chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt.'s wife states that after receiving the 2nd dose of Moderna 03/10/2021, started experiencing symptoms 03/11/2021 of chills, confusion, and shortness of breath. Emergency Room visit 03/11/2021, Chest X-Ray, Cat Scan, and Blood Panel = Normal. Admitted for Observation at for 3 days. Symptoms have subsided.
Fever, (L) thigh - lower inj site 2ml pink area; (L) upper site firm node under skin.
Pt had nausea and almost fainted. Pt had chills, possible fever, body aches all over. Stomach cramps, diarrhea, fatigue, and headache. Symptoms lasted 24 hours.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrive at facility. On 1-Dec-2021 vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. No treatment medications were reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-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) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of covid-19 which include paxlovid from 10Aug2022 to 14Aug2022.  Clinical course: The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
no adverse event; Past lot that had also been expired that was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) in a 14-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient).    Patient age was reported as 14 Year 11 Month. No concomitant medication was provided.  Treatment medication was not provided by the reporter.
just died; This is a Spontaneous report from a Pfizer Sponsored Program from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient just died on an unspecified date.  It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: just died
Pt had inconsolable crying X 3-4 hours. She also had a large, red lump on her thigh at injection site.
no symptomatic side effects/No additional AE; administration of improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 31-MAY-2023, the patient was vaccinated with improperly stored (Product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin)(PROQUAD) injection, 0.5 milliliter, once, lot # was reported and upon internal validation confirmed as: X011437, expiration date was reported an confirmed as: 18-JUL-2024, administered (site and route of administration were not provided) for prophylaxis. No previous temperature excursion. The patient had no symptomatic side effects. No additional adverse event reported.
I continually thought my glasses were dirty. on 10-31-2019 I saw purple flashes in my left eye. Then I could not see from that eye. It was like looking through bubbles. I called my eye doctor. He did an examination and determined that it was not glocoma, cataracs any other eye issue. He said that my optic nerve had ruptured. He referred me to an opthomologist . I then had bloodwork, MRI, doppler Peripheral Veno. I also had a sleep study test. He said I have non-arteritic ischemic optic neuropathy. I will return to him in June for a field of view test. My distance vision is slowly improving. I cannot read with my good eye covered.
Sudden complete blindness in left eye. Right eye blurry. Possible exacerbation of Temporal Arteritis. Or possible that vaccine caused Temporal Arteritis. Severe inflammation response.
Information has been received from a nurse concerning a 18 year old female patient who was vaccinated with first dose of GARDASIL (Lot # not reported).  After the patient received the vaccine she developed hives and rashes on her face.  The patient sought medical attention with the physician.  Additional information has been requested.
Patient came in for booster number 3 and she already had history of hyperventilation and dizziness on those 2 pfizer vaccines.   Prior vaccination patient was place on the gurney by RN.  At 1145 took her BP=118/82, HR=102; hyperventilating,  encouraged patient to do deep slow breathing.  felt nauseous and dizzy.  around 1200 noon BP=130/80, HR=102, 02sat=100% RA.  At 1215 called AOD, and he stated you don't have to call MERT you can directly send patient to ED. At 1220 BP=117/70, HR=104, still Dizzy and Nauseous.  Brought patient to ED via Wheelchair with another person.
This infant had a sudden personality change, crying spells, sadness, unresponsive to games or social interaction, disturbed by any change in environment,irritated by direct attention.
High fever, dizziness, vomited, peeing blood, aches all over the body.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 19-JUL-2018, the patient was vaccinated with an improperly stored dose of VARIVAX for prophylaxis (strength, dose number, anatomical location, route of administration were not reported). There was unknown if the patient received the lot No N031001 (Exp date 03-NOV-2019), lot No N034557 (Exp date 05-DEC-2019) or lot No N034553 (Exp date 05-DEC-2019). The VARIVAX was reconstituted with a properly stored sterile diluent and there was not adverse effect reported. The temperature was from 6 degrees Fahrenheit (°F) to 14°F for a time frame of 35 minutes without previous temperature excursions and was called because a digital data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA012257: Original Case: 1807USA011606: US-009507513-1807USA011606: US-009507513-1807USA012256: US-009507513-1807USA012264: US-009507513-1807USA012258: US-009507513-1807USA012259: US-009507513-1807USA012260: US-009507513-1807USA012261: US-009507513-1807USA012262: US-009507513-1807USA012263: US-009507513-1807USA012255: US-009507513-1807USA012254.
Pain/tingling in arm, arm felt heavy. Fatigue, fever, muscle aches, chills, loss of appetite. Lasted 3 days (missed 2 days of school).
PATIENT WAS OKAY AFTER THE COVID SHOT, WAITED 15 SECONDS THEN FLU SHOT WAS GIVEN. STARTED TO THROW UP IMMEDIATELY, THEN BECAME UNCONCIOUS, SHORTNESS OF BREATH, LIPS TURNED BLUE, EYE CLOSED, 1 SHOT OF EPIPEN IS GIVEN, 911 WAS CONTACTED, PATIENT IMMEDIATELY CAME TO. WAS RESPONSIVE, TALKED TO THE MOM AND THE PHARMACIST, THEN STARTED TO THROW UP AGAIN, LEANED ON CHAIR, BECAME UNCONCIOUS AGAIN, LIPS TURNED BLUE, ANOTHER SHOT OF EPIPEN WAS GIVEN, PATIENT CAME TO. WAS RESPONSIVE, 911 CAME, PARAMEDIC CAME, FIRE FIGHTERS CAME, BLOOD PRESSURE OKAY, OXYGEN LEVEL GOOD, PATIENT WAS COMPLETELY RESPONSIVE, WAS ABLE TO WALK WITH THE PARAMEDIC TEAM TO THE BED. MOM AND DAD WERE ALL PRESENTED AT THE SCENE.
Information has been received from a 26 year old female dental hygienist with an allergy to penicillin and sulfonamide who on 07-MAY-2007 was vaccinated with the first dose of Gardasil (lot# not reported). There was no concomitant medication. On 21-May-2007 the patient developed vomiting which "lasted for one day". The patient also reported that she experienced nausea, dizziness and heartburn for one week following vomiting. The patient was examined in the emergency room (date not provided) and was diagnosed with gastritis. The patient reported that "blood work and an ultrasound (dates of tests not provided) were performed. The patient was not admitted to the hospital and was released that same day. The patient considered the events to be disabling. The patient reported that she recovered from gastritis and dizziness on 28-May-2007. On 04-Feb-2008 the patient received the second dose of Gardasil (lot# not reported). No additional information is expected.
iIjection site swollen, hard and red; chills, joint pain, weakness, nausea and loss of appetite, dizziness, fever, headache, elevated Blood Pressure. Still fighting symptoms, dr has now prescribed antibiotics.
Site reaction with redness and swelling; Site reaction with redness and swelling; This spontaneous case was received on 27-Sep-2021 from other health professional via Communications (reference number: SEQW21-02807) and concerned a 22-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications.   On 20-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 38518 and expiry date 30-Jun-2022.    On the same day, after receiving Flucelvax Quadrivalent, the patient experienced moderate to severe site reaction with redness and swelling. The patient was treated with unspecified antibiotics.  On an unspecified date in Sep-2021, the patient recovered from both events.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  The case is linked to 202103208 and 202103209 due to same reporter.   Company comment: The events of 'vaccination site erythema' and 'vaccination site swelling' were assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events of 'vaccination site erythema' and 'vaccination site swelling' were assessed as related to Flucelvax Quadrivalent.
ocean sound in head making not sleep and not put head down/whistling in head; ocean sound in head making not sleep and not put head down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: TINNITUS (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down/whistling in head"; SLEEP DISORDER (non-serious), outcome "unknown", described as "ocean sound in head making not sleep and not put head down".  Additional information: Reporter called about an "ocean sound in their head" making them not sleep and not put their head down. Also, there was a whistling in their head while on the phone. Reporter stated that she knows five people off the bat that has the same experience.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300124718 same reporter, product and event, different patient;
I had chest pains that mimic those of a heart attack in women for multiple months. I had to visit the cardiologist during this time. All test results came back normal according to the doctor. I have never had chest pains before until this point in time so this alarmed me greatly. I also had to use my inhaler, which I hardly used in previous years.   When I got the booster shot on 6/24/22, my adverse symptoms started the day I received the vaccine. I could not walk around for more than 5-10 minutes without needing to sit down to rest, I could not breathe- it felt as if my CO2 and O2 exchange were not occuring, while in conversation with people I had to take multiple deep breaths after about every five words because I could not seem to catch my breath, this also caused me to use my inhaler multiple times. Before any of this, I hardly used my inhaler, too. I also felt like I was about to pass out multiple times. My chest pains came back, although not nearly as bad as they were in August 2021. These symptoms lasted for about 4 days, but recently I have noticed that when I work out or go on long walks my chest pains come back and I cannot breathe as efficiently as I need to.
Started feeling very tired as the evening went on. Went to bed around 10pm and woke up at 11pm with extreme chills and violently shaking, that shortly turned into feeling very warm showing sines of a fever along with nausea. Temperature seemed to normalize around 4 am and then a severe headache followed and has lasted all day.  Slight chills started again approximately 24 hours after receiving the shot.
5 days after receiving the shot I had terrible pain in my abdomen and 2 spots that itched also on my abdomen. 8 days after receiving the shot I went to my doctor and was diagnosed with shingles. I am currently taking valacyclovir through March 19th.  No more spots have emerged and the itching/pain is very mild but I am fatigued.
Patient reported chills several hours after her injection. Following chills, the patient reported jerking of her jaw. The jerking continued and affected her entire right side of her body. She consulted emergency services at her senior living facility and was evaluated. She did not seek further emergent care and her symptoms resolved by the following day.
Moderna COVID-19 Vaccine EUA Experienced mild injection site tenderness when rubbed for 48 hours after injection.
3 COVID vaccine was administered. Patient completed Pfizer series with first dose 4/9/2021 and second dose 4/30/2021
slight pain at the site; This is a spontaneous report received from a contactable reporter (Consumer).  A 49 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Mar2021 16:52 (Lot number: EN6207) at the age of 49 years as dose 1, single for covid-19 immunization. Relevant medical history included: "breast implants" (unspecified if ongoing), notes: she has breast implants and so she will be taking antibiotics too. There were no concomitant medications. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 17Mar2021, outcome "recovered" (17Mar2021), described as "slight pain at the site".  Additional information: The patient had not received any other vaccine within 4 weeks.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021368147 same reporter/drug/event, different patients.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. On 04-DEC-2018, the patient was inadvertently vaccinated with an expired dose of VAQTA lot # N020951 and expiration date: 15-OCT-2018 (exact dose, frequency, route of administration were not provided). No adverse effects were reported. The causality assessment was not provided.
Positive "soreness", erythema (about 2 inches x 1 1/2 inches) to (L) deltoid - flu vaccine site with associated tenderness, hot to palpation.
After first two injections..tired..weak..sore..dizzy. After booster shot..experienced same symptoms as above But with chest pain. Chest pain..hard to breathe. Started on 7/7..went to er on 7/11/22 pain was too intense and breathing difficulty. Was released that night...returned to er on 7/12/22 via squad for chest pain and breathing difficulty more severe than previous day
Approximately two weeks post vax, the pt experienced a cold, shortness of breath, and stated possible walking pneumonia. His symptoms were treated with antibiotics and an asthma inhaler.
to er 12-24-22  and tested  for covid same date:   with shortness of breath and cough.  dx with pneumonia and copd exacerbation and had acute on chronic resp failure.  treated with remdesivir, oxygen , vapotherm, bipapa and baricitinib , dexamethasone and felt better and discharge was ordered 1-1-23.  He deceased under the care of Hospice
Initial bilateral lower extremity pain within 24 hours post-vaccination. Red sores/welts developed on thighs bilaterally, buttocks, and bilaterally on back upper arms. Welts grew in size and pain. No swelling in joints (knee/ankles).  Began to have difficulty walking. APAP was taken but did not alleviate pain. Hot water from shower aggravated welts.
Malaise, fevers and chills, loss of appetite x 2 days, very painful, hard, warm, swollen and redness from above the injection site almost to the elbow. Was unable to lift my arm for 3 days.
COVID-like symptoms; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID-like symptoms) and FATIGUE (Extreme fatigue) in a 72-year-old male patient 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 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 10-Mar-2021, the patient experienced FATIGUE (Extreme fatigue). On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID-like symptoms). At the time of the report, SUSPECTED COVID-19 (COVID-like symptoms) and FATIGUE (Extreme fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Weight: loss of weight (Low) Experienced loss of weight.         Concomitant medications reported included anticoagulant and statin, for unknown indication. No treatment medication were admisnistered by the patient.   This case was linked to MOD-2021-259121 (Patient Link).
Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; Swollen lymph nodes in armpit, sore arm at injection site, severe great toe joint pain; This is a spontaneous report from a  non-contactable other healthcare professional. A 49-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), second dose on 06Jan2021 at 07:30, and first dose on 16Dec2020 at 10:45; both via unspecified route of administration on the right arm at a single dose for immunization. Medical history included asthma. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included diphtheria vaccine toxoid, tetanus vaccine toxoid (TD) on 29Dec2020 at right upper arm. The patient experienced swollen lymph nodes in armpit, sore arm at injection site, and severe great toe joint pain on 06Jan2021 at  21:00. The patient did not receive treatment for the adverse events. Outcome of the events was not recovered.  No follow-up attempts are possible. Information on the batch/lot number cannot be obtained.  No further information is expected.
She had welts on her stomach, they turned into blisters that she popped and pus came out. She also got red all over her arms, chest and face. Her lips got really big. She decided to ER 09/15/2016 at 10:45 pm where she was diagnosed with shingles.
Pt recvd DTP/OPV/MMR 25APR91 & became pale w/in 24 hrs of inject; low grade fever 3 hrs post vax given APAP x 2 days; Continued to be pale & listless, dec appetite on 4th day fever 102, 5th day temp 105; Seen @ Hosp;