chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had been menstruating when I received my second dose and the day after I received this second dose, I found that I had a period blood clot.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), administered in arm left, administration date 26Nov2021 15:00 (Lot number: FH8028) at the age of 16 years as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cefcil, reaction(s): "Known allergies: Cefcil". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: fh8028, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 05Nov2021, when the patient was 16 years old, for COVID-19 immunization. No any other vaccines within 4 weeks prior to the COVID vaccine. The patient not diagnosed with COVID prior to vaccination and not tested for COVID since the vaccination. The following information was reported: THROMBOSIS (medically significant) with onset 27Nov2021, outcome "unknown", described as "I had been menstruating when I received my second dose and the day after I received this second dose, I found that I had a period blood clot.". Therapeutic measures were not taken as a result of thrombosis.  No follow-up attempts are possible. No further information is expected.
Mom call into Health Department from her work due to daughter calling her to tell her she felt like she has a lump in her throat and was  not able to swallow her on saliva. I ask mom if patient was  having any breathing problems and mom said she sounded like it but was at work and wasn't sure if it was just her anxiety.  I encourage mom or someone that was with patient to take her to the ER as soon as possible. Mom called back to the Health Department with a update at 135 pm  to let us know it was not a reaction to the Varicella Vaccine she was treated  for her anxiety with medication and sent home.
This spontaneous report as received from a male patient with unspecified age, gender, pertinent medical history or drug reaction/allergies. The patient was vaccinated with a dose of ZOSTAVAX on 26-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced a few side effects such as fatigue and headaches after the shot in approximately July 2012. Symptoms went away 2 weeks after vaccine and felt fine at the time of the report. The patient was recovered from fatigue and headaches on approximately 10-AUG-2012. There were not treatment information or diagnostic test reported. Additional information is not expected.
Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022; No adverse event; administered dose 10 days expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose 10 days expired), PRODUCT STORAGE ERROR (Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 7-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Aug-2022 at 4:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose 10 days expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered dose 10 days expired), PRODUCT STORAGE ERROR (Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered dose 10 days expired) and PRODUCT STORAGE ERROR (Vial was put out of the freezer into the fridge on 01Jul2022 and administered on 10-Aug-2022).    The vial was initially stored in the refrigerator on 01-Jul-2022. The vial did not undergo any temperature excursion. No concomitant medications were reported. No treatment  medications were reported.
blood pressure is high; nausea; headache; fever; chills; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she had covid virus in March 2020 and December 2020). Concurrent medical conditions included Blood pressure high and Allergy. Concomitant products included VERAPAMIL for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, HYPERTENSION (blood pressure is high), NAUSEA (nausea), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2021, SARS-CoV-1 test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included Allergy medication. Treatment information included tylenol pm for headache and fever.
vision was blurry; face was tingly; torso area began to itch but no sign of hives; cough a wheezing kind of cough for a day; loss of appetite; diarrhea; This is a spontaneous report received from a contactable consumer or other non HCP (Patient).  A female patient of an unspecified age received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that following dose 1 of the Covid vaccine (date unspecified), after about 20 minutes, patient vision was blurry and face was tingly, felt puffy although it was not actually puffy. This went away after approx. an hour. Within a couple hours torso area began to itch but no sign of hives. On an unknown date, the patient had cough a wheezing kind of cough for a day, had a loss of appetite and diarrhea for three days following. It was reported that CDC website labels this as a non-severe allergic reaction and suggests not to get dose 2. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Left upper arm/bicep is very swollen. Started yesterday evening - burning sensation warm to touch - ice pack all night.
Received immun at appox 9:00am. Was fine till around 2:00pm same day at which time he began crying. Crying lasted an hour when she called health department and was advised to call Dr. Called Dr who advised tylenol dose and who did not feel it was a bad reaction to the shots. Infant cried off and on until 5:00pm at which time he fell asleep. Stated if she held him he would stop crying but the minute she put him down he would cry again. Denied fever. high pitched cry.
Second dose / (8-12-2021) / total bilirubin was 2.2 today (8-13-2021); This case was reported by a consumer via call center representative and described the occurrence of bilirubin total increased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of blood bilirubin increased (1st dose received in June 2021 and total bilirubin was 1.7 in June, refer case US2021171387).   On 12th August 2021, the patient received the 2nd dose of Shingrix. On 13th August 2021, 1 days after receiving Shingrix, the patient experienced bilirubin total increased. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bilirubin total increased was unknown.   It was unknown if the reporter considered the bilirubin total increased to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself. The age at vaccination was not reported. On 13th August 2021, the patient's total bilirubin was 2.2. The limited demographics and details obtained, due to reporter disconnecting call abruptly after being told that they would not receive a copy of the adverse event report and definitive confirmation of whether Shingrix caused the increased total bilirubin. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021171387:Same reporter.
Severe pain in shoulder and elbow similar to arthritis for 4-5 weeks, post vax. Extremely stiff.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Pt. received her flu shot. She appeared to be fine when she left the pharmacy area. A few minutes later she came back asking for help-she felt lightheaded. She sat down and slumped over. A nurse was in line and she assited me to get the patient on the floor and put her legs up on a chair. We called EMS in the meantime. She attemped to sit up once but she was lightheaded still so she laid back down on the floor. EMT arrived and took her by stretcher out to the ambulance.
full blown flu infect w/fever, malaise, fatigue & cough; No culture done; husband also got flu; 30APR93 f/u t103, weakness, cough, diarrhea for 3 days; vax did not provided immunization;
Per patient, she had a 15 minute seizure about 13 hours after the booster pfizer shot.  She had the shot between 9:30-9:50am that same day.  She said it only occurred the one time and now she feels ok.
Arm with shot hurts I can not lift it. Pain is bad redness around shoulder. Joint pain as well as muscle.
About a month after COVID vaccine I had heart attack symptoms. Chest pain, sweating, clammy. Over the course of a week or so I had 3 such episodes.  They lasted between 15-30 minutes.  I have since had a nuclear stress test and a echo stress test. Both have come out normal.  All I?m wondering is  if anyone else has had these symptoms.   I have never had these symptoms before or since.
G62.9 NEUROPATHY 4/24/2023 BILIARY COLIC G62.9 NEUROPATHY 4/24/2023 CHOLELITHIASIS
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hyperventilation-Medium
11/24/2022 that morning I had a scratchy throat, runny nose, and I did not feel well. I did a home COVID-19 test and it was positive. As the day went along, I was worse, coughing, sneezing, fever of 99.99 and that is the highest it went. The next day I coughed so much it hurt. On that Friday, 11/25/2022, I could not find a clinic that was open. Then next morning, 11/26/2022, I had a conference by phone in the parking lot at the local clinic. The doctor did not recommend the PAXLOVID because it does not work well with simvastatin. Also, because I have a little kidney function loss and that is why he did not recommend PAXLOVID. He said we will treat the symptoms. He prescribed prednisone, benzonatate, 3 per day for 10 days. He said if I was not better by Monday, 11/28/2022 to go to the emergency room. Several hours after taking the medicine on 11/26/2022, I started feeling better. By Monday, I was feeling better, and I did not go to the emergency room. I still do have cough every once in a while. I tested negative last Friday, 12/9/2022. I quarantined for 5 days, and 5 days with a mask. I have been wearing my mask to work, I work at a school.
Pt came in for update on vaccines records and school record patient needed varicella. Record were pulled record showed Varicella had been given on 09/02/2020, Varicella was then given per record today 01/24/2023. Patient parent was made aware that Varicella was given before 4years of age and would not be needed at 4-year check do to being given 6 months early for recommended age. Per guidelines Varicella can be given with 3 months in between dose 1 and 2, mother of child understood had no concerns.
This case was reported by a healthcare professional and described the occurrence of yellow appearance in a 46 year old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine for prophylaxis. On 7/20/05, the subject received the first dose of Twinrix (lot AHABA026AC). At an unspecified time following the first dose of Twinrix, on or after 7/20/05 and on or before 9/6/05, the subject experienced a yellow appearance, and lethargy. The subject was seen at the physician's office and was treated with antibiotics. The healthcare professional reported that, " the patient claims that she developed hepatitis A from the Twinrix vaccine." As of 9/6/05, "tests for hepatitis A have been conducted but the results are not known at this time." The vaccination course with Twinrix was discontinued. The outcome of the events was not reported. The healthcare professional considered the events were not related to vaccination with Twinrix. Comment: Yellow appearance was assessed as medically serious (OMIC).
This spontaneous report was received from a vaccine coordinator (non-health care professional) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL lot # L033347, expiration date 23-JUL-2017 (dose, route of administration and anatomical location were not provided). The vaccines were refrigerated and exposed to the following temperatures and time frames out of range: 1 Celsius degree for 165 hours between 01-JUL-2016 and 07-JUL-2016, 1 Celsius degree for 126.75 hours between 14-JUL-2016 and 19-JUL-2016, -2 Celsius degrees for 70.5 hours between 22-JUL-2016 and 25-JUL-2016, 1 Celsius degree for 191.5 hours between 28-JUL-2016 and 05-AUG-2016, 1 Celsius degree for 77 hours between 06-AUG-2016 and 09-AUG-2016, 1 Celsius degree for 166 hours between 12-AUG-2016 and 18-AUG-2016, 10 Celsius degrees for 79.5 hours between 19-AUG-2016 and 22-AUG-2016, 9 Celsius degrees for 22 hours between 23-AUG-2016 and 24-AUG-2016, 1 Celsius degree for 71 hours between 26-AUG-2016 and 29-AUG-2016, 1 Celsius degree for 53 hours between 30-AUG-2016 and 31-AUG-2016, 0 Celsius degrees for 168 hours between 15-SEP-2016 and 21-SEP-2016, 0 Celsius degrees for 218 hours between 22-SEP-2016 and 30-SEP-2016 and 1 Celsius degree for 92 hours between 01-OCT-2016 and 05-OCT-2016 (summary time of excursions 1500.25 hours). There were no adverse effects reported. Data logger was not used and there were no prior excursions. This is one of several reports received from the same reporter. Follow-up information has been received on 16-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA004014: MERCK 1610USA013021:Mfr number.
Pt recvd 2nd dose of vax @ site of 2nd dose just above the elbow pt devel small red lump which p/awhile became hard; It was removed & found to be malignant melanoma;
At 9:30PM patient started experiencing shortness of breath, chest pain, fever of 102, sharp pain between the shoulder blades, vomiting, and fatigue that has lasted 2 days now.
24 hrs p/vax pt devel redness, bruising & swelling @ site; approx 2 x 1 1/2" site warm to touch;
pt recv vax JUL97 & approx 1 1/2 wk later pt devel rash, fever & lymphadenopathy;
I woke up  several times in the night of the vaccine and had pretty bad pain in my knees and other joints.  This pain was twice as bad as normal joint pain an almost 63 year old has.  Additionally and strangely, I had either shooting pains, continuous dull pains or burning pains everywhere I have scar tissue (kidney removal (2016), hernia (2012?) and laser/cryo surgery on my right eye (2012?) which was in pain and watering profusely around 4:30).    I had a couple of bouts of nausea around 3:00 and 5:30.  Finally, when I got up at 5:30 and 7:30, I had what I call "brain-zaps", which I remember from when I was withdrawing from Cymbalta at the time of my kidney surgery.  These are called brain-zaps because they feel like an electric shock to your brain that zings you and makes you lightheaded.  It's like this thing recognized and went after every medical "vulnerability" I had, very strange.  I then was light-headed all day on the day following the vaccine.  Then three days later after swimming 20 laps in our pool, I again became light-headed and was fatigued the following day.  I am writing this the day after my swim, so unsure on how long this will continue.
This spontaneous report as received from a physician refers to a 67 year old male patient with benign prostatic hypertrophy, carpal tunnel, hypertension, skin neoplasm, spinal stenosis, scalp malignant squamous cell carcinoma, organic impotence and hyperlipidemia. On 08-MAY-2013 the patient was vaccinated with ZOSTAVAX lot # J000436, exp. 10-APR-2014, subcutaneous in the left arm. Concomitant therapy included tetanus and diphtheria toxoids, absorbed (manufacturer unknown) administered on the same day at separate site. Concomitant therapy also included other unspecified medications. The physician reported that the patient developed an injection site reaction following vaccination with ZOSTAVAX. The physician described the injection site reaction as an erythematous, indurated, swollen area at the injection site about 5 by 15 cm in size. No lab test was done. The patient was not recovered from the event. The patient contacted office to seek medical attention. Additional information has been requested.
Aches, fatigue, nausea, stiff back and hips fir 24 hours. . Injection site pain during injection and fir 2 days after injection.
This spontaneous report as received from a physician refers to an 11 year old male patient. On 15-APR-2014 the patient was vaccinated with his first dose of GARDASIL intramuscular. The physician reported that on 15-APR-2014 "the patient experienced nausea, vomiting and substernal chest pains, lasting for 15 minutes, after receiving the initials dose of GARDASIL." The reporter also reported that the patient received MENACTRA (unspecified dose/frequency and manufacturer) and T-DAP (unspecified dose/frequency and manufacturer) concomitantly, with the dose of GARDASIL. Patient sought medical attention by office visit on 15-APR-2014 and was given no treatment for AEs. The outcome of substernal chest pains, vomiting and nauseas was unknown. Additional information has been requested.
Contracted COVID Jan 14, 2022. Started with a sniffly and itchy nose then progressed to a cough with difficulty breathing
experienced both ankles swelling; swelling of the legs, a little bit of fluid; experienced both ankles swelling/swelling of the legs, a little bit of fluid/it may be idiopathic; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 45-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type-I diabetes" (unspecified if ongoing), notes: type-I diabetes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "experienced both ankles swelling"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling of the legs, a little bit of fluid"; OEDEMA (non-serious), outcome "unknown", described as "experienced both ankles swelling/swelling of the legs, a little bit of fluid/it may be idiopathic". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter is a physician (family doctor) who has a patient with Type-I diabetes who experienced both ankles swelling, had swelling of the legs, a little bit of fluid, who received the Pfizer COVID-19 vaccine bivalent booster for adults a week before. The physician said that he thinks it was not vaccine related, it may be idiopathic, but he still thought he would call for the patient to see what he could find out. The physician also mentioned that the patient's ultrasound was clean (06Jan). The reporter clarified that there was no pain on ankles. The patient wanted to know if the Pfizer vaccine had anything to do with it or if there were any reports of ankle swelling. The reporter considered "experienced both ankles swelling", "swelling of the legs, a little bit of fluid" and "experienced both ankles swelling/swelling of the legs, a little bit of fluid/it may be idiopathic" not related to BNT162b2, BNT162b2 omi ba.4-5.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received. ; Sender's Comments: Based on the information currently available and currently known drug safety profile, the reported events more likely represented intercurrent illnesses, but not related to BNT162b2, BNT162b2 omi ba.4-5.
headache; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th October 2021, the patient received Shingles vaccine. On 13th October 2021, less than a day after receiving Shingles vaccine, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient took the shingles vaccine and experienced body aches and headache. The patient enquired if he/she could take acetaminophen. The follow-up would not possible as no contact details were available.
Itchy, hot, swollen arm. Resolved on its own after 7 days.