chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning an 18 year old male patient with no pertinent medical history or drug allergies. On 29-JUN-2015, the patient was vaccinated with the first dose of GARDASIL (lot# reported as L010587, expiration date 03-NOV-2016, 0.5 ml/once) intramuscularly and a dose of MENACTRA. There was no other concomitant therapy. On 29-JUN-2015, approximately 5 minutes after receiving vaccination, the patient fainted in the office and he additionally experienced slight sweating. No lab diagnostics studies were performed. The patient recovered from the events within 30 minutes and went home with his mother. Additional information has been requested.
PRODUCT STORAGE ERROR; THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; This spontaneous report received from a health care professional concerned a 43 year old female. 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 not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 01-NOV-2021 for prophylactic vaccination. Age at time of vaccination 43 years old. No concomitant medications were reported. On 01-NOV-2021, the patient experienced the janssen covid 19 vaccine was refrozen and administered to patient. On an unspecified date, the patient experienced product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product storage error and the janssen covid 19 vaccine was refrozen and administered to patient was not reported. This report was non-serious. This case, from the same reporter is linked to 20220538292, 20220538693, 20220537356, 20220537444, 20220537532, 20220537548, 20220537688, 20220538146, 20220538149, 20220538210, 20220538238, 20220538297, 20220538316, 20220538347, 20220538411, 20220538428, 20220538666, 20220538890, 20220539045, 20220540420, 20220540435, 20220540474, 20220540536, 20220540570, 20220540611, 20220540642, 20220538480, 20220540853, 20220540816, 20220540814, 20220540765, 20220540688, 20220541085, 20220537341, 20220537507, 20220538425, 20220538437, 20220538573, 20220538627, 20220540324, 20220541180, 20220541401, 20220541506, 20220540524 and 20220538758.
Information has been received from a licensed practical nurse concerning an adult female pt with unk medical history and unk drug reactions/allergies, who on 24Oct05 was vaccinated in the right deltoid IM with 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot649979/0531P). The pt called the office within 4 hrs complaining of redness, warmth to injection site, body aches and vomiting. She was ordered promethazine hydrochloride (Phenergan) by mouth. Subsequently, within 24 hrs vomiting and body aches had resolved. It was reported that as of 27Oct05 the pt is fine. No further information is available.
Patient came in as a walk in to receive a Covid Vaccine with her father. She spoke English, but he spoke Spanish. She was translating to her father as I was counseling them regarding the vaccine.  I asked the patient if she was 18 and she said, "yes."  Her paperwork stated a 01 birthday. They were talking to each other as I was preparing vaccine and I am not sure what they were discussing.  She stated that she understood all of the information. She waited the required 15 minutes and left with her father. As we were entering her vaccine into Web IZ we noticed her birthday was changed to a  04.
Low grade fever.  Severe body aches.  Nausea.  Headache.  Diarrhea. 'Burned' tongue and lips.  Fatigue.  Weakness. Malaise.  Bronchial congestion.  Deep productive cough. .  Tylenol.  Ibuprophen.  Pepto bismol.  Sudafed.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported.On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (1 expired booster dose was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) had resolved.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication information was provided.No treatment medication were provided.The vial was exposed to room temperature range from 9:30AM 17Nov2021 to administration 18Nov2021.The expired booster dose was administered to a female patient 18Nov2021.
(L) arm with 1+ edema from shoulder to hand, painful to touch and move no erythema. Rx BENADRYL, naproxen, prednisone 20mgm (2 tab daily 3 days).
This spontaneous report was received from a medical assistant and refers to a 7 month old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 03-JUN-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB lot # L048849, expiration date 04-FEB-2018 (dose and route of administration not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient with the history of Guillain-Barre syndrome received Menactra/ No AE; Initial information was received on 09-Jul-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 17 years old patient who had history of guillain-barre syndrome and still received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (contraindication to vaccination).  The patient's past medical history included Guillain-Barre syndrome. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included third dose of VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  Case details: First the caller states that a patient was given MMR (measles, mumps, and rubella vaccine) and Menactra at the same time and  would like to know if there are any side effects that they should be worried about in regards to the additional vaccine given. After that the caller reported that the consumer did not get a MMR (measles, mumps, and rubella vaccine) but a varicella vaccine on the same day and was wanting to know if the Guillain-Barre syndrome was a contraindication for the varicella vaccine  It was a case of contraindication to vaccination  At a time of reporting no adverse event reported.  There will be no information available on the batch number for this case.
Patient experienced fever approaching 103 degrees Fahrenheit beginning approx 6 hours post vaccination and continued unabated until 48 hours post vaccination.   Patient had very mild pain in left arm upon contact to go along with 42 hours of fatigue and lethargy.
Pt states she felt she was going to throw up and doesn't remember anything else. Pt states she was holding her breath. Pt states she feels fine this time. Pt states she may have passed out, unwitnessed.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions, allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 for prophylaxis (lot # M043987, expiry date: 30-JUN-2018). No adverse events were reported. The temperature/Time frame was as follows: 32°F to 35°F for 8 minutes. 32°F to 35°F for 6 minutes. No previous temperature excursion reported. Call was because of data logger (Yes). As of 11-MAY-2018, all telephone attempts to obtain follow-up information have been unsuccessful.
she tested positive for COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she tested positive for COVID-19) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 13-Jul-2023, the patient experienced COVID-19 (she tested positive for COVID-19). At the time of the report, COVID-19 (she tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2023, SARS-CoV-2 test: Positive.     For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient's all previous doses were Moderna vaccines. Patient queried how long she need to wait for received the Moderna vaccines. Treatment information was not provided.   Reporter did not allow further contact
TC fr MOC on 3MAY 2 days p/DTP/OPV given to report redness, swelling, & warmth @ inject site-RA; Seen in clinic that morning; rt upper arm red, warm & swollen; Eval by MD later in day ?rxn vs ? cellulitis;
patient given Moderna booster dose instead of Pfizer (5-11y/o).  I reported to the Health Department.  Called Moderna and received information in a few days recommending a second dose of Pfizer (5-12y/o) 28 days from this vaccine.  Mom called pediatrician and they reassured her kids would be ok.
Patient received Pfizer COVID vaccine at on 1/12/21, 2/2/21, and 10/12/21 (lot #s unknown). On 1/18/22, patient tested positive for COVID. On 1/20/22, patient admitted to our inpatient facility (med/surg unit) with MRSA UTI/bacteremia and COVID19 infection (mild cough, on RA, CXR stable).  As of today (1/24/22), patient is still admitted in the med/surg unit for MRSA UTI/bacteremia.
Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Joint Pain-Medium, Additional Details: Patient claims to have had dizziness, stiff neck, nausea, and stomach irritability the following day after administration as well as up through today (7/26/21). Patient has not confirmed symptoms have not ceased as of yet (note: 3 days after administration).
9 days after vaccination area of injection started itching and became red. A little bit warm also. There seems to be a small bump. Before that there were no symptoms whatsoever.  I do not feel any other reactions. Because of the original reaction to the vaccine which was none whatsoever, I was surprised by the redness and itching some 9 nine days later and decided to report it just in case it has some meaning.
arm and joints feel stiff; arm and joints feel stiff; felt dizzy; sharp shooting pain down my right arm.; My nose suddenly started to bleed (stopped after ~2 mins); This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 09Apr2021 at 17:15 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to tree Nuts and eggs.  Concomitant medications included Birth Control, Collagen supplements, Multi-vitamin; all from unknown date for unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 19Mar2021 at 16:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was  not 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 vaccination. On 09Apr2021 at 17:45 about 30 minutes after the dose, the patient felt a little dizzy, then had a sharp shooting pain down right arm. Her nose suddenly started to bleed(stopped after ~2 mins). On 09Apr2021 at 18:15 after an hour had passed, patient experienced arm and joints feel stiff. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events dizzy,  sharp shooting pain down right arm and arm and joints stiff were unknown and of the nose bleeding was recovered on 09Apr2021.  No follow-up attempts are needed. No further information is expected.
Information has been received from a Registered Nurse concerning a 15 year old female patient with allergy to AMOXIL and without pertinent medical history or illness at the time of vaccination, who on 28-SEP-2009 at 4:00 PM was vaccinated intramuscularly in the left arm with her first dose of GARDASIL (Lot number 663451/0216Y). Concomitant therapy included influenza virus vaccine (manufacturer unknown). The reporter mentioned that the patient has not had her period since for (approximately 2 months). No laboratory or test diagnostics were performed. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered. Follow up information has been received from the Registered Nurse who reported that the patient who got the first dose of GARDASIL on 28-SEP-2009 was having regular periods for over 1 year and had no period since GARDASIL (no period in the month of October). The patient did get period on 24-NOV-2009. No further information is expected.
no swelling in knees and her elbow swelling was reduced; sore arm; achy; reduced swelling all over body; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (no swelling in knees and her elbow swelling was reduced), PAIN IN EXTREMITY (sore arm), PAIN (achy) and SWELLING (reduced swelling all over body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (no swelling in knees and her elbow swelling was reduced), PAIN IN EXTREMITY (sore arm), PAIN (achy) and SWELLING (reduced swelling all over body). At the time of the report, JOINT SWELLING (no swelling in knees and her elbow swelling was reduced), PAIN IN EXTREMITY (sore arm), PAIN (achy) and SWELLING (reduced swelling all over body) outcome was unknown. Unknown          Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
felt like crap; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than a week after receiving Shingrix, the patient experienced feeling bad. In August 2019, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received her dose of Shingrix last week and felt like crap for 2 days. The patient did not consent to follow-up.  It is 1 of 5 cases reported by same reporter.
1350 : Throat felt itchy, tight, sore.  Pt attempted clearing throat.  Water given.  No change.   1353 : Pt given 25mg Benadryl  1400 : 8mg Dexamethasone IM.  1430 : Pt symptoms improved.  Able to swallow without feeling of tightness 1430 : Pt left clinic stable.  Informed to go to ER if symptoms return
Pt reported have a feeling similar to how she feels prior to a seizure, although she did not progress into a seizure. In addition to an aura, she felt sluggish and felt like she was not thinking clearly.  The feeling began "shortly after" her vaccination and has not completely gone away as of several hours later.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 49.62.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
My wife lost her kid, a miscarriage; my unborn child who has died because of the COVID-19 Vaccine; My wife lost her kid, a miscarriage; my unborn child who has died because of the COVID-19 Vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient (pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: ABORTION SPONTANEOUS (medically significant), MATERNAL EXPOSURE TIMING UNSPECIFIED (medically significant), outcome "unknown" and all described as "My wife lost her kid, a miscarriage; my unborn child who has died because of the COVID-19 Vaccine". Clinical Course: The reporter stated that, his wife lost her kid, a miscarriage; the unborn child died because of the COVID-19 Vaccine.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided) (lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever 105 in 20 minutes, listles, glassy eyed, red swollen, hard arm @ site some red streaks running downward;
Two hours after receiving the vaccination, patient reported that she had a fever of 102 degrees. Later, she reported that she also experienced joint pain in her ankles, wrist, elbow, and back. She also reported that she started to have major muscle spasms in her major muscles. She also reported that she had extreme migraines, vertigo, dehydration, and insomnia. She said that she felt like this since receiving the shot (did not go out or do anything from Wednesday through Sunday).
second dose not administered yet; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered yet) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered yet). On 12-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose not administered yet) had resolved. 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 relevant concomitant medications were reported. Treatment information was not provided by reporter.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.
THAT NIGHT AFTER TAKING THE SHOT, WENT TO SLEEP.  WOKE UP SHAKING UNCONTROLABLY. WEAK TODAY 12/7/2021
RD swollen RCV'd 4yr vaccines on 11-9-20 (Kinrix/Proquad) Gma noticed site getting Red later that evening. Gave Benadryl. Next day a little bigger swollen, called office made appt for 11/12/20-prednisolonex3days; Keflex BIDx7d continue Benadryl.
Severe lung congestion  Severe sinus congestion  Severe body aches  Extreme tiredness Three weeks  Z-pac Albuterol inhaler Mucinex
In late December 2022 I noticed I began to feel warm, and I had a sore throat just before going to bed. I walked up the stairs and I just began to shiver. The next morning, I felt better but I was positive for COVID-19. I had no more symptoms. I contacted my doctor and got Paxlovid. The horrible side effect was a bad taste in my mouth. I tested positive with no symptoms for another 10 days.
Admit for COVID like symptoms. O2 sat WNL, mild infiltrates on CXR. DC'd to home to take 14d steroid tx.