chrisvoncsefalvay/vaers-outcomes huggingface dataset:
couple of hr p/shot t104 gave APAP as instructed fever did not go down;face red, eyes swollen x 3 days-took to ER was told rxn to shot;1mo later ate eggs for breakfast-couple hr then t104 face red, eye swollen;MD said allergy to eggs
Constant  ringing in ears.  Continuous ringing in ears since 8/29/2021
pt recvd vax & mom awakened to sound of pt gagging; was pale; shakey & irritable; eyes rolled back; t 104; mom tx w/ apap; mom stated gagging & eye rolling occured every few hrs for 8-9 hrs;
Diagnosed with Covid after vaccination; Diagnosed with Covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Both have COPD and emphysema.; "emphysema" (unspecified if ongoing), notes: Both have COPD and emphysema. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Diagnosed with Covid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller stated that his wife and himself they both had COVID back on May. He took Paxlovid and she took a monoclonal antibodies therapy. Caller wanted to know if they were still eligible for the new bivalent booster dose of the Pfizer-BioNTech COVID-19 Vaccine. He mentioned that he had the 2 primary series and 1 booster dose from Pfizer (and he had COVID on May). He didn't specified this for his wife.  Follow-up attempts are completed. No further information is expected.
Left arm hurt for 2-3 days then resolved on its own; This is a spontaneous report from a contactable consumer.   A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), via an unspecified route of administration on 12Feb2021  as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 12Feb2021, at 15:00 patient experienced left arm hurt for 2-3 days then resolved on its own. No covid test post vaccination was snoted.  The outcome of event was recovered in Feb2021, with no treatment given.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .
The nurse injected the vaccine very high up on my arm, close to my arm and shoulder joint. I get the flu shot every year, and I never had any symptoms before, and this year the shot was painful and the pain has persisted since. I can't remove my arm forward at shoulder-level, or lift my arm up over my head without a sharp pain in my upper arm. I went to my family doctor, he prescribe me the Naproxen 500 mg for one month with 1 times refill. It did reduce some pain when I put on my jacket. After taking the medicine for over a month, I am afraid the addiction, and I stop taking the medicine. The pain came back in full force again. I am going to see my primary doctor again, see what can I do to stop the pain.
Rec'd flu vaccine 11/6. Notes swelling, pain, redness at site. Exam shows 2cm area of erythema at site and 8x8 area erythema anterior and medial to injection site. Some warmth and purplish area. No nodes.
dry cough; chest pain; you have to catch your breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Lot number: FF2590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administered in arm left, administration date 05Nov2021 (Lot number: FK5127) as dos enumber unknown, single for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose #1 in her right arm in the morning  between 08:00 am-10:00am. Lot EN6208.), administration date: 13Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose #2 in her left arm, unknown time. Lot EP7533), administration date: 03Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: COUGH (non-serious) with onset 06Nov2021, outcome "not recovered", described as "dry cough"; CHEST PAIN (non-serious) with onset 06Nov2021, outcome "not recovered", described as "chest pain"; DYSPNOEA (non-serious) with onset 06Nov2021, outcome "not recovered", described as "you have to catch your breath". No follow-up attempts are possible. No further information is expected.
NEUROLOGICAL PROBLEMS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced neurological problems. The action taken with covid-19 vaccine was not applicable. The outcome of neurological problems was not reported. This report was non-serious.
Pt recvd 2 doses of Engerix-B & 1 wk p/vax pt devel delayed upper resp viral illness described as mono-like; tx bedrest;
Information has been received from a physician concerning a 43 month old female who had been vaccinated on 5/3/01 and 2/27/02 with a first (634836/0547K) and second (640711/1394K, left "lat") dose of hep A virus vaccine inactivated. On 7/5/02 the pt presented to the office with a "febrile illness-suspicion for hep A." It was also reported that the "child became sick and did not develop any antibodies." Additional info revealed that the physician who administered the second dose, "ran hep A and hep A&B totals to determined what antibody levels for child was." Results were reported as, "IgG and IgM negative, non-reactive antibodies." An epstein-Barr virus antibody test from 7/5/02 was > or =1.10 (positive antibody detected) which had the following interpretation, "suggestive of a past epstein-barr virus infection. In infants, a similar pattern may occur as a result of a passive maternal transfer of antibody." It was further clarified that the pt did not have hep A. Follow-up info received from the physician indicated that the reason for his report on this pt was solely because of a viral illness, which prompted lab work. Those labs indicated that the pt had no immunity to hep A, "despite the administration of the appropriate series of hep A vaccine." The pt recovered from the viral illness on an unspecified date. Additional info is not expected.
concerned about poss reaction to 1st covid vaccine - been 17-18 days since vaccine. sx started couple days after she got the vaccine the prednisone affected her bipolar d/o so does not want more prednisone. but still c/o feeling like her lungs are not normal, usually asthma flareup if ill, usually prednisone helps and the inhaled corticosteroid usually helps. also c/o neck and back pains flared up again since covid vaccine though no recent trauma not radiating to arms/legs
difficulty with urination; high fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of urination difficulty in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced urination difficulty, fever and general body pain. On an unknown date, the outcome of the urination difficulty, fever and general body pain were unknown.   It was unknown if the reporter considered the urination difficulty, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received Shingrix and had urinary difficulty, high fever and body aches also. The reporter asked was a side effect of Shingrix difficulty with urination.
Muscle aches at 10 PM September 30th.  Fever 102.6 fever, chills, muscle aches, and inability to sleep from 12:45 Am to 5Am  on October 1st. Tylenol taken at 1:45 Am, 10 Am, and 4 PM on October 1st. Some sleep between 5 to 10 Am. Some sleep between 2 to 4 pm. Muscle aches, fatigue, less chills, and fever of 101.6 still present at 4:30 PM.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-DEC-2015 at 18:50, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Taste salty; Smell of smoke in her nose; This spontaneous case was reported by a patient and describes the occurrence of DYSGEUSIA (Taste salty) and PAROSMIA (Smell of smoke in her nose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-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 DYSGEUSIA (Taste salty) and PAROSMIA (Smell of smoke in her nose). At the time of the report, DYSGEUSIA (Taste salty) and PAROSMIA (Smell of smoke in her nose) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. On 11-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication provided by reporter. No treatment medication provided by reporter.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with first 0.5mL dose of GARDASIL (route and lot number not provided). The physician reported that the patient experienced tachycardia after receiving the dose. The patient sought unspecified medical attention. Additional information has been requested.
w/in 1 day of vax a few pt devel redness & a nodule @ inj site;
c/o lightheadedness/dizzy with diarphoresis and near syncope-noted head pain to occipital reg. Dull non-radiating 2/10 in severity w/o visual disturbances (onset) 1 hr after injection.
On 12/12/12, after vaccines administered, pt. reports she experienced '(L) arm muscle twitching' and the appearance of "a crater" in between both injections sites. This still persists. No pain, fever or chills. Pt. states area is "pink". No evaluation or tx at time of this report. Recommended pt. f/u with her doctor.
Patient got up from sitting down about 5 minutes after receiving vaccination and walked towards the pharmacy window and fell down and knocked his head against the wall. He began to sweat and vomit until 911 arrived. Within 10-15 minutes the patient was able to get up and walk. He insisted he was okay and did not want to go to urgent care with them.
I have a high fever of 103 and I am vomiting AT 11:03 PM
High grade MDS; Multiorgan failure; Pancytopenia; shortness of breath; Inflammatory marker increased; Chills; Fever; Fatigue; A spontaneous report was received from a healthcare provider concerning a 71Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced chills, fever, fatigue, pancytopenia, shortness of breath (dyspnoea),  multi organ failure, and myelodysplastic syndrome (MDS).  The patient's medical history was reported to include Breast Cancer and mastectomy. No relevant concomitant medications were reported.  On 16 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unkown) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, The patient experienced events like chills, fever, and fatigue.  On an undisclosed date, the patient was admitted to the hospital for shortness of breath. Laboratory details include Bone Marrow biopsy with abnormal results such as showed high grade MDS with 19% blasts. Blood work done with normal results. Body temperature results came out 103 degrees Fahrenheit.  On 30 Jan 2021 the patient experienced worsening shortness of breath and was intubated.  Her IL-6 was very high, and she had profound liver failure. She ended up needing pressors and requiring continuous renal replacement therapy.  Treatment included steroids.  Action taken with mRNA-1273 in response to the events was not applicable.   The patient died on 12 Feb 2021. The cause of death was reported as high grade MDS. An autopsy was planned.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Reported Cause(s) of Death: unknown cause of death
Nausea and vomiting.  Tired and achy. Slight fever (100)
PATIENT DOES NOT LIKE NEEDLES. AFTER A FEW MINUTES OF SITTING IN OBSERVATION AREA AFTER HER VACCINATION, PT FELL OUT OF CHAIR ONTO STOMACH ONTO THE FLOOR. WHEN I GOT TO HER SHE HAD VOMIT RUNNING OUT OF HER NOSE WITH SPECKS OF BLOOD. AND WAS UNCONSCIOUS. I HELD HER ON HER SIDE TO ALLOW FLUID TO COME OUT AND TOLD TO CALL 911.  HER FACE WAS VERY RED (ROSACEA FLARED). AFTER A 1-2 MINUTES SHE GAVE A BIG JERK THEN QUICKLY SAT UP UNAWARE OF WHAT HAPPENED. EMT ARRIVED AND CHECKED PATIENT. SHE REFUSED HOSPITAL AND HER MOTHER AND SISTER PICKED HER UP.
The patient had erythema, possible cellulitis of the left upper arm. The patient developed this twelve hours after the injection and it progressed for 12 hours. The patient was treated with Keflex, it slowly resolved in 1 week; no residual problems.
body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0171321A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
After second Moderna dose: First night: insomnia, agitation during the night, flashes in brain like electrical discharges between ears and sharp pain in joints.. In morning chills, sharp pain in joints that made walking difficult, fever of 100.1. Felt miserable all day. Second night: slept well and  felt much better in morning and  almost myself again. Still some muscle pain in injection arm.  No adverse effect after first dose on January 10.
DVT left axillary & subclavian veins   Pt's primary vaccine was J&J; received Pfizer booster on 11/1/21
Dry skin on hands; flaky skin on hands; Skin issues on my hands : picks on everything; Skin issues on my hands: dry, flaky, picks on everything, covering tips of fingers.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic headaches, some seasonal allergies, tree nuts allergy and adhesive allergy; all from unknown dates. The patient previously took amoxicillin for unknown indication from unknown date and experienced drug allergy. Four weeks prior to the COVID vaccine, the patient received hepatitis A (MANUFACTURER UNKNOWN) administered in the right arm on 23Feb2021. The medications received within 2 weeks of vaccination included doxycycline (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D), desvenlafaxine fumarate (MANUFACTURER UNKNOWN), ubrogepant (UBRELVY), ibuprofen (IBUPROFEN); all started on unknown date for unknown indication. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, the patient developed skin issues on hands: it was dry, flaky and picked on everything, tried lotions, covering tips of fingers. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient tried lotions as treatment for the reported events. The clinical outcome of the dry skin, flaking skin, skin disorder and exfoliation on fingertips were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
I discovered bleeding like bruise; I discovered bleeding like bruise; This is a spontaneous report from a contactable consumer. A 61-year-old male patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included known allergies: penicillin. The patient's concomitant medications were not reported. The patient reported "I discovered bleeding like bruise in about 1 X 1 inches on my right fore arm" on 04Mar2021 at 14:30. Outcome of the events was unknown.   Information about lot/batch number has been requested.
The patient was given the diluent and not the medication.  There was no adverse reaction but this was a medication error.
This spontaneous report as received from a nurse refers to a 7 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
arm was sore for 2 months after the second one; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine and his/her arm was sore for 2 months. The follow up would not be possible as no contact details were available.
At 48 hrs, 3cm circular area of redness and erythema (L) deltoid.
expired MENACTRA was administered to a patient with the expiration date of 23Aug2021 with no reportd adverse event; Initial information received on 24-Jun-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves 14 years old patient of unknown gender to  whom  expired menactra was administered with the expiration date of 23aug2021 with no reportd adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccination included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation.  On 24-JUN-2022, the patient received a  0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, frequency, formulation was unknown, lot U66908AAA  and expiry date: 23-Aug-2021) via unknown intramuscular route in right deltoid for Immunization. Patient was not taking it for the first time.  On 24-JUN-2022 the patient developed a non-serious event of  expired menactra was administered to a patient with the expiration date of 23aug2021 with no reported adverse event (expired product administered) (same day latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken :  not applicable.  Outcome: unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Had a syncopal episode for a few seconds about 2 minutes after receiving 2nd dose of Gardasil (HPV #2).
I have a rash on the left side of my neck going down to my chest. does not itch really  but looks awful.
6 Months  old  Male parents with fever x 1 day.  Per the parents, the patient received vaccinations earlier in the morning and as the day progressed the patient developed a fever and soreness to the right thigh where the shots were administered. Symptoms viewed as moderate by parents.  No history of other contacts with same symptoms. No travel overseas. . Denies any medical history.  Associated symptoms:  Normal urine output