chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Enlarged liver; Pain in liver; This is spontaneous report received from a contactable consumer. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 30Apr2021 at age of 18-year-old at single dose, unknown dose number for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at time of vaccination and events onset. It was unknown if there was other vaccine in four weeks. It was unknown if patient had COVID-19 prior to vaccination. And it was unknown if COVID-19 was tested post vaccination. Patient experienced enlarged liver and pain in liver, both on 01May2021 with outcome of unknown. Events were serious as hospitalization. It was unknown if patient received treatment for the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial unsolicited report received from a physician on 20 July 2017. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiration date, route, dose not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had a severe respiratory reactions. Lab data and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced URTICARIA (Hives). On 24-Mar-2021, URTICARIA (Hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Updated medical history.
This spontaneous report as received from a pharmacist refers to a newborn (male) patient of unknown age. On 24-OCT-2012 05:56, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
4/9/21 High blood pressure and high heart rate. Taken by ambulance to Hospital. Observed and released.  4/11/21 10:30 AM High Heart rate and Blood pressure along with shaking taken to ER and admitted for 3 days. Began 4/11/21 11:15 PM with vomiting and diarrhea for 3 days. CT scan and many tests, given IV fluids and heart meds. Released home Tuesday 4/13/21. Back at ER night time. Released. Continue of really high BP and HR in range of 215/130 and heart rate of 115. Taken to another ER where more extensive tests given. Released 4/19/2021 with BP meds. and follow up required with personal doctor, Scheduled to see also Rheumatologist.
pt was taken to ER following vax due to prolonged screaming @ 230 in the evening; mom says pt cried for 6 hrs; was seen by MD;
Pruritic rash on left upper arm that started on 1/18/2021. Pain intermittent. Rash about six inches below injection site medio-lateral with mild erythema, slightly warmer than surrounding area, non tender.
Patient received that vaccine at 1130 at 1142 patient noted she was having a flush feeling her her face, tingling in her tongue. No noted swelling to lips, tongue, face, no breathing events. Patient was administered Benadryl 50mg IM and was brought for continuous monitoring in our clinic. She noticed relief in flushing within 2 mins of injection and tongue tingling within 5 minutes. It was approximately 30 minutes after Benadryl injection she had improvement with her lip tingling. Patient was monitored in total in clinic for 1 hour prior to be discharged home, no other administration of medications needed. All symptoms resolved prior to discharge by provider.
Myalgia, SkinRash, Rash, UrticariaPruritus, Pt reported flu like symptoms approx 6-8 hours after dose of vaccine. Also reported skin rash and itching to bilateral posterior lower legs. Narrative:  Approx. 6-8 hours after vaccination, pt. developed "flu like symptoms" which lasted approx. 12-24 hours, then resolved. She also reported developing very itchy skin patch on posterior bilateral lower legs in the calf area. These occurred approx. 10-12 hours after vaccination. The size of the skin irritation was about a 2" x 1" size with an irregular shape. There was no redness, swelling, or discoloration, however pt. reported that the skin felt "rough" and it appeared "shiny" compared to surrounding skin. She used topical anti-itch creams with no relief. Has been taking OTC cetirizine with some improvement. As of 11/12/2021, symptoms are mostly resolved with exception of small itchy area on back of rt leg, which has improved since initially observed, but not entirely resolved.
no additional adverse event; a patient was inadverently administered a dose of MMR II, that had been improperly stored; This spontaneous report was received from a nurse and refers to a 12-month-old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was provided. On 15-APR-2020, the patient was inadvertently vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot # S013415 with expiry date: 01-MAY-2021 ; dose, dose number, route of administration were not provided). Albumin status for lot # S013415 has been verified as recombinant human albumin (rHA). The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT) (dose, lot number, expiry date were not provided). No adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 10 degrees Celsius for 4 hours and 30 minutes. There were no previous excursions related. Data logger was involved.
Medical assistant called and reported that an expired ROTATEQ was administered to patient.; No adverse affects reported.; This spontaneous report was received from a Medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.    On an unknown date, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (strength, dose, frequency, and anatomical location were unknown) with  lot # R012957 and expiration date 11-JUN-2019. No adverse affects were reported.
sick; This is a spontaneous report from a Pfizer sponsored program, received report from a contactable male consumer (patient).A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 05Apr2021 (Batch/Lot number: EW0150) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified patient was sick. The patient stated he did not take the 2nd dose of the Covid-19 vaccine which was on last 26Apr2021 because he was sick then and he wanted to reschedule his 2nd dose appointment. The outcome of event was Unknown.  There were no unaddressed medical questions referred or forwarded to Medical Information.  Follow up (28Apr2021):New information was received from consumer included: additional lot number added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date with outcome of unknown. Patient had shingles for 10 days and query if patient should get the second COVID shot Friday.   Information on the lot/batch number has been requested.
HPI Started feeling ill the evening after she received the pneumonia vaccine. Fever up to 103 and feels terrible.  Body aches, cough. The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, past family history, past medical history, past social history, past surgical history and problem list.   Review of Systems  Constitutional: Positive for fatigue and fever. Negative for chills.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for constipation and diarrhea.  Neurological: Positive for weakness. Negative for dizziness and headaches.  Psychiatric/Behavioral: Negative for dysphoric mood. The patient is not nervous/anxious.
Site: Pain at Injection Site-Mild, Systemic: Vaccine 'squirted' through connection between needle and barrel (shot re-administered)-Mild, Additional Details: Vaccine 'squirted' through connection between needle and barrel. Original shot was not administered. Shot re-administered.
pt recv vax 5MAY98 & 19MAY98 devel a low grade fever & a rash (30-50 lesions-face, trunk, genitalia);pt called primary MD to report it;n tx given;
The next day after I got the shot, I was very sick. I just felt very out of it. Then about three weeks after the shot I puked up blood. It was a lot of blood.
13 days after the flu vaccine, patient developed Bell Palsy right side of face.  Patient recovered p.o. steroid.  12/18/07 Reviewed ER medical records which reveal patient experienced acute onset right sided facial droop, unable to close right eye or furow forehead.  Tx w/steroids & antiviral meds & to tape eye at night. PMH: seasonal allergies FINAL DX: Bell's palsy.
This spontaneous report as received from a pharmacist refers to a female patient in her early sixties. On an unknown date the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneous in the arm to prevent shingles (lot # not reported). The pharmacist reported that the patient reported rash at injection site starting on the same day that the ZOSTAVAX vaccine was received. The rash was located on an unspecified arm and lasted a few weeks. The outcome of rash at injection site was reported as recovered. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 4 (booster), single (Lot number: Gh9697) at the age of 47 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: Er8731), in left arm, on 05May2021 as dose 2, single (Lot number: Ew0171), in left arm and on 14Jan2022 as dose 3 (booster), single (Lot number: 33130ba), in right arm for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Morbid obesity" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 25Apr2023 to 30Apr2023.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event vaccination failure and covid-19 cannot be excluded.
Sore arm; Fever of 100.4 degrees Fahrenheit; Body soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.4 degrees Fahrenheit) and MYALGIA (Body soreness) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.4 degrees Fahrenheit) and MYALGIA (Body soreness). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever of 100.4 degrees Fahrenheit) and MYALGIA (Body soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) Fever of 100.4 degrees Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.
Dose 1 and 2: Pfizer / BioNTech; dose 3 and 4: Moderna; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and on 22Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing), notes: IBS. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1 and 2: Pfizer / BioNTech; dose 3 and 4: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2022) Negative; (11Oct2022) Negative; (12Oct2022) Negative; (16Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My brother took the day off work on May 12, 2021 to receive his 2nd dose of the Moderna vaccine. He communicated with friends later that same day saying he was tired and needed to rest. On May 13, 2021, a work colleague followed up with a text message to see how he was doing to which my brother did not respond. This same colleague went to his house a few days later to find him dead lying on his couch.
Pain at injection site (second dose) on the day of vaccination followed by continued muscle soreness and weakeness of deltoid muscle to this day
slurring her words; tongue started tingling; couldn't speak; tongue swelled up; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 72 years old patient who received an unknown dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], via unknown route.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was reported that the patient received fluone HD and she had any reaction aside from a sore arm, pain at the injection site, and a fever. She stated that she went home and had dinner and she was talking to a friend on the phone when her tongue started tingling and then she was slurring her words. She accepted a call back and/or paperwork from Agency but states that she would be out of town for quite a while for the holidays but she could check her phone message remotely. She stated that they gave her epinephrine, steroids, and Benadryl in the emergency room. She recently had cataracts surgery so she had given herself her eye drops and she was suspecting this had something to do with the eye drops. She stated that one eye drop was Prednisolone, and one was an antibiotic and the other was an antiinflammatory. She stated that she had checked with her eye after her cataract surgery if she could get the flu shot and he told her it was ok. She stated that her tongue started swelling half an hour after she administered her eye drops and 3-4 hours after the flu shot. She stated that they wanted her to take prednisone for 5 days but it made her very sick and stayed in her system for more than a month. She stated that she was now getting back to normal. She stated that her eye drops usually drain into her sinus passage and she experienced a bitter taste on her tongue. This was all the information she provided.  At the time of reporting, the patient had adverse event.  The batch number information was requested.
Pfizer BioNTech COVID-19 Vaccine: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/6/2021 and 1/27/2021. Patient presented to ED on 9/29/2021 with complaints of diarrhea, fever, chills and diagnosed with COVID-19. CT abd/pelvis showed mild diverticulitis- levaquin/flagyl ordered.  Meduri protocol ordered but no bari or toci due to active infection (diverticulitis).  Placed on Airvo for hypoxia initially and later on had worsening hypoxia and work of breathing.  Admitted to ICU required intubation, line placement, paralysis. Was started on Meduri protocol of steroids. Started flagyl and cefepime for sigmoid diverticulitis and bacteroides bacteremia. Had worsening AKI and Additional information for Item 18: and also had Afib with RVR. Her clinical status continued to deteriorate and patient expired on 10/16/2021.
Inflammation 10x10cm area left upper arm; one large 3x11cm bulla and small bullae surrounding the large one. Warm to touch. Keflex 500mg TID x 10 days. RTC in 24 hours or sooner if worsening.
The day after I was vaccinated I got my period three days early. I had cramps for 5 days ? I usually only have cramps on day one. My period blood was brown the whole time instead of red and it had tons of clots. SO MUCH CLOTTING. And then the blood was grainy like it had sand in it. I normally bleed for a reliable 4 days, but this period extended into 8. None of this is normal for me.
This spontaneous report was received from a pharmacist who referred to an unspecified patient of unknown demographics. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 23-MAY-2017, the patient was administered an expired dose of VARIVAX (lot# L01799 and expiration date: 19-MAY-2017; dose, route of administration and anatomical location were not reported) for prophylaxis. A dose of sterile diluent (manufacturer unknown) (lot# N007932 and expiration date: 06-MAY-2018) was used to reconstitute the vaccine. The vaccine had no prior temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Pain in joints, body aches,  and loss of appetite. Pain at injection site and could not lift left arm for over 24 hours.  Fever of 101 started about 13 hours after the first vaccination.  Fever went up to 103 and remained at that level for another  22 hours.  Total recovery time was about 3 days.
HR 86, BP 98/52, AP 86, PR 22, C/O dizziness, fell in bathroom, mother called . Mother arrived and took child home. Child alert and stable at discharge. End of Sept ITP.
Pain at site of injection, patient took ibuprofen/ADVIL on 9/14/17-9/15/17. Redness around upper right deltoid/arm on 9/16/17, warm to the touch. Pharmacist advised patient to ice the upper right arm and continue to take ibuprofen as needed, also asked patient to report back to pharmacy on improvement or worsening of symptoms.
Cough  Shortness of Breath  Difficulty breathing  Fatigue  Muscle or body aches  New loss of taste or smell  Sore throat  Congestion or running nose  Diarrhea
Expired Engerix administered; This case was reported by a other health professional via other manufacturer and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number BG92Z, expiry date 7th April 2022) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter's comment: The medical assistant called to asked a question about Recobivax Hib. During that call, she mentioned that Engerix-B was administered past its expiration date. No additional information was reported. No product quality complaint was reported. The reporter consented to follow-up. The case was linked with case US2022113782, reported by same reporter. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022113782:Same reporter
Severe dizzieness, Nausea, Vomiting, Achy, Very weak for 4 days, Horrible headache
Hives on the arm; Hives on chest, spreading; Lesions are starting to weep with fluid that is crusted over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Hives on the arm), URTICARIA (Hives on chest, spreading) and URTICARIA PAPULAR (Lesions are starting to weep with fluid that is crusted over) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Hives on the arm), URTICARIA (Hives on chest, spreading) and URTICARIA PAPULAR (Lesions are starting to weep with fluid that is crusted over). At the time of the report, VACCINATION SITE URTICARIA (Hives on the arm), URTICARIA (Hives on chest, spreading) and URTICARIA PAPULAR (Lesions are starting to weep with fluid that is crusted over) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax & 1wk p/vax pt exp thrombocytopenia pt recovered;