chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body pains; Fatigue; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization and was administered in hospital. The patient medical history included covid from an unknown date and unknown if ongoing. The patient allergies was unknown. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on unspecified date at single dose for covid-19 immunization and was administered in hospital. On an unspecified date, the patient developed body pains and fatigue after second Pfizer vaccine shot. AE resulted in doctor or other healthcare professional office/clinic visit and was not hospitalized. The patient treatment received was unknown. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
during the noc following vax pt devel rash over entire body;pt also running low grade temp w/rash;
This case was reported by a consumer via call center representative and described the occurrence of sodium decreased in a adult female patient who received Influenza vaccine Quadrivalent. The patient's past medical history included stroke (2 months after the double bypass) and spinal operation (in 2005 or 2006). Previously administered products included flu shot (see case: US2018GSK019042). Concurrent medical conditions included clot blood (The patient was taking medication to avoid blood clotting), esophageal acid reflux and congestive heart failure (since 2010, they tried a cauterization and it did not work so they did a double bypass). Concomitant products included carvedilol, clopidogrel bisulphate, Losartan, Digoxine, Magnesium, omeprazole, pravastatin sodium and PROAIR HFA. On an unknown date, the patient received Influenza vaccine Quadrivalent. In October 2017, several days after receiving Influenza vaccine Quadrivalent, the patient experienced sodium decreased (serious criteria hospitalization). In December 2017, the patient experienced sneezing. On an unknown date, the patient experienced cough. On an unknown date, the outcome of the sodium decreased, cough and sneezing were recovered/resolved. It was unknown if the reporter considered the sodium decreased, cough and sneezing to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient's concomitant medication included multi vitamin. The patient had a flu shot a couple of days before her sodium dropped. The patient was hospitalized because of her sodium dropped. The patient experienced sneezing and coughing after the flu shot but she did not remember the flu shot name or manufacturer. This case has been linked to the US2018GSK019042, reported by the same reporter.
5-18-11 Mother reports childs arm was red and warm to the touch that evening. 5-19-11 Child continued to complain of pain at the site. Redness and swelling at the injection site that extended down to the elbow and wrapped around the childs arm.  Mother states arm was very hot and was swollen twice the size of his normal arm and hard to the touch.  The child was seen by NP and confirmed that it was a localized reaction but no testing or labs were ordered.   5-20-11 Mother states the arm is still red and swollen but not as swollen as before. The child is not complaining of pain at the site but the site is itching now.  Mother continues to use Zyrtec 5mg qd and watching the child.
Patient came in four days later and was concerned about a red spot on the right arm. Following up on the 27th was told that the red mark disappear and she had no concerns.
Information has been received from a registered nurse concerning an 11 year old female who in approximately the year 1997, when he was 12 months old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In May 2007 5 to 10 days after her brother the patient experienced breakthrough chicken pox with 2 dozen lesions on this torso and 3 dozen lesions on his head. Unspecified medical attention was sought. Unspecified medical attention was sought. He was treated with calamine (+) camphor (+) diphenhydramine hydrochloride (CALADRYL) and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) baths. It was reported that his lesions healed. No diagnostic laboratory tests were undertaken. No product quality complaint was involved. This is one of several reports received from the same source. It was reported that the patient's brother WAES0706USA01505 experienced a similar event following vaccination with varicella virus live (Oka/Merck). Additional information has been requested.
Missed second dose of Vivotif; Spontaneous report received on 07JAN2020.  A male consumer reported he had "missed second dose of Vivotif" (PT: Product dose omission). He was receiving Vivotif for immunisation. The consumer took his first dose of Vivotif on 04JAN2020 and then missed second dose of Vivotif. 48 hours had passed after his second dose was due at the time of the report. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed taking second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.; Sender's Comments: A consumer missed taking second dose of Vivotif (missed dose). Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.
chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received the 2nd dose of Shingrix. On 14th December 2020, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing chills, but not fever.  It was 5 day later and reporter asked how long would these side effects continue.  The reporter considering a COVID test but had no fever nor any of the common symptoms of COVID.
Pt. RELATES NECK PAIN AS WELL AS FRONTAL HEAD PAIN APPX 10 MIN POST VAX, PT. WALKED TO EMS AT 16:00 REMAINED WITH EMS UNTIL 16:20 AND STATES PAIN HAS LESSENED AND ALMOST WENT AWAY. NO OTHER C/O 128/72  HR 61  RR 24  97%  98.3 TEMP
Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of nausea, a causal relationship cannot be excluded.
Injection site bright red, swollen and painful, approx. 5" in diameter; slight dizziness, ill feeling & nausea. By today, redness has lessened and other symptoms have finally gone. Two days after the injection, the doctor prescribed cortisone-type cream for injection area.
Child awoke from sleep screaming, was unconsolable, both arms where vaccine given were red, painful. Child was given Tylenol throughout the day as instructed by Health Dept nurse.  Mother was scared, carried child to local ER. Child treated with Benadryl and Motrin, and instructed to continue Motrin/Tylenol at home. Info provided by mom
Aches; chills; Fatigue; Fever; This is a spontaneous report from a contactable consumer. A 50-year-old non-pregnant female patient received her unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6208), via an unspecified route of administration in the left arm on 15Mar2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within for weeks prior to the COVID-19 vaccine. On 16Mar2021, around 10:45 (24 hours after vaccine), the patient experienced chills and then fatigue and aches. The patient taken ADVIL which helped. Later that afternoon, patient had to take a nap and ran a fever. It reached 101.3 degrees. The patient woke up on 17Mar2021 and felt completely fine. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, fatigue and aches were recovered on 17Mar2021.  No follow-up attempts are needed. No further information is expected
pt exp massive edema of the arm following vax w/2nd dose of Pneumococcal vax; No further details were provided;
26Feb90 pt vax;  28Feb90 exp probable seizure, febrile oriented, fever 102.4F, & upper respiratory infection.  Chest x-ray neg.  Tx w/ Ceclor.  01Mar90 URI persisted & fever 100.5 w/ no seizures.
With first dose, patient got sick. With second dose, patient did not get sick. In Nov. 2021, patient was diagnosed with Hepatitis C. Patient is of the belief that Hepatitis C is result of vaccination.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Tiredness-Mild, Additional Details: Per pt, red swollen at injection site. 3-4 inches. Egg or oval shaped reaction. Took benadryl. Onset not immediate but wanted let pt know.  Reaction yet to resolve but patient will report if any changes. Received Friday 12/9 and reported Sund 12/11.
after receiving both shots, i started to notice heart palpitations.  After that, notice i would get winded and heart rate would elevate after very minimal exertion.  At the end of the year/beginning of 2022, symptoms increased in severity.  Was rushed to emergency room by ambulance, had Afib, cardiomyopathy, heart failure, kidney failure, liver failure, blood clots in heart, low blood pressure, extremely high heart rate (180-190 while in hospital bed).  After 8hrs in ER, was admitted to the cardiac ICU where i remained for 22 days until heart was at a slow enough rate they could do a MRI.  Once that was completed and they shocked my heart and rhythm, i spent another 3 days in ICU recovery.  Had emergency surgery after blood clot left heart and stuck in my thigh. Had monthly visits with heart failure team after released from hospital.  Feel back into afib few month after being release, had to have heart shocked back into rhythm.  Went back in afib a 3rd time, had a cardiac ablation on 10/31/22.
does not work had shot still got shingles/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: does not work had shot still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received form the patient via interactive digital media. The patient stated that the shingles vaccine did not work as he or she had the shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
GOT COVID TWICE; This spontaneous report received from a consumer via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported , 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient got covid twice (Dose number in series 2). As per reporter "got the vaccines and still got covid twice. They worked so well didn't they. Those were the lies and conspiracy theories" (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid twice was not reported. This report was non-serious. This report was associated with a product quality complaint 90000262861.
pt recv vax 8FEB96 & in mid FEB96 pt was treated for OM;13MAR96 p/sulfa drug initiation pt dx w/stevens-johnson synd;pt given med x 14 days & returned to baseline hlth;MD felt stevens-johnson synd not r/t vax & that the sulfa drug etiology
Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 08-SEP-2015 the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L013068, expiration date 14-APR-2017, dose and route were not reported). Concomitant drug was not reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Starting day after injection, experiencing severe shoulder pain and findings of rotator cuff damage.  Pain continues to this day.
covid 19; had a runny nose in both nostrils.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) and RHINORRHOEA (had a runny nose in both nostrils.) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On an unknown date, 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 an unknown date, the patient experienced COVID-19 (covid 19) and RHINORRHOEA (had a runny nose in both nostrils.). At the time of the report, COVID-19 (covid 19) and RHINORRHOEA (had a runny nose in both nostrils.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient took multivitamin, when was a kid, high schooler, and as an adult too. Patient was very athletic as a teenager. Patient lived by the Moderna vaccine for COVID-19. Patient had majority of all adult vaccines as well. A couple days ago, for the first time patient had a runny nose in both nostrils. Patient have never had this before. Patient had a runny nostril out of one nostril, left mainly, and usually after breakfast. Patient either have COVID and everyone else in the community was very happy. No treatment information was reported.   Reporter did not allow further contact
tongue was swollen/The front half of her tongue was swollen and stinging; tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging; had white dots and a sore tip on the tongue; Sinus Pressure; Body Aches; Tired; Dizzy; Nausea; This is a spontaneous report from a contactable licensed practical nurse (LPN) reporting on behalf of physician. A 39-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on 09Mar2021, at 39 years of age, (Batch/Lot Number: EN6206) as single dose for COVID-19 immunization. The patient had no medical history; concomitant medications were not reported. On 09Mar2021, a few minutes after receiving the vaccine, the patient felt sinus pressure that lasted the rest of the day, she was tired and dizzy for two days and also had nausea for two days and body aches for the first 3 days, all assessed as non-serious. Then the patient stated that when she woke up on 11Mar2021, her tongue was swollen and had white dots and a sore tip on the tongue. The front half of her tongue was swollen and stinging. The patient stated she did not feel as if though her throat was swollen, just her tongue, but it resolved after 3 days. These events were assessed as medically significant and the tongue swelling was what the reporter was mainly concerned about. There were no treatments, no medication was given, the patient was not seen in the Emergency Department, she was not hospitalized and was not admitted to an Intensive Care Unit. She visited the Physician Office on 15Mar2021 and Physician Assistant advised the patient not to get the second COVID vaccine. The event "sinus pressure" resolved on 09Mar2021, the events "Tired", "Dizzy" and "Nausea" resolved on 11Mar2021, the event "body aches" resolved on 12Mar2021, the events "tongue was swollen and had white dots and a sore tip on the tongue; the front half of her tongue was swollen and stinging" resolved on 14Mar2021.; Sender's Comments: Based on the information available, a causal association between BNT162B2 and the reported serious events 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 RAs, Ethics Committees, and Investigators, as appropriate.
That evening patient's arm was extremely sore, patient went to bed and took some APAP body was aching and woke up in the middle of the night, patient ate and drank tea and place heating pad on the area, body is sore and tired and patient is nauseous with headache and ear ache. Patient also has chills.
Approx. 4 hours after inj pt called c/o red, warm, 'tight' left deltoid (inj site). Encourage antihistamine and icing area. RC in 4 hours found pts arm red, warm and indurated with diff raising arm due to "tightness @ arm" otherwise felt fine.
Reported on call 2/3/2021 with angioedema and hives, treated with prednisone and antihistamines.  Labs were done that day. We were NOT expecting a reaction to the vaccine at that time and it wasn't discussed.  It was 13 days after vaccination (first dose 1/20/2021).  We did a change of a BP medication at the first visit as well from verapamil to carvediolol.  She was seen 2/22/2021 again for angioedema of the lips and hives again.  She did also have bed bugs at this visit.   I prescribed another round of prednisone however advised her to wait 2 weeks after her second covid 19 vaccine (Moderna second dose Lot 013M2A, also left arm,  2/17/2021) to take it.  I did an allergy referral.    She did see Allergist March 17, 2021.   They have continued her antihistamines.
dry mouth; inappropriate dose; arm extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth), INCORRECT DOSE ADMINISTERED (inappropriate dose) and VACCINATION SITE PAIN (arm extremely sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient experienced DRY MOUTH (dry mouth), INCORRECT DOSE ADMINISTERED (inappropriate dose) and VACCINATION SITE PAIN (arm extremely sore). At the time of the report, DRY MOUTH (dry mouth), INCORRECT DOSE ADMINISTERED (inappropriate dose) and VACCINATION SITE PAIN (arm extremely sore) outcome was unknown.             Treatment details not provided.  No relevant concomitant medications were reported.      This case was linked to MOD-2021-018719 (Patient Link).
Information has been received from a medical assistant referring to a patient of unknown age and gender. On 17-APR-2015 the patient was vaccinated with an improperly stored dose of MMR II (dose, route and lot# were not reported). No symptoms were reported. This is one of several cases reported by the same reporter. Additional information has been requested.