chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle twitching calfs, arms, neck etc (both sides of body),; Internal tremor; some muscle fatigue in calfs and forearms; Dose 1: J&J COVID-19 vaccine and Dose 2: Pfizer COVID-19 vaccine; Dose 1: J&J COVID-19 vaccine and Dose 2: Pfizer COVID-19 vaccine; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 09Nov2021 at 13:00 (Lot number: FH8028) at the age of 51 years as dose 2 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin. There were no concomitant medications. Vaccination history included: Jnj 78436735 (DOSE 1, SINGLE, Lot Number: 1808980, Anatomical site: Left Arm), administration date: 31Mar2021, when the patient was 50 years old, for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) both with onset 09Nov2021 at 13:00 , outcome "unknown", and both described as "Dose 1: J&J COVID-19 vaccine and Dose 2: Pfizer COVID-19 vaccine"; MUSCLE TWITCHING (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Muscle twitching calfs, arms, neck etc (both sides of body),"; TREMOR (non-serious) with onset 15Nov2021, outcome "not recovered", described as "Internal tremor"; MUSCLE FATIGUE (non-serious) with onset 15Nov2021, outcome "not recovered", described as "some muscle fatigue in calfs and forearms". The events "Muscle twitching calfs, arms, neck etc (both sides of body),", "Internal tremor" and "some muscle fatigue in calfs and forearms" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of muscle twitching, tremor and muscle fatigue.  Additional Information: Other medical history was reported as None, healthy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. It was reported that symptoms were still there 6 weeks after second shot and he did not have these symptoms after the first shot and its very concerning and it was reported that will those ever dissipate. Since the vaccination, the patient had not been tested for COVID-19.
(L) thigh received MMR & KINRIX. That evening, the parent noticed a large red bump. States child never had a bump as such. Called 2/16/12 at 11:21 A to report this. Will try ice or compress +/or po pain reliever.
Info. has been received from a physical therapist concerning a 1.5 y.o. female who in 2001 was vaccinated with measles virus vaccine live. The physical therapist reported that a co-corker of his stated that her child had received measles virus vaccine live in 2001 and had 2 seizures w/in 7 days of receiving the vaccine. Upon internal review, seizure was considered to be an other important medical event. No further info. is available.
NEUROPATHY ISSUES; EQUILIBRIUM ISSUES; TIGHTNESS IN LEGS; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, administered on 18-APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced neuropathy issues, but it was not confirmed if patient had neuropathy prior to the vaccine or not. Patient complains about equilibrium issues and tightness in his legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the neuropathy issues, equilibrium issues and tightness in legs was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20231019612.; Sender's Comments: V0:20231019738-neuropathy issues. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
The day after my second immunization, I began feeling extremely fatigued.  The extreme fatigue continued until June 14, 2021, when I went to my doctor.  The VA doctor indicated that it could be related to a heart issue.  Testing confirmed an abnormal ECG with atrial fibrillation with rapid ventricular response.  I was given a prescription for blood pressure medication and sent a heart monitor to wear for two weeks.  I have never had any issue prior to the second immunization with my heart.  I had an EKG last year as part of a routine examination and my heart was deemed at that time to be absolutely normal.  I am still having issues with extreme fatigue that has not improved with time.
I blacked out while driving and my husband took me to the hospital. We went to the ER and I passed out again. My heart stopped. I was admitted to the hospital in ICU for 6 days and hospitalized for a total of 18 days. 2 weeks ago an implanted cardioverter defibrillator installed to regulate an irregular heartbeat and to shock my heart if necessary. I do not know whether I have completely recovered or not. I saw my general practitioner today and had an additional COVID-19 vaccine today.
two weeks later, began to have heavy vaginal bleeding; red spots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VAGINAL HAEMORRHAGE (two weeks later, began to have heavy vaginal bleeding) and PETECHIAE (red spots) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VAGINAL HAEMORRHAGE (two weeks later, began to have heavy vaginal bleeding) (seriousness criteria hospitalization and medically significant). January 2021, the patient experienced PETECHIAE (red spots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 4 days due to PETECHIAE and VAGINAL HAEMORRHAGE. At the time of the report, VAGINAL HAEMORRHAGE (two weeks later, began to have heavy vaginal bleeding) and PETECHIAE (red spots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Platelet count: 0 (Low) Obstetrician ordered blood work, and the platelet count was 0.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  Treatment for the events included platelet transfusions, immunoglobulins and steroids.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information could not be requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information could not be requested.
Case number PHEH2013US009605, is an initial spontaneous report received from the physician on 26 Apr 2013. This report refers to a 17-year-old male patient. His medical history and concomitant medications was not reported. He was vaccinated with expired MENVEO (batch number: M10051 and expiry date: Jan 2013) intramuscularly on 26 Apr 2013. No additional information was available.
1/31/22 pt had a positive COVID test 2/16/22 pt admitted to the hospital; worsening SOB past 3 days; checked O2 saturation at home and reports it was in the 60s; O2 supplementation; CXR showed bilateral PNA; given decadron, ABX; pt's condition worsened; transitioned to comfort care and he passed away in the hospital
Patient responded to an internal health system survey regarding vaccine adverse reactions.   Reported (in December) that he had experienced side effect following  his second vaccine dose in April.  No additional follow-up or work-up found in the patients chart or mention of the adverse effect.  Patient reported:  Memory loss.  And that he thought he had Alzheimer's.
TWO HRS AFTER VAX, DIZZINESS, BACK PAIN, COLD FEELING, AND PARESTHESIA. NO TREATMENT. RECOVERED 11-20-89.
headache; muscle aches; low grade fever; chills - It lasted a week - 7 days. Had a doctor visit. Just palliative care - rest, hydration, OTC meds.
Child woke up crying with a headache, a flushed face.  Mother gave TYLENOL by mouth at 7:00 AM.  Temp 1 hr after TYLENOL 100.8.
blurred vision; This case was reported by a consumer and described the occurrence of blurred vision in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2019, the patient received Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was unknown.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. On 15th August 2019, in the night, the patient received a dose of Shingrix and the next day in the morning had some blurred vision.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single 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 completed but unknown manufacturer), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre syndrome". Patient is in his late 60's or 70's who is healthy. After having the Comirnaty booster shot, he had Guillain-Barre syndrome. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Forgetful; Detached; Stomach still feels strange; Dizzy; Stomach hurt; Felt miserable; Fever; Chills; Headache; Body aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 16Apr2021 at 12:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), levothyroxine sodium (SYNTHROID) and esomeprazole (NEXIUM); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 26Mar2021 at 11:00 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 17:00 (reported as the following day), the patient experienced fever, chills, headache, body aches and she knew "rhoa" was typical. On 19Apr2021 (Monday), the patient tried to go to work and could not, she was dizzy, her stomach hurt and she felt miserable. The patient did go back to work on Wednesday (on 21Apr2021) after spending 48 hours in bed. On 21Apr2021, the patient was still feeling dizzy, forgetful and detached. Her stomach still felt strange. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, chills, headache, body aches, dizzy, stomach hurt, felt miserable, forgetful, detached and stomach still feels strange were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: unknown) dose was not reported, 1 total administered on 12-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported.  On 23-AUG-2021 the patient had suspected clinical vaccination failure and suspected covid-19 infection. The patient underwent laboratory test included: COVID-19 virus test with result positive The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000190583.; Sender's Comments: V0: 20210846305 -Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
cold-like symptoms; runny nose; stuffy nose; sneezing; congested sinus headache; loss of taste; numbness in mouth; This is a spontaneous report from a contactable pharmacist, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0175) via an unspecified route of administration in the left arm on 29Apr2021 at 09:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism.  Concomitant medications were not reported. The patient previously took cephalosporin nos (MANUFACTURER UNKNOWN) for unspecified indication from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0150) via an unspecified route of administration in the left arm on 08Apr2021 at 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Prior to the 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 four weeks prior to the vaccination. On 02May2021, the patient experienced significant cold-like symptoms - runny nose, stuffy nose, sneezing, congested sinus headache, loss of taste and numbness in mouth. Therapeutic measures were taken as a result of the reported events and included treatment with zyrtec, sudafed, and advil. The clinical outcome of the event cold symptoms, runny nose, nasal congestion, sneezing, sinus headache, loss of taste and numbness mouth were not recovered at the time of report.   No follow-up attempts are possible. No further information is expected.
Extreme pain and limited arm movement for 5 days.  Inflammation in left index finger.  Was prescribed prednisone.
My son started complaining about all of a sudden, getting incredibly fast heartbeat in winter/early spring (unsure first time he mentioned it) and that it had been happening for a while. The first time he told me, I used my sports watch/tracker to take his heartbeat/blood pressure and it was over 100 beats per minute. His heart beat was visible from his chest, thumping away and we couldn't get it to stop so had him lie down and do deep breathing and it eventually went away. It has happened a few times. We told our pediatrician when we were there in person for a well-child appointment; she advised an EKG but I made 5 phone calls -- and no pediatric EKG place will call me back to set up an appointment. Will keep trying.  We don't KNOW that this was related to the vaccine, but he never had random fast heartbeat issues before getting vaccinated.
Very low symptoms i.e., Low grade fewer ~97F, Fatigue and Body discomfort  during the day after the the inoculation.  Jus rest, No treatment. Everything was normal two days after the inoculation.
Notes per administering nurse  4:40 pm Vaccine given in Left arm (deltoid) 4:50 pm Pt says it tastes metallic in mouth  4:55pm States lips "feel numb" 5:00pm Diphenhydramine 50 mg/ml (1 ml) given IM in Right deltoid muscle, BP 141/94, HR 84, no visible signs of respiratory distress, no dizziness (denies), denies having any other symptoms 5:10 pm Says her lips feel less numb now, sitting on chair, talking husband here after she called him via cellphone 5:15 pm BP 138/108, HR 74, still talking, sitting in chair. Husband got her warm tea, drinking. Denies any new issues. Lips still slightly numb, no respiratory distress visible. Denise any respiratory or throat issues.  5:25 BP 164/94, HR 84 5:35 BP 153/80. Calm, talking joking, husband at her side. Husband went to bring car to Vons front door.  5:45 Walked with her and assisted her to her husbands car. Other symptoms subsided. No new symptoms, no respiratory distress .Able to walk to car without difficulty. Encouraged to call 911 if allergy symptoms incrase or reappear again.
First day I had immediate swelling at the injection site, red circle form around the site of injection following up with an itch that lasted for 3 days. Along on those immediate symptoms I got the injection on my right arm and I experienced pain shooting up from my right arm into my neck and currently still have those pains from time to time when I move my right arm at an elevated angle. Day 4 of the vaccine I woke up one morning with swollen glands, congestion, swollen nasal glands, low grade fever of 100 degree F, very itchy irritated throat and hard to swallow, visited a clinic to see if I possibly had flu or strep but all my test results returned negative, also I had a covid test done and it was negative, I have never contracted covid 19 prior to vaccine and current day. Additionally, symptoms of congestion worsened and I am now experiencing some laryngitis due to the swelling of my lymph nodes, only sinus medication lessens the congestion to manage, I feel very fatigue, and experiencing some migraines.  Today only marks 1 weeks since the vaccine
This spontaneous report as received from a 28 years old female consumer reporting herself with no pertinent medical history and no drug reactions/allergies. The patient was not pregnant at the time of the report. The patient was vaccinated with lot # (0469U); exp. date 28-FEB-2010 GARDASIL (dose and route not reported) on 11-JUN-2008. No other co-suspects were reported. Concomitant medications included CLARINEX and SINGULAIR. Consumer reported that she learned she was diagnosed with HPV (type unspecified) and abnormal cell around 26-JUN-2012. She also stated that on an unspecified date, she experienced mild topical irritation and lesions in the vaginal are. Consumer was no longer seeing the physician who provided the vaccine and plans to see a new physician on 13-JUL-2012. Tests were scheduled for colposcopy. No treatment was given for the events. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for hpv (type unspecified)/abnormal cells, lesions in the vaginal area and mild topical irritation was unknown for GARDASIL. Additional information has been requested.
Patient stated that starting the Friday after the vaccine, he felt weak and some shortness of breath. Of note, the shortness of breath is a problem that has occured previously in his medical history. He called the office today, 12/11/18 complaining of back pain and that was his concern. He denied any fever or other symptoms. He tried TYLENOL without relief and his PERCOCET has helped some. Patient was advised to use a heating pad to help relieve back pain and to call if things did not improve.
Chills, body aches, headache, TYLENOL helped x 4 hours.
Abnormal breathing patterns,lightheaded, cold, clammy, primary impressions: respirations/acute distress/breathing difficulty Secondary: Allergic reaction (ht:86, BP: 148/92, R: 20, T: 99.0) Hx of first inoculation included mild respiratory reaction, treated with Benedryl. EMT arrived post swelling of entire face and sinuses. Post vaccination patient experienced increased sensitivity to known food "sensitivities" and airborne allergens. Patient was diagnosed with asthma as dry cough was continuous. Patient was prescribed asthma medication: Symbicort, Losartam-HVTZ, Nasacort and Zertec. Cont,
1 day after: fever, body aches for one day 3 days after: headache, fatigue for 3 days 1 week after: itchiness at injection site for 2 days 2 weeks after: rash at injection site (hasn't resolved)
Pt received second dose of series on 6/22/19.  Nothing out of the ordinary occurred during or immediately following vaccination.  The patient waited at the pharmacy following her vaccination for about 10-15 minutes and seemed fine upon her departure.  We received a phone call from patient Monday morning stating that she had a "large goose egg" at her injection site.  She described it as "itchy, red, and painful."  The pharmacist on duty recommended taking benadryl, ibuprofen, and applying ice and to follow up with her dr if symptoms did not improve.  I called the patient at noon 6/24/19 to follow up with her.  She said that nothing had really changed since earlier that morning, but that she had taken both ibuprofen and benadryl.  I called Dr. to inform them of the reaction her patient was having.  I had to leave a message, but was told that they would give to the dr and follow up with the patient.  Tuesday 6/25 I called Dr.'s office for updates.  They had spoke with the patient Monday afternoon and told her to take benadryl three times daily and to apply ice pack for 20 minutes for 3 days.   Office staff informed me that the patient had called again Tuesday morning and said that she still had the "goose egg".  They were sending message to Dr. and awaiting her response.
This spontaneous report was received from the patient's grandfather and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date in September 2018, reported as "last 3 weeks", the patient was vaccinated with a dose GARDASIL 9 as vaccination (dose, route, frequency, lot/batch # and expiration date were not reported). It was reported that the patient experienced a seizure immediately after the vaccine was administered and the seizures had been ongoing for the last 3 weeks (since an unknown date in September 2018). The patient received unspecified treatment at an unspecified hospital (unspecified if the patient was hospitalized) and had seen various specialists including a neurologist for unspecified treatment. The outcome of seizure was reported as not resolved. The causality assessment between seizure and GARDASIL 9 was not reported. Upon internal review, seizure was determined to be a medically significant event.