chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot number, expiration date and route was not reported). No concomitant medications were reported. On an unknown date, the patient developed injection site reactions after receiving PNEUMOVAX23. The patient developed scar at the injection site. The outcome of the reported event was unknown at the time of this report. This is one of the two reports received from the same reporter. Additional information has been requested.
Weakness, lethargy, loss of appetite, inability to concentrate, some memory loss, dizziness, blood in urine, fainting spells and lightheaded symptoms.
Subsequent progressive iron deficiency anemia with SOB and profound exhaustion - Ferritin levels plummeted to 3;  iron, Hgb, HCT, MCHC, etc all low (especially iron). Required EGD/colon to rule out GI bleeding (normal) and subsequent Injectafer infusions x 2. Appt in July to repeat labs. O going February 2021- current
had the flu within the same week of getting the shot/Every year she got the shot she came down with the flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (daughter of the patient) via social media (public post on the Sanofi flu shot campaign) on 14-Oct-2020.  This case is linked to case 2020SA294157, 2020SA294125 (same source).  This case involved a 58-year-old female patient who had the flu within the same week of getting the shot/every year she got the shot she came down with the flu (Influenza), while she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history of the patient were not provided. Concomitant medication was not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had the flu within the same week of getting the shot/every year she got the shot she came down with the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.  There will be no information available on the batch number for this case.
Information has been received from a registered pharmacist (R.Ph) concerning 69 years old female patient who on 29-SEP-2010 was vaccinated subcutaneously with a 0.65mL dose of ZOSTAVAX (Merck) (lot number unknown). The pharmacist reported that the patient developed a zoster-like rash on her trunk after receiving ZOSTAVAX (Merck). The patient stated that was too painful to wear a bra. The patient sought unspecified medical attention. At the time of report, the patient had not recovered from zoster-like rash on her trunk. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 46.67  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 9A temperature was 34 total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Widespread Pain; diarrhea; fever; vomiting; This is a spontaneous report from a non-contactable other healthcare professional. An 85-year-old female (non-pregnant) patient received first dose bnt162b2, intramuscularly on right arm on 14Dec2020 at 14:00 at single dose for immunization. Medical history included High cholesterol (no cholesterol lowering medication) edema, dementia, and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA) on 30Nov2020 for immunization within 4 weeks prior to the COVID vaccine, other medications the patient received within 2 weeks of vaccination included daily vitamin, diuretic, dementia medication, anti inflammatory.  On 14Dec2020, the patient experienced widespread pain, diarrhea, fever, vomiting. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not resolved.   No follow-up attempts are possible. Information about Lot/Batch could not be obtained. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of feeling unwell in a female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 31st May 2018, the patient received SHINGRIX. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced feeling unwell, insomnia, lethargy, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the feeling unwell, insomnia and lethargy were recovering/resolving and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the feeling unwell, insomnia and lethargy to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that the patient received only the adjuvant portion of the SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient stated that later that night they were lethargic, felt like they were getting sick, and experienced insomnia. The health care professional was certain the patient only received the adjuvant for the SHINGRIX. The patient insists they received the complete vaccine because of the side effects experienced. The patient did not want to come back to be revaccinated with the complete vaccine.
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On 20-OCT-2015, the patient was vaccinated with PNEUMOVAX 23, (dose, lot # and expiration date were not provided). Concomitant medication was not reported. On 21-OCT-2015, reported as "within 24 hours", the patient experienced terrible pain in the arm after being vaccinated with PNEUMOVAX 23. The outcome of pain in extremity was reported as recovered on an unspecified date in October 2015, reported as "approximately one week after vaccination". The reporter did not assess the relatedness between pain in extremity and PNEUMOVAX 23. This is one of the several reports received from the same source. Additional information has been requested.
Aches/pains; Slept all day; Drug effect incomplete; Fatigue; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches/pains), SOMNOLENCE (Slept all day), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), FATIGUE (Fatigue) and VOMITING (Vomiting) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Rheumatoid arthritis. Previously administered products included for Product used for unknown indication: REMICADE (She was doing okay and not doing as when on Remicade.). Past adverse reactions to the above products included No adverse event with REMICADE. Concomitant products included METHOTREXATE and PREDNISONE for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced PAIN (Aches/pains), SOMNOLENCE (Slept all day), PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), FATIGUE (Fatigue) and VOMITING (Vomiting). At the time of the report, PAIN (Aches/pains), SOMNOLENCE (Slept all day), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), FATIGUE (Fatigue) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that RINVOQ not working as well as Remicade. Prednisone was being tapered off. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided by the reporter.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.  Company comment-This spontaneous case concerns an adult female patient of unspecified age with relevant medical history of Rheumatoid Arthritis reported, who experienced the non-serious unexpected event product effect incomplete that occurred on an unknown date in the context of mRNA-1273 vaccination. It was reported that RINVOQ WAS NOT WORKING AS WELL AS REMICADE, No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical.; Sender's Comments: This spontaneous case concerns an adult female patient of unspecified age with relevant medical history of Rheumatoid Arthritis reported, who experienced the non-serious unexpected event Therapeutic product effect incomplete that occurred on an unknown date in the context of mRNA-1273 vaccination. It was reported that RINVOQ WAS NOT WORKING AS WELL AS REMICADE, No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical.
This spontaneous report was received from an office manager and refers to a 12 month-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 31-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004466: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499: US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Grandmother called the clinic 8/2/2018 in the afternoon stating that her daughter brought the child to the clinic for vaccines and physical on 7/31/2018. She stated that she gave her daughter the wrong vaccine record. The record that was brought to the clinic did not have the last set of vaccines on it. She stated that the child had already had the vaccines done 2-3 months earlier.  Grandmother stated that the child was complaining that her hip was hurting and there was some swelling in her left knee. Instructed to take the child to see MD for evaluation.
In 2 wks after receiving MMR and Varicella vaccine pt developed itchy chicken pox like rash which after 8 days started scabbing and drying, by 2 wks the scabs started coming off.
7 days post-administration-left deltoid slightly raised, bruised (purple/yellow) and painful at touch. Patient was asked many questions by the pharmacist. He is currently taking Aspirin 325mg daily.
Moderna COVID-19 Vaccine EUA Around five days after receiving my first shot I started feeling aching and throbbing on my left side in my neck, shoulder blade, shoulder, bicep area down to my elbow, and a swollen lymph node in my left arm pit.  My neck, bicep area, and shoulder is still producing a throbbing type pain.  On April 18, 2021 I awoke to the tip of my left thumb being numb.  It is still numb as of today, April 23, 2021..
p/vax pt had redness on rt thigh;9/3/99 entire thigh reddened & firm & warm to touch;reddened area measures approx 2" by 3";encouraged to apply cold packs & refer to MD if any problems;
Patient states immediate pain after injection that seemed worse than typical pain from an immunization. The same day, the area around the injection got red and swollen. Since the injection, the patient has experienced new joint pain.
Shot given in underage patient.  This immunization indicated for those over 18 and over.  Mom stated child is okay
Rash started on 11/7/2018, on forehead and arms, now spread everywhere. Many scaterred 1-2 mm erythematous blanching papules on forehead, behind ears, back of neck, throughout trunk and arms. Blanching red spots on palms and soles.
Blood Clots & Stroke He never had a blood clot before, 1-1/2 weeks after receiving the Vaccine Booster Moderna, he formed the clot, and had a stroke while in the hospital   Currently still recovering, was discharged from Rehab center today.
Fevers to 104.8 starting ~36 hours after vaccine administration, febrile seizure ~48 hours after vaccine administration.
She had burning in the eye; Another nurse was preparing doses of the Moderna Covid-19 Vaccine, and it splashed in her eye; This spontaneous case was reported by a nurse and describes the occurrence of EYE IRRITATION (She had burning in the eye) and OCCUPATIONAL EXPOSURE TO PRODUCT (Another nurse was preparing doses of the Moderna Covid-19 Vaccine, and it splashed in her eye) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2022, the patient experienced EYE IRRITATION (She had burning in the eye) and OCCUPATIONAL EXPOSURE TO PRODUCT (Another nurse was preparing doses of the Moderna Covid-19 Vaccine, and it splashed in her eye). On 26-Jan-2022, OCCUPATIONAL EXPOSURE TO PRODUCT (Another nurse was preparing doses of the Moderna Covid-19 Vaccine, and it splashed in her eye) had resolved. At the time of the report, EYE IRRITATION (She had burning in the eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 medication was reported.
Reporter stated a Doctor injected an office worker w/40mcg of Hep B vax (recomb) instead of 10mcg; @ the time of the report there was no adverse rxn; No further details were provided;
I developed tinnitus in one ear only. Also eustashun tube dysfunction in the opposite ear
Mtr. states pt. was "fine" when he went to bed, but woke up at approx 2am, c/o "severe headache", increased temp & felt like could not get a deep breath," when arrived at ER. Temp was 103.4. Was given ibuprofen & sent home.
The pt experienced joint stiffness, numbness following injection. Within 1-2 minutes the pt experienced burning and later noticed swelling and massive bruising, pain at injection site, bruising covered 30 mm. No other reaction.
Within three hours sore arm; Within 6 hours waves of being tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 08:30 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Mar2021, outcome "recovered" (07Mar2021), described as "Within three hours sore arm"; FATIGUE (non-serious) with onset 06Mar2021, outcome "recovered" (07Mar2021), described as "Within 6 hours waves of being tired". Therapeutic measures were not taken as a result of pain in extremity, fatigue. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any medication within two weeks of the vaccination. On 06Mar2021, the patient experienced a sore arm within three hours and waves of being tired within 6 hours of the first shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body ache starting 11 hours after vaccination; headache shortly after, then fever 99.5, up to 100.9; insomnia; aches lasted ~14 hours
Redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 87-year-old patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On 15th July 2019, less than a year after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced a red area 5 inches long and 3 inches wide at the Shingrix injection site following Shingrix administration.  The reporter consented to follow up.
Muscle pain all over, fatigue and hot/cold flashes. Patient also reports feeling very thirsty.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 1/28/2022 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION
I had dermal fillers under my eyes in May of 2020.  I had the expected body aches and chills the day after the second covid vaccination  (Moderna) on the second day I woke up with my under eyes being swollen in the area of the filler
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of GARDASIL 9 which had a lot # of M011117, with an expiration date of 07-DEC-2017 and lot # of L043214 and an expiration date of 30-AUG-2017 (concentration, route, dose number, dose and anatomical place of vaccination were not provided). Which were reported because a data logger. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Shingles on the left side of the abdomen, burning at touch, blister around the bellybutton and side of the abdomen. Burning last for a entire month. Anti-Viral and steroids used as treatment. On June 17th lost sense of smell and taste.
Bruising on inner left arm and outer right arm ...unknown reason ..started on 3/22 bruise still present on left arm
Around 5am on May 1st caller woke up and could not breathe. She took 4 puffs of her inhaler. She  advised husband to call 911. Sister came and gave patient another 4 puffs.  When EMT arrived patient was unconscious. Patient was told that she lost her bowels urine  and was forming at the mouth. Patient was transferred hospital. Patient was sent to ICU. Patient was put on the vent. Patient was in ICU for 40 days. Patient was then sent to a respiration clinic to help wing her off the vent. Patient walked a little. Patient was released on July 20th and sent to a rehabilitation center. Patient also stated that she received fecal tube.