chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stuttering; periods of screaming; spinning oneself; excessively playing with doors, lights and windows; diarrhea; nightmares; bed wetting; itchy eyes; runny nose; belly aches; social withdrawal; hitting others.
Patient reports that left arm became painful the evening of 3/2/16.  Deltoid is reddened and hard and warm to touch.  Patient states today (3/4/16) it is difficult to move her left arm.
2 episodes of 2 second tonic appearance of both arms with slight eye deviation.  (+) Immediate recovery with postictal state - no other neurologic symptoms - pt irritable during period of time as well.
Received shot in left arm - next day my right shoulder and arm started hurting and then maybe 2 days later my hip and leg started hurt.
itchy rash; rash on the neck,chest, back, legs, arms (inside of my arms - both arms; terrible body ache; chills; severe headache; nauseated for hours; 101 fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash), RASH (rash on the neck,chest, back, legs, arms (inside of my arms - both arms), MYALGIA (terrible body ache), CHILLS (chills) and HEADACHE (severe headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: Johnson & Johnson vaccine on 17-Mar-2021. Concomitant products included VENLAFAXINE, METFORMIN, METOPROLOL, APIXABAN (ELIQUIS), VITAMIN D3, CALCIUM, VITAMIN 15 and PANTOPRAZOLE for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Nov-2021, the patient experienced MYALGIA (terrible body ache), CHILLS (chills), HEADACHE (severe headache), NAUSEA (nauseated for hours) and PYREXIA (101 fever). On 15-Nov-2021, the patient experienced RASH PRURITIC (itchy rash) and RASH (rash on the neck,chest, back, legs, arms (inside of my arms - both arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 14-Nov-2021 at an unspecified dose and frequency. On 14-Nov-2021, MYALGIA (terrible body ache), CHILLS (chills), HEADACHE (severe headache), NAUSEA (nauseated for hours) and PYREXIA (101 fever) had resolved. At the time of the report, RASH PRURITIC (itchy rash) and RASH (rash on the neck,chest, back, legs, arms (inside of my arms - both arms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Erythematous, warm around VX 81 T 7 x 9 cm.
Lump on left collarbone, visit to PCP who referred to General Surgeon, lump was enlarged lymph node that surgeon removed on 4/20/2021.  Result was benign.
This spontaneous report was received from a 55 year old female patient with food allergies and migraines and no drug allergies/reactions. On 15-FEB-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # reported as 998115, dose and route not reported). Concomitant therapies included progesterone. On 16-FEB-2013 (the day after the vaccine), the patient had a migraine for 2 days. The patient saw the allergist for medical attention. No treatment was given for migraine. No lab diagnostics studies were performed. As of 17-FEB-2013, the patient recovered from migraine. The patient stated she was all better now. The patient was trying to figure out if something else she ate might have brought on her recent migraine and would like to know what foods used (corn or egg perhaps) in the production of shingles vaccine. Additional information has been requested.
Fever, headache, sweating, left armpit very painful(assuming my lymph nodes are swollen), exhaustion, body aches, chills, arm pain(to be expected), feeling unwell.  Just resting arm down my armpit hurts!
Starting 12/20/2022, I had a fever of 101.7, and I had a sore throat, hoarseness and cough. I tested myself for COVID-19  with an at-home test and it was positive. I decided I would go to urgent care the next day and get a confirmation test and for treatment. They did a swab for Flu and COVID-19 and it came back positive for COVID-19. They prescribed Paxlovid and Benzonatate capsules for cough. I started taking them right away. The Paxlovid tasted awful but I did finish it. The fever went away quickly. The hoarseness and fatigue lasted until about January. On 01/02/2023 I went back to urgent care and they tested me for COVID-19 again and I was positive. They said I either had it again or it never went away. Also, I had oral thrush at that time. They gave me a prescription for 1 capsule for oral thrush. She told me to treat the other symptoms with over the counter medications. I was also told to isolate again for 5 days and then wear a mask for 5 days when going out. I am feeling fine now.
Pt developed severe nausea vomiting 3 days after vaccine administration. Unable to tolerate PO including meds. Went into DKA and had NSTEMI following.
This spontaneous report was received from a healthcare worker regarding an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported) and on an unknown date, with the second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). There was no adverse effects reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 15 year old patient of unknown gender. On 08-JUL-2014 the patient was vaccinated with a dose of improperly stored GARDASIL (lot # J009788, expiration date: 17-MAR-2016, strength, dose and route unknown), which was exposed to 31 F for one hour. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash on the face; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2020, the patient received the 1st dose of Shingrix. On 11th February 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced rash on face one day after receiving the dose of Shingrix. The reporter consented to follow up. No vaccine's data provided.
pt recv vax 20AUG93 & 4 days later exp nausea, lightheadedness, palpitation & confusion stated as slow thought process & to ER approx 1 wk following the vax; drank large amounts of water & food & felt better; pt had low BS;eye yellow;
Right arm hurt more than usual after flu shots shortly after shot given.  At 11 p.m. had chills, fever.  Right arm continued to hurt for 1-2 weeks.  Noticed Left arm also started hurting during the 2nd week after shot.  Describes pain as 11 on 1-10 pain scale. Saw different MD, who did MRI, and referred to Physical Therapy.  Completed PT in 6 weeks, with continued but less severe pain.  Also noticed left leg pain.  Continues with pain in both upper arms and left leg, rated as 4 on 1-10 pain scale.
This spontaneous report was received from a healthcare worker who refers to a 5 year old patient of unknown gender. On 29-AUG-2013 the patient was vaccinated with an expired dose of M-M-R II lot # 671320/1121AA (rHA), expiration date 17-JUL-2013. No adverse effect reported. The outcome and action taken were not reported. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 04Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid fluctuations" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 10Feb2023 to 15Feb2023. 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-202300078241 same reporter/patient/product, different dose/event.;
lymphocyte count high 4.0 m 4/11/2022, 3.6 on 11/22/2022 monocyte count high 1.0 m 4/11/2022, 1.0 on 11/22/2022
On 24-AUG-2009 pneumococcal vaccine, polyvalent (23-valent) and pneumococcal vaccine (unspecified)/ on 06-JAN-2016 pneumococcal vaccine conj 13v (crm197) and 22-SEP-2016 pneumococcal vaccine, polyvalent (23-valent); This spontaneous report was received from a nurse practitioner, referring to a 70-year-old patient, via a immunization record from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs# 1801USA001762). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.    On 24-AUG-2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis and with pneumococcal vaccine (unspecified) (strengths, doses, routes of administrations, anatomical locations, lots numbers, and expirations dates were not reported). On 06-JAN-2016, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) and on 22-SEP-2016, was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strengths, doses, routes of administrations, anatomical locations, lots numbers, and expirations dates were not reported)(inappropriate schedule of product administration).      This is one of two reports from the same patient.; Sender's Comments:  US-009507513-1801USA001762: US-009507513-2107USA008801:
It was First Punctured at 10AM on 20JUL2021 and kept at 69 Fahrenheit; kept at room temp for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It was First Punctured at 10AM on 20JUL2021 and kept at 69 Fahrenheit) and PRODUCT TEMPERATURE EXCURSION ISSUE (kept at room temp for 26 hours) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (It was First Punctured at 10AM on 20JUL2021 and kept at 69 Fahrenheit) and PRODUCT TEMPERATURE EXCURSION ISSUE (kept at room temp for 26 hours). On 21-Jul-2021 at 11:30 AM, EXPIRED PRODUCT ADMINISTERED (It was First Punctured at 10AM on 20JUL2021 and kept at 69 Fahrenheit) and PRODUCT TEMPERATURE EXCURSION ISSUE (kept at room temp for 26 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that patient has received vaccine from an expired vial. She stated that one punctured vial of Moderna COVID-19 vaccine was kept at room temp for 26 hours. The vial was moved from refrigerator to the room temperature on 20-JUL-2021 around 7:30AM and was first punctured at 10AM on 20-JUL-2021 and kept at 69 Fahrenheit. The vial was never exposed to temperature excursion in the past.  No relevant concomitant medications were reported. No treatment information was provided.
One week after the second dose of the Pfizer COVID-19 vaccine (4/8/2021), I woke up with loud bilateral tinnitus, which has not stopped since. Working with three different doctors (Primary Care, ENT, & Audiologist), I have tried courses of oral steroids, oral antibiotics, antibiotic ear drops, oral antivirals, over-the-counter ear ringing drops, and over-the-counter ear ringing tablets. None of these medications have stopped the ringing. Per my Audiologist, I am presently trying sound therapy to mitigate the ringing before we proceed with hearing aids.
Fever, aches, shaking, chills, diarrhea, bed ridden for 24+ hours, lingering headache,
administered: 04-FEB-2005, 30-OCT-2009; This spontaneous report was received from a physician and refers to a 65-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapies and other events were described in main case (US-009507513-1904USA006765).  On 04-FEB-2005, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The patient received another dose on 30-OCT-2009.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1904USA006765:
I have had severe Diarrhea, that started a week after the vaccine.  I am currently on Lomotil, but have break-through diarrhea, and if I stop the diarrhea comes right back.  I am going  sometimes 2-3 times an hour, day and all through the night.
In addition to the expected chills, arm pain,  achiness, & fever of 101, I experienced such severe nausea that I was unable to even sip water. I also experienced the worst migraine pain of my life, even though I have had chronic migraine for 50+ years, & was so nauseous that I was unable to take my migraine medication. I was unable to get out of bed & lift my head off the pillow. I also experienced 2 hours of severe foot cramps in both feet, which I have never had before. I am 66, live alone, & if I had not been too ill to move my head, I would have gone to the hospital for intravenous medication. The illness lasted from 11 pm till 4pm the next day. I worked as a medical assistant for 32 years & I would not describe this as simply side effects of a vaccine, but felt seriously ill.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX (batch number P3777, expiry date 30th January 2020). Concomitant products included PNEUMOVAX 23. On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were not recovered/not resolved. The reporter considered the injection site erythema and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. On the same day, the patient concomitantly received PNEUMOVAX 23 (batch number N031947, other manufacturer) in the right deltoid. The pharmacist reported that a consumer experienced redness and an elongated rash at the injection site. It was not painful. It had been 10 days since she had received the vaccine and the symptoms had not resolved. The reporter was unable to provide additional details. He would call back if he obtains more information.
Dizziness, Myalgia, Arthralgia, Fever,  Fatigue, Chills, Injection Site Pain Narrative:
Pregnancy miscarriage at  91/2 weeks spotting started 10/25/09 ultrasound determined pregnancy failed to progress post 91/2 wks; corresponding to date of vaccination.
threw up a little bit of orange stuff; needed help getting out of truck and into house,/could barely walk; Patient was weak. Heat, may have been warm; Heat, may have been warm; This case was reported by a pharmacist via sales rep and described the occurrence of vomiting in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 2g2x7, expiry date 29th July 2023) for prophylaxis.   Previously administered products included Shingrix (received first dose on 28th April 2022).   On 19th July 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 19th July 2022, 30 min after receiving Shingrix, the patient experienced vomiting, unable to walk, weakness and feeling hot. On an unknown date, the outcome of the vomiting, unable to walk, weakness and feeling hot were unknown.   It was unknown if the reporter considered the vomiting, unable to walk, weakness and feeling hot to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-JUL-2022 Reporter's comment: The patient received a dose of Shingrix and was weak when he got home and needed help getting out of truck into the house. He could barely walk and threw up a little bit of orange stuff. He had been warm since there was no AC in car nor at home and he did not wanted to go to doctor as he suffered from heat and his truck had no AC. The reporter consented to follow up.
COVID test positive; COVID test positive; Vaccine brand other: Moderna Bivalent/ vaccine brand: Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: E1685), in left arm, on 07Jan2021 as dose 2, single (Lot number: EJ1686), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 26May2022 as dose 4 (booster), single (Lot number: FN2908), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 02Nov2022 as dose 5 (booster), single (Lot number: 016H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "shrimp" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neomycin, reaction(s): "known allergies: Neomycin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2022, outcome "unknown", described as "Vaccine brand other: Moderna Bivalent/ vaccine brand: Pfizer / BioNTech"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID test positive". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information, a lack of efficacy (Vaccination failure and COVID-19) under Interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Patient had two episodes of seizure 9 days after the covid vaccine (11FEB21) . He didn't had past medical history of seizures. This event happened on the 20th FEB 21. Went to the hospital and is following up with Neurology.
Massive headache for 24 hours following the 2nd dose  Mini stroke (TIA)
Approximately two to four minutes after vaccination, the patient's significant other stated the patient was dizzy.  Nursing staff noted the patient was having jerking movements and patient became slumped over.  911 was called.  Nursing staff obtained vitals and administered an Epi Pen 0.3 mg at 1415.  Patient became alert and was able to communicate.  Initial vials were pulse 52, Sp02 94%, and B/P 140/72.  Vitals were taken again at 1419 and pulse 72, Sp02, 94, and B/P 112/70.  Emergency medical crew arrived and assessed patient.  Patient signed paperwork declining to go to the ED.  Patient felt her condition had stablized.  Patient was advised to contact her Primary Care Physician on Monday or call 911 STAT is any issues arise.  Patient left the drive-up with her significant other.  Patient was seen by her PCP on 4/6/2021.
Pt's original reported DOB was 2/27/1982.  Insurance records indicated pt's DOB is 3/17/2010.  Moderna is not approved under EUA for anyone younger than 18 years old.  Pt recieved a 2nd dose of Moderna vaccine lot # 033c21a in the LD on 5/26/2021
PATIENT HAD WIDESPREAD, BRIGHT RED, PIN-PRICK LOOKING RASH ON LEGS, ARMS, BUTTOCKS. PATIENT SAID IT WAS VERY ITCHY. SAW PHYSICIAN TODAY 9-17-18 AND WAS RECOMMENDED BENADRYL.
Sweaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CRESTOR. Vaccination history included: Covid-19 vaccine (Dose: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweaty".  Additional information: Patient mentioned that she started taking "-statin, which is a generic for Crestor" after the third dose; however, patient cannot verify the exact date as she mentioned she cannot exactly remember it but she also mentioned that she was taking "5mg and was increased to 10mg before the first booster." Patient also mentioned "November" but she cannot confirm this information. Patient wanted to know if taking "statin" was related to the COVID vaccine. Patient stated that she feel a little better, but she was sweaty and just wanted to let Pfizer know that she experienced this. After providing response about the potential interaction of "Crestor and/or -statins", patient mentioned that it was just a minor side effect and it was probably too early to know if there are reported side effects from the second booster dose. Patient also stated that she had already read information about the side effect from the internet.  The lot number for bnt162b2 was not provided and will be requested during follow up.