chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine administered after 24 hours of vial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered after 24 hours of vial puncture) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after 24 hours of vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered after 24 hours of vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment information mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 11-Nov-2021: Follow up received on 12-NOV-2021 Not significant follow up contains no new information
This spontaneous report was received from a consumer via company representative. The consumer was reporting about her mother, a female patient on an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (also reported as (unspecified) shingles vaccine) for prophylaxis (dose, route of administration, anatomical location, lot# and expiration date were not reported). On an unknown date, the patient experienced shingles (also reported as lack of therapeutic efficacy). At the reporting time, the patient was going to receive another shingles vaccine: SHINGRIX, due to the event. The outcome of the vent was not reported. The relatedness between the event and zoster vaccine live (manufacturer unknown) was not provided.
J & J Covid-19 Vaccine on 9/4/2021 and death occurred on 9/19/2021. Adverse events almost daily leading up to death.
When I woke up the day after my vaccine my injected arm had a large red circle it is swollen and itchy.
Narrative:  COVID infection following COVID vaccine series 01/15, Pfizer, dose #1 02/08, Pfizer, dose #2 09/02, Pfizer, dose #3 12/21 COVID swab, result: detected 12/21 SARS-COV-2 Variant Sequencing: pending 12/16 pt cc: cough, rhinorrhea, sore throat, exposure: wife 12/26 clinically resolved
daughter of Pt stopped by the pharmacy and reported to pharmacy staff that her father had passed away days after receiving the Moderna shot. Tried calling Pt family back to obtain additional details but have not recd a response.  date of death as listed below is estimated and exact date is not known.
06/05/2003: Mother cammed MD, states left arm redness and swelling at vaccination site.  Size of an egg, and warm to touch. Temperature 99.6 on 06/02/2003hs, no temperature today.  No problems with earlier vaccinations.   06/06/2003: Conference with mother.  Today the swelling is down and is not warm to touch.  Has only redness today.  No temperature today.  Insisted mother to take child to private doctor if problems arise and report back to the Health Department.
Myopericarditis. Chest pain 2 days after second vaccine.  Ekg consistent with pericarditis and troponin elevated.
Contracted Covid.  Symptoms (tickly throat and cough) first appeared on October 25, 2022 but Antigen Rapid Test was negative.  Test on October 28 was positive.   Symptoms were cough, sneezing, fever, chills, fatigue, loss of appetite; began taking Paxlovid on October 28.
Acute DVT (tibial vein lower left extremity); bivalent administration date= 07Jan2023, administration time= 02:45 PM, as dose number= 1,; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Jan2023 at 14:45 as dose 1, single (Lot number: GJ6743) at the age of 52 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Hypertension (controlled)" (unspecified if ongoing), notes: other medical history: Hypertension (controlled). Concomitant medication(s) included: LOSARTAN POTASSIUM AND HCTZ. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 07Jan2023 at 14:45, outcome "unknown", described as "bivalent administration date= 07Jan2023, administration time= 02:45 PM, as dose number= 1,"; DEEP VEIN THROMBOSIS (medically significant) with onset 09Jan2023 at 10:00, outcome "recovering", described as "Acute DVT (tibial vein lower left extremity)". The event "acute dvt (tibial vein lower left extremity)" required emergency room visit. Therapeutic measures were taken as a result of deep vein thrombosis, wrong product administered.  Clinical Course: Other medications in two weeks: Losartan Potassium-hctz (100-12.5 mg), Vitamins. AE treatment was Oral anticoagulants.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the causality of the event deep vein thrombosis with the suspect can not be ruled out completely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt came in on 11/20/15 and said that the day after he got the vaccine he had signs/symptoms of shingles so went to MD.
Extreme headache, dizziness, nausea without vomiting, fainted twice (my wife said I tipped over like a tree).  When I fainted the first time, my wife said I said, "I can't see" or "I'm dizzy", then I tipped over.  She said I got up after a minute and walked to the livingroom where I fainted again.  I got up again after a minute and lay down on the couch the rest of the evening.  I took 3 Advil for the bad headache.  I felt better later that evening.  The next morning I felt fine, but went to Dr. at his request because he wanted to check my heart since fainting isn't a known side effect for flu shots and tetanus shots (I also got the tetanus/dip/whooping cough shot the same time I got the flu shot.).  He checked to see if I had the flu.  It was negative, but he wanted me to use Theraflu anyway.  I decided not to since I feel fine and haven't had a temperature since I came back from the doc's office.  It's now Friday and I feel fine, temp is at 97.5.  Still don't know why I fainted.  Never fainted in my life before that and my heart is fine according to his EKG machine.
Within first 2 hours - fever and chills Within 12 hours - severe muscle pain, chills/sweats, headache Within 24 hours - muscle pain, chills, fatigue, joint pain, fatigue. This lasted 2 days.  Muscle pain  was the worst down the spine and at injection site, but persisted for 7 days! Joint pain worsened in hands particularly. Had to take anti inflammatory medication to alleviate it at day 6.  Still taking medication, so unsure if this is over.
broke out with severe psoriasis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for covid-19 immunization. The following information was reported: PSORIASIS (non-serious), outcome "unknown", described as "broke out with severe psoriasis".  Additional information: The patient broke out with severe psoriasis a few weeks after the 2nd vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt exp sudden onset of cough and back pain 8 hr post vax. Denies temp, headache, dizziness. Has been essentially bedridden due to back pain. Cough subsided next a.m. Pt. told not likely related to vax but would report
10 minutes after having shot administered, I had severe hypertension/ faint and dizziness. My BP is usually 120/87. My BP went as high as 180/110 and did not go down until 5 hours later. I was recommended to go to the ER by ambulance and instead had a friend take me. After blood screening, the doctor stated it was adverse effect from vaccine. They treated with saline, benedryl and Ativan and was sent home. I will continue to monitor and notate any other symptoms
Vaccine leaked out of syringe during administration; Vaccine leaked out of syringe during administration; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked out of syringe during administration) and DEVICE CONNECTION ISSUE (Vaccine leaked out of syringe during administration) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced UNDERDOSE (Vaccine leaked out of syringe during administration) and DEVICE CONNECTION ISSUE (Vaccine leaked out of syringe during administration). At the time of the report, UNDERDOSE (Vaccine leaked out of syringe during administration) and DEVICE CONNECTION ISSUE (Vaccine leaked out of syringe during administration) outcome was unknown.        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 relevant Concomitant medications were reported.  No Treatment Information Provided.
Worsening of the bone pain in the entire right arm from shoulder bone to fingers; Hot and cold; Numbness all over body; Pain in the Right Arm; Felt very tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Worsening of the bone pain in the entire right arm from shoulder bone to fingers), FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), HYPOAESTHESIA (Numbness all over body), PAIN IN EXTREMITY (Pain in the Right Arm) and FATIGUE (Felt very tired) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), HYPOAESTHESIA (Numbness all over body), PAIN IN EXTREMITY (Pain in the Right Arm), FATIGUE (Felt very tired) and PYREXIA (Fever). On 19-Mar-2021, the patient experienced BONE PAIN (Worsening of the bone pain in the entire right arm from shoulder bone to fingers). The patient was treated with OXYCODONE for Pain in arm, at a dose of UNK dosage form; OXYCODONE for Pain in arm, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Pain in arm, at a dose of UNK dosage form and NAPROXEN SODIUM (ALEVE) for Pain in arm, at an unspecified dose and frequency. On 20-Mar-2021, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), HYPOAESTHESIA (Numbness all over body), FATIGUE (Felt very tired) and PYREXIA (Fever) had resolved. At the time of the report, BONE PAIN (Worsening of the bone pain in the entire right arm from shoulder bone to fingers) had not resolved and PAIN IN EXTREMITY (Pain in the Right Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Email correspondence received it does not contain new information
After my first dose I experienced- body aches, left arm soreness and stomach pain which lasted a couple of days.
Headache for 2 days after the shot; Injection site hurt/pain; Looked like purple bruise on left arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for 2 days after the shot), INJECTION SITE PAIN (Injection site hurt/pain) and CONTUSION (Looked like purple bruise on left arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (Headache for 2 days after the shot), INJECTION SITE PAIN (Injection site hurt/pain) and CONTUSION (Looked like purple bruise on left arm). At the time of the report, HEADACHE (Headache for 2 days after the shot), INJECTION SITE PAIN (Injection site hurt/pain) and CONTUSION (Looked like purple bruise on left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Side effects started approximately 8:45 PM night of shot; Started with shaking chills, fever, sore arm  Took Tylenol; 10 PM - fever climbed, severe nausea, chills, full body aches, increased HR to 115, exhaustion; 11 PM - symptoms above continued new symptoms began:  dry mouth, dizziness, headache; 12 AM - 3:30 AM - symptoms above continued, nausea got worse; Took old rx Phenergan NEXT DAY  (Friday); 10 AM - symptoms continued "felt like I was hit by a train and left out in the snow"; 5:45 PM   - symptoms above continued; new symptoms started including sore throat and congestion; 6-8 PM - symptoms continued; HR 132; 9 PM - fever finally broke; 10 PM - still feeling sore, exhausted, very stiff neck; SATURDAY feeling slightly better no fever; symptoms still present included muscle and joint pain, fatigue; new dry bloody nose; SUNDAY continuing to feel better; itchy nose, fatigue, mild body aches; Monday - Thursday nearly back to normal; mild fatigue and left hip pain; All symptoms completely resolved by Friday (a little over a week later)
feeling under the weather; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling under the weather), NAUSEA (nausea) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cancer (history of tongue and lymph node cancer from 4 years ago) and Cancer. Concomitant products included LOSARTAN for Blood pressure high, METOPROLOL and AMLODIPINE for an unknown indication.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced FEELING ABNORMAL (feeling under the weather), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (feeling under the weather), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2021, Blood pressure measurement: 181/105 (High) 181/105.         No treatment medications were reported.  The doctor was suggested to that patient on 13dec2021 to switch her blood pressure medication from losartan to valsartan and she has not yet started the new medication.
This is first of three reports from the same reporter. This is a spontaneous report from a contactable Physician, reported through a Pfizer sales representative. A 3-year-old male patient was administered a dose of PREVNAR13 on the thigh on an unknown date. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the dame day were unknown. Vaccines taken within the last four weeks were unknown. On an unknown date, after administration of PREVNAR13 the patient experienced redness, erythema, pain and itchiness on the thigh. Relevant lab data was unknown. At the time of report the patient was recovering from the above mentioned events.
Left arm examined with evidence of erythema and few small vesicles scattered on inside of forearm. Prescribed Valtrex and hydrocodone with follow up next week with Dr.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer (parent) via a company representative concerned a 26-year-old female unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 infection (suspected clinical vaccine failure and suspected covid-19 infection) with symptoms of fever of 100 degrees (unit unspecified), deep wet cough and loss of smell. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100 degree (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection and the outcome of suspected clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210815284-Covid-19 vaccine ad26.cov2. s- suspected clinical vaccine 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
Patient called to report that she experienced an extreme injection site reaction - approximate size is 4 inches by 5 inches on left arm. Arm is extremely swollen, red, and warm to touch. Discussed with patient over the counter remedies and also counseled her to seek additional medical treatment if it does not self-resolve.
High fever appx 102, went to ER. Treated with antipyretic, TYLENOL and Ibuprofen.
Woke up the following morning with a spasm (for lack of better words) from my left mid back to my left glutes, left lower abdomen, into left hip, with pubic symphysis pain and left bony femur pain that stopped above the knee.  Pudendal neuropathy, with the urge to urinate frequently, but couldn't empty my bladder.   With the  spasm on the left,, I had some right sided abdominal tightness under the diaphragm area, and musculoskeletal tightness below the left clavicle with a sore sternum on the left.  All of thisnlastednfor about 12 hours, less the left sided back pain, lower abdomen,, pubic symphysis pain, which continued for several days, slowly getting better. As this initial events eased up, I had neuropathy-like pain in my anterior and posterior thigh, that I could feel to my left great toe; however the more distal, the less severe the neuropathy was (i.e. faint neuropathic sensation in the great toe).
Fever  chills numbness tongue weakness legs. Muscle spasms pain.  Headache. Neck pain jaw pain
I developed a rash at the site of the injection, red, approximately 2 1/2 inches high and 1 1/2 inches across.  I went back to the pharmacy 2 days later and showed the pharmacist and she advised to use neosporin and cold compress.  I used the neosporin several days and afte about 3 to 4 days it cleared up.
Information has been received from a registered physician assistant concerning a 71 year old female with diabetes mellitus and a history of chickenpox when she was 10 years old, who on 23-OCT-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 652947/1212F) 0.5 ml subcutaneously in her left deltoid (start date also reported as 11-SEP-2006). Concomitant therapy included citalopram, LIPITOR, DIOVAN, and LEVOXYL. The physician assistant reported that on 16-JUL-2008, the patient developed a mild case of Shingles on the right side of her chest, 4-6 small lesions, R T7 distribution. There were no other systemic symptom and no rash at the injection site post vaccination. The patient was treated with VALTREX. On 23-JUL-2008, the patient had a vesicle specimen collection send to the laboratory (test results not provided). At the time of the report, the patient was recovering. The patient sought medical attention at the physician's office. Follow up information was received which reported the results of the CPR. The specimen was obtain from a vesicle lesion. VZV DNA and B-globin DNA was amplified. Interpretation: adequate specimen, wild type strain. Additional information has been requested.
body aches; Felt tired; Fever; Head felt funny/weird; Did not have appetite; Slept around 11-12 hours; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, DECREASED APPETITE, BEDRIDDEN, MALAISE, and FATIGUE in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant history was provided by the reporter.  Concomitant products included LOSARTAN POTASSIUM for Blood pressure management, OMEPRAZOLE, ASPIRIN 81, and VITAMIN D3 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FEELING ABNORMAL, DECREASED APPETITE, BEDRIDDEN, FATIGUE, and PYREXIA. On 19-Feb-2021, the patient experienced MALAISE. The patient was treated with TYLENOL at an unspecified dose and frequency. On 20-Feb-2021, FEELING ABNORMAL, DECREASED APPETITE, BEDRIDDEN, MALAISE, FATIGUE, and PYREXIA had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-051576. This case was linked to MOD-2021-051576.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Non-significant follow-up: Consumer informed that she will be mailing the ADR form to the address indicated on the first request.    US-MODERNATX, INC MOD-2021-051576: first dose
Sore and painful injection site for 2 days after injection. Event resolved on day 3. Developed covid arm  1 week after injection. Symptoms include red rash approximately 2 inches in diameter, burning/hot sensation, itchiness,  pain, and soreness.
Mom noticed hives on pt buttocks 10:00.  By 2:00 they had spread all over body.  Pt was seen and treated with Benadryl in urgent care.  Will follow up with allergist.
irritability, crying for more than 4 hrs; swelling & redness 2cm in diameter @ the site of inject;no fever;