chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lip swelling; Tingling; Spontaneous report received on 17JAN2020.  A nurse reported that a 24-year-old female who developed "lip swelling" (PT: Lip swelling) and "tingling" (PT: Paraesthesia), while receiving oral Vivotif for immunisation. The consumer also had Vaxchora, Flu shot (influenza), and rabies vaccine before taking Vivotif. On 13JAN2019 (Monday), the consumer received Vaxchora (cholera vaccine), flu shot (influenza vaccine), and one dose of rabies. On an unknown date (Wednesday), the consumer took one dose of Vivotif at night and woke up in the middle of the night with lip swelling and tingling. Thus, she took Benadryl (diphenhydramine) for lip swelling and went to bed again. She awoke in the morning and still had swelling, and then she went to urgent care where the doctor told her it was possible it could be related to Vivotif. The consumer did not receive any treatment at the urgent care but was prescribed Epi Pen (epinephrine) as a precaution for future reactions. Moreover, the consumer was stopping oral typhoid and will attempt to take injectable vaccine. It was reported that the consumer did not have any allergic reactions.  Action taken with Vivotif with respect to reported events was vaccine withdrawn.  Action taken with Vaxchora and Flu shot with respect to reported events was not applicable.   Action taken with rabies vaccine with respect to reported events was unknown.  The patient was recovering from the event "lip swelling", while the clinical outcome of event "tingling" was unknown.  Company Comment: A consumer took one dose of Vivotif at night and woke in the middle of that night with lip swelling and tingling. The consumer also took Vaxchora, flu shot and one dose of rabies two days before taking the Vivotif dose. In response to the events, she took Benadryl and her lip swelling was resolving. The consumer stopped taking further doses of Vivotif. Considering the potential of Vivotif to cause allergic reactions, and the case information, the causality of both the events is assessed as possible with Vivotif. Considering the case information, the causality of both the events is assessed as unlikely with Vaxchora.; Sender's Comments: A consumer took one dose of Vivotif at night and woke in the middle of that night with lip swelling and tingling. The consumer also took Vaxchora, flu shot and one dose of rabies two days before taking the Vivotif dose. In response to the events, she took Benadryl and her lip swelling was resolving. The consumer stopped taking further doses of Vivotif. Considering the potential of Vivotif to cause allergic reactions, and the case information, the causality of both the events is assessed as possible with Vivotif. Considering the case information, the causality of both the events is assessed as unlikely with Vaxchora.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 22-Nov-2010. On 23-Nov-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
4/10/2017 upper arm sore became swollen began having tingling and pain in in arm and hands. Has put warm pack on arm and is taking Ibuprofen.
Information has been received from a physician concerning a female patient who were vaccinated with completed series of GARDASIL. It was reported that within 2 years after completing the vaccine series the patient came back and had cervical dysplasia. Papanicolaou smears were performed. The patient sought medical attention by going to the physician's office. At the time of report the outcome was unknown. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Redness, swelling, fever in arm at injection site. Red bumps/itching on scalp.
Brief Epistaxis in the evening that he received the shot. He has no history of frequent eoistaxis. No other bleeding events or bruising were noticed
Patient reported immediate tightness in throat and nasal area. 20mL of liquid benadryl was given followed by 0.3mL dose of Epi.
No adverse effects reported.; Patient inadvertently received first dose of ROTATEQ in series that had expired.; This spontaneous report has been received from a medical assistant referring to a 3 months old patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 31-JUL-2019 the patient inadvertently received first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (oral, lot # R000911, expiration date: 28-FEB-2019, dose unknown) in series that had expired for prophylaxis (expired product administered).         No adverse effects reported.
Spiked a high fever and had a seizure, followed by subsequent fevers a few hours later, the night sweats the following day.
This case was reported  by a physician and described the occurrence of syncope in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 21 July 2010 the subject received unspecified dose of BOOSTRIX (details unknown). On 21 July 2010, within 2 minutes after vaccination with BOOSTRIX, the subject experienced syncope, seizure and loss of muscle control. A call was placed to 911 and she was taken to the hospital emergency room. The extent of hospitalization was unknown. The subject was treated with oxygen, VALIUM and NARCAN. At the time of reporting the events were resolved.
getting hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (getting hives all over the body) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076H21A, 021B21A-1 and 007C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FISH OIL, B-COMPLEX, MULTIVITAMINS [VITAMINS NOS] and MAGNESIUM for an unknown indication.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, the patient experienced URTICARIA (getting hives all over the body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (getting hives all over the body) had not resolved.            The patient's allergist told the patient to take Zyrtec. It had been 2 months since then and the patient still had the hives. The hives pop up and then go away.  The patient had no history of testing positive for COVID-19 and had taken the booster dose.
DAUGHTER CALLED TO SAY HER MOM'S ARM WAS SWOLLEN, BLOODY AND BRUISED THE DAY AFTER THE SHOT. THERE WAS ALSO A RED RING ON HER ARM FROM THE BARRIER BANDAGE.
received her Moderna Booster vaccine 11/4/2021 at approximately 10:20am. She reported to nursing staff that she started to feel numbness in the lips and lower cheek 10 minutes after being vaccinated. No swelling of the lips, tongue, throat upon initial assessment and no shortness of breath. She stated she had no previous reaction to first 2 doses of Moderna. Patient drank some water and finished her observation period with frequent nursing reassessments. She reported no changes throughout, except for the report of mild tongue swelling at the end of her 30 min obs. Pt denied shortness of breath or trouble swallowing. Instructed patient to follow up at Urgent Care immediately to be seen by an MD. She verbalized understanding and left the COVID Vaccine Clinic at 10:55am.
Ears twice size, eyes swollen, hives all over.Itching all over.TX - Decadron 1/2cc
hx of pituitary adenoma - post surgical resection back in April 2021; presented to ED with weakness and SOB, positive for COVID - 19; pt's condition worsened where he passed away in the hospital; Acute hypoxemic respiratory failure secondary to COVID pneumonia
No adverse event; Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent) 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 UNDERDOSE (Administration error: 7 patients received 0.25 mL doses instead of 0.50 mL of bivalent).    Concomitant medications were not reported. It was unknown if patients reported any AEs. No treatment information was provided by the reporter.
Breakthrough case admission after 4 vaccines Pfizer 3/11/21 Lot# EN6207; Pfizer  4/1/21 Lot# Ew0150;  Pfizer 10/30/21 Lot# FF2589;  Pfizer 4/28/22 Lot# FM99
COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: gh9692) at the age of 45 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: er8731), in left arm, on 13Apr2021 as dose 2, single (Lot number: er8731), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 32020f0), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Losartan, reaction(s): "Known allergies: Losartan". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (May2023) Positive, notes: COVID test came up positive 4-5 days after completing Paxlovid course. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Adverse event COVID test came up positive 4-5 days after completing Paxlovid course.
This is a spontaneous report from a contactable consumer via a Pfizer sales representative. This consumer reported similar events for four patients. This is the fourth of four reports. An infant patient of an unspecified gender received PREVNAR 13, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling and a little hardened area at the injection site. The reporter spoke to the doctor that said the swelling and a little hardened area at the injection site was okay and nothing serious. The outcome of the events was recovered within a few days on their own. The information on the batch/lot number and expiration date has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018482503 Same reporter, same drug, same events; different patient.
NO OTHER AE; a temperature excursion involving GARDASIL 9 / GARDASIL 9 was administered; This spontaneous report was received from a person of physician's office, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported.   On 12-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0,5 ml, lot # 1602284, expiration date 26-SEP-2021 for prophylaxis (strength, route and frequency were not reported).  The temperature excursion was of 31.2 Centigrade degrees (°C) during 30 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No other adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Two bullous lesions on lateral left upper arm 4cm where patient reports injection was given. Patient states that he received immunization 09/26/2017 and later that day he took of the band-aid and noticed 2 fluid-filled lesions.
Extreme tiredness; grogginess; body felt lightweight too.; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep7534) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unknown date in Mar2021 (the day after vaccination), the patient experienced extreme tiredness, grogginess and the body felt lightweight too. The clinical outcome of events extreme tiredness, grogginess and body felt lightweight were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
L delt area red swollen, warm to touch-Dad brought child in, and mom pick her up next day. Noticed it was red-child c/o arm hurting-Advised to put ice on/off - Tylenol for pain - if got worse to see PCP.
Parent called today to report a quarter-sized red, raised area on right thigh. Not painful or itchy. "Looks like frost bite" per mother. On 9/21, it was less red, had blotchy white spots and "seems to be going away."
Patient Received Rotavirus vaccine (along with DTaP, Hep B, IPV, HiB, Prevnar) on 5/29/07. On 7/11/07, she presented to the ED and was diagnosed with intussusception.  Did not resolve with air enema.  Required surgical reduction.  8/21/07 Received hospital medical records which reveal patient experienced nausea, vomiting & bloody stools x 1 day.  Admitted 7/11-7/15/07.  X-ray revealed IS & air enema failed to reduce.  Taken to OR for exp laparotomy.  Patient did well post op & d/c to home. FINAL DX: Intussusception, s/p surgical reduction. 8/21/07 Received clinic records including vax records which confirm RO dose & lot as reported.  Patient w/runny nose & cough on day of vax.  RTC 6/5 w/fever, runny nose, cough.  Dx: viral syndrome.  7/23 f/u visit post op for vomiting, cranky, cough, fever.  DX: viral syndrome & possible UTI.
Dizziness, Bleeding, Myalgia, Fever, Diarrhea, NauseaVomiting, GastricBleeding, Syncope, ,  and severe abdominal pain, severe GI bleeding Narrative:
I woke with a high fever (101) at midnight after getting the vaccinations at about 11 am. I ached all over so badly I could hardly lie down. I couldn't sit up longer than to urinate. The body aches felt like I had shingles all over my body. I also had a headache. I took Tylenol and my pain was reduced enough to go back to sleep for 5 hours. I repeated Tylenol every 6 hours through midnight of day two. My fever and severe body aches persisted through the next 32 hours. My fever broke and body aches subsided on day 3 at noon after the vaccinations. I still feel weak and wrung out but I'm on the mend. I had no treatment. I expected moderate to severe side effects.
Patient had a sudden fall for the first time at 73 years old.  He acquired cervical stenosis requiring a C3-C6 posterior decompression and fusion.  He was also having severely low blood pressures requiring a levophed drip.   Patient is currently unable to move his lower extremities as well as he has no hand and finger dexterity on either hand.
tired; fever; nausea; chills; circumstance or information capable of leading to medication error; 2nd dose 10 day before the 2 month; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced tiredness, fever, nausea, chills, circumstance or information capable of leading to medication error and drug dose administration interval too short. On an unknown date, the outcome of the tiredness, fever, nausea and chills were recovering/resolving and the outcome of the circumstance or information capable of leading to medication error and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the tiredness, fever, nausea and chills to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix about a month and a half ago and experienced the effects as noted in this report the day after her vaccination. She would like to receive her 2nd dose 10 day before the 2-month mark so she may travel out of the country, which led to circumstance or information capable of leading to medication error and shortening of vaccination schedule. The reporter did not consent to follow up. The call was transferred from MI and the patient did not want to provide her contact information.
Felt ill - flu like symptoms for several days with suspected fever, Very sore arm, injected muscle sore and hard for couple weeks - resolved with cold packs and time.
Hypertension; This is a spontaneous report from a contactable nurse or other health care professional.   A 53-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0176), via an intramuscular route of administration (at the age of 53-years), in deltoid right on 30Apr2021 as single dose for COVID-19 immunization. The patient's medical history included cyst of kidney and surgery to remove cyst from 2017 to an unknown date, bells palsy from 1992, 2002 to an unknown date, hypogonadism from 2018 to an unknown date, hypertension from 2005 to an unknown date, hyperlipidemia and hernia surgery from 2018 to an unknown date, gerd, allergy and blood pressure from an unknown date and unknown if ongoing. Patient family history included MI (myocardial infarction), Heart disease (Father) and hypertension, diabetes (Mother) from an unknown date and unknown if ongoing. The patient's concomitant medications included metoprolol succinate (TOPROL XL) taken for blood pressure as 50 mg per oral route starting from 2015 and ongoing, pantoprazole taken for gastrooesophageal reflux disease as 40 mg per oral from 2015 and ongoing, lisinopril taken for blood pressure measurement from 2020 as 20 mg per oral and ongoing, testosterone cipionate (DEPO TESTOSTERONE) taken for an unspecified indication from 2018 as 80 mg weekly intramusculary and ongoing, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergy from 2020 as 10 mg daily per oral and ongoing. On 01May2021, the patient experienced hypertension. The treatment was not received for the event. The adverse events resulted in physician office visit. The clinical outcome for the events was reported as recovered on 10Jun2021.  The Pfizer product did not have a causal effect to the adverse events.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be established as the patient is a known hypertensive
Two firm lumps starting approximately 1" below injection site; First lump oval shaped approximately 1" tall by 3" wide; second lump approximately 1/2" below the left end of the first lump, not quite the size of a dime; some itchiness; no indications of a rash, and unable to determine if redness is from the lump or from scratching it.   Note that there was arm soreness in this same area for a day or two after the injection.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2020, the patient received Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had headache. The reporter asked how long do the side effects last.