chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vial sat out at room temperature unpunctured for greater than 12 hours/ gave dose from this vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vial sat out at room temperature unpunctured for greater than 12 hours/ gave dose from this vial) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vial sat out at room temperature unpunctured for greater than 12 hours/ gave dose from this vial). On 14-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna vial sat out at room temperature unpunctured for greater than 12 hours/ gave dose from this vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications includes blood pressure medication. No treatment information was provided.  Reporter stated that the vial was initially stored in refrigerator on 12-Jan-2022 and the vial sat out at room temperature unpunctured for greater than 12 hours. It was first punctured on 13-Jan-2022 at 12:15 PM and on 14-Jan-2022 at 11:54 AM it was administered to the patient.   This case was linked to MOD-2022-452549 (Patient Link).
Screaming through night, high fever of 103, then listlessness - TYLENOL and visit back to doc.
full body dermatitis, pityriasis like rash on trunk, ab legs and arms, very itchy, within 24 hours of shot
flu; cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for crohn's disease. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". The action taken for adalimumab was unknown.  Additional information: This report was non-serious. Janssen covid-19 vaccine: Causality for events flu (flu, influenza) causality as per reporter was possible; Cold (cold, nasopharyngitis) causality as per reporter was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3RD MODERNA COVID VACCINE GIVEN 8/19/21, #052E21A;  pt brought to ED after being found slumped over, abnormal speech, right sided weakness; CTA showed left A2 ischemic stroke; pt arrived for embolectomy and could move all extremities; not a candidate for TPA; large right pleural effusion on CXR; worsening respiratory status; DNI; Chest tube placed; pt's condition deteriorated and passed away in the hospital
very mild symptoms after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (very mild symptoms after first dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (very mild symptoms after first dose). At the time of the report, ADVERSE EVENT (very mild symptoms after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (Inconclusive) normal. On an unknown date, Oxygen saturation: normal (Inconclusive) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080212 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080212:second dose
One week after injection my arm at the injection site was red, itchy, raised and moderately sore.
Likely cellulitis due to superinfection of TDAP injection site.  Perimeter drawn around border start cephalexin 250 mg / 5 ml 4 tsp bid.  Call if worsening redness, fever, other concerns.
Large ball/dry feeling in the back of throat; Extreme nausea that has persisted for over 8 hours; Large ball/dry feeling in the back of throat with difficulty swallowing; Large ball/dry feeling in the back of throat; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 22:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. The patient did not receive any concomitant medications. The patient previously received no medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 12:30, the patient experienced large ball/dry feeling in the back of throat with difficulty swallowing and extreme nausea that persisted for over 8 hours. The clinical outcome of the events large ball/dry feeling in the back of throat with difficulty swallowing and extreme nausea that persisted for over 8 hours was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: treatment received updated as No and updated narrative.
10/24/06 (day following vaccines) mother reports, pt pale, nausea, vomit x 1, headache, fever of 102+
PNEUMONIA, COVID-19 VIRUS INFECTION, ABDOMINAL. DIAGNOSIS: PNEUMONIA DUE TO COVID-19, ACUTE RESPIRATORY FAILURE WITH HYPOXIA. GI HEMORRHAGE, CHRONIC AFIB, HYPERTENSION, UNSPECIFIED FALL, CAMPYLOBACTER ENTERITIS, BACTEREMIA. NEGATIVE FOR INF A AND B, NEGATIVE FOR RSV. PUI PRESENTED WITH BLOODY STOOLS, ABDOMINAL PAIN, AND GENERALIZED WEAKNESS, SHORTNESS OF BREATH, COUGH. ADMITTED RECENTLY FOR FALL AND PNEUMONIA. GIVEN REMDESIVIR AND SOLUMETROL, DOXYCYCLINE,
Metallic taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 1, single (Lot number: EL9266) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious) with onset 13Feb2021, outcome "unknown", described as "Metallic taste". Additional information: The reporter's husband experienced metallic taste in his mouth after the Pfizer Covid shot. That was a long time ago, right after the immunization came out. It occurred right after the shot, within minutes. Her husband had 4 doses Covid 19 vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116007 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;US-PFIZER INC-202300115780 Same Reporter/Patient/Drug, Different AE/Vaccine Dose;
Bilateral chest tightness, fever, aches, muscle soreness, fever 101 at home. Injection 7/22/13. Seen by MD 7/23/13.
she went to bathroom to pee, it was cloudy and had blood in it; she has pain and has urge; she has pain and has urge; Not able to pee; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; Left arm was swollen at injection site.; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198), via an unspecified route of administration, administered in left arm (unable to confirm if given in the muscle) on 12Jul2021 at 20:20 (at the age of 19 years old) as single for covid-19 immunisation. Medical history included ongoing peanut allergy diagnosed when she was 1 year old. Concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRAN), 1 tablet daily in the morning for 28 days for contraception from Jan2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. She began to be experienced unconfirmed urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating on 13Jul2021. She asking have this been reported after receiving the Pfizer Covid-19 Vaccine? She just took it two days ago and woke up not being able to pee and peeing blood and stated that it caused a UTI on 13Jul2021. She has never had one before in her life. This happened the night after she got the vaccine and it may be just a coincidence. Her left arm was also swollen and when she went to bathroom to pee, it was cloudy and had blood in it. She knew it had to be the vaccine because she never had that before. A couple of hours after the vaccine she noticed her left arm was swollen at injection site on 12Jul2021 at 22:00. Yesterday morning on 13Jul2021 at 08:00 she was not able to pee. It improved a bit, but she has pain and has urge. It feels like she just has to pee even though she just peed. She googled it and it said it was a UTI. She has not been formally diagnosed yet. She first stated the peeing blood started on 13Jul2021. At around 1:00 am, there was a little bit of blood when she got up to pee. She did not see any this morning, but does not know how it will be throughout the day. It has improved for now. She would like to find out if this has been reported before. The patient did not visit emergency room or physician office. No relevant tests were performed. The outcome of events was she went to bathroom to pee, it was cloudy and had blood in it, she has pain and has urge was unknown, while with other events recovering.  Follow-up attempts are completed; no further information is expected.
Patient received 1st dose of Moderna on 2/24/2021 never returned for final dose and later came back to restart doses with Pfizer. Both Pfizer doses were administered to patient 1st dose 5/25/2021 & 2nd dose 6/22/2021.
Delayed body rash on left shoulder, right neck, stomach,waistline; Delayed body rash on left and right arms; This is a spontaneous report from a Non-contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, in left arm on 14Feb2021 15:00 as dose number unknown, single for Covid-19 immunisation. Facility type vaccine was pharmacy or drug store. Patients medical history included thyroid disease from an unspecified date and unknown if ongoing. Concomitant medication included Np Thyroid, taken for unspecified indication, start and stop date not reported (taken in two weeks). Patient was not pregnant at the time of vaccination. No other vaccine in four weeks was administered. On 17Feb2021, patient experienced delayed body rash on left shoulder, left and right arms, right neck, stomach, waistline onset 2 - 3 days after vaccination until present (lasting 5 days at present). No treatment was given as a result of the adverse events. Doctor or other healthcare professional office/clinic visit took pace due to the adverse events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of event was not recovered.   No follow-up attempts are possible. No further information is expected.
fully vaccinated (Pfizer, 4/17/21, 5/8/21).  exposed on 7/21/21.  asymptomatic
pt recv vax 9DEC96 & exposed to varicella 2wk ago-rash started 31MAR several erythematous papules face, back buttocks;
Patient was inoculated 12-22-06 child developed ataxia 1-10-07 seen at hospital ER and admitted for work-up. 03/01/07-records received from PCP for DOS 12/21/06-02/06/07 Hospitalized 01/10-01/12/07-DC DX:Lack of coordination. Late effects of vrial encephalitis. PCP note 2/6/07-all diagnostic tests negative, and conclusion was post viral cerebellitis. On visit 2/6/07-alter, no ataxia. Stye on left eye. Well visit 12/21/06-WNL No one ever suspected that her condition was caused by vaccination, event was reported due to occuring within 45 days of a vaccination. Followup 3/30/2010 We never thought the vaccine caused her problem but we made the report because they symptoms presented within 45 days of immunization. She is ok and did get a 2nd flu shot without incident.
I had vaccination on 09/11/2022. On the evening of 09/15/2022 I was starting to feel unwell. On 19/16/2022 by 01:00PM  I didn't have any energy and I did take a COVID-19 test and it was negative. On Saturday I started to get a fever coughing sore throat achy and chills. I had a temperature of 102. On 09/18/2022 I tested COVID-19 positive. I was prescribed PAXLOVID. On 09/29/2022 I am not 100% still congested and fatigued. Each day I am getting better and about 90%.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: Ew0158), in left arm, on 02May2021 as dose 2, single (Lot number: Ew0175), in left arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Jan2023 as dose 4 (booster), single (Lot number: 042H22A), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Jan2023, outcome "unknown", described as "vaccine brand other Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
3 days p/administration of the MMR @ another facility; pt devel Bell's palsy;
pt recv vax in 1990 & 2 days later devel delirium & was taken to hosp; pt exp mania for 2 days then recovered; pt also exp some sz activity; EEG was nl, & CT scan revealed just an old scar; MD reported that pt had vax induced encephalitis;
Woke up next morning with a temperature of 103F, fussy, clingy and acting spacy. 2 days later, had red and warm spot on right thigh and continued temperature. Seen in office on 2/12/00. No temperature; no rash and is better.
Pt was given Covid Pfizer pediatrics (5-11)  dose of 0.2 on 11/12/21 at 1;23. Child is 13 years old. No s/s or reaction not harm done to child.
Information has been received from a physician and a certified medical assistant (CMA) concerning an 10 yr old male who on 25Mar96 was vaccinated with a dose of varicella virus vaccine live. On 24Mar05 the pt presented with about 30 lesions on the trunk and was diagnosed with breakthrough varicella. No treatment was required. It was reported that the pt recovered (date unspecified). No product quality complaint was involved. The physician also reported that the pt's younger brother developed varicella after receiving the vaccination (associated WAES0504USA00521) and his younger unvaccinated sister also developed the varicella rash (associated WAES0504USA00523). Additional information has been requested.
Headache; Fatigue; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Dec2021 09:45 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 12Apr2021, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 23Mar2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 08Dec2021 07:00, outcome "recovered" (Dec2021), described as "Headache"; FATIGUE (non-serious) with onset 08Dec2021 07:00, outcome "recovered" (Dec2021), described as "Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 08Dec2021 07:00, outcome "recovered" (Dec2021), described as "pain at injection site". Therapeutic measures were taken as a result of headache, fatigue, vaccination site pain.  Additional information- It was reported that Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccine in four weeks. Patient did not suffer from  covid prior  to vaccination and not covid tested post vaccination. It was also reported that patient did not suffer from any allergy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received FLUARIX influenza vaccine instead of tetanus vaccine she requested. She did not report any adverse reaction.
swelling in the arm of injection.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm of injection.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the arm of injection.). At the time of the report, PERIPHERAL SWELLING (swelling in the arm of injection.) outcome was unknown.            No concomitant medication reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
I got the flu shot at 9:00 am and around noon I was having trouble breathing. My airways felt really tight and I was wheezing and couldn't breath normally. I went home from school and took my dad's inhaler. It helped open my airway back up. I have never had the flu shot before and I am not allergic to eggs.
Pt called 3 days after receiving vaccine & stated arm was red (about size of palm) & warm. Pt advise to use ice & ibuprofen & if not better call to be seen.
Large red swollen spot in area of injection site  --- sore to touch --- warm to touch -- approx 2.5" in diameter minimal itchiness.... noticed it when I woke up day 2nd after vaccination (4-23-21) circled area with a pen, today, 4-24-21 the redness has spread slightly...   In doing my own research --- appears to perhaps be "Covid Arm"
headache / lo grade headache; frequent diarrhea; fatigue has improved; chills; body ache; This case was reported by a nurse via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 17th February 2021, the patient received the 2nd dose of Shingrix. On 17th February 2021, less than a day after receiving Shingrix, the patient experienced fatigue, chills, general body pain, headache and diarrhea. On an unknown date, the outcome of the fatigue, chills, general body pain and diarrhea were recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the fatigue, chills, general body pain, headache and diarrhea to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient was an athletic man with no pre-existing issues. The age at vaccination was not reported. The reporter stated that, for the first 48 hours, the patient experienced frequent diarrhea, headache, body ache and chills. The patient also experienced fatigue, which has improved, however on the day of reporting patient still had low grade headache. The reporter stated that, the patient was fine with 1st dose of Shingrix. The reporter consented to follow up.
Mother reports 1 1/2 cm reddened raised lesion appearing 1st on left upper arm near vaccination site. 24 hrs later multiple areas asymmetrical "uch-like" appeared on wrist under arm and upper trunk and back. Pt c/o pain and intense itching at site. Mother Tx'd with Benadryl and Tylenol and all areas and s/s subsided 6 pm on 11-4-05