chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a 15 year old female patient. No information on patient's pertinent medical history, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with the first dose of unidentified Merck HPV vaccine (unknown if GARDASIL or GARDASIL 9), dose, route, lot number and expiry date were not provided). The patient had no adverse effects after first dose. Approximately on 29-SEP-2016 (reported as 2 weeks before the time of this report), the patient was vaccinated with the second dose of unidentified Merck HPV vaccine. There were no concomitant medications. On an unspecified date in 2016 (reported as shortly after the injection), the patient experienced pain at the injection site. Approximately in October 2016 (reported as a week and a half after the second dose injection), the patient had swelling, warmth to the touch and an unspecified mass or knot at the injection site. The patient sought medical attention by an office visit with the physician and was prescribed ibuprofen. The primary reporter reported that all the symptoms listed above did not improve. The outcome of events was reported as not recovered. The causality between events and the vaccination with unidentified Merck HPV vaccine was not provided. Additional information has been requested.
30 minutes to 2 hours after shot: Swelling of left eye (eye completely shut), some hives on back, and swelling and redness of injection site (left leg). Day after shot: continued swelling of left eye (less severe) and some swelling of right eye.
DISPENSED FROM PHARMACY, BUT PHARMACY DID NOT ADMINISTER VACCINE. ADMINISTERED BY HOME HEALTH CARE NURSE.  Technician grabbed wrong patient's vaccine bag (same last name), gave bag to home health care nurse, and home health care nurse vaccinated patient with high-dose flu shot without checking patient name on bag. Patient was to receive regular quadrivalent flu shot, but recieved high-dose flu shot instead. No adverse drug events to report at this time.
Lung Infection; Difficulty Breathing; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung Infection) and DYSPNOEA (Difficulty Breathing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Difficulty Breathing) (seriousness criterion hospitalization prolonged). On 12-Apr-2021, the patient experienced PNEUMONIA (Lung Infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 12-Apr-2021 due to DYSPNOEA and PNEUMONIA. On 14-Apr-2021, PNEUMONIA (Lung Infection) had resolved. At the time of the report, DYSPNOEA (Difficulty Breathing) outcome was unknown.            Reporter states patient got released from  hospital after 1.5days , Patient never had lung infection in the past and all of a sudden she had one right  about 2 hours after vaccination  No concomitant medications reported by Reporter No treatment medications provided by the reporter  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Pfizer covid vial diluted.  Drawn out and administered 3 doses from dilluted vial. Upon drawing up 4th dose, there was not enough solution.
uncontrollable crying, redness & swelling @ inj site;adm to hosp for 24hr observation, IV DPH given per MD office
patient states  a few days after the vaccine she woke up with her heart pounding,  she was very dizzy and her blood sugar went up to 210 which she states is unusual for her.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 9:53 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
Chills, fatigue, fever, body aches, headache, lower back and hip pain, diarrhea, sore arm. Started about 6 hours after injection. All symptoms except sore arm and diarrhea stopped after about 36 hours after injection. Took acetaminophen and Advil and excederin to alleviate some symptoms starting about 12 hours after injection.
Lt shoulder pain, chills, myalgias, diarrhea, local redness and swelling.
SHINGRIX administered intramuscularly to right deltoid while standing patient then a few seconds later said she felt dizzy/lightheaded she immediately sat down. Her eyes started rolling back in her head and her head tilted back she was unresponsive upon questioning, breathing labored. then at 1:20pm pharmacist administered epinephrine 0.3mg into her Right thigh muscle and had a coworker call 911.  A few seconds after she was able to respond and speak sentences and breathing seemed to regulate. She felt like she was going to vomit and needed to make a bowel movement when the paramedics arrived.
A month after taking my second dose, I had a fever over 102 - that would not go away. I also had body aches and was fatigued. I talked to my doctor on the phone. I also took a Covid-19 test, which came out negative. My doctor recommended for me to go to the Emergency Room.  I went to the Emergency Room and I took many tests. I was later diagnosed with the CMV virus.
sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a few days) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a few days). On 21-Mar-2021, PAIN IN EXTREMITY (sore arm for a few days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090547, US-MODERNATX, INC.-MOD-2021-090554 (E2B Linked Report). This case was linked to MOD-2021-090584 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090547:Wife dose 1 case US-MODERNATX, INC.-MOD-2021-090554:Wife dose 2 case
rash looks like rash of poison Ivy that patient had developed before when he was exposed to poison ivy.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash looks like rash of poison Ivy that patient had developed before when he was exposed to poison ivy.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Poison ivy rash.    On 09-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced RASH (rash looks like rash of poison Ivy that patient had developed before when he was exposed to poison ivy.). At the time of the report, RASH (rash looks like rash of poison Ivy that patient had developed before when he was exposed to poison ivy.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.
Has not received 2nd dose yet; felt sick; felt bad; runny nose; Felt like she was coming down with something; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt sick), FEELING ABNORMAL (felt bad), RHINORRHEA (runny nose), DEPRESSED MOOD (Felt like she was coming down with something) and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose yet) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MALAISE (felt sick), FEELING ABNORMAL (felt bad), RHINORRHEA (runny nose) and DEPRESSED MOOD (Felt like she was coming down with something). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose yet). At the time of the report, MALAISE (felt sick), FEELING ABNORMAL (felt bad), RHINORRHEA (runny nose) and DEPRESSED MOOD (Felt like she was coming down with something) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Information has been received from a 62-year-old female physician, with a history of hepatitis B and an allergy to penicillin, who in February 1997, was vaccinated with a dose of ATTENUVAX vaccine (Enders-Edmonston) (formulation unknown). On 25-APR-2008 the patient had a negative measles titer. No problems reported. A product quality complaint was not involved. Additional information has been requested.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 1-year-old patient who received Hib (Hiberix) (batch number 242A7) for prophylaxis.   On 20-JAN-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
The patient recently had an abnormal papanicolau (PAP) smear; This spontaneous report has been received from a consumer via company representative. The information provided about the patient's concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history was unknown by the reporter.  On an unspecified date in 2006, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection for vaccination (strength, dosage schedule, route of administration, anatomical site of vaccination, vaccination scheme frequency, lot number, and expiration date were not reported).  On an unspecified date (reported as recently), the patient had an abnormal Papanicolaou (PAP) smear (smear cervix abnormal). On 23-SEP-2020 (reported as yesterday), the patient completed a loop electrical excision procedure ((LEEP) reported as LEAP) which results are not available yet. At the reporting time, the patient was recovering from the event and did not south for medical attention.   The causal relationship between quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the events occurrence was not provided.
Pfizer-BioNTech COVID-19 Vaccine EUA: one day after receiving vaccine patient presents to urgent care with left eye swelling, drainage, and burning sensation. Patient also reports nasal congestion for one month. Diagnosed with sinusitis and acute conjunctivitis, possibly due to COVID-19 vaccine, virus, bacteria, foreign body, or chemical/mechanical injury. Prescribed oral and ophthalmologic  antimicrobials. Discharged to home.
Pt was accidently scheduled in error when mom called to make covid vaccine appointment for sibling that is older.   Mom asked to add him on the schedule as well and he accidently was added on.  He was administered by covid vaccine in error.  Mom reported to the physician here that does not have any side effects from the vaccine.  We have reported information to the CVSM and the state is looking into it and going to return our call.
Onset of severe HEADACHE on 11/09/03 after Flu Vaccine on 10/29/03 Ultimately she had MRI(brain) CT (brain), ER visits *3+ ,Hospitalization with LP. Still has residual HA although is less and she is able to partially function. The medical records state visual disturbance and dizziness. 60-day follow up on 02/05/04 and 02/09/04: "Pt has not recovered from adverse events. Persistent headache."
Started with a fever PM of 10/04/04, continued and was 103.6 R AM of 10/7/04. Blood and urine test done NL, Motrin and Tylenol prn as needed for high temp.
stress; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient) via a Pfizer-sponsored program. A 62-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Jan2021 at a single dose as vaccine. Medical history and concomitant medications were not reported. The patient experienced stress on an unspecified date. It was noted that she was unable to keep her 2nd dose appointment and she's having surgery before her second dose. She had the vaccine last Friday, 22Jan2021. Her 2nd dose would be on 12Feb2021 and she wanted to change it to 2/8 because she's scheduled for surgery on 11Feb2021. Could her appointment be changed? She has been trying to change the appointment for the past 4 hours. She called one number and they said it was not the correct number and they gave me another number. She told the person before what she wanted and needed to do and didn't listen either. The patient said thank you, had been very helpful and alleviated her stress right now. Now, she could relax. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Nodular melanoma surgery Nov2020", start date: Nov2020 (unspecified if ongoing), notes: Nodular melanoma surgery Nov2020. Concomitant medication(s) included: MIMVEY, start date: Nov2016; DORZOLAMIDE + TIMOLOL, start date: Feb2022. Past drug history included: Amoxicillin, reaction(s): "known allergies Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 25Apr2022, outcome "recovered with sequelae" (2022) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested, bright line positive; negative, notes: Tested negative, twice. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Took Paxlovid, as directed Treatment start date: 17Apr2022, Treatment stop date: 22Apr2022, Singulair. Toward end of treatment, Felt better for several days. Felt well, healthy. Started to feel ill a couple days later. Chest tightness. Next day felt flulike. Was quite ill for a solid 10 days after. Very bad cough. 3 weeks from initial positive test - Still experiencing residual tiredness, ear and sinus congestion, minor cough.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient presented to ER 4/26/21 with sharp chest pain associated with SOB that started the night of 4/25/21.  EKG suggestive of pericarditis. Troponin I peaked at 11 and trended down to 6, TTE showed normal EF, no structural abnormalities and no pericardial effusion. patient was observed overnight, did well, discharged 2nd day on Ibuprofen 600 TID PO for 2 weeks. chest pain persisted for two more days and now completely resolved off the NSAID.
pt was given  Td w/ a 5/8" needle; pt devel a sterile abscess;
Covid-19 POSITIVE; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 POSITIVE) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No Medical history or known allergies reported.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 POSITIVE). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 POSITIVE) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, COVID-19: positive positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications listed. Patient reports after receiving Covid-19 vaccine he tested positive for Covid-19 on 03-APR-2021 and did not take any medication to treat the illness.
I recently had the shingles and was vaccinated/Suspected Vaccination Failure; I recently had the shingles and was vaccinated; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I recently had the shingles and was vaccinated/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: I recently had the shingles and was vaccinated). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient recently had the shingles and was vaccinated with shingles.  The patient wondered how that happened. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Flu mist given (not 24 mos old yet).  Instructions were to watch for any respiratory distress as well as flu symptoms.  On 11-8-07 (day after) mother stated child had runny nose and 2 diarrhea diapers.  No ther symptoms or fever.  11-9-07 doing fine.
Vaccines given MMR and Varicella. Whelps at 5 mins after given. Benadryl given, whelps smaller. Sleeps no wheeze, cry when woke 30 minutes after. Sleeping wheeze - Epi Jr given 35 after. Pulse ox 98-99%, HR 125 40 min after. Good cry awake report called to doctor. Transferred to hospital via EMS 45 min after.  7/7/09 ER record received dated  with DX: Acute Allergic Reaction (Anaphylaxis).  Pt presented from MD's office where pt developed red welts at the injection sites immediatedly after receiving MMR and Varivax. Given Benadryl and Epi. Later sleepy and wheezing so transported to ER. Given pred with good response. D/C.
After getting a tetanus shot yesterday at the doctors I drove to grocery store after and my legs began to ache and then I felt really weak and dizzy so ended up leaving before I could finish my shopping once I got home I just rested my body sitting so I didn't faint while standing and then my neck and back muscles started to hurt really bad and all night I could barely sleep and when I got up this morning I could barely turn my neck it hurt so bad and my muscles from my neck all the way to my glute muscles hurt so bad and I can barely bend over. This is very strange to me but I am typically more sensitive to things that are given to me.
In the first few minutes, my heart rate went up (my heart rate is always up now after the injection- it's always 100 something and I have never had this before)  and I had brain fog right away, too  (the brain fog left about 15 minutes after injection). That night, I had severe arm pain. It continued and was lingering. Pain from my shoulder to my injection site and to my shoulders, neck and jaw pain. It was like a heart attack pain - with the racing heart and the pain in my shoulder - it's similar to those kind of symptoms. Every day I had the pain. The neck pain and jaw pain went away about a week prior to my second dose. The arm pain never went away. I called my doctor and he said he still wanted me have second dose. He prescribed me at that visit, Steroids to start taking after the second dose to deal with the pain in my arm. I had the 2nd dose on January 30th. The arm pain from the first dose has never left and has continued. I am still experiencing the pain. After the second dose, I still had  arm pain (although the pain was masked at first because I took Advil for chills, body aches etc after the second dose). But when I stopped taking the Advil, the pain was back in my arm. I took the prescription for Steroids for two or three days but then I quit as I had side effects from them. After that, I started taking Advil and CBD oil on it. I did see online that it would take 6-8 weeks to heal so I have now called my doctor again because it's been longer than that. I want to see the doctor again at this time. It's getting worse - especially at night. It's really painful and I can't sleep at night.
No adverse effects; improperly stored MMR II was administered; This spontaneous report was received from a pharmacy technician and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 15-AUG-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) subcutaneously, lot# R027063, expiration date: 20-SEP-2020 (exact dose, frequency and site of administration were not reported).  Administered dose of vaccine was exposed to a temperature excursion of 70 degrees Fahrenheit for 4 days. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.
vaccine stored out of range - in freezer for greater than 14 days; offered revaccination and patient denied; had adverse events from dose on 1/6/22 including flu-like symptoms