chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARM; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a male of unspecified age.  Initial information was processed along with the additional information received on 12-May-2021.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Consumer called to report her side effects and mentioned that her boyfriend received the Janssen vaccine and on 18-APR-2021 patient experienced suspected clinical vaccination failure, suspected covid-19 infection and on 18-PR-2021 patient tested positive for Covid-19.On an unspecified date the patient experienced sore arm for four days. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000179160.; Sender's Comments: V0:20210520726 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
Headache,dizziness,muscle pain  Weeknees,  left arm pain (injection site)
nausea, vomiting begun 30 minutes after administration and last 4-5 hours per patient
Pt had a red flare /spot that lasted 3 weeks. Per her Dr. she went ahead and got the 2nd one. I recommended that she contact her Dr. if she had any  other ill effects. Spot went away. On  5/28- she got another red spot  which she treated with Benadryl she will followup w/Dr.  No other issues present
fainted approximately 15-20minutes after injection. Happened in the parking lot getting into my car. Ems was called. i was full alert upon waking up. bp 120/60 hr 62 pulse ox 99.
Red rash on left arm, inflammation, and warm to touch, informed patient to seek medical help or go to the emergency room, told patient to follow up with us, outcomes unknown
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 08-SEP-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 for prophylaxis (strength, exact dose, route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions reported. Digital Data Logger was involved. No adverse symptoms were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
This spontaneous report as received from a nurse refers to unspecified patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot #L019835, expiry date: 23-MAR-2017). No adverse reactions were reported. The outcome of the events was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Subsequent to receiving two doses of varicella virus vaccine live, pt's laboratory evaluation revealed a lack of response. Pt was vaccinated with a third dose of varicella virus vaccine live on 10/22/99. Pt had the 1st dose on 6/26/96.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX. On 11th May 2018, 1 days after receiving SHINGRIX, the patient experienced tiredness and feeling unwell. On 12th May 2018, the outcome of the tiredness was recovered/resolved. On an unknown date, the outcome of the feeling unwell was recovered/resolved. The reporter considered the tiredness to be related to SHINGRIX. It was unknown if the reporter considered the feeling unwell to be related to SHINGRIX. Additional information was reported as follows: This case was reported by the patient's spouse (wife). The patient took vitamins as a concomitant medication. The reporter stated that after vaccination the patient experienced tiredness for two days. The patient felt exhausted and didn't feel well and spent two days on the couch and then the event resolved. This case was linked to case US2018105431, reported by the same reporter.
Symptoms started after 2nd dose of vaccine more markedly.  He started to complain of fatigue, weight loss and appetite loss.  Was seen by primary care physician by end of June, and malignancy was ruled out, negative endoscopy, colonoscopy, PET/CT, CT chest/abd/pelvis.  started having more fatigue, and dizziness. By the end of July 2021 started using a cane and then a wheelchair for . In September 2021, the patient started complaining of orthotic dizziness, urinary urgency, incontinence, bowel incontinence and paraosmia . On September 17, 2021, EMG and nerve conduction study showed neuropathy and dysautonomia. On September 30, 2021, the patient underwent extensive workup to rule out paraneoplastic disorder, malignancy including lumbar puncture and all of them were unremarkable. lost about 50-60 lbs during this time and also developed temporal wasting. Also developed a right popliteal clot managed with oral anticoagulant.  Dysautonomia neuropathy Difficulty in gait and ambulating  Cognitive decline
5 days of heart palpitations; racing heart; extreme light sensitivity; dizziness; fever; chills; This is a spontaneous report from a contactable other Healthcare Professional (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 30Dec2020 18:45 (Lot Number: EK9231) at age of 30 years as single dose for covid-19 immunisation. Medical history was not reported. Patient was not pregnant. Concomitant medications were reported as none. Patient reported 5 days of heart palpitations, racing heart, dizziness, fever, chills and extreme light sensitivity. These symptoms kept happening since vaccine off and on. The latest landed patient in the hospital for 5 days. Patient had been released but was bedridden with all euro symptoms listed above. Treatment received scans etc, IV fluid and medications to relieve sym. Since the vaccination, the patient had not been tested for COVID-19. Adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events.  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.
Redness, itching, burning swelling *where injection site (given at inner bicep).
she had better breathing and perfect oxygen level; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (she had better breathing and perfect oxygen level) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Diabetic neuropathy, Heart disease, unspecified, Allergy NOS and Long COVID since 15-Nov-2020. Concomitant products included LORATADINE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and FAMOTIDINE for Allergy, INSULIN for Diabetes, GABAPENTIN for Diabetic neuropathy, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Gastrooesophageal reflux, VERAPAMIL, ISOSORBIDE and CARVEDILOL for Heart disease, unspecified, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Post-traumatic stress disorder.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (she had better breathing and perfect oxygen level). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (she had better breathing and perfect oxygen level) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication provided. No adverse events reported but therapeutic benefit was mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow up document was attached on 18-Jun-2021 which contains no new information.
couldn't lift my arm; headache; very sore first day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm), HEADACHE (headache) and MYALGIA (very sore first day) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm), HEADACHE (headache) and MYALGIA (very sore first day). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift my arm), HEADACHE (headache) and MYALGIA (very sore first day) had resolved.            Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Outcome of all events updated to recovered.
Hair loss; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 16Apr2021 (age at vaccination was 36 years) as unknown, single for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient experienced hair loss on 26Apr2021 with outcome of recovering. No therapeutic measure was taken as a result of the event. The event was reported as non-serious. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
shoulder joint pain in the same side as the pneumovax 23 injection; This spontaneous report was received from a consumer via company representative, referring on herself a 66-year-old female patient with rheumatoid arthritis as a concurrent condition. There was no information about the patient's concomitant therapies, previous drug reactions, allergies or medical history.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # N019838, with expiration date on 16-FEB-2019 (formulation, strength, dose, frequency, route of administration, anatomical location, were not reported) for vaccination.    On an unknown date (reported as a day or two after the injection), the patient experienced shoulder joint pain in the same side as the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection. The outcome of injection site joint pain was reported as resolved.        The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
Patient complained of left shoulder pain. Deltoid area red and swollen. Placed on Keflex 250mg and Motrin prn Qid x 10 days.
had both shots, now have shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected  vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots.  The patient was told by her/his surgeon that he/she now had a small case of shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
1 of 2 pts immunized who exp an adverse event; pt devel urticaria, erythema & sl swelling @ the inject site w/in 24 hrs p/vax;
Pt recvd vax on 1DEC92 & approx 1/2 hrs later exp soreness @ inject site; 2 hrs following vax exp sharp stabbing pain through lt upper arm; numb sensation in the lt hand & fingers; pain @ inject site;
Hours after the second dose I became dizzy, nauseous, had a racing heartbeat, had severe body aches and headache, and ran a fever of 101. I began throwing up, even water, and this continued for 3 days.  As of today, I have a very red and swollen arm, sore and itchy, and am still experiencing nausea, chills, vertigo, and intermittent body aches in my back, hips, knees, shoulders. I also developed diarrhea.  My fever ended yesterday. I have also noticed loss of taste and tinnitus.  I was so ill on Thursday and Friday that my partner was prepared to take me to the ER if I didn't improve by Saturday.  Fortunately, I did begin to feel a bit better on Saturday, but as of this evening I am still far from recovered. I have taken photos of my injected arm daily.  Based on my experience with this 2nd dose of Moderna, I will never voluntarily take another COVID-19 vaccine, no matter the manufacturer.
Presented with SOB, cough x10 days; fatigue, nausea, body aches, fever, loss of taste & smell, diarrhea; admitted with Covid PNA; tx with maxipime, steroids, remdesivir, zinc, vit C, vit D, supplemental O2 Patient did not need home oxygen Upon arrival to the ED he was found to be hypoxic with chest x-ray revealing bilateral infiltrates Patient tested positive for COVID-19 on August 19, 2021
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:03 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
Patient informed of receiving a Pneumoccocal vaccine (PPSV23) who is allergic to Diphtheria Toxoid/Pertussis Vaccine/Tetanus Toxoid on 4/19/2022. Pt indicated receiving Covid Booster Vaccination on 4/19/2022 as well. Patient with ER visit on 4/20/2022 d/t chest pain and SOB.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 65-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Remission from lymphoma", start date: 2005 (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: Antigen test had been negative; (23Aug2022) Positive, notes: symptoms returned and antigen test again became positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks included lisinopril. There were no Known allergies. Anti-viral details: Product for COVID 19 Treatment included Brand: Paxlovid, treatment start date 12Aug2022, treatment stop date 17Aug2022 by oral route for treatment of COVID-19.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events covid 19 and Drug ineffective and the suspect product BNT162B2cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201087377 Same reporter/patient, different drug, different event.;
Moderna COVID-19 Vaccine EUA I have had since first injection a weird tingle or itch in my back. The same spot every time. The center of my back, to the right. Feels like bugs are crawling under my skin. This happens daily. Sometimes once daily, sometimes several times a day
hives, nausea, vomit, tinnitus for several days;given po DPH, short course pred;
About 39 minutes after the shot, felt my cheeks become warm, felt a little numbness in my hand for a couple of minutes and weird sensation of vibrations all through the body. Also felt a little nauseous and felt chills for a few minutes. Felt better after one hour.  About 10 days later, got swollen lymph nodes in left armpit.  Then got a bad headache , chills and body aches.  Got tested for COVID-19 (PCR test), came out negative. Excruciating body aches lasted for 3 days.  Felt feverish but forehead thermometer read 98 degrees all 3 days.  A rash developed  near the armpit on side of breast. It is still there and causes discomfort. The lymph nodes have gotten better but still causing discomfort.
June 2002 shortness of breath, fatigue Dec 2002 lung biopsies, began 24/7 use of oxygen          numbness in fingers frequently May 2003- present- development of anemia; blood infusions 7 times; need to see kidney specialist  Nurse follow up on 06/25/04 states: "Review of medical records confirms diagnosis of anemia, already coded.."  Nurse follow up on 09/15/04 states: "leukopenia."
Left arm pruritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; Left arm pruritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Lot number: Fm0698), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Latex" (unspecified if ongoing), notes: known allergies Latex. Concomitant medication(s) included: TYLENOL; CLARITIN [CLARITHROMYCIN]; FLONASE [FLUTICASONE PROPIONATE]. Vaccination history included: Bnt162b2 (Other vaccine same date product Pfizer,, Other vaccine same date lot number Ek5730,, Other vaccine same date dose number 1,, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine"; Bnt162b2 (Other vaccine same date product Pfizer,, Other vaccine same date lot number El183,, Other vaccine same date dose number 2,, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine"; Bnt162b2 (Other vaccine same date product Pfizer,, Other vaccine same date lot number Fc3183,, Other vaccine same date dose number 3,, Other vaccine same date vaccine location: Left arm), for COVID-19 Immunization, reaction(s): "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine". The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), outcome "recovering" and all described as "Left arm puritic rash with pain 4x6 cm.  Reporting as this is only rash after 4 previos vaccines and this was the bivalent vaccine". Therapeutic measures were taken as a result of vaccination site rash, vaccination site pruritus, vaccination site pain.  Additional information: Facility of vaccine was pharmacy or drug Store. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and not tested covid post vaccination. Clinical course: It was reported that patient developed left arm pruritic rash with pain 4x6 cm. Reported as this was only rash after 4 previous vaccines, and this was the bivalent vaccine. Patient treated with tylenol and steroid ointment.