chrisvoncsefalvay/vaers-outcomes huggingface dataset:
needle was very short hence very uncomfortable/felt the needle was not long enough; needle was very short hence very uncomfortable for her; burning; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunization. The patient's medical history and concomitant medications were not reported. It was reported that regarding PREVNAR 13, the patient complained that the needle was very short hence very uncomfortable for her and burning. The patient felt the needle was not long enough. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Migraine; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2, lot EZ8982), via an unspecified route of administration from an unspecified date at SINGLE DOSE for Covid-19 immunisation. Medical history included asthma Concomitant medications included montelukast sodium (SINGULAIR), budesonide, formoterol fumarate (SYMBICORT) and adapalene (ADARET). The patient experienced migraine (taking Imitrex as treatment) on an unspecified date. The outcome of event was unknown.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 05May2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in left 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: "Coronary artery disease" (unspecified if ongoing), notes: Other medical history: Coronary artery disease; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: two negative antigen tests; Negative, notes: two negative antigen tests; Positive, notes: I experienced a positive antigen test; Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment from 24Jun2022 to 29Jun2022. Adverse event: After full course Paxlovid and two negative antigen tests, patient experienced a positive antigen test and recurrence of symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left eye doesn't hurt or burn, but cannot see out of the eye suddenly. Can only see black, white, and grey.
No additional AE reported.; Nurse called and reported that PROQUAD was administered Intramuscularly rather than subcutaneously to a 12 month old female.; This spontaneous report was received from a registered nurse, referring to a 12-month-old female patient. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided.  On 20-APR-2022, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD) dose of 0.5 mL, lot number: U029322 was confirmed to be valid, expiration date: 19-MAR-2023, administered intramuscularly (anatomical location was not reported) for prophylaxis (incorrect route of product administration). No additional adverse event (AE) reported (no adverse event). No product quality complaint (PQC) reported. No additional information provided.
Information has been received from a registered pharmacist concerning a 68 year old female patient with hypertension, hypercholestrolemia and stomach condition with no drug reactions/allergies, who on 19-NOV-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 665514/0145Z) SQ. Concomitant therapy included unspecified medications for hypertension, hypercholesterolemia and stomach condition. The pharmacist reported that on 20-NOV-2010 the patient developed a red area on her left arm at the injection site after receiving ZOSTAVAX (Merck). The pharmacist stated that this did not look like a rash, and that the patient reported that sometimes that area was itchy. The patient seek medical attention by came back to pharmacy. There were no Lab diagnosis/studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Pregnant and received Moderna COVID vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine) in a 32-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever. Concomitant products included PRENATAL + DHA for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Nov-2020 and the estimated date of delivery was 04-Sep-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no treatment medication reported. No maternal history of subfertility was reported. No family history of congenital anomalies/genetic disease was reported. No complications or acute illnesses during this pregnancy to date were reported.  On an unknown date in Nov-2016, it was reported that 1st pregnancy ended with live, full-term birth. On an unknown date in Nov-2019,  it was reported that 2st pregnancy ended with live, full-term birth.
Client received vaccinations on 9-11-10. On 9-13-10 developed hives that worsened causing tongue swelling and required an ER visit. Where he was dx with an allergic reaction to the vaccinations rec'd (seen in ER on 9-18-10).
Leg swollen very much, red, and warm to the touch, knee fluctuant, thigh twice the size as right.
For 48 hours, I had alternating fever and chills, severe body aches, and sore throat. I only took ibuprofen and naproxen and after that 48 hours I was fine, although slightly weak.
arm so sore; Initial information was received on 30-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.   This case is linked to cases 2020SA307387, 2020SA307452, 2020SA306301, 2020SA302198, 2020SA307939, 2020SA307940, 2020SA307941, 2020SA308033 and 2020SA308034.  This case involves an unknown demographic patient who experienced arm so sore (pain in extremity), while the patient received vaccines INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  Medical history, concomitant medication, past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer and PNEUMOCOCCAL VACCINE not produced by Sanofi Pasteur (lot number expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious arm so sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE PNEUMOCOCCAL VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was unknown.  There will be no information available on the batch number for this case.
Patient vaccinated with smallpox on 27 Nov 05. Then had myocardial infarction on 29 Nov 05.
pt exp fever of 105 twelve hrs post administration; Also, @ inject site, lt thigh displayed a 10cm x 5cm circle of edema & an induration; reaction resolved w/treatment of Ibuprofen;
Arm started hurting around 1:30. I was general tired. No appetite Took a 2-3 hour nap that evening. Got up and ran a low grade fever all night long. Headache and muscle aches. Nauseous - but I've dealt with since my pregnancy from 4 weeks pregnant on. Next day, body aches and low grade fever continued. I was triaged at labor and delivery at about 5:00 pm. The fever did me in - I was already getting dehydrated on my own and fever escalated it.  I went to hospital. Sent me home with Pepcid for heartburn. I went into the clinic on Friday after that and got two more liters of fluid which was scheduled previous to injection. Overall, it helped with symptoms. I was still tired on Thursday and into Friday but otherwise I fine. But from Tuesday to Friday afternoon I was pretty crummy. Pregnancy History - second pregnancy - first to go this far. Estimated due date: Sept 16, 2021
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, concomitant medication drug reactions or allergies. On 07-MAR-2017, the patient was vaccinated with an expired dose of VAQTA (lot # L048460 and expiration date of 14-JAN-2017) (strength, dose, frequency and route of administration were not provided) for prophylaxis. Additionally, no adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a Nurse Practitioner refers to a 16 year old female patient. On 22-SEP-2008, the patient was vaccinated with first dose of GARDASIL (lot #, expiry not reported). Nurse practitioner reported that the patient was in the office today on 13-AUG-2013 to receive the second dose of GARDASIL. No adverse effect reported. Additional information has been requested.
As of todays date (3/9/2010), I still have a constant ache (muscle pain) at the site of the injection. On scale of 1-10 (10 being worst), pain is about a 3. I was told that I might have discomfort for about a week or two, but it has been over a month now. Is this a symptom of the vaccine???
6x8 cm area around injection site tender, red and warm. No streaking or adenopathy
the day after the second vaccine he developed pain in left ear, nasal congestion and facial pain. one week following  vaccine he developed skin rash on left scalp, face and neck. diagnosed with shingles in ED on 8/6/21.
Pt. was administered several vaccines simultaneously for travel - YF, Hep A/B combination, and MMR, in the left arm.  She developed soreness initially but 8 days later developed swelling, firmness, redness and localized heat in that arm, to just below her elbow.  NO fever.  Three days later she called her family doctor, "felt OK other than my arm".  Family doctor did not see pt. but prescribed a course of Keflex.  Sx. improved gradually, still has one small area of firmness, not tenderness.
Wrong vaccination given.  Client was supposed to receive 2nd Pfizer vaccine.  Janssen given.
I have been having monthly migraine attacks. Every month they come on and they are worse than they normally are- at first they were just headache but have developed into migraines. I saw the doctor on February 7th 2022 and discussed this and started to try over the counter meds for the headaches. They became worse and were full blown migraines so I  saw another doctor on March 22nd. He gave me a medication to help me sleep and we also discussed how the migraines were keeping me from sleeping and coming on a monthly basis. I saw a different doctor on May 10th 2022 who gave me samples of a new migraine medicine and stated it may be Ocular Migraine and the sample he gave me to try which is Nurtec seems to help more than the other things I have tried.
pt recv vax 31OCT96 & 10 hr p/vax pt devel bright spots on upper chest which were itchy @ times;rash was flat & not raised;no tx was given;pt had rash for 5 days;sx were fading still there as of 6NOV96;
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was reported as 07-May-2021. Concomitant medications were not provided. Treatment information was not provided.
ADMINISTRATION ERROR:  She got her vaccine, while waiting the pharmacist spoke to her and informed her that they had given her an adult dose and not a child's dose.  The pharmacist informed her that her daughter should be OK.  She said that she had 13 year old children that come in and get adult doses and do OK.  Mother informed them that she would let them know if anything happened to her.
a lot of dizziness; some weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (a lot of dizziness) and ASTHENIA (some weakness) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1 Lot number: EI0142) on 12-Jan-2021, Pfizer (Dose Number: 2 Lot number: E13249) on 02-Feb-2021, Pfizer (Dose Number: 1st booster Lot number: FF2587) on 19-Nov-2021, Pfizer (Lot number: FM9992 Dose Number: 2nd booster) on 20-May-2022 and flu shot on 14-Sep-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, Pfizer and flu shot. Concurrent medical conditions included Blood pressure high, Anxiety, Stress, Allergy to antibiotic and Latex allergy.   On 29-Sep-2022 at 9:00 AM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced DIZZINESS (a lot of dizziness) and ASTHENIA (some weakness). At the time of the report, DIZZINESS (a lot of dizziness) and ASTHENIA (some weakness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) positive.   No concomitant information provided. It was told to the patient that she tested positive a month ago, but she did not believe it. The patient had a severe reaction to the newest Moderna shot. She lives in a senior center. She states that people from the pharmacy came to her senior home to administer the shots. She got the shot an hour to an hour and a half later, she got the severe reaction. She was feeling better. Adverse reactions did not cause patient to seek medical care. No treatment information provided.
Red rash on the inside of the elbow; Itchiness on the inside of the elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH ERYTHEMATOUS (Red rash on the inside of the elbow) and PRURITUS (Itchiness on the inside of the elbow) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on the inside of the elbow) and PRURITUS (Itchiness on the inside of the elbow). At the time of the report, RASH ERYTHEMATOUS (Red rash on the inside of the elbow) and PRURITUS (Itchiness on the inside of the elbow) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
dryness; pain and tightness in right leg; pain and tightness in right leg; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on unknown date as dose number unknown single, for COVID-19 immunization. The patient's medical history was not reported. No prior vaccinations reported. The patient concomitant medications were Atorvastatin calcium for the cholesterol from 16 oct to unknown date and Fenofibrate for unknown indication from 16 oct to ongoing (start date year not specified). On 19Dec (year unspecified), the patient had experienced dryness, pain and tightness in right leg. Therapeutic measures were taken for the AE and treatment included physical therapy for 2 months and still experiencing moderate symptoms. Reported issue occurred after use of Pfizer product. It was unknown if events required hospitalization or visit to emergency room. The clinical outcome of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
pt recvd vax & next day exp a hot,itchy,raised,swollen,eyrthematous inj site;addl had an induration of 1/2 cm @ inj site;elocon cream was applied locally;
Varicella vaccine admin 7-30-09. Family report that blister appeared either the next day 7-31-09 or 8-1-09. To Dr. 8/2/09. Dx with bacterial infection & given antibiotic - name? To be taken TID x 5 day. Area on arm with blister approx size of a quarter - inflamed, redness around edge of blister.
sycope, pt started experiencing fainting symptoms such as sweating, paleness, hearing disturbances, weakness, dizziness, coldness of extremities after about 3 minutes of the vaccine, symptoms resolves in about 20 minutes.
PT DEVELOPED DYSFUNCTIONAL UTERINE BLEEDING SOON AFTER RECEIVING THE VACCINE WHICH LASTED FOR 4 WEEKS  REQUIRING A HOSPITAL VISIT FOR A HEMOGLOBIN OF 6.
Case previously recorded as MA2009-3425. Initial case report received from a consumer via MedCom, on 28 OCT 2009. A 2-year-old male child was vaccinated with 0.5 ml S-OIV FLUVIRIN (batch no. unknown) i.m. on 28 OCT 2009. S-OIV FLUVIRIN 0.5 ml was given to a 2-years-old child. Upon reading the package insert, the mother noted that the product was not indicated for children below the age of 4 years. No adverse event was reported. Reference no.: NA09-007196.
This spontaneous report as received from medical assistant refers to a patient of unknown age and gender. No information received regarding medical history and concurrent conditions. On an unknown date the patient was vaccinated with PROQUAD (Merck), (lot#, dose, route not reported). No concomitant medications reported. The medical assistant has reported that over the last 30 days (approximately from the 09-NOV-2014) an unknown number of doses of PROQUAD (Merck) which underwent a supported temperature excursion had been administered to the patients. No adverse effects reported. No treatment was given for the adverse event. Product quality complaint was not reported. This is one of the several report received from the same source. Additional information has been requested.
Information has been received on 05-NOV-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not provided. In or about May 2014, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown), as recommended prescribed, and/or administered by a physician for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. Later in approximately September 2014, the patient was treated by a physician for shingles. The patient was prescribed Gabapentin to treat pain related to his shingles and zoster-related injuries. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Red, swollen Left arm from shoulder down to elbow with vesicles around area of injection.
headaches 3 weeks, phantom smells since vaccination, and now I have not had my period (2 weeks late) - verified not pregnant through serum HCG.
patient has had a red, sore knot in arm at site of administration since shot in Feb.  He had hoped it would be gone but it is not.  He said the knot is now about 1 and 1/2 inches below administration site and is about the size of a tennis ball.  He is going to be seen in a few weeks by his PCP.
Severe pain, induration erythema myalgias localized left UE +shoulder +chest pain, mild pruritis. Pain swelling extended from deltoid to pectoral trapezius axillary distrubtion, lymphadenopathy  within 24 hours