chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician on 17-DEC-2014 via a company representative. The physician, who was also the mother of a 20 year old female patient, disclosed that her daughter has been getting headaches after receiving her first dose of GARDASIL (lot number and expiration date not provided) about 30 days ago. These headaches have been persistent for the last 30 days. The outcome was not reported. The causality was not reported. No other information was provided. Additional information is not expected.
Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022; 21 patients administered with expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  It was reported that 21 vials were initially stored in refrigerator on 17-Feb-2022 and doses were administered 30 day use by date or after manufacturer date of expiry. The vials did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received contains no new information.
Right arm became red, swollen, and warm to the touch, Fever on Saturday of 101.3
There was no adverse event, mother requesting vaccination for child as she reported public health was not able to get moderna vaccine, Mother requested to give pfizer vaccine.
Pt reports hives, upset stomach, flushing/heat. Suggest BENADRYL for hives and watch out for worsening symptoms.
Dose administered from a vial that was more than 30 days on the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-326226, MOD-2021-326432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow-up information received on 23SEP 2021 contains Non- Significant  information.
Initially started with a headache, then developed fever of 101, then left arm became red and swollen to elbow. Symptoms lasted 3-4 days. MD called and suggested cold compresses and Ibuprofen as needed.
The vaccine was given to a 16 year old.  Moderna is for 18 years and older.
heart attack; This is a spontaneous report received from a Pfizer sponsored program Pfizer RxPathways via a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; and varenicline tartrate (CHANTIX), route of administration, start and stop date, batch/lot number and dose were not reported to quit smoking. The patient medical history and concomitant medications were not reported. The patient experienced heart attack in Feb2021 with outcome of unknown. Caller called in seeking assistance with the medication Chantix. During the call caller stated."I had a heart attack in February and the patient was trying to quit smoking and trying but it was pretty hard to do. The action taken in response to the event(s) for varenicline tartrate was dose not changed.   Information about batch/lot number has been requested.
This case was reported by a nurse and described a 50 year old female pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. On 12/2/02, the pt received her first dose of Engerix B (5351A4). On 1/2/03, the pt received the second dose of Engerix B (5351A4). On 6/3/03, the pt received the third dose of Engerix B (5389A4). On 7/31/03, a hep B surface antibody titer was "negative." The nurse considered the events to be related to vaccination with Engerix B. The reporter stated that "many" patients did not seroconvert following receipt of three doses of Engerix B. However, only one other pt is presently identifiable; please see report A0427422A.
Anaphylaxis: Throat swelled, difficulty breathing. She went to urgent care on her way home, they administered EPI x2 and gave her a steroid injection.
I had Vertigo pretty bad. The ground was moving like I was on a ship in the ocean. I started projectile vomiting and was taken to the Emergency Room. I was in there for four hours before I was seen, and it was almost over. They ran a couple tests, and they were normal, and I was released. They prescribed a couple medications in case I started having Vertigo again, Meclizine and Ondansetron. I have not had to use them though.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Former smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Covid rebound, return of symptoms & tested positive for Covid on 18May2023  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain at the injection site; hot to touch at injection site; swelling at the injection site; redness at the injection site; body aches; tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included fibromyalgia.   On 12th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2021, 3 hrs after receiving Shingrix, the patient experienced tiredness. On 14th August 2021, the patient experienced injection site pain, injection site warmth, injection site swelling, injection site erythema and general body pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, injection site warmth, injection site swelling, injection site erythema, general body pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, injection site erythema, general body pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient reported that she received her 1st dose of Shingrix vaccine in the left arm.  Adverse reactions to the Shingrix vaccine included pain at the injection site, hot to touch at injection site, swelling at the injection site, redness at the injection site, body aches and tiredness.  About 3 hours after receiving the Shingrix vaccine tiredness started and all the other mentioned symptoms started 2 days after receiving the Shingrix vaccine. The reporter thought the side effects from the Shingrix might be related to her pre-existing Fibromyalgia, but the reporter ruled that out.  The patient had taken Advil and it helped a little with the symptoms.  The patient stayed in bed most of 14th and 15th August 2021.  The symptoms were better on the day of reporting, but none of the symptoms stated were completely resolved. The reporter did not consent to follow-up. The reporter also did not give permission to contact health care professional.
lost of hearing in the right side/lost hearing in one ear; is loosing balance; pain in right jaw; throat sore; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS (lost of hearing in the right side/lost hearing in one ear) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced DEAFNESS (lost of hearing in the right side/lost hearing in one ear) (seriousness criterion medically significant), BALANCE DISORDER (is loosing balance), PAIN IN JAW (pain in right jaw) and OROPHARYNGEAL PAIN (throat sore). At the time of the report, DEAFNESS (lost of hearing in the right side/lost hearing in one ear), BALANCE DISORDER (is loosing balance), PAIN IN JAW (pain in right jaw) and OROPHARYNGEAL PAIN (throat sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The onset of events occurred 18 hours after the vaccination.  The patient saw his doctor and has an appointment scheduled with and eye and ear clinic.  It was not reported if any treatment was administered in response to the events.  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.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Verbatim added to event term; 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.  Further information has been requested.
Patient unknowingly received 4 doses of covid vaccine and had a cardiac arrest on 7/12/21
Chest pain, Myocarditis, seen in ED on 7/2/21 (2 days after vaccine) with diagnosis confirmed. no EKG changes, treated with toradol and ibuprofen 600mg TID x 5 days, symptoms resolved by 7/9/21
DIZZY; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 18-JUN-2021, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dizzy was not reported. This report was non-serious.
Vaccinated after the excursion; Product storage error; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-403721 (Patient Link).
Patient is still experiencing arm pain 10 days after having her vaccine.  She is also reporting that she has been experiencing some chest "discomfort", some heart palpitations, and doesn't feel like she can take a deep breath. She says she has been experiencing pain more towards the left side of her chest.  We recommended she be seen immediately by a physician.
This spontaneous report as received from a health care worker refers to an approximately 14 year old female patient. The patient had no pertinent medical history or drug allergies. On 16-AUG-2012, the patient was vaccinated with GARDASIL dose 1. Subsequent does of GARDASIL were administered on 02-NOV-2012 dose 2 and 08-NOV-2013 dose 3. No concomitant medications were reported. On an unknown date approximately in 2013, the patient experienced abnormal periods. The reporter stated that the patient first reported abnormal periods on 03-DEC-2013 and mentioned that the patient was bleeding for 27 days. The patient had some blood work done and diagnosed to be low in iron. The patient received treatment with iron supplement. The outcome of abnormal periods and low in iron was reported as not recovered/not resolved. The patient sought medical attention by visiting the doctor's office. Additonal informatkon has been requested.
Patient experienced lightheadedness and decrease in blood pressure (76/53) after vaccination with FLUVIRIN.
Possible allergic reaction. Unsure if from vaccine, or apple juice. Pt has body rash, including head area. Benedryl 12.5/5ml 2ml po Q8H given as treatment, and pt will return in 2 days to follow up.
Right thigh red and warm to touch. .5"x1" about .5" below immunization site. Immunization given at 630PM 2/13/03. Reaction occurred 11AM 2/14/03. Patient was given 1/2 tsp Benadryl and advised to give every 4-6 hours while rash is present.
Gotten both vaccines; tested positive/but I have shown no symptoms at all except for runny nose, some sneezing; Gotten both vaccines; tested positive/but I have shown no symptoms at all except for runny nose, some sneezing; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) first dose on unknown date and second dose on 25Feb2021 both via unspecified route of administration as single dose for COVID-19 immunization. Medical history and Concomitant medication were not reported. It was reported that consumer stated, "I received the Pfizer vaccine one and two at the (Hospital name withheld). I received the second shot on 25Feb2021, and that was on a Thursday. I went on the next day, on Tuesday and I tested positive on 02Mar2021, but I have shown no symptoms at all except for runny nose, some sneezing which has popped already. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 02Mar2021. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Large red swollen area over most of left upper arm, centered around injection mark. The area is warm to touch and a bot tender. Symptomatic care discussed such as ice, Tylenol, and Benadryl suggested.
Lymphadenopathy, severe Left SI joint and low back pain, including Left leg down to foot. chills,headache, nausea,  Ibuprofen every 12 hours with Tylenol in between. Warm compresses
Hemolitic Anema, Kidney Failure, Neurophy.i yf1
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient reported to be lightheaded a few minutes after shot. I had her lay down with her feet up. She felt better. After 15min I got her to sit up. No more lightheadness. I had her drink some water. She said she was completely ok when I allowed her to leave.
He developed Bells Palsy on the right side on 7/4/08. He subsequently developed Bells Palsy on the left on 7/29/08; He was also given Hep B Vaccine on 02/25/08 and 3/25/08
Itchy throat, feeling uneasy, slight tightness in throat @ 1135 Emergency zertec given @ 1140  Patient reports feeling better @ 1150 Patient observation time extended from 30 minutes to 1 hour with constant monitoring  Patient leaves @ 1234 and states he feels better
Patient was tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient was tested positive for COVID-19) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Patient was tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient was tested positive for COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
SkinRash, ErythemaMultiform, Fatigue, Injection site pain, Swelling at injection site Narrative:  Other Relevant History:
Pt was given a DTaP vaccine on 8/27/13 the vaccine had expired on 8/15/13.
This spontaneous report was received from a healthcare worker and refers to a 6 months old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On 07-DEC-2015, the patient was vaccinated with an improperly stored ROTATEQ (lot # K014826, expiry date 28-MAY-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A. was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A. will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; COVID Rebound; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group.  A female patient received BNT162b2 (BNT162B2), on 05May2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4991), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DISEASE RECURRENCE (medically significant) with onset 09Aug2022, outcome "not recovered", described as "COVID Rebound"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Patient had all the same symptoms 4 days prior reporter with the same vacation history, Paxlovid & rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Rebound with nasal congestion, cough, sneezing. Patient had all the same symptoms 4 days prior to reporter with the same vacation history, Paxlovid & rebound.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Received the vaccine Sunday March 7th, had normal sick reaction the next day on Monday. Felt better by Tuesday but noticed dark colored urine which I correctly assumed was blood. Unsure if this was present the previous day or not. Immediately booked an appointment with my doctor for the next day given my history of having 1 kidney. There, they confirmed there was large amounts of blood in my urine. I had no pain. No evidence of UTI. Urine slowly became lighter over the next week or so, however microscopic amounts of blood still remained (confirmed via lab testing). As of now, August 29th, to my knowledge I am still urinating microscopic amounts of blood. Otherwise in good health.