chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it itches quite a bit/ Itching; pain and discomfort with her arm; pain and discomfort with her arm; couldn't get to sleep; rash looks like little blisters; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient started received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date: Nov2021), via an unspecified route of administration on her left arm on 12Jan2021 12:40 at a single dose  for her age (COVID-19 immunization). Medical history included blood pressure (abnormal) and surgeries (had so many surgeries but none recently). Concomitant medications included ongoing atorvastatin for more than a year for blood pressure, ongoing amlodipine for more than year for blood pressure, ongoing losartan for more than year for blood pressure and ongoing terazosin from 09Dec2020 for blood pressure. The patient got her first injection on 12Jan2021 Tuesday and the following day (13Jan2021) she broke out with a rash on her right arm, right under her wrist and where you bend arm. She was asking if this a normal or expected side effect. The patient mentioned it was not in the arm where she received the vaccine. The rash was located in four places on her right arm; at the bend; maybe about two inches from where she bends it; a little bit on the outside of the arm and at the inside of her wrist. Last night (14Jan2021) she went to bed at 11PM and couldn't get to sleep until 3:00AM due to the pain and discomfort with her arm. Now (15Jan2021), it itches quite a bit. She put Neosporin (31254-7238-090 Lot 3259L or a 1 2/1 Expiration date Oct2021) on it and it helped but then when it dries up she can feel the itching again and was painful. The rash looks like little blisters. She is planning to get the next dose; she has to call in. Her next dose is due by 02Feb2021. The events did not require a visit to physician or ER. No prior vaccinations (within 4 weeks). The outcome of the events rash looks like little blisters, Pain in arm and it itches quite a bit/ Itching was not recovered and it was unknown for the other events.
Large hot itchy red rash about 4 inches round with a large knot under it. Arm painful to touch. Fatigue, headache, chills
a blood clot in his leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 30 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number and expiration date unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose unknown, manufacturer unknown), for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "a blood clot in his leg".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Patient had some swelling and blistering/rash at the injection site.
Fever up to 102.5 F off and on for 18+ hours Chills for 4-6 hours overnight Joint pain for 4-6 hours overnight Large swollen lymph node under left armpit Fatigue and dizziness all day today Loss of appetite all day today Mild-moderate headache all day today
tip of nose still funny feeling; Slight dry cough; clearing throat; hoarse voice; pins and needles on face; numb face; Red spots on nose and legs; mottled leg color but looked like a flat rash; mottled leg color but looked like a flat rash; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1283 and Expiration Date unknown) via an unspecified route of administration on 19Jan2021 07:15 PM (vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EJ1685 and Expiration Date unknown) via an unspecified route of administration on 31Dec2020 11:30 AM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included asthma, chronic migraines from neck injury, increased weight, known allergies to Reglan. No covid prior vaccination. The concomitant medications was reported as pregabalin (LYRICA), cefixime (FLEXERIL), sertraline hydrochloride (ZOLOFT), omeprazole (PROTONIX), sumatriptan succinate (IMITREX).On 19Jan2021 08:00 PM, patient experienced pins and needles on face. Then numb face. Red spots on nose and legs. Then mottled leg color but looked like a flat rash. Next day (20Jan2021) tip of nose still funny feeling. Spots remain. Slight dry cough, clearing throat, hoarse voice. Events resulted in Emergency room/department or urgent care. Treatment information included IV fluid, Benadryl, pepcid, steroids.The outcome of events was recovering after treatment given.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Patient became flush with red, swollen lips. Was having fight wheezes and reported difficulty breathing. Gave him 0.1cc of 1/1000 epinephrine and 12.5cc of oral Benadryl and symptoms resolved within 30 minutes. Nurse follow up on 06/08/04 states: Remove edema lip, Add itching foot.
tested positive for HPV.; had an abnormal test; exposure during pregnancy; started the series of doses at age 10-11 and never received the 3rd booster. She eventually had to restart the series of doses; This spontaneous progressive pregnancy report was received from the patient's mother and refers to a 25-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2006 (reported as at "10-11 years of age"), the patient started vaccination series with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date, she received a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) but never received the third dose booster. The patient had to eventually restart the series of doses. All vaccines were administered for prophylaxis. She became pregnant (date of last menstrual period (LMP) and estimated due date (EDD) were unknown) (vaccine exposure during pregnancy). Pregnancy outcome was pending. On an unknown date, the patient had an abnormal test and tested positive for human papillomavirus (HPV). The outcome of the events was reported as not recovered.   Causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA007385:
Information has been received from a physician concerning a 40 year old white female physician with bronchiectasis, C4 deficiency, and asthma and a history of serum sickness with penicillin who on 6/5/96 was vaccinated with pneumococcal 23v polysaccharide vaccine, IM in the arm. In July 1996, seroconversion documented with > 5300 ng/ml Ab. It was also reported that post vaccination a titer did not show seroconversion to all 23 serotypes found in the vaccine. On 2/18/04, the patient developed streptococcus pneumoniae. In February 2004, the patient was admitted to the hospital with streptococcus pneumoniae serotype 19. It was also reported that the patient developed serum sickness. The patient received IV vancomycin as streptococcus pneumoniae was resistant to azithromycin and patient with serum sickness to all other non-resistant usable antibiotics. The patient was hospitalized for 6 days and recovered. On 3/15/04 a serotype 19 (25.6 ug/ml) was recorded. Subsequently, the patient delivered a healthy baby girl. Additional information has been requested.
Information has been received from a nurse concerning a 28 month old female patient with no drug allergies or pertinent medical history who on 10-FEB-2009 was vaccinated with a first dose of series of VARIVAX (Merck) (Lot number not provided), a dose of MMR II (MSD) (Lot number not provided) and a dose of VAQTA (manufacturer unknown). The nurse reported that on 07-MAY-2010 the patient came into the office and was diagnosed with chickenpox. The nurse stated that the patient had 50 to 70 varicella like rash. At the time of the report the patient was recovering. Follow up information has been received from a registered nurse who reported that the patient with no pre-existing allergies, birth defects, medical conditions, no illness at the time of vaccination, no known adverse events following prior vaccination, on 05-MAY-2010 experienced chicken pox. On 07-MAY-2010, the patient was diagnosed with chickenpox. The patient presented with 50-75 macules in the left flank and in the axilla and he was afebrile. There were no labs performed. On 11-MAY-2010 the patient went to a follow-up visit at the office, the chicken pox was eaning up without complications. On the same day the patient recovered. The patient did not require an emergency room/doctor visit (previously reported as the patient went to the office). This is one of several reports received from the same source. No further information is expected.
Early period/Breakthrough Bleeding when this has never happened before, except when breastfeeding.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a female subject of unspecified age who was vaccinated with FLULAVAL. On 2 November 2007 the subject received unspecified dose of FLULAVAL in an unknown arm. Immediately after vaccination with FLULAVAL, the subject experienced an injection site reaction. On 4 November 2007, the event was resolved.
Itching, swelling, burning sensation and blisters. (Red lumps and spots, still remain). Treated with Benadryl and resolved in 1 week.
shrill crying, leg red & swollen, couldn't keep APAP down; temp next AM 101.5 R; lasted 3 days; MD-vax reaction dx;
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 32-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. No adverse reactions were reported by patient.
Day four after second immunization: Cough Chest Pressure, difficulty catching breath and difficulty taking in full breathes.  Lasted 4-6 weeks
Tinnitus, blurred vision, nausea, low blood pressure, hypoglycemia   Deep breathing, called medics. Sx started subsiding after some time, breathing and paramedic arrival.  Bp  95/63 pulse 66. Pt reported not eating much before shot. No prior history of vaccine teaction
Case number PHEH2011US03617, is an initial spontaneous report received from a pharmacist on 06 Sep 2011: This report refers to an adult female patient. She was vaccinated with MENVEO (batch number A100053), intramuscularly, on 25 Aug 2011. She subsequently developed pain in her arm where MENVEO was administered that radiated up to her neck. Pain was persisting at time of this report.
Felt anxious and lightheaded.  Given crackers and juice.  Observed 30 minutes. Felt better and mom drove home.
On 4/22/21 in the evening I noticed that an area above my knee on my left leg was sensitive/ painful any touch.  Through out the night the issue persisted.  Even my sheets touching my the area on my left thigh caused mild pain (2-3 on pain scale).   Area on the back was really tender to touch.  No signs of bruising or swelling was present .  The next day I called a nurse at work to ask what I should do and she suggested I come in to be evaluated.  I was then sent to the ER to rule out a blood clot.  An ultrasound was done on the left leg and no clot was found.  The area remained sensitive to touch and tender for about 36 hours and then resolved.
ABOUT 2 HOURS AFTER INJECTION, I NOTICED DISCOMFORT IN MY JOINTS WHICH PROGRESSIVELY WORSENED OVER THE COURSE OF THE DAY AND ACCOMPANIED BY FEELING OF FATIGUE THAT INTERFERED WITH CONCENTRATION ON MY WORK.
This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (he got shingles 4 weeks ago) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In June 2022, the patient experienced HERPES ZOSTER (he got shingles 4 weeks ago). At the time of the report, HERPES ZOSTER (he got shingles 4 weeks ago) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Patient wanted to get the booster dose of Moderna COVID-19 Vaccine but patient was not sure to get it due to recent shingles that patient experienced. Unknown if any treatment was given, or if patient was under any concomitant or regular medication. It was also unknown if previous doses of COVID-19 Vaccine were from Moderna. Reporter did not allow further contact.
Severe insomnia, which has persisted to date and has been treated with Quetiapine.
Patient developed erythema and swelling at injection site extending to shoulder and elbow lasting 3 days.
Moderate local reaction at injection. Erythematous, indurated area on left anterior thigh. No systemic symptoms.
Systemic: Fainting / Unresponsive-Medium, Additional Details: After vaccination patient was instructed to wait 15 minutes in the store, within a few minutes pharmacist was alerted patient had fainted. 911 was contacted immediately, patients vitals were checked, patient was breathing/normal pulse. Patient became responsive and allerted severe anxiety to needles and noted fainting had occured in the past.
104 degree fever, treated with Tylenol and Ibuprofen (alternating medicines every two hours) and cool baths. Has lasted four days, and she is still ill. Very lethargic, cranky.
fever of 104.5; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever of 104.5) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 104.5). At the time of the report, PYREXIA (fever of 104.5) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Headache, responded slightly to Tylenol, fatigue, mentally foggy, generally achy. Symptoms started about 8 hours after the injection, lasted for +/- 24 hours.
Soreness since vaccine. Joint and muscle pain since vaccine. Joint clicking and stiffened after 10 days.
Patient was given Tdap in left arm and FLUARIX QUADRIVALENT in right arm (both IM) on 8-29-17. Patient said both arms were sore as expected for the first two days. On 8-31-17 the patient said the soreness in the left arm was increasing to the point where she could not sleep at night. On 9-3-17 patient returned to pharmacy complaining of shoulder pain and limited range of motion. I told her to contact her primary care physician. I spoke to patient on 9-4-17 and she was told by her physician to take 800mg of Ibuprofen and 1000mg of TYLENOL around the clock for one week.
gave 0.30 ml of booster rather than .25 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (gave 0.30 ml of booster rather than .25 ml) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milligram. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (gave 0.30 ml of booster rather than .25 ml). At the time of the report, ACCIDENTAL OVERDOSE (gave 0.30 ml of booster rather than .25 ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided. The reporter reported that 0.30 ml of booster was given rather than .25 ml.   Reporter did not allow further contact
Client states that she started having symptoms on Wednesday morning (07-07-21). These symptoms included weakness and fatigue, decrease in appetite, and a metallic taste in her mouth. She states on Friday (07-09-21) she had nausea, vomiting, diarrhea, severe abdominal pain. facial swelling, hives around her mouth, tightness in her tongue, and had developed a rash from head to toe. She states that she used Benadryl prior to going to the Emergency Room. She states that she was treated in the ER with oral steroids and pepcid and was discharged home on a steroid pack.
While giving the vaccination the needle retracted; Patient did not receive full dose. Pharmacist said that half of the dose was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of SYRINGE ISSUE (While giving the vaccination the needle retracted) and UNDERDOSE (Patient did not receive full dose. Pharmacist said that half of the dose was administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 30-Mar-1900, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 UNK. On 30-Mar-2021, the patient experienced SYRINGE ISSUE (While giving the vaccination the needle retracted) and UNDERDOSE (Patient did not receive full dose. Pharmacist said that half of the dose was administered). On 30-Mar-2021, SYRINGE ISSUE (While giving the vaccination the needle retracted) and UNDERDOSE (Patient did not receive full dose. Pharmacist said that half of the dose was administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
First dose, light headed immediately and for 48 hours or more. Mild flu symptoms for about 5 days. Heartbeat felt higher than normal. Second dose, light headed immediately and higher heartbeat than normal. By the next day after the second dose, severe heart pains. Then, heart rhythm felt elevated and heavy breathing at least at night before bed. Trouble sleeping and fatigue and cloudiness. Cardiologist states, "Sinus rhythm, ST & T abnormality, consider recent inferior myocardial or pericardial damage." Possible sleep apnea and study pending. All after second Moderna dose.
had intense pain in left hip and upper leg. Had x-rays and saw NP at facility. Was told that the problem was muscular. Was given pain medicine and told to exercise the area. The pain ceased in two weeks in my hip but persisted in my upper leg. Pain was focused in the muscle on front of my leg so not thought to be nerves. Pain decreased over time and moved to lower leg.  Now I have little pain and some numbness in lower shin area.  Not sure if this at all related to the vaccination
Tested NAAT positive for COVID 11/1/21 after being fully vaccinated.
high fever 102-103;severe swelling redness inj site;small area of skin necrosis noted @ inj site;
Tested positive for COVID-19 on 6/18/2022 using an at-home antigen test. Symptoms: headache, nasal congestion, muscle pain, fatigue Spoke to PCP on 6/19/2022 over the phone; he called in a prescription for Paxlovid Took Paxlovid orally from 6/19/2022 to 6/24/2022 along with Tylenol and Ibuprofen All symptoms except fatigue have subsided
Onset urticaria, cellulitis left thigh on 5/7/14 - ill visit 5/8/14 no fever. Dx: Urticaria. Dx: Cellulitis, unspecified. Treatemnt: KEFLEX susp. 250 mg/ml 1 tsp PO TID x 10 days. BENADRYL q6h x 24-48 hrs, then prn.
One week after 2nd Pfizer COVID 19 vaccine, my bilateral frozen shoulder which had been mostly stable or even improving, relapsed with worsening range of motion and increasing pain.  Wondering if the vaccine caused an inflammatory state that re-triggered the frozen shoulder.
Vaccine was drawn up on 09/30/22 and given 10/03/22