chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of diabetic ulcer in a 62-year-old male patient who received MENVEO (batch number M16199, expiry date August 2018) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included TRUMENBA and eculizumab (Soliris). On 12th June 2018, the patient received the 1st dose of MENVEO. In July 2018, less than a year after receiving MENVEO, the patient experienced diabetic ulcer (serious criteria GSK medically significant) and infection. On an unknown date, the outcome of the diabetic ulcer and infection were recovering/resolving. The reporter considered the diabetic ulcer and infection to be unlikely related to MENVEO. Additional details were provided as follows: The patient was diabetic. The patient was also on soliris. On 12th June 2018, the patient was administered MENVEO in the right deltoid and TRUMENBA. The patient experienced a diabetic ulcer on the foot at the end of July 2018. The health care professional stated that the patient was due for 2nd dose of MENVEO in August 2018. The health care professional wanted to delay the vaccine for a few months and wanted to know what the efficacy would be. Also, the health care professional stated that the ulcer was infected and the patient might need surgery. No additional information was provided.
Staff administered 2 doses of JEV vaccine and 2 doses of Typhoid vaccine to same patient during appointment.  Patient was monitored for 1 hour post vaccine, without any adverse reaction.   Discharged from clinic with strict return precautions.
Shivers; Headache; Body aches; Fever 102; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the right arm on 20Apr2021 at 04:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B-12) and multi vitamin (reported as multi vit); all from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep6955) via an unspecified route of administration in the left arm on 30Mar2021 at 01:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 21:45, the patient experienced shivers, headache, body aches, 102 (unspecified units) fever. Therapeutic measures were taken as a result of shivers, headache, body aches, 102 (unspecified units) fever and included treatment with Motrin, following which the patient had a bad reaction and then took Tylenol next day fever decreased. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events shivers, headache, body aches, 102 (unspecified units) fever was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Started with a headache the day of vaccine and then the day after she got chest pain and trouble breathing.
Report described chest tightness in a 50 year old male who received hep A vaccine. This report was received from a director of clinical development and has not been confirmed by a physician or other healthcare professional. Allergies, medical history, and concomitant medications were not specified. On 03/14/2001, the vaccinee received his second right deltoid dose of havrix. "Within two minutes," post vaccination, the vaccinee felt dizzy, nauseous, faint and had fluctuating blood pressure. He then complained of chest tightness and numbness and tingling. The vaccinee was placed on an examination table and given oxygen. 911 was called. the vaccinee was taken via ambulance to the hospital ER, where he was discharged. As of 03/20/2001 the outcome of the events was unknown.
About 4.5 hours after receiving her 4th dose of Moderna (second booster), she noticed a rash and blotchy red spots on her hands, arms, mid-section, and upper legs.  They were not raised, but were itchy.  She applied Ivarest cream (which has an antihistamine in it) and took a cool bath with Aveeno, and reported some relief of the  itching.  Today (the day after), she called me to report the adverse event.  She reports today that the  rash is already starting to improve and lighten, though the itchiness has not improved.  I took the information and suggested she take an oral antihistamine.  She had Zyrtec on hand, so that's what she  took.  She  saw her  PCP a couple  hours later, and he recommended the exact  same thing.  The prescriber concluded that she should not get another  booster within the next 6 months (if another becomes recommended), and that if she does ever get another covid shot, she should choose a different one.
About 8pm on 03/28/21, patient noticed a small painful lump on left side of neck at the base, just behind the collar bone. Consistent with an enlarged lymph node. There was tenderness in left armpit. As of 03/31/21, the pain and swelling has become more prominent. No unnatural protrusion. It is uncomfortable for patient to tilt or turn head past 45 degrees. Left armpit has increased in tenderness. No fever noted at this time. Monitoring for fever or worsening symptoms, at which time a doctor visit would be initiated.
Pregnant woman (35 weeks) was given wrong RSV vaccine. Instead of Abrysvo she received Arexvy. Before giving the shot pharmacist looked up vaccine information and the only information was found is that the RSV (not specific name) was just recently approved for pregnant women bw weeks 32-36. Then pharmacist looked up the difference b/w Abrysvo and Arexvy and the information found was only difference in strain protection. At the time pharmacist did not find any information indicating that one vaccine is for pregnant women and another (Arexvy) for people 60 years and older. With that information vaccine was given to the patient.
No adverse effects reported.; patient was inadvertently administered one dose of expired VAQTA (lot R018935 exp 09/05/2019) on 09/06/2019; This spontaneous report was received from a nurse and refers to a 12-month-old female patient. No information regarding the patient's concurrent conditions, pertinent medical history and concomitant medications was reported. On 06-SEP-2019, the patient was inadvertently vaccinated with one dose of expired hepatitis a vaccine, inactivated (VAQTA) lot # R018935, expiration date: 05-SEP-2019 (strength, dose, frequency, route of administration were not reported) for prophylaxis. No adverse effects were reported.
Severe joint pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 53-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 12Feb2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included spironolactone (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 22Jan2021 at 16:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 26Feb2021, the patient experienced severe joint pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe joint pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
all tested positive for Covid last week. No hospitalizations resulted.; The seven year old tested positive on 04Jun; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: COVID-19 (medically significant) with onset 04Jun2022, outcome "unknown", described as "The seven year old tested positive on 04Jun"; DRUG INEFFECTIVE (medically significant) with onset 04Jun2022, outcome "unknown", described as "all tested positive for Covid last week. No hospitalizations resulted.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jun2022) Positive, notes: The seven year old tested positive on 04Jun.  Clinical course: My Wife and all three of the children who were all fully vaccinated with Pfizer Covid vaccine all tested positive for Covid last week. No hospitalizations resulted. My wife is 46 years old and has had other medical issues. She was prescribed Paxlovid and reports a foul taste in her mouth after starting the initial does on 02Jun22. The children are 11, 8 and 7 years old and had only received the initial two doses. Thanks for the reply. I am up to date on my training and am aware of the time constraints for reporting. It initially did not occur to me to report until I spoke to my wife about her treatment and then realized that everyone had had Pfizer vaccine and I needed to report. The first positive case was on 30May22 for the oldest son. The 8 year old tested positive on 01Jun22. My wife tested positive on 01Jun. The seven year old tested positive on 04Jun.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Localized wheal (3 cm x 1 cm) and flare (5 cm x 6 cm).  Started within 5 minutes of vaccination.  At 10 minutes was still spreading without systemic symptoms.  Treated with Benadryl 1.25 mg/kg with good response.
Onset of bilateral constant tinnitus within 24 hours of 2nd shot.  Hearing normal, no risk factor/exposures
She got her vaccine and had no reaction, did not feel shot going in.  She went home, worked for 4 hours and then rested the rest of the day.  She was waiting for the 6:00 news and felt a chill and then got colder, colder and colder and turned her heat on being 80 something outside.  She had a headache, went to bed at 8:30, felt worse the next morning, still had the chills, body hurting, bad headache, no appetite and noticed that her urine was very dark.  She drank fluids most of the day, did not eat much and felt cold, achy and headachy all day, no energy.  Felt better the next day and about the same, felt a little better yesterday.  She went to the grocery store and came home.  She ate a little last night, not much, and went to bed.  Got up today and she is still has no energy, no appetite, urine is still a little dark, little headache and arm is still real sore.  Is concerned as it has been there for 5 days.
No additional AE; Patient missed 3rd dose of GARDASIL 9, 5 years ago.; This spontaneous report was received from a pharmacist referring to a 25-year-old female patient. The patient's concurrent condition, medical history and concomitant therapies were not reported.  On an unknown date in 2018 (reported as 5 years ago), the patient was vaccinated with first 2 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dose, lot #, expiry date, anatomical location and route of administration were not provided) and forgot her last dose (product dose omission issue). The patient wanted information on when she could receive her next dose since 3rd dose missing. There was no additional adverse event (no adverse event).
Right after the injection I got dizzy, chest and throat got tight. The next day I had fever, numbness, and tingling in right arm.
Caller reporting a missed dose for GARDASIL 9. Caller stated a customer received her first dose in December 2022 and was back in the pharmacy today to get the second dose. Caller provided no additional information. No additional AE. No PQC.; No additional AE; This spontaneous report was received from pharmacist technician, concerning to female patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in December 2022, the patient was vaccinated with first dose  of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (strength, lot #, expiration date, and route of administration were unprovided) for prophylaxis.   On unreported date, the patient missed dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 23-MAY-2023 (also reported as today), the patient was back in the pharmacist to get the second dose. No additional adverse event was reported.
red, itching, burning rash; red, itching, burning rash; rash that looked like mosquito bites between her legs and arms/ She says in a matter of hours it spread all over; they kind of clumped together to make one bigger mosquito bite, like welts; This is a spontaneous report from a contactable consumer (patient's mother) Pfizer-sponsored program  A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), an unspecified route of administration, administered in left arm on 15Sep2021 (Batch/Lot Number: FC3183) (at the age of 16 years old) as dose 1, single for COVID-19 immunisation. Medical history included seasonal allergies. There were no concomitant medication. The patient previously took Allegra, patient had seasonal allergies and occasionally takes over the counter Allegra for that but not every day and only on occasion. Patient had a reaction to her first dose of the Pfizer COVID-19 vaccine she got on 15Sep2021. Patient had a red, itching, burning rash that started two days after the vaccine on 17Sep2021. It started for hours between her legs and then was all over her body kind of like mosquito bites that were more concentrated on lower body mostly. The patient's mother said that she gave her daughter Benadryl (25mg Ultra-tabs; LOT: SHF054 EXP: Feb2022) and that it didn't do anything. She developed a rash that looked like mosquito bites between her legs, a lot of them, and she said it was itchy and burning. She says in a matter of hours it spread all over, a lot on her bottom half, and some on her back, arms, and chest. She says that they kind of clumped together to make one bigger mosquito bite, like welts, they kind of make one bigger one. She says they spread a lot, the little bumps, into big huge one. She says that this was on her thighs and all around, but she didn't see any on her feet, they were on her ankle but not on her feet. Patient suffered with the rash over the weekend, but she didn't get to look at her legs before she went to school today, which she let the school nurse know she was having an adverse reaction to the shot. She says Friday was the worst when it was developing, then on Saturday it was still itching and burning with redness. She says the red was clumped together to make big ones. She says Sunday the rash was still there, this morning it is unknown if still there. The outcome of the events was unknown.
Large Hive appeared around the area of vaccination; Itchy; Tender to touch; Normal redness; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE URTICARIA (Large Hive appeared around the area of vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Tender to touch) and VACCINATION SITE ERYTHEMA (Normal redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Large Hive appeared around the area of vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Tender to touch) and VACCINATION SITE ERYTHEMA (Normal redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE URTICARIA (Large Hive appeared around the area of vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Tender to touch) and VACCINATION SITE ERYTHEMA (Normal redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Benadryl and Ice used as a Treatment medication   This case concerns a female of unknown age who experienced NS expected events of vaccination site erythema followed by vaccination site urticaria, vaccination site pruritus, and vaccination site pain.  Event onset occurred a few days after the first dose of mRNA-1273. Treatment included Benadryl and ice. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Narrative:  1st moderna vaccine: 1/1/2021 2nd moderna vaccine: February 2021 covid positive 1/27/22 hospital stay 1/27/22 - 1/30/22
Swelling in feet, lower legs, hands, abdomen and face that started the day after the vaccine, 3/4/2021. Symptoms continued and became worse following the second vaccine dose on 3/31/2021.
get sick; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a patient who got sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious get sick (illness) unknown latency following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
there was an excursion from their freezer on 01 oct 2021; expired product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from their freezer on 01 oct 2021) and EXPIRED PRODUCT ADMINISTERED (expired product administered) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from their freezer on 01 oct 2021) and EXPIRED PRODUCT ADMINISTERED (expired product administered). On 12-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from their freezer on 01 oct 2021) and EXPIRED PRODUCT ADMINISTERED (expired product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.
right arm soreness was worse; nauseated; feeling exhausted; dizzy (lasted 20 minutes); right arm became sore; weak; no energy; didn't feel very good; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy), MALAISE (didn't feel very good) and CONDITION AGGRAVATED (right arm soreness was worse) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Obesity, Hypertension and Gout.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced ASTHENIA (no energy) and MALAISE (didn't feel very good). On 01-Mar-2021, the patient experienced CONDITION AGGRAVATED (right arm soreness was worse). On 02-Mar-2021, CONDITION AGGRAVATED (right arm soreness was worse) had resolved. At the time of the report, ASTHENIA (no energy) and MALAISE (didn't feel very good) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Blood pressure measurement: 170/110 (High) 170/110.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Blood pressure medication and Gout preventive medication.  No treatment information was provided.
Breakthrough case admission after 5 vaccines Pfizer 3/16/21 LOt# EP7534;  Pfizer 4/6/21 Lot# Er8729;  10/15/21 Pfizer Lot# EW0164;  Pfizer 4/7/22 Lot# FM0698;  Pfizer 9/13/22 lot# GJ2524