chrisvoncsefalvay/vaers-outcomes huggingface dataset:
First dose in NOV 2019 / second dose in SEP 2020 / due to COVID concern; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case number US2021004407.).   In September 2020, the patient received the 2nd dose of Shingrix. In September 2020, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received dose of 2nd dose of Shingrix in left arm. The patient was unable to space 2nd dose of Shingrix within 6 months due to COVID concern and travel plans. The reporter did not consent to follow up. This case has been linked with US2021AMR005804, reported by same reporter and same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR005804:Same reporter US-GLAXOSMITHKLINE-US2021004407:Same reporter. Case for reporter's mom.
Raised rash on left arm below injection side. Skin red and warm, size started small continued to expand to approximately 4" x 3" at the time this report was written.  Itchy but painful at the same time Fever of 100.6 Extreme fatigue
Red welt at injection site - cold compress, ibuprofen. Diarrhea, stomach cramping - IMMODIUM. Symptoms started 2-3 days after injection.
pt recvd vax & w/in several hrs p/vax pt exp h/a, nausea, vomiting & diarrhea;pt was seen by MD on 5JAN95;
9/22/07 - Mild fever, dizziness, headache (Ibuprofen) 9/23/07 - headache, dizzy, body ache (pepto) 9/24/07 - severe dizziness.
Chills, low grade fever (100.4), nausea, severe headache all resolving within 24 hours
Sore arm (but not very sore) on day 1 of first vaccine and barely felt it on day 2.No side effects for dose 2.; This is a spontaneous report from a non-contactable consumer.   A 32-year-old female patient (age at vaccination 31 years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 25Jan2021 at 20:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. On 25Jan2021 at 20:45 the patient experienced sore arm (but not very sore) and barely felt it on day 2 (as reported). It was also informed that patient received second dose of BNT162B2  (lot #: EL9266) on 15Feb2021 at 08:00 on left arm and no side effect occurred. At the time of the reporting event outcome was unknown.   No follow-up attempts are possible. No further information is expected.
3rd set of immun given in AM, phone call later stated pt had fever, pt was heard crying in background; Seen by MD in afternoon; pt fussy, t101.7, & vomited; MD advised no further Pertussis;
Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL, LEVOTHYROXINE, VITAMIN C [ASCORBIC ACID], MELATONIN, MAGNESIUM and CALCIUM for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced NIGHT SWEATS (Night sweats). On 15-Feb-2021, NIGHT SWEATS (Night sweats) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment medications were not provided.   This case was linked to MOD-2021-046013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-May-2021 contains non-significant information.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot # K004948 Expiration date: 04-APR-2016) (dose, route and anatomical location of administration were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
On 09/17/2000 the patient was seen in a clinic with truncal ataxia. The patient appeared to be a little fussy but was afebrile and had no rash. The physician stated that the child had been a good walker previously but currently had what she described as acute cerebellar ataxia. Follow up information received 11/06/2000 from a physician stated that she felt that the ataxia was secondary to vaccination with varicella virus vaccine live. The physician stated that the child has made a full recovery. The patient's mother noted that the right leg seemed to "give way at times". It was noted there was no trauma. The diagnosis was right lower extremity pain and difficulty in walking. The patient was treated with Tylenol or Motrin. No further information is available.
pain to the touch; swelling - pea sized just above injection, maybe peach size; This spontaneous case was reported by a consumer and describes the occurrence of   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 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Treatment drugs were not reported.
About 30 minutes following vaccination, the patient reported left-sided numbness. At first it was just her left jaw, which she described as feeling like "she just received a novocaine shot" and said you could "drill her tooth and she wouldn't feel it." She also reported numbness down her left side of her neck and arm. About an hour after vaccination, she could not feel her tongue. No other symptoms were present. No swelling, tingling, redness, urticaria, etc. Her BP was taken at 3:10pm and was 131/88mmHg, pulse of 81bpm. The patient has a history of migraines, but has never experienced this symptom before. I advised the patient to go to the ER after her tongue was swelling and even offered to drive her. She refused, saying that she "doesn't want to catch COVID" and she will go home and have her adult son monitor her. I advised that she take a benadryl, to which she said she would do when she got home. I let her know that I will follow up with her in 2 hours and again tomorrow. She left the store at 3:25pm.
Pregnant, EDD 01/11/2023 GA35weeks and 5 days. DTP/aP was given instead of Tdap No adverse reactions to report
After arm soreness, headaches and sleeplessness the first day afterwards, those resolving by yesterday, I noticed On second morning after shot a swelling, sensitivity, and hardness of lymph node in armpit on same side of body of vaccine shot, continuing today.  No treatment has been undertaken.
Pt presented at 0905 with c/o covid symptoms and numbness to face and h/o Guillian Barre Syndrome.
Sporadic itching in multiple parts of the body/ Itchiness sporadic multiple places of my body; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration on 05Jan2021 at 16:45 on Arm left at single dose for COVID-19 immunization. The patient medical history included Cholesterol y Triglycerides high. Prior to vaccination, patient was not diagnosed with COVID-19. No known allergy, no allergies to medications, food, or other products. Concomitant medications included Multivitamin, ascorbic acid (VITAMIN C), ergocalciferol (VITAMIN D), Zinc, ibuprofen sodium (IBUPROFEN). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sporadic itching in multiple parts of the body (also reported as itchiness sporadic multiple places of her body) on 05Jan2021 at 17:30. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the event. The outcome of the event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
2 MONTHS AFTER THE 4TH VACCINATION AN ITCHY PIMPLE RAISED FOR 2 DAYS THEN SUBSIDED.  5 MONTHS AFTER THIS SAME VACCINATION THE PIMPLE RETURNED THIS TIME IT WAS 5x THE SIZE OF THE FIRST AND EXTREMELY ITCHY.  ALSO JOINT PAIN IN LEFT ELBOW AND LEFT KNEE WAS PRESENT AND STILL HAS NOT SUBSIDED (AT TIME OF SUBMITTAL OF THIS REPORT)
Stiffness and soreness around injection site. Irritability. Tried icing the injection site, administered recommended dosage of childrens Advil.
Patient became very weak on 3/06/12 at home.  Presented to ED with paralysis of lower extremities on 3/07.  Neurology diagnosis: Guillain-Barre Syndrome.  Treated with IVIG.  Patient quickly developed respiratory issues and required ventilatory support.
Extreme diarrhea  - began slowly at 6 pm and 6:30 then nonstop from 7 - 8 pm. Took an additional prednisone and 2 imodium tablets.  My internist assured me that despite my compromised immune system, these shots would pose no problem.  Do i take the second shot or not?
the area was very red; the area was very big/ it's coming down now/ area was swollen/ She was surprised to see it big and swollen this time.; now she had chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (the area was very red), VACCINATION SITE SWELLING (the area was very big/ it's coming down now/ area was swollen/ She was surprised to see it big and swollen this time.) and CHILLS (now she had chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039FUA, 015M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE ERYTHEMA (the area was very red), VACCINATION SITE SWELLING (the area was very big/ it's coming down now/ area was swollen/ She was surprised to see it big and swollen this time.) and CHILLS (now she had chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 19-Nov-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (the area was very red), VACCINATION SITE SWELLING (the area was very big/ it's coming down now/ area was swollen/ She was surprised to see it big and swollen this time.) and CHILLS (now she had chills) was resolving.            No concomitant medication details was provided.   Reporter did not allow further contact
pt recv vax 23SEP97 & w/in 4hr of vax pt exp a local rxn (3 inches in size) that was red, hard, warm & painful;pt arm was reported as sore & APAP gave some relief;
2 days after shot sore arm,  felt achy with headache upon rising from chair. 3rd and 4th day felt short of breath. 5th day still short of breath and called doctor's ofc. 6th day felt weak, a little queasy briefly, shaky, shortness of breath and generally ill.  Compared it to when I had pneumonia .No fever, vomitting or diarrhea. Went to Drs ofc for check up. For info...first shot had sore arm and a period one evening of chills for 15-20 min. Since shortness of breath now suffering from anxiety attacks....not sure if this is direct effect or indirect effect of shot.
MEDICATION ERROR (RECEIVED JANSSEN COVID-19 VACCINE AFTER 1ST DOSE  OF THE MODERNA VACCINE); This spontaneous report received from a pharmacist concerned a 47 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: No known daily medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 16-SEP-2021 for prophylactic vaccination. Concomitant medications included mrna 1273 for prophylactic vaccination. On 16-SEP-2021, the patient experienced medication error (received janssen covid-19 vaccine after 1st dose of the moderna vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error (received janssen covid-19 vaccine after 1st dose of the moderna vaccine) was not reported. This report was non-serious.
I was seeing spots in my right eye that were not normal. I had a routine eye appt and I told them I was having vision problems in my right eye and it turns out that when she examined it there was a burst blood vessel and it was actively bleeding. She recommended me to a specialist and I have been under observation and it has been clearing up.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. It was reported that "recently" the patient was vaccinated with a dose of VARIVAX (Merck) (lot # not reported) that expired in 2009. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Day 12- Noticed a bullseye where the vaccine was injected- slight itching- no other sx.  advised by employee health to report
patient felt "flu like symptoms" as described by fatigue and dizziness.  Resolved with lying back in seat and drinking water, 30 minute obs and back to baseline.
mild fever; chest pressure; dizziness; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received dose number 1 of BNT162B2 (solution for injection, lot number Eh9899/expiration date unknown) via an unspecified route of administration on her right arm on 16Dec2020 at a single dose for immunisation. Medical history included penicillin allergy and allergies to gluten. Concomitant medications were not reported. The patient experienced chest pressure and dizziness that later turned into a mild fever on 16Dec2020; all of which prompted visit to the emergency room/department or urgent care. The patient received Tylenol for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. She was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the event was recovering.
Dizziness, muscle pain, tiredness, joint pain I woke up to use the bathroom.  after relieving myself I stood up and got very dizzy, then I fell down.  I fell again after I got myself up.
This spontaneous report as received from a pharmacist refers to an approximately 5 year old patient. In August 2008 the patient was vaccinated with first dose of MMR II (strength, route, indication, lot number and expiration date not reported) and (Oka/Merck) VARIVAX (strength, route, indication, lot number expiration date not reported). In September 2013 the patient was vaccinated with second dose of (Oka-Merck) PROQUAD (strength, route, indication, lot number and expiration date not reported). In May 2014 (reported as just last week) the patient was vaccinated with third dose of (Oka-Merck) PROQUAD 0.5 ml, subcutaneous (indication, lot number and expiration date not reported). No adverse effects had been reported. Additional information has been requested.
Patient had chest pain that started at 7:30 pm on 11/22/22.  he felt tightness in his chest on and off in right upper and substernal areas. Pain lasted 10-40 minutes at a time.  No palpitations or shortness of breath but pulse felt irregular to mother, felt like it skipped a beat.  Patient was seen in ED on 11/23/22.  Pain has improved but still intermittent since.  last had pain on 11/24 in the evening that went away prior to going to sleep.  He did take tums on 11/22 which did help the pain.   No fevers.
With First Vaccination  , shortly after, I had increased heart rate, 120s/130s  (old apple watch no ekg) tachycardia. I felt shakey, light headed, cold hands, clammy and felt like I was going to pass out. I called the team over. They monitored me extra, gave me juice and cookies, and the feelings subsided.  One month later 2/1/21  I  got my second dose and I  again felt my heart rate increase to 120/130s at rest old apple watch/no ekg), but did not have other symptoms.  That was Moderna Lot 028L2oA  I have not had a booster because of this, and my new onset heart problems.  I have since been followed by my PCP and a cardiloogy for onset of SVT/arrythmia. (healthy, no meds, no supplements, no changes to diet, weight, exercise.  I do not drink alcohol regularly,, no smoking, no drugs. 1 cup of coffee a day.)  Cardiology work up, stress test, ECHO, Zio patch indicating runs  of SVT, VT , frequent PVCs, atrial ectopy.    prior to vaccination  I have never had any heart or health conditions. I have not been with cold or fever over the last 2 years, , and I have never been sick. I have never tested positive for Covid ( I need to get weekly test for my clinical site).
Within 5 minutes of getting his flu shot the patient started complaining of being cold, he started shivering, given TYLENOL and blankets. After about 30min the patient again began to shiver and c/o of being cold after having some relief, he was without fever or perspiration, did not vomit. Symptoms: NauseaVomiting & chills. Treatment: Acetaminophen 500 MG other.
I woke up with a headache, drainage, sore throat, full sinuses, fever of about 99 and I normally run about 97. Shortly afterwards temperature up to 100, then I think later that day it got up to 101 and that's when I went to urgent care. They tested me for COVID-19 and flu, both came up negative. The attending Dr. told me to test again the next day and come back if I got a positive test. The next day the temperature got up to 102 and my symptoms were more exaggerated. I went to a nurse her at the retirement home to get another test and that test came up positive. I went back to urgent care and the doctor gave me a prescription for PAXLOVID. Within 24/hrs. all symptoms were gone. Back to normal temperature, but had some drainage and sore throat for about a week or so. I isolated for 10 days per retirement home regulation.
This spontaneous report was received from a 72 year old female patient regarding herself. Medical history of the patient included a bypass surgery on an unknown date approximately in January 2008 (5 years). On 30-NOV-2012, the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry date and dose unspecified) subcutaneously. Concomitant medications included simvastatin, metoprolol, PLAVIX, NORVASC and aspirin. On 09-DEC-2012 (9 days after receiving live ZOSTAVAX), the patient experienced severe shingles like rash and post herpetic neuralgia. The patient sought medical attention (patient visited doctor at outbreak of shingles) and she was treated with hydrocodone. No lab tests were completed. The outcome of severe shingles like rash and post herpetic neuralgia was reported as not resolved as the patient was still suffering with pain and mild rash at the time of reporting. The relatedness for severe shingles like rash and post herpetic neuralgia was unknown for live ZOSTAVAX. Additional information has been requested.
Pain in leg with TETNUS shot, fever of 103.5, he 'acted strangely'; did not recognize his mother, upset crying & disoriented.
Pt vax w/ 3 doses; pt was not immune to hepta B virus.
A pt who has a medical history of common variable immunodeficiency and has been treated with intravenous immunoglobulin received her first 2 injections of Prevnar and reportedly, has not had any antibody response. The mother indicated that her daughter's post-vaccination numbers were lower than her pre-vaccinations numbers. The mother also reported that her daughter received Pneumovax following immunization with Prevnar and still has no antibody response
large, itchy, red spot on my left arm where shot was administered. about the size of a soft ball. irritated for 4 days.
Patient had Pfizer vaccine on 08/17/2022 on his right thigh and 15 minutes later mom reported rash on right thigh on the site of the vaccine and provider evaluated patient and diagnosis urticaria right thigh and right buttock and prescribed Benadryl 5 ml and patient took it. After 10 minutes, mom reported patient with lips itchy and provider found slight swollen lip and patient had EpiPen Jr one dose and he was sent to the Emergency room. In ER, got PO steroids, observed, symptoms resolved, didn't recur.
whole body ached, couldn't walk, both arms were hurting, knees hurting, then the following month hospitalized for high potassium levels. Prednisone, Hydroxychloroquine 200mg, Veltassa 8.4g, Acetami/Codein 300-30mg tab. 1 tablet every six hours
No adverse event; Patient GARDASIL 9 schedule history as follows, 1st dose on 7/18/2019, 2nd dose on 2/19/2021, and 3rd dose on 4/26/2023; Third dose of GARDASIL 9 given in error, was meant to administer MENQUADFI (other company vaccine).; Patient GARDASIL 9 schedule history as follows, 1st dose on 7/18/2019, 2nd dose on 2/19/2021, and 3rd dose on 4/26/2023; This spontaneous report was received from Other and refers to a 16-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 18-JUL-2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 19-FEB-2021, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 26-APR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml/dose 3 of 3, lot #W021345, expiration date: 01-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient started therapy with meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On unknown date, risk manager called to report that a 16 year old patient was given 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of vaccine administered). Third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) given in error, was meant to administer MENQUADFI (other company vaccine) (Wrong product administered). Concomitant administration of both vaccines reported.  No side effects or symptoms reported. Caller filed with VAERS 4/27/2023. No additional AE/PQC.
Can?t remember the exact dates, just now found out that you can report adverse reactions.  The issue i had was what felt like my heart working hard when i laid down for bed a couple nights.  One time i put a heart rate monitor one because it felt like my heart rate was very high but the monitor showed normal.
Patient presented to the ED and was subsequently hospitalized for suicidal ideation within 6 weeks of receiving COVID vaccination.