chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This retrospective pregnancy case was reported by a consumer and described the occurrence of miscarriage in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) while pregnant.  A physician or other health care professional has not verified this report. Concurrent medications included Multivitamins. On 10 August 2010 at 11:00 the subject received 1st dose of CERVARIX in the left arm. The subject discovered she was pregnant one week later on 18 August 2010. The subject experienced vaccine exposure during pregnancy. The date of last menstrual period was not provided and her estimated date of delivery was 20 May 2011. On 7 November 2010, 89 days after vaccination with CERVARIX, the subject experienced a miscarriage. This case was assessed as medically serious by agency. No additional details were provided.
About a week in I noticed that my arm was itching and had a red, hot spot, the size of a silver dollar at the location of the injection.
I had Covid vaccine Pfizer 1st dose on May 28, 2021 and 2nd dose on June 21, 2021 at Clinic. I felt Fever or Chill, Fatigue, Headache, Muscle pain, but eventually these reactions were gone 3-7 days after vaccination.   In the morning on Jan 27, 2022, I had Pfizer booster shot at Pharmacy. Besides the reactions when 1st and 2nd dose, this time I also had left chest pain (burning feeling) and tightness after 12 hours, and shortness of breath, difficult to walk in second days. And left chest pain (burning feeling) and tightness did not go. On Jan 31, 2022, I told the pharmacist who administered the shot to me those vaccine reaction. He said if symptom was getting better with time, then should not worry about that. The week Jan 31 to Feb 06, 2022, the symptom got better, but left chest pain and tightness did not go. I am a life scientist. I searched online other peoples reports and thought that the booster shot may triggered asthma to me. Then late Feb and late April 2022, I bought Primatene bronchodilator tablets two times. I felt better when taking the tablets. But left chest pain and tightness still did not go.   On May 11th, I visited Asthma specialist Doctor for the left chest pain and tightness, she prescribed Albuterol Sulfate inhalation aerosol and Fluticasone Propionate nasal spray. I was taking the two inhalers since then. It worked somewhat and improved symptom but not solved the issue. Doctor also suggested me to visit a family doctor. I visited Doctor at facility on June 13, 2022. She listed my symptom as atypical chest pain and ordered the exam Chest X-rays, electrocardiogram and echocardiogram (TTE). And Doctor had no idea for my chest pain. And my left chest pain and tightness still did not completely go.
started getting rash on back of neck & forehead;spread to whole trunk in 1-2 days;erythematous purpuric & fussy;tx w/DPH, calamine lotion;
Red, swollen left upper arm. Hot to the touch. *2 vaccines given in (L) deltoid.
Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching). At the time of the report, PRURITUS (Itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment details included Calazime cream.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
% minutes after the patient was vaccinated he c/o abdominal discomfort, he told his mother that he felt like he was falling. Patient the fell to the floor and had a seizure the lasted approximately 5-10 seconds. Pt awoke postictal.
Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022; No adverse event; Patient administerd expired Moderna Covid-19 vaccine (Monovalent); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administerd expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2022 at 11:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Aug-2022 at 11:56 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administerd expired Moderna Covid-19 vaccine (Monovalent)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administerd expired Moderna Covid-19 vaccine (Monovalent)), PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022) 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 EXPIRED PRODUCT ADMINISTERED (Patient administerd expired Moderna Covid-19 vaccine (Monovalent)) and PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 29-Aug-2022 and administered to the patient on 30-Aug-2022).    No concomitant medications were reported.  Patient received 2 doses of unknown manufacture and 1 booster dose.  Vial size was reported as 5.5 ml. The vaccine was delivered and placed into the freezer on 18-Apr-2022 and the vial did not undergo any temperature excursion.  Vaccines were only offered on Tuesdays from Mar-2022 forward. For each Tuesday vaccine date, only one vial was removed from the freezer to place in the refrigerator the day before it was used (each Monday, one vial was removed from the freezer and placed into the refrigerator). Therefore, for administration on 30-Aug-2022 vial was placed into refrigerator on 29-Aug-2022.  No treatment information was reported.
pt recv vax 25AUG97 & 31AUG97 pt devel 9 red raised lesions;
Local histamine based reaction with in 5 minutes of dose and resolved in 30 minutes with benadryl
pt got up to go to bathroom early am, did not feel well and felt weak and dizzy.  She sat and vomited and felt faint- called for help and husband found her on floor- he call 911.  The ambulance took her to BRMC ER where she was Tx Dx and release
reports a two year old patient received a dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional detail details were provided as follows: The reporter reported that, two year old patient received a dose of Kinrix, which led to inappropriate age at vaccine administration. The reporter did not provide full address, patient demographics, lot number, or expiration date of the product administered. The reporter consented to follow up.
losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at injection site; dizziness; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 18 years old. The patient medical history was not reported. There were no concomitant medications. No other vaccines if four weeks. Patient received the first dose of bnt162b2 at 12Mar2021 16:30, arm left for covid-19 immunisation, at 18 years old. Patient is not pregnant. The patient experienced after second dose: losing vision, almost passing out, dizziness, fever, chills, headache, body ache, pain at injection site on 10Apr2021 00:00 (12AM). Treatment was not given. Outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was very very sweaty/ I woke up in a pool of sweat; Symptoms are much worse; I was a little tired; slight fever; chills; I am very weak; I can hardly walk; I totally lost my appetite; The injection site blew; It is very hard/ It is like a ball; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk), DECREASED APPETITE (I totally lost my appetite), HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat) and CONDITION AGGRAVATED (Symptoms are much worse) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Polymyalgia rheumatica. Concomitant products included INSULIN, METFORMIN and DULAGLUTIDE (TRULICITY) for Diabetes, METHOTREXATE for Polymyalgia rheumatica, LISINOPRIL for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk), DECREASED APPETITE (I totally lost my appetite), INJECTION SITE SWELLING (The injection site blew) and VACCINATION SITE INDURATION (It is very hard/ It is like a ball). On 29-Aug-2021, the patient experienced PYREXIA (slight fever) and CHILLS (chills). On an unknown date, the patient experienced HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat), CONDITION AGGRAVATED (Symptoms are much worse) and FATIGUE (I was a little tired). At the time of the report, ASTHENIA (I am very weak), MOBILITY DECREASED (I can hardly walk) and DECREASED APPETITE (I totally lost my appetite) had not resolved and HYPERHIDROSIS (I was very very sweaty/ I woke up in a pool of sweat), CONDITION AGGRAVATED (Symptoms are much worse), INJECTION SITE SWELLING (The injection site blew), VACCINATION SITE INDURATION (It is very hard/ It is like a ball), PYREXIA (slight fever), CHILLS (chills) and FATIGUE (I was a little tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes FIBRIC ACID for Diabetes.  No treatment medication were provided by the reporter   This case was linked to MOD-2021-301856, MOD-2021-301864 (Patient Link).
Pt c/o muscle tightness/soreness at site of Td injection for 2-3 weeks. Pt reports symptoms began several hours after administration of Td. Pt confirms symptoms did get better Sunday 3/16 after taking Tylenol however continues to have problems. C/o left arm became worse this week with "muscle spasms" radiating to neck. Referred to primary physician.
Temp 101.6, Rash scattered over trunk area, lacy macular pink.
Moderna Covid 19 vaccine second dose.  Experienced migraine within 5 hours, sore arm, fever up to 100.8F, fatigue, body aches
mom reported elevated t104.5 on 130AM 3NOV94; t105 R on 4NOV94; mom stated APAP given q 4-6 hrs po; seen by FMD on 4NOV94; sinusitis dx; Ceclor ordered; improved by 5NOV94 p/2 dose of ceclor;
Initial unsolicited report received from a non-healthcare professional on 23-Oct-2017. This case involves a female patient (age not reported), who was vaccinated once with 0.5 ml FLUZONE QIV via intramuscular route (batch number: UT5911NA, expiry date: 30-Jun-2018; dose in series and site of administration not reported) on 17-Oct-2017. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed right deltoid abscess and cellulitis. Lab test and corrective treatment was not reported. Patient did not recover from the events. Case was reported serious for medically significant events. Documents held by sender: none.; Sender's Comments: Patient vaccinated FLUZONE QIV with Patient developed R Deltoid abscess and Cellulitis. Time to onset is compatible with the role of the vaccine. This case is very poorly documented to assess the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headache".  Additional information: Patient was concerned about "tomorrow it will be 1 week since his 2nd dose of the Pfizer BioNTech Covid. How long before he can take Excedrin for a headache and also take Cialis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician via pregnancy questionnaire concerning a female baby whose mother was vaccinated with a dose of GARDASIL (Lot # 659184/0843X) on 03-APR-2009. Concomitant therapy included vitamins (unspecified), ZITHROMAX, iron (unspecified), vitamins (unspecified), iron (unspecified) and ZITHROMAX. It was reported that the baby was born at 36.6 weeks of gestation but there were no congenital anomalies. On 09-APR-2010, the Apgar score showed the following results: 8/9. At the time of the report the outcome of the patient was unknown. The mother's experiences have been captured in WAES # 0909USA01172. No further information is available.
Fainted. Sore shoulder, more sore than with previous shots. Arm was sore to raise and move.  Lethargic for day's remainder.
shingles; This initial spontaneous information was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. In or around February 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and prevention of shingles. In or around July 2018, the patient was diagnosed with shingles by her primary care physician. Patient's shingles lasted for several weeks causing severe pain and suffering. The patient continued to suffer from back pain for several months after the rash resolved. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient symptoms resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient have incurred and would continue to incur medical expenses and other economic harm as a direct result of zoster vaccine live (ZOSTAVAX). The outcome of shingles was considered to be not recovered. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of shingles was considered to be disabling.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 23-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call  was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007: US-009507513-2001USA009210: US-009507513-2001USA009216: US-009507513-2001USA009217: US-009507513-2001USA009218: US-009507513-2001USA009211: US-009507513-2001USA009212: US-009507513-2001USA009213: US-009507513-2001USA009214: US-009507513-2001USA009215: US-009507513-2001USA009200: US-009507513-2001USA009201: US-009507513-2001USA009202: US-009507513-2001USA009203: US-009507513-2001USA009204: US-009507513-2001USA009205: US-009507513-2001USA009206: US-009507513-2001USA009207: US-009507513-2001USA009208: US-009507513-2001USA009209: US-009507513-2001USA009220: US-009507513-2001USA009221: US-009507513-2001USA009222: US-009507513-2001USA009223: US-009507513-2001USA009224: US-009507513-2001USA009225: US-009507513-2001USA009226: US-009507513-2001USA009227: US-009507513-2001USA009228: US-009507513-2001USA009229: US-009507513-2001USA009230: US-009507513-2001USA009231: US-009507513-2001USA009232: US-009507513-2001USA009233: US-009507513-2001USA009234: US-009507513-2001USA009235: US-009507513-2001USA009236: US-009507513-2001USA009237: US-009507513-2001USA009238: US-009507513-2001USA009239: US-009507513-2001USA009240: US-009507513-2001USA009241: US-009507513-2001USA009242: US-009507513-2001USA009243: US-009507513-2001USA009244: US-009507513-2001USA009245: US-009507513-2001USA009246: US-009507513-2001USA009247: US-009507513-2001USA009248: US-009507513-2001USA009249: US-009507513-2001USA009190: US-009507513-2001USA009191: US-009507513-2001USA009192: US-009507513-2001USA009193: US-009507513-2001USA009194: US-009507513-2001USA009195: US-009507513-2001USA009196: US-009507513-2001USA009197: US-009507513-2001USA009198: US-009507513-2001USA009199: US-009507513-2001USA009250: US-009507513-2001USA009251: US-009507513-2001USA009252: US-009507513-2001USA009253: US-009507513-2001USA009254: US-009507513-2001USA009189:
9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended), POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 9-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended), POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) 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 TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended).    No concomitant product use was reported.  HCP stated the temperature happed on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.  No symptoms were reported after the administration of the vaccine.  No treatment information was provided.
Recvd Japanese Encephalitis dose #2 (had dose #1  28 days ago without any problems) at 9:30 am. at 8:00 pm states startd getting hives on the back of her lower leg in the calf area. By midnight the other leg had hives as well  Texted me at 1:30 am asking what to do.I referred to Urgent Care or ER. Denies any other symptoms. No fever, aches or headache. No SOB, difficulty swallowing or other symptoms. Stated injection site was fine. Sent me a pic of hives on legs. Mild, but do confirm it was hives.
72 hrs p/vax given pt devel severe diarrhea & abdominal cramping for 24 hrs;