chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history was not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (Strength, dose, frequency, route, anatomical location and expiration date were not reported) of lot # M034586 for prophylaxis. Concomitant therapies included sterile diluent. The nurse confirmed that the sterile diluent used to reconstitute the VARIVAX was properly stored. No adverse effect reported. There was no product quality complaint involved. Sender's Comments: US-009507513-1708USA008906: US-009507513-1708USA008905: US-009507513-1708USA008907: US-009507513-1708USA008368.
Patient experienced acute onset diplopia the morning after her Pfizer booster vaccine. She had chills the night preceding her vision changes. Patient was evaluated at ED. A brain MRI was normal.
Patient previously received Moderna in March and April and failed to notify us. Insurance company informed us upon billing.
took one in my life and was never sicker; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who experienced took one in my life and was never sicker while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.   On an unknown date the patient developed a non-serious "took one in my life and was never sicker (illness)" (unknown latency) following the administration of influenza vaccine.  It was reported that "I took one in my life and was never sicker, won't take another, they mostly miss the strain that is out for the year anyway! After Covid with all the lies,I don't trust Government for much of anything! They only care about money, not people".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (took one in my life and was never sicker).  At time of reporting, the outcome was Unknown for the event took one in my life and was never sicker.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT) No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
(L) delt, baseball sz, swelling, redness, warmth, (102.0, headache, sore throat, achy). Warm compress, TYLENOL, cool compresses.
Bleeding in between menstrual cycles, and period every 15 days, for the past two months.
Large red welt at injection site.  Painful and itchy.  Mom reports that she is able to see when vaccines were injected.
Reddened 8cm x 7cm area to left upper arm, warm to the touch and with swelling. Treated with Duricef 250/5 tsp BID for 10 days and Benadryl PRN.
Headache, PAINFUL, SORENESS, RED, SWOLLEN AT INJECTION SITE, FATIGUE, CONGESTION Narrative:
Rec'd 15 mo vaccinations 9/02/15 at WCE. Also had 0.25 FLU. (+) edema, redness 9/03/15. Seen 9/04/15 in office for s/s. (+) (Lt) thigh with faint pink area approximately 6 cm diameter with slight warmth & induration. Tx = ibuprofen-prn/BENADRYL-prn/warm compresses.
Headache, Myalgia, Fever, CHILLS, SHAKEY, SORE ARM Narrative: STAYED HOME FROM WORK
Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 04JUN-2015 the patient received a dose of improperly stored LIQUID PEDVAXHIB. The outcome is unknown. No adverse effects were reported. Additional information is not expected.
pt recvd vax; pt devel a rash & possible serum sickness w/ hives & swelling over body;
On injection site, red, swollen and hard. The site is very swollen and looks as if a golf ball is under my skin. It is irritated and very painful. I have had a fever of 104 and the worst headache of my life.
PATIENT WAS DUE FOR HER SECOND DOSE OF COVID VACCINE. UPON ADMINISTERING THE VACCINE, PATIENT EXPERIENCED A BUMP ON HER RIGHT DELTOID.
Severe body aches, pain when trying to walk, weak, fever, diarrhea. Fever came on after 24 hours of injection. Body aches started the morning after the injection. Pain and redness at injection site more than 48 hours after injection. Feeling of weakness still on the 2nd day after.
Moderna COVID?19 Vaccine EUA  2nd dose of Moderna COVID-19 vaccine received at 10:05am. Slight headache beginning around 3pm and intensifying throughout day along with onset of joint/body aches. Chills/shivering/fever/rhinitis beginning around 9:30pm same day. Symptoms continued overnight. 400mg Ibuprofen taken early the next morning. Symptoms mostly alleviated by 4pm the following day.
FIRST DOSE INFO: 07/31/2021 4:30PM, COVID19 (Pfizer\BioNTech) Lot FA-7484 Intramuscular. 1. CHRONIC COUGHING (ONGOING); 2. IRREGULAR HEART RYTHM EVENTS (ONGOING); 3. HEART MURMUR; 4. ENLARGED HEART;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient received a partial dose of ZOSTAVAX (19400 plaque-forming units, PFU) (injection, for prophylaxis, lot # M042851 with expiration date at 28-JAN-2018; dose, route of administration and anatomical location were not reported) reconstituted with stored sterile diluent (STERILE DILUENT) (strength, dose, lot # and expiration date were not reported). On the same date, the patient experienced a skin exposure to ZOSTAVAX reconstituted with stored sterile diluent (STERILE DILUENT). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L042836. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was NSTEMI.
Rash over the torso (chest, back, abdominal area)   started 5 days after booster.
covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (covid-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.         Treatment information was not provided. Concomitant medications were not reported.  Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of COVID-19, is assessed as unlikely related.  Further information has been requested.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of COVID-19, is assessed as unlikely related.  Further information has been requested.
PER SCHOOL NURSE APPROXIMATELY 30 MIN AFTER DOES ADMINISTERED, HE HAD FACIAL REDNESS, SWELLING TO SITE, AND GENERALIZED RASH. HE WAS GIVEN BENADRYL 25 MG PO AND MOM TOOK HIM TO MD OFFICE. PER SCHOOL NURSE HE WAS GIVEN 'ANOTHER SHOT' AND HE IS NOT BACK AT SCHOOL. SPOKE WITH SCHOOL NURSE AT 1:00 PM. HE IS DOING WELL AT THIS TIME.
Large red circle, itching, burning, soreness & pain. Headache, flu symptoms - aching joints and severe malaise. Fever twice and blisters once in nose. Loss of appetite, trouble sleeping - All over a month before I was well.
On 12/1/16 patient received Flu and Pneumonia vaccine. By 12/31/16 patient noticed soreness, redness and swelling. Was concerned so patient called pharmacy. MD was notified. Patient had been taking BENADRYL and swelling is down, but now notices bruising.
Pt rec'd 2nd Anthrax with 1 day local redness and swelling 12" from site. swelling caused parathesia.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-AUG-2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, route, anatomical location, lot number and expiration date were not provided), for prophylaxis, and on 05-AUG-2016, she/he was vaccinated with a dose of GARDASIL 9 (lot number M013636; strength, dose, route and anatomical location were not provided), also for prophylaxis (interchange of vaccine products). No adverse effects were reported.
pt recvd vax JUN95 & was exposed to chickenpox;lab eval following exposure to chickenpox revealed a neg titer;no further details were provided;
Vaccine given 4/8/15, 2-3 days later the right lateral leg became red, swollen around the site. Parents used topical antibiotic ointment. He was seen in office, advised to start oral BENADRYL and cool compress.
headache; redness at the injection; First dose of the Shingrix vaccine about a year ago; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In January 2020, the patient received the 2nd dose of Shingrix. In January 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced headache and injection site erythema. On an unknown date, the outcome of the headache, injection site erythema and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the headache and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Wife stating her husband received the first dose of the Shingrix vaccine about a year ago and received the second dose past the six month period, which led to lengthening of the vaccination schedule.  He received the second dose last week. She states he did experience headache and redness at the injection site with the first dose.  Customer did not want to provide her address.  No additional information provided. The reporter consented to follow up.  This case has been linked with US2020015816, reported by same reporter.
Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
A week after the injection of the covid Phyzer vaccine I developed a vision of checkerboard in the perifical area of my left eye. It lasted about 30 to 60 seconds. This was my second vaccine dose. I also experienced a similar experience within 24 hours of my first dose in February of 2021
Symptoms matched physical condition prior to medication for Parkinson's Disease and included; extremity immobility and collapse, compromised ambulation, weakness and fatigue after  limited exertion.  The first day of incidence was on 3/15/2021 and was at the upper limit on 3/18/2021.
erythema; vaccination site pruritus; vaccination site erythema; my arm got sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE ERYTHEMA (vaccination site erythema), PAIN IN EXTREMITY (my arm got sore) and ERYTHEMA (erythema) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE ERYTHEMA (vaccination site erythema) and PAIN IN EXTREMITY (my arm got sore). On an unknown date, the patient experienced ERYTHEMA (erythema). At the time of the report, VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE ERYTHEMA (vaccination site erythema), PAIN IN EXTREMITY (my arm got sore) and ERYTHEMA (erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Treatment of COVID-19; Treatment of COVID-19; Jansen:Start date:24Mar2021/Pfizer / BioNTech start date:11Aug2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 24Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "depression" (unspecified if ongoing); "dysthymia" (unspecified if ongoing), notes: dysthymia with intermittent anxiety; "intermittent anxiety" (unspecified if ongoing), notes: dysthymia with intermittent anxiety; "POIS (Post Orgasmic Illness Syndrome)" (unspecified if ongoing), notes: POIS (Post Orgasmic Illness Syndrome). Concomitant medication(s) included: NALTREXONE; ATOMOXETINE; DICLOFENAC. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Aug2021, outcome "unknown", described as "Jansen:Start date:24Mar2021/Pfizer / BioNTech start date:11Aug2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
13JAN96 recvd vax & 14JAN sore-sl;15JAN more sore; red area size of hand & hard by 17JAN remained hard
Symptoms began with numbness and tingling in hands and feet with a gradual progression over 14 days to complete numbness from navel down, arm numbness, loss of fine motor movements in hands, face and feet.
Back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced BACK PAIN (Back pain). At the time of the report, BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. The nurse reported that on 15-JAN-2015, the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiry date 09-APR-2016 (dose and route of administration unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient came in today to ask about the flu vaccine and stated that he was still experiencing stiffness and swelling in the right arm that he got the vaccine in. He went to his doctor's office twice and they recommend him to go for physical therapy but that would be too expensive.
stomach cramps; tenderness at injection site; This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced stomach cramps and injection site tenderness. On an unknown date, the outcome of the stomach cramps and injection site tenderness were unknown.   It was unknown if the reporter considered the stomach cramps and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had the first dose of Shingrix and experienced tenderness at the injection site and stomach cramps the same day of the injection. The patient did not want to share any more information and provided case number for follow up.
Began with sweating than pain  in upper back between shoulder blades, radiated from back to  chest.  Tightening of jaw (as when eating something really tart).  Pain felt similar to muscle spasms and would be bad enough to cause nausea & vomiting.  When pain subsided would experience chills and shivering.  This would come and go over the next 5-6 hours.    Checked for fever, but temperature was within normal range.
client was found having pseudo seizure like symptoms,arrival at site she was found pale and disoriented.assisted to lay down,elevated legs,vs was checked .snacks and water given,ice packs placed on. After 25 mins ,Patient responding  well. Assisted onto wheelchair and was wheeled out.
4-08-2021  Frequent urination 4x during night vivid dreams 4-22-2021  Muscle weakness, loss of muscle tone , falling,  red eyes, swollen wrist 5-1-2021     Went to Urgent care for adverse reactions was prescribed  muscle relaxant 5-5-2021   Feel and broke wrist from muscle weakness
BAD CASE OF COVID AND REFUSED TO GO THE HOSPITAL; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a regulatory authority through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, weight and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. The dose number in series was 1. No concomitant medications were reported.  On an unspecified date, the patient had a bad case of covid and refused to go the hospital, and suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bad case of covid and refused to go the hospital and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested. This case, from the same reporter is linked to 20211230489.; Sender's Comments: V0.20211230784-covid-19 vaccine ad26.cov2.s -Bad covid 19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211230784-covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Started 5/11 in the morning with headache and dizziness. Left arm started feeling heavy and numb also finger tips got tingling.  Started to get sharp chest pains near my heart then started to feel fatigue. Then my tongue started to get swollen/numb and I couldn't really talk. Went to urgent care and due to my condition they called the ambulance and went to hospital. They did an EKG/chest x-rays and blood work. Couple hours later they send me home with no diagnosis just to see primary doctor.  Symptoms were mild for 2 days then again on 5/14 symptoms came back and went back to urgent care. They did an EKG/Covid test/ only and doctor just said it was a panic attack. I disagree I still don't feel completely right.
pt recvd vax 4AUG92 7 1 1/2 mo later began stiff, popping joints, unco-ordinated & pins/needles feeling in hands; now w/numbness, achey elbows & wrists;  Nov menses 1 wk early, lasted 17 days, bruised easily, hair loss;