chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When patient came to get her 2nd dose on 3/17/21, she reported that after getting the first dose, she had a reaction to it. The night of vaccination and the following day, she apparently had a swelling in the left side of her face including her lips and ears all the way including her head. She took Tylenol and was ok later the next day. She did not seek medical care for this. Discussed these with the MD who determined that she is not a candidate for the 2nd dose due to the allergic reaction. Explained to her and no 2nd dose given on 3/17/21.
Presented to Emergency Department on 4/11/03 with a rash on chest.  No other signs or symptoms; no other complaints.  Vital signs within normal limits.   (Referred reporter to military smallpox program, but reporter was not successful in submitting a report).
booster; contracted COVID; contracted COVID; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An 81-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart disease" (unspecified if ongoing); "dementia" (unspecified if ongoing). The patient took multiple concomitant medications in two weeks. Unknown if other vaccine in four weeks. No Covid prior vaccination. The following information was reported: IMMUNISATION (medically significant), outcome "recovering", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) both with onset 15Nov2021, outcome "recovering" and all described as "contracted COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown results, notes: post vaccination. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. Event did not result in death, hospitalized, life-threatening, congenital anomaly, disability. Also reported that at least 19 patients in this nursing home have recently contracted COVID after receiving booster. Reporter mother-in-law believes patients were given Pfizer vs Moderna vaccine but reporter had not confirmed with nursing home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
giving the entire diluent, 0.85 mL; giving the entire diluent, 0.85 mL; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in unspecified number of patients who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments: Registered Nurse called in to inquire about if any information was available.  The reporter reported that they reconstituted the Hiberix lyophilized vial with 0.85 mL of diluent instead the 0.6 mL diluent recommended and administered to around 700 patients.  The reporter stated that patients were administered the 0.5 mL dose after the reconstitution of the 0.85 mL.  The reporter mentioned that these was how they have reconstituted the vaccine since obtaining the Hiberix.  The reporter unable to provide any additional details.  The reporter consented to follow up. Additional Supportive Information: Reconstituted the Hiberix lyophilized vial with 0.85 mL of diluent instead the 0.6 mL diluent recommended and administered to around 700 patients which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2022108804:FU1 - Deleted
Patient was given a Moderna booster dose on 11/29/21, from a vial that had 1st been opened on 11/26/21. It was stored in the refrigerator between uses. Confirmed with Moderna that the biggest concern would be risk of infection rather than decrease in efficacy.
Muscle aches and stiffness to neck, shoulders, and legs.  Treated on 11/04/09 with cyclobenzaprine and acetaminophen.  Later treated with methylprednisolone dose packs on 11/16, 11/30, and 12/7/09.  1/8/10 progress notes indicated improvement.
pt recv vax 8MAY97 & w/in min of vax pt went to the waiting room & started to feel stomach tension became diaphoretic & then fainted;awoke w/in sec w/o problems or w/o intervention;pt also exp inj site pain;
Severe back pain; Stiff back muscles; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 25Apr2021 at 09:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included measles vaccine; mumps vaccine; rubella vaccine (MMR) and tetanus vaccine toxoid; diphtheria vaccine toxoid; pertussis vaccine acellular (Tdap); both on 04Apr2021. Concomitant medications taken within two weeks of vaccination was not reported. On 25Apr2021 at 23:00, the patient experienced severe back pain and stiff back muscles. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe back pain and stiff back muscles was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
fevers; body aches; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 60 year-old female patient received tofacitinib citrate (XELJANZ XR), oral since 2016 (ongoing) (Batch/Lot number: unknown) at 11 mg daily for rheumatoid arthritis; bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster),single for covid-19 immunisation. Relevant medical history included: "discouraged/depressed" (ongoing); "discouraged/depressed" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2022, outcome "recovered" (2022), described as "fevers"; PAIN (non-serious) with onset 2022, outcome "recovered" (2022), described as "body aches". The action taken for tofacitinib citrate was dosage not changed. The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: Patient reported she was sick following COVID booster Jan2022. symptoms included fevers and body aches that lasted 8 days, md aware. patient previously reported that rheumatoid arthritis symptoms had worsened following a break in therapy from Nov20221 to 12Feb2022. She reports that symptoms have now improved and are "much better". patient responds "generally agree" with statement "generally it's been hard to cope with rheumatoid arthritis and sometimes i feel discouraged/depressed,"- started prior to start of therapy and has not changed. patient reports she missed Xeljanz dose one day in 2021 due to forgetting to refill and running out of medication - unknown if there was an adverse event following this missed dose. advised to update md with new/worse symptoms.
Day after 2nd dose: Headache, light sensitivity, fever, fatigue 2.5 weeks after 2nd dose: Headache, shooting pain in head/ear, skin sensitive to touch on scalp, lesions, eye pain. Visit to ER -diagnosed with Shingles.  Treatment: Valacyclovir 10 days & steroid for 5 days. Did not resolve. Continued Valacyclovir 10 more days with Antibiotic eye ointment. Cornea lesions resolved. Nerve pain continued. 9/10/21 started treatment for possible new shingle recurrence - Valacyclovir & eye ointment.
Change of smell. Everything smells like glue or paste all the time now both in my home and while driving my car. It's difficult to fall asleep because the smell is so strong. I can't smell ordinary other odors now.
This spontaneous report was received from a pharmacist, via a company representatives, concerning a female patient of unknown age. Medical history and concurrent conditions were not reported. On 20-JUL-2014, the patient was vaccinated with ZOSTAVAX (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Pharmacist reported that patient developed shingles 30-JUL-2014. Pharmacist that the patient did not had any pain but had minimal vesicles on her back. At the time of the report the outcome was unknown. Additional information has been requested.
pt claimed that she got skin rash on her arm and I advised her to take otc Benadryl and if it got worse she will need to go to er or call 911
5 pm 10-30-03 achy, fever, chills 10-31-03 symptoms continue - fever 102, heart racing.  11-01-03 & 11/02/03 remains in bed. Did not check temp. but feverish, chills continue.  11-03-03 temp to 99. feeling stronger.  Can eat.
My arm was more sore from the booster (Moderna); Headache and fatigue were worse from the first two shots (Pfizer); Headache and fatigue were worse from the first two shots (Pfizer); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (My arm was more sore from the booster (Moderna)), HEADACHE (Headache and fatigue were worse from the first two shots (Pfizer)) and FATIGUE (Headache and fatigue were worse from the first two shots (Pfizer)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Two shots (Pfizer)), Pfizer (Two shots (Pfizer)), Pfizer (Two shots (Pfizer)), Pfizer (Two shots (Pfizer)), Pfizer (Two shots (Pfizer)) and Pfizer (Two shots (Pfizer)). Past adverse reactions to the above products included Fatigue with Pfizer and Pfizer; Headache with Pfizer and Pfizer; and Pain in arm with Pfizer and Pfizer.    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 PAIN (My arm was more sore from the booster (Moderna)), HEADACHE (Headache and fatigue were worse from the first two shots (Pfizer)) and FATIGUE (Headache and fatigue were worse from the first two shots (Pfizer)). At the time of the report, PAIN (My arm was more sore from the booster (Moderna)), HEADACHE (Headache and fatigue were worse from the first two shots (Pfizer)) and FATIGUE (Headache and fatigue were worse from the first two shots (Pfizer)) had resolved.            No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I felt dizzy and sat down on a stool. I was in the company of someone. I was told I then fainted. I hit my head on a wood piece of equipment and the floor. I went to the ER. They did a CT head and cervical scan, chest x ray, EEG and blood work. I received a tetanus shot.  Everything was ok. I needed glue on one of the cuts. My eye and forehead have cuts and bruises. I continue to have a headache 2 days later.
PATIENT SEIZED FOR 5 SECONDS NOTHING ELSE HAPPEND, OFFERED TO CALL 911 , PATIENT REFUSED AND SAID THAT SHE IS FINE, BLOOD PRESSURE WAS 100/60, PULSE 60. WE WATCH THE PATIENT FOR 20 MORE MINUTES AND SHE LEFT FINE.
Pain at injection site - started middle of the night ~ 12 hours Elevated temperature/low grade fever (100.2-101.2) - recorded in the morning ~17 hours after vaccine, but believe to have also spiked in middle of night ~12 hours Full body aches, throbbing muscles, stiffness, achy joints - started in morning ~ 17 hours *worst side effect, very painful, did not want to move, just lied on couch for hours* Fatigue - started in morning ~17 hours
The patient stated that her upper arm from elbow to shoulder became swollen and red almost immediately after leaving.  She was seen at an urgent care and given a course of antibiotics for treatment.
Sore body; Heavy menstrual cycle; sore heavy breasts; loss of appetite during entire week; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine;Lot Number: 5729) via an unspecified route of administration in the left arm on 08Apr2021 at 14:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not  diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: 2613) via an unspecified route of administration in the left arm on 19Mar2021 at 13:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On  19Apr2021 at 00:00, the patient experienced sore body, heavy menstrual cycle, sore heavy breasts, loss of appetite during entire week and  stomach pain. The events did not result in doctor or other healthcare professional office/clinic visit. No Therapeutic measures were not taken as a result of the events . Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events sore body, heavy menstrual cycle, sore heavy breasts, loss of appetite during entire week and  stomach pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Rash and swelling to pt (right) upper arm. BENADRYL 50 mg every 8 hrs. Ice.
PATIENT BEGAN ITCHING VIOLENTLY ON THE TOP OF HER RIGHT HAND AROUND 6PM (4/6/2021). I NOTED SEVERAL SCABS RELATED TO SCRATCHING HER HAND.  SHE DECIDED TO TAKE A 25MG BENADRYL AND WAS MUCH BETTER AT 9AM TODAY (4/7/2021) WHEN I SAW HER.  SHE DID TAKE ANOTHER 25MG BENADRYL AND ON A PHONE CONVERSATION AT 12:15pm SHE SAID THE REACTION AND ITCHING WAS COMPLETELY GONE.
SEVERE SHORTNESS OF BREATH, GRAY COLOR, ITCHINESS OF FACE AND HEAD; NO HIVES
States pt awoke the morning of 1/29/03 with swollen face, flushed cheeks. Denies high temp. 1/30/03 grandmother states pt's face is no longer swollen. Client was not taken to MD.
Breatkthrough case of COVID. Fever, cough, fatigue, headache, congestion, dizziness
feeling achy; (rash) swollen; (rash) raised; (rash) itchy; developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (feeling achy), SWELLING ((rash) swollen), RASH PAPULAR ((rash) raised), RASH PRURITIC ((rash) itchy) and RASH (developed a rash on her lower arm, from mid cuff and down, in both arms, and also in lower leg) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.
adult received pediatric dose; adult received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 63-year-old patient who received HBV (Engerix B pediatric) (batch number MB744, expiry date 1st March 2024) for prophylaxis.   On 9th May 2022, the patient received the 3rd dose of Engerix B pediatric. On 9th May 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2022 Reporter's comment: The health care professional reported that adult patient received pediatric dose of Engerix-B. The reporter consented to follow up. No other details of patient could be provided.  Additional supportive information: The adult patients received pediatric dose of Engerix-B, which led to underdose and adult use of a child product. This case had been linked to the case US2022076273 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022076273:same reporter
9-10 hours after vaccine patient developed swollen eyes, face, lips and scratchy throat.  Seen in ED and was given IM epinephrine and oral steroids
Patient states that the first Pfizer vaccine affected her hormones through the form of inducing the start of her menstrual cycle (period) even though it was not time for her period and she is generally very regular. Patient was very concerned about this and ask that I report it. Yet, she still did receive the second shot the day this report is being filed.
Vertigo with vomiting; Vertigo with vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057MZHA) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EL3246 Location of injection: Arm Left) on 18-Jan-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EL9265 Location of injection: Arm Left) on 08-Feb-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: EW0168 Location of injection: Arm Left) on 06-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Addison's disease, Hypothyroidism, High cholesterol, Type 2 diabetes mellitus and Allergy to antibiotic (Cipro). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Feb-2015 to an unknown date, HYDROCORTISONE from 01-Feb-2015 to an unknown date, FLUDROCORTISONE from 01-Feb-2015 to an unknown date and ATORVASTATIN CALCIUM (LIPITOR) from 01-Feb-2015 to an unknown date for an unknown indication.   On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 24-May-2022 at 11:00 PM, the patient experienced VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting). At the time of the report, VERTIGO (Vertigo with vomiting) and VOMITING (Vertigo with vomiting) was resolving.            It was reported that patient took Motion sickness medicines for the adverse event. The patient previously received a COVID-19 Vaccine. It was reported that he patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.
Patient administered 1 ml of the vaccine; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced incorrect dose administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Lot number 011L20A) on for prophylaxis of COVID-19 infection.   A healthcare provider called stating that 1 mL of the vaccine was administered to a patient as the patient's first dose instead of the 0.5 mL. The healthcare provider did not know which arm the vaccine was administered.  Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, incorrect dose administered, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
On Friday afternoon after child got off of school bus, around 3:30 pm, developed knot on upper right arm at area of injection. Had swelling, redness, and area is warm to touch. Pain and soreness extended up into neck.
This case was reported by a nurse and described a subject (age and gender unknown) who did not respond to immunization to Engerix-B. On an unspecified dates, the subject received Engerix-B. On an unspecified date before 12 May 2006, a hepatitis B surface antibody titer was negative. It was reported that the titers were taken from one to five months after the third dose of Engerix-B was received. No adverse events were reported.
5 days later, fever (101 w/APAP), vomiting, & diarrhea every 10min; p/2 days of diarrhea & being seen by MD pt was sent to Hosp;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-SEP-2017 the patient was vaccinated with PROQUAD lot # M044720 for prophylaxis.    Concomitant therapies included sterile diluent. On 01-SEP-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. This is one of several reports from the same reporter. Lot number N013863 has been verified to be a valid lot number for PROQUAD. Sender's Comments: US-009507513-1709USA002186.
Information has been received from a physician concerning a 9 year old male who on an unknown date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot#654523/1155F). Concomitant therapy was not reported. On an unknown date, the patient received varicella virus vaccine live in the right arm and the skin raised 7" x 8" around the injection site. Additional information has been requested.