chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 26 year old female who on 19-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL vaccine (yeast). There was no concomitant medication. Within hours of receiving the vaccination, the patient experienced swelling at the injection site that was about 1/2 inch in diameter. On 25-OCT-2007, the patient experienced nausea, vomiting and body aches, chills and fever (patient did not take her temperature, but felt like she had a fever)The patient recoved on 02-Nov-2007.  No other symptoms were noted. The patient sought unspecified medical treatment by phone. Additional information has been requested.
Parent reports that the day after receiving the vaccine (given 1/13/22) the child had numbness in the right arm, vomited x 3, had low grade fever, and was disoriented. Improved over 24 hours
Second dose is scheduled > 36 days from the first dose; Second dose is scheduled > 36 days from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is scheduled > 36 days from the first dose) and PRODUCT DOSE OMISSION ISSUE (Second dose is scheduled > 36 days from the first dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is scheduled > 36 days from the first dose) and PRODUCT DOSE OMISSION ISSUE (Second dose is scheduled > 36 days from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is scheduled > 36 days from the first dose) and PRODUCT DOSE OMISSION ISSUE (Second dose is scheduled > 36 days from the first dose) had resolved. 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.
WHEN SLEPT ON RIGHT HAND FELT EXTREMELY COLD (FREEZING COLD) FROM FINGER TIPS TO THE MIDDLE OF THE ARM; THROAT MUSCLE PAIN (AROUND THROAT MUSCLES) / THROAT GOT SORE (CONTINUED TO GET SORE); WHEN SWALLOWS THROAT AND HEADACHE PAIN INCREASES FROM THE LOWER EAR TO THE SHOULDERS AND UP TO THE CRANIUM / WHEN SWALLOWS FEELS LIKE PULLED MUSCLE; MUSCLE ACHE THAT STRETCHED FROM SHOULDER TO HIS NECK; HEADACHE; EXTREME FATIGUE; NO NORMAL BOWEL MOVEMENT SINCE VACCINATION; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's past medical history included: contracted covid-19 (experienced headache, nausea, fatigue which lasted off and on), and concurrent conditions included: high blood pressure, sometimes smokes marijuana, alcoholic, and smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-SEP-2021 for prophylactic vaccination. Concomitant medications included metoprolol for high blood pressure, and nicotine for smoker. On SEP-2021, treatment medications included: paracetamol. On 12-SEP-2021, the patient experienced no normal bowel movement since vaccination. On 15-SEP-2021, the patient experienced headache. On 15-SEP-2021, the patient experienced extreme fatigue. On 16-SEP-2021, the patient experienced throat muscle pain (around throat muscles) / throat got sore (continued to get sore). On 16-SEP-2021, the patient experienced when swallows throat and headache pain increases from the lower ear to the shoulders and up to the cranium / when swallows feels like pulled muscle. On 16-SEP-2021, the patient experienced muscle ache that stretched from shoulder to his neck. On 17-SEP-2021, the patient experienced when slept on right hand felt extremely cold (freezing cold) from finger tips to the middle of the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and the outcome of extreme fatigue, throat muscle pain (around throat muscles) / throat got sore (continued to get sore), when swallows throat and headache pain increases from the lower ear to the shoulders and up to the cranium / when swallows feels like pulled muscle, when slept on right hand felt extremely cold (freezing cold) from finger tips to the middle of the arm, muscle ache that stretched from shoulder to his neck and no normal bowel movement since vaccination was not reported. This report was non-serious.
Information has been received from a 73 year old female patient with allergies to "apernepherin" and codeine, who on 28-OCT-2008 was vaccinated with ZOSTER (Oka-Merck).  The patient reported that on 29-OCT-2008 experienced soreness in her right arm where received the vaccine.  She stated that as the days went on the pain and soreness were a little more to the point where she had to adjust the weight she lifts on her right arm.  She also reported that the pain and soreness was not bad enough to have to take something for it, but about 2 days ago (approximately 17-NOV-2008) she was up through the night because of the pain.  The patient stated that on 19-NOV-2008 the pain was not really there is a more of a weakness in her arm and she felt it was going away.  Additional information is not expected.
On the second day after her vaccination she had headaches and tremors. The 3rd day she had swelling and her skin was very hot at the injection site. It is still tender to the touch. She took Benadryl, 1 tablet every 4 hours and it has helped relieve the reaction.
Narrative:  Patient seen checking own pulse said he felt lightheaded and dizzy possibly low blood pressure, he was given water and juice symptoms alleviated on their won, he was monitored for additional 15 mins and left clinic without any further complaints
LIGHT HEADEDNESS; SWELLING IN FACE; SWELLING IN THE THROAT AREA; THYROID PROBLEMS; BALANCE PROBLEMS; BODY ACHES; CHILLS; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported.  The patient's past medical history included colon cancer, sinus problems, neck injury, jaw virus, and hashimoto disease and concurrent conditions included allergy to hay fever, allergy to cleaners, allergy to rubber gloves, steroids allergy, and allergy to some chemotherapy medications, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 10-APR-2021, the subject experienced fever. On an unspecified date, the subject experienced light headedness, swelling in face, swelling in the throat area, thyroid problems, balance problems, body aches, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thyroid problems, light headedness, swelling in face, fever, chills, balance problems, body aches and swelling in the throat area was not reported. This report was non-serious.
No adverse effects reported; Patient received unspecified dose of VAQTA that was improperly stored.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions and allergies were not reported.  On 23-MAR-2019, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) (lot number: R021233, expiration date: 05-SEP-2019), intramuscular for prophylaxis. Administered vaccine was stored in a temperature of 50.1 degrees Fahrenheit (F) for 1 hour and 55 minutes, and below 36 degrees F for 235 minutes. There was a previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Reddness around injection site started about 2 days after receiving vaccine. A week after receiving vaccine redness was slightly worse, little swelling, and itchiness. Day 8 after vaccine itchiness and swelling have gone down slightly. Employee health advised reporting side effect here.
Vaccine administered after the 30-day beyond use date of 18-Mar-2022; patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and PRODUCT STORAGE ERROR (Vaccine administered after the 30-day beyond use date of 18-Mar-2022) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 012H21B and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after the 30-day beyond use date of 18-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired dose) and PRODUCT STORAGE ERROR (Vaccine administered after the 30-day beyond use date of 18-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  On 24-Feb-2022, the vaccine was moved from the freezer to the refrigerator. On 21-Mar-2022, at 04:00 P.M., the vaccine vial was opened.   This case was linked to MOD-2022-520795 (Patient Link).
Patient had nausea,felt nauseous; Patient had vomiting; Patient was dizzy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NAUSEA (Patient had nausea,felt nauseous), VOMITING (Patient had vomiting) and DIZZINESS (Patient was dizzy) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (All other boosters). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 05-Jun-2023 at 3:00 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jun-2023 at 3:00 AM, the patient experienced NAUSEA (Patient had nausea,felt nauseous), VOMITING (Patient had vomiting) and DIZZINESS (Patient was dizzy). At the time of the report, NAUSEA (Patient had nausea,felt nauseous), VOMITING (Patient had vomiting) and DIZZINESS (Patient was dizzy) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient has taken some motion sickness pill to try and helped for his symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2023-727955 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727955:Same reporter(Wife's case)
Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).; positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced COVID-19 (positive for COVID-19). On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).). At the time of the report, COVID-19 (positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Concomitant medication includes birth control medication.   Treatment information was not provided  On 14-Aug-2021, Patient started with COVID-19 symptoms (water eye, couldn't breath, no sense of smell).  A pharmacist said that she should wait 14 days for 2nd vaccine but other pharmacist (they were evacuees due to a stage 4 hurricane) said that patient had to wait 90 days.
COVID vaccine breakthrough case Pfizer 2/2/21 EL3248,  2/23/21 EN6200 and boosted 10/12/21 FF8847 and 5/13/22 Moderna 056M21A
Left leg swollen hot to touch and redness 10-18-06. Patient received vaccine on 10-17-06.
achiness & pityriasis rosea are reported in a pt receiving 1 dose of fluogen vax;  pt recvd vax in fall 1993 & approx 3 wks later exp achiness & rash which was later dx as pityriasis rosea;
feels achy all over especially in her arms and legs/It's gotten achier; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (feels achy all over especially in her arms and legs/It's gotten achier) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Dec-2022, the patient experienced MYALGIA (feels achy all over especially in her arms and legs/It's gotten achier). At the time of the report, MYALGIA (feels achy all over especially in her arms and legs/It's gotten achier) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was reporting adverse event for herself and her husband. After receiving the first and second dose of SHINGRIX vaccine the patient experienced redness at the injection site. This lasted for about a week. No further details were provided. The reporter also mentioned that her husband heard from someone that someone had a stroke from SHINGRIX and someone had died from SHINGRIX vaccine. Her husband does not know who the exact person was or any details. The reporter did not give consent to follow up. For tolerance after 2nd dose refer case US2019GSK020713. This case has been linked with the case US2019015771, reported for patient's husband.
08/09/18 @ 3:48pm. Mother reports swelling and redness occurred the evening of 8/7/18 after receiving vaccines, she expected this, applied ice and administered TYLENOL. Wednesday, left arm was very swollen, up to shoulder, under arm and chest, she thought it would get better, it got worse. Reports today, child went to school, arm is much worse, with swelling of arm, under arm and chest to shoulder blade, brought child to Urgent Care and was referred to the Emergency Room, where she is calling from. Doctors have diagnosed condition as Cellulitis.
24 hrs after injection, swelling, itchy, pain, body aches - took Benadryl, hot compress and ibuprofen. The injection site redness never went away, swelling came and went but 3/6 into 3/7 the swelling got worse. I called the on call nurse (2:30pm) where I got the vaccine and they advised me to be seen if it does not get any better. 2 hours later the swelling progressed to my left elbow. It was hot to touch, painful, burning sensation.   3/8 ER Dr gave me an oral steriod at the hospital, I was prescribed Keflex, Pepcid, Kenalog.  Diagnoses: adverse effect of vaccine, initial encounter & cellulitis to left upper extremity
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; Chills; Fatigue; stomach pains; nausea; diarrhea; migraine; dizziness; body aches; faint; This is a spontaneous report from a contactable consumer reporting for self. A 49-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 10:00 (Batch/Lot number was not reported) at the age of 49 years old, as single dose for covid-19 immunisation. Medical history included allergies to penicillin, codeine, Bactrim, sulfa drugs. Concomitant medications included alprazolam; sumatriptan succinate (IMITREX); amitriptyline. The patient experienced Chills, Fatigue, stomach pains, nausea, diarrhea, migraine, body aches, dizziness, faint from 01Apr2021. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient had Nasal Swab on 07Apr2021 with negative result, and on 13Apr2021 with Positive result. Outcome of event COVID-19 virus test positive was unknown, of other events was not recovered.   Information about lot/batch number has been requested.
10cm X 8cm erythematous, inflammed patch over right deltoid. No systemic reaction.
Diarrhea; Couldn't get out of bed; Temperature was 99.5 F and back to 96.5 F/temperature was fluctuating; Shooting headache; Muscles were achy; Extremely fatigue; She decided not to take 2nd dose because of side effects; Really bad rash all over her chest; She started throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), RASH (really bad rash all over her chest), VOMITING (she started throwing up) and PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (she started throwing up). On 08-Jan-2021, the patient experienced RASH (really bad rash all over her chest). On an unknown date, the patient experienced DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating), HEADACHE (shooting headache), MYALGIA (muscles were achy), FATIGUE (extremely fatigue) and PRODUCT DOSE OMISSION ISSUE (She decided not to take 2nd dose because of side effects). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), RASH (really bad rash all over her chest), VOMITING (she started throwing up), PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating), HEADACHE (shooting headache), MYALGIA (muscles were achy) and FATIGUE (extremely fatigue) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She decided not to take 2nd dose because of side effects) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) 99.5 F and 96.5 f (normal) 96.5 F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient decided not to take 2nd dose because of side effects. The patient wanted to take half of the second dose because she thought that her system can't tolerate the full dose.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Headache, fatigue, tinnitus, dizziness, and body aches (mostly back and neck) Side effects lasted 7 days  Patient was taking ibuprofen and Tylenol around the clock alternating therapies while hydrating often throughout the 7 days course
This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 11Jun2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included none. Patient did not know about any known allergies.  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 COVID-19 vaccine. Patient did not receive any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 21May2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced back lower pain and stomach upset since he vaccinated. 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 events. The clinical outcome of the events back lower pain and stomach upset was unknown at the time of this report.
pt vax hepta B. arm became swollen, red and hot.  md said allergic reaction to thimerosal in hepta B.
Pt seen in office 3/25/03. Generalized papular lesions over entire body. No vesicles noted. Mother gave history of rash x 2 wks. Post cervicle nodes enlarged. Return to office 3/28/03. Lesions had multiplied despite Rx of Keflex on 3/25/03 (given to r/o impetigo).