chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She got her vaccine, had body aches, extreme chills to the point feeling like she was in an ice bucket and then extreme heat, headache, nausea all the time, felt like she was pregnant, extreme tiredness.  She could only function to eat some crackers or water.  She just slept which is not her normal.  She did have fever, does not know what it measured.  Whatever symptoms she read about she had.  She had a sunburn type rash on her chest.  She woke up sopping wet on Wednesday evening, she went to the bathroom and was feeling a little better, felt that her fever broke, and noticed the sunburn type burn.  At one point her temp was 101.4, but she was not able to measure other times as was too weak to get out of bed.  The rash then moved down her body, from her chest/breast area to her stomach, down to her thigh area and then it went down her back and went down the upper arms on the inside, craping type skin.  Then the itching started when the color went away.   It was not a blotchy rash, just a red rash.  This rash lasted for a couple of days.   She has had this reaction before with the other vaccines but not to this extent.  She has also had similar reactions to the medications that she is allergic to.    She is not sure if it is a fever type rash or what, as she does get it when she gets a fever.    She did also get her flu vaccine on 9/14/21, does not know which one she got, just the regular flu vaccine.    There is nothing regarding the sunburn rash in the reactions section of side effects, but would like people to know this does happen.  It does not blister up, it's like a itchy blanket of sunburn.
EDEMA FROM SHOULDER TO ELBOW, RED, TENSE, NONTENDER TO GENTLE TOUCH.
3 days after vaccination, red, swollen, sore muscle, bruised with yellow center at site of injection.
Patient said her arm got swelling and painful, hot to touch the second day and she can't raise her arm. She took some Motrin and apply ice pack and the swelling went down today. She complained of itching now and was advised to take Benadryl.
Patient stated that approximately 40 minutes after vaccination she "had an asthma attack." After a couple of hours she was better, but then awakened the next morning with "blotches, not hives" on her body.  She was working at the time of the asthma attack and did not report the incident until 24 hours later.
He got terrible pain where he got his shot in his arm.; It went through his joints and into his wrists/It settled into his joints; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (He got terrible pain where he got his shot in his arm.) and ARTHRALGIA (It went through his joints and into his wrists/It settled into his joints) in an adult patient of an unknown gender 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.     Concomitant products included CORTISONE and LIDOCAINE for an unknown indication.    On an unknown date, 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 an unknown date, the patient experienced VACCINATION SITE PAIN (He got terrible pain where he got his shot in his arm.) and ARTHRALGIA (It went through his joints and into his wrists/It settled into his joints). At the time of the report, VACCINATION SITE PAIN (He got terrible pain where he got his shot in his arm.) had not resolved and ARTHRALGIA (It went through his joints and into his wrists/It settled into his joints) 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.   Unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It settled into his joints and he's not the only one with the trouble.   No treatment medication was provided by reporter.
Lymphocytic colitis; severe diarrhea; Tiredness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COLITIS MICROSCOPIC (Lymphocytic colitis) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Augmentin). Concomitant products included MULTIVITAMIN [VITAMINS NOS], CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.   On 22-May-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021 at 2:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced DIARRHEA (severe diarrhea) and FATIGUE (Tiredness). On 28-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLITIS MICROSCOPIC (Lymphocytic colitis) (seriousness criterion medically significant). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date at an unspecified dose and frequency and BUDESONIDE for Adverse event, at a dose of two weeks. At the time of the report, COLITIS MICROSCOPIC (Lymphocytic colitis) and DIARRHEA (severe diarrhea) had not resolved and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, Stool analysis: normal (normal) no infection. On 28-Jul-2021, Colonoscopy: abnormal (abnormal) Lymphocytic colitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Updated  reporter information, patient demographics, Added medical history, Lab data, updated,concomitant ,Vaccination facility information, Event onset date; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Fever 100.4, chills, joint pain, muscle ache, headache, site injection pain and PALPITATIONS
My infant had projectile vomiting for approximately 1 minute at 9:00 pm and the same happened at 9:15 pm.
Severe chills 16 hours after injection which lasted 10 hours.  Nausea, headache and horrible body ache.  Left arm (injection site) could not be lifted, very sore.
Information has been received from a consumer, referring to a 12 months old male patient. The patient had ear tube insertion and penicillin allergy. There were no concomitant medications. On 22-APR-2011, the patient was vaccinated with the first dose of PROQUAD (dose, strength, expiration date and lot# unknown), intramuscular. On 14-AUG-2015, the patient was vaccinated with the last dose of PROQUAD (dose, strength, expiration date and lot# unknown), intramuscular, both for prophylaxis as scheduled (Incorrect route of drug administration). On an unknown date, the patient experienced "bruise much more easily". On 19-APR-2016, the patient experienced "covered in petechiae and bruising" and was taken to see an unspecified physician. The patient had a platelet count of 7000 (unit unspecified) and was admitted to hospital after being diagnosed with idiopathic thrombocytopenia. The patient had multiple intravenous immunoglobulin (IVIG) treatment, multiple courses of dexamethasone and prednisone. The patient had been admitted to the hospital on for separate occasions including for an unspecified time in the summer of 2017 for a brain bleed that required long term treatment. On unknown dates the patient had auto-immune testing, multiple computed tomography (CT) scans, Magnetic Resonance Imaging (MRI), platelet testing, Antinuclear Antibody (ANA) testing and blood draws 6-8 times per month. The outcome of idiopathic thrombocytopenia and "bruise much more easily" was reported as not recovered. The causality assessment was not reported. Upon internal review, idiopathic thrombocytopenia was determined to be medically significant.
Vomiting; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and FATIGUE (extreme fatigue) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VOMITING (Vomiting) and FATIGUE (extreme fatigue). At the time of the report, VOMITING (Vomiting) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10 days after GARDASIL (#2) Pt developed acute respiratory problems.  "Lack of breath" after thanksgiving dinner.
Itchy, raised, red circular rash, 4-5 inches in diameter.  Still hot and red 9 days after injection. Itching reduced with Benadryl.
Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA09509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Objective: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. Methods: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. Results: Since 2013, 7, 378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7, 152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were adminsitered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). Conclusion: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7, 378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7, 152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposed in utero, thus 12 (0.2 percentage) neonate patients had developed 5 minute Apgar less than 4. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Not an actual adverse event. Patient came for vacation from another state. They filled out the consent form for a COVID vaccine and stated on the form they hadn't received any COVID vaccines beforehand. Dose of Moderna was given in the AM. Billing took place in the PM and insurance rejected the claim stating the patient got something different. After investigation, it turns out the patient had already finished their Pfizer COVID series.
Vaginal pain. Feels pressure and painful like I have my period but I do not; Vaginal pain. Feels pressure and painful like I have my period but I do not; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Nov2021 19:00 (Lot number: FIT8020) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "TBI frontal lobe diffused axonal injury" (unspecified if ongoing); "left kidney removed due to car accident", start date: 2011 (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 01Nov2021; ZOLOFT; ADDERALL; VRAYLAR; WELLBUTRIN. Vaccination history included: Bnt162b2 (DOSE NUMBER-1, Prev dose lot number=F51620, Prev dose number=1,, Prev dose vaccine location=Left arm), administration date: 01Nov2021, when the patient was 33 years old, for COVID-19 IMMUNIZATION. The following information was reported: VULVOVAGINAL PAIN (non-serious), VULVOVAGINAL DISCOMFORT (non-serious) all with onset 25Nov2021 01:00, outcome "recovering" and all described as "Vaginal pain. Feels pressure and painful like I have my period but I do not". Therapeutic measures were not taken as a result of vulvovaginal pain, vulvovaginal discomfort.  Additional information: No known allergies. Patient received other vaccines with in four weeks. Patient not had covid prior vaccination. Patient had not tested covid post vaccination. She got her period on time after the1st vaccine but also had the same symptoms after receiving the vaccine.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 57 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 07-OCT-2013, the patient was vaccinated with M-M-R II (Lot number H016132; expiry date 31-AUG-2014; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the M-M-R II administered to the patient was exposed to temperatures above 8 degrees C (approximately between 8.09 and 9.55 degrees C), since 05-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Early april wen to PCP for a physical, she did a breast exam/lymphnode exam  and unremarkable, tumor marker CEA 3 normal.  I had to follow up with my plastic surgeon for an MRI to check integrity of implants around April 28,  she felt enlarged lymph  nodes and detirmed because of the proximity of the vaccine, she needed to wait 6 weeks for MRI from second dose of Vaccine,  this got moved to about 12 weeks post dose because of an emergency surgery she had to conduct.  Lymph nodes in left arm still enlarged, got MRI and US, and another follow up 6-8 weeks with US.  The follow up US a biopsy was indicated and returned positive for occult breast cancer in left lymph node, no other location including chest wall.  The earlier primary cancer was in right breast. This new cancer is in contralateral side, and new tumor type,  97% E+ 24% P +,Her2 equivalent, KI 67 58%,  tumor markers CEA 4.9,  CA 27.29 marker 22.7.  CTScan with contrast Chest, Abdomen, Pelvic area clear, insurance denied PET.  The directives surrounding Covid-19 reactive lymph nodes delayed diagnosis, as well as the Vaccine seemed to take something that was subclinical to clinical manifestation.
Rash under arms/ Rash on breasts; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number Z9E99, expiry date 2nd June 2021) for prophylaxis.   On 4th May 2019, the patient received Shingrix. On 7th May 2019, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: On the day of reporting, the patient developed a rash under both arms and breasts. No additional information was provided.
no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 23-MAR-2020 at 15:50, the patient was vaccinated with improperly stored doses of PROQUAD rHA, lot# S030206, expiration date 24-MAR-2021 at a dose of 0.5 milliter, subcutaneously on the left thigh for prophylaxis and KINRIX lot# PP9L5 at a dose of 0.5 milliter, subcutaneously on the left thigh for prophylaxis (expiration date not reported). No adverse effects reported.  Administered doses of PROQUAD experienced the temperature excursion between -14 and -10 degrees Celsius (-11.2C) for 3 hours and 42 minutes. Digital data logger was involved. There were no previous temperature excursions reported.   This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008875: US-009507513-2008USA008884: US-009507513-2003USA002275: US-009507513-2008USA008889: US-009507513-2008USA008877: US-009507513-2008USA008880: US-009507513-2008USA008886: US-009507513-2008USA008876: US-009507513-2008USA008882: US-009507513-2008USA008890: US-009507513-2008USA008879: US-009507513-2008USA008881: US-009507513-2008USA008883: US-009507513-2008USA008885:
really tired; "COVID arm"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("COVID arm") and FATIGUE (really tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION COMPLICATION ("COVID arm"). On 02-May-2021, the patient experienced FATIGUE (really tired). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, VACCINATION COMPLICATION ("COVID arm") and FATIGUE (really tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-260201 (Patient Link).
As of today my left forearm is still hurting since vaccine dose 1. It?s very difficult to pull / push / turn / lift
swollen hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 16Mar2021, outcome "unknown", described as "swollen hands".  Additional information: Event was experienced 2 days after receiving his first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Report feeling of fogginess.  Treatment: none. Outcome: Continue to work without difficulty and does not interfere with ADLs.
swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; swelling or mask like feeling to face with sensation changes (mild numbness) to face(both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands; This is a spontaneous report from a contactable nurse, the patient.  A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: ek5730, via an unspecified route of administration on 30Dec2020 at 12:00 (at the age of 51 years old) as a single dose in the right arm for COVID-19 vaccination.  Medical history included lupus from an unknown date, and allergy to Celebrex (itching).  The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL), levothyroxine, vitamin D3, and zinc, all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was given at a hospital. On 30Dec2020 at 14:30, the patient experienced swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands. The patient received treatment for the events which included Pepcid, Benadryl and prednisone. The clinical outcome of swelling or mask like feeling to face with sensation changes (mild numbness) to face (both sides), tongue, lips and feeling of lump in throat; also same changes in sensation to fingers on both hands was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
sick; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a female patient (unknown demographics) who was sick (Illness), while received INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) (lot number, expiry date and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, patient was sick (Illness), (unknown latency), following the administration of INFLUENZA VACCINE. It was reported (I never had one my husband either we've seen how sick his mom after taking it).  Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.