chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After patient received the vaccine, went to sit on a chair for observation, he fainted and fall on the floor.  He reported to fill dizzy and sweaty. Applied cold pack in the neck area on the back. The ambulance was called and patient was taken to the hospital for further treatment.
Pt presented about 30 minutes after injection with a red non-itchy rash on her stomach and side.  Noticed it while trying on a shirt in the store - had been working all day and couldn't say when it actually began. Denied exposure to anything new or different. Pt didn't show any other progressing symptoms of anaphylaxis and refused benadryl. Called pt about 2 hrs later to follow up. Pt said rash was resolving without the use of benadryl, and denied any progressing symptoms of anaphylaxis.  Called pt again today for 2nd follow up; had to leave a message. Pt has not yet returned our call, but did say last night she would call us if anything got worse.
molar pregnancy; molar pregnancy; This is a spontaneous report from a contactable consumer (parent). This consumer reported information for both mother and fetus/baby. This is the fetus report. A fetus patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Jun2021 at 11:00 (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunisation. The patient's medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19), Known allergies. No other medical history. The mother received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 18May2021 at 11:00 (Batch/Lot Number: EE0185) as dose 1, single for COVID-19 immunization. Concomitant medications included vitamin d [vitamin d nos] (received within 2 weeks of vaccination). It was reported that the patient mother was pregnancy fine then turned into a molar pregnancy shortly following second injection on an unspecified date. Treatment (surgery) received for the adverse event. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, life threatening illness (immediate risk of death from the event), and congenital anomaly or birth defect. Since the vaccination, the patient has been tested for COVID-19: Covid test (Nasal swab) was performed on 26Jun2021 with negative result. The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021810772 mother/fetus case
arm pain persisted and is still slightly present / had her second dose / experienced some arm pain; arm pain described as sore and stiff; This case was reported by a consumer and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rotator cuff syndrome (torn rotator cuff in right arm). Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 1st December 2020, batch number 2XG53, expiry date 12 February 2022, refer case US2021060551).   On 8th March 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm and limbs stiffness. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the limbs stiffness was recovered/resolved.   It was unknown if the reporter considered the pain in arm and limbs stiffness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the right arm and experienced some arm pain described as sore and stiff and it was resolving. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021060551:different dose.
2-year-old son was given FLUBLOK QUADRIVALENT that is used for 18 years and older; Initial information received on 25-Feb-2022 regarding an unsolicited valid  non-serious case received from father of patient.  This case involves a 2 years old and unknown gender patient who was given flublok quadrivalent that is used for 18 years and older while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrivalent recombinant vaccine by unknown manufacturer (form, strength, dose, route, lot number and expiry date not reported) in unknown administration site for immunization. Information on batch number will not be available.  On an unknown date the patient was given flublok quadrivalent that is used for 18 years and older (product use issue) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
p/vax pt had extreme stomachache cramps; gave pt mylicon drops as instructed by MD
After 30 minute observation period pt reported bad headache, foggy mind, numbness/tingling of the tongue. Pt experience dizziness upon standing and then starts to dry heave. The tingling of the tongue becomes worse at this point. Pt is then given 25mg of liquid bendryl. Pt denies EMS help.  Pt stands and "zones out". Pt unable to respond to commands and is unaware of her name. Pt is seated and has unequal hand grips, left pupil larger than right, flaccid arms when raised.  Pt then speaks clearly but not appropriate. Thought her grown adult kids were babies, couldn't tell their names or her sister's name. Pt's husband shows up and she recognizes him but doesn't know why he is there. Husband says she acts like this when she is anxious and he can take care of her. The nausea/dry heaving is a new symptom. Recommended to go to hospital but leaves with husband. Later spoke with patient and she seems better and has been taking Benadryl every 4 hours. She is still experiencing tongue numbness and is going to her PCP.
I had a rash under both of my arms another words my armpits and soreness in my throat. The rash is getting better it was itchy and red and warm to the touch, I have had it for about 8 days but I am better now.  I told the 2 pharmacist and was recommended to take Claritin and use some hydrosome cream and I have not told my doctor yet.  I am not a 100 % better yet, still have a itchy throat and applying the cream.
Patient was seen on 10/03/22 and was given a Pfizer-BioNTech Covid-19 vaccine (5yr-11yrs) that was Expired (Expiration date: 09/30/22). No adverse reaction to vaccine.
SHARP PAIN; HAVE NOT FELT QUITE RIGHT SINCE; 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) 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 sharp pain, and have not felt quite right since. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from have not felt quite right since, and the outcome of sharp pain was not reported. This report was non-serious.
Fluzone HD was accidentally given to 10 yr old patient, no AE; Fluzone HD was accidentally given to 10 yr old patient, no AE; came to a Flu Shot Clinic yesterday and were inadvertently given a Fluzone HD, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA303347 (same reporter).  This case involves a 10 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe) (lot number: UJ283AA, Expiration Date: 29-May-2020)  via intramuscular route in the left deltoid inadvertently on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose and wrong vaccine administered.  At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
TIRED; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested. No concomitant medications were reported.  On APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired. This report was non-serious.
Day of shot it became red, swollen and itchy. A heaviness in my chest and wheezing in my chest (enough to use my inhaler). Symptoms subsided after the 4th day. December 2nd the area of the shot started itching again. By December 3rd the area is bigger than a .50 cent piece inflamed, itchy, sore to touch and also hot to the touch with a welt in the middle of the circle. My back and legs are itchy. Severe headaches for the last week. The Doctor that saw me today December 3, 2021 prescribed prednisone for 2 days. If it's not better I need to get an appointment with my Dr.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 2nd July 2018, the patient received the 2nd dose of SHINGRIX. On 4th July 2018, 2 days after receiving SHINGRIX, the patient experienced injection site pain, shoulder pain, wrist pain and frustration. The patient was treated with codeine and TYLENOL. On an unknown date, the outcome of the injection site pain, shoulder pain and wrist pain were recovered/resolved and the outcome of the frustration was unknown. It was unknown if the reporter considered the injection site pain, shoulder pain, wrist pain and frustration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine on an unknown arm on Monday and on Wednesday began to experience arm pain in the injection arm around the site and from her elbow up over her shoulder. At the time of reporting, it had been 10 days and the pain was also spread down to her wrist and had retained intensity for the full 10 days. The patient went to see her physician on Thursday 5th July 2018 and was prescribed TYLENOL 3 with Codeine which had had very little effectiveness in masking the pain, failing to even make the pain tolerable. The arm was not sensitive to touch but rather felt like it was being pulled from its socket. At several points, specifically the wrist, elbow and upper back or scapula, the patient had pain that felt like a knife stabbing deep into that particular area. Just letting gravity pulls her arm down caused pain and was best when she held her arm above her head. There was nothing the patient had done over the last two weeks that could have caused any muscle or tendon injuries to her left arm. This was very frustrating and it had been excruciatingly painful. The reporter was writing to GSK as manufacturer of SHINGRIX in hope that they might help her physician and figure out how to address and alleviate that pain.
11 Feb: Patient began to develop painful nodules on bilateral arms. 14 Feb: TX w/ MEDROL pack x 5 days and symptoms resolved. 21 Feb: Completed MEDROL pack and symptoms returned in 1-2 days. 2 Mar: TX w/ prednisone 50mg QD x 5 day symptoms resolved.
Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident.    Pt noted to be slumped in chair, hives noted to forehead, diaphoretic, arms rigid, non-responsive to stimuli, Incontinent of bladder.   Pt lowered to ground Zoll applied, COR called. Vital signs: 108/58 100% RA 77 26. Pt given EPI-Pen @ approx. 1352. COR Team arrived, pt mildly responsive. Assisted to Backboard and sent to ER with ED Provider.  Pt was monitored in the ED for 3 hours with no recurrent symptoms. Pt advised to follow up with PCP and an allergist and avoid getting the 2nd dose of the covid vaccine.
On the evening of 1/18/21, my left arm started itching in the section of my arm where the vaccine was given. I rubbed on the area with my hand. noticed a rash when I woke up this morning. the itchy feeling is no longer intense as the night before. rash not as red in color
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-FEB-2022; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-FEB-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-FEB-2022) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022 at 2:01 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Feb-2022 at 2:01 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-FEB-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-FEB-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-FEB-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 26-FEB-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient ethnicity was reported. Concomitant medications were not reported.  Patient received booster dose. Patient received Moderna vaccine past 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Treatment medications were not reported.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Headache-Medium, Systemic: Nausea-Medium
Arm was sore; Arm was swollen; Arm was hot to touch; Arm was red; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, swollen, red, hot to touch.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their dose of two planned doses of mRNA-1273 (lot/batch: Not provided) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, arm was sore, swollen, red and hot to touch.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events arm was sore, swollen, red and hot to touch were unknown.
23 May - Small Pox vaccination 27 May - Pt diagnosed with sinusitis, received amoxicillin and Claritin 02 June - Red dots, hives on upper arms. 03 June - increased rash up to 1 inch above elbow, non-vesicular, non-umbilicated 05 June - spread to upper body 06 June - spread to lower body. Pt evaluated by physician who diagnosed pt with urticarial reaction most likely 2/2 delayed drug reaction (amoxicillin).
I felt my heart racing for awhile.  I read for about a half hour and then went back to sleep.
strong pain/pangs in chest at middle of the night; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 64-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6198, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 16Mar2021 (at the age of 64 years old) as dose 1, single for covid-19 immunisation. Medical history included mitral valve prolapse, allergies, Known allergies: yes, Seasonal allergy, and low blood pressure. The concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6208, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 06Apr2021 as dose 2, single for covid-19 immunisation and experienced similar events on 06Apr2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. The patient experienced strong pain/pangs in chest at middle of the night on Mar2021. Since then, she had chest pains/soreness/pangs, what she thought was myocarditis. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Local reaction: redness, slight bruising, pain and swelling. Systemic reaction: chills.
patient had adverse reaction with her left arm to upper shoulder. Patient could not lift arm, had trouble doing daily activites
From initial information received on 09/16/2004 from information received from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by the 30 year old female patient that she received a Tetanus Toxoid vaccination, an MMR vaccination, and a first dose of Twinrix on 06/21/2004.  The lot numbers, routes and sites of administration were not reported for any of the products.  Approximately seven days later, on 06/28/2004, the patient experienced hair loss and itching.  She was seen in a physician's office and was treated with corticosteroids and desloratadine.  The hair loss continued, but the itching improved.  On 07/23/2004, the patient received a second dose of Twinrix and reported that the hair loss continued following this dose.  The patient has not recovered from this event.  It was reported that the patient declined to grant authority to contact her physician for additional information, therefore none will be available.  Further information is not anticipated, this case is considered closed.
Started with a fainting spell and bumped head. Fainted again before realizing I needed to go to ER. CT scan, blood panel, COVID-19 test, X-ray and other test were done over the course of 3 days as I was hospitalized. Continue all medication as directed and was positive for break-thru COVID-19. All other test normal. Currently feeling fine and have recovered.
sore right arm for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm for 24 hours) in a 67-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 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm for 24 hours). At the time of the report, PAIN IN EXTREMITY (sore right arm for 24 hours) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-396211, MOD-2021-396324 (Patient Link).
Headache, Myalgia & Arthralgia Narrative: dose 2-day1-3-Headache, chills, body and muscle aches, and extreme fatigue
patient tested +  7/5/22 for covid and expired on 7/15-22 .  was admitted 7-12 with dyspnea and weakness.
Patient received vaccine that was stored in freezer for 19 days prior to being moved to refrigerator.
The patient started with vaginal itching, then she developed many round lesions on both legs that range in size from pennies to the size of a quarter.
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a second dose of Gardasil. Subsequently the patient experienced a seizure. The physician reported the patient had a seizure not immediately after the second dose but within a few weeks of being vaccinated with Gardasil. The patient sought unspecified medical attention. At the time of this report, the outcome was unknown. Upon internal review, the patient's seizure was considered an other important medical event. Additional information has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 06-MAY-2016 the patient was vaccinated with the first dose of VARIVAX (dose, route, and lot# were unknown), and then received a second dose of VARIVAX (dose, route and lot# were unknown) on 25-MAY-2016; which was outside of the recommendations in the VARIVAX prescribing information. No adverse effect was reported. Additional information has been requested.
Moderna booster administered on 11/16/21 with vaccine that expired on 11/7/21.  Expiration date was mistakenly read as 11/17/21.  No adverse event or outcome to recipient.