chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm hurt; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who had arm hurt (pain in extremity), when received vaccine INFLUENZA VACCINE.  Medical history,medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was arm hurt (pain in extremity) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4190023-00.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 06Dec2021 (Lot number: TH2027) at the age of 46 years as dose 3 (booster), single, intramuscular, administration date 11May2021 (Lot number: EW0183) as dose 2, single and intramuscular, administration date 13Apr2021 (Lot number: EW0161) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ex tobacco user", start date: 1989, stop date: 2014, notes: smoked cigars and a pack of cigarettes a day; "smoked cigars", start date: 1989, stop date: 2014, notes: smoked cigars and a pack of cigarettes a day; "alcohol use", start date: 1994 (unspecified if ongoing), notes: alcohol use,rarely drinks beer or rhum or cocktail; "Unable To Work" (unspecified if ongoing), notes: Disabled As Patient Was Unable To Work Like It Used To; "Acid reflux" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Sinus allergy" (unspecified if ongoing); "Hair loss" (unspecified if ongoing); "non-steroidal anti-inflammatory drugs allergy" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs allergy manifested by upset stomach, throat and cheeks swell up; "non-steroidal anti-inflammatory drugs allergy" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs allergy manifested by upset stomach, throat and cheeks swell up; "non-steroidal anti-inflammatory drugs allergy" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs allergy manifested by upset stomach, throat and cheeks swell up; "non-steroidal anti-inflammatory drugs allergy" (unspecified if ongoing), notes: non-steroidal anti-inflammatory drugs allergy manifested by upset stomach, throat and cheeks swell up. Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease; BUPROPION taken for anxiety; LORATADINE taken for allergic sinusitis; FLONASE [FLUTICASONE PROPIONATE] taken for allergic sinusitis; FINASTERIDE taken for alopecia; HUMIRA taken for hidradenitis, start date: 05Aug2021 (ongoing). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: hiv test: (Jan2022) negative; sars-cov-2 test: (09Jan2022) positive.  No follow-up attempts are needed. No further information is expected.
pt devel an abscess (dx by a MD), @ inj site w/in 24hr of vax;this site was hot, hard, red, swollen & sore, but not fluctuant;abscess has improved, but has not completely resolved;
ringing in my ears, tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 10:30 (Batch/Lot number: unknown) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "other medical history: AFIB" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE; XARELTO. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False, Prev dose lot number=EN6204, Prev dose lot unknown=False, Prev dose administration date=12Mar2021, Prev dose administration time=04:00PM, Prev dose dose number=2,, Prev dose vaccine location=Left arm), administration date: 12Mar2021, when the patient was 68 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Prev dose lot number=FJ1611,, Prev dose lot unknown=False,, Prev dose administration date=19Feb2021, Prev dose administration time=04:00PM,  Prev dose dose number=1,, Prev dose vaccine location=Left arm), administration date: 19Feb2021, when the patient was 68 years old, for COVID-19 immunization.  The following information was reported: TINNITUS (non-serious) with onset 02Jan2022 12:00, outcome "not recovered", described as "ringing in my ears, tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Additional information: If COVID prior vaccination: No. If COVID tested post vaccination: No  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient sat down after receiving a booster dose of Janssen. She began feeling dizzy and light headed with blurry vision and muffled hearing. Patient stood up to ask for water and fainted. She became alert and oriented a few seconds later. Vital signs were stable, and she was able to stand up and walk to the treatment area. She laid down on the cot for approx. 15 minutes and was given water and juice. She recovered and left the clinic. Of note, the patient had not eaten anything since 9:00PM the previous night.
given in lt arm;no local rxn but in 4hrs of inj pt had hives;no swelling, no angioedema, itches
increased blood flow like a period every day, it doesn't stop; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient received the 1st dose on an unspecified date and experienced headache and her period was not regular. The patient's medical history and concomitant medications were not reported. Patient reported that after her second dose she has increased blood flow like a period every day, it doesn't stop on an unspecified date. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pain in arm generating from the neck to wrist, also fatigue.  Rec'd X2 booster doses after exposure.  Had pre-exposure 3 yrs ago.
vaccines administered at our pharmacies that were stored in an unapproved freezer; vaccines administered at our pharmacies that were stored in an unapproved freezer; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccines administered at our pharmacies that were stored in an unapproved freezer) and EXPIRED PRODUCT ADMINISTERED (vaccines administered at our pharmacies that were stored in an unapproved freezer) 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 24-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered at our pharmacies that were stored in an unapproved freezer). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines administered at our pharmacies that were stored in an unapproved freezer). At the time of the report, PRODUCT STORAGE ERROR (vaccines administered at our pharmacies that were stored in an unapproved freezer) and EXPIRED PRODUCT ADMINISTERED (vaccines administered at our pharmacies that were stored in an unapproved freezer) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter had a group of 13 pharmacies and have administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines have never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. Approved date or the vaccine is 01Nov and BUD is 01Dec. No treatment information was provided.
100.3  fever, chills, entire body very achy, headache, fatigue lasting for 2 days.  Hands and feet very achy.   Injection site very sore (left arm).
Patient had general malaise unknown cause . Onsite EMS was called vitals BP 128/78 HR 84 97% O2 . Patient refused evaluation/care  and released against medical advise.
Within 5 minutes of shot: -Burning in throat/chest -Tight throat/chest -Difficulty breathing Within 15 minutes of shot: -Elevated BP (pharmacist gathered information); after 15 minutes, it was elevated from initial checking -Confusion/Foggy brain -Heart palpitations -Anxiety/irrational fear -Cold extremities (hands/feet) that couldn't get warm that traveled to overall cold feeling in body -Euphoric feeling
(L) arm red tender swollen 4 cm. Headache and foggy feeling.
Urticaria on arms and trunk approximately 20 minutes after vaccination. Moved to scalp as symptoms progressed.
Immediate itchy eyes, tearing, and generalized pruritus.  No injection, rash or any other symptoms.
Fever or Chills  Cough  Shortness of Breath  Difficulty breathing  Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose  Nausea or vomiting  Diarrhea
High fever and unconsciousness on day following vaccination. Loss of short term memory: severe for one week, less severe for an additional week. Interfered with my ability to maintain my household and do basic chores while at home recovering from the vaccine, then interfered with my ability to do my job on return to work five days later on Tuesday June first, through the end of the following week.
vaginal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding). In April 2021, VAGINAL HAEMORRHAGE (vaginal bleeding) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported. No treatment medications were reported.
9/28 1) Hoarseness with in 3-4 hours hives developed on 10/1/09, to arms, legs, face & neck, few on back.  Tx 1 BENADRYL gel to skin, 2. BENADRYL 25 mg - 1 pill X 3/24 hr.  BENADRYL taken for 48 hours - worked sat 10/3 & 10/4 with hives still present but 0 itching & resolving.
Four days after the first dose of the vaccine I got an extremely enlarged Lymph node under my right armpit. I got an Ultrasound on 04/14/2021. I was very concerned because it was large and I could feel it under my arm. It is still pronounced after six months. It had gone down a little by the time I got the second shot but after that it grew again.
Information has been received from a physician concerning a 44 year old male who on 24-SEP-2003 and 26-OCT-2003 was vaccinated with the first and second doses of hepatitis B virus vaccine rHBsAg (yeast) (lot# 642095/1536L and lot # 644246/0032M) respectively. In approximately 2004, the series was finished with a dose of Engerix B. There were no concomitant medications. "A week or so later", in approximate 2004, the pt developed vasculitis and was subsequently hospitalized for approximately 60 days. Other adverse experiences included: hemoptysis, arthralgia, myalgia and dyspnea. The physician reported that the pt said his experiences were, "caused by vaccine." It was reported that the pt had  recovered from the adverse experiences. Additional information has been requested.
This spontaneous report was received from a Healthcare worker regarding a fellow employee who is a female patient of unknown age. Medical history of the patient was not reported. On an unspecified date of August 2015, about a week ago, the patient was vaccinated with one dose of MMR II, subcutaneous. It was reported that on an unspecified date of August 2015, the patient developed measles after receiving the vaccine. The patient sought medical attention and was seen by unspecified physician on unspecified date. The treatment details were unspecified. The outcome of the event was unknown. Causality assessment was not provided by the reporter. No further information was reported. Additional information has been requested.
Information has been received from a registered nurse at an OB/GYN's office concerning a 14 year old female with penicillin allergy who on 13 Nov 2006 was vaccinated intramuscularly in the left deltoid with Gardasil (yeast) (lot #653938/0954F). There was no concomitant medication. On 13 Nov 2006 the patient experienced pain in the vaccinated arm, headache, dizziness, fatigue, weakness and ringing in the ears. The patient sought treatment from her pediatrician. At the time of this report the patient's pain in the arm, headache, dizziness, fatigue, weakness and ringing in the ears persisted. Additional information has been requested.
Arm, which received DTAP and IPV, noted swollen but not tender and FROM.
Red rash on torso, neck, back and injected upper arm; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Body aches) and RASH ERYTHEMATOUS (Red rash on torso, neck, back and injected upper arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Clindamycin). Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRIZINE), CUCURBITA PEPO SEED OIL, LYCOPENE, OENOTHERA BIENNIS OIL, SELENIUM, SERENOA REPENS, ZINC (SAW PALMETTO COMPLETE) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 07-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash on torso, neck, back and injected upper arm). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), MYALGIA (Body aches) and RASH ERYTHEMATOUS (Red rash on torso, neck, back and injected upper arm) outcome was unknown. Not Provided          other concomitant medications include Multivitamins.   Reporter did not allow further contact
1 day p/vax pt devel an inj site rxn characterized by a 3-inch by 5inch area of induration, inflammation & tenderness;also exp tenderness in axilla;pt was treated w/ice & motrin;
PT PASSED OUT IN THE PARKING LOT AND WAS DIAPHORETIC AND RECOVERED IN ABOUT 1 MINUTE AND SITTING UP. SHE WAS BROUGHT INTO THE OFFICE AND HER HEART RATE WAS 80 AND BP WAS 118/70.  PT WAS MONITORED AND STABLE AT DISCHARGE.
got the shot / had the 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In June 2021, unknown after receiving 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.  Additional details were provided as follows: This case was reported for reporter's husband. The age at vaccination was not reported. The reporter stated the reporter and patient got the Shingles shot and the patient had the shingles in June 2021. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Significantly reduced mental clarity, or "brain fog"; Significantly reduced mental clarity, or "brain fog"; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Lot Number: EW0183)), dose 1 via an unspecified route of administration, administered in the left arm on 07May2021 (age at the time of vaccination was 26-year-old) and dose 2 via an unspecified route of administration on 28May2021 (Lot Number: EW0191); both as single dose for COVID-19 immunization. The patient's medical history included Sulfa drugs allergy. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07May2021, the patient experienced significantly reduced mental clarity, or "brain fog". He felt these effects started immediately upon both doses and has lingered on for the past 3 months. The outcome of the events was not resolved.  No follow up attempts are possible. No further information is expected.
Expired vaccine given to two patients; This case was reported by a physician and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, expiry date 30th September 2022) for prophylaxis.   On 8th November 2022, the patient received Havrix. On 8th November 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's comments: The reporter asked information on stability of Havrix. The reporter reported that he/she had a medication error wherein a dose of expired vaccine was given to 2 patients on the day of reporting. The reporter asked about data on stability of this vaccine after the official expiration date. It was properly stored since it was arrival at reporter's clinic in a refrigerator whose temperature was monitored daily. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used. This case is linked to the case US2022163626, US2022AMR163547 and US2022AMR164695 as reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR163547:Same reporter. Patient 2. US-GSK-US2022AMR164695:same reporter US-GSK-US2022163626:same reporter
Extreme body aches, chills, fever of 102.7°F, extreme  fatigue, sore arm from injection that felt like it radiated to fingers and up to neck. Symptoms started Sunday morning, about 16 hours after booster shot, progressively got worse. Injection sign hot to touch and swollen on day 2 and still persist.
Patient received SHINGRIX in the right deltoid and AFLURIA in the left deltoid on 10/1/2018. Per 10/2/2018 Primary Care note, patient reported generalized myalgias and dizziness 6 hours after receiving vaccines. Also has bilateral erythema and possible early cellulitis at both upper arms R greater than L. Given push fluids, TYLENOL PRN fever, and Z-PAK.
My daughters both got the live flu vaccine mist on Saturday after gymnastics class. They started developing symptoms - headache, sore throat, fatigue, fever, Sunday. Patient has missed 2 days of school so far.
24 hrs p/vax pt exp severe h/a w/vomiting migrane type; pt has no hx of h/a; lasted 24 hrs severe mild next 36 hrs; accompanied by weakness;
Patient is 13 years old  and received a Moderna booster.  Patient has no side effects to report after 24 hours except sore arm.
NO ADVERSE EVENT; PEDVAXHIB was administered post temperatme excursion; This spontaneous report  was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.    On 30-NOV-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T001207, expiration date 09-JUN-2022, for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 9.3 degree Fahrenheit (°F) for 9 minutes. There was no previous temperature excursion reported. No additional adverse event reported.; Sender's Comments:  US-009507513-2012USA000834: US-009507513-2012USA000976: