chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 hrs after shot I awoke with fever that rose  to 102.5° staying  elevated for many hours. I was bedridden, too weak to be upright. I  rested & drank water. Next day my temp returned to normal, but I started experiencing erratic heartbeats? rapid, fluttering heartbeats on a daily basis. I feel unusually tired, am short of breath at times, have joint pain and mild swelling in my legs. I feel a sensation of pressure in my upper left chest &, at times, chest pain. I had some of these same symptoms after the 2nd dose of the Moderna vaccine, but milder, and I didn't know to ascribe them to the vaccine. These symptoms are more severe this time. Do I have myocarditis? I don't know. I got the 2nd dose on 4/8/21. I had the fever 12 hrs after 2nd dose. The rapid heartbeats were not immediately following.
Child developed Abnormal Seborrheic dermatitis after vaccination, also Failure to Thrive.
First dose received on 10-DEC-2021 and last dose received on 18-AUG-2022 (8 months schedule); This spontaneous report was received from a nurse and refers to an 8-month-old female patient. No information on patient's medical history, current conditions and concomitant medications was provided.      On 10-DEC-2021, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (unknown manufacturer) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 21-JAN-2022, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (unknown manufacturer) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 18-AUG-2022, the patient was vaccinated with third dose of hepatitis b vaccine (recombinant) (unknown manufacturer) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided)(inappropriate schedule of product administration).; Sender's Comments:  US-009507513-2307USA009402:Same Patient
This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (Watery eye), RHINORRHOEA (Runny Nose), HEADACHE (Headache) and NAUSEA (Nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Diabetes, Cholesterol and Heart disorder.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced LACRIMATION INCREASED (Watery eye), RHINORRHOEA (Runny Nose), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, LACRIMATION INCREASED (Watery eye), RHINORRHOEA (Runny Nose), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products include Blood pressure medicine, Heart medicine, Diabetes medicine and Cholesterol medicine. No Treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU received contains outcome of the events as not recovered not resolved.
Shot receive 11:40. 15:40 coughing, white of eye turning red.  18:40 white of eyes very red, difficulty breathing, skin in pain 22:30 body in a lot of pain.  Felt like an ice pick stabbing mid section all over 03:20 heart reacting, chest tightening, felt like the ice pick was stabbing the heart and felt very cold, terrible headache, face swollen, top of head itching, sinus area full of pressure 06:20 symptoms starting to go away 13:00 still had headache but able to breath better and feel recovery coming 18:00 able to consume food, 10/23 & 10/24 able to attend to business but feel tired and like my organs and muscles have been through a spin cycle.
Information has been received from a consumer concerning her husband, a 78-year-old male with hypertension and no known allergies, who on 29-JAN-2008 was vaccinated subcutaneously with a 0.65 ml dose of Zostavax (Oka/Merck) (product circular# 9815604).  Concomitant therapy included blood pressure medication (name not provided).  On 04-FEB-2008 the patient was diagnosed with shingles in the physicians office.  There were no laboratory studies or diagnostic tests performed.  The patient's shingles persisted.  No product quality complaint was involved.  Additional information is expected.
Nausea, swollen lymph node right arm pit, pain and swelling and pain upper right abdominal area near ribs specifically after eating.
On 05/28/2000 the patient presented to a physician with chickenpox consisting of approximately 50 to 100 lesions. Additional information has been requested.
This spontaneous report was received from a medical assistant, via Pfizer (2016560639, 3TZW1MBU) referring to a 9 year old female patient. The patient's concomitant therapies, medical history, family medical history and relevant test were unknown. The patient did not have neither medical conditions nor adverse event following prior vaccinations. On 24-OCT-2016, when the patient was 9 years of age, she was vaccinated with an incorrect storage dose of PEDVAXHIB intramuscular, in the left arm, dose was not reported (lot # L051122, expiration date 12-OCT-2018), for prophylaxis. Other suspect therapy included INFANRIX intramuscularly, anatomical location and dose were not reported (Lot # 2M527, expiration date 07-MAY-2017). The freezer reached a maximum temperature of 47.85 degrees Fahrenheit for a maximum of eight hours. The excursion occurred on 21-JUN-2016. The practice was aware of the temperature excursion before these doses were administered.  The practice thought that "everything was okay" because the product returned to within normal range within one to two hours after the temperature was reset, also because "the vaccine was not over the maximum temperature". Additional information has been requested.
patient inadvertently received Pfizer vaccine as 2nd dose. 1st vaccine was Moderna vaccine.
5/19/17 pt was seen at emergency dept. Dx'd with pneumonia. Prescribed LEVAQUIN x10days.
felt "bed sick"; Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell and injection site pain. On an unknown date, the outcome of the feeling unwell and injection site pain were unknown.   It was unknown if the reporter considered the feeling unwell and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age group was not reported but was selected as per the vaccine indication. The pharmacist reported that several patients had experienced pain at the injection site of felt bed sick after receiving the 1st dose of Shingrix or 2nd dose of Shingrix. The reporter did not mention specific patient, no vaccines data, no patients data. The reporter did not consent to follow up.
KIDNEY FAILURE; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; STROKE; This spontaneous report received from a physician concerned a 75 year old male (Retired Physician). The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple myeloma, and cited multiple melanoma, and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total, administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had kidney failure and he was on dialysis for kidney failure. On 05-JAN-2022, the patient got COVID (captured as suspected covid-19 infection and hence suspected clinical vaccination failure), 2 days after his wife got positive for COVID-19. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Reporter called about Paxlovid but they had not taken Paxlovid yet, reporter said she called to get help, she got infected by a patient as she was a physician and then her husband (Patient) got it, they wanted to get information about how to get the Paxlovid medication. The reporter said that patient also had a good positive experience with no allergic reaction to his COVID-19 vaccine. On an unspecified date in earlier this year JAN-2022, the patient had a stroke.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from kidney failure, and the outcome of suspected covid-19 infection, stroke and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220132972- covid-19 vaccine ad26.cov2.s  kidney failure, stroke. 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).  20220132972-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 06-AUG-2014, the patient was vaccinated with M-M-R II lot # H014649; expiration date 03-AUG-2014, 0.5 ml, subcutaneous. Secondary and concomitant therapies were not reported. The pharmacist reported that the patient was inadvertently administered M-M-R II on 06-AUG-2014 that was expired on 03-AUG-2014. No adverse effect reported.  Additional information is not expected because the reporter do not want to be contacted for follow-up.
Positional vertigo and headache leading to vomiting lasting 9hrs total. I took meclizine, Tylenol, and Zofran 4hrs into symptoms which helped stop the progression.
Sore muscle on left upper arm near injection site; This is a spontaneous report from a non-contactable consumer (patient). A 46-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administrated in Left arm on 10Feb2021 14:00 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not have known allergies to medications, food, or other products. On 10Feb2021, the patient experienced Sore muscle on left upper arm near injection site. No treatment was received for the adverse event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Recv'd PNEUMOVAX right deltoid in 9/17/09 FLUVIRIN left deltoid 9/17/09.  Complained of a sore shoulder while driving - a few hours after vaccination.  9/18/09 call to pt - still w/ shoulder - upper arm pain.
vaginal bleeding, placental abruption at 30 weeks gestation, emergency cesarean section performed
pt recv vax 12JUL96 & was seen in ER-pt reports being told that a rxn occurred from the tetanus shot;was placed on med for pain;exp pain, muscle spasms, difficulty moving lt arm p/vax;
Missed period for a week, not bleeding the right way, chills, sweat, watery mouth and dry cramps really bad.
pt brought to ED with lethargy, SOB; in shock with respiratory distress; intubated on mechanical vent; vasopressors; positive for COVID; ABX; ICU; tracheostomy and PEG tube placed; poor prognosis; pt's condition continued to worsen and pt passed away in the hospital
DIAGNOSIS 1. Acute chest pain    2. Elevated troponin level    3. SOB (shortness of breath)    4. Elevated d-dimer    DECEASED
This spontaneous report was received from a Licensed Practical Nurse, concerning unspecified number of patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (dose, frequency and route were not reported) lot # M019232 with expiration date of 17-OCT-2017 and lot # M044018 with expiration date of 01-MAY-2018, for prophylaxis. The sterile diluents (lot # and expiration date were not reported) used to reconstitute the PROQUAD were properly stored. The temperature excursion of the PROQUAD was between 6 °F and 14 °F for a time frame of 18 hours and 15 minutes. No previous temperature incursion was reported. No adverse effects were reported. Data logger was involved. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004704: US-009507513-1705USA004703:
Around 6 hrs after vaccine felt fatigue. I also exp tenderness at injection site and 9 days shortness of breath with diarrhea/mild headache.I went to urgent care for Covid, PCR test (results negative). I had symptoms approximately 10 days before shortness of breath resolved.
Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 08-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The vial was initially stored in refrigerator on 04-Apr-2022. Vial did not undergo any temperature excursion. Pharmacist called to verify an expiration date of lot number 026L21B. Pharmacist told that when his pharmacy received this vaccine on 23-Feb-2022 that a pharmacy staff member looked up the expiration date and came up with an expiration date of June 2022. However another pharmacy staff member looked up the expiration date and came up with an expiration date of 01-Apr-2022. The expiry date of vaccine was confirmed as 01-Apr-2022. Pharmacist asked how to proceed in the care of the patient who received expired vaccine.  No treatment medication were provided.   This case was linked to MOD-2022-551714 (Patient Link).
Tested positive for COVID19 one week after receiving the 1st dose of the Moderna COVID19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID19 one week after receiving the 1st dose of the Moderna COVID19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID19 one week after receiving the 1st dose of the Moderna COVID19 vaccine). At the time of the report, COVID-19 (Tested positive for COVID19 one week after receiving the 1st dose of the Moderna COVID19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Patient tested positive for COVID19.     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.   No concomitant medication were reported. No treatment medication was reported.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 and mRNA-1273 is assessed as not applicable.
1 to 3 days (small residual after) with localized redness and swelling and tenderness, of entire-circumference mid-arm swelling (distal to deltoid site). 1 day after peak 2 days after.
The patient developed cellulitis.  Warm, redness and fever that radiated down her arm.
10/17/21 SEEN IN THE ER THEN ADMITTED: WITH ACUTE RENAL FAILURE, AKI, AFEB, COVID-19, DIARRHEA DUE TO COVID -19, FEVER. SYNCOPE. CHEST XRAY SHOWING DEVELOPING PNEUMONIA, REQUIRED OXYGEN. 10/24 DISHCHARGED HOME WITH OXYGEN. 2 L.
Tremors in left arm, chills, headache, lightheaded ness,  and sore arm at injection site.
This spontaneous report as received from a nurse refers to a patient of unknown gender, currently 10 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose and frequency were not reported) subcutaneously for prophylaxis. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F (-9 degree Celsius (C) to 8 C) (25.2F) for 13 hours 36 minutes. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1811USA002372:Original Case : 1811USA002232 US-009507513-1811USA002374:Original Case : 1811USA002232 US-009507513-1811USA002375:Original Case : 1811USA002232 US-009507513-1811USA002371:Original Case : 1811USA002232 US-009507513-1811USA002373:Original Case : 1811USA002232.
Chills, Fever, and Leg weakness/pain, mild posterior right knee pain after taking the booster shot.
This spontaneous report was received from a 57 year old female patient, regarding herself. Patient was reported as allergic to indocine and SEPTRA DS. On 18-DEC-2014 the patient was vaccinated with PNEUMOVAX23, 1 single shot, subcutaneous. It was reported that the patient received PNEUMOVAX23 approximately 4 weeks after receiving the flu shot. Concomitant therapies included NORVASC, LIVALO, SINGULAIR and ADVAIR. On 18-DEC-2014, patient reported having an upset stomach for about a week along with having injection site pain, vomiting (8 hours after receiving the shot), diarrhea which lasted 24 hours, and towards the end of her night she felt dizzy and fell. This all occurred after receiving PNEUMOVAX23. Patient also explained having an itchy rash on her chest and post nasal dripping. Outcome of the events were not reported. No product quality complaint (PQC) was reported. Causality assessment was not provided. Additional information has been requested.
9/22/17 Patient was sweaty "warm to the touch" in the evening. Felt like he had a fever. Went to bed early and it broke by the next morning. Patient is fine otherwise.
Severe headache, body aches, flu-like symptoms began 7-8 hours following vaccination, fevers up to 100.7-improving with TYLENOL, but still has body aches, low grade fever on/off. States had same symptoms following flu shots past 2 years, but did not report.
Pt was given diluent for Pfizer vaccine 5-11yr. Diluent was not mixed with vaccine.
On the morning following vaccination, patient noted a painful reddened area at the site of the injection.  Upon assessment, this RN noted an area of redness approximately 3" in diameter, which is firm and hot to touch.  Patient had not yet taken anything for relief of these symptoms.  Patient would like to monitor symptoms from home and consult with Occupational Health if symptoms worsen, or do not resolve on their own.
This spontaneous report as received from a pharmacist refers to a female patient in her fifties. On 17-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX, dose 0.65 ml, subcutaneous (lot number not reported). On 19-OCT-2014, the patient broke out in shingles. The pharmacist stated the client came into the pharmacy on 22-OCT-2014 and had shingles on right side from her neck down the right side of her body. The pharmacist stated client was experiencing pain; and the rash/blisters still remained. The pharmacist stated he would have the client followed up with her primary healthcare physician. The outcome of the event was reported as not recovered/not resolved. Additional information is not expected as the consent for follow-up was not provided.
Body chills; Body aches; Fever; Headache. Took ibuprofen "aspirin". Stay in bed.
This spontaneous report as received from a health professional refers to a 14 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.