chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old male patient received BNT162b2, on 25Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Known allergies: Lasix, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Paxlovid was taken to treat Covid-19 from 28Jul2022 to 01Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd vax & devel fever & rash; t 102; apap taken & benadryl;JUL94 pt need school physical hx of DTP allergy skin tested w/ .2cc DTAP vax pos rxn; DTP not given;
12hr p/vax pt devel itching @ site;16hr post vax pt devel swelling, itching & redness of entire upper arm;itching generalized entire body;felt warm face flushed;tx w/DPH x 48hr;no resp difficulty;no hives;
sl wheezing about 2hr p/vax;swelling in lt testicle & tender to touch;no allergies-wheezes if is in tall grass;no notable rxn w/1st dose;
Patient's arm was slightly pink below the injection site, warm to the touch, and a bit swollen.  She said that started the day after injection.
Redness, swelling, muscle pain progressing. Second day redness and swelling increased, traveling across and under arm. Second night fever, chills. Took Chlorpheniramine and applied Benedryl cream to area. Third day swelling, redness and pain continued, spreading further. Area was 5" by 3" at that point. Notified pharmacist and physician, adverse reaction confirmed. Swelling subsided by day 5, but still persists. Day 6 redness was diminished, but pain and some redness continues.
headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration in Arm on 08Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced headache on an unspecified date on Mar2021. Reporter reported as, He was told by the vaccination site "don't take advile if your arm gets store, tylenol is fine but not advil." He states that he doesn't have arm soreness but has a headache from his job today and only has Advil to take for it. He feels this is not vaccine related. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with nirmatrelvir/ritonavir (PAXLOVID) from 19Mar2023 to 24Mar2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
received dose from vial punctured more than 12 hours before; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial punctured more than 12 hours before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Patient presented to Emergency Department (ED) lethargic and listless. He proceeded to a shock state and had a cardiac arrest. He was not able to be resuscitated and died in the ED.
MMR vaccine was drawn @ 4:15 on 2/21/22.  I gave it @ 12:18 p.m.  on 2/22/22 not knowing it could only be in the fridge after reconstituting for a max of 8 hours. I thought it was 24 hours.
Hives around injection site after 24 hours.  Body shaking after 3 days. We have been to the ER 6 times in 4 weeks for uncontrolled body shakes, High blood pressure, Nausea and vomiting. Muscle soreness in arm and difficulty talking. Painful migraine like headache Heart rate elevated.  This is a nightmare  for my wife as the ER doctors just throw painkillers at her.  The second dose has changed my wife.  Please. Please help
inadvertent administration is reported in a pt who recvd a double dose of fluogen vax-2oOCT93 pt recvd 1 cc fluogen instead of .5cc fluogen IM inadvertently from a multi-dose vial; pt was asymptomatic; no other details known;
52y.o. female with a history of renal transplant, HTN, dyslipidemia, type IIDM, GERD who presented to EC with a fever and chills. She also reports malaise, sore throat, nonproductive cough. She was instructed to come to EC by her transplant office. Patient was admitted for covid 19 positive test results and evaluated by ID and Nephrology. She was on room air, no respiratory distress, was given 5 days of remdesivir. Adverse effects were discussed. She had a history of CKD s/p renal transplant- she was on  Prednisone myofortic and tacro per transplant. Myfortic was adjusted to 360mg bid and then on 8/29 go  Back to 720mg bid on discharge. Discussed changes with patient bedside. Discharged home on room air.
Information has been received from a Registered Pharmacist concerning a 67 year old female patient who on 20-APR-2011 was vaccinated with ZOSTAVAX (Merck) by other immunizing pharmacist (dose, route and lot # not specified). The pharmacist stated that the patient thought some of the vaccine leaked out at the injection site. At the time of the report patient's outcome was not reported. It was unspecified if patient sought medical attention. Additional information has been requested.
pt recvd vax & exp inject site rxn ( redness, pain & swelling of arm ); pt exp t 100; dx w/ cellulitis;
high blood pressure; HCP was reconstituting the Rabavert vaccine incorrectly and using the wrong size needle to reconstitute and administer; HCP was reconstituting the Rabavert vaccine incorrectly; using the wrong size needle to reconstitute and administer; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a female patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced blood pressure high, inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong technique in product usage process. On an unknown date, the outcome of the blood pressure high, inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong technique in product usage process were unknown.   It was unknown if the reporter considered the blood pressure high to be related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the high blood pressure but did not know if it started after receiving Rabavert injections or before.  The reporter reported that the HCP was reconstituting the Rabavert vaccine incorrectly and using the wrong size needle to reconstitute and administer, which led to preparation of medication, inappropriate dose of vaccine administered and wrong technique in product usage process. The reporter refused to provide date of birth and did not want HCP contacted and was not able to provide specific information about these events and did not have lot numbers or expiration information. It was unknown if patient received Rabavert for pre or post exposure.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR124275:same reporter
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information about patients concomitant medication, pertinent medical history, drug reactions or allergies was provided. On an unspecified dates, an unspecified number of patients received improperly stored GARDASIL lot# J009243, exp. date: 23-APR-2016 and lot# K011562, exp. date: 08-APR-2017 (dose, frequency and route of administration not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Chickenpox- Per MD as was reported by parent. Breakthrough Chicken pox- had Varivax 10/18/1998.
EE presented at COVID vaccine clinic for Pfizer #2.   Lot: EL3247  Administered at: 1001   He noted that he was itching and went to the observation room.  I reponded.   Pt reports that  after 15 minutes or so,  pt began to itch  Notes that he did not itch with the first vaccine   he is itching all over.  His not scratching and does not appear to be in distress   10:20  124/69  HR 73  O2 99   AAO, pink, talkative   10:26  HR: 78  O2: 98   not scratching or itching by appearance   no anaphylaxis in the to vaccines or food in the past  previous reaction to Belpuca-- cannot swallow and tongue feels fat   Discharged home.  He will go home and take benadryl.  WIll notify us if anything more happens
THREE DAYS POST INJECTION I BECAME ACHES AND PAINS IN BONES AND CHEST, ALSO HEADACHES AND LOOSE STOOL. SUPRESSED APPITITE WITH SOME NAUSEA. ON THE FITH DAY POST INJECTION I WAS HAVING FREQUEANT LOSE STOOLS. FOR ABOUT ONE WEEK I WAS NOT FEELING GOOD AT ALL. THIRD WEEK I AM MUCH BETTER AND NOT HAVING ANY SIDE EFFECTS.
Patient was given 0.3 mL of the COVID-19 vaccine, instead of the correct 0.2 mL dose.
Covid19 breakthrough.  1st vaccine received on 02/15/2021.  62 y/o female with PMHx of COPD, Asthma, HTN, Pulmonary HTN, Anemia, Type 2 Diabetes, Diabetic Neuropathy, OSA, Depression, Morbid obesity, home O2 presents to ED on 4/20 with c/o worsening SOB, cough and increased sputum production x1 week.  Initial Covid test negative. While at home, pt had to increase O2 from 2L to 3L-sats 92%.  Pt continued to require increased O2 and was eventually intubated on 4/22, also started on CRRT. 4/27, bronch washings positive for Covid.  CXR with diffuse interstitial and alveolar opactities.  Pt received IV ABX/steroids.
Erythema and warmness to Right thigh, vesicle present; pt. referred to PCP. Proper hand hygiene, PPE (gloves), and alcohol wipe cleansed injection site prior to administration.  Parent applied icepack to site. Pediatric Benadryl recommended. Referred to PCP for antibiotic if appropriate.  PCP recommends oral Benadryl and wants to see patient if no improvement.
A LOT OF RASHES; HIVES; This spontaneous report received from a consumer via a company representative 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. Batch /Lot number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced a lot of rashes, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from a lot of rashes, and hives. This report was non-serious.
sick as a dog; FEVER OF 103; VOMITING; FELT LOUSY FOR 2 DAYS; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), PYREXIA (FEVER OF 103), VOMITING (VOMITING) and FATIGUE (FELT LOUSY FOR 2 DAYS) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 ILLNESS (sick as a dog), PYREXIA (FEVER OF 103), VOMITING (VOMITING) and FATIGUE (FELT LOUSY FOR 2 DAYS). At the time of the report, ILLNESS (sick as a dog), PYREXIA (FEVER OF 103), VOMITING (VOMITING) and FATIGUE (FELT LOUSY FOR 2 DAYS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Fever onset 8/7/07 lasted four days developed rash vesicular in nature on 8/13/07
The pt experienced a red, swollen injection site which had a hard, pea sized lump.
R09.02 HYPOXIA 5/24/2022 MAJOR DEPRESSIVE DISORDER, RECURRENT EPISODE, MODERATE R09.02 HYPOXIA 5/24/2022 ADJUSTMENT DISORDER W MIXED ANXIETY AND DEPRESSED MOOD
Could not get warm; Diarrhea; Extreme Chills; A spontaneous report was received from a healthcare professional concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme chills, could not get warm and diarrhea.  The patient's medical history included as asthma. Concomitant medications reported were Dulera Inhaler,  Albuterol Nebulizer.  On 31 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 000UM20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced extreme chills. could not get warm, diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of all events were considered resolved on 2 Feb 2021.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Chills is consistent with the known safety profile of the vaccine.
Skin to break out; My arm was red; vaccination site eryhema; Arm was red" and in a couple of days later "sore"; It break out in hives in different parts of the body,the hives was inside; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (My arm was red), VACCINATION SITE ERYTHEMA (vaccination site eryhema), PAIN IN EXTREMITY (Arm was red" and in a couple of days later "sore"), URTICARIA (It break out in hives in different parts of the body,the hives was inside) and RASH (Skin to break out) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 12A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ERYTHEMA (My arm was red). In March 2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site eryhema), PAIN IN EXTREMITY (Arm was red" and in a couple of days later "sore") and URTICARIA (It break out in hives in different parts of the body,the hives was inside). On an unknown date, the patient experienced RASH (Skin to break out). The patient was treated with CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (My arm was red), VACCINATION SITE ERYTHEMA (vaccination site eryhema), PAIN IN EXTREMITY (Arm was red" and in a couple of days later "sore"), URTICARIA (It break out in hives in different parts of the body,the hives was inside) and RASH (Skin to break out) outcome was unknown.            Concomitant medications reported included blood pressure meds.  The patient reported that post their 2nd dose of the Moderna COVID-19 vaccine, on the same day the patient noticed their arm was red and in a couple of days later it was sore and then it broke out in hives in different parts of the body. The patient went to the doctor 2 or 3 times and, they told that the hives was inside the patient's body and caused the skin to break out. It was also reported that the patient was taking blood pressure meds as regular medication and for the treatment a cortisone cream. The patient also informed other regular med and, other cream the patient was taking but was not clear.
No adverse events were reported. However, during a routine local Department of Health inspection, temperature logs were reviewed and a temperature exursion for 58 minutes with a minimum temperature of 33.8F was discovered on 6/26/2023. This patient received the vaccine on 6/27/2023. I filed an incident report with the local DOH and contacted Moderna. Moderna assured me that revaccination was not necessary and that the vaccine activity remained.
dizziness; nausea; occasional vomiting; inappropriate route of vaccination; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced dizziness, nausea, vomiting and intramuscular formulation administered by other route. The patient was treated with dramamine (nos) (Dramamine). On an unknown date, the outcome of the dizziness, nausea, vomiting and intramuscular formulation administered by other route were unknown.   The reporter considered the dizziness, nausea and vomiting to be related to Shingrix.  Additional details were provided as follows: The patient received his 1st dose of Shingrix about a week or two ago from the date of reporting.  Since, then the patient had been experiencing dizziness, nausea and occasional vomiting.  The patient had took Dramamine as suggested by his pharmacist which helped a little.  The vaccine was given in his left shoulder but he could not say it was intramuscular, which might led to wrong route of vaccination. The patient saw his physician but had discontinued seeing him.
8 minutes post-vaccination, patient started to feel tingling on her left arm. Treatment: monitored patient for another 15 minutes (total 30 minutes); outcome: adverse reaction resolved.
At about, the one-hour mark had a metallic taste in my mouth for a few minutes; 1st shot, just soreness to the injection site for like 5 hours; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 27Jan2021 (Batch/Lot Number: EN5318) (at the age of 66 years) as dose 1, single for covid-19 immunisation. Medical history included heart, digestive, knee injuries, post-traumatic stress disorder, all from an unknown date and unknown if ongoing. There were no known allergies. There were other medications in two weeks. There was no other vaccine in two weeks. There was no COVID prior vaccination. The patient was not tested post vaccination. After 1st shot, patient experienced just soreness to the injection site for like 5 hours. At about, the one-hour mark (as reported) had a metallic taste in the mouth for a few minutes. The outcome of events was recovered.  No follow-up attempts are Possible. No further information is expected.
Headache; 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 female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache". Additional information: The reporter was querying if it was okay to take Advil a day after the vaccination. It was reported that the patient did not have time to speak to Safety and that she knew headache was an expected side effect from the vaccine, but she did not want to jeopardize the efficacy by taking Advil or Tylenol and wanted to know how long she would personally wait or which medication would she take/consider best to take. The patient also queried about the vaccine's efficacy during clinical trials and against the (ethnicity) variant.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
seen @ 1PM @ hosp ER admitting MD stated general  sl hypotonia, weak cry, mottled extremities, circumoral cyanosis, pale; dec tone, t101.2 to 101.4
10/17 PAINFUL SWOLLEN LYMPH NODES ON LEFT SIDE, 10/18 SHINGLES
Beginning of first week in February 2021 a low buzzing sound (Tinnitus) in bilateral ears. March 1, 2021 a constant louder ringing bilaterally, insomnia, headaches, and fatigue (2° lack of sleep).
Shingrix by subcutaneous route instead of intramuscular; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number GY559, expiry date 15-AUG-2025) and (batch number 42KG3, expiry date 15-AUG-2025) for prophylaxis.   On 23-AUG-2023, the patient received the 2nd dose of Shingrix (subcutaneous, left deltoid). On 23-AUG-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Shingrix by subcutaneous route instead of intramuscular).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 24-AUG-2023 Pharmacy Intern reported she administered a dose of Shingrix by subcutaneous route in left upper arm instead of intramuscular, which led to intramuscular formulation administered by other route. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 12-MAY-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (dose, route and lot number were not reported). No symptoms were reported. Additional information has been requested.