chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a serious observational study case initially received on 07-Nov-2018, concerning a 28-year-old, adult pregnant. The subject had 1 previous pregnancy in which she had a spontaneous abortion. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal/paternal history with major congenital malformations. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's current condition included history of depression and anxiety. The subject's last menstrual period date was 09-Sep-2018. The pregnancy status of the subject was collected, and no complication was noted. The subject's concomitant medications included ZOLOFT for depression and Prenatal vitamins for pregnancy. On 25-Oct-2018, the subject underwent ultrasound, and no major congenital malformation was noted. On 06-Nov-2018, the pregnant subject (gestation period: 8 weeks) was administered Flu Vaccine Egg Split QIV CSL (influenza vaccine, batch number: YF41708, dose, route of administration, expiry date and anatomical location: not reported) for an unknown indication (explicitly considered as vaccine exposure during pregnancy). On 30-Nov-2018, the subject underwent first trimester screening and no major congenital malformation was noted. On 10-Jan-2019, the subject underwent maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and no major congenital malformation was noted. On an unspecified date after vaccination, the subject developed leiomyoma (reported as leiomyoma x 3) which was noted by the ultrasound scan on 25-Jan-2019. The subject's estimated delivery date (EDD) was reported as 10-Jun-2019. Non-significant amendment (07-Nov-2018): The subject's EDD was corrected from 31-May-2019 to 10-Jun-2019 in narrative. Follow up received from the investigator on 30-Jan-2019: The subject's prenatal tests (first trimester screening, maternal serum alpha-fetoprotein (MSAFP)/ serum markers test and ultrasound scan) were added in the relevant tests of patient tab. Added two new events leiomyoma and ultrasound scan abnormal in the event tab and listedness was done accordingly. The narrative was amended accordingly. Reporter's Comments: A 28-year-old pregnant female, was diagnosed with leiomyoma more than 2 months after receipt of Flu Vaccine Egg Split QIV CSL. The event had multitude of causes ranging from genetic, familial, hormonal and environmental factors. Considering no known biological mechanism to explain the event following vaccination, the causality was assessed as not related to suspect vaccine. The event vaccine exposure during pregnancy was assessed as not related to suspect vaccine, due to intended use of the vaccine. The company assessed the case as serious (medically significant).
Information has been received from a physician concerning a female patient with no allergies, who on approximately 17-JUL-2007 "about four weeks ago", was vaccinated IM with a third 0.5 ml dose of Gardasil.  "Recently" the patient experienced a painful knot at the injection site where the last dose was given.  Unspecified medical attention was sought.  No diagnostic laboratory studies were performed.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Information has been received from a registered nurse concerning a 13 week male with gastrooesophageal reflux disease and no known drug allergies, who on 10-Jun-2009 was vaccinated with the first and only dose of ROTATEQ (Lot: 661581/1461X). Concomitant therapy included REGLAN and PREVACID. On 11-Jun-2009 (reported as 24 hours after vaccination) the patient initially did not want to eat, and then started to vomit once or twice a day for 2 weeks. Sometimes the patient had projective vomiting. Subsequently, the patient recovered from the symptoms. Follow-up information was received on 17-Jul=2009 which reported that the 13 week old white male patient, on 11-Jun-2009 started out with extreme irritability along with this within 24 hrs, did not want to drink. Child typically ate 6 times a day and 3 of these times very irritable and would take a long time to finish bottle, spit up small amounts daily for 2 weeks at least one a day and projective vomiting for 1 week. He went from extreme irritable to being totally fine, low grade temperature from 01-Jun-2009 until 15-Jun-2009. Mother gave TYLENOL every Q4H, no diarrhea or loose stools, continued nutritional supplements (ISOMIL) formula. No dehydration, increased GERD meds approximately 2 weeks did not help. On 24-Jul-2009, the registered nurse reported that on 10-Jul-2009, the patient received her second dose of ROTATEQ. She said within the following 24 hours after vaccination, the child was slightly irritable lasting 5 days and had a low grade temperature for 1 day. Child did not get vomiting or diarrhea. Additional information has been requested.
tachycardia in 90s, 100s, and 110s x about 4 hours
constipation got worse; Both legs swelled up; Stings like electric shocks; Disoriented; wobbly on her feet (unstable); Fatigue; A spontaneous report was received from a consumer concerning a 84 year old, female patient who developed fatigue, disorientation, wobbly on her feet (unstable), both her legs swelled and got stings like electric shocks and constipation.  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the events, included Novastix, Amitiza, thyroxine, Nexium, calcium, vit d3, Blood thinner Aggrenox. Patient was allergic to codeine.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) on 16 Feb 2021 intramuscularly in the injection site for prophylaxis of COVID-19 infection.   On 16 Feb 2021 she had her 1st shot of moderna covid- 19 vaccination from that day onwards she had fatigue that lasted for 2 days. On 18 Feb 2021 she was disoriented dizzy and wobbly on her feet (unstable). On 20 Feb 2021 both her legs swelled and got stings like electric shocks. She usually had trouble with her bowels (constipation) but got worsen on 21 Feb 2021. Treatment for the event included Tylenol.  Action taken with mRNA-1273 in response to the events was not provided.  The events, fatigue, disorientation, wobbly on her feet (unstable), both her legs swelled and got stings like electric shocks and constipation, was considered resolved.    The reported event, fatigue was considered related to mRNA- 1273.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020371:Same reporter, reporter's sister US-MODERNATX, INC.-MOD-2021-020515:Same reporter, reporter's son
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:44 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.63 for dose administered on 31-Mar-2021 and 68.55 for dose administered on 03-Mar-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Batch number 014M20A administered on 03-Mar-2021 underwent temperature excursion with temperature range 51 to 35 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
The shot made my arm very sore for about an hour. When I went to sleep that night, I experienced feeling chilled all night long. It ended by morning. I had one bought of mild diahrea the next morning. Then all was fine.
Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023; No adverse event; 9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In June 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.), PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 patients received vaccine after the 30 day BUD between 06-JUN-2023 to 09-JUN-2023.) and PRODUCT STORAGE ERROR (Dose was placed into the refrigerator initially on 4-MAY-2023 and administred between 06-JUN-2023 to 09-JUN-2023).    No concomitant medication was reported.  Dose was placed into the refrigerator initially on 04-MAY-2023. No treatment information was reported.  The case contains information for patient 3 out of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-729624 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729624:Master case
Swelling in right upper arm, extending down to elbow. Extreme tenderness, some heat and swelling the size of "an orange" below injection site. Febrile, 100 degrees on 10/16/03. Pt to PCP. Rx: Clairin and Cephalexin 500mg every 6 hours for 10 days. Redness spreading, blotchy, redness on entry upper arm.
low grade fever, hitting head and saying "ouch", laid on floor and did body spasms, body spasms throughout the evening, no sleep (these symptoms occured for one week), fever got higher and higher everyday - then on the 9th day he had 104.5 deg. fever - that's when we rushed him to the e.r.  he stayed overnight for testing.  after all kinds of tests - they could not find anything (however they refused to say that it was due to the immunizations, so they said it may be a virus).  no tests proved this, but all documentation showed it when we were released. 11/13/2009 MR and DC summary for 9/10-11/2009. Patient admitted with c/o's fever, lethargy. No DC Dx noted.
This spontaneous report as received from a healthcare worker refers to 60 patients of unknown age and gender. No information of concurrent conditions and medical history were reported. Approximately in 2015 (reported as since 23-AUG-2015 till 04-SEP-2015, today) the patients were vaccinated with improperly stored VARIVAX (Merck) (unknown strength, route and dose) lot # L016124 with expiry date of 06-MAY-2015. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
She had chills at 5pm, by 8pm she had heart palpitations, beat red face, nausea and swollen glands in throat. She then went to bed. She woke up around 10pm and felt fatigued but better.
8/5 - left tender axillary node (now better). 8/8: 8:30-9:oo am fever up to 103.8 degrees F, chills, sweats, left upper arm vaccine site redness, induration, tenderness, dry cough.  8/9 - in infirmary - got acetaminophen, ibuprofen, NS.  8/10: diarrhea for 2 hours - 8-9 times. Stools watery, non-bloody, mucoid. 8/11 am: generalized myalgia, arthralgias.  9/18/07 Reviewed hospital medical records which reveal patient experienced nausea, vomiting, diarrhea, dry cough & fever/chills/sweats x 3 days w/redness, tenderness & induration of left upper arm at vax injection site, around arm & into cervical & axilla lymph nodes.  Admitted 8/10-8/12/2007.  ID consult done. FINAL DX: Probable acute viral gastroenteritis, resolved; small pox vaccine reaction w/local cellulitis, improved w/antibiotics.
Patient stated that her heart was racing  and her feeling shaking in her limbs. Vitals were BP 135/80, HR 90, RR.14. Patient denied any other symptoms. After about 15 minutes patient stated that she felt better, Denies any medical history and instructed to follow up with her PCP. Patient stated that she wanted to return to work and denied any further medical treatment.
Patient's mother stated that his temperature went up to 102.8, and patient was experiencing chills, dizziness, sharp pain in his head, throat pains, body aches, mucus buildup, bad cough and he's also been sleeping a lot. Mother was able to get temp down to 100 even. Patient  is being rushed Emergency Room as this report is being taken bc patient's temp went back up to 102.8.
Improperly stored vaccine adminstration; shipment was received a day late; This spontaneous report was received from a an administrator via a field representative referring to a 83 years old female patient. Information about concurrent condition, concomitant medication, medical history, drug reactions or allergies was unknown.   On 22-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) shipment was received a day late (expected arrival date was 21-OCT-2020, product shipment delay) to the reporter's practice, they were not viable for use, and someone in the office mistakenly placed them in the vaccine fridge (confliction information: the box of vaccines got placed into a refrigerator at recommended storage range once received).   On 26-OCT-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # T020638, expiration date 26-FEB-2022; route was not reported) for prophylaxis (improper storage of product in use).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2011USA015360: US-009507513-2011USA015361: US-009507513-2011USA015362: US-009507513-2010USA011251: US-009507513-2011USA015363: US-009507513-2011USA015358: US-009507513-2011USA015357:
Pt had episode of "limpness," "eye deviation" and "pallor" associated with fever 8 days after MMR and Varivax given.   Nurse follow up on 08/19/04 states: "agitation; Sinusitis; Rash; Diarrhea." Information from Annual Follow-up report states parents remain concerned that MMR will have long term effects.
5/14/19 3PM HEADACHES STARTED, OCCURRED ON & OFF THROUGHOUT DAY TIL 11PM. 11PM CHILLS, SHIVERING, SWEATING STARTED & CONTINUED ON & OFF X 4 HRS. 5/1519 3AM - 8PM WOBBLY, HEADACHES, DIZZINESS. 5/15/19 8PM ALL SYMPTOMS RESOLVED.
This case was reported by a physician via call center representative and described the occurrence of urticaria in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 6 days after receiving SHINGRIX, the patient experienced urticaria, pruritus and intramuscular formulation administered by other route. On an unknown date, the outcome of the urticaria and pruritus were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the urticaria and pruritus to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that he received a dose of SHINGRIX subcutaneously. The patient experienced extreme itching that lasted up to 10 days after receipt of vaccine and also experienced urticaria which started 6 days after receiving vaccine. Both symptoms were resolved at the time of reporting. Other patients might had been given SHINGRIX subcutaneously at his facility, he did say he could get the lot and expiry date of the SHINGRIX he was given, just did not have at the time of the call. This case has been linked with US2018GSK069183 by the same reporter.
Approx 2 weeks after vaccination I experienced acute pain in my left knee.  After approximately a day of this severe knee pain I noticed that my left leg was visibly swollen below the knee
Stomach ache, fever, N/V.  Patient said this happened twice (2009 and 2010)
Pt was given 1/2 tsp Motrin, 10:35 am, 730 pm -Pt's head was warm, 8:30 pm-temp-103.2-103.5-state dinner and played 2 ml Advil given-wet wash cloth applied, 12 am-8/3-pt warm to touch 3:30 am-Pt afebrile
COMPLETED OBSERVATION TIME OF 15 MINUTES POST VACCINATION, WENT TO CAR AND FELT DIZZY AND SWEATY. MEDICAL PERSONNEL RESPONDED WITH GURNEY AND TRANSPORTED PATIENT TO TRIAGE 1. ECG COMPLETED BY EMT WITH PHYSICIAN AT BEDSIDE AND 2 RNS. RESPONDED TO WATER, ICE PACK TO BACK OF NECK. NORMAL PALLOR RETURNED. REMAINED TRIAGE 1 UNTIL 17:05. PATIENT CALLED FRIEND TO PICK HIM UP AND DRIVE HIM HOME. SAT, THEN STOOD THEN WALKED TO INSURE SYMPTOMS RESOLVED PRIOR TO DISCHARGE.
102 Fever, Loss of Taste, Loss of Smell, Headache. Everything resolved after 36 hours after vaccine.
Arm pain then when she went to the doctor, she got diagnosed with tendinitis and she said the pain lasted for 2 weeks and she might go to physical therapy to come back to normal.
Passenger in motor vehicle accident; post-traumatic pain; Juvenile idiopathic arthritis flare; Discomfort; Tiredness; Feels bad; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-4114036-00) from a contactable consumer (patient).  A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular in 2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for Moderate to severe hidradenitis suppurativa. The patient medical history was not reported. The patient's concomitant medications were not reported. In 2021, the patient experienced Pfizer vaccine caused minor discomfort/tiredness/generally felt bad. In Sep2021, the patient experienced juvenile idiopathic arthritis flare in hands. In Oct2021, the patient experienced was a passenger in a car accident/that had left in quite a bit of pain all over. On 01Oct2021, the patient experienced was a passenger in a car accident/that had left in quite a bit of pain all over. he action taken in response to the events for adalimumab was unknown. In 2021, the juvenile idiopathic arthritis flare in hands and pfizer vaccine caused minor discomfort/tiredness/generally felt bad resolved, the outcome of event Post-traumatic pain was not recovered, the outcome of rest events was unknown.  The reporter's assessment of the causal relationship of the events Feeling abnormal, Discomfort, Fatigue with the suspect product bnt162b2 was provided as Possible and for events Juvenile Idiopathic Arthritis flare, Road traffic accident and Post traumatic pain as Not reported..   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Juvenile Idiopathic arthritis flare, Feeling abnormal, discomfort and Fatigue and suspect drug BNT162B2 cannot be completely excluded. 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 Based on information available, events Road traffic accident and Post traumatic pain are  considered unrelated to BNT162B2 vaccine.
SPLOTCHY RASH STARTED ON CHEST AND SPREAD TO ENTIRE BODY WITHIN 2DAYS.  PATIENT ALSO HAD UP TO 102.4 TEMPERATURE.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Nontraumatic retroperitoneal hematoma.
Approx. 48 hrs. after administration, patient reported (to PCP) approx. softball-sized raised/tender area around vacc. site. Stated she felt a little "punk-y", otherwise ok.