for the next 2-3 days and the burning nerve pain came and went. 3/13 - patient is improving.  Taking only ibuprofen.
took it twice years gone by got the flu three days after; Initial information received on 22-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp via social media.  This case involves patient of unknown demographics who took it twice years gone by got the flu three days after   while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, frequency, formulation, route, lot number and expiry date was unknown) for unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious  event "took it twice years gone by got the flu three days after" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (took it twice years gone by got the flu three days after  ).  At time of reporting, the outcome was Unknown for the event took it twice years gone by got the flu three days after  .
no AE/PQC reported; temperature excursion/PROQUAD was Improperly stored and administered; This spontaneous report has been received from nurse referring to a 2 years old patient with unknown gender.  Information about concurrent condition, concomitant medication and medical history was not provided.  On 19-AUG-2021, the patient was vaccinated with a improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant Human albumin/rHA) (lot # T034824, expiration date reported as 01-APR-2022, but upon internal validation established as 11-APR-2022; dose detail and route of administration were not provided) for prophylaxis (product storage error). The vaccine was stored above -15 degree Celsius (-13) for 30 minutes. Previous temperature excursion was also reported. No adverse effects reported at this time.