chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/9/21 (EL1283) Pfizer Dose 2 3/3/21 (EN6200) Pfizer Dose 3 10/16/21 (lot NA) COVID Positive 12/21/21 COVID Positive 12/24/21  12/13/21: Pt is an 83 year-old female with history of nonischemic cardiomyopathy, congestive heart failure, COPD, CKD IIIA, and proteus UTI approximately 1 year ago who presented to the ED this morning with acute right flank pain. Pt states she woke up with right flank pain radiating to her pubic bone at 1 am this morning and was unable to urinate. She then called her son who picked her up and brought her to the ED. Over this time, her pain increased significantly and was severely tachycardic in the 140s and tachypneic in the 40s in the emergency department. CBC revealed a leukocytosis of 16, ABG showed a metabolic acidosis, and abdominal CT showed an obstructing 8mm stone at the right UVJ. She received 2 gm ceftriaxone and 10 mg diltiazem in the ED.  Urology was consulted and the pt was taken to the OR for urgent stent placement of the right ureter. After the procedure, pt was hemodynamically stable and determined to be medically stable for admission to the medicine floor. Pt is currently feeling much better than this morning. She complains of low back pain and shortness of breath that are similar to her baseline. Daughter is requesting voltaren ointment for pt's arthritic low back pain. Pt has a history of tobacco and alcohol use with cessation approximately 1 year ago.  12/31/21: 83-year-old woman who presented with complaints of right flank pain and obstructive lower urinary tract symptoms.  In the emergency department she  was noted  to meet sepsis criteria with leukocytosis, tachycardic and hypertensive.  CT abdomen / pelvis demonstrated right ureteral calculus obstructing the right ureteropelvic junction.   Urology was emergently consulted and she underwent emergent cystoscopy with right ureteral stent placement following initiation of empiric antibiotic therapy.  Post procedural course was complicated by hypotension for which she was admitted to the intensive care unit for pressor support.  Blood cultures were subsequently positive for Proteus mirabilis for which she was appropriately treated with IV Zosyn.  She was also started on stress steroid  which is being tapered down to previous home dose.  Clinical response was favorable with resolution of leukocytosis, tachycardia and  hypotension.  COVID-19 PCR was subsequently noted to be positive during hospital course for which was treated with Decadron and remdesivir with good effect.  She was evaluated by Physical and Occupational therapy and recommended for further rehabilitation.  She has been discharged in stable medical condition to the acute rehab unit today.
received one moderna vaccine and 1 pfizer vaccine he has about the same side effects with both; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (received one moderna vaccine and 1 pfizer vaccine he has about the same side effects with both) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (received one moderna vaccine and 1 pfizer vaccine he has about the same side effects with both). At the time of the report, IMMUNISATION REACTION (received one moderna vaccine and 1 pfizer vaccine he has about the same side effects with both) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Reporter son had received one moderna vaccine and 1 pfizer vaccine he had about the same side effects with both. Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2023: Live follow-up received include no new information.
Throat felt tight about 10 min p/inject; pt came in from parking lot, look faintly recvd Epi; tongue, lips & mough still felt tingly @ time of call;
Tinnitus/Ringing in ears; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus/Ringing in ears) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus/Ringing in ears). At the time of the report, TINNITUS (Tinnitus/Ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided. Patient also received Pfizer COVID-19 vaccine.   This case was linked to MOD-2021-348408.   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: No new information.
Tested negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Tested negative) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative.         Other concomitant medications include Blood pressure and cholesterol medications (not specified) No treatment details were provided.  Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to US-MODERNATX, INC.-MOD-2021-106786 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106786:Case for wife
calling for temperature evaluation for VARIVAX and notifed it was administered to multiple patients; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 27-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)(strength, dosing schedule, lot#, expiration date and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature from -14 Celsius degrees to -10 Celsius degrees for 4 hours 15 minutes. There was a previous temperature excursion noted: from -9 Celsius degrees to 8 Celsius degrees for 2 hours 21 minutes, as recorded by a digital data logger.   This is one of multiple reports from the same reporter.; Sender's Comments:  US-009507513-2007USA003458: US-009507513-2007USA005030: US-009507513-2007USA005031: US-009507513-2007USA005032: US-009507513-2007USA005033: US-009507513-2007USA005034: US-009507513-2007USA005035: US-009507513-2007USA005036: US-009507513-2007USA005037: US-009507513-2007USA005038: US-009507513-2007USA005039: US-009507513-2007USA005040: US-009507513-2007USA005041: US-009507513-2007USA005042: US-009507513-2007USA005043: US-009507513-2007USA005044: US-009507513-2007USA005045: US-009507513-2007USA005046: US-009507513-2007USA005047: US-009507513-2007USA005048: US-009507513-2007USA005049: US-009507513-2007USA005050:
Case number PHEH2014YS022091, is an initial spontaneous report from a consumer (patient) received on 03 NOV 2014. This report refers to a 58-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with intramuscular dose of FLUVIRIN 2014/2015 on 15 OCT 2014. On the same day, after vaccination, he experienced lower back pain. It was reported that the pain was tolerable during the day because he was otherwise preoccupied, however it worsens at night and he was unable to sleep well because of it. It has been persistent since the vaccination. Final outcome of the event of lower back pain was reported as condition unchanged and sleep disturbance as unknown. Seriousness and causality of the events was not reported.
Around mid-April 2021 I began to experience frequent bowel movements akin to diarrhea. I made an appt with my PCP on 5/12 and got an ultrasound. The doctor determined that I passed a gallstone. There was another small gallstone discovered which was causing sore stomach, dizziness and fatigue and bladder pressure. After visit stomach pain began to recede as did the other symptoms.
Patient was administered Moderna vaccine at roughly 5:45pm. An estimated 3 minutes  later, patient passed out briefly for about 10-20 seconds. Patient was hugging the father prior to passing out. Patient was held by father and no injury fall occur. Pharmacist assisted standing by. Patient opened her eyes and stated she didn't remember passing out. No signs of breathing issues were noted. No signs of external skin reactions , redness, or flushing was noted. Patient remained calm throughout process. No pain complaint. Patient requested water bottle to drink and was given as such. Patient was able to communicate verbally without issues. Patient was able to count to 10 in numerical order and answered simple questions without issues. Upon talking to the father, he stated that she doesn't like needles. Patient was able to walk without assistance, without pain, without any obvious issues. Patient left pharmacy and stated that she felt fine and ok. Pharmacist texted patient's mother that evening and mother said that patient was lying down and ok.
Height: Commented she has lost some inches; she tested Covid-19 positive after receiving the first dose; This is a spontaneous report from a contactable female consumer (patient).  A 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9267; Expiry date: unknown) via an unspecified route of administration, administered in arm left (left shoulder) on 24Feb2021 15:30 (3:30 PM) (at the age of 83-year-old) at a single dose for COVID-19 immunization. It was unknown if the reporter was a health care professional. It was unknown if reporter was the prescribing HCP. The patient's medical history included experienced sore arm (AEs following prior vaccinations: Stated nothing more than a sore arm with the Flu Vaccine (the patient always got this with the Flu Vaccine). It occurred with whatever part of arm got the injection in and it would hurt and bother her for a day or so). the patients concomitant medications were not reported. (Confirmed has no lot/Exp to provide). Patient received a call from HCP informed that on 04Mar2021, the patient tested positive for COVID 19. Patient is due to get her 2nd vaccine on 17Mar2021 and stated that she was in quarantine for 10 days. Patient asked whether the patient could still get her second vaccine dose on the 17th. Patient have been trying to get an answer to this question since 10:00 this morning. The reporter stated the patient has lost some inches of height which led to Body height decreased on an unspecified date. The patient did not visit physician office/emergency room. She mentioned she was at the doctor's office for a regular check-up and then it was discovered there she was positive for COVID. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. The patient underwent lab tests and procedures which included body height was she has lost some inches and Covid 19 was tested positive on 04Mar2021. The clinical Outcome for the events was unknown.  Follow-up (04Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient) reported that: historical vaccine (sore arm with the Flu Vaccine), product details (lot number: EL9267, anatomical location: left shoulder, vaccination time: 3:30 PM), event details (Covid-19 positive onset date: 04Mar2021, reported new event height: commented she has lost some inches), lab details (04Mar2021- tested positive for COVID) were added.  Follow-up (04Mar2021): This is a follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient): event verbatim (patient tested Covid-19 positive after receiving the first dose on 24Feb2021) was added. Medical Information (Live Operators Only): there were no unaddressed medical questions referred or forwarded to Medical Information.
occasional fever which was treated w/APAP (mom did not actually take temp) vomited x 1 first noc p/shots; no cough; no running nose until 22JUN; dec appetite x 5 days; fussy x 1 wk; afebrile x 4 days; no change in stools; did not see MD;
Left Arm pain and redness, extending to neck and sternum, Treated with antibiotics.
Patient described an intense burning sensation of the skin. He did not have a rash anywhere on his body and there was no redness as the injection  site. He described it as extremely painful to the point where it was uncomfortable to wear clothing and difficult to walk.
child was given 3 doses of Rotarix /Extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis.   On 21-OCT-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 21-OCT-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix /Extra Dose). The outcome of the extra dose administered 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 Information: GSK Receipt Date: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient, same reporter US-GSK-US2023AMR142498:different patient, same reporter US-GSK-US2023AMR142502:different patient, same reporter US-GSK-US2023AMR142500:different patient, same reporter US-GSK-US2023AMR142501:different patient, same reporter US-GSK-US2023AMR142496:different patient, same reporter US-GSK-US2023AMR142499:different patient, same reporter US-GSK-US2023AMR142512:different patient, same reporter US-GSK-US2023130319:same reprter, different patient
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 19-NOV-2015, patient received improperly stored VARIVAX dose 1, from batch/lot # L015045 (expiry date, dose units, route and anatomical location were not specified). Concomitant medication were not reported.  No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
24 hours later I experienced the following  Rash on inner upper thighs Rash  below the left breast on rib area Lathargy or Depression
Information has been received from a consumer concerning her granddaughter, a 14 year old female with a history of migraines who was vaccinated with the first dose of GARDASIL. There was no concomitant medication. Subsequently the patient developed a red rash and swelling. The patient was experiencing dizziness, muscle weakness, malaise, hot and cold flashes, vomiting, irregular menstrual periods and an increase in severity of migraines. The patient was more prone to illness. The patient's red rash and swelling and dizziness and muscle weakness and malaise and hot and cold flashes and vomiting and irregular menstrual periods and increase in severity of migraines and more prone to illness persisted. Medical attention was sought in the physician's office. No further information is available.
At 5 min after the administration, the rash started on the whole hand where the vaccine was administered, petechiae and his right hand fingers began to swell, then eyes started swelling, back with rash, had vomits. On the second had swelling of the face and dark color on the orbit of the eyes and red and yellow lacerations on the inside of the eye. In addition a lot of pain in the joints without being able to walk.
12Sep90 pt vax w/ 3rd hepta B. pt exp n/v, and sore arm. pt sx persisted for 2 days.
Pain of lower extremities; SHORTNESS OF BREATH; WEAKNESS OF THE UPPER ARMS; WEAKNESS OF LEGS; Chills; Fever; VIBRATION SENSE ON BOTH LEGS; Chest tightness; STIFFNESS/TIGHTNESS OF LEGS; This spontaneous report received from a consumer concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergies and no any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vibration sense on both legs. On 09-MAR-2021, the subject experienced chest tightness. On 09-MAR-2021, the subject experienced stiffness/tightness of legs. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F. On 16-MAR-2021, the subject experienced weakness of legs. On 23-MAR-2021, the subject experienced weakness of the upper arms. On 04-APR-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced pain of lower extremities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, chills, and fever on 10-MAR-2021, and had not recovered from vibration sense on both legs, shortness of breath, weakness of legs, weakness of the upper arms, stiffness/tightness of legs, and pain of lower extremities. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as Non serious.
Received RUBELLA vaccine 2 days post partum. After about 1 week, reports "rash", arthralgias, headache. Not going away. Rash appears to be urticarial. No other known cause.
p/vax pt exp bump & knot on arm (inj site); lasted one wk; pain in lt hip when standing; walks w/a limp; pain is intermittent;
arm soreness for 2 days after injection, lips swelling and numbness for couples hours on the second day after injection, consistent headache on second day, significantly decrease in breastmilk supply starting 2-3 days after injection and hasn't recovered (I'm breastfeeding my baby completely since birth in July 2020).
Patient experienced tinnitus four hours after injection.  The tinnitus occurred 24 hours per day and 7 days per week.  The volume fluctuated and was enough to interfere with level of focus and sleep.  Small seizure was experienced by the patient approximately 7 hours after second Moderna dose.
Open ulcers in her mouth, primarily under her tongue; Open ulcers in her mouth, primarily under her tongue; This case was reported by a physician via sales rep and described the occurrence of mouth ulcer in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. In September 2019, couple of days after receiving Shingrix, the patient experienced mouth ulcer and tongue ulceration. On an unknown date, the outcome of the mouth ulcer and tongue ulceration were resolved with sequelae.   It was unknown if the reporter considered the mouth ulcer and tongue ulceration to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient was over 65 years old.  The physician reported to a field representative that a patient developed open ulcers in her mouth, primarily under her tongue, a couple days after receiving Shingrix.  This occurred within the last month.  The physician did not want any follow up. The reporter did not consent to follow up.
Pain at injection site for 6 days, then on 7th day severe itching and fever with redness at injection site.  Took oral antihistamine, and rubbed site with cortisone cream
Information has been received from an obstetric technologist concerning a 24 year old female who on 23-JUN-2009 and 17-AUG-2009 was vaccinated with the first and second dose of GARDASIL (0.5ml, lot # 0947X) in her left deltoid respectively. On 18-AUG-2009 the patient experienced hives on chest, upper back and arms. On 22-FEB-2010, the patient did not present with rash, however still experienced transient rashes. The patient had sensitivity to "Tide" detergent. The patient did not intend to receive the third dose of GARDASIL. Additional information has been requested.
Buzzing type Tinnitus in both ears which has continued from the day of the first vaccine and has increased after the 2nd vaccine.
Very red inflated red spot here that doesn't seem to be going down; The spot is very hot, and very inflamed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Very red inflated red spot here that doesn't seem to be going down) and VACCINATION SITE WARMTH (The spot is very hot, and very inflamed) in a female 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.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Very red inflated red spot here that doesn't seem to be going down) and VACCINATION SITE WARMTH (The spot is very hot, and very inflamed). At the time of the report, VACCINATION SITE ERYTHEMA (Very red inflated red spot here that doesn't seem to be going down) and VACCINATION SITE WARMTH (The spot is very hot, and very inflamed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact