chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; 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 67-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 30Oct2023. Clinical Course: Caller prescribed the Paxlovid yesterday evening. She also mentioned that she was up to date with the Pfizer COVID vaccines.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300353163 Same patient, different drug, different event;
Raised red 2 x 2 area on left deltoid. Hot to the touch, remained red and raised for several days.
Pt c/o SOB, anxiety, chills, did not resolve. Mother with pt. Pt c/o chest pain. Transferred to hospital with mother.
Patient was completely unresponsive by 4:45-5:00 pm. BP was over 220/100+. Eyes were closed and could not move. EMS transported to ER where pt was admitted until Sunday evening. All test were done with no answers to what caused this. It was found that the patient had a mini stroke earlier that year with some neurological troubles. This was not known until admitted to hospital.
I experienced severe vertigo.  I visually saw the room spinning. I had to close my eyes but I still felt the spinning in my head. I used the wall to lean on to get down on the floor. Lasted  about 1 1/2 - 2 minutes with nausea. I never had vertigo.  When I went to bed I had an ache under my left breast. It eventually subsided.
Beginning approx. 3am 4/20/21 - fever, chills, muscle aches, nausea/vomiting.  Fever, chills, muscle aches continued through 4/21/21. Rash on torso began 4/21/21.
Information has been received from a health professional through the Merck pregnancy registry concerning a 17 year old female who on 22-JAN-2008 was vaccinated with the first dose of GARDASIL (lot# 657868/0523U). On 26-MAR-2008 the patient came to the physician's office for the second dose and told the nurse that she was "3 to 4 months pregnant" (LMP = 31-DEC-2007). The patient did not receive the second dose. No adverse reactions were reported and no other information was available. Follow up information has been received from the nurse practitioner who indicated that the baby was born on 02-SEP-2008 at 39 weeks of gestation by cesarean-section was performed because the baby failed to descend the birth canal. The mother remained in the hospital for an extended 6 days total because her cesarean-section wound dehisced. The mom had also experienced "out break of HSV" two weeks prior to delivery on approximately 19-AUG-2008, and was treated with Valtrex. The date the baby was developmentally normal, "cheerful" and "thriving". She reported that were not known birth defects, the baby is normal. She also mentioned that the baby was seen in the office on 19-MAR-2009 for some nasal congestion "like a any child in a day care". The mother of the baby was in school and shared care with the foster mother. Upon internal review, C-section performed because the baby failed to descend was determine to be an other important medical event. Additional information is not expected.
Sore throat; Congestion; Cough with some phlegm; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration in the right arm on 07Sep2021 at 19:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 08Sep2021, the patient experienced sore throat, congestion and cough with some phlegm. The patient was tested negative for COVID in two different methods of testing over three times. The events resulted in doctor or other healthcare professional office/clinic visit.  Since the vaccination, the patient had been tested for COVID-19. On 10Sep2021, the patient underwent antigen test and nucleic acid amplification test (NAAT)/molecular test via nasal swab and the results were negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events sore throat, congestion and cough with some phlegm were resolving at the time of the report.  No follow-up attempts are possible. No further information is expected.
Pt. came in with a rash all over his body. The injection site was red and big. Very flared up. No temperature or swelling. The rash started about 6 days after injection.
Hard, itchy bump at injection site. Cannot see if discolored due to tattoo. Bump is approximately 1cm wide.
Information has been received for the Merck pregnancy registry, from a nurse concerning a female patient, who was vaccinated with two doses of GARDASIL on 28-Sep-2006 and 27-Nov-2006 respectively. The patient is currently pregnant and her LMP was 15-Dec-2006. The patient's outcome was unknown. Follow-up information was received via the registered nurse from pregnancy questionnaire. The 17 year old patient with a history of 1 previous pregnancies and 1 full and a history of gestational diabetes mellitus was vaccinated with three doses of GARDASIL on 28-sep-2005 (lot # 653735/0688F), 27-Nov-2006 (lot # 653978/0955F) and 05-Oct-2007 (lot # 658282/0929U) respectively. Other medication use during pregnancy included prenatal VITAMIN. On 04-APR-2007, serum alpha-fetoprotein test was performed with negative delivered a male normal baby weighting 7 pounds 5.5 ounces with apgar score 9/9 at 36 weeks. The length of the baby is 19 inches. There were no congenital anomalies, other complication or abnormalities. There was no complication during pregnancy and labor/delivery. Additional information is not expected.
Pt recvd vax 18OCT92 & 30OCT92 exp acute rheumatoid arthritis flare-up back pain & bone chips in knee;  ER visit 1NOV92; ANA, RA profile & Sed rate done (ESR was elevated);inflammation both knees & lt shoulder given med; erythema; edematous
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history.    On 12-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nausea) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Treatment information in response to events was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Additional information received on 22/Jul/2021: Contains no significant information.
No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (009C21A, Dose 1) on 22-Apr-2021, COVID-19 VACCINE (022C21A, Dose 2) on 20-May-2021, COVID-19 VACCINE (026D21A and Dose 3) on 03-Dec-2021. Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE; and No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On 20-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    Concomitant medication was not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2023: Live Follow up received and updated patient DOB updated, added Relevant Past Drug History.
my heart started racing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took it now and was not sure whether to take the second shot or not, the seconds shot due next Friday. And the day after the patient took it (Jan2021), the patient's heart started racing. "It's did that, I mean it's still doing that off and on is that one of the side effects. Cause I saw but I thought it was immediately after." Outcome of the event was unknown.   Information on the lot/ batch number has been requested.
TINGLING IN FEET AND HANDS; This spontaneous report received from a consumer via a company representative concerned a 35 year old of unspecified 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced tingling in feet and hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tingling in feet and hands was not reported. This report was non-serious. This case, from the same reporter is linked to 20220114079, 20220114182 and 20220114533.
Initial misuse report received from a healthcare professional on 07 January 2014. A patient received a dose of FLUZONE on 26 September 2013 and it was reported that the patient had received a dose of FLUZONE HD one month ago. No adverse event was reported. Documents held by sender: none.
BODY ACHE; CHIILS; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070) dose was not reported, administered on 06-MAR-2021 17:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 100 Degree F. On 07-MAR-2021 06:00, the subject experienced body ache. On 07-MAR-2021 06:00, the subject experienced chiils. On 07-MAR-2021 06:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chiils, and fever, and the outcome of body ache was not reported. This report was non-serious.
After the first shot on March 29th at 9am,  my lip went numb almost immediately after the shot for about an hour.  After the second shot April 19th at 9 am, which is the one whose date is noted in the main bracket,  my cheeks flushed about 20 minutes after the shot.  Within an hour, my cheeks were numb.  This time the numbness grew, and spread to my right eye as well.  I could not feel my eyelid, my cheeks, and my sight was a little fuzzy.  It felt as though I had been injected with Novocain and it lasted for about 5 hours.  It was accompanied by a terrible headache.
7/39/2018, extremely fatigued in morning; took 3+ hour nap in morning and tired rest of day. Also, digestive system felt off. By dinner, appetite and energy increased. 7/31/2018, awoke with indigestion and took famotidine. In afternoon, felt light pressure in chest but then subsided. Back pain developed in one spot on right shoulder blade area. Up part of night with strong pain in same spot on back.    Also, very sharp pains in right breast radiating into chest. During the night and into next day. Saw cardiologist on 8/2 and PCP on 8/3. Both checked for rash but none present. 8/4, awoke with no right back pain but same pain in chest. 8/5, awoke with shooting and intense pains on right side of back.   Developed rash on right side of back. 8/6, dermatologist Dr., said it was Shingles and did biopsy.  Confirmation of shingles Dx on 8/14.
The (BUD) refrigeration date on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022; No adverse event; erroneously vaccinated clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The (BUD) refrigeration date on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine), PRODUCT STORAGE ERROR (The (BUD) refrigeration date on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated clients with expired vaccine) and PRODUCT STORAGE ERROR (The (BUD) refrigeration date on 01-Jul-2022 and vaccine was adminstered on 11-Jul-2022).    Concomitant medications details were not reported by the reporter. It was reported that 10 days past expiry date the patient received the vaccine. Vial was initially stored in refrigerator on  07-JUN-2022. Vial size was reported as 5.5 ml. Vial did not undergo any temperature excursion. Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681156.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681156:Master Case
Extreme itchiness throughout trunk, arms and legs, as if wearing a wool sweater, lasting more than 48 hours
Redness swelling hives around vaccine site ~ 3 hours post vaccine disipating over next 15-20 min.
Pt. received PENTACEL, Hep B (Pediatric), PCV13 on 1/18/12 - Mom called morning of 1/19/12 stating he started running "fever" (unknown how high as Mom never measured this) "he felt warm". She said he awoke at night fussy and usually sleeps all night. He awoke in AM crying, fussy with congestion and nasal cong. and coughing - con't "fever" and fussy, only take few drinks of formula - referred to her doctor.
About 5 days after I received  the SHINGRIX shot (2-15-19) at Pharmacy my right forearm started to itch. I went to see my dermatologist on 2-28-19. He took a photo of the rash and did a biopsy. The result  was erythematous papules. Today I saw him again and he prescribed a 10% cortizone cream to hasten the rash recovery. My next appointment is in a month to see if the rash heals. The info I have on my receipt says SHINGRIX 50 MCG SUS NDC#58160-823-11.
This spontaneous report was received from a radiation technician referring to a patient of unknown age and gender. On 17-SEP-2018, the patient was inadvertently administered an expired dose of VARIVAX (Lot#M037643, Expiration date: 01-SEP-2018; route was not reported) for prophylaxis, that was properly stored. The lot of VARIVAX was reconstituted with properly stored sterile diluent. No adverse effect was reported.
This is a spontaneous report from a contactable Nurse (patient). A 28-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL9262), via an unspecified route of administration on Jan2021 at 02:15 pm (at the age of 28-year-old ) on the left arm as a single dose for COVID-19 immunisation. Medical history included Ulcerative Colitis and allergy to NSAIDS. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID tested post vaccination was none. Patient's other medication 2 weeks prior vaccination included Mesalamine. The patient stated that 3 days after receiving the first dose on 26Jan2021, the patient had extreme arm pain, soreness and decreased mobility in the arm. The patient stated that the pain and mobility got better. The patient further stated that it has been over 2 months and she was still experiencing arm pain and had difficulty in moving her arm above the head. The patient stated that when she checked out of the vaccination centre, there was a pocket of fluid noted where her vaccine was given. The patient had a physician office visit due to the events. The patient did not receive any treatment medication for the event. The outcome of the events was recovered on an unspecified date (with lasting effects).  No follow-up attempts are possible. No further information is expected.
This young lady was at the school to receive her second dose of the Pfizer vaccine, she answered all the questions with a No answer, she stated she was feeling well and had minimal reaction to first vaccine.  She appeared to be nervous as reported by the nurse.  after recieving her second shot, as the nurse was finishing up paperwork and filling out card, the student felt like passing out, one of the other nurses that were at her side, caught her as she fainted out of chair, she was placed on the ground and EMS was called at 10:10 and Nursing Supervisor was notified at 10:15.   EMS determined she had a Vasovagal Syncope.   EMS attended to patient and it was unknown if she was released after observation or taken to ED for further evaluation.  a field emergency record was recorded and return to the nursing supervisor at the health department.
shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 81-year-old patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced shingles (Verbatim: shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Flu vaccine.     It was unknown if the company considered the shingles to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023. This case was reported by a patient via interactive digital media. The patient got shingles after a flu shot. The patient never went to the physician.  The patient used Transcutaneous Electrical Nerve (TENS) units 2 - cuz wore out the 1st one and patient thought it was l-arginine an amino acid The follow-up could not be possible as no contact details were available.
itching; redness; hot to touch; peanut allergy; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2019, the patient received Shingrix (intramuscular). On 28th May 2019, 12 days after receiving Shingrix, the patient experienced generalized pruritus, generalized erythema, feeling hot and peanut allergy. On 28th May 2019, the outcome of the generalized pruritus, generalized erythema and feeling hot were recovered/resolved. On an unknown date, the outcome of the peanut allergy was unknown.   It was unknown if the reporter considered the generalized pruritus, generalized erythema, feeling hot and peanut allergy to be related to Shingrix.  Additional case details were provided as follows: The patient's neck and chest started to itch and became really, really red.  Also, the outside of both elbows became red like tomatoes and hot to the touch. The patient thought that, this might be an allergic reaction to some peanuts she ate but she had never had a peanut allergy before.  The patient was wondering if Shingrix could cause someone to develop a peanut allergy. These reactions stayed that way for about 45 min.  The patient did not consent to follow-up.
This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labelling documents. This spontaneous report was received from a physician, via a company representative and concerns a 19 year old subject of unspecified gender. The subject's weight, height and medical history were not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) 1 dose total, on 06-MAY-1999, 08-MAY-1999, 10-MAY-1999 and 12-MAY-1999 as a prophylactic vaccination. Concomitant medications included poliomyelitis vaccine inactivated, meningococcal polysaccharide, tetanus vaccine and hepatitis A vaccine as prophylactic vaccination. On 07-MAY-1999, 1 day after starting typhoid vaccine oral ty21a the subject developed abdominal pains. On 14-MAY-1999, 8 days after starting typhoid vaccine oral ty21a the subject developed nausea, bloating and abdominal pain. Action taken with typhoid vaccine oral ty21a was not applicable. The subject had recovered from abdominal pains on an unspecified date. The subject outcome was unknown for events nausea and bloating. This report was serious (medically significant).