chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Recovering from shingles; Got 3 shingles shots; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and extra dose administered. On an unknown date, the outcome of the vaccination failure and extra dose administered were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had 3 shingles shots, and still experienced shingles. The patient was in the process of recovering from shingles . This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Information has been received from a physician concerning a 12 year old male who was vaccinated with a first dose of VARIVAX (Merck). The patient had a chicken pox outbreak. The patient's chicken pox persisted. The patient sought medical attention, he went to the physician. Additional information has been requested. The patient's sister also had an adverse experience after vaccination with VARIVAX (Merck). (WAES# 0806USA01251).
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with rheumatoid arthritis and no drug reactions or allergies. On an unknown date the patient was vaccinates with a dose of ZOSTAVAX (lot # J000435, exp. date:10-APR-2014) for vaccination. There was no concomitant medication. On an unknown date the patient was started HUMIRA for the treatment of rheumatoid arthritis following vaccination with ZOSTAVAX. The pharmacist could not provide the reason for the use of HUMIRA. The pharmacist could not provide if the patient was having problems with their rheumatoid arthritis following vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
The patient received 2nd dose COVID vaccine.  Patient received first dose COVID on 3/18/2021.  Patient notified of vaccine administration error at time of event.
Shot received at 10:00am Thursday 3/18/21 4:00pm felt achey and tired 9:00pm felt nauseous, began vomiting, severe headache Vomited every half hour until 1:00pm on 3/19/21.   Accessed Urgent Care Facility at 2:00pm and received anti-nausea medication. Ondansetron ODT 4 MG Tablets  Stopped vomiting after receiving medicine. By 4:00pm nausea had stopped, headache had improved.  3/20/21 Most symptoms have faded.  Mild headache and aches continue.
I have had severe, watery diarrhea for the past 8 weeks  following the first  vaccination and continuing through second vaccination.  Vomiting has also occurred with weight loss of 20 pounds.
Bruising, extreme low platelet count (2000) Platelet infusion, IVIG ( multiple doses), Rituxin Treatment course still underway Diagnosed June 21, 2021- under care of doctor, multiple doctor visits including emergency room
SWOLLEN LEFT ARMPIT (Swelling, Swelling) PAIN IN LEFT ARMPIT (Armpit pain, Axillary pain) This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 192 pounds, and height was 161 centimeters. The patient's concurrent conditions included hypertension, diabetes mellitus, gerd, and lexapro allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Mammogram (NR: not provided) unknown. On 04-MAR-2021, the patient experienced swollen left armpit and pain in left armpit Patient reported that after covid vaccination in left arm she developed a swollen left armpit and pain in left armpit. Patient had to go to urgent care. The action taken with covid-19 vaccine as26.cov2.s was not applicable. The patient had not recovered from swollen left armpit, and pain in left armpit. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210313453. Additional information was received from patient on 12/Mar/2021. The following information was updated and incorporated into the case narrative: Patient information (age, age group, weight, height) added, Patient medical history and lab details added.
shortness of breath; loss of appetite; diarrhea; nausea; fatigue/tiredness; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), NAUSEA (nausea) and FATIGUE (fatigue/tiredness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient did not had any history of myocarditis or pericarditis. Patient did not had acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: flu shot (flu shot before the first booster) in 2021. Past adverse reactions to the above products included No adverse reaction with flu shot. Concurrent medical conditions included Allergic reaction to bee sting (Bumblebees).   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), NAUSEA (nausea) and FATIGUE (fatigue/tiredness). At the time of the report, DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), DIARRHOEA (diarrhea), NAUSEA (nausea) and FATIGUE (fatigue/tiredness) had not resolved.             The patient was under a lot of concomitant and regular medications (there were a lot of them), but not provided names.  It was reported that few days after second booster patient experienced stronger symptoms coming and going. At the time of reporting symptoms were still coming and going.  The adverse event did not cause patient to seek medical care. The patient did not experience a similar event in the past.  No treatment had been given for her symptoms.   This case was linked to MOD-2022-635781, MOD-2022-635784 (Patient Link).
I felt the tingling and irritation on my breast. I knew it felt like the shingles, so I called my doctor and was given meds for my shingles.
Fever at 101 Fahrenheit; Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 09Jun2021 15:00 (Lot Number: EW0217) as single dose, for COVID-19 immunisation. Medical history included torticollis, post-traumatic stress disorder, depression, cyp2b6 gene status assay, cyp2c19 gene status assay, cyp2d6 gene status assay, hysterectomy, menopause, food allergy, hypersensitivity, rubber sensitivity (to latex and latex foods), allergy to surgical sutures, food allergy, seasonal allergy, drug hypersensitivity (to gabapentinoids, SSRI's, SNRI's), COVID-19. Patient was not pregnant and was not pregnant at time of vaccination. Concomitant medications included trazodone (unknown manufacturer), diphenhydramine hydrochloride (BENADRYL), cyclobenzaprine (unknown manufacturer), erenumab aooe (AIMOVIG). Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EW0182), in right arm, on 17May2021 at 01:00 PM at 53 years, for COVID-19 immunisation and miconazole nitrate (MONISTAT) and experience drug allergy. Patient did not receive other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient experienced fever at 101 Fahrenheit (disability) on 16Jun2021 07:00 with outcome of not recovered, tinnitus (disability) on 16Jun2021 07:00 with outcome of not recovered. The patient underwent lab tests and procedures which included acoustic stimulation tests: no hearing loss on 16Jun2021, body temperature: 101 Fahrenheit on 16Jun2021. The events required physician office visit. No treatment has been administered as a result of the events. The patient has not been tested for COVID-19 since the vaccination.
feeling bad; piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve; and she can feel a knot inside and is wondering if they hit a nerve; pain spreading across chest into right arm/chest pain; muscle spasms; not able to lift right arm; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (pain spreading across chest into right arm/chest pain), MUSCLE SPASMS (muscle spasms), MOBILITY DECREASED (not able to lift right arm), FEELING ABNORMAL (feeling bad) and VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced CHEST PAIN (pain spreading across chest into right arm/chest pain), MUSCLE SPASMS (muscle spasms), MOBILITY DECREASED (not able to lift right arm), VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) and INJECTION SITE INDURATION (and she can feel a knot inside and is wondering if they hit a nerve). On an unknown date, the patient experienced FEELING ABNORMAL (feeling bad). The patient was treated with CORTISONE for Pain, at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, CHEST PAIN (pain spreading across chest into right arm/chest pain) and MUSCLE SPASMS (muscle spasms) was resolving and MOBILITY DECREASED (not able to lift right arm), FEELING ABNORMAL (feeling bad), VACCINATION SITE PAIN (piercing pain is worst at night time and she can feel a knot inside and is wondering if they hit a nerve) and INJECTION SITE INDURATION (and she can feel a knot inside and is wondering if they hit a nerve) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Electrocardiogram: unknown (Inconclusive) unknown..         Concomitant medications were not reported. Treatment was reported as:  pain pill, icy hot, hot baths, ice, heating pads   This case was linked to MOD-2021-132741 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant follow up  received on 26-may-2021 event outcome updated.
fever of 104, chest congestion, sore throat started 1 day after getting flu shot
The patient received a 1st Hep-B vaccine on 8/1/2009 10am without any difficulty at the time however, the patient reported N/V, abnormal pain with body aches sore @ 10pm 8/1/09 > sent to ER 8/2/09 10:30 am
runny eyes, very itchy, discharge, and was like pink eye; runny eyes, very itchy, discharge, and was like pink eye; runny eyes, very itchy, discharge, and was like pink eye; This is a spontaneous report from a non-contactable consumer (patient herself). A 74-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EL9261), via an unspecified route of administration in the left arm on 25Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination, did not receive any other vaccine in four weeks, and was not pregnant. The patient experienced runny eyes, very itchy, discharge, and was like pink eye on 25Jan2021. It was reported that the events started about six hours after vaccine shot and lasted 48 hours. The patient had not tested positive for COVID-19 post vaccination. The patient did not receive any treatment for the events. Outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2; It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.; It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000004355.  A 56-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunisation, reaction(s): "the patient was tired the next day and lethargic after the 1st dose", "the patient was tired the next day and lethargic after the 1st dose". The following information was reported: LETHARGY (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster."; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 2021, outcome "unknown", described as "on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2".  Additional information: On 28Nov2022, it was reported that a patient started treatment on an unspecified date in early 2021 with Pfizer COVID-19 Vaccine dose 1, on an unspecified date (reported as 2 months later) with Pfizer COVID-19 Vaccine dose 2, on an unspecified date in Sep2021 with Pfizer COVID-19 Vaccine dose 3 (reported as 1st booster) and on an unspecified date in Apr2022 with dose 4 (reported as 2nd booster) for COVID-19 immunization. It was reported the patient was tired the next day and lethargic after the 1st dose, 2nd dose and 1st booster. After the 2nd booster, the patient started to get really sick, had high fever, chills, could not be still and was in bed all the next day and described it "like having a bad flu".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PV202200124812 same patient different dose number/ event;
1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; 1. SEVERE weakness (CAN'T WORK)2. Constantly hot without a fever (skin is hot to touch)3. Can't focus to even read most of the time.4. Sporadic trouble swallowing; food, drink, and pills get "stuck; Not hungry. Not sure if that's because I can't stand up long enough to cook or what.; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204), via an unspecified route on 03May2021 at 15:00 (at the age of 44-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. The patient concomitant medications included gabapentin, hydrocodone bitartrate, paracetamol (VICODIN), and a multivitamin from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0150), via an unspecified route on 12Apr2021 at 15:00 (at the age of 44-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 03May2021 at 17:00, the patient experienced severe weakness (can't work), constantly hot without a fever (skin is hot to touch), can't focus to even read most of the time, sporadic trouble swallowing food, drink, and pills get "stuck" in chest, not hungry, not sure if that's because she can't stand up long enough to cook or what. Patient received treatment for events. Patient visited to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab, covid test was negative on 20May2021. The outcome of the events was not recovered.  Follow-Up (26Aug2021): Follow-up attempts are completed. No further information is expected.
I have COVID now for the 2nd time despite being vaccinated and not doing great; I have COVID now for the 2nd time despite being vaccinated and not doing great; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID now for the 2nd time despite being vaccinated and not doing great".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Within first half hour I experienced increase in heart rate (110 BPM) , dizziness and headache. This subsided within 10-15 minutes. I experienced slight fatigue and soreness at injection site approximately 4 hours after receiving vaccination.  This morning upon waking, approximately 20 hours after, I experienced a slight headache and continued soreness at injection site. Headache and soreness at site continue 25 hours after vaccination. No treatment needed other than resting, maintaining hydration and taking naproxen.
Patient had to go to the Emergency room because she had a rash all over her arm and tingling sensation in her arm.  Patient had to follow up with 3 doctors and had to take medication.  Tingling lasted many days and still was present in hand after a couple weeks.  Rash has gone down but still present at last interaction with patient.
Very sore and red arm from shoulder to elbow. Chills and sweats. Max fever reached 102.7 with Tylenol Body aches Extreme fatigue. Started about 24 hours after i got the shot and the worst part lasted about 48 hours. fever of 100.2 lingered for another day or so. Arm is still a bit red and now itches like crazy.
THE DAY FOLLOWING THE VACCINE PATIENT EXPERIENCED: 1. NEW ONSET LEFT LEG NUMBNESS AND TINGLING THAT WAS CONSTANT AND NOT RELIEVED BY ANYTHING. SHE WAS ABOUT TO DO HER ROUTINE WORK AND SEEMED THAT IT WAS MILD. SHE WAS CONCERNED ABOUT IT. 2. PELVIC DISCOMFORT IN CROTCH AREA.
04/12/2021 03:00 pm Responded to a 24-year-old male found sitting on a chair in the 30-minute observation section with c/c anxiety/heart palpitations. Patient was a/o x 3 with GCS 15. As per patient, he had sudden onset heart palpitations and stated that he felt 'anxious.' Patient stated that he felt nervous to for the second vaccination and that he felt 'more nervous when placed in the 30-minute observation section.' Patient was taken into tent for further evaluation by HCP. Patient had history of anxiety. (-) allergies. (-) medications. (-) dizzy. (-) n/v. (-) MLAPSS. All vitals were normal. 13:15 -- 152/86 HR:75 RR:22 SpO2: 98 13:19 -- 138/82 HR:65 RR:20 SpO2: 97 13:24 -- 151/74 HR:66 RR:20 SpO2: 98 Patient was given water and food and stated that symptoms had resolved. Patient was escorted back to seat and left w/o incident.  Entered medical area after being notified of patient in medical area by EMT. Upon arrival patient was sitting on cot with BP and Pulse oximeter on. No visual signs of distress. Could see patient pinching inside of upper arm and reported feeling anxious. His vital signs WNL EMT was chatting with the patient and patient was responding to all questions. Informed patient I wanted to check to see how he was feeling then excused myself outside of the area.
I am 70 years old and after the 2nd vaccine in 11/16/2021 I started having a vaginal discharge. I went to urgent care and the said that I have had a UTI and prescribe me some antibiotics. My OB GYN did a vaginal biopsy on me. I starting bleeding for one day. He ran a lot of different test on me.
Medical assistant diluted vaccine with .18ml diluent rather than 1.8ml. Administered 0.3ml dose to patient, however does was more concentrated than should have been. Peds doctor of the day Dr. consulted. She spoke with infectious disease Dr. who said no additional concern for reaction or side effects, no additional monitoring or follow-up required. Patient should receive second dose as scheduled. Parent informed of extra concentrated dose given.