chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart palpitations: sudden bursts of racing heatbeat, and the sensation of sudden pause of heartbeat followed by one very hard beat. I went to a local ER after experiencing several instances of these symptoms over a 12-16 hour period. They performed an EKG at the ER that did not capture anything. I was on a continuous heart monitor for a couple of hours while I was there (can't recall how long). The doctor mentioned seeing one example of a "multifocal heart palpitation" come up on the monitor during that time--while he was actually talking to me at the bedside with me, in fact--but I don't see it mentioned in my discharge summary. Bloodwork was done, and looking at my discharge summary, everything apparently came back within normal range.   The doctor did note in the discharge summary that the vaccine was suspected as a possible cause of my complaint. The occasional symptom(s) persisted on and off for a few days, becoming fewer and further apart until they resolved. I can't recall exactly how many days the symptoms lasted in total.   According to the discharge summary, the doctor appears to have been MD, but I recall seeing two different male doctors over the course of my visit (shift change?).
Redness and swelling on one thigh 2 days after immunizations. Advised to apply warm compresses. Pt is doing better.
Shaking chills x 2 hrs 102 - 105 degrees F temp after TYLENOL & Ibuprofen, fever down to 102 degrees F at 3am shaking chills & fever increased. Seen in fast care clinic the next day with no apparent cause.
Patient was nervous for vaccine.  She sat for the vaccine and was told to wait 15 minutes before leaving.  About 4 minutes after the shot, she told boyfriend she was going to pass out and she did.  BP - 133/72.  Patient said she had a vagal response to pain.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 28-DEC-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles.  Throughout April 2015, the patient was treated by a physician for the onset of blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles.  As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related.  Additional information has been requested.
Idiopathic thrombocytopenic purpura (ITP); This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Mar-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Idiopathic thrombocytopenic purpura (ITP)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Full blood count: 238 (Inconclusive) 238. On 06-Mar-2021, Platelet count: 3 x 1000 (Inconclusive) 3 x 1000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. She was first admitted to the ER on 06Mar2021. Indicator was that her platelet was 3x 1000.  She received a platelet infusion and her platelet count went up and then down.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: New information includes reporter email address, lot # of vaccine, treatment information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that between 30-JUN-2015 and 18-AUG-2015, the patients were vaccinated with the improperly stored doses of M-M-R II (lot # K024036 with expiration date 26-NOV-2016 and lot # K024824 with expiration date 02-DEC-2016; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
This patient had cellulitis at the injection site from administration of pneumococcal vaccine Prevnar. Required antibiotics to treat the cellulitis.
On November 17 felt exhausted. On November 18 woke up with vertigo. Lasted about fifteen minutes. Moved slowly for several hour and seemed better. about 2:30 I went for a walk with a neighbor . After fifteen minutes the same feeling of vertigo started. told my friend as I stopped walking. Could not keep my balance and fell backwards in the road, Called a friend to give me a ride home because I didn't feel comfortable walking.
I have pain at the site of injection as well as pain when I lift my arm (side and forward).
Subsequent to receiving one dose of varicella virus vaccine live the pt developed approximately 50 lesions with no fever.
itching at injection; Redness at injection; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PRURITUS (itching at injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO REPORTED MEDICAL HISTORY).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching at injection). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at injection) and VACCINATION SITE PRURITUS (itching at injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
This spontaneous report as received from a medical assistant (working in a physician's practice) refers to a 12 year old female patient with no concurrent conditions and no medical history. The patient did not take any concomitant medicines. On 16-JUL-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot# and expiry date were not provided) 1 dosage form (DF), intramuscularly (indication reported as vaccination). On 16-JUL-2015 the patient experienced severe injection site pain after receiving GARDASIL 9. Then "about 15 minutes later" she felt hot and light-headed. The physician laid the patient down and placed a cold cloth on her forehead. The patient rested for five minutes, then rose slowly and took long slow deep breaths as the physician instructed. No laboratory diagnostic tests were performed. The patient felt better and was sent home. The outcome of feeling hot, light-headed and injection site pain was described as recovering/resolving (the patient's soreness lessened but was still present at the time of the patient's most recent visit with the physician on 04-AUG-2015). It was unclear if the patient would continue with her GARDASIL 9 series. The relatedness between the all events and suspect therapy was unknown. Additional information has been requested.
Patient was given Moderna vaccine as booster instead of Pfizer.   No adverse reaction or side effects from incorrect vaccine.
About two weeks after receiving SHINGRIX I stood up and while getting out of bed I experienced excessive dizziness which reoccurred with less severity during the day. At 2 AM in the morning I went to the ER, and was diagnosed with vertigo. I mentioned receiving the shingles vaccine approximately two weeks prior to this event, and that account seemed to be discounted by the medical staff.
Patient received 3 doses of COVID vaccine on 9/30/2021, 2/20/21 and 1/30/21 and was hospitalized from 1/14/22 - 1/16/22 with shortness of breath from COVID
Call from mother 6/4/20, 8 days post vaccine. Telemedicine visit completed by physician 6/5/20. Patient has quarter size red area at vaccine site that feels hard to touch. Patient has fever high of 101. Patient received 2 other vaccines in the opposite leg on the same day and both are fine.  Vaccine reaction versus cellulitis?? Patient prescribed antibiotics starting 6/5/20 for treatment. Parent to call if red area becomes worse.
Patient related her arm was red and inflamed in an area about the size of a softball which resolved after 3-4 days.
Local pain at injection site, diffuse joint and muscle pain, elevated WBC, dizziness. Required hospitalization x 3 days.
Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing.; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for herself that the 57-year-old female patient received first dose of bnt162b2 (BNT162B2,COVID 19, brand: Pfizer BioNTech, lot number: EL3247), via an unspecified route of administration on 17Feb2021 15:45 on Left arm at single dose for covid-19 immunisation. Medical history included high cholesterol from an unknown date and unknown if ongoing.  Concomitant medication included rosuvastatin, zinc, ascorbic acid (VITAMINS C), ergocalciferol (VIT D), fish oil and Occuv. The patient experienced unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing (medically significant) on 20Feb2021 11:45AM with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown, unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing on 20Feb2021 11:45 with outcome of unknown. She is not pregnant. Facility type vaccine was workplace clinic. No other vaccine in four weeks. Unusual sound in left ear where hearing was impaired temporarily and slight decrease in hearing. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. Known allergies was none.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported auditory hallucinations cannot be 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.
Case number PHEH2012US019408, is an initial spontaneous report received from a physician on 02 Oct 2012. This report refers to 71 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown), on an unspecified date. The patient developed diabetes, with blood sugar of 800 (units not reported). It was reported that, the patient was non diabetic prior to receiving vaccine. Event outcome, seriousness and causality were not reported.
vomiting; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program, Pfizer First Connect. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient took the first dose 2 days ago (21Jan2021) and then started vomiting on an unspecified date. The reporter asked if the patient can take Zofran without having any reactions. The outcome of event was unknown.  Information about lot/batch number has been requested.
Aches; Fever; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) in a 36-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 1 diabetes mellitus (Type 1 diabetic).    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PAIN (Aches), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant medications were reported. No treatment medications were reported.  Patient had received 2 doses of the Moderna COVID-19 vaccine as well as 1 booster dose. Patient experienced fever, chills, and aches that lasted for about 10 to 12 hours after receiving all the doses.   This case was linked to MOD-2022-642058 (Patient Link).   Reporter did not allow further contact
1/2/2023  I started out not feeling well. It progressed to night sweats. This lasted for about a week. The second week of January, I started feeling bad, but nothing I could put my finger on.  I was down with clogged sinuses and night sweats. I was not eating, I lost around 5 or 6 pounds. I started taking Flonase but stopped because it made it worse.  The third week, I started feeling a little better, just mainly sinuses. The fourth week, it really got bad. It was mainly clogged sinuses, I had to breath out of my mouth.  My son said I was having labored breathing. I had a telehealth visit and he prescribed a Z Pak and Prednisone. I did not take the Prednisone.    It took another three days to actually blow the congestion out of my nose. This went on for three or four days. It finally cleared up.  I was literally down for the month of January.
Redness around the eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema periorbital in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number T5T79, expiry date 24-NOV-2023) for prophylaxis.   On 12-JAN-2023, the patient received the 1st dose of Shingrix (left deltoid). In JAN-2023, 2 days after receiving Shingrix, the patient experienced erythema periorbital (Verbatim: Redness around the eye). The outcome of the erythema periorbital was resolved.   It was unknown if the reporter considered the erythema periorbital to be related to Shingrix.     It was unknown if the company considered the erythema periorbital to be related to Shingrix.   Additional Information: GSK Receipt Date:1-May-2023  The reporter was a pharmacist.   The reporter reported a patient experienced redness around the eye about 2 days after receiving the first dose of Shingrix.   The redness lasted about 2-3 days. Adverse event was filed The reporter did not consent to follow up.
Intensely itchy blisters on inside of upper and lower right lips.  Upper roof of mouth as well.  Never had this symptom prior.  Took Zyrtec in case it was allergic reaction, but did not get better.
This spontaneous report as received from a registered pharmacist refers to a 71 years old female patient. On 08-NOV-2012 the patient was vaccinated subcutaneously with a single 0.65 dose of ZOSTAVAX (lot # reported as 0366AE, exp. Date: 23-MAR-2013) for prevention of shingles. Concomitant medications included eye drops, famotidine, CELEXA, hydralazine, clonidine, SETAZINE, NOVOLOG, furosemide and VENTOLIN INHALER. On 12-NOV-2012 the patient experienced fever and redness at the injection site. The outcome of the events were unknown. Additional information is not expected.
Double vision - 1/29/21 to present. Noticed double vision when was about to drive to work (7:30am 1/29/21). Double vision currently being monitored by neuro-ophthalmologist. Cause of double vision not yet known. Currently still have double vision.  Severe headaches - 1/20/21 to 1/24/21 Vomiting - 1/20/21 Woke up in middle of night (3:00am 1/20/21) with severe headache. Started vomiting few hours later. Vomiting continued throughout the day. Went to clinic later that night and was given IV for dehydration. Vomiting stopped, but headaches continued for about 3-4 days.
PER NOTES FROM FACILITY  9/8/21  @ 15:05  --  "RESIDENT COVID POSITIVE, HAVING S/S COUGHING, TEMP 100.1, AND WEAK". 9/8/21 @ 16:25 -- "RESIDENT TRANSFERRED TO HOSPITAL BY AMBULANCE ASSISTED BY 2 EMT'S FOR POSITIVE COVID SCREENING".
left thigh became painful, it seems its the muscle on top of the thigh. Most painful at hip site and at out side of left knee, sometimes directly in middle.
Immediate pain in arm.  Worsened over time.  Now 31 days later, I'm going for an MRI to see if there is permanent nerve damage.  I cannot lift my arm to hold a 12 oz. can or cell phone.  The pain is pretty bad and I need physical therapy 3x/week.  Even with therapy, there has been no improvement to the muscle weakness and pain in the left arm.  Doctors predict that the virus went into nerve and shut down typcial neuro-muscular function.
Headache day after vaccine. About 3 hours after, patient face felt hot. Hives and rash started 3 days later. MD gave pt Prednisone and VALTREX.
Prevnar, Hib, MMR, Varicella immunizations given 5/31/2007. Mother reports fever 6/1/2007 103.2 et 6/2/2007 102.4. Today has 7 papular lesions varying in size from approx. 3mm to 3mm X 10mm irregular in size. PCP notified previously et recommends use of Tylenol alternated with ibuprofen for fever et notification of HD staff.
Approximately 24 hours after receiving anthrax vaccine, pt developed urticaria on her wrists, which subsequently spread to her arms, neck and trunk.  Symptoms/lesions completely resolved about 6 hours after pt treated with Benadryl 50mg IM x1.
102.8 FEVER, CHILLS, SHIVERING, MUSCLE ACHES, BODY ACHES, SEVERE HEADACHE AND FELT HORRIBLE AND COULD NOT LIFT MY HEAD OUT OF BED FOR 36 HOURS HORRENDOUS - 2nd shot for me (first shot pain in the arm was only side effect).
I was feverish, chills, ached all over, tired, nauseous, headache.  Only relief was to sleep, this lasted for 2 days on both vaccines.  Missed work for 2 days on each vaccine.
pt recv vax 16SEP96 & c/o of sore arm, swollen, reddish hard & warm to touch;
Mother reported that his left leg was swollen and he was favoring it the night of the injection but she thought it was just sore from injection.  The next morning the child's left leg was more swollen, warmer that the right leg but there was no redness.   The child was seen and evaluated in the clinic and was prescribed Cleocin 195mg 3 times per day for 10 days but mother didn't pick it up due to the cost.  Mother reports that 2 days after the injection the swelling reduced.
Fever of 101-104 for more than 24 hours, headache, dizziness, weakness, shivering, achy, shooting pain in right hand
pt recv vax 5JAN97 & on 10JAN97 pt c/o heavy feeling in legs;11NOV97 c/o bilat weakness in the lower extremities & ascending paralysis;13JAN97 was hosp for GBS;
Information has been received from a pharmacist on 28-MAY-2010 concerning a 23 year old female. The patient had received a first dose of GARDASIL (lot # not reported) in her arm on 20-APR-2010. Immediately after vaccination the patient presented with injection site pain which lasted for a week (recovered on 26-MAY-2010). One month after vaccination (on approximately 20-MAY-2010) the pain returned radiating from shoulder to elbow and preventing the patient from making certain movements. The patient was treated with anti-inflammatory cream. At the time of reporting the patient had not recovered. Follow-up information received on 02-SEP-2010: The patient had received the first dose of GARDASIL (lot # 0777X, batch # NJ35160) via intramuscular route in the left arm on 20-APR-2010. She received the second dose of GARDASIL (lot # NJ49350, batch # NL35360) via intramuscular route in the left arm on 24-JUN-2010. One month after each vaccination, the patient experienced incapacity to move the arm during 7 days and formications in the vaccinated arm which lasted 4 days. The most severe pain had regressed at the injection site but the patient had always a persistent pain at the injection site when touching the arm. According to the reporter, the events were moderate and not serious and the patient was on her way of recovering at the time of reporting. A corrective version was created on 25-NOV-2010: upon internal review, "paralysis of arm" was considered as an important medical event and the case was upgraded to serious. Other business partner numbers included E2010-03349.
This case was reported by a other health professional via sales rep and described the occurrence of erythema in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema, skin warm and inflammation. On an unknown date, the outcome of the erythema, skin warm and inflammation were not recovered/not resolved. It was unknown if the reporter considered the erythema, skin warm and inflammation to be related to SHINGRIX. Additional details were provided as follows: The case was received from the District Manager. The patient experienced redness, inflammation and warmth several inches down from the injection site and she thought it was getting bigger.