chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a female patient who was vaccinated with first dose of GARDASIL, 0.5mL intramuscularly (IM). The patient was unable to wait in the office for 15 minutes after receiving GARDASIL. As the patient was walking out, she felt faint, fell and bumped her head. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 23 year old female patient (65 inches, 144 pounds) who on 19-OCT-2007, at 16:15 was vaccinated with first dose of GARDASIL, 0.5mL intramuscularly (IM) to the right deltoid. The patient was unable to wait in the office for 15 minutes after receiving GARDASIL. As the patient was walking out, she felt faint, had a vasovagal reaction, fell and bumped her head. Vital signs were within normal limits after "passing out". Unspecified medical attention was sought. Subsequently, the patient recovered on 18-OCT-2007. The product quality complaint unit was not involved. Further information is not expected.
Booster (3rd shot) was given to a patient under 18 yo. The booster was given 6 months after the second dose. No adverse event was reported by the patient.
covid vaccine breakthrough case  dose 1 moderna  1/21/21  012L20A dose 2 moderna 2/15/21  004M20A
Patient woke up the next day with a swollen red burning sensation in her arm. She had a rash on the arm also. She went to the emergency room  and received Keflex and Motrin.
Somewhat hard lump under arm in same arm that was vaccinated. Lump is about the size of a walnut.
As I said before I had COVID in December and have experienced the same symptoms.  It is probably nothing but I know trials are still going on and I am hoping this information could help.  No treatment.  I am feeling better, only one day of severe symptoms.
This spontaneous report was received from a registered nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates since 05-JUN-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency and route were not reported) lot # N003702 with expiration date of 08-NOV-2019, lot # N002914 with expiration date of 04-NOV-2019 and lot # N002202 with expiration date of 04-NOV-2019, that were reconstituted with diluent MRK (injection; lot # and expiration date were not reported), for prophylaxis. The temperature of the RECOMBIVAX HB was between 9°C and 25°C for a time frame of 2 hours and 2 minutes. No previous temperature excursion occurred and data logger was involved. No adverse effects were reported. This is one of four reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA006312: US-009507513-1706USA006313: US-009507513-1706USA006314:
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L013429 and expiration date 21-JUL-2017, lot # L014415 and expiration date 25-JUL-2017, lot # L016429 and expiration date 09-AUG-2017, exact doses and route of administration were not reported). No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Pt recvd 2nd dose of Hep B vax @ one month of age; subsequently, pt devel fulminant Hep B & was hospitalized for a liver transplant; In mid-November 91, pt died @ 5 months of age;
1st night: Body Aches, Fatigue, Sleeplessness 2nd day: Body Aches, Fatigue, Sleeplessness, Shortness of breathe 3rd day: Fatigue, sharp pain in heart 4th day - 10th day: Fatigue, sharp pain in heart after jumping or any strenuous movements (immediate), Shortness of breathe Until now: shortness of breathe (unlike before, I become winded more quickly), heart is a little sensitive to physical activity, have not felt a sharp pain since the 4th - 10th day
Expired Booster Doses Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Information has been received from a physician concerning a 24 year old female with no specified pertinent medical history or drug allergies, who on 05-JUN-2007 was vaccinated with the first dose of GARDASIL.  The second dose of GARDASIL, was given on 02-AUG-2008.  The third dose of GARDASIL, IM, was given on 03-DEC-2008.  Subsequently the patient developed genital warts.  The patient sought unspecified medical attention and had not recovered at the time of reporting.  Additional information has been requested.
The patient was monitored for allergic reactions post injection for 15 mins.   During the observation period the patient experienced: 1230- 20 minutes post Pfizer booster vaccination, pt c/o of Chest pressure/"tightness", generally not feeling well after getting up and ambulating in clinic. Patient assisted to chair. BP 177/94, HR 90, T 97.8, RR 16 O2 sat 100%, denies SOB. Pt reports Hx of CAD w/3 stents, DM, & HTN. Last cardiac episode reportedly occurred in 2019.   No signs of allergy noted. Pt. reports not having issues with 1st vaccination series except for neck stiffness 3 weeks post 2nd dose. Plan and Outcome:  1230 Pt with personal Nitroglycerin tabs, 1 taken SL. BP 177/94 1235 Still reporting chest pressure but not as intense/"relaxed". Nitroglycerin tab, 1 taken SL. BP 168/95. Blood Glucose 387, pt administered, per own supply 14 units of insulin. Discussed with pt the need to call EMS for further evaluation, however, pt refused.  12:40 Pt reports improvement with chest pressure. BP 144/84 12:45 Chest pressure reported as worsening, Nitroglycerin tab, 1 taken SL. BP 162/92  1247 Contacted Dr and reported pt condition. Dr. agreed for EMS to be called and spoke directly with pt, however, pt still refused.  1255 Dr. called the clinic and was also informed of pt condition. Dr. also discussed with pt the importance of being evaluated. Pt again refused EMS and said her husband would come pick her up.  1300 Pt excused herself to go to the restroom and upon returning she was asked to sign an AMA form. At that point the pt felt it would be best to call EMS as the she reportedly was still having chest tightness.  1304 EMS contacted  1315 EMS arrived, report of pt condition provided to EMS personnel and pt transported out of clinic via stretcher by EMS.  1330 Dr's notified of pt transport.
Father said fever started at 8 PM, and febrile seizure was at 4 AM.
Patient received vaccine from punctured vial stored more than 12hours.; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from punctured vial stored more than 12hours.) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from punctured vial stored more than 12hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine from punctured vial stored more than 12hours.) had resolved.        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.   Concomitant medication history not provided. Treatment information was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-154927 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154927:Crosslink
This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2015 (reported as "after the first excursion reported on 19-JUN-2015"), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route of administration, lot# and expiry date were not reported). No improperly stored doses of (Oka/Merck) VARIVAX were administered after the second excursion reported on 16-JUL-2015. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed herpes zoster rashes on 9/23/2019 and was seen by me on 9/27/2019. Raised erythematous vesicular patches extending from mid back to front along the chest wall on L side in a band. He was put on Valtrex for treatment.
Pt called hospital call center reporting reporting mild headache, fatigue in legs , and fever of 99.8. Patient scheduled for provider appointment for 10/21/2021 @ 8:20 AM. Patient understood instructions and to call 911 or seek immediate medical attention if symptoms progressively  get worse.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11 Feb 2022) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2022 at 12:30 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-Feb-2022 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 11 Feb 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time of vaccine administered provided as 11-FEB-2022  12:30:31 Patient received booster dose. Patient ethnicity reported. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022 and they no longer possess this lot number.  No treatment medications were reported.
muscle and joint pain; muscle and joint pain; chills; This is a spontaneous report from Pfizer colleague. A contactable consumer or other non-HCP (patient) reported that: A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) on 23Mar2021 (Lot number: EP6955) as single dose and patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection) on 01Mar2021 14:30 (Lot number: EL3247, at the age of 58-year-old) as single dose both via an unspecified route of administration, administered in left arm for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications within 2 weeks of vaccination included vitamins via an unspecified route of administration from an unknown date for an unspecified indication unknown if ongoing. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 24Mar2021 patient experienced muscle and joint aches, chills. Therapeutic measures were taken as a result of the event muscle and joint aches which included medication for pain and muscle spasms (Tylenol). Events were non-serious. Outcome of the event chills recovered on 25Mar2021. Outcome of the event muscle and joint aches recovered on 26Mar2021.  No follow-up attempts are needed, no further information is expected
tinnitus - wasn't aware of it initially after shot - became more pronounced after a week - hasn't dissipated over time
Dizziness, lightheaded, cold sweats, feeling faint. Lasted 5-8 minutes, occurred five hours after injection took place.
Red raised warm area at injection site (about the size of a quarter per Mother) noted early AM 5/10/17.
patient reports "felt fine all day yesterday after getting the shingles and flu shots together around 9am until 6pm, then I got chills and went in and out of sleep. I passed out in my computer room around 3 am and called 911. I'm in hospital now.
A Second Moderna Monovalent was administered instead of a Moderna Bivalent dose.
About 16 hours after the vaccine I noticed that my left arm had a warm, red and swollen patch starting about 2? below the injection site.  The patch looked to me like the type of reaction I get to some insect bites (green head flies and some horseflies).  The patch is oval shaped and about 4? in length.  I was concerned because it was hot and worried that it might be cellulitis.  Before calling my doctor the next day, I looked online and read about this type of reaction being a not uncommon side effect of the moderna vaccine so I didn?t call my doctor.  I did not have a topical antihistamine cream, so I put cortisone 10 on it (about 48 hours post vaccine).  The cream didn?t have any effect so I only did it the one time.  I have been taking OTC Zyrtec  and Flonase daily both before and after my vaccine (from mid-March to present for seasonal allergies).  72 hours  post vaccine the spot persists but hasn?t gotten any bigger.   If it seems to get worse or doesn?t go away within a few days I will definitely call my doctor.  I have taken Advil in the period after my vaccine for headaches?not sure how many doses or when?I have had the headaches in the past week before the vaccine so I didn?t think it was specifically related to the vaccine.
Myocarditis; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDITIS (Myocarditis) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No treatment medication details was reported.  Company comment Very limited information regarding the event has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information is not expected.
Pt recvd vax & exp flu-like sx following vax w/1st dose of vax; sx resolved p/20 mins; No further details were provided;
approx 2 1/2 hrs p/vax pt beginning vomiting, t100.7 ax; vomited x 6 throughout the noc including dry heaves; t101 oral; no redness, swelling etc; c/o sore upper lt thigh;
Local injection reaction (not systematic); Not feeling well; Pain on injection site; Redness; Itching with significant induration at the site; Iching with significant induration at the site; Swelling around 8cm at the site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, and INJECTION SITE PRURITUS in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, INJECTION SITE PRURITUS, INJECTION SITE INDURATION, and INJECTION SITE SWELLING. At the time of the report, INJECTION SITE REACTION, MALAISE, INJECTION SITE PAIN, ERYTHEMA, INJECTION SITE PRURITUS, INJECTION SITE INDURATION, and INJECTION SITE SWELLING outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Headache; This is a spontaneous report from a contactable consumer (Patient). A 88-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3248, Expiry Date: unknown) via an unspecified route of administration at left arm on 04Feb2021 10:15 as single dose and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 14Jan2021 as single dose for COVID 19 immunization. Medical history included history of migraines. Concomitant medication was not reported. Patient experienced headache on 04Feb2021. It was reported that she has had migraines in the past, so it is possible that this could be one of those, but she has not had one quite this long. She started having these about 10 years ago. She says she cannot claim that the headache or migraine has to do with the shot, since sometimes she has migraines, since this happens to her, she is not claiming that the vaccine caused it. Patient experienced terrific shooting pains in her head except for a little time. She says that she has been taking Tylenol, and she is still experiencing them all night. She says that this was her second dose of the vaccine, she had no reaction to the first, not even a sore arm. She initially provides PF12ER as LOT for her first dose she received on 14Jan2021. She says that her Tylenol is finally kicking in, she feels a lot better, she might go sleep it off. She clarifies that she has been taking Tylenol PM from a great big bottle, that she cannot read fine print, it is huge green bluish aqua colored. She says the dose is 500mg, it was very effective at 04:30AM to 08:30AM, and she took it again about 11:00AM. She says she is just now having another shooting pain in her upper right head. Tylenol PM UPC Queried but not provided. LOT: SJA051, EXP: Apr2022. Outcome of the event was unknown.
11-17-16 - Parent reports Ct. has baseball size redness with hard lumps at all 3 injection sites. Ct. c/o pain, reports hot to touch, swelling increasing since this a.m. I referred Ct. to M.D. Was seen by M.D. and treated with Sulfametox for infection.
08/21/2022 onset of symptoms of pink eye; 8/22/2022 then started with sore throat and fatigue. Progressed to body aches and severely fatigued, and congestion. Took home COVID-19 test - positive on 8/23/2022. Called Dr. and was advised to get an Pulse Oximeter to monitor oxygen levels. It averaged at 90 BPM. Dr. then put me on prednisone and a Z-PAK of erythromycin. Took home COVID-19 test and it was negative after 2 weeks.
only adjuvant portion administered; only adjuvant portion administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 7F234, expiry date 13th October 2022) for prophylaxis.   In September 2021, the patient received the 2nd dose of Shingrix. In September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix a week ago (date not specified) and only the adjuvant portion was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Patient received J&J vaccine and walked to sit down for her post injection wait time.  Patient had previously fainted after a vaccine so she was suppose to sit for 30 minutes anyway. Patient immediately after sitting down got extremely light headed, pale, and dizzy. We immediately moved her to the floor and put her feet up.  After approximately 3 minutes, patient regained color and was feeling a lot better. EMS was called but father who was with her called to cancel and refuse after patient felt better so quickly. Patient had history of anxiety with shots and it seemed to be truly an anxiety issue.
Body aches; chills; fever; blurred vision; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 34-years-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm on 12Mar2021 14:15 (age at vaccination: 34-years) as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient had no known allergies. No other vaccines were given to patient in four weeks. On 13Mar2021 2:15 patient experienced body aches, chills, fever, blurred vision, fatigue. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No treatment was given due to the adverse events. The outcome of events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained