chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in for first dose of covid vaccine (moderna) and received the shot in her left arm at 03/25/21 approx 1:30pm.  She was told to sit down near pharmacy for 15 minutes after receiving shot for observation.  However, since she is an employee, she decided to sit in the break room.  For 15 minutes, she was fine and she came back to pharmacy to let staff know she was fine.  At 30 minute point, she started feeling lightheaded, heart racing, shaky, foggy, and some nausea.  She sat down, was given ice pack for back of neck, instructed to put head down between legs and rest.  After talking to patient, she had eaten some after her shot, she was well hydrated.  She has had no previous major adverse effects from shot, aside from sometimes sore arm.  She is alert, communicative, and aware of her surroundings when I spoke to her.   At 2:17pm, patient is feeling a bit better, but still has lessened but similar SE.  Also, reports she has a bit of headache now.  Another coworker has offered to drive her home and she has her grandmother at home to watch her too.  Advised her to rest at home, take tylenol if headache persists, stand up and sit down carefully, and drink chicken soup until nausea is over.
A healthcare professional reported the occurrence of hives in a 5 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On 5/15/03, the subject received his fifth injection of Infanrix (lot DTPA594A2). On the same date, he received injections of inactivated poliomyelitis virus vaccine, and MMR. On 5/15/03, one to two hours post immunization, the subject developed hives on the ears and face. The parents telephoned the physician and were instructed to administer diphenhydramine hydrochloride and to keep the area cool. The reporter considered the hives to be probably related to Infanrix administration.
This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site swelling and injection site lump. On an unknown date, the outcome of the injection site swelling and injection site lump were not recovered/not resolved. The reporter considered the injection site swelling and injection site lump were not recovered/not resolved. The reporter considered the injection site swelling and injection site lump to be probably related to BEXSERO. Additional detail were provided as follows: This case was reported by a medical assistant. The age at vaccination was not reported. The patient received the BEXSERO vaccine approximately one week ago from the date of reporting and was still experiencing swelling and a lump at the injection site at the time of reporting. On the date of reporting, the field representative received and email with the above information. She was unable to provide any additional details at the time of the call. The field representative did not know the last name of the medical assistant.
Adverse effect from 1st  dose of Pfizer vaccine for COVID: - swelling of head with hives,  - swelling of face, lips, eyes - swelling of feet, - shortness of breath, chest tightness  - extreme itching and rashes across all over body.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, past drug reactions, allergies, and medical history were not provided. The patient's concomitant therapies included sterile diluent. On 28-OCT-2018, the patient was vaccinated with an improperly stored dose of PROQUAD reported lot number R012415, expiration date 28-OCT-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -9 Celsius degrees to 8 Celsius degrees (-6.09 Celsius (C)) for 1 hour and 36 minutes as recorded by a data logger. The vaccines had not had any previous temperature excursions. There were no adverse effects reported. No product quality complaint was filed. Sender's Comments: US-009507513-1810USA013853.
Pain down from arm to forearm; Rash in left arm; Felt tired; slight headache; Slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain down from arm to forearm), VACCINATION SITE RASH (Rash in left arm), FATIGUE (Felt tired), HEADACHE (slight headache) and NAUSEA (Slight nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Vestibular vertigo. Previously administered products included for an unreported indication: Cipro (No allergic reaction), Levaquin (No allergic reaction), VIT D3, CRANBERRY EXTRACT [VACCINIUM MACROCARPON] and CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]. Past adverse reactions to the above products included Nausea with Cipro; and Tremor with Levaquin. Concurrent medical conditions included Hypothyroidism (Not worsened) and Vestibular disorder. Concomitant products included LEVOTHYROXINE and FISH OIL for an unknown indication.    On 01-Apr-2021 at 10:10 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain down from arm to forearm), VACCINATION SITE RASH (Rash in left arm), FATIGUE (Felt tired), HEADACHE (slight headache) and NAUSEA (Slight nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain down from arm to forearm) was resolving and VACCINATION SITE RASH (Rash in left arm), FATIGUE (Felt tired), HEADACHE (slight headache) and NAUSEA (Slight nausea) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that she had no allergies, hives, asthma or hay fever. Hypersensitivity reactions were unknown. No laboratory diagnostics test were done.  The patient did not seek medical care for the reported events. The patient did not receive any treatment for the reported events.   This case was linked to MOD-2021-103091 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Historical condition, historical drug, concomitant medication, new event and events outcome updated; Sender's Comments:  MOD-2021-103091:2nd dose case
04/04/2003 at 9am. Mother called. Had shot here yesterday, right  after we left he started runny off with his bowels and vomiting. Supp for vomiting. This morning mother states still has diarrhea. Referred to PMD for further evaluation.
BOTH LEG PAIN; HIVES / WORSENING HIVES; GASTROESOPHAGEAL REFLUX DISEASE; FELT LIKE HAVING HEART ATTACK; SLEEP INTERRUPTIONS; FLU-LIKE SYMPTOMS; ACHES; NAUSEA; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Investigation (NR: not provided) blood clots which were negative. On 24-MAR-2021, the subject experienced flu-like symptoms. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced sleep interruptions. On 24-MAR-2021, the subject experienced nausea. On 27-MAR-2021, the subject experienced felt like having heart attack. On 27-MAR-2021, the subject experienced gastroesophageal reflux disease. On 30-MAR-2021, the subject experienced hives / worsening hives. On 04-APR-2021, the subject experienced both leg pain. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and famotidine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, aches, felt like having heart attack, sleep interruptions, gastroesophageal reflux disease, hives / worsening hives, and nausea on 2021, and both leg pain on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
fever; Headache; Very tired; 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 PYREXIA (fever), HEADACHE (Headache) and FATIGUE (Very tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (Headache) and FATIGUE (Very tired). At the time of the report, PYREXIA (fever), HEADACHE (Headache) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided by the reporter.
1st dose: wirhing ~6 hrs: extreme itchy face (forehead and cheek area), eyes, and inside nose (similar itchiness to what happens when spinal block epidural wears off (I've had 3 c-sections). 2nd dose: within 2 hours: itchy scalp, itchy eyes, some itchiness around nose and eyes, and itchy inside nose: 24 hours: burning eyes watery eyes and low grade fever; 36 hours: dry eyes and clogged tear ducts
This is an instance of breakthrough COVID-19 disease after which death occurred.   The indiviudual was vaccinated with the Moderna product on 03/04/2021, 04/01/2021, and 11/04/2021. I do not have lot numbers or injection sites or the facility that administered the vaccine available to me in the state immunization system (only manufactuer and dates). The individual presented to emergency department on 02/21/2022 with primary complaints of abdominal pain, dehydration, and unintentional weight loss. They were hospitalized 02/21/2022-02/23/2022.  They were then transferred to a different hospital on 02/23/2022 and upon admission to this second hospital, they tested positive for COVID-19 (specimen was collected on 02/24/2022) It was thought the individual was having issues with gallbladder, but was not a candidate for exploratory surgery due to age and medical conditions. The individual was discharged from this second hospital on 02/28/2022. They were seen by a family medicine physician on 03/07/2022. The notes from this clinical encounter indicate the individual may have attempted to get abdominal surgery at a more advanced hospital out of state. The individual died on 03/12/2022.
Within 4-5 minutes she felt her throat start to tighten,over couple hours got quite a bit worse around 1pm,felt different but still there and just as bad as before; Was really tightening and burning through the evening; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Within 4-5 minutes she felt her throat start to tighten,over couple hours got quite a bit worse around 1pm,felt different but still there and just as bad as before) and THROAT IRRITATION (Was really tightening and burning through the evening) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) and ETANERCEPT (ENBREL) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced THROAT TIGHTNESS (Within 4-5 minutes she felt her throat start to tighten,over couple hours got quite a bit worse around 1pm,felt different but still there and just as bad as before) and THROAT IRRITATION (Was really tightening and burning through the evening). At the time of the report, THROAT TIGHTNESS (Within 4-5 minutes she felt her throat start to tighten,over couple hours got quite a bit worse around 1pm,felt different but still there and just as bad as before) and THROAT IRRITATION (Was really tightening and burning through the evening) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment medication.
Initial unsolicited report received from a nurse on 01 June 2015. This case is linked to the case 2015SA077114 (same reporter, same suspect). Two female patients had received a intramuscular dose one of ADACEL (batch number- U5030AA, expiration date- 1 May 2017, site of administration was not reported) on an unspecified date. Patients did not have any illness and pre-existing physician diagnosed allergies, birth defects, medical conditions at time of vaccination. The patient did not have any known drug allergy. Patients did not receive concomitant medications. On an unspecified date after vaccination, patients developed pain at the injection site and superficial cellulitis. Patients required ER/doctor visit. Laboratory investigations were reported as none. The patients were treated with antibiotics and steroids. At the time of this report outcome of events were unknown. Upon medical review, the case was considered as serious due to important medical event- cellulitis. Documents held by sender: none.
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 08-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Red area size of a bar of soap, on antibiotics, then grew to 8-9 inches in (L) leg. Saw Dr. prescribed steroid. Dx was localized infection following injection.
3 cm circular raised, red, hard, hot, lump at vaccine site. Resembling cellulitis.
3/21/31 emergency room  ! Dizziness ,  Took blood work , ekg , gave IV  WAs dehydrated  3/23/31 Tuesday noticed my knees swelled up especially left knee , painful still could barely walk.  Hadn?t been swollen since chemo summer of 2020
Swelling and redness at injection site. Entire arm swollen and painful 6/10 scale. Treated with Benadryl and ibuprofen with minimal relief. Edema and pain reduced after approximately 3 days.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY 12/20/2022 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE
Chills. Fever. Hurt in arms - legs - mid section. Unable to walk alone. Talking unreasonable.
Covid19 breakthrough.  1st vaccine received on 02/13/2021.  69 y/o PMH of cardiomyopathy, DVT, Heart disease, DVT, Hypothyroid, HTN, left femoral artery stent, depression with psychotic features presents to the ED by daughter who found pt agitated and wandering.  Pt tested positive for Covid19 one week ago. Pt afebrile, O2sat room air 100%.  Per ID no particular tx indicated for Covid19.
Extreme sneezing; runny nose both indoors and outdoors; Sensitive nose; Nose congestion in the mornings; Sleep disorders; Developed allergies towards avocados; This is a spontaneous report from a contactable consumer. This consumer (patient reported for herself). A 26-year-old (at the time of vaccination) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: ER8736), via an unspecified route of administration, administered in left arm on 10May2021 at 16:00 as 1st dose, single dose for COVID-19 immunization. Patient's medical history included allergy of Ibuprofen. Patient received other medications the patient received within 2 weeks of vaccination Tylenol, Allegra. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. On an unspecified date, the patient experienced extreme sneezing, runny nose both indoors and outdoors, sensitive nose, nose congestion in the mornings, sleep disorders and developed allergies towards avocados. The events were reported as non-serious. The Patient was not hospitalized. The outcome of events was not recovered.  Follow-up attempts are possible. Other information is expected.
Information has been received from a Registered Nurse (R.N.) concerning an approximately 9 month old (reported as "35-36 weeks of age") patient who on 29-JUN-2011 was administered a third dose of ROTATEQ (Lot # not reported). The nurse did not know the dates of when the first two doses of ROTATEQ were given. No adverse event was reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19.The patient took COVID-19 Treatment with Paxlovid Pfizer from 01Jun2022 to 05Jun2022. The patient received vaccine and other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a physician (the mother of the patient) and described the occurrence of systemic shot reaction in a 1-month-old female subject who was vaccinated with Diphtheria tetanus pertussis (A or W not known), (manufacturer unspecified). Concurrent vaccination included tetanus toxoid vaccine (manufacturer unspecified) given on unspecified dates following reactions to Diphtheria tetanus pertussis (A or W not known). On 02 July 1985, at 1 month of age, the subject received primary 1st dose of Diphtheria tetanus pertussis (A or W not known). At an unspecified time after vaccination with Diphtheria tetanus pertussis (A or W not known) the subject experienced systemic shot reaction with irritability, injection site induration, inconsolable crying, and swelling injection site. Resolution of irritability and injection site induration was noted (no date specified). Attribution of these same events was indicated to be possible. Outcome of systemic shot reaction, inconsolable crying, and swelling injection site and attribution of these events to vaccination with Diphtheria tetanus pertussis (A or W not known) was not specifically reported (unknown). It was reported that the subject is now 26 years old and the physician (mother) was wondering if her daughter (now grown) would still have reactions to Tdap if given. Similar events occurred in the subject's brother following vaccination with Diphtheria tetanus pertussis (A or W not known). For details on the sibling case, refer to linked case A0943969A. The physician (mother) stopped further Diphtheria tetanus pertussis (A or W not known) vaccinations in the female subject (her daughter) after seeing the same reactions in older son after doses of Diphtheria tetanus pertussis (A or W not known).
Severe Pain at the injection site on the left arm. The arm was warm to touch. Vitals were taken at 1:45 PM as followed Temp 97.4, P 84, R 16, B/P 72/60. On 12/11/00, per phone call; the patient complained of generalized swelling of the upper arm. On 12/06/00 she had a temp of 101 F for 2 days with pain at the injection site. On 12/05/00 she had itching for 1 1/2 days after the injection. No additional medical follow up. Treatment of cool compresses and Ibuprofen taken by the patient. Presently feeling much better. Enc medical care if needed. In later October 2000, the patient was diagnosed and hospitalized with Influenza. Complained of weakness, elevated temp, and a sore throat. Treated with antibiotics names unknown.
Employee has worsening local reaction. Initially had no problems, but then at about day 10-11 started having swelling, itching, redness at site of the vaccination, about 10cm x 5cm ER MD felt it was a delayed hypersensitivity reaction.