chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Nurse Practitioner referring to a 17 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 03-FEB-2017, the patient was vaccinated with RECOMBIVAX HB intramuscularly (strength, dose number, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that the patient received an adult dose of RECOMBIVAX HB, however no known adverse effects reported. Additional information is not expected, since no consent to contact the reporter was provided.
Subsequent to a MMR vaccination pt has a positive rubella titer.  Pt recently had a negative rubella titer. Follow up provided no additional data.
No other AE noted.; She administered an expired PNEUMOV AX 23 PFS today; This spontaneous report was received from a Medical assistant referring to a 66 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.      On 02-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, route, dose, frequency, and anatomical location were not reported), with lot # S026366, and expiration date 17-SEP-2020 for prophylaxis. No other adverse event was noted. The Medical assistant wanted to know if the vaccination was still viable or did she needed to revaccinate the patient. No prior temperature excursions on the product. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pericarditis; Chest pains, Soreness in chest; Soreness in  left arm; This case was reported by a nurse via sales rep and described the occurrence of pericarditis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several weeks after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant), chest pain and pain in arm. On an unknown date, the outcome of the pericarditis, chest pain and pain in arm were unknown.   It was unknown if the reporter considered the pericarditis, chest pain and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-FEB-2023 Reporter's comments: The nurse had stated that patient got Shingrix shot at the pharmacy.  A few weeks after receiving the Shingrix shot the patient experienced pericarditis, chest pains and soreness in chest and left arm. No other information was provided to the representative. The reporter had consented to follow-up.
I have had five Pfizer Vaccines for Covid and I didn't have Covid so, I got Covid recently; I have had five Pfizer Vaccines for Covid and I didn't have Covid so, I got Covid recently; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 54 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic. Concomitant medication(s) included: LOSARTAN POTASSIUM taken for diabetes mellitus; CENTRUM FOR WOMEN; METFORMIN HCL; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Aug2023, outcome "unknown" and all described as "I have had five Pfizer Vaccines for Covid and I didn't have Covid so, I got Covid recently". The patient underwent the following laboratory tests and procedures: Full blood count: Normal. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient finished the 5 doses and then five days after that of Paxlovid as covid-19 treatment. Patient is not taking Atorvastatin now, she haven't taken it since she got Covid. She normally takes it but was not taking it while being sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Tuesday 9/19/2017 minor muscle pain after the injection with hours, next day Wednesday 9/20/17 all over body aches and joint pain, by 3-4 PM fever minor 99.6 by 10 PM fever of 102.2, chills, body/muscle aches, joint pain. Ibuprofen taken did not lessen the symptoms, Thursday AM fever 99.6 minor body aches but by 9-10 PM fever of 101 more aches ibuprofen alleviated some symptoms (body aches and fever reduced), woke during the night in profuse sweating (2-3 AM); Friday 9/22/17 still dealing with body aches, joint pain fever of 99.6. - symptoms appear to be lessening - hopefully will be gone by tomorrow.
paresthsia - pins and needles sensation over all of body. Especially the sensation was experienced in my hands and feet. I also had a burning pin prick sensation behind my right eye socket.  I felt like I was having a shingles attack.
Patient was given her booster dose of the Moderna vaccine from a vial taken out of the fridge the previous day. The vial was punctured 3 times on 11/20/21, then sat at room temperature until 11/21/2021 when it was punctured a 4th time for a booster dose (administered to the patient). At the time of report, approximately 1 hour after the dose was administered, patient has not experienced any adverse events. We will be checking in with her to make sure no problems arise.
Angina Narrative:  PER PT: "MY LEFT AORTA WAS ENLARGED AND INFLAMED, I ENDED UP WITH PLEURISY BECAUSE OF FLUID RETENTION. CHEST PAINS FOR OVER 3 DAYS. I WAS PUT ON LASIX AND 850MG OF ANTIBIOTICS."  Other Relevant History:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006960, expiration date 19-FEB-2017; dose and route of administration were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
The pt developed red cheek rash on 04/29/2002. On 05/01/2002, he developed loose stools and crying when lifting legs. On 05/04/2002, he developed temp of 101 deg. F. On 05/05/2002 pm fever of 102 deg. F, and seizure (no response, loss of consciousness) noted. He then was taken to a medical center and he could not stand or walk. He was admitted to the hospital and continued to have leg pain. Intermittantly, spinal tap and blood done all reports were negative.
Patient received 2nd dose of vaccine at 1120 today . He had 2 petite mall seizures, tingling, numbness to right hand, glazed stare, slurred voice within 30 min of receipt of vaccine.   Patient transported to emergency room via wheelchair.
10/18/2005 C?O flushing at home in evening, 10/19/2005 generalized erythematous rash with pruritus scattered over arms, legs, torso. Lungs - no difficulty Resp, Treatment Benadryl, Hydrocortisone cream.
Itchy, sore muscle underneath right arm sore. Redness (14 x 8) area, right arm.
Erythema to injection site w/20 min, generalized pruritis. W/in 20, erythema to face/neck- urticaria to neck w/40 min.
Possible seizure or syncope 2 days after vaccination-episode lasted < 5 minutes.
Lethargic; Got COVID; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), COVID-19 (Got COVID), FATIGUE (Tired) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027D21A and 939902) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals (Sulphur), Shellfish allergy and Fruit allergy (Avocado).   On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced LETHARGY (Lethargic), COVID-19 (Got COVID) and PYREXIA (Fever). 30-Jul-2021, the patient experienced FATIGUE (Tired). The patient was treated with VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency; VITAMIN D [VITAMIN D NOS] for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 06-Aug-2021, PYREXIA (Fever) had resolved. On 08-Aug-2021, COVID-19 (Got COVID) had resolved. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         Relevant concomitant medications were not reported.  Patient went to urgent care on 8-Aug-2021.
This spontaneous report was received from a 70 years old female consumer reporting on herself with allergy to penicillin, sulfa drugs and steroids and diabetes and a medical history of kidney stones and shingles (in 1989) who in 2007 was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose and lot # not provided). In June 2012, the patient developed shingles. She stated she had the rash and blisters. The patient was treated with antivirals (unspecified) and "pain" On an unknown date, electrocardiogram was done, results were not provided. The patient sought unspecified medical attention. At the time of the report, the event outcome was unknown. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
COVID; This spontaneous report received from a patient and by a company representative concerned a 67 year old patient of unspecified age, sex, race and ethnicity. Initial information processed with additional information received from Complaint department on 28-NOV-2022. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose and start therapy date were not reported, 1 total, first dose administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, second dose administered on an unspecified date in NOV-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 7 decade old. No concomitant medications were reported. On 14-NOV-2022, the patient experienced covid (Covid-19) (Dose number in series: 2). It was reported as "Thank you I am 67 years young and had the J&J covid series. It has been a year since I took the 2nd shot. Today I am on day 11 of covid. I would not say it is been exactly easy but I did not have to go to the hospital. My 70 year old spouse is doing even better than I am. You delivered. We were alive and did not have to go to the hospital". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid. This report was non-serious. This report was associated with a product quality complaint: 90000260886. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.
pain at the injection site; sore arm; This is a spontaneous report received from a contactable consumer (patient) via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that vaccine was given, pain at the injection site and sore arm were reported. The events took place after use of product. The outcome of the events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Left deltoid became red, warm to touch, tight and swollen. These symptoms started 9/27/17. Patient states no pain from site but arm feels "tight". Parent told by PA that she could use warm compress to help and to return if worsened. No trouble swallowing or SOB. PA states there is no lymphadenopathy. Face/ears are red but pt says not related to reaction to Lt. arm.
first 3 days tired, headache, cold chills followed by sweating in bed.  Now through day 10, I still have headaches and upset stomach pain/nausea.
Pain in the injection site a couple of hours after injection. Felt slight dizziness on the day of administration (on and off). The headache started to appear around 3pm the following day and continues on 2 days after. Feeling weak. Diarrhea also started two days after the administration. Noticed body aches in upper and lower body. Four days after the administration, no more pain in the injection site. Diarrhea had subsided but the headache is still there on and off.
Vaccine was given past BUD time. Vaccine was diluent and BUD time was 9/22/2-21 1635 and vaccine was given 9/23/21 0813
Headache, swelling under the armpit, rash from the bandage started on 17 April 2017. Visited clinic on 19 April 2017, prescribed Codeine and given Quarters x 1 day.
Information has been received from a pharmacist referring to a 66 year old female patient. The patient had no drug allergies/reactions. Patient's medical history and concomitant medications were unspecified. On 18-JUN-2015 the patient was vaccinated with a dose of ZOSTAVAX (subcutaneous, 0.65 ml, lot# K024034, expiry date 20-FEB-2016). The patient developed an unspecified lump and bruise at the injection site "immediately" after receiving ZOSTAVAX. The patient had sought for medical attention by going into the pharmacy on 23-JUL-2015 and showed the pharmacist her injection site. No treatment was given for the adverse events. No lab diagnostics study was performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Heart murmur; Prolapse valve heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC MURMUR (Heart murmur) and CARDIAC DISORDER (Prolapse valve heart condition) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC MURMUR (Heart murmur) and CARDIAC DISORDER (Prolapse valve heart condition). At the time of the report, CARDIAC MURMUR (Heart murmur) and CARDIAC DISORDER (Prolapse valve heart condition) outcome was unknown. Not Provided          No concomitant medications were reported. No treatment drugs were reported.  It was reported that patient had (heart murmur) prolapse heart valve condition and concerned to know before the booster dose.
10:23 a.m. Administered Poli-4 and MMR TT vaccines. The patient went backwards and started having involuntary movement for a duration of 4-5 seconds. She responded quickly. 10:24 a.m. Doctor evaluated the patient. Another doctor evaluated the patient and ordered hospitalization at hospital.
3 days after my vaccination I had a huge lump under my skin and the area was hot.  I notified the Physician's office who told me that this was not uncommon and that I should massage the area.  I explained that the lump was 2-3 inches in circumference I knew this wasn't normal but did what the physician instructed me to do.  Present day I have an extremely huge lump and it is even bigger when my arm is flexed.  It hurts really bad and gets hot off and on.  Any activity hurts to do.  I never had this before I got the T-dap shot that I got.  I messaged the physician's office again but still haven't heard back.  I did request that this get reported but took it upon myself to do it myself since I wasn't getting a response.
Case number PHEH2014US006925 is an initial spontaneous report received from a nurse on 04 Sep 2014 with a follow-up received on 02 May 2014. This report refers to a 61 year old male patient. His concurrent conditions diabetic and immunodeficiency (HIV positive-undetectable His vaccination status was reported as up to date. He received only Men C, Y, W-135 liquid component of MENVEO (batch number: X12025, A12025) intramuscularly, without reconstitution with Men A lyophilized component on 04 Apr 2014 at 2:00 pm. The patient reported that he was feeling fine and had no complaints. No adverse event was reported following this administration error. Follow-up received from a health care professional on 02 May 2014: Concurrent conditions, batch number, time of vaccination and reporter's details were updated. Non significant follow up received on 07 May 2014: No new medical information added.
I first experienced soreness at the site, a headache that was supposed to last at least two days. However, it progressed during that week for longer than two days. Then, I had experienced stiffness in my neck for about four days after the first symptoms and the continued headaches and soreness in both arms and I did my measurements and realized I lost nine pounds of muscle. I continue to have stiffness in my neck as well as the headaches appear off and on after three weeks of having the shot. I also experienced increased heart rate the first five days after I received the shot.
I had a fever, bumps and redness on vaccine arm and a not under the arm, shortness of breath, diarrhea, chest pain, body aches, headaches,  and nausea.
patient was administered an expired dose of Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   On 22nd April 2022, the patient received Engerix B. On 22nd April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comments: The manager reported that a dose of Engerix-B was given to the patient and it was already expired. The reporter consent to follow up. Additional Supportive Information: The use of Engerix-B dose which was already expired on 6th April 2022, which led to expired vaccine used. The Vaccine Administration Facility is the same as primary reporter.
non-epileptic seizures onset 3 days after 2nd dose.  5-6 hours in the ER, trying to figure out if it was epilepsy, then 48 hours of observation once valium was given to calm the muscle spasms down. 5-5-2021 patient still has seizures less frequently, but they still occur.  patient did not have these prior to 2nd dose of vaccine.
pt recv vax 10AM & went back to school;@ noon c/o h/a & devel fever 99.1-100 despite the fact that mom had given APAP;afternoon temp inc to 102 & c/o severe cramping, arms, thighs, shins & feet, couldn't walk;T103.6 & 102.6;
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 72-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) Citrate Free. In July 2022, the patient experienced COVID-19 (Covid-19). In 2022, COVID-19 (Covid-19) had resolved. The reporter's causality for the event of COVID with humira was not provided. No relevant concomitant medications were reported.  No treatment information was provided.
2nd dose of Moderna given 2/25/21 after 1st dose of Pfizer vaccine (given 2/2/21). Recipient asked if she knew she was receiving Moderna and she said yes. I said she would be given Moderna. When we finished, I turned over her card and saw "3 weeks" written on back of card. The I noted Pfizer was written on the front of card. No side effects noted. Recipient called. She stated facility where she received 1st dose did not have any vaccines and she was told to get it 3 weeks later. It was explained that she received 2 different vaccines (different manufacturers) and that she should have receive the same type of vaccine. She stated, " I'm sorry, I just wanted to get it". She was told she should not repeat a dose.
no adverse event; expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired vaccine used).    Patient age was reported as 23 Year 4 Month.  Concomitant medications details were not reported by the reporter.  Reportedly, the patient at facility received Moderna vaccine between 08-Apr-2022 and 15-Dec-2022.       ID was reported as 80777027399.  Completion date provided as 25-Jul-2022.  Treatment details were not reported by the reporter.
Pt fainted 10 mins after vaccine. Recovered and felt better. Did not go w/ ambulance to hospital. Vitals stable.
Patient experienced syncopal episode approx. 5 minutes past immunization. Patient was allowed to rest for about 30 minutes, color returned, pt left w/mother.