chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maternal vaccine exposure with no reported adverse event; Initial information was received on 04-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an adult female patient who was exposed to vaccine influenza vaccine in context of maternal vaccine exposure with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Maternal vaccine exposure with no reported adverse event occurred at unknown gestation period the gestation period at onset and gestation period at exposure data needs to be populated, if available  The date of last menstrual period was reported as 07-Jul-2023. The estimated due date is 12-Apr-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancies. It is unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included hepatitis b vaccine for Prophylactic vaccination; and hepatitis a vaccine for Prophylactic vaccination.  On an unknown date, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). The information on batch number was requested.  On an unknown date the patient was maternal vaccine exposure with no reported adverse event (maternal exposure timing unspecified) (unknown latency) following the administration of influenza vaccine. Relevant prenatal testing after exposure included  It is unknown if there were lab data/results available.   Action taken with influenza vaccine was not applicable.  At time of reporting, the outcome was Unknown for the event maternal vaccine exposure with no reported adverse event. Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as and fetal outcome was reported as unknown.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022 at 6:18 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Dec-2022 at 6:18 PM, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains the information of 5th out of 13 elderly patient who received the vaccine as described by the reporter.
Initial report received on 08 July 2009 from a health care professional. A 29-year-old male patient, who had no concurrent illnesses, but who has medical condition of allergy to pollen, dust and soaps; and who has a history of bronchial spasm, had received a first left deltoid subcutaneous injection of YF VAX (lot number UF437AA) on 07 July 2009 at 19:15 pm. Fifteen minutes after receiving the vaccine, the patient developed a rash on his arms and axilla, throat discomfort, wheezing and diarrhea that lasted three hours. The patient took CLARITIN and was seen in the physician's office the following day with no symptoms. No diagnostic tests or laboratory data were performed. The patient had been evaluated by a physician, but it was unclear if the patient had been seen the same day of the event, or the next day only. It is noted the patient had received the month prior (date unknown), a dose of Hep A vaccine (trade name, manufacturer name, lot number, route and site of administration unknown), and a dose of TYPHIM VI (lot number, route and site of administration unknown). It was not reported whether there were any adverse events associated with those vaccinations; however, it was reported the patient had not experienced any adverse events with prior vaccinations in the past. At the time of this report, the patient had recovered. Documents held by sender: None.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 4 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and presented with shingles symptoms on approximately day 4 or 5.  The reporter asked what was the recommendation for the timing of his 2nd Shingrix dose.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received SHINGRIX. On 14th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th March 2018, 2 days after receiving SHINGRIX, the patient experienced injection site swelling, injection site warmth, pain and injection site erythema. In March 2018, the outcome of the injection site swelling, injection site warmth and injection site erythema were recovered/resolved. On an unknown date, the outcome of the pain was unknown. The reporter considered the injection site swelling, injection site warmth, pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had a consumer that received the SHINGRIX vaccine approximately one month before the date of reporting. The patient was achy and the injection site was swollen, red, and warm. The next day the patient reported that the injection reaction had enlarged and was two inches in diameter. It resolved the next day. The reporter was unable to provide additional information at the time of the call. This case has been linked with US2018068916, reported by the same reporter.
This spontaneous report was received from a pharmacist via a company representative regarding a currently 4 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated a dose of VARIVAX (via subcutaneous route, dose and lot # were not reported). It was reported that the patient's mother could not remember if her daughter had received a VARIVAX injection. On an unknown date, the patient was diagnosed with chickenpox by her physician. On 13-MAY-2016 (reported as today), the patient's mother came to a pharmacy with an unspecified prescription to treat her daughter's chickenpox. The patient's outcome was reported as recovering/resolving. The relatedness between the event and the therapy with VARIVAX was not provided. Additional information has been requested.
Swelling of right knee 7 days later. Not painful. Walking with limp. Resolved without treatment within 4 days. CBC, RP, ANA-WNL
3" X 3" area of redness (L) upper arm posterior tricep in center of red area a 3/4" X 3/4" induration. Advised to go to medical provider's office.
VACCINE THAT WAS GIVEN WAS LATER FOUND TO BE EXPIRED. PFIZER LOT #EW0161 EXP DATE OF 10/31/2021
Trigeminal never V1 distribution sensory loss which started 10 days after the vaccine and is still ongoing.
PATIENT RETURNED TO OUR OFFICE TODAY WITH REDNESS & SWELLING AT INJECTION SITE. ALSO COMPLAINED OF EXTREME NECK AND SHOULDER PAIN. NSAID,ANTISPASMOTIC,STERIOD GIVEN IN OFFICE TODAY
I have had COVID was out for 5 weeks. I also had both shots of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I have had COVID was out for 5 weeks. I also had both shots of Moderna) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (I have had COVID was out for 5 weeks. I also had both shots of Moderna). At the time of the report, COVID-19 (I have had COVID was out for 5 weeks. I also had both shots of Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided. Company comment:This is a case concerning patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (with SARS-CoV-2 test positive). The event occurred on unknown date after the first dose of mRNA-1273 vaccine. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious as per Regulatory Authority´s report.    Reporter did not allow further contact; Sender's Comments: This is a case concerning patient of an unknown age and gender with no medical history reported, who experienced the unexpected non-serious AESI COVID-19 (with SARS-CoV-2 test positive). The event occurred on unknown date after the first dose of mRNA-1273 vaccine. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious as per Regulatory Authority´s report.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 06-JUN-2014 the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # J005067, expiration date 17-JAN-2015) (dose and route unspecified) that was exposed to 63F for 48 hours and then exposed to 66F for 22.5 hours. PNEUMOVAX 23 was found to be unsupported by in-house stability data. No adverse symptoms reported. Additional information has been requested.
A few hours after receiving the first shot ... I felt Very Cold and tired~ went to sleep for a few hrs and lasted about 6 hrs after waking. Nest day was okay-just a little dizziness. Third day brought on more symptoms: eyes burning,  little dizziness, neck hurt and I had a feeling like the flu ~ spaciness in my head and Very tired...stayed in bed all day. Next five days were normal. Then on following Wed (a week after the shot) a rash or hives formed around the injection area -was itchy. I felt sleepy & my head had a spaciness again. Stayed in bed all day, napped and this lasted about 10 hrs. This morning I feel better but very dizzy. And the 4' circle around injection is still noticeable.
72 hours of loss of appetite, weak, headache, stuffy nose and sinuses, nocturnal coughing and sneezing. Insomnia, low grade fever.
Became dizzy, chills, diaphoretic, high blood pressure, slurred speech. Sent to E.R. 11/8/13 Still weak, ill, fatigued.
3/19/2021 the area near the injection became irritated, itched with a burning itch, inflamed and sensitive. A cold compress did not alleviate the pain and itching.  3/20/21 Same area is the same as yesterday. What should I do?
approx 2yrs p/vax pt devel chickenpox that consisted of rash over body.
chills; tired; low-grade fever 98.7 F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (tired) and PYREXIA (low-grade fever 98.7 F) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 017B21A) for COVID-19 vaccination. Concurrent medical conditions included Palpitation and Kidney disorder (to help kidneys filter better). Concomitant products included LISINOPRIL for Kidney disorder, ATENOLOL for Palpitation, FAMOTIDINE, CLONAZEPAM, LEVOTHYROXINE, ASPIRIN [ACETYLSALICYLIC ACID], FLUOXETINE, ATORVASTATIN, TAMSULOSIN, SUCRALFATE, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and VITAMINS NOS for an unknown indication. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced CHILLS (chills), FATIGUE (tired) and PYREXIA (low-grade fever 98.7 F). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills), FATIGUE (tired) and PYREXIA (low-grade fever 98.7 F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 (High) lowgrade fever 98.7 F.The patient did not had any reactions after first two doses.  The adverse events were treated with Tylenol, hot drinks.
Redness and induration at site of injection - (L) deltoid only first noted day after vaccination.
numb pockets on face, a little swelling of tongue and a little tired/flushed
24 hrs p/vax high pitched uunusual cry; 42.5 hrs p/vax extreme lethargy, very diffcult to arouse; poss petite mal sz; this lethargy lasting 48 hrs; afeb throughout; taken to ER
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-DEC-2018, the patient was vaccinated with an expired dose of PROQUAD, lot # N008826, expiry date 12-SEP-2018, subcutaneously for prophylaxis. No adverse effects were reported.
Pt developed an area of redness at the site of injection. The area was 6.25cm X 5cm. There was no itching or swelling but the area was warm to the touch.
Fever leading to chills and confusion for 1 day, shortness of breath for 1 day, tightness in chest at end of day for 1 hour, extreme fatigue for 1 day
Lymphoma; This is a spontaneous report from a contactable nurse. An 85-year-old female patient not pregnant received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 02Jul2021 the patient experienced lymphoma. The patient was hospitalized for lymphoma for 5 days. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Therapeutic oncology measures were taken as a result of lymphoma. Patient did not have COVID prior vaccination, patient was tested for COVID post vaccination with Nasal Swab result was negative on unknown date. Patient had not recovered from the event, at the time of the report.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the events "lymphoma" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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, and Investigators, as appropriate.
Patient was given booster dose of the Pfizer vaccine 1 month after finishing the initial 2 dose series in December. Patient was unable to recall when last shot was given, no longer had her card and states it was "a long time ago". No adverse events have need reported at this time.
I developed a lump or swollen gland under my arm within 24 hours of the vaccine and it lasted 3-4 days. On 11/8/2021, I decided to go see my doctor about my swollen ankles that I've had since before the vaccine. My BP was 148/90 at my appointment. I had my BP taken about a month ago and it was normal. I had an EKG on 11/8/2021, and my doctor said it was abnormal and my heart was slowing down. She made me an appointment with a cardiologist, which is scheduled for 11/19/2021, at Cardiology.
Swelling to upper right arm "whelp about 3 inches in diameter" per mother's report. Seen in ER 8/24/11.
Moderna vaccine was for 12+ not the 6m-11 yr old but only 0.25mL was given
syncope vaccine pass out with blood draw; Initial information received on 14-Feb-2023 regarding an unsolicited valid serious case received from a physician.  This case involves a 16 years old female patient who experienced syncope when vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] pass out with blood draw.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Notes: history of syncope and dentist parents anxiety sister with amplified pain syndrome.   On 01-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (lot UT7183LA) (Solution for injection) via intramuscular route in the left deltoid and meningococcal A-C-Y-W135 (T CONJ) vaccine (Suspension for injection) (lot U7596AA) via intramuscular route in the right deltoid for routine immunization.  On 01-Nov-2022, (latency: same day) the patient was syncope when vaccines meningococcal A-C-Y-W135 (T CONJ) vaccine and influenza quadrival A-B vaccine pass out with blood draw.  Additionally, the patient was passed out while needle still in arm approximately 5.10 seconds from first vaccine did not receive.   It was unknown if there were lab data/results available.   Action taken with  influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] was not applicable.  The patient received corrective treatment as she was lied down after the event.   At time of reporting, the outcome was Recovered / Resolved on 01-Nov-2022 for the event syncope vaccine pass out with blood draw.  Seriousness criteria: The event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 17-Feb-2023: This case involves a 16 years old female patient who experienced syncope vaccine pass out with blood draw after receiving vaccines influenza quadrival A-B vaccine [Fluzone Quadrivalent] and meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, vaccination history and concomitant vaccinations.
A report has been received from a health professional via medical representative concerning a female patient. Medical history of the patient was not reported. There was no information on the concomitant medication. On an unknown date the patient received FLUMIST QUADRIVALENT (intranasal) 0.2 ml, then hospitalised for pancreatitis. Action taken with FLUMIST and outcome of pancreatitis was unknown. Company physician considered pancreatitis to be serious with hospitalisation criterion.
Initial misuse report received from a healthcare professional on 06 June 2013. It was reported that MENACTRA vaccine was administered to an elderly male patient. No adverse event was reported. List of documents held by sender: none.
Warm to hot feeling during injection. Sharp pain more than previous injection. Right deltoid soar but expected. Soarness never went away. Certain movements can cause debilitating sharp pain. Pain radiates throug deltoid muscle and under arm at times. Time over 2.5 months
No adverse event. GSKAFLLA173AA State Supplied Adult. FLULAVAL labeled for adult use only administered in error to a 12 year old.
On 12/31/01, the child received vaccines and on the same night, her temperature was 103F and she had a seizure. The child was seen in ER and discharged. Dx'd with a febrile seizure.
give 4 patient booster doses, with more than 30 days refrigerated stored vial; Expired Booster Doses Administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) and PRODUCT STORAGE ERROR (give 4 patient booster doses, with more than 30 days refrigerated stored vial) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A, 036C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (give 4 patient booster doses, with more than 30 days refrigerated stored vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster Doses Administered) and PRODUCT STORAGE ERROR (give 4 patient booster doses, with more than 30 days refrigerated stored vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 21 Jan 2022 6 am No concomitant medications were provided. No treatment medications were provided.
Sick six days three of which I had a severe migraine.  Second and third day confusion, delirious,  couldn't write and couldn't think properly.