chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SORE ARM; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 11-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-SEP-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 24-SEP-2021. This report was non-serious.
Pt vaccinated with Tet Toxiod on 4SEP90, on 6SEP90 pt returned; redness, swelling, warmth of lt arm where injection was given. Benedryl 25mg tid given.
Syringe malfunction - Haiou 1ml retractable safety syringe lot# 20JC2 supplied by Pfizer/CDC with vaccine. Needle and hub remained in patient arm, and other cases of needle not retracting properly. Narrative:  Not severe for our patient, however, could cause needle sticks for employees, and frightening if patients knew the needle and hub could remain in their arm when the vaccinator removed the syringe after injecting. Thus a serious problem for all. Manufacturer: Haiou 1ml retractable safety syringe Lot #20JC2. Supplied with the Pfizer vaccine by Pfizer/CDC in the ancillary kit.
CHOCKING SENSATION 30 MIN AFTER VACCINE MONTH AFTER HAS JOINT PAIN, MUSCLE IRRITATION AND EXTREMELY HIGH INFLAMMATORY MARKER PER PATIENT CRP OVER 70
On 12/2/00 the pt complained of left arm weakness, pain in left upper arm, numbness in fingers on left hand and an aching in left arm. Constant ache continued until 12/6/00. She tool OTC Advil for pain relief on 12/2/00 and 12/3/00. She reported these symptoms to her MD.
heart problems including 5 bypass surgeries; lung problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart problems including 5 bypass surgeries"; LUNG DISORDER (non-serious), outcome "unknown", described as "lung problems". Clinical course: Patient has health issues including heart problems including 5 bypass surgeries, lung problems and a pacemaker.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe headaches beginning next day after vaccine last one month, also post menopausal bleeding 3 weeks after the vaccine lasting several days. Went to OB/Gyn provider for a uterine, vaginal and pelvic ultrasound with no etiology for bleeding.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On 28-MAR-2016, the patient was vaccinated with expired dose of RECOMBIVAX HB (strength, dose and frequency were not reported) lot # J006511, expiry date: 28-JAN-2016. Concomitant medications were not provided. No adverse effects were reported. No further information was provided. The outcome of expired product administered and no adverse event were unknown. Product quality complaint was not filed. Additional information has been requested.
Client reported nausea, lightheadedness, dizziness 14 minutes onset from receiving first Moderna dose.  Client denied shortness of breath, trouble breathing, throat tightening, chest pain.  Client able to sit in zero-gravity chair.  Vital signs assessed, with initial  blood pressure 148/100, then rechecked and 130/110.  Client denies history of high blood pressure, arm and blood pressure cuff readjusted.  Vitals signs at 12:26 pm:  blood pressure 102/76, pulse 78, respirations 18.  Client continues to complain of nausea, dizziness,  and headache now.  Benadryl offered and client declines.  Vital signs remain stable during observation, client reports symptoms have lessened but not resolved.  At 1:06pm, headache and lightheadedness continue, Benadryl offered again and client declines again, also offered EMS, client declines.  Client calls husband to come for her, she states she wants to go home.  1:16pm, husband arrives.  Client educated on follow up with primary care for second dose guidance and ER precautions given.  Client is able to stand, wheelchair offered and client declines.  Client is able to leave observation area, walking with husband and escorted by RN at 1:18pm.
breastfeeding and 1st dose and 2nd dose Moderna's COVID-19 vaccine received; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and 1st dose and 2nd dose Moderna's COVID-19 vaccine received) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hashimoto's disease. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and 1st dose and 2nd dose Moderna's COVID-19 vaccine received). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (breastfeeding and 1st dose and 2nd dose Moderna's COVID-19 vaccine received) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
Red, warm, firm, swelling around injection site 2 days after injection, concerning for infection - patient also with MRSA boils on buttocks - history of MRSA.
1st dose had no reaction but sore arm.  24 hours after 2nd dose: 101 fever, severe chills, body aches, migraine level headache, nausea put me in bed for the rest of the day. Woke the next morning with all symptoms gone except headache, but right armpit was swollen huge and super painful.  36 hours after that armpit is still swollen and sore, but beginning to recede.
Patient presented to the ED with complaints of change in mental status, forgetfulness and lethargy. He was also experiencing hypoxia at home. He was subsequently admitted for acute metabolic encephalopathy and pneumonia. He was discharged in stable condition 6 days later to a skilled nursing facility.
A nurse was administering the vaccine when it leaked between the needle and the piston; A nurse was administering the vaccine when it leaked between the needle and the piston; A spontaneous report was received from a healthcare facility staff member concerning a 19 year old, male patient who experienced the vaccine  syringe connection issue and vaccine under dose as it leaked between the needle and the piston.  The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.  The patient received their first of two planned doses of mRNA-1273 (batch number not provided) on 06-FEB-2021 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 6FEB2021, he took his son "Jr." who has the same first and last name to an  vaccination location. He is a dental assistant in the office and a first responder. A nurse was administering the vaccine when it leaked between the needle and the piston. He is unsure how much of the vaccine was administered and how much was lost.  The injection was attempted by intramuscular injection to the left deltoid. He has had no symptoms following vaccination and has not taken any treatments.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event vaccine under dose and syringe connection issues were considered resolved.; Reporter's Comments: This report refers to a case of syringe connection issue and underdose for mRNA-1273 (lot number: not provided) with no associated AEs reported.
one had to get their wits about them before driving an hour home because they weren't confident about their driving abilities after getting the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's concomitant medications were not reported.  The patient was the one who had to get their wits about them before driving an hour home because they weren't confident about their driving abilities after getting the vaccine on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Pt. fainted for a few minutes after receiving ADACEL. Pale, sweating. Mother saw him shaking, also blurred vision. Paramedics were called, returned to consciousness. Vital signs normal, refused to transport to ER.
Patient presented to the ED 3 times for rash that started on face and went down to chest. Rash spreading to lower abdomen and under L>R breast. Swelling of face (lips, eyelids), neck area. Tingling of lips. Events started about 24 hours after 2nd dose of Pfizer vaccine. Differential: allergic reaction vs. reaction to vaccine vs. AED related hypersensitivity/rash vs. much less likely SJS. Dermatology consulted. Patient reports gardening on 4/18 and near weed whacking activities in an area that has poison ivy. Patient reports extreme sensitivity to poison ivy historically. Rash biopsy: differential diagnosis includes drug reaction and allergic/irritant contact dermatitis. Presence of a couple days of treatment may hinder histologic features for diagnosis.
First dose January 10, 2021.  Second dose January 31,2021.  Awakened early February 1  and admitted to ICU where she remained until death March 5, 2021
3 days post immunization patient developed swelling of right hand 2nd -5th digits.  Described sausage digits.  Symptoms resolved within ten days .  Seen on December 29., with mild swelling of 2nd-5th digits.
Patient presented to clinic on 6/19/2021 with SOB, collapsed in a grocery store after his visit, was admitted to the hospital with Cardiac Arrest and  Pulmonary Embolism and died 6/23/2021.
At the end of the 15 minute observation time, the patient stated she felt like her throat was closing and that she was having a difficult time swallowing. Her O2 sat was 98%, HR 61, lungs CTA, right side of neck and jawline had mild swelling. She was given 50 mg of liquid Benadryl and 911 called. She continued to complain of back of tongue tingling. O2 sats remained at 98%. She started to say she was feeling better just before EMS arrived and departed with the patient. Patient spoke Spanish and was interpreted by her car passenger, a medical interpreter was not used as this was an emergency.  ED note indicates she had an anaphylactic reaction after 2nd Moderna vaccine. Epinephrine had been given approximately an hour after first complaining of symptoms. ED note says she initially had rash and throat swelling but now is feeling well and tolerating PO. She was counseled on Epi Pen and discharged same day.
Fainted about 20 minutes after receiving vaccine. Later that night developed fever. Today pain and swelling at injection site. Taken to ER on night of vaccine. Temperature over 102 F.
Donor states "violently" vomiting and nausea x 3 days. Did not seek medical attention or take any medications.
pt recv vax 24SEP97 & 1OCT97 pt devel a blister near the inj site & 104 fever;
Septic encephalopathy. ED Visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
I had a seizure that evening on the 29th and I had not had a seizure before that for over 20 years. I think it was an indicator that the vaccine increased my seizure threshold. Outside of the seizure, there wasn't too much I remembered about it. I bit my tongue and I didn't breathe for a minute and my husband called 911, but they didn't take me to the hospital. I have not had another seizure since. It was the one off seizure and that was the only thing that happened. I couldn't drive as a result of it, and just recently started driving again (about a week ago). I did go to the doctor and he made an assessment and we both agreed we did not need to go back on seizure medication. He did do an EEG and they didn't find anything from that. Definitely seems to be suspect of the timing of the vaccine which is why I reported it.
Inappropriate schedule of vaccine administered; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 05-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  In 2021, patient experienced flu like symptoms. Patient took second dose on 19MAR2021 and booster on 05DEC2021.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Erythematous rash with mild induration of left mid-anterior thigh. 1st noted about 24 hours, post vax.
Husband received Moderna vaccine at the time of wife's pregnancy; This spontaneous case was reported by a consumer and describes the occurrence of PATERNAL EXPOSURE BEFORE PREGNANCY (Husband received Moderna vaccine at the time of wife's pregnancy) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A, D33B21A and 027H21B) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced PATERNAL EXPOSURE BEFORE PREGNANCY (Husband received Moderna vaccine at the time of wife's pregnancy). In 2021, PATERNAL EXPOSURE BEFORE PREGNANCY (Husband received Moderna vaccine at the time of wife's pregnancy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided.  The patient's wife mentioned that she had registered for pregnancy registry earlier in the day. She mentioned that her husband had received the vaccine before she was pregnant. Date of last menstrual period of caller: 04-JUN-2021. She believed she became pregnant on 15-JUN-2021.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 11:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Feb-2022 at 11:56 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.   This case was linked to MOD-2022-542869 (Patient Link).
pt recv 2nd dose of typhoid; devel fever  of 102.6;tx w/ apap;
pt 5OCT97 20hr p/vax pt broke out in hives on neck & chest accompanied by rash & rapid heart rate;saw MD who prescribed DPH;
Pt received fluzone HD on 9/22/2000. Pt came to pharmacy on 12/9/20 reporting of continued arm pain at site of injection.
H/A, nausea vomiting, achy joints x 4 days. Despite ADVIL 800mg TID et BENADRYL.
feeling nausea; kidneys were hurting; Felt awful; had bad diarrhea; stomach hurting; Chills; Wet on herself; All the color of face went away; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidneys were hurting), URINE ABNORMALITY (Wet on herself), PALLOR (All the color of face went away), MALAISE (Felt awful) and DIARRHOEA (had bad diarrhea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included PREGABALIN (LYRICA), ATENOLOL, LOSARTAN, HYDROCHLOROTHIAZIDE, AMLODIPINE, TRAZODONE, CLOPIDOGREL, MONTELUKAST, SERTRALINE and LEVOTHYROXINE for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced URINE ABNORMALITY (Wet on herself) and PALLOR (All the color of face went away). On 01-Mar-2021, the patient experienced RENAL PAIN (kidneys were hurting), MALAISE (Felt awful), DIARRHOEA (had bad diarrhea), ABDOMINAL PAIN UPPER (stomach hurting) and CHILLS (Chills). On 03-Mar-2021, the patient experienced NAUSEA (feeling nausea). At the time of the report, RENAL PAIN (kidneys were hurting), URINE ABNORMALITY (Wet on herself), PALLOR (All the color of face went away), MALAISE (Felt awful), DIARRHOEA (had bad diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), CHILLS (Chills) and NAUSEA (feeling nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.  Concomitant products also included Statin for an unknown indication.  Patient had other health problems, not specified.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Followup was received on 08-jul-2021: contains no new information
Narrative: COVID infection following COVID vaccine series 01/27, Pfizer, dose #1 02/17, Pfizer, dose #2 08/11 COVID swab, result: detected 08/03 pt cc: cough, fatigue, dyspnea, exposure: unknown 08/11 COVID swab, result: detected 08/11 SARS-COV-2 Variant Sequencing result: pending 08/13 pt admitted non Facility ED LOS: 1 day 08/14- 08/19 Pt symptoms continue
Reaction to site administered. (L) thigh tenderness, swelling, erythema in an elevated circular pattern measuring 20.5 cm x 10 cm.
Hard to swallow. Shortness of breath. Swelling edema. Rash over body and shoulders. Muscle weakness. Exhaustion. Extreme fatigue. Medication for symptoms.
Swollen left side  inside of THROAT, like "blocking" the throat and very irritated. Excessive coffing and dryness inside the mouth and throat, specially at night or lying down.  Left ear is swollen and very painfull, and all this is giving me a painful headache all the time. My left nose has blood clots when I wwake up in the mprning and bleeds heavelly  for some minutes when I wake up.This started when I took the vaccine and is getting worst, some nights it is so painful that I don't sleep.The hospital told me to go see my doctor. I called my doctor and tried to go to walking clinics.Everyone is busy or not seeing patients, just phone call.
Localized redness at injection site; Swelling at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Localized redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Medical history was not provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Localized redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Localized redness at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not reported. Concomitant medications were not reported.
02/16/04 fever 104 axillar-lasted until 2/17/04, irritable, constipated. Mom stated child better on 2/18/04 and had BM. No more fever since 2/17/04.