chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lower heart rate; no heartbeat; At an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) / at 10 weeks the baby measured 7 weeks and 1 day; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable consumer (the parent). This consumer reported information for both mother (self) and fetus/baby. This is the second of two reports. This is a fetus report.  A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 transplacental on 06Oct2021 at 18:45 (Batch/Lot Number: FF8839) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's mother (34 year-old female) previously received bnt162b2, dose 1 on 24Aug2021 at 12:45 (Batch/Lot Number: FC3183) as dose 1, single for COVID-19 immunisation.  The patient experienced maternal exposure during pregnancy, first trimester, at an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) and had a lower heart rate, at an ultrasound at 10 weeks the baby measured 7 weeks and 1 day with no heartbeat, resulting in a miscarriage on an unknown date in 2021. The events were serious for congenital anomaly and death. The events resulted in doctor or other healthcare professional office/clinic visit. The mother underwent doctor visits and follow ups. The patient died on an unknown date it 2021.  It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101463694 Same reporter/drug, different patient and event (Mother case).; Reported Cause(s) of Death: no heartbeat; At an ultrasound at 8 weeks 4 days the baby was measuring small (about 7 weeks) / at 10 weeks the baby measured 7 weeks and 1 day; lower heart rate
Manufacturer: GlaxoSmithKline: ** Please note that I do know the correct vaccine name other than that it was an influenza vaccine and that it was quadrivalent. The site will not allow me to continue without entering a value  Following the injection, I had the typical shoulder/arm soreness that accompanies the influenza vaccine. Since that time, the pain has not abated.  Reaching for an object or stretching my arm causes intense soreness. I believe, but do not have any information to verify, that the injection may have been incorrectly administered secondary to  inaccurate placement of injection at site.  The pain is not incapacitating  and I am able to perform my activities of daily living without issue. I did not have any other symptoms other than arm soreness after the injection. I do not believe the person who performed the injection was careless or intending to cause harm.
Gave Tdap in (R) upper arm- pt c/o stomach ache with swelling & redness at injection site & splotchy areas on entire arm. Complaints lasted 24 hrs. Now resolved.
Product storage error; possible administration of invalid dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients). At the time of the report, PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   There are 4 days temperature data for the freezer storage unit was between 4/1/2022 and 4/4/2022 however it never reached an acceptable range and was always warm by 4/26/22 there is no other temperature data other than what is listed above. 6640 doses of COVID-19 Moderna Vaccine were received by the facility during this time period. Lot numbers include: 017C21A. Some vials may have been moved to a refrigerator at some point. There were no temperature data for that storage unit so the reporter has requested to provide guidance on the viability of the vaccine given the missing temperature data.
Injection was given at the very top of the left arm. I told the nurse it felt like she hit my bone, "I would have felt that" was her response. I have NEVER had a shot that far up on my arm before. I'm still having pain in my arm and almost feels like strength loss.
Scattered Hives over body which he stated started shortly after receiving vaccine. He came to medical on 11/28/10 when symptoms became worse. He was treated with Benadryl and Prednisone. Has had 8 episodes of Hives and one incident of shortness of breath since receiving vaccine on 11/24/09 with treatment consisting of steroids and antihistamines.
9 yr old male received 0.2cc of vaccine from Purple vial, essentially 20mcg. No adverse reactions noted during time in clinic.
Mom states child received vaccinations on 05/24/02. First noted 6m area of redness on upper right arm yesterday 05/29/02. This morning area on right arm larger more swollen and complained of itching. Brought to the office and was seen by a nurse. Also seen by a doctor. Area of right arm red raised 7cm x 7cm in diameter. Child complained of itching. No other symptoms noted. Advised to use children's Benadryl, cool compresses and Hydrocortislone cream locally.
got the vaccine and got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several weeks after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the shot few years ago and got shingles few weeks later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
red spot at area of vaccination; itching at injection  site; the area generates discomfort; The area is warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot at area of vaccination), VACCINATION SITE PRURITUS (itching at injection  site), VACCINATION SITE DISCOMFORT (the area generates discomfort) and INJECTION SITE WARMTH (The area is warm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On 03-Feb-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot at area of vaccination), VACCINATION SITE PRURITUS (itching at injection  site), VACCINATION SITE DISCOMFORT (the area generates discomfort) and INJECTION SITE WARMTH (The area is warm). At the time of the report, VACCINATION SITE ERYTHEMA (red spot at area of vaccination), VACCINATION SITE PRURITUS (itching at injection  site), VACCINATION SITE DISCOMFORT (the area generates discomfort) and INJECTION SITE WARMTH (The area is warm) outcome was unknown. Not Provided      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.   Concomitant product use was not provided/unknown by the reporter
Fever of 104.9 F shortly after MMR-V & KINRIX (DTaP-POL) given 1/21/2011 resolved quickly with TYLENOL.
Medication error. Pt exceeds age limit for MMRV combined vaccine. No signs/symptoms reported.
pericarditis; a large pericardial effusion; This is a spontaneous report from a contactable physician. An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), at the age of 18 years old, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter explained the only probable trigger to the 18-year-old male patient developing pericarditis and a large pericardial effusion was the receipt of the first dose of BNT162B2, 2-3 weeks before the diagnosis. The reporter added he read through the CDC website, about increased cases of myocarditis and pericarditis after getting the second dose of BNT162B2. The reporter asked if the second dose was contraindicated after such adverse reaction to the first dose. The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of Pericarditis and Pericardial Effusion 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, Ethics Committees and Investigators, as appropriate.
side effects like the flu; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (trade name unspecified), via an unspecified route of administration, in Oct2020 (batch/lot number was not reported), as single dose, at age 80 years old; and influenza vaccine (trade name unspecified), via an unspecified route of administration, in Oct2020 (batch/lot number was not reported), at unspecified dose, at age 80 years old, for immunization. Medical history included hair loss from 1960 and ongoing (it never came back). The patient's concomitant medications were not reported. In the end of Oct2020, the patient experienced side effects like the flu after his flu shot and pneumonia shot. The event lasted about a day and a half. The patient recovered from the event on an unspecified date.  Pfizer is a marketing authorization holder of Pneumococcal 13-Valent Conjugate Vaccine (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased. This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Valent Conjugate Vaccine (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  No follow up attempts are needed. No further information is expected.
expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        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. The vial was stored in refrigerator on 01 December 2021 and it did not undergo any temperature excursions. Vaccine expiry date was on 02 January 2022.  The reporter stated that some patients had reported flu like symptoms after receiving the vaccination.
08/15/2001 onset joint pain wrists, ankles and back pain. Was seen by PMD X 2. 08/30/2001 seen at ER for severe joint pain. Mom reports told could be rheumatoid arthritis or possibly reactive from MMR. Has appointment 09/17/2001 with pediatric Rheumatologist. Mom reports fever "off and on." On moprossyn bid.
Basically the same as the beginning of a common cold: sore throat early in the morning of the fifth day following the vaccination, runny eyes and sniffles during the day, symptoms becoming less noticeable toward late afternoon. Symptoms almost completely gone the next day (today).
Had anaphylactic reaction approx half hour after pediarix #3, prevnar #3 and Flu #1. Swelling og face/ears/lips. Urticaria generalised. No tongue swelling and wheezing. Given epinepherinr IM, benadryl IV and solumedrol IV.
Information has been received from a health professional concerning a 66 year old female with allergic reaction to "a lot of antibiotics" who on 06-FEB-2008 was vaccinated subcutaneously into the left arm with a first dose of Zostavax (Oka/Merck) (Lot # 659403/1825U).  Concomitant therapy included LIPITOR.  On 09-FEB-2008 the patient developed a rash around injection site, inside the left arm, upper chest, and at the bend of the elbow.  There was no illness at the time of vaccination.  It was reported that the rash "itched a little" and that the patient took BENADRYL.  It was also reported that the patient had a quarter size knot at the injection site.  On 11 FEB 2008 the patient's rash was going and it was "just red at the site".  The patient was reportedly recovered on 11 FEB 2008.  Additional information has been requested.
Immediately after the injection and got a pounding headache behind her eyes.  Then about 7:30 PM she started to ache all over and very tired.  She went to bed around 8:00 PM and then she couldn't sleep all night.  She kept trying to drink liquid, running fever, hot and opened a window with temp being 30 outside.  She could hardly walk to the bathroom due to the muscle weakness and fear of falling.  She tossed and turned all night long.  She got up and her temp was 99.8, and she was told not to go to PT this morning.  She is being treated for a frozen shoulder.   She feels dehydrated and is drinking water, and going to drink Ginger ale and crackers due to the nausea.
low grade fever 100.4; This is a spontaneous report from a contactable consumer or other non hcp.    A 62-years-old female patient received bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was Reported that, the patient experienced low grade fever 100.4 on 20Mar2021 with outcome of recovered.    Reports of ADEs in which the initial reporter identifies the suspect drug as one marketed by another applicant should be promptly forwarded to that applicant .  Additionally , per 21 CFR 314.80 , post marketing Reporting of Adverse Drug experiences , updated 01Apr2016, the requirements of paragraphs (c)(1) (ii) of this section Concerning the submission of post marketing 15 day alert reports , also apply to any person other than the applicant whose name appears on the label of an approved drug product as manufacturer a Packer distributor non applicant. To avoid unnecessary duplication in the submission to FDA of reports required by paragraphs (c) (1)(i) and (c)(1)(ii) Off the section, obligations office none applicant may be met by submission of all reports of serious adverse drug experiences to the applicant. Is a non applicant elects to submit adverse drug experience reports to the applicant rather than to FDA, the applicant must submit, by any appropriate means, each report to the applicant within 5 calendar days off initial receipt of the information by the non applicant, and the applicant must then comply with the requirements of this section.  VR, therefore, forwarding the information below relating to your product which was obtained by one of our employees during the normal course of business.   follow-up attempts are needed; information about lot/batch number cannot be obtained.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
Post vax, the pt had a severe headache, chills, fever, and painful swelling. Hot, painful swelling moving down inside of arm to elbow-very red with muscle weakness. 60 day follow up states the pt has extreme high blood pressure,
Information has been received from a nurse practitioner via the patient's mother concerning her daughter with a history of bulimia who about 9 years ago, was vaccinated with a second dose of RECOMBIVAX HB (manufacturer unspecified) and experienced a seizure (date unspecified). No other symptoms were reported. The patient recovered on an unspecified date. Upon internal review, the seizure was determined to be an other important medical event. Additional information is not expected.
HEADACHE (WAXING / WANNING); ACHING IN LEGS; ACHING IN BUTTOCKS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) .5 ml, administered on 06-MAR-2021 08:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced headache (waxing / wanning). On 06-MAR-2021, the subject experienced aching in legs. On 06-MAR-2021, the subject experienced aching in buttocks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache (waxing / wanning), aching in legs and aching in buttocks was not reported. This report was non-serious.
The patient is an 11-year-old( at the time of vaccine administration)  female who received the COVID-19 Pfizer vaccine on 6/23/2021. At this time, there are no reported symptoms by the patient or guardian.
pt taken to hosp ER p/suffering from swelling of lt arm which extended to lt hand & fingers;pt had as a result of the swelling limited mobility of extremity;area was sl reddened warm upon extremities & swelling was subsiding;dx lymphedema;
Chronic Urticaria starting localized at the base of the head and shoulders then progressively moving to trunk, then extremities. Urticaria locations are random differentiating from day to day.  Time has been approximately 5 months. I have completed a steroid regiment and 2 months of antihistamines. Symptoms have not resolved. Previously no skin issues declared , no medications prior, and no allergies prior. No other symptoms.
Information has been received from a medical assistant concerning a 15 year old female who on 27-DEC-2007 was vaccinated with GARDASIL vaccine (lot# unspecified). There was no concomitant medication. It was reported that on the same day the PAP test was performed and that the results showed a "lot-grade" abnormality. No other information was available. Additional information has been requested.
Fever, large welt (approx. 5 inches by 3 inches) the site of shot was hot and getting larger. Also blisters formed. 2 forms of antibiotics were given. ER visit and 2 trips to the Dr. Patient missed 2 days of school.
Developed shakes a few days after shot.    Broke out with Shingles on 28/29 of March.   Started medicine (IC VALACYCLOV-IR  1 Gram every 12 hours for 10 days)  on 4/3/2021 from Doctor.    Rash starting to clear up on 4/5/21.   Still burning slightly on 4/7/21.
Information was received on 11-JUL-2017 from a licensed practical nurse who was reporting on an unspecified patient (age and gender unknown). No medical history or concomitant medications reported. On 11-JUL-2017, the patient received a dose of ZOSTAVAX (lot # M017294, expired 28-JUN-2017). The nurse reported that the sterile diluent (lot N015631, expires 18-MAR-2019) (dose not reported) used to reconstitute ZOSTAVAX was not expired. No adverse effect reported. No other information was provided. Additional information has been requested.
pt recv vax 30MAR95 & the next day had a serious local rxn; adm to the hosp on 15APR95 w/fever, myalgia, arthralgia, a small joint effusion & capillary leak resulting in bilat lower extremity edema; MD made dx aseptic meningitis;
he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading; The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this says booster doses only.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT LABEL ISSUE (he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this says booster doses only.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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. On an unknown date, the patient experienced PRODUCT LABEL ISSUE (he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this NDC says booster doses only.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL ISSUE (he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this says booster doses only.) 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 PRODUCT LABEL ISSUE (he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this NDC says booster doses only.).    No concomitant product use was reported.  The pharmacist reported that previously, the packaging would say bivalent on the boxes and vials. But at the time of report says booster doses only. Pharmacist was not sure if the package change or if that was considered bivalent, or if that was the older boosters.  No treatment information was provided..