chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PAIN HURTED; HUGE FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain hurted, and huge fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain hurted, and huge fever. This report was non-serious.
Fever 10-12H after vaccine given (injection form), uni Saturday, 101 today
Pregnant with one baby; due date of 04/26/2021 I received the flu vaccine but am unsure of what type or manufacturer.  I believe I received it in the early afternoon and that my symptoms began several hours later, around 6:00 PM local time.  These symptoms included: chest and throat pain, hoarseness and coughing, trouble breathing, and weakness.  By a few hours later, I was feeling a little better.  By the next day, most of my symptoms were gone.  That next day, 09/16/2020, I called my general practitioner's office for advice.  I thought I had contracted COVID-19, but they thought it was just a reaction to the flu vaccine.  The day after that, 09/17/2020, I felt completely better.
I?m barely able to use this arm it?s burning tingling  and hurt in the muscles from the injection spot down to my hands and tender to touch
11pm - body aches, sweating fever, tired, weak 3/10/21 - aches, tired, and fever - 100.7
Headache; This is a spontaneous report from a contactable consumer (patient).  A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. Patient received a long list of concomitant medications which were not specified. The patient experienced headache on 07Jan2021 with outcome of recovered in Jan2021.  Information on lot and batch number has been requested.
Covid19 breakthrough.  1st vaccine received on 03/26/2021.  Pt presented to ED for routine pregnancy delivery.  Pre procedural Covid swab +, pt asymptomatic.
Got the vaccine, had a burning sensation at the injection site and still has that feeling, serious stinging.  She could not raise her arm initially (dead arm), could not hold a cup in it or anything.   She took off the Band-Aide and put another one on it and then when she removed that she had blood on it, but did not when she first took off the first one.  She woke up, was able to lift her arm, but the rash was red, blotchy, bumpy rash that is not hot, just a little red but it itchy.  She has been taking Benadryl for this reaction.
arm was very sore all over; like a mucosa on them; ever since then his vision is blurry; his eyes were red; his eyes were swollen; his eyes were puffy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore all over), EYE SWELLING (his eyes were swollen), PERIORBITAL SWELLING (his eyes were puffy), EYE DISCHARGE (like a mucosa on them) and OCULAR HYPERAEMIA (his eyes were red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced EYE SWELLING (his eyes were swollen), PERIORBITAL SWELLING (his eyes were puffy) and OCULAR HYPERAEMIA (his eyes were red). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was very sore all over), EYE DISCHARGE (like a mucosa on them) and VISION BLURRED (ever since then his vision is blurry). On 19-Apr-2021, EYE SWELLING (his eyes were swollen), PERIORBITAL SWELLING (his eyes were puffy) and OCULAR HYPERAEMIA (his eyes were red) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (arm was very sore all over), EYE DISCHARGE (like a mucosa on them) and VISION BLURRED (ever since then his vision is blurry) outcome was unknown. Not Provided
Pain; Difficulty sleeping; Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), INSOMNIA (Difficulty sleeping) and BRONCHITIS (Bronchitis) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced BRONCHITIS (Bronchitis). On an unknown date, the patient experienced PAIN (Pain) and INSOMNIA (Difficulty sleeping). In February 2022, BRONCHITIS (Bronchitis) had resolved. At the time of the report, PAIN (Pain) and INSOMNIA (Difficulty sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: The value was 104/abnormal..         On an unknown date, the patient experienced could not stay on the same sleep schedule because of pain. In September 2021, the patient experienced sick/temperature 104. In September 2021, the sick/temperature 104 resolved. In December 2021, the patient experienced bronchitis. In February 2022, the bronchitis resolved.  The patient after the second covid vaccine was sick and 104 temperature for four days.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Elevated blood pressure 144/93 heart rate 100 Saturation of peripheral oxygen 96 respiration 16 at 4:50pm Benadryl given at 4:55pm BP 138/106 HR 93 SpO2 94 RR 16  at 5:01pm.   Patient reports swelling or edema to lip.  Reports after injection previous reaction after another unknown injection in previous years.  Patient refused transport via EMS advised to go to ER if symptoms worsen.
Several minutes after shots were given, client began to complain of "feeling funny with ringing in his ears and headache, diaphoretic and pale. Cool cloth and ice pack placed on neck. Client unresponsive for seaveral seconds. color improves and client moved to clinic room to lay down for 20 minutes.
got colds after the first dose; This is a spontaneous report from a non-contactable consumer (patient) from a Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced colds after the first dose on an unspecified date. The patient took Tylenol and Acalka Ferrer for his colds. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient sent letter to pharmacy that she developed severe pain and swelling after getting vaccines and said she developed cellulitis on november 29th, which was days after immunization. letter states that this is negligent because patient got both shots on same day and in same arm, which are normal procedures here
Patient was given TUBERSOL as injection of 1 ML vial given intramuscular in the left arm LOT # 2CA92C2 EXP 08202023.
Swelling and rash at injection 48 hours after receiving first dose. Rash disappeared six days after first reactions. Swelling is still apparent. Swollen lymph nodes in the left arm pit of the left arm that received the first dose. Swelling of lymph nodes appeared 5 days after first dose
Patient received Fluarix immunization in left arm at approximately 1030am. Immediately upon inject patient developed quarter size welt at the site of injection. Was given a cold compress to see if swelling decreased, as well as a 10ml dose of Benadryl a few moments later. Patient reported no pain, no dizziness, no shortness of breath. Said he was fine. Size of self had not gotten larger before patient left pharmacy roughly 15 minutes later. Called patient later on in afternoon and he said the welt had gone down and he was in no pain still.
Fever began around 10am. Motrin was given. Fever persisted until Thursday evening and remained low grade 100F & under. Rash began Wednesday evening & became progressively worse through the week. It actually looks like the measles. Fever broke Friday night.
Severe body aches over entire body. Extreme fatigue- slept almost 24 hours. Swollen severe pain in left armpit that is still present. Unable to lift left arm about 18 hours after shot.
pt recv vax; red rxn 6"x7 3/4" lateral lt arm to elbow, swollen, warm to the touch, cellulitis;
Syncopal episode after receipt of dose 2 of Pfizer Covid-19 vaccine.  Presumed to be vasovagal in nature, but due to the broad differential diagnosis and lack of health history /primary medical care, patient was transported by EMS out of an abundance of caution.  Scheduled an appointment for patient to establish care with in-house pediatrician ASAP (2 business days later).
Finished the series 2 months early; This case was reported by a pharmacist and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 13th July 2021) and Twinrix (2nd dose received on an unknown date).   On 17th November 2021, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 17th November 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient finished the series of Twinrix 2 months too early, which led to drug dose administration interval too short. No further information reported. The reporter did not consent to follow-up.
Oct90 pt vax w/ 2nd hepta B; exp shortness of breath + was admitted to ER. Sx resolved + discharged. No other doses administered.
Within 4 hours of receiving the vaccine, my left shoulder was very sore. By the next morning, I could NOT raise my left arm, put on clothes, or do my normal activities. I took ibuprophen for 3 days to dull the pain. But the pain and the pain and immobility have returned. It feels like the needle must have hit a nerve a bone or a ligament. My fingers tingle sometimes.
Period came 8 days early on the day after the 2nd vaccine shot. This is rare for me.
Had strong flu like symptoms for 1 and a half days generally weak. Had fever of 100 degrees.. Slept poorly. Unable to rise from seat alone.
Pt received her second dose of Pfizer COVID vaccine 0.3 ml. Pt immediately began to curl her arms and had a blank stare. Pt was pale but did not pass out. Pts mother stated she did the same thing at her 11 year old vaccines. Pt was very anxious prior to getting the vaccine.
Per mom, noticed redness and swelling and c/o pain on L arm and R arm, one day after child given vaccines.
Reportedly, the pt developed a local reaction 4-inches in diameter that was warm to the touch and itchy approximately 40 hours after the vax. Further information is requested. Follow up on 10/25/02: "From follow up telephone call with the receptionist from the clinic, it was stated that they do not know a person by the name.  Therefore, no further information can be obtained. This case is closed."
This spontaneous report was received from a pharm technician, concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, dose number and route were not reported) lot # J004332, expiration date 26-SEP-2014. Co-suspect and concomitant therapies were not reported. The pharm technician reported the patient received an expired dose of PNEUMOVAX 23 on 01-OCT-2014. The PNEUMOVAX 23 did not have any previous temperature excursions and was supported with post-expiry in-house stability data. No adverse symptoms reported. Additional information has been requested.
Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.) and EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 011F21A, 044A21A and 011A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 2:46 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 2:46 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.). At the time of the report, PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.) and EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.).    Concomitant product use was not provided by the reporter.  Vial expired on 13-May-2022 and were placed in refrigerator on 17-May-2022.  Event didn't cause the patient to seek medical care and no other potential causes.  It was unknown that the patient experienced similar event in the past.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to PR-MODERNATX, INC.-MOD-2022-585601 (Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-585601:MCN No.
"JANSSEN COVID-19 VACCINE EUA" the 3rd day after being vaccinated I woke up with mild pain/discomfort in my left arm pit of vaccinated arm.   I have now had the mild pain/discomfort in the left armpit for 3 days.
pt recv vax APR97 & devel a fever of 105 on the day of inj;pt was treated w/motrin;as of today the fever cont to fluctuate up to 101 & pt is still using motrin;
During echo this afternoon patient became bradycardic and lethargic and rapid response team called, then went asystole and unresponsive and CODE BLUE was called.
This spontaneous report was received from a physician referring to six female patients of unknown age. The medical history, concurrent condition and concomitant therapies of the six patients were not reported. On an unknown date, the six patients were vaccinated with ZOSTAVAX (lot number, expiration date and route of administration were not reported). On an unknown date, after getting ZOSTAVAX, the patients experienced herpes zoster. The outcome of the herpes zoster was not reported. The causal relationship between ZOSTAVAX and the event was not provided. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a licensed professional nurse (LPN) concerning a 33 yr old female who on 18Oct05 was vaccinated IM in the deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 7091P). Concomitant therapy included hormonal contraceptives (unspecified). On approx 18Oct05 the pt experienced injection site swelling, redness and pain. Unspecified medical attention was sought. Subsequently, the pt recovered. The LPN requested a check of the lot number. Additional information has been requested.
1.25 hours after receiving flu vaccine, noticed redness at site, pruritis of neck and arms.  No SOB, no angioedema.
I came home after the vaccine and had the expected fatigue, headache and weakness.  I drank plenty of water and took a nap.  When I awoke, my tinnitus in my right ear was so severe and pulsating, it was so much louder than ever in my life.  It was unbearable.  It has gotten a little better but is still much worse than before the vaccine. Also, this evening, my lips are peeling and I have sores in my mouth.
Pain in left groin, radiating pain down left leg, left leg swelling beginning 9/24/21
Patient presented to the vaccination site on 10/18/21. The client notified RN that she received a single dose of the (Moderna) COVID vaccine on (3/15/21).  Client stated that she presented with a rash 48 hours after getting first dose on both shoulders, chest and stomach. Client went to Doctor and received treatment. Client was given Avapena through IV. She was sent home, the next day she woke up at home and the rash was worse. She then self medicated at home and took celestamine. Patient stated that she started feeling better. Client stated that the rash lasted 2-3 days. Client stated that her doctor said that it was up to her whether or not to get the second dose of Moderna or J&J. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Moderna. Per CDC guidance, approval to proceed with COVID vaccine Moderna second dose with 30 minute observation was obtained from medical consult team, Vaccine Operations Lead via text message. Client received COVID vaccine Moderna Lot# 011F21A on 10/18/2021. The client did not report any symptoms during the observation period. The client left the vaccination site at 1525. VAERS completed.
Initial unsolicited report received from an other non-health professional on 11 Jan 2018. This case was linked with 2018SA014660. This case involves a patient of unknown age and gender, who was vaccinated with 0.5 ml dose of ADACEL once via intramuscular route (Batch number: U5879AB, expiration date: 13-Mar-2020, dose in series and site of administration were not reported) on an unknown date (reported as 12/17). Patient's medical history and concomitant medications were not reported. On an unknown day (reported as 1/17), following the vaccination, the patient had flu like symptoms. Laboratory investigations and corrective treatment were not reported. The outcome of the event was unknown. Documents held by sender: none.
Estimated date of birth of unborn babe -  4 weeks pregnant at date of covid vaccine injection. Went to initial OBGYN appointment(1/12/2022) for check up to verify pregnancy at 9 weeks pregnant. Ultrasound was done(1/12/2022), babes heart rate was measured and concluded to be 50 BPM.  Came back 2 weeks later(1/26/2022) to do another ultrasound, no heart beat was present, resulting in miscarriage. Following day(1/27/2022) a D&C was performed to remove miscarriage.
Pt states arm got swollen and red at site of injection the day after shot. States in 2001 had slight redness at injection site.
Exactly one week after my first dose of Moderna COVID-19 vaccination, I developed a rash and redness at the injection site.  The redness is growing slightly and is now 3 inches by 2 inches on my left arm where I got vaccinated.  It is hot and slightly swollen.
Hard, raised lump with redness, swelling and itchiness. The lump appeared several hours after injection and or the right of the injection needle mark. The lump has grown overnight and is about the diameter of a golf ball
Started not feeling well the day after first shot! Fever, nausea, runny nose, cough, sweating and extreme fatigue, ankle swelling
Severe swelling, tenderness, pain to touch in the lymph nodes on the left side of my body. From my neck, to my armpit, to my low back and in my groin, i have swelling in spots up and down my left side. I had a fever starting 24hr after the injection. This lasted until today and was treated with OTC IBUPROFEN. The ibuprofen has had no effect on the swelling or pain in nodes. Aches, chills, and joint pain are other secondary complaints/effects with more milder level of pain.  It?s been 3 days since injection and the swelling in my lymph nodes does not seem to be getting better.
This case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a adult male patient who received Hepatitis B vaccine (batch number A4NV8909AB ?, expiry date 15th November 2017. GSK note: the reported lot number did not match with any GSK lot number. Clarification has been requested). On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were provided as follows: The healthcare professional reported that after the patient received Hepatitis B in 2010 and had titer read, that showed no immunity. No side effects were reported.
Patient received the flu vaccination and the next day couldn't walk, and complained about his leg hurting.  It has been a week and he still keeps his leg stiff straight, barely will bend at the knee. No abnormal redness at injection site. Child cries when his thigh is lightly touched, or when he is picked up from the pain. He says, "owe! it hurts!" It's been concluded that child is likely suffering from Rhabdomyolysis, with the hopes that he should regain full mobility and function in the next week.
Inadvertent temperature excursion, vaccine stored in freezer beyond allowable two week excursion protocol per Pfizer, no concern for any other adverse events, recommended repeating the dose
Patient complained of severe shoulder pain and significant rash and redness at injection site. She stated she was admitted to hospital with pneumonia a little over one month after receiving vaccination.