chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Full body chills; This is a spontaneous report received from a non-contactable consumer, the patient. A 40 -year-old non-pregnant female patient, received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN,) solution for injection in the left arm, on 15Mar2021 at 13:15 (at the age of 40-years-old) for COVID-19 immunisation. The patient's medical history and drug history included penicillin allergy. concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not undergone COVID-19 test. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 15Mar2021, at 19:00 hours the patient experienced full body chills. No therapeutic measure was taken for the adverse event. At the time of report in Mar2021, the patient had recovered from full body chills.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SOB, hypoxia, COVID + at Nursing home. no remdisivir (outside of window); tocilizumab, decadron, intubated; AKI; transfer to hospice
Uncontrollable crying, high fever (104 deg), lethargy on 12/22/01. Loss of language and eye contact in the week to follow. Autism. The 60 day follow up received on 1/7/04 states no eye contact, poor communication, no social skills, sensory integration disorder, autistic traits, higher than normal blood titers.
Rash on his right inner and posterior thigh and calf. Also with two small rashes left buttock.
Information was received from a nurse referring to an unknown number of unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On unspecified dates, the patients were administered doses of improperly stored M-M-R II injection, recombinant human albumin (rHA) (lot# M039913, expiration date 26-SEP-2018; lot# M042846, expiration date 21-OCT-2018) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. The concomitant therapy included sterile diluent which was used to reconstitute M-M-R II injection, was stored properly. The vaccines were exposed to 47 to 77 Fahrenheit degree (F) for 2 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects was reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Lot number (M042846) has been verified to be a valid lot number for M-M-R II.; Sender's Comments: US-009507513-1707USA012152: US-009507513-1707USA012416: US-009507513-1707USA012417: US-009507513-1707USA012418: US-009507513-1707USA012419:
A non-serious spontaneous report of inadvertent administration of a partial dose only was received from a registered nurse/health professional concerning an eight-year-old child of unknown gender. Neither relevant medical history nor concomitant medications have been reported for this patient. On 09-Jan-2010, a nurse failed to remove the dose divider clip of H1N1, Intranasal and administered approximately half of the dose, divided into both nostril of the patient. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Redness, swelling and hot to touch at injection site. Area measures 6 cm x 8 cm.
Moderna dose #1 Given 4/21/21 Lot # 047B21A IM Right deltoid at the same clinic as booster Moderna dose #2- Given 5/19/21 Lot # 026C21A IM Left deltoid at the same clinic as booster Moderna booster- Given 12/14/21 Lot #030H21B IM right deltoid  Patient is a 19-year-old male who presented to the ED at a local Medical Center on 12/29/2021 with acute onset of chest pain. The chest pain occurred at rest while playing video games at his home.  He had fairly abrupt onset and progressive worsening of left-sided double chest discomfort with associated shortness of breath and diaphoresis. Troponin levels resulted at 0.67 ng/mL and continued to trend up to 4.27 the next day. Repeat EKGs show inferior ST segment elevation The following medications were started to treat myopericarditis on 12/29/21: heparin drip, aspirin 81 mg daily with loading dose,  atorvastatin 80 mg daily, colchicine 0.6 mg BID, ibuprofen 600 mg TID and metoprolol 12.5 BID.
Patient received PCV23 at 1:20 PM on 1/22/2016. At 4PM on 1/22/216, patient developed swelling at the injection site/arm (left arm) from the left elbow to left side of the neck. MD on call was notified, MD ordered ice applied to the left arm. On 1/23/2016 at 4PM, pt. developed a low grade fever of 99 degrees, the left arm continued to be swollen, painful and warm to touch. MD on call notified, patient ordered to be sent to local ER for evaluation. Patient diagnosed with cellulitis, KEFLEX ordered.
Severe chills, body aches, headache all over head with ear pain, fever, nausea. All started 10 hours after shot and started slowly resolving 12 hours later, except the severe headache that continued to linger.
Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 25th of 40 adult patients.  Concomitant product use was not provided by the reporter.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
Pt devel rash x 2 wks, hives x 2 wks; 2mm pink macule & poss urticaria;
Severe, persistent eczema-like rash to diaper area that appeared first on 5/21/19. Rash has peeled, improved, and reinflamed multiple times and continues to be ongoing. Rash is not fungal or bacterial per pediatrician. Moisturizers, barrier creams are ineffective. Changed diaper/wipe type, soaps, and cannot find an allergen that could be the cause.
The day after my vaccine I woke up with a very bad headache stomach ache diarrhea fever and chills and all of my symptoms besides a severe headache have subsided I am on week eight of a constant headache I have had to ER visits one of which was because of my headache and elevated blood clotting factors
Itching on back, arms, thighs and hands; occasional shortness breath.; Bumps on thighs and arms; This is a spontaneous report from a contactable consumer (Patient). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EM9809), dose 1 intramuscular, administered in Arm Left on 09Feb2021 15:00 (at the age of 68 years) as dose 1, single for COVID-19 immunisation at health Department. Medical history included high blood pressure, high cholesterol and hormone replacement. Concomitant medication(s) included amlodipine besylate (AMLODIPINE BESYLATE) taken for hypertension (taking it for a few years), simvastatin (SIMVASTATIN) taken for blood cholesterol increased (taking for years), estradiol (ESTRADIOL) taken for hormone replacement therapy (taking for a long time but not as long as her others. On 11Feb2021, consumer experienced itching, bumps and sometimes shortness of breath. Consumer would like to know what consumer can do about it and was there something can take so it won't come back or will it come back. Prescriber not provided. Itching and bumps came late at night around midnight and it went away all during the day and then it came back again at night, but today, it came back this morning. It did not do that yesterday. Shortness of breath came back this morning but consumer does not have it now. The patient underwent lab tests and procedures on an unspecified date which included blood cholesterol and blood pressure measurement: high. The outcome of event occasional shortness breath was recovering and for all rest events was not recovered.   Follow-up attempts completed. No further information expected.
pt states arm pain, loss of appetite, body chills. Arm appears red, slight swollen, and pt states it is warm to touch.
diarrhea; INTENSE STOMACH CRAMPING; Nausea; Vomitting; This case was reported by a nurse via patient support programs and described the occurrence of diarrhea in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included treprostinil (Tyvaso) (batch number 2101674, expiry date 30th April 2020) for pulmonary arterial hypertension and riociguat (Adempas) for an unknown indication.   Concurrent medical conditions included pulmonary arterial hypertension (had primary pulmonary arterial hypertension). Concomitant products included diltiazem.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On 31st July 2019, the patient started Tyvaso (inhaled) at an unknown dose 4 times daily. On an unknown date, the patient started Adempas at an unknown dose and frequency. On an unknown date, 2 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced diarrhea, stomach cramps, nausea and vomiting. The action taken with Tyvaso was unknown. Adempas was discontinued. On an unknown date, the outcome of the diarrhea, stomach cramps, nausea and vomiting were unknown.   It was unknown if the reporter considered the diarrhea, stomach cramps, nausea and vomiting to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient received dose of Flu vaccine and experienced  diarrhea, intense stomach cramps, nausea and vomiting. The patient reported that stopping Adempas, helped to relieve the issues. On 31st July 2019, the patient received Tyvaso 6mg per ml for primary pulmonary arterial hypertension by inhalation as a treatment medication. The patient received Diltiazem as a treatment medication. No further details were provided.
No MICR. Pfizer per chart Hospitalized 1/9/22-1/21/22 SOB, fever, diarrhea, PNA, hypoxia, dehydration, respiratory failure
Fever, Chills, painful joints, sore injection site, red and edematous (approximately 8 cm diameter and 1 cm raised).
Redness, sharp pain,  shot area lump, redness  swollen arm lump which went down to the elbow on left side.  Doctors appointment who prescribed clindamycin. To take for 7 days 3 daily.. started 3/16/21.
Soreness at injection site; edema (size of a palm/hand); itchy; skin discoloration.
Pt received a Pfizer vaccination on 8/28 reported feeling lightheaded and then passed out but came too within seconds, Pt remained in seat entire time.  Pt reported he frequently passed out when getting vaccinations which was not disclosed prior to administration, vaccination questionnaire was marked no to fainting.  Pt was monitored 30 minutes and provided water, pt reported full recovery
Severe pain to injection area and entire upper arm. It was so severe I was unable to perform daily activities for several days. The pain has subsided but is still there even with Tylenol. I not have only kidney from donation and not comfortable taking so much medication
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient became dizzy and fell out of chair in waiting area around 7 minutes post-vaccination. He revived almost immediately and reported that he felt dizzy. He was given a bottle of water and a snack and was monitored for 30 minutes. Patient recovered well.
02/08 @ 1700 Sore throat. @2300 with fever of 102.5, chills, sweating, body aches, nausea, nasal congestion.  02/09/21:  Fever continues, chills, sweating, body aches, nausea, nasal congestion and dry heaving. Fever broke at 1300, body aches subsided,  continued with chills and sweating, nasal congestions, sore throat and dry heaving.  02/10/21: Chills and sweats GONE, body aches GONE,. Sore throat still, with nasal congestion and NEW SYMPTOM: COUGH with phlegm.  2/11/21: Nasal congestion continues and cough feels like pneumonia or bronchitis. All other symptoms are gone.
Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 037K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Drug allergy (Ibuprofen), Allergy to antibiotic (Cipro), Drug allergy (Morphine), Drug allergy (Narcan) and Drug allergy (Vicodin).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2020, SARS-CoV-2 test: positive (Positive) Positive. On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
flu-like symptoms; his tummy hurts; shot sight is red; 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 INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL PAIN UPPER (his tummy hurts) and VACCINATION SITE ERYTHEMA (shot sight is red) 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 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 INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL PAIN UPPER (his tummy hurts) and VACCINATION SITE ERYTHEMA (shot sight is red). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL PAIN UPPER (his tummy hurts) and VACCINATION SITE ERYTHEMA (shot sight is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment medications were not provided by the reporter.
Severe muscle cramps/spasms in b/l legs and thighs. B/l feet cramping. Right foot and wrist dropping/pointing downward. Muscle pain. Trouble with gait.
had a fall; This is a spontaneous report from a contactable nurse who reported for her grandmother. A 94-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 29Dec2020, at the age of 94 years, at a single dose for COVID-19 immunization. Medical history included patient was admitted for a broken hip on 19Nov2020, and was then transferred to another institution on 24Nov2020; and patient does have a diagnosis of dementia. There were no prior vaccinations within 4 weeks. There were no concomitant medications. The reporter is a Pfizer Employee calling in regards to the COVID-19 vaccine. She was calling in regards to her grandmother who is in an inpatient rehabilitation facility. On the 16Jan2021, the patient had a fall in the rehab facility and was admitted into the hospital as a part of the facility's fall protocol. The patient was on Lovenox. The patient was admitted into the hospital on 16Jan2021 and was evaluated and discharged on 18Jan2021. At that point on 18Jan2021, Lovenox was stopped. The event was reported as serious per hospitalization. The facility has also been testing residents weekly. The patient was tested negative in the hospital when she had the broken hip and also negative when she went into the hospital for the call. The outcome of the event was recovered on 18Jan2021.  No follow-up attempts are possible; information on lot/batch cannot be obtained.; Sender's Comments: The reported fall likely represents an intercurrent medical condition in this 94-year-old female, and is considered unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Pt started hurting after about 36 hrs. Every other day my arm, legs,head ached badly, my ears bled pt had difficulty hearing. Was seen by Dr pt Rt eardrum has a hole in it - now it is crusted with blood. Pt was Tx with antibiotics and drugs.
Received flu vaccine on Monday at 14:15, by that evening, the site had become reddened and hot to touch. By morning, it was grapefruit sized, reddened area, hot to touch.
Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. Patient placed on ECMO and imaging revealed bilateral large pulmonary embolism as likely etiology of arrest. Risk factors included oral contraceptive use.  Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21.
Information has been received from a registered of pharmacist concerning a female who on approximately 24-NOV-2010 inadvertently was vaccinated with a dose of VARIVAX (Merck) (Lot# not reported) instead of a dose of ZOSTAVAX (Merck). No symptoms were reported. Additional information has been requested.
I have been experiencing dizziness since Monday evening when I woke up, it has eased up but it has not gone away.
Paresthesia got worse after the 2nd dose; first dose ofShingrix in early Nov 2019 and the 2nd dose in early Dec 2019; This case was reported by a consumer via call center representative and described the occurrence of paresthesia aggravated in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019). Concurrent medical conditions included paresthesia.   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced paresthesia aggravated. On an unknown date, the outcome of the paresthesia aggravated was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the paresthesia aggravated to be related to Shingrix.  Additional details were provided as follows: In November 2019, the patient received 1st dose of Shingrix. The patient received 2nd dose of Shingrix in early December 2019. After vaccination, paresthesia got worse. The patient received 2nd  dose early than the recommended schedule, which led to shortening of vaccination schedule. The reporter stated that at the time of reporting, paresthesia aggravated plateaued.
Got extremely weak when provoked to laugh, almost fell down. I thought it was funny at the time, thinking my baby was pressing a nerve in my back. However, it progressed until I was getting cataplexy at any strong emotion. And the excessive sleepiness has progressed to the point of daily hallucinations at bedtime, micro-sleeping at work, and sleeping every time I am a passenger in a car. I have a 17-month-old baby now, and I fear holding her and having a strong emotion, not to mention losing my job for sleeping at work. I do not drive right now because I have no car, but when we do get one, I don't want to drive more than to work and back.
Information had been received on 26-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 04-OCT-2017 (Date is conflicting information.) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 10-DEC-2013, the female patient was treated at a family practice facility for a vesicular outbreak that was diagnosed as severe shingles.  The female patient was prescribed gabapentin for management of her painful symptoms.  As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Additional information has been requested.