chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist via a company representative referring to an unspecified number of patients of unknown age and gender. No pertinent or historical conditions were reported. On unknown dates, the patient was concomitantly vaccinated with PNEUMOVAX 23 and unspecified influenza virus vaccine (manufacturer unknown), both for prophylaxis (strength, dose and route unknown). There was no concomitant medication reported. On unknown dates, the patient developed flu-like symptoms that required them to call out from work. The patients sought medical attention via contacting pharmacist. The outcome of the event was unknown. Causality between event and PNEUMOVAX 23 and influenza virus vaccine (manufacturer unknown) was not reported. Additional information has been requested.
Pt stated that he was feeling fine before the shot, but during administration expressed his fear of needles. After administration, walked out of the room and to the end of the aisle and started to feel vision going in and out. Pt tried to lower his body to the ground so would not pass out and then sat down near front register. Manager gave pt water and banana. Pt stated this is not the first time he has experienced this (drop in BP and anxiety setting in). Pt declined ambulance/911. Checked pt's BP at 1:33pm- 108/70 and pulse 84. Pt stated he was feeling fine after sitting and drinking water and eating banana. Pt stated he was ok to drive and leave the store after checking his blood pressure at 1:33pm.
This spontaneous report as received from a licensed vocational nurse refers to a female patient of unknown age. The patient's concurrent condition, medical history or concomitant medications were not reported. On unspecified date in 2010 the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose, lot #, expiration date and route of administration not reported). On unspecified date in 2011 the patient was inadvertently vaccinated with the second dose of PNEUMOVAX 23 (dose, lot #, expiration date and route of administration not reported). No adverse effects were reported. Additional information is not expected as the reporter declined any further contact.
Pain to left axilla with swelling, redness to inject site one week later, general fatigue x 1 week.
pt recv vax; reported testing pos for HIV p/ receiving 1 or 2 doses of Hep B vax;pt refused to provide any further details;
Patient contracted COVID after being fully vaccinated Cough, congestion, sore throat, runny nose
Client is 11 yr old female who received three vaccinations, Tdap, HPV9 and MENACTRA. She tolerated the initial vaccination without problems. She sat in chair quietly and then got up to go out to reception area to where her parents were waiting. She walked about 10-12 feet and turned fainted and fell to the floor. She sustained a 15 mm rug abrasion to right check and a bruise to rt cheek bone. She regained conscious with 30 sec of falling and laid on floor for about 5 min then in sitting position for 5 min and assisted into a chair, she was paled and clammy, PERL resp regular, A/O x 3 ice pak applied to abrasion and contusion on right side of face. She stayed in clinic for 30 min and then left with her parents and siblings. 24 hr follow up with parents indicated no lingering problems other than the small contusion and abrasion. We did encourage parents to tell any provider about history of fainting and have her stay seated for about 15 to 20 min after vaccinations are give to prevent further episodes.
heart attack; COVID; COVID; This is a spontaneous report from Pfizer. A non-contactable consumer (patient wife) reported a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had COVID. The patient had recently had a heart attack and was hospitalized for two weeks. Lab data included positive COVID 19 test. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
circular red edematous area at site of injection, measuring 6 cm. in width and 5.5 cm. in lenght. Left upper arm.
Coughed and choked most of night after shot. Ears started hurting, and I started chilling off an on for 24 hrs.
ABOUT 5 HOURS AFTER THE IMMUNIZATION, PATIENT STARTED TO HAVE A HEADACHE. THEN PATIENT STARTED EXPERIENCING NAUSEA, LOSS OF APPETITE, FEVER, BODYACHES, AND COUGH AND HAS BEEN HAVING THESE SYMPTOMS EVERY DAY.
Had chills during the night after 2nd shot, enough to wake me, gone in morning.
Patient who is 14 years old received incorrect second dose of COVID-19 vaccine.  First dose was Pfizer and second dose was Moderna. No adverse reactions have been noted since administration.
patient received 2 doses of Fluarix 1 week apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLUARIX).   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced drug dose administration interval too short (Verbatim: patient received 2 doses of Fluarix 1 week apart).  The outcome of the drug dose administration interval too short 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: 13-Oct-2023 The health care professional reported no reactions. The reporter declined to follow-up. The patient received 2 doses of Fluarix 1 week apart, which led to shortening of vaccine schedule.
Patient noticed a rash that moved from the injection site down the arm to his fingers over the last 4 days. He is also experiencing numbness and tingling down that arm. The injection site is clearly in the center of the deltoid, and not too high. Today he started experiencing blurred/halo vision, as well as quite a lot of dizziness.  He also said he was experiencing tightness in his jaw. We sent him home from work today. He was going to lay down.
Feeling lousy; 3x3 rash on left arm right above injection site; Diarrhea; A report was received from a nurse, also a 59-year old female patient who was participating in the mRNA-1273 a Program and experienced feeling lousy, 3x3 rash on left arm right above injection site, and diarrhea.   The patient's medical history was not provided. Concomitant medications included acetylsalicylic acid, diltiazem, sitagliptin phosphate, escitalopram oxalate, esomeprazole sodium, simvastatin, ezetimibe and losartan potassium.   The patient received their first dose of two planned doses of mRNA-1273 on 22 Dec 2020. On 22 Dec 2020, one day prior to onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot 011I-20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the patient woke up feeling lousy with diarrhea and a 3x3 rash on her left arm above the injection site that was not itchy, spreading, or getting bigger. No treatment was taken.    Action taken with mRNA-1273 in response to the event was unknown.   The outcomes for the events, feeling lousy, 3x3 rash on left arm right above injection site, and diarrhea, were not reported.   The reporter did not provide an assessment for the events, feeling lousy, 3x3 rash on left arm right above injection site, or diarrhea.; Reporter's Comments: This case concerns a 59 year old female patient with medical history not reported, who experienced the unlisted events of feeling abnormal, injection site rash, and diarrhea.  The events occurred 2 days after the first dose of mRNA-1273 vaccine.  The events were considered possibly related to the vaccine due to the plausible temporal relationship and known safety profile.
I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn red, tightness in the upper part of my body, lips tingling, tightness / swelling in my cheeks and mouth, very severe headache.   I was rushed over to ER. Next day still had tingling of lips, felt unwell. By third day, felt better.  I had an anaphylactic reaction to the vaccine.  Three of my systems were adversely effected. Dr. and others are UNDERREPORTING the anaphylactic reactions cases.  Just because I didn't die or an Eppie  Pen was not given to me. doesn't mean I should not be included in the statistics.
Nausea and diarrhea; Nausea and diarrhea; This is a spontaneous report from a contactable nurse (patient).  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Dec2020 at 08:45am at single dose in left arm  for COVID-19 immunization. No known allergy to medications, food or other products. Concomitant medications included Multivitamin (unspecified) received within 2 weeks of vaccination. On 21Dec2020 at 02:00 am the patient experienced nausea and diarrhea. Patient was treated with unspecified medication.The outcome of the events was recovering.  Information about lot/batch number are requested.
Got COVID-19 got very sick. Should have had high immunity. 1 month out, 14 days. Have been unvaxed for 2 years. Exposed several times at work. I believe I got COVID-19 after flu vaccine 11/19. Very sick. Had trouble breathing. Had to sleep on stomach. Went to urgent care for chest pain.
This case was reported by a consumer via call center representative and described the occurrence of runny nose in a 9-month-old female patient after exposure to breast milk of the mother who received HAVRIX. On an unknown date, the patient received HAVRIX (transmammary). On 7th May 2018, less than a week after exposure to HAVRIX via breast milk, the patient experienced runny nose, irritability and cough. On an unknown date, the patient experienced vaccine exposure via breast milk. On 9th May 2018, the outcome of the runny nose, irritability and cough were recovered/resolved. It was unknown if the reporter considered the runny nose, irritability and cough to be related to HAVRIX. See case US2018085744 for details regarding the mother case. Additional details were provided as follows: The age at vaccination was not applicable for this report, as patient's mother received HAVRIX on 4th May 2018 while she was breastfeeding her child (patient). The reporter stated the baby had her symptoms on 7th, 8th and 9th May 2018. The patient felt off for two to three days. The patient experienced runny nose and cough possibly from the breast milk as per the patient. The patient had a 9 month check up with the pediatrician and was notified of the mother having the vaccine. The patient's mother gave permission to contact child's pediatrician if needed. No additional information was available.
day after injection I was fatigued, nauseous , chills, head ache, diarrhea  low grade fever
my blood pressure has rose about 140/82  to about 152/75 a few weeks after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (my blood pressure has rose about 140/82  to about 152/75 a few weeks after the vaccine) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (my blood pressure has rose about 140/82  to about 152/75 a few weeks after the vaccine). At the time of the report, BLOOD PRESSURE INCREASED (my blood pressure has rose about 140/82  to about 152/75 a few weeks after the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 140/82 mmHg (High) blood pressure increased..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    No concomitant medications and no treatment medications was provided.   Reporter did not allow further contact
1st dose Jun2021, 2nd 19Dec2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2021).   On 19th December 2022, the patient received the 2nd dose of Shingrix. On 19th December 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-Dec-2022. Reporter's Comment: The reporter was a pharmacy technician. The reporter provided information about patient but not about the location of the application of the second dose and neither did they provide information about vaccine. The reporter did not consent to Follow-up. Additional supportive information: The patient received 2nd dose late than recommended which led to lengthening of vaccination schedule.
Cold; Some aches and pain; Cough; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PAIN (Some aches and pain), COUGH (Cough) and CHILLS (Chills) in a male 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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced NASOPHARYNGITIS (Cold), PAIN (Some aches and pain), COUGH (Cough) and CHILLS (Chills). At the time of the report, NASOPHARYNGITIS (Cold), PAIN (Some aches and pain), COUGH (Cough) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications reported. No treatment information provided.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient turned pale. Color resumed after sitting for ~15 min. was okay when left the facility
C/o redness & pain Rt deltoid s/p tdap on 3/25/11; neck stiffness.
Patient was given an expired dose of COVID-19 vaccine. The vial of Moderna 034C21A had been refrigerated and had a 'use by' sticker on the box, hand-written with the date 9/15/21. I (the vaccinator) did not register the date as being in the past until after having administered the vaccination. All other safety precautions were were adhered to.
Arm is swollen; Red rash; Hot to touch; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling arm, red rash and skin warm. On an unknown date, the outcome of the swelling arm, red rash and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, red rash and skin warm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine over 24 hours ago (before the reporting time) and arm was swollen with a red rash that was hot to touch. The patient asked should he/she be concerned. Additional Supportive Information: Follow-up would not possible as no contact details were available.
has cold symptoms since Sunday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: Not Provided) 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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "has cold symptoms since Sunday".  No follow-up attempts are possible. No further information is expected.
Just last night arm starting to itch, itching comes and goes; Some redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Just last night arm starting to itch, itching comes and goes) and VACCINATION SITE ERYTHEMA (Some redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DULAGLUTIDE (TRULICITY), METFORMIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), PREGABALIN (LYRICA) and VITAMINS NOS for an unknown indication.    On 04-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 PRURITUS (Just last night arm starting to itch, itching comes and goes) and VACCINATION SITE ERYTHEMA (Some redness). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Just last night arm starting to itch, itching comes and goes) and VACCINATION SITE ERYTHEMA (Some redness) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Changed event outcome from unknown to recovering/resolving
Swollen and red left arm, knot in arm (golf-ball sized), dizziness, fatigue, no appetite.
Narrative:  SOB, decrease oxygen sats in 50s on arrival, monoclonal antibodies-sarilumab., dexamethasone, oxygen, pt expired while in the hospital.
sore arm, tired, achy, slightly nauseous, some chills, sweats, supra ventricular tachycardia, diarrhea, upset stomach, general aches & pains, low grade fever
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/20/21 2nd dose04/10/21 Diagnosed covid positive:09/17/21 Symptom onset:09/15/21 Exposure: Symptoms:cough,fatigue,muscle aches,runny nose, HA
Moderna 1/21/21 Lot# 012L20A;  Moderna 2/18/21 Lot# 004M20A;  Moderna 11/15/21  Lot# 004F21A;  Moderna 4/25/22 Lot# 057M21A
Localized swelling at injection site. Cool to touch. Client denies any SOB, itchy or pain.
Fever; Uncontrollable shaking; Extreme pain and body ache; Nausea; Burning skin; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 08Apr2021 at 14:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included lung disease (lung damage from COVID back in Oct2020) and COVID-19 infection in Oct2020. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), baclofen (MANUFACTURER UNKNOWN) and hydroxyzine (MANUFACTURER UNKNOWN) from unknown date, for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 18Mar2021 at 15:15 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021 at 01:00 the patient experienced fever, uncontrollable shaking, extreme pain and body aches, nausea and burning skin. Many of the symptoms the patient had previously with COVID back in Oct2020. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of reported events. The clinical outcome of the events fever, uncontrollable shaking, extreme pain and body aches, nausea and burning skin was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
COVID ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry :unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced covid arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid arm was not reported. This report was non-serious.
4 x 5 cm welt on thigh, no pruritus, warm to touch, swelling and redness increased per parent from 11/10 to 11/11/2017. Advised Mom to give ZYRTEC 10 mg BID for next few days, also BENADRYL PRN until follow up.
Two days after receiving H1N1 vaccine, child developed a rash all over his body, had complaints of itching, headache, some abdominal pain. No treatment required.
This case was reported by a pharmacist via call center representative and described the occurrence of welts in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The pharmacist had another patient who had whelps, but did not have any further information at this time. The pharmacist informed to call back with any additional information. The pharmacist thought that there was something wrong with this lot of SHINGRIX. The pharmacist stated, he was not returned the 1 vial to the GSK but might be returned to his wholesaler. This case has been linked with case US2019009093, reported by the same reporter.
rash on face & neck (red & blotchy) about 15 min p/leaving hlth center; resolved in 10min; lethargic @ 8PM; cried loudly from 1030PM until next morning; would not sleep; temp did not go above 100 ax; scratching all over body, leg sore;
Patient had scheduled a vaccine for their first shot of the COVID19 Pfizer monovalent but was given the COVID19 Pfizer booster bivalent shot instead.
Reports he got flu a few hours after receiving vaccine, fever, muscle aches, upper respiratory symptoms. No documentation of positive flu test.