chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; cold; chills; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (Patient's wife). An 82-years-old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Mar2021 (at the age of 83 years old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 17Feb2021 (at the age of 82 years old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. On 12Mar2021, the patient experienced nausea, cold and chills. The reporter stated they have had both doses of the vaccine. A day after her dose she had nausea, cold, and chills, her husband (the patient) experienced the same symptoms as her (nausea, cold and chills) 2 days after the 2nd dose. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from two nurses at a physician's office concerning one of the nurses' daughter (age not reported). On an unspecified date, the patient was vaccinated with the first dose of Gardasil. Subsequently, the patient developed excessive vaginal bleeding (during her period). At the time of this report, the outcome of the event was unknown. Additional information has been requested.
My wife came down with COVID-19 first. Her symptoms began 3 days before mine, and she got a positive test result. I got a negative test result at this time. A few days later, I developed myalgias and a cough. I took the test again and got a positive result. I called my physician, who suggested I try Paxlovid. After a virtual visit the next day, my order for Paxlovid was delivered, and I took it for 5 days. The symptoms were greatly improved and were gone after taking Paxlovid for 5 days. At the time of this writing, this is my third day off of Paxlovid, and I feel fine.
left arm site of shot / upper arm is red and it itches / problem with Shingles shot site; left arm site of shot / upper arm is red and it itches / problem with Shingles shot site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and experienced upper arm redness and itches.
difficulty breathing, hoarseness, wheezing, paleness, weakness and fast heart beat. About 10 hours after immunization.  Treated in emergency room with ventilator, Benadryl & Prednisolone and kept for 4 hours for observation.  Treated with benadryl every 6 hours around the clock for 2 days and Prednisolone for 5 days.
14 yr old received the 2nd dose of the Pfizer Covid vaccination; Sore arm; This is a spontaneous report from a non-contactable consumer. A 14-year-old patient of an unspecified gender received second dose of BNT162B2 (Pfizer Covid vaccine, Solution for injection) via an unspecified route of administration on 03Jun2021 (Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (at age of 14-year-old) as single dose for Covid-19 immunization. It was reported that, 14-year-old received the second dose of the Pfizer Covid vaccination on 03Jun2021 and had a slight sore arm the following morning. Event took place after use of product. Reporter did not wish to be contacted for follow-up. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 06-JUL-2011, the patient was inoculated with ZOSTAVAX at a healthcare facility (family medicine department) for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 14-APR-2015, the patient was treated at a healthcare facility/urgent care, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Information has been received from a nurse concerning multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with ROTATEQ oral liquid (dose, strength, frequency, lot # and expiration date were not reported), for prophylaxis. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). The administered vaccines were improperly stored at temperature greater than 9°C but less than 25°C for 1 hour and 13 minutes without any previous temperature excursion; this information was registered in a digital data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002917: US-009507513-1706USA002314: US-009507513-1706USA002914: US-009507513-1706USA002915:
Initial report received from a healthcare professional on 15 November 2012. A adult female patient, whose age, concomitant medications and medical history were not reported; had received a dose of FLUZONE ID vaccine (lot number: UT4471AA, anatomical site of administration was not reported) on an unspecified date. On an unspecified date, the patient's entire upper arm was swollen and was warm to touch. Corrective treatment and laboratory details were not reported. The patient's outcome was not reported. Follow-up information was received from a healthcare professional on 01 April 2013. Based on the new information, this case has been upgraded to serious. The patient was 37-years-old who received the injection of FLUZONE Intradermal in the left deltoid area. The patient was diagnosed with cellulitis that resolved after treatment with KEFLEX. The patient had no past medical history and no illness at the time of vaccination. Outcome was reported as recovered. Documents held by sender: none.
Serve chills that lasted for 38hrs. Serve headache that lasted for 26hrs. A red lace looking mark on arm, approximately the size of a baseball - still present after 6 days. Arm was hot to touch in vaccinated area for 4 days after. Arm after 6 days still has a lump, now size of a golf ball but prior was as large as a baseball. Extremely sleepy for 48 hrs.
Reports severe bilat upper arm pain w/ limitation on ADLs and ROM;  some relief w/ application of heat; pain initially 8/10; now reports chronic pain ~ 3/10;  patient did not contact the office about this problem - learned of issue when she returned for follow up care on 11/8/2014.
fever; arm sore; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on an unspecified date, as DOSE 2, SINGLE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 21Jan2021, as DOSE 1, SINGLE for covid-19 immunization and experienced, fever, joint pain and armsore. After second vaccine on an unspecified date, the patient experienced fever and arm sore. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache). On 19-Feb-2021, HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
Administered to a patient more than 24 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered to a patient more than 24 hours after puncture) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 10:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021 at 10:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered to a patient more than 24 hours after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered to a patient more than 24 hours after puncture) had resolved.        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 medications were reported.  Treatment information was not provided.
Redness and swelling around the vaccine site 7 days after vaccine administration. Conservative monitoring.
This case was reported by a healthcare professional (nurse and co-worker to subject) and described the occurrence of nodule injection site in a female subject of unspecified age who was vaccinated with influenza vaccine (GlaxoSmithKline). On an unspecified date the subject received a dose of influenza vaccine unspecified (unknown details). The reporter stated that the subject received "a GSK flu vaccination given several years ago." At an unspecified time after vaccination with influenza vaccine unspecified, the subject experienced nodule injection site (described as "a severe apple sized reaction"). The reporter refused to provide additional details regarding the event at the time of reporting. It was unclear from the report what location on the body the "apple sized reaction" occurred or where the vaccination was administered. At the time of reporting the outcome of the event was unspecified.
Pt adm 1st dose of Hep B vax (recomb) SC on 15NOV90; @ time of the report there were no other adverse exp reported; No further details were provided;
Syncope resulted immediately after vaccination, lasted 5 seconds. Then seizure activity (decerebrate/decorticate movements of limbs) for 5 seconds. Nausea afterwards, pallor, weakness and dizziness. Resolved after 10 minutes of rest, juice and crackers.
Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of GARDASIL9 (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA004629: US-009507513-1709USA004630: US-009507513-1709USA004632: US-009507513-1709USA004633: US-009507513-1709USA004628: US-009507513-1709USA004627: US-009507513-1709USA004631:
Fever of 101 +, severe weakness, pain having anything touch skin lasted 6 days Shot site swollen as large as a softball, red inflamed, extremelypainful, lasted 5 weeks Stomach issues of not being able to keep food down started day 5, vomiting, severe pain in stomach area, lasted 3 months.  Started daily, then decreased to 4 times a week and then 2 times a week, now in September,  finally able to digest food without vomiting multiple times a day.   Extreme weakness lasted 4 weeks
symptoms started last night around 6pm; headache, fever, chills, bodyaches and left arm pain at injection site. Taking tylenol.  She reports taking tylenol at 2am, she had covid March 6 and took first dose of moderna vaccine yesterday per the recommendation of her doctor. She tested positive for antibodies prior to vaccine.  5/3-Placed follow up call on 5/3/2021 at 1203 hours: Pt reports she is feeling ok now, but her ADEs was really bad and this made her hesitant to go get her 2nd dose. Adv pt her symptoms are common ADEs that usually occurred with post-vaccination, and it is not a contraindication from getting the second dose. Pt also reports that her MD also advised her to go get the second dose. Advised pt that every person is different, whether she'll experience any ADEs with her 2nd dose is not know. Advised pt if she experience any ADE with second dose to call back and report.
shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Short-term memory loss.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient had a history of COL. patient was on Oxygen therapy for symptoms.
Information has been received from a physician concerning a 26 year old female patient with no pertinent medical history who on 25-NOV-2009 was vaccinated with a second dose of GARDASIL in her "butt". There was no concomitant medication. On 25-NOV-2009 the patient developed vaginal watery discharge. Subsequently, the patient recovered. No laboratory or diagnostic studies were performed. No further information is available.
Heart palpatations, shortness of breath, nausea , later extreme tiredness, but could not sleep heart too fast,  muscle spasms, jaw pain lack of feeling in arms and legs, @ 10pm  I had a seizure in bed w husband, next day feeling exhausted, today still feeling pre seizure
Nausea and drowsiness began 2.5 hours post injection, resolved 9 hours post injection. Sore and tender injection site (left arm), began 30 minutes post injection. Has improved, but still slightly tender 49 hours post injection.
Information has been received from a licensed practical nurse concerning her approximately 61 year old father with a history of myocardial infarction who on 11-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). On 18-MAY-2010, the patient had previously scheduled surgery for stents and a quadruple bypass of his heart in a hospital. On 18-MAY-2010, he broke out in a rash on his back from neck to waist bilaterally, on both sides of his back. He had serious pruritus with about 100 pustules and lesions. Diagnosis was not available at this time. It was unknown if treatment was required. The nurse reported that this did not prolong his hospital stay. The patient had been discharged from the hospital. At the time of this report, the patient was recovering. Additional information has been requested.
The patient received a 0.5mL dose of Moderna for their 1st booster dose. The patient was supposed to receive a 0.25 mL dose. No adverse reaction reported.
Patient had syncope, BP 68/35 -- > 72/40 -- > 78/44 -- > 86/50. During 4/9/21 visit at facility, BP was 97/59. She is also experiencing menses. Left site feeling much better, stable, released from vaccination site.
Spondylitis ankylosing aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant). At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) outcome was unknown.            Other concomitant Medication use information was not provided by reporter.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality of humira vaccine for the event(s) of increased ankylosing spondylitis symptoms was not provided.  Treatment Medication use information was not provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A 58-year-old female patient, in treatment with Adalimumab for Ankylosing spondylitis, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of Spondylitis ankylosing aggravated (AESI). Onset date of the event was not provided; hence, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Spondylitis ankylosing can flare as part of its natural history. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 58-year-old female patient, in treatment with Adalimumab for Ankylosing spondylitis, received 2 doses of mRNA-1273 vaccine and experienced medically significant event of Spondylitis ankylosing aggravated. Onset date of the event was not provided; hence, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Spondylitis ankylosing can flare as part of its natural history. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Details of death not documented in chart but note from 2/25/21 mentions patient was in hospice care. Patient was 101 yo with comorbidities including COPD, CAD, DM, CKD, pacemaker, hypothyroidism, HTN, HLD
After receiving the FLUZONE vaccine, my arm was a little sore a few hour later and I took 650 mg of APAP. On 10/05 my arm was just a little sore all day but I did not take anything. On 10/6 at approximately 0330 AM, my arm was stinging (it felt like the needle was still in my arm which of course it wasn't) and sore. I just decided to take a 2.5 mg prescribed AMBIEN and fell back to sleep. At approximately 0515 or so, I woke up with both feet tingling severely and numb which went up to my knees although not as severe. My hands were also tingling severely and numb. Around my nose and nose was tingling and numb. It was a little difficult to swallow but my breathing was okay. I woke up my husband and we went to Hospital Emergency Department.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, in May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. The patient received COVID-19 treatment from 01Mar2023 to 05Mar2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.