chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid positive result; Covid positive result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EL3247) at the age of 44 years as dose 2, single and administered in arm right, administration date 02Mar2021 (Lot number: EL3247) at the age of 44 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history and no known allergies. The concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient didn't receive any other vaccines within 4 weeks. The patient tested for COVID-19 post vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Dec2021, outcome "recovering" and all described as "Covid positive result". It was reported that Vaccinated Family members in same household also positive after a Covid exposure on 28Nov2021. 12 vaccinated family members now covid positive. The event "covid positive result" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Dec2021) positive, notes: Nasal swab. Monoclonal antibody infusion were taken as a result of the adverse events.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101733546 same reporter/drug/AE with different patient
1st dose and tested positive for COVID afterwards; she already passed 42 days time frame; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (1st dose and tested positive for COVID afterwards) and PRODUCT DOSE OMISSION ISSUE (she already passed 42 days time frame) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (1st dose and tested positive for COVID afterwards) and PRODUCT DOSE OMISSION ISSUE (she already passed 42 days time frame). At the time of the report, SARS-COV-2 TEST POSITIVE (1st dose and tested positive for COVID afterwards) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: Positive.     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.   No concomitant medications were provided.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No specific follow-up information recorded.
4hrs post rcv vax devel fever of 102.5 deg F, persistent screaming, and an inject site rsn w/ redness and swelling; one of three pt who exp adverse events after vax.
Patient says that the needle hit her bone and was extremely painful. Her arm is still painful 2 days later and she cannot sleep because of the pain.
according to mom child well yesterday about 12AM last noc;pt vomited & seemed to became listless, eyes rolled back as if having sz x 2;t99.4 R;
Chills; Body aches; temperature of a 100 degrees; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: EN6206) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHILLS (non-serious) with onset 11Mar2021, outcome "not recovered", described as "Chills"; PAIN (non-serious) with onset 11Mar2021, outcome "not recovered", described as "Body aches"; BODY TEMPERATURE INCREASED (non-serious) with onset 11Mar2021, outcome "not recovered", described as "temperature of a 100 degrees". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Consumer stated that, his first dose of the vaccine was on 08Mar. He was experienced the side effects chills, body aches, temperature of 100 degrees, 7 days after the first shot. Chills began exactly 3 days after the first shot. Body aches began the same day as the chills, 3 days after the shot. He stated that with the temperature of a 100 degrees, the fever goes down through the day but it was high in the morning time when he gets up. He confirms it is off and on but still ongoing. The fever began 3 days after the dose as well.  No follow-up attempts are possible. No further information is expected.
received a dose that had expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number 75F27, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th July 2022, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On 7th July 2022, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-JUL-2022 Reporter's Comment: Nurse reported that a patient received dose of Fluarix that had expired on 30th June 2022.  The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Fluarix which was already expired, which led to expired vaccine used.
This spontaneous report was received from a pharmacy student (also reported as a healthcare student) on 09DEC2014, regarding a 63-year-old female patient with a history of no drug reactions and no allergies. Medical history and concomitant medications were not specified by the reporter. The patient had been vaccinated on 08DEC2014 subcutaneously with a dose of 0.65 ml (once) ZOSTAVAX (Merck) (Lot # K008883; expiration date 20SEP2015). The pharmacy student reported that the reason for the therapy was "She's in the age group for it." The pharmacy student reported that the patient has now been prescribed ENBREL, after receiving the dose of ZOSTAVAX (Merck). The pharmacy student could not confirm that the patient was prescribed ENBREL for a pre-existing condition. (It was not specified why the patient was prescribed ENBREL). It was not specified if the patient sought medical attention. No further information was provided. (The pharmacy student had reported degree of Pharm D. It was not further specified if she had received the degree or was working toward receiving the degree). Additional information has been requested.
arm pain; chills; This is a spontaneous report received from a non-contactable consumer (patient's sister). A female patient of an unspecified age received the second dose of BNT162B2 (BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine and after the second dose experienced arm pain and chills that same day (unspecified date). The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Copious vomiting for about 5 hours, headache, chills, fever = 100.7. Treated in ED with IV fluids, antiemetic, IV Toradol, and sumatriptan to cover for possible migraine. Released from ED after about 3 hours; moderately recovered.
Patient had several ED visits, on 4/17/21, 4/20/21, 4/24/21. He presented to the ED on 4/25/21 and was subsequently admitted. these visits are within 6 weeks of receiving COVID vaccination.
severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; severe nausea and vomiting/diarrhea; Chills; body aches; tired and slept all day; Tingling at fingertips; This is a spontaneous report from a contactable consumer(patient).  The 49-year-old female patient(not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot: EL3247), via an unspecified route of administration at left arm on 11Jan2021 16:30 at single dose for covid-19 immunisation.  Medical history included hashimotos disease, allergy to penicillin and sulfa, tree nut intolerance. There was no COVID-19 Prior to vaccination.   Concomitant medication included levothyroxine sodium (UNITHROID), ethinylestradiol/levonorgestrel (ENPRESSE). There was no other vaccination within 4 weeks prior to the COVID vaccine. On 22Jan2021, 04:00, The patient woke up with severe nausea and vomiting/diarrhea, lasted for the morning, she also experienced chills and body aches. By noon she was fine but tired and slept all day. She also experienced tingling at fingertips. That was all done by night. There was no treatment. Outcome of events was recovered in 22Jan2021. Events were assessed as non-serious. Since the vaccination, the patient had not been tested for COVID-19.
Shot received on 3/27 around 3:15pm.  3/28 around 10:58am daycare notified us that there were red bumps on legs, stomach, face. Called pediatricians office right after and ended up going to walk in clinic around 12pm. Was advised to give benadryl. By 4pm rash and hives spread over entire body and low we noticed a low grade fever. 3/29 rash worsened and now see hives all over body. Face, neck, and ankles swollen. Cough started. Took to hospital around 9am.
Shortly after administering the patient's 1st dose of Pfizer, the patient fainted. I laid her on the floor and a gentleman helped me call 911. When the patient awoke, the store manger and I helped her get up and moved her to seats to lie down and gave her water. The EMS arrived 15 minutes after the call and stayed with the patient until 7:18pm after she refused going to the ambulance/hospital several times, saying she needed fluids and iron. The patient left the store alone without informing pharmacy staff around 7:22pm even though she told us someone was coming to pick her up.
Patient hospitalized 8/9/21 with  pneumonia due to COVID -19 with acute hypoxic respiratory failure.
injected pt @ 230PM mom reported pt started throwing up @ 5PM x 2-3 times;
Injection site pain. Headache two hours after shot. Ibuprofen helped greatly at 600mg dose.
Patient presented to our COVID vaccine site for a first dose COVID vaccine. Appointment was scheduled as such by patient or family. Patient asked if this was her first dose with affirmative response. No prior vaccine card was presented. Proceeded with administering the Moderna COVID vaccine. Patient was scheduled for dose 2 Moderna on 3/25/21. When we called to confirm her appointment today her son informed us that she had "already received two doses of COVID vaccine." Upon further electronic chart review, I reconciled the outside CAIR record and found that she received the Pfizer vaccine at the Forum through an LA County Vaccine site on 2/8/21.
RASH DOWN THE SIDE OF THE TORSO, ARMS, WRISTS AND CHEST AREA; HEADACHE; FEELING TIRED; SEVERE VOMITING; GENERAL ACHE; FEVER; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination, vaccinated at the left deltoid. No concomitant medications were reported. On 31-MAR-2021, the subject experienced general ache. Laboratory data included: Body temperature (NR: not provided) 99.9 F. On 01-APR-2021, the subject experienced severe vomiting. On 01-APR-2021, the subject experienced headache. On 01-APR-2021, the subject experienced feeling tired. On 03-APR-2021, the subject experienced rash down the side of the torso, arms, wrists and chest area. On an unspecified date, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol, aloe vera, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe vomiting on 02-APR-2021, and headache on 03-APR-2021, was recovering from general ache, had not recovered from rash, and feeling tired, and the outcome of fever was not reported. This report was non-serious.
Approximately 10 minutes after vaccination, nose started itching, chest tightness, and dizzy; used inhaler. Nurse administered Epi.; did not improve. EMS arrived and transported to ER. Arrived at ER at 11 AM.
Pt experienced aching shoulder pain on right site since soon after vaccination, reported hurt when laying on his side pain has since plateaued, a little better. Pain relieved by ibuprofen 600 mg twice daily. Advised to report back if getting worse.
high pitched persistent cry p/vax;reporter feels that tetramune vax caused rxn;
enlarged lymph nodes; rashes on chest and back; This case was reported by a consumer and described the occurrence of enlargement of lymph nodes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ELASOMERAN (MODERNA COVID 19 BOOSTER) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and MODERNA COVID 19 BOOSTER. On an unknown date, several weeks after receiving Shingrix, the patient experienced enlargement of lymph nodes and rash. On an unknown date, the outcome of the enlargement of lymph nodes and rash were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes and rash to be related to Shingrix.  Additional details reported were as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received Shingrix shot and a few weeks later she had a Moderna Covid booster shot.  Since then the patient experienced enlarged lymph nodes and skin rashes on her chest and back.  The reporter asked was there a possibility that her symptoms were related to these events. It was unknown if the reporter considered the enlargement of lymph nodes and rash to be Moderna Covid 19 Booster vaccine.
acquired haemophilia; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jan-2022 and was forwarded to Moderna on 25-Jan-2022.    This literature-non-study case was reported in a literature article and describes the occurrence of ACQUIRED HAEMOPHILIA (acquired haemophilia) in a 70-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACQUIRED HAEMOPHILIA (acquired haemophilia) (seriousness criterion medically significant). At the time of the report, ACQUIRED HAEMOPHILIA (acquired haemophilia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACQUIRED HAEMOPHILIA (acquired haemophilia) to be related.    Concomitant medications were not reported.  Company comment: This is a literature case concerning a 70-year-old male patient with no medical history reported, who experienced the unexpected serious event of Acquired haemophilia eight days after the first dose of mRNA-1273 vaccine. The outcome was reported as unknown. Patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature case concerning a 70-year-old male patient with no medical history reported, who experienced the unexpected serious event of Acquired haemophilia eight days after the first dose of mRNA-1273 vaccine. The outcome was reported as unknown. Patient's advanced age remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mine mouth right side pallet gums and teeth mostly upper but sometimes lower is causing me pain hot warm mouth if you cut the mouth and 3/3 I?d be 1/3 of the right side up and lower on and off throughout the days and evening warm or hot sometimes eyesocket
This spontaneous report was received from a pharmacist via a company representative and refers to a 78-year-old female patient. The patient's concomitant therapies, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, site of injection, lot# and expiration date were not reported). On an unknown date, the patient experienced redness that localized at the injection site following the administration of ZOSTAVAX. It was unknown if the patient sought medical attention. The outcome of adverse event was not reported. The relatedness between the adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Approximately 1 week after having the primary dose, I developed tingling/paresthesia in my left lower leg, which subsequently developed on my left forearm and left side of my face.  I did not have any change in strength in upper or lower extremities.  Symptoms have persistent for the past 2 weeks, seem to come and go, but still persistent.
was administered Tdap, no previous allergy to Td, was being worked up for allergy - tested + seafood and almond; approx 15 minutes after vaccine developed allergy/mouth sensation, referred to ED, hospitalized for observation, discharged and had persisting sx,  now ? gelatin allergy - was getting med w/ gelatin during subsequent hosp., as of 5/11/09 still on Prednisone,antihistamine and periodic epi  5/19/09 Received hospital medical records of 4/26-5/2/2009. FINAL DX: Anaphylaxis & asthma exacerbation Records reveal patient experienced polyarthralgias, facial swelling, ANA(+) s/p HPV vaccine given 9/2008.  Tx intermittently w/steroids & plaquenil.  On 4/15/09 given TDaP vaccine due to pertussis outpbreak at her job.  Within 10 min, noted tingling & swollen lips, tongue & face w/SOB.  Tx in ER w/steroids, antihistamine.  Developed crushing chest pain & tx w/epi.  Improved but admitted overnight & had further episodes of swelling, flushing, chest tightness & puffy hands.  Saw PCP on 4/16 & began steroids.  Recurrent episodes of angioedema tx w/steroids & nebs.  On seen in urgent care & admitted to ICU 4/18-4/23 requiring epi several times for chest tightness.  Again developed flushing, facial swelling & tx as outpatient w/epi w/resolution of symptoms.  Recurred again on 4/26 & admitted.  Allergy consult done.  Stabilized & d/c to home w/allergy clinic f/u. ICD9 Codes: 999.4; E948.6; 493.90; 784.0; 796.2; 530.81; 785.0;300.00; E941.2; E939.5; V14.8; V58.65.
Severe Joint and Muscle Pain as well as fatigue with a moderate headache and accompanied by fever. Started at 3:30 AM on Sat., 04-24-21 Tried to report through my phone but kept getting error message. Pain and fever where more tolerable by Sun. 04-25-21 but now have lower left pain in the abdomen. Around the kidney area.
on 6/12/99 pt states child leg swollen w/blisters around inj site;leg viewed approx 3PM on saturday 2 blisters noted w/redness & swelling;cont to swell on Sunday w/an added blister;now bruising;
My boyfriend and I both received the hepatitis A vaccine on 11/16/2006.  We both developed red, itchy, irritated skin one week following administration which has almost resolved.
About 5 minutes after receiving his first covid vaccine the patient reported feeling very hot. He became pale and diaphoretic. He complained of dizziness and feeling lightheaded. He was immediately given attention by myself and an RN. We turned a fan on him, gave him a mint, and placed cool cloths to his face and neck. He had not eaten anything this morning prior to his vaccine. He was instructed to lay down but declined. He recovered from this event after about 10 minutes and felt comfortable enough to leave the clinic on his own accord.
COVID vaccine breakthrough case. Moderna 4/27/2021 044B21A, 05/25/2021 037A21B, 04/09/2022 001M21A.
Hematuria, gross, with urinary retention.  Recent instrumentation as above.. CBI discontinued on 10/31, failed voiding trial, Foley replaced on 10/31 and patient discharged home with Foley catheter, per urology recommendations.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Patient was administered PROQUAD vaccine (MMRV) instead of MMR. Also rec'd varicella vaccine that day no s/s or tx noted/given.
From initial information received on 15OCT2004 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 18 month old male patient received a second dose of Fluzone SV2004-2005 administered in the left thigh on 6OCT2004. 24 hours later, the patient developed a fever of 103 degrees F, which persisted for 24 hours. The patient experienced a febrile seizure at 11:00PM on 7OCT2004. The parents contacted emergency medical services , but refused to go to the ER. The patient was seen by a physician on 8OCT2004 for evaluation. He recovered form these events. From additional information received on 01Nov04 from a RN, the pt's full name, address and telephone number were provided. Pt's birth weight was reported as six pounds and seven ounces. The pt was reported to have two siblings. The vaccine administrator's name was also provided. On 20Sep04, the pt received his fourth dose of Daptacel, administered IM in the right upper thigh, his third dose of IPOL, administered IM in the right thigh, a dose of MEASLES, MUMPS and RUBELLA vaccine, manufacturer administered SC in the left thigh and a dose of Prevnar, manufacturer Lederle, administered IM in the left lower thigh. Reportedly, the nurse reviewed the information on 26Oct04.
no adverse events have been reported; instead of Proquad they were attempting to give MMRII.; The vaccines given were Proquad [Lot Number= T013540, Expiration Date= l 7Oct2021] given subcutaneously in the right thigh; Varivax; This spontaneous report as received from a licensed practical nurse and refers to a 12-month-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.      On 23-DEC-2020 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) albumin status rHA, lot # T013540 has been verified to be a valid lot number, expiration date 17-OCT-2021, subcutaneously in the right thigh (exact dose was not provided), varicella virus vaccine live (oka/merck) (VARIVAX) lot # reported as T0101315 expiration date reported as 04-MAR-2022 subcutaneously in the left thigh (exact dose was not provided) (drug use for unapproved combination) and hepatitis a virus vaccine inactivated (HAVRIX) lot # ZJ3G3 expiration date 12-JUN-2022, intramuscularly in the left thigh (exact dose was not provided); all for prophylaxis. It was reported that instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) they were attempting to give measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). No adverse events have been reported.