chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 tested postive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 tested postive) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22H) for COVID-19 prophylaxis.     The patient's past medical history included Blood disorder NOS (Blood thin). Concurrent medical conditions included Allergy to nuts (Allergy to cashewnuts), Allergy to nuts (Allergy to pistachio nuts), Pollen allergy (Allergy to seasonal pollen), Blood pressure abnormal, Enlarged prostate and Iron deficiency (Low iron). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] from 2007 to March 2022 for Blood disorder NOS, LISINOPRIL from 2007 to an unknown date for Blood pressure abnormal, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) from 2005 to an unknown date for Enlarged prostate, IRON from 2010 to an unknown date for Iron deficiency.    On 01-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced COVID-19 (COVID-19 tested postive). At the time of the report, COVID-19 (COVID-19 tested postive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2022, SARS-CoV-2 test: (Positive) At home rapid test. On an unknown date, Blood iron: Low.         The height of the patient was reported as 6 inches.  No treatment medication were provided.   This case was linked to MOD-2023-716553 (Patient Link).
Member observed to be lethargic.  Member stated just feels hot, clamy and feels overheated.  Not observed to be diaphoretic.  Member also reports feeling dizzy.  symptoms lasted approximately 10 mins.  911 called , triage completed and member declined to be transported to emergency room
Moderna COVID-19 Vaccine EUA Warm, silver dollar sized rash directly below injection site appeared one week after vaccination.  It is not painful or itchy.  I can submit a photograph if needed.
I experienced a distorted vision problem covering the upper left corner of my visual field.  I assumed it was fatigue.  When it didn?t get better by 4/1/21, I went to Patient First be checked out.  They sent me to Advanced Eye Care to follow-up with an ophthalmologist.  She confirmed that the vision loss was being caused by something in my brain, at which time she sent me to the ER.  At the hospital, an MRI revealed that I had suffered a stroke in the lower right rear side of my brain that was affecting my site in the upper left part of my visual field.
strange little headache with a "prickly"; This is a spontaneous report from a contactable consumer (patient) or other non-HCP. A 82-yerar-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: unknown; expiration date: unknown), via an unspecified route of administration on an unspecified date, as 1ST DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced strange little headache with a prickly. Caller mentioned that she had nothing to complain about the aches and pain but there is a strange little headache with a prickly (like little dots; no pain) sensation on the forehead 3-4 days after getting the shot. Caller was concerned about getting the second shot, and enquired about the efficacy after receiving only one dose of the vaccine Caller mentioned that she had heard a lot of possible problems like sterility and heart failure, and would like some clarification on the known risks of the Pfizer-BioNTech COVID-19 Vaccine. The outcome of events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Acute urticaria on torso, back, neck, arms, and face within 2 weeks of the second dosage.
Approx. 5 min after receiving HPV vaccine, pt was waiting in treatment room for 15-20 min per office police when mom came out of room stating pt had passed out and fell off exam table. RN went into room and pt was unconscious for approx. 5-10 sec. then sat up and was pale, diaphoretic, and talking incomprehensible words. MD and RN assisted pt back onto exam table, propped feet up, applied ice to scalp, VS stable. APRN treating pt came to bedside. Pt was monitored in the office for approx. one hr but then taken to ER due to pt still being pale, nauseous and making inappropriate comments not relative to the current conversation. The ER performed a head CT which was WNL and the patient was discharged home.
Fever up to 102.7 degrees rectally within 24 hours after immunization at 6 months. Fussy, sleeping more, seen at urgent care.
PT HUSBAND CALLED PHARMACY AROUND NOON ON 3/4/21. HE STATED THAT PT WAS 'DELIRIOUS' TALKING AND HAD A TEMP OF 103*. HISTORY HE GAVE WAS THAT AT 7:OOPM ON NIGHT OF VACCINATION (3/3/21) PT ARM BECAME SORE, THEN AT 10PM IT BECAME SORE WITH MUSCLE ACHES, BY 1:20AM SHE WAS HAVING SEVERE MUSCLE ACHES WITH FEVER. PT SAID ON 3/4/21 HE CAME HOME FOR LUNCH AND PT WAS CRYING, TALKING DELIRIOUS AND TEMP WAS AT THE 103*. PT HAD TAKEN TYLENOL BUT ONLY 10 MINUTES PRIOR TO THEIR CALL TO THE PHARMACY. PT'S HUSBAND HAD TRIED TO CALL THEIR DOCTOR BUT WAS TOLD THEY WOULD HAVE TO WAIT FOR A CALL BACK. AFTER CALLING PT LATER THAT DAY TO CHECK ON HER SHE SAID THAT SHE HAD GONE TO THE ER WHERE THEY ADMINISTERED FLUIDS TO HER.
Onset time is unknown, patient was re-admitted to our facility 3/27/13 at 8:53 AM. Nurse noticed a large scab and eschar during assessment. The patient explained that it had been there for a while ever since she received the vaccination. Wound care nurse was consulted, provider notifed.
Pt has persistent low grade pain since time. No functional ROM deficits, pain 1-2 of 10 in nature. Clinical exam normal w/palpation of deltoid. No palp. hematoma, No muscle atrophy motor function normal.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 01-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL lot # K009482 expiry date: 06-MAR-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Severe pain in site of injection. Pain was so bad it was throbbing at night and couldn?t fall asleep. Pain was so severe I needed assistance getting dressed for 3 days as I couldn?t move my arm or the pain would be so bad. Finally got better  3 days after the shot was given.  Not bad enough to go to the doctor, but  it was an intense prolonged pain.
After 10 days after receiving the vaccine the PT had a rash show up as an oval shape at the injection site that lasted four days. It was red and itchy but the itchiness went away after two days.
Swelling under arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33T42, expiry date 1st February 2021) for prophylaxis.   On 11th July 2019, the patient received Boostrix (intramuscular) .5 ml. On 17th July 2019, 6 days after receiving Boostrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Boostrix.  Additional details were provided as follows: The pharmacist stated the patient was administered a dose of Boostrix vaccine in right arm.  On 17th July 2019, the patient was experiencing swelling under the arm at the site of injection where Boostrix was given.  No further details were provided.
Sore arm, fever, fatigue, body aches, and slight headache.  Sore arm started the evening after vaccination while other symptoms started the next day.  I received the shot on Monday morning and for the most part felt back to normal on Wednesday.
By history, received shingles vaccine 2 mos ago. Presented today for eval of rash which on exam appears to be shingles rash (R) posterior thigh.
pt has swelling @ the site of the flu inj about 1 1/4" on 18NOV97 & 2" x 3" on 19NOV97;swelling was red & hot;advised that pt could use DPH;
Myalgia, Arthralgia, SkinRash, Diarrhea, NauseaVomiting fatigue, skin inflammation, tendonitis, chills, skin peeling on roof of mouth Narrative:
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 04-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K006447, expiry date 16-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): one lasting for 24 hours, with the highest recorded temperature of 49 degrees Fahrenheit (9.44 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Client c/o shoulder hurting and not being able to move aem, i.e lift without aches. Arm never red or swollen, was advised to see MD
After having the Flu shot I have had a 24/7 headache since the end of September. I have started my 5th month with this headache. I have spoken to a couple other people who have had the same side effect.
A non-serious spontaneous report of administration of expired product was received from a clinic administrator concerning a 24-month-old female subsequent to the administration of FLUMIST.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient's medical history and concomitant medications were not reported.  On 23-Feb-2010, the patient was administered FLUMIST.  There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. No late occurring adverse events were reported. Additional information was received on 13-May-2010 and incorporated into the narrative: information on late occurring adverse events.
On 11/17/2022, I started experiencing symptoms of sore throat, a dry cough, on/off headache and fatigue. I decided to go to the urgent care near me and they tested me for COVID-19, Flu and Strep. My COVID-19 test came back positive. I was given a prescription for PAXLOVID, a nasal solution and benzonatate. The cough and sore throat has subsided, but I still feel weak and hazy.
Information has been received from a nurse referring to an unspecified number of unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. Since 21-JUL-2016, the patients have been administered doses of GARDASIL 9 (lot number and expiration reported as L037554, 25-DEC-2017 and M011117, 07-DEC-2017). All of which were improperly stored. No adverse effects have been reported. There was no prior excursion. This report is for data logger. Additional information has been reported.
I am experiencing terrible ringing in my ears. I realize this is not as serious as COVID, but I didn't have it before this 3rd booster dose and it's especially hard to sleep.
Peri-oral edema, hives, esophageal spasm/pain. Avoiding NSAIDs and taking fexofenadine have been preventive.
Hearing loss, Tinnitus, and Electrical hypersensitivity (EHS), which feels like my body is trying to connect to some mainframe computer, or non-grounded wires.
Boody pink fluid built up in his lungs; Bloody pink fluid built up around his heart; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY OEDEMA (Boody pink fluid built up in his lungs) and PERICARDIAL EFFUSION (Bloody pink fluid built up around his heart) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY OEDEMA (Boody pink fluid built up in his lungs) (seriousness criteria death and medically significant) and PERICARDIAL EFFUSION (Bloody pink fluid built up around his heart) (seriousness criteria death and medically significant). The reported cause of death was boody pink fluid built up in his lungs and bloody pink fluid built up around his heart. It is unknown if an autopsy was performed.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was died 15 weeks after taking the vaccine.  Company Comment: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected events of Pulmonary Edema and Pericardial Effusion. The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine)  and had a fatal outcome, with death occurring approximately 15 weeks after the dose. It's unclear if it was the first or second dose. The rechallenge was not applicable, as the event happened after a dose and resulted in death. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a male patient (age not provided) with no relevant medical history, who experienced the unexpected events of Pulmonary Edema and Pericardial Effusion. The events occurred at unspecified interval after a dose of mRNA-1273 (Moderna covid-19 vaccine)  and had a fatal outcome, with death occurring approximately 15 weeks after the dose. It's unclear if it was the first or second dose. The rechallenge was not applicable, as the event happened after a dose and resulted in death. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Reported Cause(s) of Death: Boody pink fluid built up in his lungs; Bloody pink fluid built up around his heart
5/17/2022-Presents to ED from NH, new onset unresponsiveness. Covid + on 5/7/2022-EGFR-37. WBC-13. Ferritin 626.0. 101.5 temp. Spo2 98% on 3L nc. CT head neg for subacute intracranial abnormality. CT chest-right sided PNA and AAA 6.3 cm with  some wall hemorrhage, CTA bad/pelvis. Sepsis s/t r sided pna with covid infection , concern of aspiration. Ordered baricitinib , vanco, cefepime and Flagyl. Renally adjusted Decadron.   5/19/2022- D/C vanco MRSA swab neg.  NA went up to 152, swithced to D5. Vascular surgery in contact with family regarding endovascular repair likely oupatient. VSS Afebrile.  5/20/2022-BP-166/111 prn hydralazine 10 given, Labetalol 5mg prn ordered, Transferred to cardiovascular ICU gtt @2L. 5/20/-2022- AKIl likely prerenal , resolving. Cont cleviprezx and titrate down, hydralazine 5mg Q6. Continue Flagy, baricitinib and decadron.  5/21/2022- Restart clonidine patch, Toprol daily. Stop hydralazine. VSS BP-115/69. Downgraded to Med/surg.  5/24/2022- Creatnine 1.2. VSS. maintain of RA.  5/25/2022- D/C to sub acute rehab. Nephro follow up. Finished Flagyl, cefepime and baricitnib.
Approx 8 hours after shot, developed fever, chills, myalgias, nausea, vomiting and abdominal pain, severe. Symptoms lasted over 12 hours. By 24 hours, fever and arm soreness persisted.
Client received vaccines at health unit at approximately 10:30am. Reported that at 1:15pm felt like chest was tight and c/o SOB. At 3:30pm redness to face and chin noted and swelling to face. Also reported HA at that time. TC to health unit. Spoke to M nurse recommended she go to ER. Went to ER at 4:30pm. Given steroid injection and oral steroids for home use x4 days. Symptoms resolved.
This spontaneous report as received from a pharmacist refers to a 64 years old male patient with diabetes, neuropathy, high cholesterol, high blood pressure, gout and allergy to DEMEROL. The patient was vaccinated subcutaneously with a dose of ZOSTAVAX (lot # 672676/0069AE; expiry date 03-APR-2013) on 02-OCT-2012. No other co-suspects were reported. Concomitant medications included tramadol hydrochloride, losartan potassium (manufacturer unknown), JANUVIA, CRESTOR, PLAVIX, COREG, gabapentin, morphine, allopurinol and FLUVIRIN. On 05-OCT-2012 the patient developed pain at the injection site. The patient sought medical attention; he spoke to the pharmacist. No treatment was provided for the event. No laboratory tests were performed. At the time of report the patient was recovering. The relatedness for pain at the injection site was not reported for ZOSTAVAX. Additional information is not expected.
Began on 12/5/21 (8 days after booster)-- itching all over body, including scalp; redness and swelling of ears and ankles; hives all over body-- raised lines all over body like writing; aching palms of hands  Began taking 1 generic Zyrtec 10mg daily on 12/10/21 to control symptoms... switched to 1 tablet every 2 days, beginning 12/23/21
first dose just sore arm for 1 day; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:30 (at the age of 60-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was none. Concomitant medication included escitalopram oxalate (LEXAPRO), rosuvastatin, ezetimibe all drugs were taken for an unspecified indication, start and stop date were not reported. Patient received dose 2 of bnt162b2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:15 (at the age of 60-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced sore arm after first dose for 1 day on an unspecified date in Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have any allergies to medications, food, or other products. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient did not receive treatment for the adverse event. Outcome of the event was recovered on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.
COVID 19 Pfizer - 2nd dose, 2/16/2021 Lot number - EL9261 -   About 48 hours later, I got this pain breastbone. I couldn't turn over to the left or right when down because of the pain. It was not shortness of breath. It was pretty bad. This pain lasted about 3 weeks.  Soreness is my arm appeared the day of vaccination but that went away within 2 days.  I also kept sneezing non stop, and my nose was runny this also started about 48 hours after vaccination. It is better but not completely gone yet. The sneezing is not constant, as of today but still there.
Slight fever on 12/01/2010, high fever 12/02/2010. Very rosy cheeks, body felt quite hot. 12/03/2010, my son isn't feverish, but he is cold, body temp 96.5, hot baths to warm him up...won't sleep more than 25 minutes at a time, not much appetite, increased thirst and very very unhappy. Ibuprofen has no effect on relieving his symptoms.
On an unspecified date, the pt received a dose of Engerix-B; it was not known whether the vaccinee had received previous doses of Engerix-B. The physician stated that he has a pt he thought had encephalitis prior to vaccination with Engerix-B. Post vax, the encephalitis symptoms worsened. This event is considered GSK "Medically Serious". As of 8/16/01, the outcome of the adverse event was unknown.
INCORRECT PRODUCT STORAGE; VACCINE ADMINISTERED 1 HOUR AFTER THE ALLOWED 6 HOUR WINDOW AFTER INITIAL PUNCTURE (WITHOUT ANY ASSOCIATED ADVERSE EVENT); This spontaneous report received from a pharmacist 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: UNKNOWN) dose was not reported, administered on 18-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced vaccine administered 1 hour after the allowed 6 hour window after initial puncture (without any associated adverse event). On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered 1 hour after the allowed 6 hour window after initial puncture (without any associated adverse event) and incorrect product storage was not reported. This report was non-serious.
Arm felt like bones were cracking; Could not sleep for 24 hours; Fever; Feels tired; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced that her arm felt like bones were cracking, could not sleep for 24 hours, fever and felt tired. The patient underwent lab tests and procedures which included body temperature unknown result on an unknown date. As therapeutic measure paracetamol (TYLENOL) was taken for fever and diazepam (VALIUM) was taken for insomnia. The outcome was unknown for the reported events.  Information about the lot/batch number has been requested.
Breakthrough Case Fully vaccinated  Received Moderna Booster on 11/01/2021 at Pharmacy. Lot #033F
11/3/03: Pt came in with laceration on 2nd digit left hand. Tetanus shot given in right arm. Pt had no reaction at time given. Pt came to office 11/6/03 at 08:30 complaining of red, swollen and itching right arm. Pt stated it started shortly after returning home 11/3/03. Pt was told to take Benadryl.