chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vertigo; had to hold on to the walls & has had to crawl at times; vaccine has caused biologic changes to his body; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), BALANCE DISORDER (had to hold on to the walls & has had to crawl at times), VACCINATION COMPLICATION (vaccine has caused biologic changes to his body) and DIZZINESS (dizziness) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo), BALANCE DISORDER (had to hold on to the walls & has had to crawl at times), VACCINATION COMPLICATION (vaccine has caused biologic changes to his body) and DIZZINESS (dizziness). At the time of the report, VERTIGO (vertigo) and DIZZINESS (dizziness) had not resolved and BALANCE DISORDER (had to hold on to the walls & has had to crawl at times) and VACCINATION COMPLICATION (vaccine has caused biologic changes to his body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported.  Patient had not taken second dose of vaccine.
Severe diarrhea; To the point of extreme dehydration; This is a spontaneous report received from a contactable consumer (patient).  A 34-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 22Apr2021 15:00 (Batch/Lot Number: EW0161; Expiration Date: 31Jul2021), age at vaccination of 34-years-old, as single dose,for covid-19 immunisation. The patient medical history was not reported; patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 17:00 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) for covid-19 immunisation. The patient had no allergy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced non-serious severe diarrhea and non-serious extreme dehydration, both on 23Apr2021 06:00 AM. No treatments were administered. Facility where the most recent COVID-19 vaccine was administered: Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events.  No follow-up attempts are needed. No further information is expected.
On 4/9 had sore left arm and fatigue, side effects lasted throughout the day and resolved. 4/13 woke up with bad nausea and headache (6/10 pain) stayed in bed and did not go to school, woke up 11 am and headache/nausea started to resolve throughout the day.
Moderna given to under age person. Mother present and aware. She will get Pfizer for her next dose
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, route and lot were not provided). No adverse effects reported. This is one of several reports received from the same reporter.  Additional information is not expected, because is not possible contact the physician.
This is a spontaneous report from a contactable medical assistant on behalf of a physician via a Pfizer sales representative. A patient of unspecified age, race, ethnicity and gender received TRUMENBA at single dose via an unspecified route of administration in Jul2017 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced pain/ a lot of pain at the injection site and tennis ball sized lump at the injection site in Jul2017. No treatment was needed. The patient recovered on an unspecified date in 2017.
It was reported that a 4 year old male pt received vaccines on 11/8/99. 36 to 48 hours, post vax, the pt developed local erythema and tenderness. From additional information received on 12/14/99, it was reported, "Reviewed, no additional information at this time."
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medication and concurrent conditions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 from lot # M037770 with expiry: 01-JUN-2019.  No adverse effects reported. The vaccine was exposed to a temperature of 35 degree Fahrenheit for 20 minutes. It also had 3 previous temperature excursion of 35 degree Fahrenheit for 20 minutes each. The temperature excursion was detected by digital data logger. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received from a medical assistant. The patient's identifiers were provided. This report refers to a 15-year-old patient of unknown gender, who on 25-JUL-2017 was vaccinated with a dose of improperly stored GARDASIL 9 lot # M037770, expiry date: 01-JUN-2019 for prophylaxis. The reporter confirmed the temperature excursions on 12-JUN-2017 at 8:00 am and 13-JUN-2017 at 8:00 am. On these days, the temperature in storage unit dropped down to 35 degree Fahrenheit for about 15 minutes each day. The minimum temperature was reported as 35 degree Fahrenheit on both days and maximum temperature 41 degree Fahrenheit on 12-JUN-2017 and 43 degree Fahrenheit on 13-JUN-2017, room temperature when discovered was 72 degree Fahrenheit on both days. The reporter contacted manufacturer, they were able to use vaccines, she adjusted the temperature on the storage unit, there had been no other problems. It was also reported that GARDASIL 9 was improperly stored before with cumulative timeframe of 32 to 35 degrees Fahrenheit for 1 hour and 20 minutes. This is one of a few reports received from the same reporter.; Sender's Comments: US-009507513-1707USA007096: US-009507513-1707USA007097: US-009507513-1712USA010536: US-009507513-1712USA010548: US-009507513-1707USA005936:
Received the first dose of COVID-19 immunization on 8.15.22 - four hours after receiving dose - minor developed hives all over her trunk and both upper and lower extremities. Minor strongly denies any respiratory distress. Minor states that she felt itchiness all over her body.  Minor took Diphenhydramine 25 mg and after one hour of taking it symptoms completely subsided.
days after receiving the vaccine my arm  had a 1/4 to 1/2 in raised area about the circumference of an orange around the injection site. Was also red and very warm to the touch. Dr ordered Keflex 2x per day. Today, Monday, the swelling is down, less pain an the warm skin has gone away.
Information has been received from the office manager concerning a 20 year old female with no pertinent medical history and no drug reactions / allergies who on 13-JUL-2009 was vaccinated with the first dose of GARDASIL (lot # 662300/0100Y) 0.5 mL, IM. Concomitant therapy included SEASONIQUE. On 13-JUL-2009, a few hours after vaccination, the patient experienced rash and hives on her chest, abdomen and extremities as well as itching and tingling. The patient was evaluated at a local emergency room and was prescribed BENADRYL and prednisone. The patient called the office on 03-SEP-2009, and relayed that the hives have resolved but the rash is persistent. The patient was referred to an unspecified dermatologist for evaluation. At the time of the reporting, the patient had not recovered from itching and tingling. Follow-up information was received from the office manager who reported that the student patient was vaccinated on 13-JUL-2009, with the first dose of GARDASIL (lot # 662300/0100Y) into the right deltoid. On an unknown date (previously reported as "a few hours after vaccination") the patient experienced rash and hives on chest and abdomen and extremities, tingling and itching. The patient required emergency room/doctor visit and was started on prednisone by emergicenter. No further information is expected.
Pt recvd vax DEC92 & devel sx of transverse myelitis; eval revealed lesions on thoracic & cervical spine; dx w/MS; MRI of the brain revealed small periventricular changes not a typical of MS;
1/12 vaccination 1/13  swelling and pain at injection site.  Admitted for 4 days.
Pain was just killing me/Body aches; Extreme headache to migraine; Extreme headache to migraine; Experiencing fever of 99.6 yesterday, this morning I am experiencing 99.5; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0181 and Expiry date: Unknown), via an dose 2 intramuscular, administered in Arm Right on 20Jun2021 08:40 (at the age of 22-years-old) as Dose 2, Single for Covid-19 immunization.The patient medical history was not reported. Concomitant medication(s) included ergocalciferol (VIT D) taken for an unspecified indication from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Jun2021, after 6 days of vaccination, the patient experienced pain was just killing me, extreme headache to migraine, experiencing fever of 99.6 yesterday, this morning i am experiencing 99.5, body aches. Therapeutic measures were taken as a result of pain was just killing me (pain) treatment included: took Ibuprofen 400 mg, 2 tablets, so they were 200 mg per tablet, but I took 2 because the pain was just killing. The outcome of events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
"left arm increased redness and pain and 4 inches in circumferernce, with soreness and pain with movement or touch"
seizure like violent tremors in the middle of the night.; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received second dose of BNT162B2 [PFIZER-BIONTECH COVID-19 VACCINE (also reported as MODERNA; pending clarification), solution for injection, lot number and expiry date were not reported], via an unspecified route of administration, administered in the left arm on 25Mar2021 13:00 (at the age of 39 years old) at a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient experienced seizure like violent tremors in the middle of the night on 26Mar2021 04:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications received within 2 weeks of vaccination. The outcome of the event was recovering.  Information on the batch/lot number has been requested.
Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 03-Nov-2021 at 3:24 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 81.65.  No concomitant medications were reported.  The vial was initially moved to the fridge on 05-Oct-2021 and proposed beyond use date was 05-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 11.00 A.M., the temperature recorded was 35 degree Fahrenheit and that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. Vial was stored on cooler 1 ,Excursion duration At 8AM: 36 9 AM: 36, 10 AM: 36, 11 AM: 35, 12 AM: 36, 1PM : 37, 2 PM : 36, 3 PM: 36, 4 PM: 37 and 5PM: 42.   No treatment information was provided.
Headaches in the morning at he time of waking up. Lingering headaches through out the day Fatigue chest pains for the last 3 days
Upper arm very sore, redness, welt, swelling spreading to all upper arm hot to touch. Antibiotics: cephalexin 500 mg for 10 days (4 capsules a day) elevate arm, ice pack. Doctor at Urgent Care identified it as cellulitis infection.
Discharge Provider: Private MD Primary Care Provider: Private MD Admission Date: 8/23/2022 Discharge Date: 8/25/2022  Clinical Narrative: The patient is 49-year-old with advanced cirrhosis who is being seen at the local hospital and at the transplant center for hopeful eventual entry into a transplant program for hopeful eventual candidacy. He has 7 months of sobriety from alcohol under his belt at present. He was noted to be significantly hyponatremic. He may have had some mild confusion with this foot likely has grade 1 hepatic encephalopathy as well. He was noted to be grossly edematous with anasarca from decompensated acute on chronic cirrhosis without actual coma. He was diuresed accordingly with improvement in his serum sodium and clinical exam. He did not require other interventions. He was noted to have suffered from COVID recently but is improving and just beyond the dating were PACs lobe it may have been indicated. This continued to do well. He is being discharged home today with the caveats that he is requesting early discharge as he is in the process of being evicted from his apartment. Have asked him to seek repeat labs within 1 week.
painful shingles; Information has been received from a lawyer referring to a female (also reported as male, inconsistent information) patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 01-NOV-2018, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequent to the zoster vaccine live (ZOSTAVAX) vaccine being administered, the patient developed an outbreak of skin rash on her upper right thigh on 28-NOV-2018. On the same date, the patient was diagnosed with painful shingles by her physician. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had 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 her 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 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. The patient also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the patient. The outcome of painful shingles was considered as not recovered and causal relationship was assessed as related.  The event painful shingles was considered as disability by the lawyer.
Information has been received from a Nurse Practitioner concerning a female who was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL vaccine (yeast) (lot # not reported). Subsequently the patient developed severe and prolonged arm pain in the same arm that the vaccine was administered. The pain lasted for a period of two weeks. the patient sought unspecified medical attention by speaking to nurse practitioner. Subsequently, on an unspecified date, the patient recovered from the severe and prolonged arm pain. Additional information has been requested.
arm slightly swollen; soreness in the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm slightly swollen), INJECTION SITE PAIN (soreness in the injection site) and FATIGUE (fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm slightly swollen), INJECTION SITE PAIN (soreness in the injection site) and FATIGUE (fatigue). At the time of the report, PERIPHERAL SWELLING (arm slightly swollen), INJECTION SITE PAIN (soreness in the injection site) and FATIGUE (fatigue) outcome was unknown.            Reportedly, Patient and his partner received the third dose. Patient thought he had pain because had moved a big piece of antique furniture a night before.  Concomitants included HIV medication, Blood thinner medication, Chronic pancreatitis medication and Blood pressure medication.  Patient gave affirmative consent to follow-up with Safety Team.  No treatment medication was reported.   This case was linked to MOD-2021-308689, MOD-2021-308626 (Patient Link).
Syncope with stiffening and jerking of left leg. Brief episode one minute not longer than two client was confused as to what had happened. No treatment was needed.
Approx 5 minutes after receiving vaccine pt stated "I don't feel good". Her head tilted forward and she lost consciousness while being supported by nurse. Became cyanotic O2 applied wake up with fatigue.
patient was suppose to receive the Pfizer paedriatic bivalent but the patient received Pfizer paedriatic original dose. patient parent already informed.
Right arm has not been the same/can barley lit right arm to forehead without it hurting/right arm is uncomfortable/walks with right arm against chest to help with the uncomfortable arm; Painful and at night he sleeps on his side to avoid laying on the affected arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Right arm has not been the same/can barley lit right arm to forehead without it hurting/right arm is uncomfortable/walks with right arm against chest to help with the uncomfortable arm) and PAIN IN EXTREMITY (Painful and at night he sleeps on his side to avoid laying on the affected arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LIMB DISCOMFORT (Right arm has not been the same/can barley lit right arm to forehead without it hurting/right arm is uncomfortable/walks with right arm against chest to help with the uncomfortable arm) and PAIN IN EXTREMITY (Painful and at night he sleeps on his side to avoid laying on the affected arm). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (Right arm has not been the same/can barley lit right arm to forehead without it hurting/right arm is uncomfortable/walks with right arm against chest to help with the uncomfortable arm) and PAIN IN EXTREMITY (Painful and at night he sleeps on his side to avoid laying on the affected arm) had not resolved.      No concomitant medications were reported.  It was reported that the symptoms were intermittent.
Routine hospital follow up 1. COVID-19: complete course of decadron, end date 1/12/23. 2. Acute CHF- Initiated lasix 20mg BID on discharge. 3. AKI- Holding home ARB at discharge. Repeat BMP in 1 week given initiation of lasix.   Clinical Summary 1. Recurrent COVID-19 Infection: Vaccinated x4, had COVID in 11/2022 (then negative testing) and now (+)1/3/22, no Remdesivir given symptoms present > 1 days, continued 10 days of Decadron end 1/12/23. Out of isolation 1/14/23. 2. Acute HFpEF: New diagnosis,  Admit CT-Chest: Diffuse pulmonary edema and bilateral pleural effusions. Held home ARB-hydrochlorothiazide, added IV Lasix 1/6/23. TTE 1/6/23 EF 65% with Grade-2 diastolic dysfunction. Transition to PO lasix at discharge.   3. Acute hypoxic respiratory failure: Secondary to COVID-19 pneumonia and CHF. Required 5L nasal oximyzer on admit, weaned to 2L NC by 1/6/23  4. AKI: Baseline Cr ~0.7-0.8, admit Cr 1.3. likely cardiorenal and COVID. Held home ARB. Repeat BMP as OP in 1 week.  5. Elevated troponin:  demand ischemia from COVID and CHF 6. UTI: Thought to be present on admit, ruled out 1/6/23  7. CAD: Continued home ASA/statin/BB.  8. HTN: Continued home amlodipine and Coreg.  Held home Hyzaar. 9. T2DM: with steroid induced hyperglycemia. A1c 7% (1/6/23) added Lantus and SSI 1/6/23. Continued home metformin at discharge.  10. Code status: DNR-CCA, confirmed with son