chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose October 2021, second on 13-JUN-2022; Headache; Jaw pain; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (received 1st dose in October 2021 and experienced headache, refer case US2022AMR094558).   On 13th June 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 13th June 2022, unknown after receiving Shingrix, the patient experienced drug administration duration too long. In June 2022, the patient experienced headache, jaw pain and fatigue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache, jaw pain and fatigue were recovered/resolved and the outcome of the drug administration duration too long was unknown.   It was unknown if the reporter considered the headache, jaw pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The reporter was the patient's wife.  The patient received Shingrix in arm and experienced headache, jaw pain and fatigue.  The reporter stated that the effects were resolved. The reporter had nothing else to report. The patient was not available to give consent for follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. This case has been linked to US2022094109, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094109:Same reporter US-GLAXOSMITHKLINE-US2022AMR094558:Same reporter
Low grade fever (99.5-100.4); significant pain to left upper arm, unable to left arm; headache; difficulty sleeping due to pain; decreased appetite.
Approx. 10 minutes after receiving his immunization the patient fainted and fell backwards, hitting his head. No one saw it happen so it is unknown if anything happened immediately prior to the fainting. He was on the ground for less than a minute and it is unknown if he loss consciousness. Upon finding him, the patient was disoriented and unsure of what happened. He hit the back of his head and was bleeding quite a bit. An ambulance was called and he was taken to the hospital.
Red rash on the chest and abdomen; Itchy rash on the chest and abdomen; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash on the chest and abdomen) and RASH PRURITIC (Itchy rash on the chest and abdomen) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 RASH ERYTHEMATOUS (Red rash on the chest and abdomen) and RASH PRURITIC (Itchy rash on the chest and abdomen). At the time of the report, RASH ERYTHEMATOUS (Red rash on the chest and abdomen) and RASH PRURITIC (Itchy rash on the chest and abdomen) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was not reported. The patient did not take any treatment medication.
On 08/21/00 a pt was vaccinated at 14:15 and post vaccination at 19:00 the pt experienced mild to moderate soreness/pain at the injection site. The swelling affected the pt's ability to move her right shoulder. On 08/22/00 the pt had fever and chills; (99.2 F) which resolved on 08/23/00. She still had soreness and swelling and it began to move down to towards the elbow. The right elbow became swollen. On 08/24/00 the swelling moved from the right elbow to the forearm, approximately 2 inches below the elbow. Unspecified medical attention was sought. The pt took Tylenol on 08/21/22/00 to alleviate discomfort at the injection site. The pt was asymptomatic and recovered by 08/28/00.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 22-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 3:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:50 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 22.12 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Vial was moved to fridge on 30-Mar-2021. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 09:00 AM and on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM.  Product moved to clinic on 03-Apr-2021. Beyond use date for the vial was reported as 29-Apr-2021.  20 vials from this batch were sent to the clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Nausea and pulse decreased to 40's . Symptoms started as patient was discharged. Patient rested, heart rate increased with oxygen and. Patient observed for 45 minutes, paramedics called and patient stable, no further complications.
1 1/2" raised, red, blotchy area at injection site on right upper arm. 1 week, post vax, 2 pox on face. 3 pox on face, 2 weeks, post vax. No fever or runny nose. No other symptoms. Traveling forearms.
Hives around injection site warm, red, itchy. Lasted 2 hours approx.
Around 4:30 noticed discomfort to left forearm, swelling, redness,and warm to touch. Following morning, 10/12/01 area of redness larger, pain and temperature of 101.2 F. Seen at PCP and given antibiotics, antihistamines, and pain meds. Med administered should have been PPD for routine TB testing at place of employment.
p/vax pt exp malaise x15day, ongoing; extreme fatigue off & on; had to walk x4 during pt run
Red, swollen, warm to the touch, 2 to 3 inches below the injection site, about the sizes of her palm. Treated with Benadryl. Received vaccine Wed, started reaction Friday and lasted 2 days.
First vaccination: 1) Sore arm after 2 hours of the shot.                                         2) Tired in the evening.                                         3) Next day I was lethargic and my legs were very tired.                                                4) Day 3 my I felt fine.                                         5) It took about 3-4 days for my arm to feel fine. Second vaccination: 1) Sore arm after 2-3 hours after shot.                                               2) Started feeling tired in the early evening.                                               3) Next day I was lethargic, arm was sore, and  I layed on the couch all day and watched TV. Mid-afternoon                                                     I started shaking like I had bad Parkinson, really shaky, for about a half hour.                                               4) The day after I felt fine.                                               5) My sore arm was gone in about 3-4 days.
Paraethesia, bilateral but mainly right side of body Hypothesis , right side of body Muscle tension Vertigo Irregular Menstrual Cycle
Redness, swelling, heat to area of injection of MMRV. Site of IM injection near this site was normal.
Moderna COVID?19 Vaccine EUA  I had a rash that began at the site of the injection a week after my first Moderna vaccine.  The rash started about the size of a dime and grew over several days to about 4 inches by 4 inches.  It was warm to the touch, my skin felt firm, and it was extremely itchy.  It is March 24, about 10 days after the reaction started, and the rash is gone by the area is still itchy.
I had intense dizziness that started about 24 hours after getting both Pfizer vaccines. This persisted for a day or two after the vaccine. It went away after around day 2.
5-6hrs p/vax pt ran temp of 102.6 w/APAP;fussy but no other sxs;devel diarrhea 1 wk p/shot;had diarrhea stools;tolerating fluids well;afeb;referred to PMD for further f/u
infection on her mouth; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech COVID19 vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced infection on her mouth on an unspecified date with outcome of unknown.  Information about lot/batch number has been requested.
fatal meningococcal disease serogroup C confirmed by BOL.  10/19/07 Reviewed hospital medical records 9/6-9/9/2007. FINAL DX: Neisseria bacterial meningitis, serogroup C Records reveal patient experienced URI, sore throat, HA, stiff neck & high fever.  Seen in ER on 9/6/07 where LP done.  D/c to home w/dx viral infection.  Smptoms worsened & became lethargic.  Returned to ER.  Admitted 9/8-9/9/2007.  Tx w/IV antibiotics, antivirals & steroids.  Cerebral edema increased after 2nd LP.  Neurology & neurosurgery consults done (reports not available).  Pupils were fixed & dilated. Declared brain dead then experienced ventricular fibrillation & resuscitation unsuccessful.  Family refused autopsy.  11/09/2007 Received death certificate which states COD as cerebral edema +/- herniation: Bacterial Meningitis; cerebral edema; brain herniation.
warm to touch at the injection site; slightly raised at the injection site; 6 inch diameter red area at the injection site; arm was achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was achy), VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE SWELLING (slightly raised at the injection site) and VACCINATION SITE ERYTHEMA (6 inch diameter red area at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was achy). On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE SWELLING (slightly raised at the injection site) and VACCINATION SITE ERYTHEMA (6 inch diameter red area at the injection site). On 09-Mar-2021, PAIN IN EXTREMITY (arm was achy) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE SWELLING (slightly raised at the injection site) and VACCINATION SITE ERYTHEMA (6 inch diameter red area at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.  No concomitant product was reported.
Left arm swelling, redness, induration, warmth, pain at injection site. Several days after. Treated with Keflex.
Severe body aches- 12+ hours; presently current Chills: 12+ hours; presently current Nausea: 12+ hours; presently current Soreness at injection site with stiffness in receiving arm: Onset 2 hours to current
Patient received 3rd dose of Covid19 Pfizer vaccine due to incomplete record keeping by the facility. Patient condition unknown at the time of reporting.
I noticed my periods were longer apart. I went from 28 to 30 days apart to now 55 to 60 days apart. When I get my periods, I am bleeding for 12 days. I have developed and been diagnosed with Iron Deficiency Anemia June 21, 2021.  I was put on a medicine to stop the bleeding as of now. My periods have changed substantially from 5 days to 12 to 14 days. I am still going to specialist to try to figure out what has happened.
Pt. described a sharp pain upon administration of immunization, and stiffness of neck for next week. On Tues 10/20/15 pt reported feeling better and no or v. little stiffness of the neck.
Patient came to immunization clinic to receive a Tdap vaccine for her 28 week pregnancy.  A medication error occurred and the patient received a Pfizer vaccine instead.  she had received her 2 doses previously on May 14, 2021 and June 12, 2021.  The patient was fine for the next 30 minutes without any adverse effects noted.
Severe body aches in both shoulders across her back and down to her lower back that started one or two weeks after second shot and still continues; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe body aches in both shoulders across her back and down to her lower back that started one or two weeks after second shot and still continues) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-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 MYALGIA (Severe body aches in both shoulders across her back and down to her lower back that started one or two weeks after second shot and still continues). The patient was treated with THERAWORX RELIEF for Myalgia, at an unspecified dose and frequency and HISTAMINE HYDROCHLORIDE (PAIN RELIEVING ARTHRITIS) (topical) for Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (Severe body aches in both shoulders across her back and down to her lower back that started one or two weeks after second shot and still continues) had not resolved.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients. The patient's medical histories and concurrent conditions were not provided. On an unknown date in January 2016, the unspecified number of patients were vaccinated with ROTATEQ (lot # L013202, expiration date 27-JAN-2017, oral)(dose number, frequency and concentration were not reported). It was reported that the vaccines administered were improperly stored at 47.1 F for a time frame of 5 minutes and 45 seconds. No product quality complaint (PQC) was reported. This is one of two reports from the same source. Additional information has been requested.
My colitis acted up - I had increasingly severe abdominal pain, diarrhea and bleeding. The severity subsided after 3 days, now after 2 weeks I have minimal pain and bloody stools.
fever, chills, severe muscle aches, severe migraine head ache, nausea lasting from 3 hours after injection until 36 hours later
Patient received Moderna for their first dose in January 2021 and had an allergic reaction to it. He spoke to his allergist who recommended that he restart his COVID vaccine series with Pfizer. He received both doses of Pfizer at another healthcare facility. He received his first Pfizer dose on 1/15/2022 and his second dose on 2/5/2022.  The second dose of Pfizer that he received is considered a first booster because the Moderna vaccine he received is still considered a valid vaccination.  Therefore, the error is that he had received his first booster too early. This error was discovered when the patient came in for his first booster shot, believing his first Moderna shot did not count. The patient was advised that the first Moderna shot still counted and that he received his first booster too early. Based on the guidelines to repeat the first booster three months after the early booster shot, the patient received his valid first booster shot today, 7/16/2022.
Moderna COVID-19 Vaccine EUA  Severe pain in injection site.  Fever of 102.4, weak, lethargic, chills, achy all over.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned an adult of unspecified 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 not reported, batch number: 026A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine was not reported. This report was non-serious.
Injection site with reddened form mass 2 weeks after injection-supportive only. c/w-sterile abscess.
This spontaneous report was received from a physician via a company representative, concerning an 11 year old male patient. The patient's medical history and concurrent conditions were not reported. On 05-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 0.65 ml (route of administration, lot # and expiration date were not reported) for prevention of HPV. No concomitant medication was reported. On the same date, on 05-FEB-2016, after being given GARDASIL 9, the patient fainted and when he did hit the counter and cut his lip. Therefore, on an unspecified date, the patient was brought to an unspecified emergency room (ER) where he got stitches for the cut and also to get a computerized tomogram (CT) scan. The reporting physician stated that there were no findings on the CT scan. It was unknown if the patient was admitted to the hospital. No product quality complaint was involved. It was reported that the patient got the stitches taken out on 17-FEB-2016. At the time of the report, the outcome for syncope was reported as unknown, and the outcome for lip injury was recovering. The relatedness between syncope and lip injury with GARDASIL 9 was not provided. Additional information has been requested.
Fatigue; Dizziness; Double vision; could not get out of bed; Vision changes; right eye pulls inward and becomes crossed; drastically changed her quality of life; sick; Head pain; Nausea,horrible nausea; symptoms only got worse after the second shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision), BEDRIDDEN (could not get out of bed), VISUAL IMPAIRMENT (Vision changes), STRABISMUS (right eye pulls inward and becomes crossed) and QUALITY OF LIFE DECREASED (drastically changed her quality of life) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was Provided by Reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESTROGENS CONJUGATED (PREMARIN) and PRAVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced CONDITION AGGRAVATED (symptoms only got worse after the second shot). On 05-Mar-2021, the patient experienced DIPLOPIA (Double vision), BEDRIDDEN (could not get out of bed), VISUAL IMPAIRMENT (Vision changes), STRABISMUS (right eye pulls inward and becomes crossed), QUALITY OF LIFE DECREASED (drastically changed her quality of life), ILLNESS (sick), HEADACHE (Head pain) and NAUSEA (Nausea,horrible nausea). On an unknown date, the patient experienced FATIGUE (Fatigue) and DIZZINESS (Dizziness). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 1 dosage form; HYDROMORPHONE HYDROCHLORIDE (DILAUDID) at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, DIPLOPIA (Double vision), BEDRIDDEN (could not get out of bed), VISUAL IMPAIRMENT (Vision changes), STRABISMUS (right eye pulls inward and becomes crossed), QUALITY OF LIFE DECREASED (drastically changed her quality of life), ILLNESS (sick), HEADACHE (Head pain), NAUSEA (Nausea,horrible nausea), FATIGUE (Fatigue), DIZZINESS (Dizziness) and CONDITION AGGRAVATED (symptoms only got worse after the second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown   This case was linked to MOD-2021-022364 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Significant follow up On 30-May-2021: No specific follow-up information recorded. On 01-Jun-2021: Significant follow up