chrisvoncsefalvay/vaers-outcomes huggingface dataset:
11-8-07 - Shot given at 250 pm; finished work - home by 515 pm, Horse voice, chest tight, mucus, Eyes Red, musucsey, cold, chills, runny nose, Sinus congest slept on n off. Went to work; came home after one hr - Slept - Eyes red - better by 630 ish pm.
The evening after the injection, she had fever of 103, body aches, her arm at the injection site was red and swollen, she was unable to get out of bed for 48 hours.
Feel like crap; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel like crap) and DIARRHOEA (diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced FEELING ABNORMAL (Feel like crap) and DIARRHOEA (diarrhea). At the time of the report, FEELING ABNORMAL (Feel like crap) outcome was unknown and DIARRHOEA (diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided.
Thurs: Shot 7pm, no adverse effects Friday: Face very red, allergic/histamine type reaction; begin OTC antihistamines Saturday: Massive facial and genital swelling Sunday: Same, PCP prescribed 4mg Prednisolone; symptoms lessen after 4 hours, most symptoms unnoticeable by 7pm Monday 7am; Less intense, but significant facial swelling, no genital swelling  Fatigue during entire episode Antihistamines seem to yield little to no improvement Steroids help but it is now a tennis match overnight
pt recv vax 9OCT96 & 1996 pt exp pain down rt arm, soreness & weakness;pt devel no visual manifestations;
Day following vaccines became faint, weak, trembling. Extreme pain (L) arm. Unable to work. To ER x 2. Symptoms remain.
1 inch long sloughed skin/blister, reported itching under bandaid - took bandaid off and saw clear gel looking fluid oozing from sore.
Got very nauseous and thought I was going to throw up. Walked into kitchen and sat at table and passed out shortly thereafter. Husband said it took him like 10 seconds to bring me back to consciousness.
I was needing excessive amounts of sleep every day and sleeping through alarms. And needing naps after having slept 10 hours at night - two hour naps. Went to doctor - he saw that my thyroid was exceedingly high and attributed it to that - reduced my thyroid dose significantly. It improved but it's still not great. I am sleeping a lot less but I occasionally sleep 10-12 hour nights. I am going to have a sleep study done next month.   Recently clinic check-in on the 16th of October: I had a three week long gastro intestinal problems with diarrhea, nausea and vomiting. Those started about 4 1/2 weeks ago from today.  No treatment. I am still having symptoms but not as severe - they are slowly improving.
R thigh swelled from the knee up pt.  Came to doctor the very next day.  Is doing fine now.
She has itchiness; Warm around the injection site area; Felt like she was vaccinated again; Red around the injection site area; A bump on the injection site; Initially she had arm pain; Initially swelling on injection site, a bump on the injection site, she woke up with swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt like she was vaccinated again), VACCINATION SITE MASS (A bump on the injection site), PRURITUS (She has itchiness), VACCINATION SITE WARMTH (Warm around the injection site area) and MYALGIA (Initially she had arm pain) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Diabetes.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE MASS (A bump on the injection site), MYALGIA (Initially she had arm pain) and VACCINATION SITE SWELLING (Initially swelling on injection site, a bump on the injection site, she woke up with swelling). On 08-Feb-2021, the patient experienced VACCINATION COMPLICATION (Felt like she was vaccinated again), PRURITUS (She has itchiness), VACCINATION SITE WARMTH (Warm around the injection site area) and VACCINATION SITE ERYTHEMA (Red around the injection site area). At the time of the report, VACCINATION COMPLICATION (Felt like she was vaccinated again), PRURITUS (She has itchiness), VACCINATION SITE WARMTH (Warm around the injection site area) and VACCINATION SITE ERYTHEMA (Red around the injection site area) outcome was unknown and VACCINATION SITE MASS (A bump on the injection site), MYALGIA (Initially she had arm pain) and VACCINATION SITE SWELLING (Initially swelling on injection site, a bump on the injection site, she woke up with swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Pregnant patient was administered Menactra, with no reported adverse event; Initial information was received on 27-Sep-2021 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 25 year old female patient who was exposed to vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] during pregnancy (Exposure during pregnancy).  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The pregnant patient was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], and was exposed to MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE during first pregnancy trimester.  The date of last menstrual period was reported as 27-Jul-2020.  The estimated due date was 17-Mar-2021.  It was unknown if the patient had any medical history, concomitant disease or risk factor  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 24-Sep-2020, the patient received a dose 1 of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: 46952AA; expiry date: 09-Jul-2022; form: Solution for injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of vaccine exposure during pregnancy (latency same day).  No adverse events were reported at the time of this report.  The outcome of the reported event was unknown.  At time of reporting, the outcome of the pregnancy was unknown.
Anger; High blood pressure; not being himself; Confused; Agitated; Combative, became aggressive; Crying, yelling, clapping; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGER (Anger), AGGRESSION (Combative, became aggressive) and MENTAL STATUS CHANGES (Crying, yelling, clapping) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event history.). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), ALLOPURINOL, DOXAZOSIN MESILATE (CARDURA), TELMISARTAN (MICARDIS) and AMLODIPINE.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced ANGER (Anger) (seriousness criterion hospitalization), AGGRESSION (Combative, became aggressive) (seriousness criteria medically significant and life threatening), MENTAL STATUS CHANGES (Crying, yelling, clapping) (seriousness criterion medically significant), FEELING ABNORMAL (not being himself), CONFUSIONAL STATE (Confused) and AGITATION (Agitated). On an unknown date, the patient experienced HYPERTENSION (High blood pressure). At the time of the report, ANGER (Anger), AGGRESSION (Combative, became aggressive), MENTAL STATUS CHANGES (Crying, yelling, clapping), HYPERTENSION (High blood pressure), FEELING ABNORMAL (not being himself), CONFUSIONAL STATE (Confused) and AGITATION (Agitated) outcome was unknown.        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.   Treatment of these events included Seroquel 400mg once a day.  Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of complications associated with elderly age of patient. Further information has been requested. Company assessed the events to be unlikely related to company product.
Erythema, edema, pruritis and pain at the site of the injection. Reaction area covers upper arm (deltoid and biceps). Patient was evaluated by PCP for the reaction and was asked to take over the counter antihistamine. Dr. advised patient to return to the Clinic and report reaction.
Developed swelling of right lower ext. from groin to mid calf. Pink, blanching maculopapular rash around 13cm in diameter on mid thigh, medially, distant to vaccine site.
Chills/shivering, nausea, headache, dizziness 12 hours after the vaccine. Chills/shivering resolved 24 hours after the vaccine. Nausea, headache, dizziness persisted with new development of numbness on center of tongue, roof of mouth, upper lip, left nostril, and drooping of left eyelid.
Child developed fever and rash.  Fever began two hous after vaccinations and lasted two days.  Rash came and went. Child seemed to be scratching itchy rash areas.  CHild not eating well.  Dcotor noted child had pinpoint macular rash
hot to the touch; extremely sore; red; rash getting bigger/ spreading; A spontaneous report was received from a healthcare professional concerning a 28-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash getting bigger  spreading/vaccination site rash,  extremely sore/vaccination site pain, hot to the touch/vaccination site warmth, red/vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) rash getting bigger  spreading.  On an unknown date, the patient experienced events, extremely sore, hot to the touch, red and has spreading on her left arm  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash getting bigger  spreading, extremely sore, hot to the touch, red was unknown.
The patient presents with COVID positive. ED Nurse states pt is was tested for COVID on 8/9/2021 and had an X-ray that showed COVID pneumonia but it wasn't confirmed. Nurse states pt was sent so COVID pneumonia can be r/o and pt can get medically cleared back to facility. She states the pt is 93% on room air, and pt has no complaints at this time. HPI limited to pt's history of dementia.  The course/duration of symptoms is constant.  The degree at present is none.  Risk factors consist of hypertension, diabetes mellitus and age. Patient was still admitted at time the form was submitted.
pt began to c/o numbness & tingling in lat arm;noted to have bright red color up lt arm;whelps & itching upper lat arm began to swell;pt c/o rapid heart beat but only p/1st epi given;VS 256PM BP 160/84, R22, P100-3PM P98, R24, BP 158/80;
This case was considered medically important. Information regarding Hib-Titer Vaccine (haemophilus b conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from an attorney alleging that a male child received a series of childhood vaccinations including Hib-Titer, Acel-Imune, Tripedia, Act-Hib, IPOL, Engerix-B, MMR II and Varivax vaccines from 7/12/99 through 11/28/2000. The male child experienced toxic effect of mercury (metal poisoning) and it's compounds and neurological toxicity. No additional info was available at the time of this report.
Allergic attack; Missed her 2nd dose and its been 3months she had her 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Allergic attack) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic attack) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose). At the time of the report, HYPERSENSITIVITY (Allergic attack) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed her 2nd dose and its been 3months she had her 1st dose) 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 medications were not reported. The patient received steroid shot  several days after receiving the first dose of the Moderna COVID-19 vaccine for allergic attack. The patient missed her second dose and looking for second dose. First shot was administered 3 months ago.
lower GFR; This case was reported by a consumer via call center representative and described the occurrence of glomerular filtration rate low in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in May 2019). Concurrent medical conditions included solitary kidney (has one kidney).   In August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced glomerular filtration rate low. On an unknown date, the outcome of the glomerular filtration rate low was not recovered/not resolved.   It was unknown if the reporter considered the glomerular filtration rate low to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had a glomerular filtration rate in April and then again last week and the glomerular filtration rate rate was lower last week than it was in April 2019 prior to the Shingrix vaccines. The reporter declined follow up
Developed UTI that led to acute pyelonephritis in June 2022. NOTE:  Developed another UTI on 8/19/22
This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a neonate patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis. On 24th December 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On 24th December 2021, unknown after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, a medication error occurred, an adult Flu vaccine of GlaxoSmithKline was given to a newborn (patient), which led to inappropriate age at vaccine administration. The reporter would like to know if there was any possible side effects or reaction they should watch out for.  The reporter asked to contact and ask to speak to any nurses available on the shift.
By parental report: fever 105.3. Took patient to ER where she was administered TYLENOL. Fever broke after 2 doses.
I suffer from basic hypertension which is completely stable taking 2x 2.5mg Amlodipine.  Following the vaccines my blood pressure was consistently dropping as low as 102/62/89. I had pain in my head and my heart was beating aggressively. I stopped taking my Amlodipine
"Bad" headache, fever 99.6, fatigue, severe chills for approximately 1 hour, pain @site.
SKIN PAINFUL TO TOUCH ENIRE L ARM, DELTOID AREA VERY SWOLLEN L ARM, AND BRIGHT RED, DELTOID AREA L ARM GREATER THAN 1/2" RAISED IN CIRCULAR PATTERN APPROX 2-3" WIDE; TOOK JUST OVER ONE WK TO RESOLVE; HAS NEVER HAPPEN BEFORE
ARM OF INJECTION IS STILL VERY SWOLLEN AND SORE.  LOTS OF MUSCLE FUNCTION IN SITE ARM.
Admitted 2/27/2016 with widespread vesicular rash lesions positive for Varicella by DFA. Patient on AALL-1131 chemotherapy maintenance phase for ALL diagnosed in May 2014.
been a weird 2 months; shingles symptoms/it's been mild; swollen lymph nodes; yeast or bacterial vaginosis; yeast or bacterial vaginosis; Joint pain; fatigue; This is a spontaneous report from a contactable consumer (the patient).  A  44 year old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6208), intramuscularly, on 13Mar2021 at 12:00 (at the age of 44 years old) as a single dose in the right arm for COVID-19 immunization. Medical history included ongoing hypertension and ongoing decreased appetite. Historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number:EL9269) in the right arm on 13Feb2021. Concomitant medication included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; metoprolol (METOPROLOL) taken for hypertension from an unspecified start date and ongoing; phentermine (PHENTERMINE) taken for decreased appetite from an unspecified start date and ongoing. The patient experienced shingles symptoms/it's been mild on 03Apr2021 with outcome of recovering. The event shingles required a physician office visit and it was considered medically significant. The patient also experienced joint pain on 16Mar2021 with outcome of recovered with sequelae,  fatigue on 16Mar2021 with outcome of recovered with sequelae , swollen lymph nodes on 20Mar2021 with outcome of recovered, yeast or bacterial vaginosis on 20Mar2021 with outcome of recovered, yeast or bacterial vaginosis on 20Mar2021 with outcome of recovered, been a weird 2 months on an unspecified date with outcome of unknown. Shingles was considered medically significant.  Therapeutic measures were taken as a result of shingles, joint pain, fatigue, swollen lymph nodes, yeast or bacterial vaginosis and included, ibuprofen, Epsom salts, ointment and Valtrex; Sender's Comments: Linked Report(s) :PFIZER INC-2021218674 Same reporter, same patient same product, different event (Dose # 1 )
Discomfort in his arm at injection site; arm was swelling; discomfort in his arm; His arm was sore, where he got injected was sore.; This is a spontaneous report from a contactable consumer. This consumer reported for two patients. This is the 2nd of two reports (father). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced discomfort in his arm at injection site; arm was swelling; discomfort in his arm; his arm was sore, where he got injected was sore; on an unspecified date. The outcome of events was unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
24 hrs after Inj. discomfort in lft deltoid then extended up into the trapecial muscle and into area of rt shoulder. Within a short time frame he began to have joint and muscle pain all over. He denies any joint swelling or deformity. No fever. Gave pt. Prednisolone 10mg, tapering dose. Ibu as needed. Monitor 48-72 hrs Emergency instructions given.
This is a spontaneous report form a contactable Physician via Pfizer sales representative through medical information team. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient became asplenic on an unspecified date with outcome of unknown. The physician wanted to know if the patient need a booster dose. Sender's Comments: Based on the information currently available, being asplenic is not related to the use of PREVNAR 13 but represents the patient's underlying medical condition.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Elevated anxiety 6/10 when in observation area post vaccine admin. VS: 138/95, 72, 98.9 oral, 99%. Provided water, juice and crackers. She shared she always has 'white coat syndrome' (elevated bp, hr) whenever at any dr. office and lives with chronic 2/10 anxiety, always. After approximately 20 minutes, she felt better and at her baseline 2/10 anxiety. Reviewed  contact numbers provided in case any additional adverse/side effect (s) develops.
Patient reports severe injection site pain, which extended up through her left shoulder. She also reports red streaks that extended up and down her left arm, which were warm to the touch and inflamed.
Shortly after vaccination, patient reported itching at the injection site that then spread to his arms, chest and face. There were no visible signs of anaphylaxis (no rash, hives, or swelling) and no trouble breathing. He also said he was experiencing some dizziness. Patient was asked to stay for further observation. As he waited near the pharmacy, he also reported chills and feeling faint. At that point 9-1-1 was called. He was evaluated by paramedics and released. He declined transport to a hospital and was driven home by a companion about on hour post-vaccination. Patient was conscious and alert the entire time.
after no reaction to initial injection and no visible injection site, abrupt onset of itchy red area at injection site, dime-sized, on day 8. Later in day ,  two additional smaller pale red satellite circular lesions 2 inches from the injection site. All 3 red lesions became slightly raised (almost like a hives lesion).    Lasted about 36 hours. Itching relieved with topical steroid x 2 doses
Mother states, "I had to take child to ER on 9/14/16, child had rash and itching on face and legs". Pt was prescribed BENADRYL 12.5 mg/5ml oral exlixir 25mg. Mother follow/up with Provider on 9/20/16.