chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Acute Massive Pulmonary Embolism detected via CT scan; Syncope; Severe anemia; Leg pain; Negatively impacted cardiac, liver, and kidney function; Negatively impacted cardiac, liver, and kidney function; Negatively impacted cardiac, liver, and kidney function; Long term effects require continuous use of blood thinners; This is a spontaneous report received from a contactable consumer or other non-health care professional. A 34-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 09:00 (at the age of 34-years-old) as Dose 1, Single for COVID-19 immunization. Medical history included none. Concomitant medications included desogestrel, ethinylestradiol (APRI) taken for an unspecified indication, start and stop date were not reported. Patient received vaccine Facility in: Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. Event occurred on 11Mar2021, exactly two weeks following 1st dose of COVID vaccine. Acute Massive Pulmonary Embolism detected via CT scan following sudden leg pain and syncope. Negatively impacted cardiac, liver, and kidney function. Long term effects require continuous use of blood thinners. Presently experiencing severe anaemia treated through infusion treatments. Continued follow up required with Gastroenterology, Cardiology, Pulmonology, Hematology, and Gynecology. Patient visited Emergency room/department or urgent care. The events assessed as serious (Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage). Treatment was received for the events as infusion. Patient admitted in hospital for 4 days. The patient underwent lab tests and procedures which included computerised tomogram: acute massive pulmonary embolism and acute massive pulmonary embolism detected via CT scan following sudden leg pain and syncope, sars-cov-2 test: negative on 11Mar2021 Nasal Swab. The outcome of the events was reported as recovering.
Child did fine with vaccine & twin who received same vaccine. Mother stated that night child became light headed, and eyes were going back - forth & didn't know anyone or could see. Went to ER, transferred to hospital - MRI (neg) d/c'd next day.
Pt vaccinated with Engerix-B developed fever, liver function test abnormal elevated, bronchitis.
No Adverse Event; the dose came from a vial punctured 23 hours ago; the dose came from a vial punctured 23 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (the dose came from a vial punctured 23 hours ago), EXPIRED PRODUCT ADMINISTERED (the dose came from a vial punctured 23 hours ago) and NO ADVERSE EVENT (No Adverse Event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Dec-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (the dose came from a vial punctured 23 hours ago). In December 2022, the patient experienced PRODUCT STORAGE ERROR (the dose came from a vial punctured 23 hours ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (the dose came from a vial punctured 23 hours ago), EXPIRED PRODUCT ADMINISTERED (the dose came from a vial punctured 23 hours ago) 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 PRODUCT STORAGE ERROR (the dose came from a vial punctured 23 hours ago) and EXPIRED PRODUCT ADMINISTERED (the dose came from a vial punctured 23 hours ago).    No relevant concomitant medications were reported. Patient received Moderna Covid-19 vaccine for her second Moderna Covid-19 vaccine series. No treatment medication reported.
An hour after he received the vaccine he had a seizure, no fever at the time. The following day he had two more seizures, one at home while eating and one at the emergency room. He had no fever at the time of any of the seizures. The Doctors indicated these were not febrile seizures.
The patient fell at home the same evening she received the vaccination.  Her daughter took her to the ER to be evaluated.
Patient experienced mouth blisters, itchy eyes/ears. Transferred to Emergency Department. Received diphenhydramine, famotidine, and albuterol. She recovered and was discharged home.
This case was reported by a healthcare professional and described the occurrence of arm knots in a 30-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 12 October 2010 at 08:45 the subject received unspecified dose of FLULAVAL (0.5 ml, unknown, left arm) and unspecified dose of Pneumonia vaccine (details unknown). On 12 October 2010, approximately 9 hours after vaccination with FLULAVAL and Pneumonia vaccine, the subject experienced 2-3 knots formed on the arm next to the injection site and pain in arm. Approximately 10 hours after the vaccinations, he spiked a fever of 104 degrees Fahrenheit. A healthcare provider was consulted regarding the events. The subject required medical attention at the doctor's office. The reporter stated she was aware of another patient who had a similar adverse event after getting the FLULAVAL (see case id A0887476A for details on other patient). At the time of reporting the events were unresolved.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient fained and regained consciousness very quickly. patient refused 911. Nurse and pharmacist checked on patient periodically. pt was under monitoring for 30 minutes and reported feeling well after drinking orange juice and some crackers.
I couldn't breathe without gasping for air for 4 hours. I had nausea and inefficient gagging, both hands tingled strongly for hours, then moved into forearms. Injection site painful.
Patient reports that following SHINGRIX vaccination, besides the initial soreness, between midnight and 1 AM following the vaccination, he experienced shivers and shaking. He reported taking a shower to warm up, and thereafter symptoms resolved. He denies any fever.
Initial report received on 23 March 2012 from a health care professional on 23 March 2012. An 18 month old patient (gender not reported) with unknown medical history had received a dose of PENTACEL on 20 March 2012 and 2 days later, the patient's mother reported to the physician that the patient had a 5 cm area of erythema and induration at the injection site that was warm to touch. The patient was treated with MOTRIN and BENADRYL. The following day, the patient was evaluated by the physician and on examination only had a purple area left at the injection site, but had fine red papules that surrounded the site. Later that day, the patient developed fine, red papules covering the trunk of the body, from the knees to the mid back. A strep test was negative. The reporter did not have time to provide any further information. At the time of this report the patient had not recovered. Documents held by sender: None.
Patient is gravida 4, parity 3, abortus 1. During the 4th pregnancy at 35 3/7 weeks (Due Date 2/1/21), dose 1 of moderna COVID-19 vaccine was administered on 12/31/2020 at 1:40pm. Mild contractions began ~8:00pm of the same evening. Mild contractions were ~3 minutes apart for several hours. After a warm bath and water PO, the contractions continued, so patient went to the emergency department (ED) ~10 pm due to history of a prior pre-term delivery in 1st pregnancy. Patient was monitored for ~4 hours total. ED healthcare team checked labor progress ~12:30am (1/1/21) and patient found to be 1 cm dilated with +1 station. ED team rechecked in ~1 hour (~1:45am on 1/1/21) and patient found to not progress further. Contractions became more sporadic by this time and less intense. Patient allowed to return home. Baby girl was born without complications at term on 1/25/21.
One week after receiving the vaccine my arm turned red around the injection site. It is hot to the touch and itches.
I had an infected tooth; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EN6199) as unknown, single dose for COVID-19 immunization. Medical history included tooth ache. The patient's concomitant medications were not reported. The patient reported that he/she woke up with a tooth ache but decided to get the vaccine first then go to the dentist. The patient went to the dentist the next day and had an infected tooth. The patient was put on a drug called Clindamycin. The patient almost taken all of the medication and then realized in the precautions it says do not have any immunization vaccinations while using this medication because it can affect the effectiveness of the vaccine. The patient asked information regarding the matter. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Felt very stuffy and my chest felt tight.; Felt very stuffy and my chest felt tight.; Extremely sore; This is a spontaneous report from two contactable consumer or other non hcp. A 56-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration administered in arm left on 06Mar2021 13:30 as single dose for covid-19 immunization. Medical history included allergy to penicillin and keflex. Concomitant medications included benzylpenicillin sodium, procaine benzylpenicillin (PANCILLIN [BENZYLPENICILLIN SODIUM;PROCAINE BENZYLPENICILLIN]) taken as an antidepressant therapy. cefalexin monohydrate (KEFLEX [CEFALEXIN MONOHYDRATE]) taken for anxiety. Patient took her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in arm left on 07Apr2021 13:30 for covid-19 immunization, The patient experienced felt very stuffy and her chest felt tight also experienced extremely sore on 17Mar2021. It was asked to patient to confirm event onset date as if case late delay comment required. Outcome of the events was recovered on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Did not start period on expected start date. 3 days late and my cycle is very predictable. When I did start it was not my normal period. I bled very heavy on day one and then on day two almost none. This is not normal for me.
SORE ARM; SHOULDER PAIN; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included: brain aneurysms, and fall on job site, and concurrent conditions included: 2 small tears in the left shoulder. The patient was previously treated with naproxen sodium for drug used for unknown indication, and ibuprofen for drug used for unknown indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient experienced shoulder pain. On 04-AUG-2021, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shoulder pain on 06-AUG-2021, and sore arm on AUG-2021. This report was non-serious.
This is a spontaneous report from a contactable consumer (patient). A 72-years-old male patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL3247; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 14Jan2021 at 17:45 (age at the time of vaccination was 72 years), as single for COVID-19 immunization. The patient's medical history included fungal infection on his body. He said he does not know the name of the fungus, but he was diagnosed with the fungal condition about 7-10 years ago. On Oct 2020, (about 3 weeks ago at the time of report), the patient had shingles vaccine about 3 weeks ago. He said he was scheduled to receive a second Shingles Vaccine dose in Jan2021. He said he cancelled his appointment for his second Shingles Vaccine dose in Jan2021 because he wanted to take the COVID-19 Vaccine instead. "The patient height: 5'9-1/2" as provided as, who said he used to be 5'10" and was sure his height had gone down". The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Jan 2021, (after 2 to 3 days of getting his first COVID-19 vaccine), the patient saw something on his feet that looked like a rash and spread to the lower part of his body, especially in his groin area. The patient said, he wears boots, so he did not notice anything sooner than that. The patient did not visit emergency room and physician Office. The patient reported, he had his Shingles Vaccine about 3 weeks ago. The patient did not visit emergency Room and physician Office. No lab tests and procedures were reported. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.
Intense pain in left knee.  Red and swollen.  Reports that she was screaming in pain and couldn't put any weight on it.  taken by ambulance to ER.  They completed a CT Scan and an ultrasound but found nothing.  No med given helped with pain.  She sent us an email on 3-23 and I called her.  She is still experiencing pain (better) but has to use a walker to ambulate.
Was very irritable day of vaccinations.  One week later started crossing eyes.  With in two weeks he lost all sight due to bilateral cataracts which in this case are not genectic.  He is delayed in his developmental skills for his age.
bilateral red warm ears and face. Given 2 Benadryl.  Patient stated she felt fine upon leaving facility after 30minutes .
fever 38.7, vomiting x2, chills, body ache, headache, swelling of left arm for the next three days.
This spontaneous report as received from a pharmacist refers to a 81 years old female patient with "Sulfa" allergy and BIAXIN allergy. On 23-JUL-2012, the patient was vaccinated with ZOSTAVAX (lot#0365AE; exp. Date: 23-MAR-2013). On August 2012, the patient experienced developed red bumps, not itchy or painful at the injection site of a ZOSTAVAX vaccination (date of vaccination: 23-JUL-2012). The red bump at the injection site of a ZOSTAVAX vaccination developed last week (exact date unspecified). The patient contacted the pharmacist today 23-AUG-2012 and the red bumps at the injection site were still present. No treatment was given to the patient. The outcome of the event was reported as not recovered. The relatedness for the event and ZOSTAVAX was unknown. Additional information has been requested.
Started having aches and pains in my muscles. The condition persists thru today, with aching in bones and joints.
Information has been received from a 65 year old female consumer referring to herself with chronic pain and was allergic to unspecified influenza vaccine. On 10-NOV-2015 the patient was vaccinated with a dose of ZOSTAVAX, (dose, lot# and expiration date were unknown, subcutaneous). Concomitant therapies included unspecified mild opiate. On 11-NOV-2015 the patient experienced injection site reactions included swelling and slight pain. It took about 1 week for the swelling to disappear (on 18-NOV-2015). Soon after the swelling went away the patient developed injection site itchiness (in November 2015). It took another 3 weeks for the injection site to stop itching (in December 2015). On an unknown date the patient recovered from injection site pain. No lab diagnostics studies were performed. The patient spoke with physician for medical attention. Additional information is not expected as we have no consent to contact the physician.
Since receiving the vaccine, I have not yet had a menstrual cycle.  It has been 5 months since my last period and before then, they were like clockwork every 28 days.
Information has been received from a registered nurse concerning a approximately 20 year old patient who was vaccinated with the first and second dose of MMR II at 13 months and 4 years respectively.  The patient was recently given another dose of MMR II (date unspecified).  The patient still has negative titers (nurse did not know if the patient had negative titers to MMR).  No adverse reactions reported and no other information was reported from the reporter.  Follow-up information was received from the registered nurse and medical records concerning the 19 year old female patient (previously reported as 20) who on 28-DEC-1990 was vaccinated subcutaneously with the first dose of MMR into her right arm.  On 11-AUG-1994 was vaccinated with the second dose of MMR (lot number not provided).  Concomitant vaccination on 11-AUG-1994 included the fifth dose of DTAP and the fourth dose of POLIO virus vaccine live oral.  On 16-JUL-2009 laboratory evaluation revealed the patient's rubeola IgG was negative.  On 20-JUL-2009, the patient was vaccinated subcutaneously with a third dose of MMR (lot # 663929/0511Y) into her left arm.  There was no known illness at the time of vaccination.  On 11-AUG-2009 laboratory evaluation revealed the patient's rubeola IgG was equivocal.  At the time of the report, the patient recovered.  Additional information is not expected.
Received immunizations at 11am 2/24/04. Noon began fussiness and crying. Brought back to clinic. Site appeared with slightly swelling and erythema, tender to touch. Area diffuse, not a well-differentiated measurable area.
Child was at childcare - had a seizure in which he turned "blue" and stopped breathing. Childcare provider gave mouth-to-mouth ventilations with which child revived. Child was taken to hospital - CT of head negative, physician exam negative - diagnosed as reaction to MMR vaccine. (Information from mother). *No fever or illness prior to incident.*
No adverse event; 22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up) and NO ADVERSE EVENT (No adverse event) in a 22-month-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057456) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU Shot. Past adverse reactions to the above products included No adverse event with FLU Shot. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 28-Sep-2023, the patient received first dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INCORRECT DOSE ADMINISTERED (22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (22-month-old patient received a first dose of Spikevax Moderna COVID-19 vaccine Single Dose Vial meant for 12 year old and up).    No treatment medications were provided.
Pt received MCV4 VZV vaccine and TDAP on 8/23/12 PM. Pt reported to have had warmth to both upper arms that night with large area of edema noted approx 3+ inches round Friday PM & then began to experience smaller raised areas with blister like appearance to bilateral arms & legs, upper back and chest. Clear fluid noted to blister centers. Mother giving BENADRYL 25 mg q 6 hours & AVENO bath. No fever c/o nasal congestion only.
Shot given in L arm/shoulder very sore 3 wks later possible nerve damage can't lift arm, fingers & circulation poor.
This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (Lot # L004742, expiry date : 18-AUG-2016, Lot # M009377, expiry date : 17-JUN-2017, NDC# 0006-4047-41 expiry date : 31-MAR-2018) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) as prophylaxis. There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved. On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported. This is 1 of 6 reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007802: