chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, she was told to wait 15-20 minutes and she did and had no reaction.  Everytime she gets a booster she gets flu symptoms and was expecting this reaction.  With this booster after supper she felt unusually not well and took a Tylenol and went to bed early about 8:00 PM.  She went to sleep and about 11:00 PM she felt strange, had shakes, chills and kind of flu symptoms and was not able to get out of bed and in respiratory distress.  She called her NP/daughter-in-law who took her BP/respirations and was below 40 and they called an ambulance as her heart rate was dropping and was not able to get up and breath.  She was rushed to the hospital, thought she had a pulmonary embolism, gave her aspirin, oxygen, IV's, and nitroglycerin.  She requested a different hospital and they took her to the closest one.  Her pulse ox was 38 when she left they left the house, they kept telling her to stay with them.  It was in the 20s when she got to the hospital and checked her all evening and checked for the blood clot.  She was there until about 4:30 AM and was then admitted to the hospital.  Her VS's were stabilized enough that she was admitted.  They wanted to do some more work ups to make sure there were no issues with her heart.  She was in the hospital and had part of a stress test on Friday and finished it on Saturday and deemed that she had a severe allergic reaction due to taking the flu and COVID vaccine at the same time.   She asked them at pharmacy if there was any problem with her taking both vaccines at the same time, and was told that no that the FDA/CDC said it was OK and that there would be no problem.  She was not informed that this was not a different type of flu shot, thought it was her usual yearly flu shot.  She then saw the TV commercial and checked and found out that she had the new vaccine.    She thinks it was terrible reaction that affected her in a terrible way.  The arm with COVID vaccine swollen, red, feverish until a week later when she still had a knot, fever, redness in the arm.  The flu vaccine arm was perfectly OK, it was sore the day after but nothing unusual.  She feels that the booster of the COVID vaccine was the worst reaction.  She was in the hospital for a week back in 2020 with COVID and had pneumonia with that, and it took months to get completely over it, possibly 6 months after that.  Her doctor kept telling her that she would not have the antibodies in her blood, but when she would check her blood she still showed that she didn't need a booster as her levels were still high.   Her doctor said that she should not get a flu/COVID vaccine and she said that she would never take a COVID booster again due to her reaction.  With every booster her symptoms would be a little worse than the previous one.  She is still having some problems with taking a deep breath.  The tests ruled out the pulmonary embolism.  The EKG's showed multiple PVC's in-between her regular heart beat.
pt recvd vax 22FEB93 devel fever of 105, vomiting & diarrhea p/getting shots; seen in ER started on ATB; fever still 104.7; sent to hosp adm to hosp;
In early May, 2000, the pt received his 1st dose of Lymerix. On approximately 6/1/2000, he began experiencing pain in both elbows (like muscle pain), right wrist, and both knees. He stated it was like a constant, annoying ache in these areas. The pain was getting worse all over. "He didn't know what to do". Additionally, he has a "strange pain" in his back, is intermittently nauseous and his "skin burns" (not constant). The vaccinee stated that the pain he is now experiencing is "different" from that which he has experienced before with tennis elbow and back "problems". The most recent information, received on 6/7/00, reports the condition of the vaccinee as ongoing.
Hearing loss; Aural fullness; This is a literature report.  A 66 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunisation. The following information was reported: DEAFNESS (non-serious), outcome "unknown", described as "Hearing loss"; EAR DISORDER (non-serious), outcome "unknown", described as "Aural fullness". The events "hearing loss" and "aural fullness" were evaluated at the physician office visit.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 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.
it was administered way too high and it felt like she hit the bone; it felt like she hit the bone and it hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious), outcome "unknown", described as " it was administered way too high and it felt like she hit the bone"; BONE PAIN (non-serious), outcome "unknown", described as "it felt like she hit the bone and it hurts".  Additional information: Patient was asking if this was still effective.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not have the patient information. The batch number and expiry date of SHINGRIX was not reported. After vaccination with SHINGRIX, the patient experienced mild rash, that went away.
Immunization site became red, hot, hard. Was sent to ER for evaluation. Received antibiotics.
Shortness of Breath, winded after walking short distances or in cold weather, fatigue, high blood pressure, gray skin color after being outside, bloating, weight gain and acid reflux discomfort.
since getting this vaccine I have developed vertigo, hyperacusis, pulsating tinnitus blood inflammation, dizziness eustachian tube blockage heart problems palpitations carotid artery ultra sound
3 x 5 inch rash; headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (3 x 5 inch rash) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Sleep disorder. Concurrent medical conditions included Drug allergy (Tetracycline and calcium blocker). Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Idiopathic hypersomnia, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Sleep disorder.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (3 x 5 inch rash) and HEADACHE (headache). At the time of the report, RASH (3 x 5 inch rash) outcome was unknown and HEADACHE (headache) had not resolved.            This case was linked to MOD-2021-066854 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patient demographics, drug allergies, indication for concomitant drugs and outcome for the event headache as not recovered added.
she lost her sense of taste.; wasn't able to eat; high-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high-grade fever), AGEUSIA (she lost her sense of taste.) and EATING DISORDER (wasn't able to eat) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (high-grade fever) and EATING DISORDER (wasn't able to eat). On 21-Apr-2021, the patient experienced AGEUSIA (she lost her sense of taste.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 21-Mar-2021, PYREXIA (high-grade fever) had resolved. On 21-Apr-2021, EATING DISORDER (wasn't able to eat) had resolved. At the time of the report, AGEUSIA (she lost her sense of taste.) outcome was unknown. Not Provided      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.   No concomitant medications were provided.   This case was linked to MOD-2021-083321 (Patient Link).
Patient reports on 9/30/2021 having fever, body aches, and fatigue. Later in the day, she noticed a growing rash starting from the left arm where she was vaccinated all the way across the chest to the right arm. She reports that the rash is hot to touch, painful and itchy. She also reported a swollen lymph node in her left arm pit. She was unable to see her physician and did not want to go to the ER for treatment.
Developed erythema multiforme rash; then Steven's Johnson Syndrome with fever and oral lesions.
Died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 83-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: Died
This prospective pregnancy case was reported by a physician via sales rep and described the occurrence of vaccine exposure during pregnancy in a 16-year-old female patient who received BEXSERO (batch number ABX711AA, expiry date 31st December 2019) for prophylaxis. Co-suspect products included MENVEO (batch number A17024, expiry date 31st March 2019) for prophylaxis. On 6th August 2018, the patient received BEXSERO and MENVEO. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. On an unknown date, unknown after receiving BEXSERO and MENVEO, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details were provided as follows: The patient received BEXSERO and MENVEO after a positive pregnancy test. There were no reported issues or adverse events. The physician asked about pregnancy registry for BEXSERO. No other information was provided.
About 20 minutes after receiving the vaccines, the patient felt feverish and mom measured a rectal temperature of 103F. She gave the patient two doses of Tylenol throughout the day but he still had a fever of 102.7F. Mom states that the patient was not behaving like his typical self and was more sleepy and tired. He also had decreased po intake and urine output.
Pt developed reddened, raised, itchy-like rash about midsection. After course of next 2 days, rash worsened & spread over trunk. Early am of 11/6/99, pt awakened with difficulty breathing & swollen tongue. Went to ER.
Moderna 1/12, 2/5, and 9/3. Positive on 12/4
Received flu shot during physical - became acutely ill within days:  Autoimmune Hepatitis.  Seen by immunologist.  Rheumatologist: presently seeing.  All labs done for physical within normal limits.  Information received from medical records state fatigue, fever.
This case was reported by a physician and described the occurrence of fever in a 2-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 15 April 2011 the subject received unspecified dose of HAVRIX (unknown). At an unspecified time after vaccination with HAVRIX (days later), the subject experienced fever (102 degrees F). At the time of reporting the outcome of the event was unspecified. Follow-up information was received via the subject's physician on 06 June 2011. It was reported that HAVRIX was given on 14 April 2011 in the left thigh. The following day, on 15 April 2011, the subject developed a fever. On 20 April 2011, the subject experienced induration of the left thigh, egg sized with tenderness. The subject was unable to walk. Fever and induration were worse at the time of reporting. Attribution of the events to HAVRIX was unknown.
Injection site became very red and swollen.  Patient became very lethargic and site became itchy as well. Patient reported this on 7/21/10 and site was still red, hot to touch swollen.  Measuring 40mm X 60mm.
Patient's injection arm is still sore 4 days after the vaccine and now has pain going down the side of her body. No fever or chills. Only reporting continued pain with it radiating down the same vaccine arm side. Patient is reaching out to primary medical doctor to determine further steps for the pain.
swelling at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site) in a 96-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (LOSARTIN), DIGOXIN, TRAMADOL, DILTIAZEM, MECLIZINE HCL, PANTOPRAZOLE, RIVAROXABAN (XARELTO) and LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes ice pack.
No adverse effect reported; Patient received her first dose of GARDASIL 9 at 13 years old and her second dose at 18 years old; This spontaneous report was received from a physician referring to a 19 year old female patient. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On an unspecified date in approximately 2013, when the patient was 13 years old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route, dose, lot # and expiration date were not reported). Then, on an unspecified date in approximately 2018, when the patient was 18 years old, she received the second dose of the vaccine (route, dose, lot # and expiration date were not reported) (inappropriate schedule of product administration). The vaccine was administered for prophylaxis. No adverse effect reported.
excruciating pain in her left arm, right between her shoulder and elbow; she was not even able to rise her arms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (excruciating pain in her left arm, right between her shoulder and elbow) and MOBILITY DECREASED (she was not even able to rise her arms) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21B, 050A22A, 002A21A and 030M20A) for COVID-19 vaccination.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient never had COVID positive test or diagnosis.  The patient's past medical history included Pacemaker insertion (cardiac) (heart issues (pacemaker), No recent change in status, since 5 years ago). Concurrent medical conditions included Arthritis (since a long time ago, No recent change in status), Restless leg syndrome (in her 20's, No recent change in status), Raynaud's disease (since 20 years ago, No recent change in status), Blood pressure high (since 20 years ago, No recent change in status), Colitis (since 4 years ago, No recent change in status), Narcolepsy (since 3 years ago, No recent change in status), Allergic sinusitis (sinus allergies) and Heart disease, unspecified (Heart issues, No recent change in status, since 5 years ago).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced PAIN IN EXTREMITY (excruciating pain in her left arm, right between her shoulder and elbow) and MOBILITY DECREASED (she was not even able to rise her arms). At the time of the report, PAIN IN EXTREMITY (excruciating pain in her left arm, right between her shoulder and elbow) and MOBILITY DECREASED (she was not even able to rise her arms) had not resolved.            Patient mentioned after 1st and 2nd dose did not experienced any symptoms but shortly after 1st booster started experiencing such an excruciating pain in the left arm, right between the shoulder and elbow, patient was not even able to rise the arms and doctor advised to go to physical therapy but it had gotten worse instead of improving. Patient mentioned had arthritis but doctors made studies and mentioned that pain had nothing to do with the disease and it was maybe due to the vaccine. Pain was still ongoing. Patient was under a lot of regular medications but did not wanted to provide names. No treatment had been given for the symptoms.  The patient did not experience a similar event in the past. The events caused patient to seek medical care.
Fever 1/3/08 up to 102.9, poor feeding.  Received immunizations 1/2/08.
Neuromuscular loss of dexterity of lower extremities occurring the morning after vaccine and following evening resulting in fall with laceration of multiple sites on face. Admitted to Hospital. Admitting physician Dr.
Information has been received from a physician concerning an about 7 year old male who on an unspecified date was vaccinated with VARIVAX (Oka/Merck). Subsequently the patient experienced herpes zoster. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # L007558, expiration date 10-NOV-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 40, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 16, 49 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Dose administered was incorrect.  The nurse giving the vaccine did not know to reconstitute the vial, so patient received a higher dose than he should have.  Once realized, we called the patients mother.  So far he is doing fine.
Information has been received from an 80 year old female consumer who on 30-NOV-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot # and route not reported). Concomitant therapy included carvedilol, NIASPAN, simvastatin (manufacturer unknown), indapamide, warfarin, DIOVAN and SPIRIVA. The consumer reported that this past week on approximately 27-SEP-2010, she developed a case of shingles. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information was received from the physician concerning the with patient who on 27-SEP-2010 developed a grouped vesicular cutaneous eruption on left abdomen and back stopping at midline with case of herpes zoster after receiving vaccination in winter of 2009. On 28-SEP-2010, a varicella zoster culture was performed which was positive for varicella zoster virus. Per herpes varicella zoster questionnaire received, a rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient had a history of chicken pox in her childhood. It was not known if the patient was recently exposure to chicken pox or herpes zoster. A direct fluorescent antibody test was not performed and a specimen was not collected for PCR. On 10-OCT-2010, the patient recovered. No further information is available.
DAY AFTER VZV WAS GIVEN TO PATIENT IN RT ARM SQ REDNESS,SWELLING AND PAIN NOTED AT SITE BY MOM ON DAY 2 POST VACCINE THE AREA OF REDNESS WAS SPREADING AND STILL PAINFUL. PATEINT WAS SEEN ON 6/6/08 VACCINE GIVEN ON 6/4/08. DIAGNOSED WITH LOCALIZED REACTION AT INJECTINON SITE BY NP. TREATMENT OF COOL COMPRESSES, TYLENOL PRN AND TO RETURN TO OFFICE FOR INCREASE IN REDNESS OF FURTHER CONCERNS.