chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 3 hours after vaccination, the patient was noted to have a bright red blotchy rash all over the body (face > trunk). Some, periorbitally, appeared to have small wheals associated with the redness. No respiratory distress. Given BENADRYL, sent to ED for eval/obs.
Pt vaccinated with DTP/OPV developed fever 105 (R), Screaming, Fussing.
8PM noc of shot c/o inc temp (did not take temp) & rash that itched (over entire body)  25AUG devel mac papular rash; upon exam by MD throat sl erythematous w/enlarged lt tonsil;
Significant abdominal pain lasting 4-5 hours the morning after the vaccine.  Seen in Urgent Care with normal exam.
HEAVY FEELING ON HIS BOTH ARMS; CONFIRMED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 (TEST UNSPECIFIED); This spontaneous report received from a consumer concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart valve replacement last year, and concurrent conditions included allergic reaction to anesthesia, non-alcohol user, and non-smoker, and other pre-existing medical conditions included patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, 1 total administered to left arm (deltoid) on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-JUL-2021 (last Sunday) patient started to develop dry cough towards the end of the day. On 19-JUL-2021 (Monday) patient started to experience weakness, heavy feeling on his both arms, fever with a temperature between 99-100 degree Fahrenheit, achiness all over the body, chills, headache and nausea. Patient decided to visit to the hospital. Patient undergone a series of blood test, flu test, pneumonia and Covid-19 test. On 23-JUL-2021, patient clinically tested positive of COVID-19 [Suspected covid-19 (test unspecified) and confirmed clinical vaccination failure]. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid 19 (test unspecified), and heavy feeling on his both arms, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187127.; Sender's Comments: V0: 20210753055:Covid-19 Vaccine Ad26.Cov2.S: Confirmed Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Vaccine that was given was drawn up on 06/29/2021. Recommended time for administering vaccine from draw time is 12 hours. A vaccine was administered that was drawn up the previous day.
Patient developed a large rash around the injection site as well as a fever. Patient treated in the hospital and given a prescription for a steroid cream and released. Fever had gone away but rash still present as of 9/24/12.
Nerve pain; This case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included post herpetic neuralgia (The patient also experienced nerve pain from shingles) and shingles (the patient had Shingles in November 2021). Previously administered products included Gabapentin and Tramadol.   In August 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: After the patient was pain free for about 3 weeks, the patient received her first dose of Shingrix.  Within days after receiving the Shingrix vaccine, the patient experienced nerve pain in the same area as before, although the pain was not as bad.  This nerve pain had not resolved.  The patient did not wish to provide contact information.  The patient did not wish to provide consent for follow up. The reporter did not consent to follow-up.
My left arm was injected with the 2nd dose of the Covid-19 vaccine.  The surrounding area where the vaccine was injected is swollen and its been 3 days now and my arm is itching.
This spontaneous consumer report (initial receipt 11-Feb-2015) concerns a female patient. On the 06-Oct-2009, the patient received influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient became very sick. The patient went into fetal position within 24 hours after vaccination and became hypersensitive, slided her legs out and moved her head in circles for weeks. Weeks later, the patient went to the medical centre and the doctor stated that she experienced Guillain Barre Syndrome and encephalitis. She was treated with antibiotics. The patient did not recover and passed away in Feb-2014. The exact cause of death was unknown. The outcome was reported as not recovered. Reporter's comments: It was reported that the exact cause of death was unknown. The reporter did not specify how her mother passed away or if it was related to the flu vaccine.
Had rash and fever of 102F and increasing. Pain if moved, stiffness and soreness at shot spot. Behavioral changes noticed first. Asked if it could be a reaction and "no" was the answer. Read article and as far as we can tell, no learning disabilities. Always felt that it was related to vaccinations but wasn't known if all the shots brought his immunity down so low that he contracted something else. Hospitalization for 3 days, following blood cultures that showed viral meningitis (not bacterial meningitis). Was treated with antibiotics in case it was bacterial until cultures came back. Following Tylenol was the treatment. Low fever came 1st boy 9/13/99. Rash on 9/17/99 (went to MD's office). Symptoms persist. Visited doctor on 9/19/97, 9/21/97. Spinal tap showed meningitis and he was admitted.
1500 pt reports not feeling well. Reports nausea and "thinks he's going into A-fib" Pt appears A&O, pale diaphoretic. Ambulated to exam room #1 without asst and EMS was asked to asst. Pt seated on cot. Pale and sweating. Apical assessed appeared to be brady and erratic possible AFib. Pt denies CP, SOB no radiating pain. PMH only Afib no DM2. 1504 EMS reports 114/58 and HR46/51 NSR confirmed on EKG with O2 sat 77% Pt remains A&O 1509 123/64 pulse 57 NSR on monitor-pt "feel better and the AFIb is gone I think"  Wife and SIL arrived at apprx 1520. PT stable No CP, SOB denies any more nausea Declines transport to hospital and encouraged to contact Agency 1548 BP 146/58 with HR 61 water consumed.
Information has been received from a physician concerning a female patient who was vaccinated with three doses of GARDASIL. It was reported that patient was positive for GARDASIL getting all three doses of vaccination. The patient did not get the vaccination at the reporting physician's office. The physician reported that the patient was High Risk for HPV. No other information to report. The outcome was reported as patient positive for HPV at the time of this report. Additional information has been requested.
Severe pain in upper arm and greatly decreased arm mobility for approximately one week after the date of the vaccination; arm mobility one day after the vaccine was approximately 30 before extreme pain; mobility gradually increased over the course of a week. One arm received BEXSERO and one received MENACTRA; GARDASIL 9 was administered in the same arm as one of the meningitis vaccines; both arms experienced similar degrees of incapacitation A doctor was not seen for these symptoms as they were improving, albeit slowly.
This case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Influenza vaccine Quadrivalent. Co-suspect products included VENTOLIN HFA inhaler (batch number Unknown, expiry date unknown) for exercise induced asthma and BREO ELLIPTA inhalation powder for cough. Concurrent medical conditions included exercise induced asthma. In November 2016, the patient received Influenza vaccine Quadrivalent. On an unknown date, the patient started VENTOLIN HFA (inhaled) 1 puff as needed and BREO ELLIPTA at an unknown dose and frequency. In February 2017, 91 days after receiving Influenza vaccine Quadrivalent and not applicable after starting VENTOLIN HFA and BREO ELLIPTA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), cough and off label use. The patient was treated with prednisone. The action taken with VENTOLIN HFA was unknown. The action taken with BREO ELLIPTA was unknown. On an unknown date, the outcome of the vaccination failure, influenza, pneumonia, cough and off label use were unknown. It was unknown if the reporter considered the vaccination failure, influenza, pneumonia and cough to be related to Influenza vaccine Quadrivalent. It was unknown if the reporter considered the influenza, pneumonia and cough to be related to VENTOLIN HFA. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient was taking VENTOLIN for years. In Feb 2017, approximately 3 months after receiving Influenza vaccine Quadrivalent the patient experienced influenza. The influenza was diagnosed by a nasal swab. Less than a year after receiving Influenza vaccine Quadrivalent, the patient experienced pneumonia and cough. After recovering from the flu, the patient developed a cough that was initially treated with one week of prednisone. After the patient completed the prednisone, the cough came back and the patient started taking BREO ELLIPTA to treat the cough, which led to off label use as the BREO ELLIPTA was not indicated to treat cough.
Mother notes the day after the vaccine, she started her first period. She is not sure if this is a side effect of the vaccine, but felt this data point was worth sharing.
Rash & UrticariaPruritus Narrative:  Left elbow, back of head, and left knee rash developed the same day  of the vaccination (left deltoid) and persisted for 2 weeks. Described as  erythematous, pruritic, and warm to touch. No associated pustules, fluid filled  areas, open sores, or serosanguinous drainage. Applied triamcinolone 0.1% topical bid (had prior to this). Elbow and knee described as being well circumscribed around joint. Unknown distribution of back of head. He  experienced some associated headache, fatigue and injection site tenderness,  which resolved within 1-2 days after the vaccination. No other adverse effects  described.
GROIN PAIN; This spontaneous report received from a consumer concerned a 6 decade old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-infectious intermediate, posterior and panuveitis. The patient was previously treated with covid-19 vaccine ad26. cov2. (suspension for injection, intramuscular, batch number and expiry were not reported) dose was not reported, 1 in total, administered on 21-APR-2021 for prophylactic vaccination. (Dose number in series was 1). On an unspecified date, the patient experienced groin pain (Dose number in series was 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: Unknown) dose was not reported,1 total administered on 31-OCT-2021 for prophylactic vaccination. (Dose number in series was 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (suspension for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate, posterior and panuveitis. No concomitant medications were reported. On an unspecified date, following vaccination with booster dose covid-19 vaccine ad26.cov2.s the patient experienced groin pain (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from groin pain. This report was non-serious. This case, involving the same patient is linked to 20211221612.
Information has been received from a physician a pt who in Oct/Nov05, who along with 6 other pt's was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 650331/0749P and 649989/0579P). Some pt's were first time vaccinated while others received a previous injection at least 5 yrs ago. Concomitantly they were vaccinated in separate sites with a dose of influenza virus vaccine (unspecified). Subsequently, the pt developed severe local reactions. The pt was reported as recovered. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review of the quality control system revealed that there were no open quarantines registered against this lot/fill. There was no product quality complaint involved. Additional information has been requested.
Soreness in the arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Soreness in the arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was reported by patient.  Concomitant products included BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALEVE) for Pain, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN), RAMIPRIL, OXCARBAZEPINE, METOPROLOL, UBIDECARENONE (COQ10 [UBIDECARENONE]), MULTI VITAMINS & MINERALS, CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, METHYLSULFONYLMETHANE (TRIPLE FLEX [CHONDROITIN SULFATE;GLUCOSAMINE HYDROCHLORIDE;METHYLSULFONYLMETHANE]), VITAMIN C [ASCORBIC ACID], multivitamin ADULTS 50+ and LINUM USITATISSIMUM OIL (FLAXSEED OIL [LINUM USITATISSIMUM OIL]) for an unknown indication.    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in the arm). At the time of the report, VACCINATION SITE PAIN (Soreness in the arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information includes for the concomitant information where patient had reported of taking Astioviflex for an unknown indication. Patient reported steroids as treatment medication.   This case was linked to MOD-2021-363342, MOD-2021-363478 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25-Oct-2021 is non-Significant Follow up- Earlier missed details of concomitant and treatment medication is updated.
diagnosed  at primary care office with SIRVA. 10/10 debilitating pain in left arm and shoulder. Tingling in left arm and neck. I have had pain and tingling in my arm since I received my second shot, I thought that that was to be expected until it worsened this week. It is now debilitating pain and I am out of work and having to use Earned Time to be out.
"Tingling/pins and needles"- left side lower jaw.  BP @ 1443 149/103, P 92, 99% RA.  BP @ 1449 153/96.  P 78.  96% RA.
SORE ARM FOR THE DAY; CHILLS  IN EVENING, FEVER 100.7 IN EVENING,  INABILITY TO LIFT MYSELF FROM CHAIR OR BED   AND INABILITY TO WALK - NEEDED ASSISTANCE FROM WIFE AND A WALKER TO WALK AND GET UP. EXHAUSTION AND VERY WEAK
Lips tingling, chest tightness, coarse throat.  Patient self took 1000mg of Tylenol within an hour of getting the shot. Subsequently after lunch he returned to the clinic and notified staff of his symptoms.  He was given 50mg of Benadryl PO.  VS stable and monitored on site.  Seen by provider.
Back pain lower muscles then upper back pain pretty bad back pain; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 15:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included lorazepam (MANUFACTURER UNKNOWN) 1mg and bupropion (MANUFACTURER UNKNOWN) 75mg; both for an unknown indication from an unknown date and unknown if ongoing. On 13Sep2021 at 16:00, the patient experienced back pain, lower muscles then upper back pain, reported as pretty bad back pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event back pain lower muscles then upper back pain pretty bad back pain was resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Fever, chill in middle of night of first day. Fever, headache, body aches second day. Felt better 3rd day but slight dizziness started. Day 3- now (day6) dizziness, tightness in neck. Today (day 6) has been worst dizziness so far (all day- hard to function).
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 21-JUN-2017 the patient was vaccinated with VARIVAX lot # N001528, subcutaneous for prophylaxis. Other suspect therapies included PROQUAD. Concomitant therapies included sterile diluent. On an unknown date the patient experienced accidental overdose and no adverse event. The outcome of accidental overdose is unknown. The reporter considered accidental overdose to be not related to PROQUAD and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and PROQUAD.
This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) 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.
A non-serious spontaneous report of accidental exposure, swollen hands and rash has been received from a non-health professional concerning an adult female nurse, subsequent to FLUMIST. The patient has a history of an allergy to eggs. No concomitant medications have been reported for this patient. The patient herself did not receive FLUMIST. She was administering FLUMIST to a child, in 2009. The patient experienced swollen hands and rash after administering the vaccine to the child and patient did not actually receive FLUMIST. The child did not experience any reaction. The outcome of event accidental exposure, swollen hands and rash considered resolved. Additional information was received on 26-Jul-201l and incorporated into the narrative: Patient's demographics.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date on 24-Jan-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date on 24-Jan-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date on 24-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date on 24-Jan-2023).    No concomitant product reported by reporter.    Case included information of patient 2nd out of 4 patients.
Very strong ringing and pain in the left ear. Took some tylenol, no effect. Still currently experiencing ringing in the left ear.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good) and PAIN IN EXTREMITY (left arm pain that occurred with certain movements) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (didn't feel good) and PAIN IN EXTREMITY (left arm pain that occurred with certain movements). At the time of the report, FEELING ABNORMAL (didn't feel good) and PAIN IN EXTREMITY (left arm pain that occurred with certain movements) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-436403 (Patient Link).
20 min after injection left arm/hand swelling. Hand swelling/difficult to bend fingers. Waited 30 min, offered benedryl, went home and rested. Arm hand still swollen on 1/25/21 but not as severe