chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature 8.2F/ Time frame: 1 hours and 30 minutes; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 23-DEC-2021, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # U020238, expiration date: 28-JUN-2023, strength, dose and route were unknown) for prophylaxis (product storage error). The vaccine was stored at 8.2 degrees Fahrenheit (F) for one hour and 30 minutes. There was no previous excursion.
Pt experienced burning under arm 1-2 days after vaccine was administered and vaccine rash appeared 5 days after administration. Recommended pt contact family physician. Pt saw family physician and they ruled it as a mild case of shingles. No tx.
Fever >100, congestion, cough. Went to ER on 11-20-09.
Severe pain, then swelling that began to worsen and redness to site. Swelling and redness from injection site to elbow. Elbow felt numb and throbbing. Red stripes noted above elbow. Elevated blood pressure and pounding head that started on 3-31-11.
Headache, Myalgia, elevated temperature, sweats, injection site soreness Narrative:
Pt recvd 1st dose of rubella vax 1 day post partum on 4APR91; On 5APR91 pt devel fever of over 103 which prolonged hospital stay; MD was unable to find a cause for fever & suspected the vax;
One week after receiving second dose (Sept. 10, 2007)started passing out with no memory.  EEG, EKG, catscan, stress test, cardio MRI.  Periods of dizziness 5-6 times a day.  After third dose (Dec. 31, 2007) 45 minutes periods of now knowing who she was, where she was, who parents, teachers, friends were.  Everyday for almost 3 months.  Psych tests done, video EEG, brain MRI.  All tests negative.  All symptoms disappeared May 8, 2008.  08/19/2008 ER record received for DOS 9/16/2008 with DX: Syncopal episode of unclear etiology. Neck strain. Pt was running and felt dizzy and nauseous. Pt didn't arrive at finish line and family went to find. Pt awoke being shaken by family member. Down ~10-15 minutes. C/o neck pain on awakening and mental status changes noted by family. Returned to baseline o/n and d/c home.  8/15/08 Cardiac consult received dated 9/18/07 with f/u 10/12/07 and 1/24/08. DX: syncope, peri-exertional. No heart disease. Vasovagal etiology most likely. Seen for eval of syncopal event 9/16/07. By 10/12/07 visit c/o SOB.  Some improvement of  dizziness on Florinef. By 1/24/08 experiencing episodes of "spacing out" with dx: altered consciousness-likely vasovagal syncope.  elevated BP.  No structural heart disease. 9/11/2008 Neuro consult received for OVs 1/29/08 and 3/10/08. No definitive dx but summarized as episodes of transient alterations in awareness, including dizziness, clumsiness and confusion. Syncope, seizures and psychogenic causes are in the differential. Pt experiencing episodes several times daily with occasional 2-3 day periods with none. Pt is pale and confused and cannot feel extremities during. Recent episode began with headache and sweating.  not tired after.  PE WNL.
Systemic: Body Aches Generalized-Mild, Systemic: Lymph Node Swelling-Medium
Severe diarrhea, lasting over 6 days; Lost 5 pounds; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration, administered in left arm on 04Oct2021 at 15:00 (at age of 75 years old, Lot Number: FE3590) as a single dose for covid-19 immunisation. Medical history included osteoporosis, glaucoma, allergies, high blood pressure, high cholesterol; known allergies: penecillin, cephalosporins, demerol, dorzolamide, meperidine, neosporin, polymixin, trimethoprim. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN), pantoprazole, losartan, simvastatin. No other vaccine in four weeks. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 administered in right arm on 02Mar2021 (at age of 75 years old, Lot Number: EN6208) and dose 1 administered in left arm on 09Feb2021 (at age of 75 years old, Lot Number: EL9269), both via an unspecified route of administration as a single dose for covid-19 immunisation. The patient not had covid prior vaccination, also not had covid tested post vaccination. On 05Oct2021 at 03:00, the patient experienced Severe diarrhea, lasting over 6 days, despite eating BRATY diet, and upon consultation with pharmacist, taking immodium for the last two days. Lost 5 pounds. The outcome of the events was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
feeling really dizzy; Blood pressure was kind of high; Chills; Feeling little cold; Pulse was like 100; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL0140), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 vaccine. The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL). The patient was feeling really dizzy, and it started maybe like 5 to 7 minutes after received it, and patient laid in a room and blood pressure was kind of high and patient was feeling chills and little cold and pulse was like 100. Treatment in response to the adverse events included fluids just like water and juices. Patient drank like 2 or 3 juices and a bottle of water and laid down in the bed at the hospital probably for about an hour. Due date for next shot for patient was 12Jan2021. Outcome of events was unknown.
Rash; skin infection on wrist; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and SKIN INFECTION (skin infection on wrist) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced RASH (Rash) and SKIN INFECTION (skin infection on wrist). At the time of the report, RASH (Rash) and SKIN INFECTION (skin infection on wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. Treatment included antibiotics and a tetanus shot   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No new information
Day 1: arm soreness Day 2: headache, fatigue, body aches Day 3: fever of 102, fatigue, headache
Pt received vaccination 3/30/18, on 3/31/18 she called pharmacy with complaint of body aches and ache at injection site.
Shingles / into eye; Double dose vaccine / he got it / One year later he got shingles so bad / covered from hairline, accross eyebrow, eyelid and into the eye; Scabs have healed; Still has nerve damage with daily attacks; Still has nerve damage with daily attacks; Double dose vaccine / he got it / One year later he got shingles so bad / suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had twice, pretty bad each time). Previously administered products included Shingles vaccine (one dose vaccine received on an unknown date) and Acyclovir (took for years because the one dose vaccine would not work for him and was told he did not need acyclovir and to stop taking it).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 9th May 2020, 1 year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and neurological symptom. On 9th May 2021, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, scab and nerve damage. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles and scab were recovered/resolved and the outcome of the nerve damage and neurological symptom were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, scab, nerve damage and neurological symptom to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient's wife. The age at vaccination was not reported. In 2019, the patient received the both doses of Shingles vaccine (double dose vaccine). One year later (the day before Mother's Day 2020), the patient got shingles so bad he was covered from hairline, across eyebrow, eyelid and into eye. The reporter stated that even though the scabs had healed the patient still had nerve damage with daily attacks and was lucky that his eye has healed with no significant damage. The reporter mentioned that during treatment they had learned that there were lots of people like this patient. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR101272 and US2021AMR104433, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case. US-GLAXOSMITHKLINE-US2021AMR104433:Same reporter. Master case: "lots of people"
had the double shots, and now we think he has shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient's spouse. The age at vaccination was not reported. The patient had the double shots of Shingles and now think he has shingles and was that really possible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Fever, chills, muscle aches, teeth chattering, painful to touch all over body, exhaustion. Starting around 11:30 pm. Fever and chills subsided around 3:00 am on 4/26. Muscle were sore and body aches until around 11:00 am 4/26. Tired and drowsy all day 4/26.
Per patient arm redness, occured approximately 1 day after administration of vaccine. Arm was slightly red then increased swelling and redness. Arm was warm, itching later in day. Patient took Benadryl and Benadryl ointment to site. Patient called Doctor for a tele visit with NP
mild subjective dyspnea; nml vs and exam: Tx with 50mg oral benadryl; observed 30 min, improved
Injection site was swollen, red and tender, cellulitis/abcess at injection site. Patient received injection and was discharged to nursing home facility and re-admitted next day with elevated WBC of 21,500 (urine culture positive also).
pt recv vax 23AUG95 & 20JUN97 pt devel an uncomplicated varicella illness which consisted of h/a, fever, chills & greater than 50 lesions on face, scalp, back, arm, & abd;
Pt alerted Oberving NP that he felt unwell. His BP was 88/68. He fainted-head slumped down and lost conciousness, his body spasmed one time and NP lowered him to the floor. He regained conciousness and we continued to monitor him and vital signs. BP returned to 133/84 and pt was transported to ER.
Pt states she just felt really tired and couldn't really move her body as much"I just didn't feel good" , Pt never came in and get evaluated pt never told us about the Sx after the vaccine that lasted 1 day until pt was seen again in clinic and we offered 2nd dose of MenB Vaccine.
Exactly 3 weeks after receiving my booster, I started having left-sided facial weakness. I ended up going to the ER and they diagnosed me with Bell?s palsy. I have not had Covid, nor have I been sick in the last year. I now have a significant left facial droop, ringing in my ears, jaw pain, headache.
Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk factors. 1-20-21 had second stroke, hospitalized for both episodes without residual symptoms.
stomach hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach hurts) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach hurts). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Friday evening 2 hours after dinner my sugar reading was 220. My sugar levels never go over 150 after a meal. My diabetes is under control
Initial pregnancy report received from a consumer who is also the patient on 02 December 2013. A 35-year-old pregnant female patient, had received a dose of FLUZONE ID in the left deltoid on 01 November 2013 (Batch number was not reported). The patient had no illness at the time of vaccination and had received has had flu shots every year, never a problem. On 29 October 2013, the patient had ultrasound which showed embryo with beating heart. On 26 November 2013, during the follow-up appointment, the fetus's heart beat were not audible and so the ultrasound was done. The ultrasound examination revealed that the fetus was not viable and the pregnancy had stopped developing on 02 November 2013. The patient had no vaccination site reactions or fever after FLUZONE ID. List of documents held by the sender is none.
Information has been received from a certified medical assistant concerning a 76 year old male with hypertension and coronary artery disease who on 26-JAN-2009 was vaccinated with ZOSTAVAX (Merck) (lot number 663178/1414X, route and site not reported).  On 03-FEB-2009 the patient was diagnosed with shingles on her leg and hip.  Additional information has been requested. This is in follow-up to report (s) previouly submitted on 3/27/2009.  Information had been received from a certified medical assistant concerning a 76 year old male with hypertension and coronary artery disease who on 26-JAN-2009 was vaccinated with ZOSTAVAX (Merck) (lot number 663178/1414X, route and site not reported).  On 03-FEB-2009 the patient was diagnosed with shingles on his leg and hip.  Follow up information was received from the medical assistant.  On 26-JAN-2009 the Caucasian patient was vaccinated with the first dose of ZOSTAVAX (lot number 663178/1414X) SQ into his left arm.  On 31-JAN-2009 the patient developed acute zoster.  The patient was treated with VALTREX and AMITHIPTYLIN.  The patient recovered.  It was unspecified if there was illness at time of vaccination.  Additional information is not expected.
Inappropriate schedule of product administration; This spontaneous report was received from nurse and refers to an 1-day-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-APR-2023 and 26-JUN-2023, the patient received doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (inappropriate vaccination schedule).  This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2307USA010202:
Pt in office 330PM at 730PM went to give a bath to child was hives head to toe. Gave CLARITIN 1 tsp. Hives dissipated then rash turned to big welts very raised red. No resp/swallowing difficulty went to be in am all gone.
The night after getting the booster i had difficulty sleeping, had a fever and chills. in the morning had extreme light sensitivity and body aches, i was immobile the entire day. the following day, wednesday i still had head and body aches noticed my underarm was swollen and i had a knot on my neck, both on the same side i received the shot. Today, friday i still have a headache and my underarm is still swollen and i still have the painful knot on my neck.
Patient reports neuropathy hands & feet, spreading to lower extremities with muscle spasm in legs, fatigue difficulty sleeping and difficulty concentrating & Symptoms have gotten progressively worsen.  Increase in anxiety injection given 7/22/21 - Symptoms unchanged on 10/11/21 - has been seen by urologist.
Soreness at injection site within 5 hours; This is a spontaneous report from a non-contactable consumer (patient). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 22Jan2021 12:00 at single dose in left arm for COVID-19 immunisation. Patient age at vaccination was 42 years. The vaccine was administered at workplace clinic. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medication included doxycycline.  On 22Jan2021 at 05:00 PM, the patient experienced soreness at injection site within 5 hours, reported as non serious. Soreness was reducing within 24 hours. No treatment was received for the adverse event. The event had resolved on an unspecified date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
routine Basic Metabolic Panel resulted in abnormally high values for Potassium (5.5) and Chloride (112). Test was repeated a week later with normal results
throat swelled, sweating, couldn't breath, light headed, fast heart rate. was given Benadryl and monitored closely for 30 min. (until I felt better)
Booster vaccine was administered on 4/1/22. Tolerated well with no apparent side effects. On morning of 4/3/22 resident was experiencing episodes of Apnea and unresponsive so was transferred to ER. Dx of urinary retention obtained with resident cathed in ER and returned to facility. Baseline upon return.  The early morning of 4/4/22 resident was very restless and not keeping oxygen on causing saturations to fluctuate. Retention was noted but nurse unable to place cath. Set to ER where Foley was placed. Resident kept at hospital for observation. No other dx given for reason to keep in hospital other than urinary retention. Resident does have underlying BPH and prior to admission on 3/29/22 resident had been hospitalized for treatment of UTI.
Pharmacy student called in to report that a patient who was vaccinated on 05-AUG-2020 with varivax and developed a injection site skin rash on the right upper arm; This spontaneous report has been received from pharmacy student concerning a 38 year old female patient. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.    On 05-AUG-2020, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection in the right arm Lot # S025914, expiration date 20-AUG-2021 for prophylaxis.   On 17-AUG-2020, the patient developed an injection site skin rash on the right upper arm.      It was reported that the patient did not seek medical attention and no laboratory tests or diagnostic studies were performed.  At the time of reporting, the patient had  not recovered from injection site skin rash on the right upper arm and the causal relationship between varicella virus vaccine live (oka/merck)(VARIVAX) and the injection site rash was not reported.
no adverse event; Unknowingly administered an expired moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Unknowingly administered an expired moderna vaccine) and NO ADVERSE EVENT (no adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 31-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Unknowingly administered an expired moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Unknowingly administered an expired moderna vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Unknowingly administered an expired moderna vaccine).    No concomitant medication was reported.. Patient had no adverse reactions. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
Employee was scheduled to receive the Pfizer bivalent dose and instead received the Pfizer monovalent dose for her last dose of the series.
Headache, Myalgia, Constipation, Diarrhea & NauseaVomiting Narrative:
8/4/21 PMH of microscopic polyangiitis, interstitial lung disease, status post rituximab; presents w/ history of cough, SOB, and fatigue
This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof- other) refers to a patient of unknown age and gender. On 23-APR-2015 the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5, injection (lot # K018181, expiry date 04-JUN-2007) (route, dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. This is one of the many reports from the same source. Additional information has been requested.