chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Interval between doses (55 days); This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses (55 days)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and Lot # 006B21A),) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses (55 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between doses (55 days)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No  concomitant medical  provided by the reporter. No treatment medication provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.
Body aches and soreness from 7pm after the injection (1:40pm).  24 hours after the injection was the most intense.  Upon wakin the second morning after the injection event was over.  Ibuprofen was taken to relieve symptoms with good results.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue Narrative:
16 year old twins received Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine) in a 16-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old twins received Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-064213 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-064213:case for 1st of of twin
17 year old patient received 1st dose of the Moderna vaccine at a previous clinic on 5/7/2021 despite the vaccine only being approved for use in patients 18 years and older. Based on CDC guidance and information from the manufacturer it was recommended to vaccinate patient with a second dose of the Moderna vaccine and follow the vaccine dosing schedule. No adverse effects were reported from the patient.
Head pressure; short of breath; Hot and cold; dizzy; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 34-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0191), via an unspecified route of administration, administered in arm left on 03Jun2021 08:30 as dose 1, single (at the age of 34-years-old) for covid-19 immunization. Medical history included reported as none. There were no known allergies. The patient concomitant medications were not reported. The patient did receive any other vaccine in four weeks. The patient did not have covid prior to the vaccination and patient did not test for covid post vaccination. On 07Jun2021 20:45, the patient experienced head pressure, short of breath, hot and cold, dizzy and nausea. The patient did not receive any treatment for the events. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Vaccination was on Saturday, within 10 minutes of the vaccination, my child reported her ears felt like they were popping, she felt dizzy, tight throat and jaw pain. On site nurses gave her apple juice and crackers. She reported feeling unwell, dizzy, light-headed, jaw pain and short of breath the following day, on Sunday. On Monday, we took her to urgent care for same symptoms - unwell, dizzy, light-headed, jaw pain, short of breath. Rapid COVID test and strep test were negative, EKG was normal. Urgent care doctor says it is vertigo.
Arm soreness, fatigue, chills started and resolved 11/25/2021. Hives and urticaria started 12/14/21. On demand video visit 12/15/21 resulted in Prednisone, Allegra, and Benadryl. Resolution while on steroids. Few days after completion of steroids, itching returned. Hives and itching returned/worsened resulting in in-person urgent care visit 12/24/2021.  Results inconclusive; provider thought stress levels -prednisone and hydroxyzine prescriptions provided. Hives/urticaria cleared while on Prednisone and returned once again a few days after stopping prednisone. Dermatology visits on January 4th, 2022. Provider noted hives. Prescribed higher dose prednisone therapy and 3 antihistamines, with plan to taper off antihistamines as able. Three antihistamines caused too much drowsiness that interfered with ability to work. Two antihistamines provided relief from constant itching, but still drowsy. Tapered down to one antihistamine in April 2022;' also saw primary care provider for referral to allergy specialist. Unable to follow up with allergy specialist due to insurance and copay limitations.
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 7/3/2022 OBSTRUCTIVE JAUNDICE
C/o sore arm 10/09-rec'd vaccine on 10/7 - took ibuprofen to decrease discomfort noticed increased numb increased pain in right arm - noticed softball size swelling in both armpits as seen in the ER & tx'd with IV fluids & INTERFERON - seen per neurologist & dc'd - no other meds or tx given - last of swelling gone by 10/23/09.   11/25/09 Medical records received for DOS 10/09/09.  ED records. Final DX: Flu vaccine reaction, extremity parasthesias.   C/O swelling bil axillae, weakness, parasthesias, 2 days s/p vaccine.  Light headed. Poor sensation bil feet. Neg patellar reflexes.
Information has been received regarding a case from a lawyer, spouse, and a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 15-FEB-2018, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 17-FEB-2018 [reported as approximately 3 days after receiving the ZOSTAVAX vaccine], the patient began to experience left-sided facial numbness, right-sided weakness, droopy right eye, and was diagnosed with Bell's Palsy. As a result, the patient also suffered from right-sided hearing issues shortly after being diagnosed with Bell's Palsy and continued to suffer from right-sided facial paralysis. As a direct and proximate result of the ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Bell's palsy was determined to be medically significant. Bell's palsy and right-sided hearing issues were considered to be disabling. Additional information has been requested.
Later that evening I began having severe chills, nauseous, my body was achy and I was very tired.  The skin of my upper body begin to itch and burn and got worse over the next couple day. It continued to get worse so I went back to the pharmacy on 15th but the pharmacist knew nothing regarding what I was experiencing and advised I used Aveno and swithch from Allegra to benedryl to help with the itching and if it didnt get any better to go to the dr.  Within the next couple weeks I reached out to my PCP a couple times but all he could provide it that I continued to take the benedryl because topical ointments wouldnt work.  Its still here but not as bad as it originally was.   I have a dermatologist appt on May 6th.  It had gotten better over the next few weeks but I am still experiencing the skin sensitivity.
SkinRash, Rash, red raised hive like area 10.5cm x 10.5cm Narrative: 10.5 cm x 10.5cm oval shaped red area at injection site. Slightly raised. Denies itching or pain.
A patient who got vaccinated with Fluad Quad got a second dose of Fluad Quad PFS; He didn't remember he was already vaccinated; This spontaneous case was received on 15-Oct-2020 from physician via agency (reference numbers: SEQW20-03706) and concerned an 83-year-old, male patient.  The patient's medical history included chronic kidney disease (CKD) stage 3, pre-diabetic, high cholesterol and prostate cancer. The patient's concomitant medications included Aspirin (acetylsalicylic acid), and Zocor (simvastatin), both used for unreported indication.  On 09-Oct-2020, the patient was vaccinated with the first Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was 279185.  On an unknown date in Oct-2020, the patient did not remember he was already vaccinated.  On 15-Oct-2020, six days after the first vaccine, the patient was vaccinated with the second Fluad Quadrivalent vaccine (dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) (explicitly coded as 'Extra dose administered') for flu prevention. The batch number reported was 279818.   The outcome of the event of 'forgetfulness' was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: On 09-Oct-2020, an 83-year-old, male patient was administered Fluad Quadrivalent vaccine. Six days after the first vaccine, the patient was vaccinated with the second Fluad Quadrivalent vaccine. The patient did not remember he was already vaccinated. The patient's medical history and concomitant medications were not reported. Regarding the event of memory impairment, causal role of the suspect vaccine is assessed as not related due to biological implausibility and strong confounder (advanced age). Extra dose administered is assessed as not related per company's conventions.; Sender's Comments: On 09-Oct-2020, an 83-year-old, male patient was administered Fluad Quadrivalent vaccine. Six days after the first vaccine, the patient was vaccinated with the second Fluad Quadrivalent vaccine. The patient did not remember he was already vaccinated. The patient's medical history and concomitant medications were not reported. Regarding the event of memory impairment, causal role of the suspect vaccine is assessed as not related due to biological implausibility and strong confounder (advanced age). Extra dose administered is assessed as not related per company's conventions.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was between the age of 10 and 18 years. Pertinent medical history and drug reactions or allergies were not specified. On 12-MAY-2014, the patient was vaccinated with a dose of GARDASIL (dose in series unspecified) 0.5 mL, once, intramuscularly, lot number J006850, expiry date 31-MAR-2016 or J011272, expiry date 21-APR-2016, that was exposed to 30 Fahrenheit (F) for 10 minutes on 06-MAR-2014. No adverse effects were reported. This is one of several reports received from the same reporter (linked to MARRS # 1405USA008203, 1405USA0082972, 1405USA008973, 1405USA008974, 1405USA008975, 1405USA008976, 1405USA008977, 1405USA008978, 1405USA008979, 1405USA008980, 1405USA008982). Additional information has been requested.
arm swelled up; sick; woke up in pain; My arm has a creater/Sink hole under the skin; This is a spontaneous report from a contactable consumer or other non hcp. A 48-year-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EW0153; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 11Apr2021 14:00 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included Asthmatic (Other medical history: Asthmatic), allergies: HOT PEPPERS (allergies: HOT PEPPERS), covid-19 (Prior to vaccination, was the patient diagnosed with COVID-19: Yes), Patient had historical vaccine of first dose bnt162b2 (COMIRNATY, Formulation: solution for injection,  Batch/Lot Number: EP7534; Expiration date was not reported), via Unknown route of administration, on 21Mar2021 (15:15) in left arm as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Concomitant medication(s) included norethindrone [norethisterone] (NORETHINDRONE [NORETHISTERONE]) taken for birth control.  The patient previously took sulfa and experienced drug allergy (known allergies: sulfa drugs). On an unspecified date the patient experienced arm swelled up, sick, on 27May2021 04:00 experienced woke up in pain, my arm has a creater/sink hole under the skin. No treatment was given to the patient. The outcome of event for event arm swelled up' was recovered, sick' was unknown, woke up in pain' and My arm has a creater/Sink hole under the skin' were not recovered.
I know of three people that had the original 2 Pfizer shots and within 90 days contracted the Delta variant.; I know of three people that had the original 2 Pfizer shots and within 90 days contracted the Delta variant.; This is a spontaneous report from a Pfizer sponsored program- General Company Information via contactable consumer. A contactable consumer reported for a patient (1 of 3 patients). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient received original 2 Pfizer shots and within 90 days contracted the delta variant. The reporter understand that Pfizer was asking the FDA for 6 months booster for the covid 19 to cover the Delta variant, but reporter know of three people that had the original 2 Pfizer shots and within 90 days contracted the Delta variant and six months was too late. The outcome of all events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021885306 Same reporter/ drug/ event, different patients.
C/o local vaccine reaction to PCV13-Pneumococcal. Pt. c/o fever/chills 3/23 PM after receiving PCV13. She was unable to abduct Lt arm the day after receiving PCV13. Pt. took Tylenol 1 tablet for pain. Lt shoulder ROM was improved on 3/28/17 visit, but Lt deltoid swelling and erythema 2-3 inch area surrounding injection site still painful with Lt shoulder and arm movement.
Syncope - fainted in observation area. Laceration above left eyebrow (2 cm x 2 cm) and on bottom lip. BPs 111/79 (pulse 104), 113/81 (pulse 98), O2 sat 100%.
Friday or Saturday face itching, red, warm to touch. Body feels warm to touch, like running a fever. Observed from patient face red, warm to touch with small red bumps all over resembling a rash. Instructed pt to take 25 mg BENADRYL and apply hydrocortisone to face BID. F/U in 1 day.
No additional AE reported; was administered after a temperature excursion; This spontaneous report was received from a office manager and refers to a 12-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5ml, lot # S024363 has been verified to be a valid lot number, expiration date was reported as 06-AUG-2021 (formulation, strength, frequency and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of (-10) to (8) (-4.2C) degrees Celsius for 17 hours and 30 minutes. Data logger was involved. There were no previous excursions reported.
Lots of swelling under the left armpit, severe stabbing and throbbing pain under armpit, pins and needles stabbing feeling in chest, severe collar bone pain and tenderness  Onset woke me up out of my sleep at 1:30 am and has continued without relief
Headache, Myalgia, Arthralgia, pain-scalp to feet Narrative: Pain from scalp to her feet extreme headache, lethargic, feeling feverish. Taking Motrin OTC and it is not helping so she is leaving work for this day.
Fever 101.9 and vomiting. DTaP (INFANRIX) given to a 11 y/o instead of Tdap.
Headache, Arthralgia, Fever, ErythemaMultifotm, Chills, Fatigue, Injection site pain, Rigors Narrative:
Dizzy; Felt like they were overheating; Rash on left arm; Felt achy; Wanted to sleep; Nausea (dry heaving),couldn't eat because of it; Overnight woke up with pounding headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN (Felt achy), SOMNOLENCE (Wanted to sleep), FEELING HOT (Felt like they were overheating) and RASH (Rash on left arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Overnight woke up with pounding headaches). On 26-Mar-2021, the patient experienced PAIN (Felt achy), SOMNOLENCE (Wanted to sleep) and NAUSEA (Nausea (dry heaving),couldn't eat because of it). On 28-Mar-2021, the patient experienced DIZZINESS (Dizzy), FEELING HOT (Felt like they were overheating) and RASH (Rash on left arm). On 30-Mar-2021, DIZZINESS (Dizzy), PAIN (Felt achy), SOMNOLENCE (Wanted to sleep), FEELING HOT (Felt like they were overheating), RASH (Rash on left arm), HEADACHE (Overnight woke up with pounding headaches) and NAUSEA (Nausea (dry heaving),couldn't eat because of it) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Treatment medication included Tylenol and lotion.   This case was linked to MOD-2021-068389 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient's demographics was updated.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2009, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles. In 2013, the patient was treated at the same medical office for a blistering vesicular outbreak which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
chills, fever 99.7, sore all over even fingernails, legs felt like jello.  tongue was numb, throat was tight feeling, started to feel better when she felt needles sticking into fingers.
stuffy nose; COVID positive; chills; cough; headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), NASAL CONGESTION (stuffy nose), SARS-COV-2 TEST POSITIVE (COVID positive), HEADACHE (headache) and CHILLS (chills) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Weight loss. Concomitant products included AMOXICILLIN for Scratch, METFORMIN for Weight loss, ROSUVASTATIN, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) and LEVOTHYROXINE for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced COUGH (cough) and HEADACHE (headache). On 30-Mar-2021, the patient experienced CHILLS (chills). On 31-Mar-2021, the patient experienced NASAL CONGESTION (stuffy nose) and SARS-COV-2 TEST POSITIVE (COVID positive). The patient was treated with IBUPROFEN (ADVIL ULTRA [IBUPROFEN]) at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. On 01-Apr-2021, CHILLS (chills) had resolved. At the time of the report, COUGH (cough), NASAL CONGESTION (stuffy nose), SARS-COV-2 TEST POSITIVE (COVID positive) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, SARS-CoV-2 test: positive (Positive) positive for COVID19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Misinformation was given to the pre-screening nurse--given 2010 as year of birth by patient's mother. Vaccine given--later discovered that pt is 10 years old instead of reported 12.