chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient took first shot of the vaccine couple month ago and then about a week ago was supposed to get second shot. Patient was tested positive for Covid. Patient just didn't know when to go get test if see test negative and now if test negative what was the procedure going forward because patient would like to get second shot or do patient had to start all over again? The outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
adult dose of Hep B energix administered in error to 19 yr old patient. Indicated for 20 yrs of age and older.
TDAP to L deltoid on 1/13/2010. Pt returned to clinic on 1/15/2010 with swelling at injection site 5cm x 4cm raised, red and streaky area.
After receiving the first shot I had normal side effects - a headache that went away in 24 hours and a sore arm that lasted 36-48 hours. I did notice a slight jitter/shaky feeling and a little tinitus. One week later the tinitus became much louder and continual. This has continued for a week. I also have moments of vertigo and an overall achy/tired feeling that I have been in bed for the past 4 days.
Pt. received vaccine, at 640pm... at 705 pm, c/o throat tightness, nausea, mouth tasting like chemical.   METS team called, taken to Emergency Room
Patient reports redness and swelling from shoulder to elbow starting the day after vaccination and continuing for 10 days, followed by rash and itching
Pink eye,eye drainage; Pink eye,eye drainage; Chills; Muscle Aches; This is a spontaneous report from a contactable nurse reported for herself. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5230), intramuscular on 17Dec2020 16:00 at single dose for covid-19 immunization. Vaccine location was at Right arm and it was the first dose number. The COVID-19 vaccine was administered at Workplace clinic. The patient's medical history was not reported. Concomitant medications included fluoxetine hydrochloride (PROZAC), atorvastatin, buspirone hydrochloride (BUSPAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's known allergies included Erythromycin. The patient experienced Chills, Muscle Aches, pink eye, eye drainage on 21Dec2020 19:00. Adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was unknown.
Anorexia, fatigue, cough and mental status changes (per family). Had sotrovimab 3/2/2022 not remdesivir  *****booster dose of COVID-19 vaccine  Pfizer lot # FC3183 on 9/9/2021
Patient reported - feeling feverish, hardness, pain and redness, at site of injection on right arm where patient had received pneumonia vaccination on 10/11/12. Patient's PCP confirmed that it was cellulitis. Patient was prescribed antibiotic Clindamycin on 10/12/12. On 10/12/12 patient reported no improvement.
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 62 years old patient (gender not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and vaccination overdose. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Ischemic stroke, preceded by nasaua and vomiting and belly issues 1-2 days prior
Chest pain with elevated Troponins, decreased cardiac function, and diagnosis of myo/pericarditis 3 days after second vaccination.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients administered expired Moderna vaccine/all doses administered more than 30 days after 11-Jan-2022) and PRODUCT STORAGE ERROR (This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, and administered on 28-Feb-2022) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients administered expired Moderna vaccine/all doses administered more than 30 days after 11-Jan-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, and administered on 28-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients administered expired Moderna vaccine/all doses administered more than 30 days after 11-Jan-2022) and PRODUCT STORAGE ERROR (This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, and administered on 28-Feb-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that reporter's team had accidentally administered expired Moderna COVID-19 vaccine to 18 patients: 9 patients on 9-May-2022 and 9 patients on 11-May-2022 (vaccine expired 5-May-2022). After further investigation it was identified that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from this lot more than 30 days after it was in the fridge) administered between 16-Feb-2022 and 11-May-2022. The vaccine in question did not experience any temperature excursions. No treatment information was reported.
I woke up on the 26th at 5:30AM after returning from traveling feel really sick. First thing i did was come down to the kitchen and took a home COVID-19 test and after 4 seconds you could see it was positive. I then had a fever of 103 and chills and the feeling like someone beat me up with a baseball back. My bones were achy and i had a very dry cough. I tried to call my cardio doctor but i didn't get a hold of them. On Monday i called my doctor they gave me Paxlovid and cough medicine i was still feeling the same. But i never took  the meds because they said it didn't mix well with my meds. The following day the cough was still there i took some Tylenol to break the fever. The day after that my fever was back but i was starting to feel better. The day after that the fever broke and i felt like could start resuming my activities.
Patient was stuck with a syringe that contained the wrong vaccine (Shingrix). Pharmacist immediately noticed error before full dose was administered.  Patient has yet to report any adverse reactions.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017; site, doses and route of administration were not reported). No adverse effect was reported. This is one of the several reports received from the same source. Additional information has been requested.
Exposed to vaccine from which vial may have been punctured more than 20 times; Exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Exposed to vaccine from which vial may have been punctured more than 20 times) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (Exposed to vaccine from which vial may have been punctured more than 20 times) and ACCIDENTAL UNDERDOSE (Exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was administered with the vaccine from a vial which was punctured 30 times. Patient's date of birth was reported.  No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-375352 (Patient Link).
Began to experience chills at approximately 6:00pm, about 6 hours after vaccination. Experienced headache about 2 hours later. Took temerature at about 9:00pm.  Tempertuere was 102.3 degrees Took 1 Tylenol and went to bed at approximately 11:00pm Temperature the next morning, at about 9:00am was 99 degrees Still experiencing slight headache.  Took another Tylenol. No longer experiencing chiils. Feeling back to normal approximately 12-15 hours after vaccination.
5/31/17 - Patient feels soreness in upper arm. 6/1/17 - Patient developed fever. Upper arm became red, swollen, and tender to the touch. Patient seen doctor who suspected cellulitis. Was prescribed Cephalexin 500mg. 6/5/17 - Patient recovered (never took the antibiotics).
Developed a half-dollar size red (round) area at site of shingles injection that was hot and itchy. Rph recommended ice pack for heat and BENADRYL for itching and ibuprofen for pain. No change in size. No worsening of red area as per call to patient on 10-20-14.
10/19/16 rash at injection site. Red, swollen, warm at site. Patient states she has been putting vinegar on site.
Fever (101), body aches, chills, head ache, fatigue, cough
Extremely severe  overall body pain to the point I could not function at all for 4 days.  Almost 2 weeks later almost back to normal
Information has been received from a pharmacist concerning a 78 year old female with peripheral neuropathy and a medical history of an "outbreak of herpes zoster" and no known allergies who in August 2007, was vaccinated with ZOSTAVAX.  Concomitant therapy included carbamazepine and baclofen.  The pharmacist reported the patient "developed a self-diagnosed case of shingles" in December 2007.  The patient's shingles persisted.  Follow-up information received from the LPN indicating that the patient "got shingles again on 04-Nov-2007".  The patient also has a history of trigeminal neuralgia.  No further information is expected.
rash on Bilateral hands and feet; This is a spontaneous report from a contactable physician (reporter) reported for a 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Not available) via an unspecified route of administration on an unspecified date at single dose for COVID-19 Immunization. Patient medical history was none, and concomitant medication were Unknown. On 10Jan2021, patient experienced rash. On 24Jan2021, patient visited the emergency room for Rash on Bilateral hands and feet and received treatment as Podiatry meds. The reporter assessed the event as serious (important medical event), and outcome for the event was recovering at the time of report.  No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event rash on bilateral hands and feet and the usage of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The night after vaccine my left leg felt weird. Pinpoint pain in areas of my quad muscle. The next day the tendon behind my left knee was very painful. Dec 7th a symmetrical diamond shaped rash appeared on my left kneecap and has been coming back off and on for over a month. I now (Jan 24tb) have a lot of pain in my left leg in my shin and quad. It feels bruised but nothing is there. My rash is coming back more frequently.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 09-SEP-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794.
This report was received from the investigator in a trial on 20 May 2010. A 19 year-old male subject received ACAM2000 (lot number not reported) on 27 January 2009 and TYPHIM VI (lot number not reported and Anthrax vaccine (other manufacturer and lot number not reported) on 26 January 2009. Eighteen days after smallpox vaccination, the subject was diagnosed with acute pericarditis. The subject's medical history was not available. On Day 14 (09 February 2009), the subject had a Troponin I and electrocardiogram which were reported as abnormal and an echocardiogram which was reported as normal. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-intervention) study. List of documents held by sender: None.
Started feeling discomfort in the armpit by evening but could not find evidence of swollen lymph nodes. It has a very slight muscle soreness feel to it and it still feels this way at the time of reporting. However, on Sunday evening, I noticed a bulge above my collarbone which feels tender to the touch. No other symptoms appeared.  Did not have any physical discomfort or swelling of any nodes with the first and second dosage of the same vaccine.
Growing rash at the injection site; Swelling at the injection site; Burning injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Growing rash at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Burning injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE RASH (Growing rash at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Burning injection site). At the time of the report, INJECTION SITE RASH (Growing rash at the injection site), INJECTION SITE SWELLING (Swelling at the injection site) and INJECTION SITE PAIN (Burning injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient administered  TT to left deltoid intramuscular on 01/26/2005 due to oral abrasion patient returned for check up as scheduled on 01/29/2005.  Patient complained of left arm pain onset 01/27/2005.  Deformity edema, eccymosis increased warm and tenderness.  Patient will return for follow up on February 2nd and 3rd.
This spontaneous report has been received from a healthcare worker (also reported as clinical manager) refers to a patient of unknown age and gender who on 15-DEC-2014 was vaccinated with a dose of ZOSTAVAX (strength, dose and route not reported, lot # K003597, expiration date: 12-MAR-2015), that had been improperly stored. The temperature during the excursion was unknown, as it was not monitored. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
9am vaccine for influenza and received depo-provera injection. 2 hours later got pleurisy pain in right chest and back with short of breath. no itching or hives but felt throat and chest tightness. VS were ok except hyperventilation. treated with benadryl,solumedrol ativan and nubain. stable in er for over 2 hours so released, thorasic back pain only.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Oct2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 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, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa antibiotics" (unspecified if ongoing), notes: known allergies: sulfa antibiotics. Concomitant medication(s) included: ATENOLOL, start date: 01Dec2021; PEPCID [FAMOTIDINE], start date: 06Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.
Shingles; This is a spontaneous report from a non-contactable consumer or other non hcp.   A 38-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 16Apr2021 14:00 as dose number unknown, single for covid-19 immunisation (age at vaccination was 38 years). Medical history included drug hypersensitivity from an unknown date and unknown if ongoing (penicillin allergy).     The patient's concomitant medications were not reported.The patient experienced shingles on 17Apr2021 10:00.Therapeutic measures were taken as a result of shingles. Treatment was received. Outcome of the event was recovering.    No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
DIZZINESS; WEAKNESS; FEVER; HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hepatitis b, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient have no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced weakness. On 17-MAR-2021, the subject experienced fever. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced muscle ache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, weakness, fever, headache, and muscle ache on 20-MAR-2021. This report was non-serious.
pt recvd vax 12JUL95 & 12JUL95 approx 9 to 10 hrs later pt devel a rash & presented to MD; dx w/characteristic wild-type varicella;greater than 50 to 60 vesicles & papules @ all stages of development were present 24hrs post vax;
fever 100.9; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever 100.9) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-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) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced PYREXIA (fever 100.9). At the time of the report, PYREXIA (fever 100.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Pyrexia: 100.9 (High) 100.9.         Concomitant medication was not provided. Treatment information was not provided.
Symptoms: Almost exactly after 12 hours, I started experiencing chills, fever, joint aches, and upset stomach. Symptoms went away over night, but arm at site of injection was very sore and painful.
Eye swelling for 2 days. Resolved. Sx began 1 day after vaccine No tx.