chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer.   A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 17May2021 at11:00 (at the age of 64 years-old), (Batch/Lot Number: ER8734) as a single dose, for covid-19 immunisation. Medical history included Hashimoto and total thyroidectomy on unspecified dates. Concomitant medications included levothyroxine sodium (SYNTHROID) and bupropion (BUPROPION) and unspecified HRT (hormone therapy).  The patient reported that on 18May2021 at 0100: "First 2 days just typical flu symptoms with bad headache. Then on 4th day fainting episode, 5th day pain in lymph node left side of neck. Hurts to turn my head." There was no treatment reported for the events. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
injection site pain; joint pain; swelling; Arm warm to the touch; Arm partially immobile; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 30-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number P4DN4, expiry date 30th June 2020) for prophylaxis.   On 11th September 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On an unknown date, 2 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain, joint pain, swelling, skin warm and mobility decreased. On an unknown date, the outcome of the injection site pain, joint pain, swelling, skin warm and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain, joint pain, swelling, skin warm and mobility decreased to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Fluarix Quadrivalent 2019-2020 season and 2 days later experienced pain at the injection site, joint pain, swelling, arm was warm to the touch, and had partial immobility. The reporter did not consent to follow up.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that, on 11-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case). Previous temperature excursion: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case). The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005376.
Approximately 2 hours after the shot I got a severe headache, runny nose, congestion, dry cough, severe itching all over my body but more on my neck, chest, both arms, and legs. The itching on my neck and chest looked red, after looking closer it was tiny petechiae on my neck and chest. I immediately took Benadryl 2 tablets, Tylenol, and rubbed Benadryl cream on my arms and legs. I didn't go to the doctor. After talking to the pharmacist he said what I was doing was correct and exactly what he would tell me to do.
This spontaneous report was received from a Healthcare Worker refers to an unspecified patients of unknown age and gender. The patient's medical history, drug allergies and concomitant medications were not reported. On unspecified dates since 13-AUG-2015, the patients were vaccinated with VARIVAX (Merck) K006133, exp 29-APR-2016; L002215, exp 21-JAN-2017; L004649, exp 11-FEB-2017 and L012035, exp 07-MAR-2017, (dose, frequency, and route not reported), which were exposed to temperatures outside of the recommended range. No  adverse experience has been reported. No product quality complaint (PQC) was involved. No additional information was provided. Additional information has been requested.
Started to experience issues with my hearing including tinnitus. Can't remember the exact onset but it was a sudden onset.
Mild headache at first,  sore arm but day after (like 30 hours after shot) Chills, fever, body aches
Narrative:  COVID infection following COVID vaccine series 09/28, Pfizer,  dose #1 10/21, Pfizer, dose #2 1/4 COVID swab, result: detected 12/27 pt cc:  cough, fever, headache, myalgias, rhinorrhea exposure: unknown 12/28 COVID  swab, result: detected 12/28 PT: 11.3 12/28 APTT/INR: 36.1/1.01 12/28 CXR  impression: No acute cardiopulmonary disease.
Heartburn started a few minutes after my shot but was mild.  Went away after a couple hours.  Then came back really bad; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 20Apr2021 at 09:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included ibuprofen (ADVIL), gabapentin (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and norethisterone (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously took ketorolac tromethamine (TORADOL) and cephalexin (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 29Mar2021 at 00:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 20Apr2021 at 09:15, the patient experienced heartburn started a few minutes after her shot but was mild.  Went away after a couple hours. Then came back really bad around 20:30. She never got heartburn and had not eaten anything unusual to cause it. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of heartburn and included treatment with pepcid, baking soda water and ginger. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heartburn was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pain in right Hip to knee; Cannot walk; Left arm  swollen; Left arm sore and hurting; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm  swollen), PAIN IN EXTREMITY (Left arm sore and hurting), ARTHRALGIA (Pain in right Hip to knee) and GAIT DISTURBANCE (Cannot walk) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Left arm  swollen) and PAIN IN EXTREMITY (Left arm sore and hurting). On an unknown date, the patient experienced ARTHRALGIA (Pain in right Hip to knee) and GAIT DISTURBANCE (Cannot walk). At the time of the report, PERIPHERAL SWELLING (Left arm  swollen), PAIN IN EXTREMITY (Left arm sore and hurting), ARTHRALGIA (Pain in right Hip to knee) and GAIT DISTURBANCE (Cannot walk) outcome was unknown. Not Provided          No concomitant medication reported. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114436 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114436:Husband Case
Seen in office on 01/26/05, with scatter papules and pustules over legs, groin, neck and face. Has 20-30 lesions. No fever. Diagnosed with Varicella secondary to vaccine. Had Varicella vaccine on 01/10/05.
Severe muscle pains in legs, groin, shoulders and arms.   Lasted two weeks. Difficult to walk and get in and out of the car and get up off the floor.  Muscle pains continue in week three but are more moderate than the first two weeks.
Warm to touch; Feels like vaccine has been dissipated; Feel heavy; Redmark appears on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE REACTION (Feels like vaccine has been dissipated), DISCOMFORT (Feel heavy) and VACCINATION SITE ERYTHEMA (Redmark appears on the left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE REACTION (Feels like vaccine has been dissipated), DISCOMFORT (Feel heavy) and VACCINATION SITE ERYTHEMA (Redmark appears on the left arm). At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE REACTION (Feels like vaccine has been dissipated), DISCOMFORT (Feel heavy) and VACCINATION SITE ERYTHEMA (Redmark appears on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
arm throbbing in his left arm where he had the vaccine administered; slight headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6199) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "arm throbbing in his left arm where he had the vaccine administered"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "slight headache". Therapeutic measures were not taken as a result of vaccination site pain, headache. Additional information: The first dose was given at around 09:30-10:30 AM. Clinical course of events: A week after the 1st dose of the vaccine, the patient experienced arm throbbing in his left arm where he had the vaccine administered and at around the same time had a slight headache. His headache was so light that he really did not pick up that it was going on and his head was hurting a little bit; stated from 1 to 10 he would rate his headache at a 2. Arm throbbing lasted about 2-3 days and the headache has resolved and lasted about 3-4 days. The patient was vaccinated with the second dose of BNT162B2 (Lot number EP6955) in the left arm on 01Apr2021 at around 10:15-10:45am for COVID-19 immunisation. The patient wanted to know how long does the Pfizer COVID Vaccine last or does he have to take another shot of it in a year or so. The patient had no additional vaccines administered on same date of the suspect drug, no prior vaccinations (within 4 weeks), no family medical history relevant to adverse effects and no relevant tests.  No follow-up attempts are possible. No further information is expected.
Dose 3: Pfizer-BioNTech Booster in left shoulder Routine doctor visit on 10/13/2021 where I discussed the Round circle on her arm over the first two week and increased in diameter. I also mention the Dermatology issue already with leg and thought it would go away and it did not. By the end of Nov. 5, 2021 and into Dec, noticed additional issue with swelling and pain. Because the issue was impacting my shoulder with one side higher than the other, arm hurt and could not reach up with arm, could not hold the arm up at all. Additional delay 12/25/2021, and can not reach her arm over her head and same with leg not able to move her leg. New medication after the vaccination was prednisone for the swelling. Kidney issues and monitor medicines going into her system. 02/2022 - 5 pills. Receiving shots Felicity 1.5 once a week. Test results of blood work did not see a health issue. Walking with a cane.
Information has been received from a physician and a medical assistant concerning an 8 year old female who on 19-Nov-1996 was vaccinated with a dose of varicella virus vaccine live. On 13-Feb-2004, the patient was seen in the office for shingles that had been present for 5 days. It was reported that the skin lesions involved the entire 6th thoracic dermatome from her spine around to the middle of her sternum. The physician reported that the rash was asymmetric spreading from the left lateral spine to the left of the sternum and it went all the way around her back. The rash was red and some oozing vesicular blisters were noted. The patient indicated that some of the lesions were itchy and painful. No cultures of the vesicles were done and the child had no known exposure to wild chicken pox. The patient was still being treated with acetaminophen (Tylenol) with codeine for pain. No other information was provided. Upon internal review the patient's experience was considered another important medical event. Additional information has been requested (OMIC).  Follow up information, this is in follow up to report previously submitted on 05/14/2004. information has been received from a physician and a medical assistant concerning a 9 year old female student with no known allergies and no known past medical history who on 11/07/1996 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on 11/07/1996 included a dose of live hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine OMPC MSD and a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The shingles lasted approximately two weeks. On Feb 28 2004, the shingles disappeared, but substantial residual redness remained. It was noted that the patient recovered. Additional information is not expected.
Treatment COVID-19; Treatment COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications or other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Tested positive after testing negative; Positive, notes: Tested positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 20Jul2022 to 24Jul2022. The patient tested positive after testing negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on possible temporal association the causal association  of suspect  cannot be excluded for reported events .The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
got sick after getting the Pfizer Covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the parent.  An adult patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick after getting the Pfizer Covid 19 vaccine".  Additional information: The reporter was calling on behalf of her children who got sick after getting the Pfizer Covid 19 vaccine and also her uncle and her girlfriend that got sick after getting the vaccine. Asking if there are some vitamins or medications that can boost their immune systems. Caller also reported that she had 2 young adult children that got sick after getting the Pfizer Covid 19 Vaccine, and also her uncle and her brother. She was only looking to find a medication or product so they could get immediate relief, but she was not finding any products that can help them. Her friend (withheld) that she worked with, had diarrhea for almost a year and was told that she had long covid. Her other friend (withheld) that lives in (state name withheld) had a heart attack and appendicitis in the same day. Attempted to verify the caller's name and phone number that was provided by the transferring agent, but caller stated that she doesn't want to be on the radar. She just wanted to know if there is a product that can alleviate the symptoms, or is it just pushing the vaccine. Verified that all patients received the Pfizer Covid 19 Vaccine. This report was for the caller's 2 young adult children.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300056777 same reporter, product and event, different patient; PFIZER INC-202300056750 same reporter, product and event, different patient (report 3 of 5);PFIZER INC-202300056738 same reporter, product and event, different patient (report 2 of 5);
Information has been received from a 28-year-old female registered nurse (R.N.) with no pertinent medical history or allergies, who on 16-MAY-2006, was administering a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 652483/0148F) when some of the fluid inadvertently splashed in her eye. Medical attention was sought. After flushing her eye with water for 15 minutes, she continued to experience a slight burning sensation of the eye. No laboratory or diagnostic tests were performed. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
A painful, swollen rash showed up at injection site the day after injection. Patient applied hydrocortisone cream to control pruritus and it helped. Cleared up on Friday 7/22/11.
The patient's lips and throat started to tingle, tongue became "thick" and she started having trouble breathing  about 13 minutes after receiving the Moderna vaccine. She also noted headache, nausea, and flushing.  The patient received 1 dose of Benadryl at the vaccination clinic and then was transported via EMS to the hospital and then received another dose of Benadryl and prednisone. She was discharged with prednisone for 5 days. One day later patient reports she is feeling better but still has facial swelling.
she got Covid; she got Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Lot number: EL3246) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she got Covid".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300077893 same reporter and patient, different AE;
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Anaphylactic shock-5 minutes post injection   Throat and tongue swelling Required 3 epipen injections EMS to the hospital 50 mg of IV Benadryl and IV Pepcid
No other adverse events reported; Caller reports that doses of improperly stored vaccines were administered to patients.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 18-JUN-2022, the patient was vaccinated with the first dose of Hepatitis A Vaccine, Inactivated (VAQTA) (dose, anatomical location, route of administration were not reported) (lot# U026792, has been verified to be a valid lot number for Hepatitis A Vaccine, Inactivated (VAQTA), expiration date reported as 28-OCT-2022) as prophylaxis. The vaccine dose was improperly stored at a temperature of 47.17 Fahrenheit degrees (°F) for 15 minutes (Product storage error); with no previous temperature excursion.  No other adverse events were reported.