chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; Swollen lips; Tingle lips; This is a spontaneous report from a contactable consumer reported for herself. A 60-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration in arm right on 04Mar2021 at 08:00 (age at vaccination was 60 years) as single dose for COVID-19 immunization. The patient's medical history included drug hypersensitivity to penicillin and NASIDS from an unknown date. The patient have any known allergies. Concomitant medication included biotin and multi vitamin taken for an unspecified indication, start and stop date were not reported in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Mar2021 at 17:00, after the first dose the patient experienced rash, swollen lips and tingle lips. No treatment was received for the adverse events. On 17Mar2021 at 08:30 patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Arm Right and experienced Severe aches, pain, chills, fatigue and full body rash. The outcome of the events was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Following the administration of COVID vaccine, the patient reported she felt flushed, similar to when she had "hot flashes" per patient. Vital signs obtained: BP 224/110, 238/114;  HR 71, RR 20, SpO2 96% on RA, Skin WNL. Patient found to have a hypertensive episode. Patient stated she has a history of HTN and she self administered her prescription BP medication at 8:30AM. EMS contacted by paramedic. Patient evaluated by EMS and recommended to be transported by ambulance to hospital. Patient alert and oriented X4, GCS 15. Patient denies chest pain, denies shortness of breath, denies dizziness, denies abdominal pain. Patient refuses ambulance transport to hospital. Patient understood and signed all necessary documentation required for refusal of ambulance transport. Patient remained in medically supervised area of clinic for 30 minutes with no further reaction to the vaccine. Patient released to care of her husband. Patient advised to home monitor her BP and contact her PCP. Patient also advised to contact 911 if any changes occur.
Both MMRV and Varicella were given, medical director was notified and patient was contacted and notified of mistake. No adverse reactions to vaccines.
This spontaneous report as received from a physician refers to an unspecified number of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with COMVAX. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that unspecified patients may have received improperly stored COMVAX exposed to maximum 10C for multiple timeframes (on an unknown date). No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Presumed hair-grooming syncope on 10/18/21 - while patient's mother was combing her hair before school, patient started to fall forward, became pale, and then slumped backwards with legs limp and arms extended and shaking for no more than one minute. Afterwards she looked up at everyone and was able to answer questions appropriately. Patient remembers feeling nauseous while mom was doing her hair, but then then says she just felt like she went to sleep.
Rash consistent with erythema multiforme minor noted approximately 40 hour after vaccine administration. No other symptoms.
Left side of face - no muscle control, continues to today.  Rx for steroid, 3 pills qAM for 7 days.   Rx  - unsure of name, to be taken by  mouth  TID, for 6 days.  Antiviral med.
I continue to feel pain in my right arm. On about day 6 after getting the first dose my arm felt heavy and weak. I have not been able to use my right arm as much due to pain and weakness. I also have been getting sharp pains going down my arm, this happens randomly throughout the day.
I got a small rash on my face; This is a spontaneous report received from a contactable consumer or other non hcp. A 56-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of ad-ministration on 02Apr2021 (age at vaccination 56years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i got a small rash on my face on unspecified date in Apr2021. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Got breakthrough case of COVID 19, mild cough and congestion, malaise,  fatigue; took two home covid tests and both were positive, phoned my home health care facility and obtained prescription for Paxlovid which I started taking second day after onset of symptoms, Very mild symptoms persisted for 2-3 days after that, recovered with no residual effects
The patient felt tired tired after second dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (The patient felt tired tired after second dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced FATIGUE (The patient felt tired tired after second dose). At the time of the report, FATIGUE (The patient felt tired tired after second dose) outcome was unknown.            The patient received her second Moderna Covid-19 vaccine dose in her left arm shoulder deltoid muscle. No treatment information was provided by the reporter. No Concomitant medicines were reported.   This case was linked to MOD-2022-439232, MOD-2022-439271 (Patient Link).   Reporter did not allow further contact
Intense itching and rash above my heels on both feet for 5 days, rash still present but the itching has subsided.
Vaccination was administered to patient in the left deltoid. As vaccinator was injecting, an unmeasurable amount of solution leaked out from the injection point and dripped down the patient's arm. Patient did receive some amount of the vaccine but cannot determine how much was actually given and injected. Patient was sent home but after receiving information from Moderna to re-administer the first shot, patient was rescheduled for a new first dose appointment. Patient experience no side effects from this occurrence.
Pfizer Sars-cov-2 Vaccination 6 mos - 4 y.o, Given 1 day before 6 month mark.
Fever/chills/headache and muscle aches. Treated with Tylenol. Symptoms resolved by morning.
It all started on 12/09/2022, with nausea, retching, and severe vomiting. I went to the emergency room where they tested for Flu, RSV, and COVID-19. They called me the next day to tell me that my COVID-19 PCR was actually positive. In the emergency room, I was having abdominal pain as well. I think I also had a fever. They also did chest X-rays, an EKG, an ultrasound of my gallbladder, CAT scan of my abdomen and pelvis, and a lot of blood work. They found that I was septic. 12/09/2022 to 12/23/2022, I was in the emergency room four time and was admitted to the hospital three of those times for treatment. My second visit to the emergency was on 12/11/2022, where they did more testing. I was admitted for treatment and more at that time. 12/13/2022, I had more X-rays and a CAT scan on my chest which showed blood clots in my lung. They said it was probably due to COVID-19. I also had another EKG. I was released from the hospital on 12/23/2022. I've been doing ok since then. I've had a follow up with my primary care physician who said there were no problems. I have also seen my cardiologist who changed a dosage on one of my medications but that I was doing well. At one point while in the hospital, I developed an abnormal heart rhythm which I have never had before. They thought that was also due to COVID-19. My heartrate went up to 140 beats a minute.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient (the nurse's daughter) of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of TRUMENBA and experienced site reaction and fever. The patient experienced loss of vision, she felt like she passed out and experienced dizziness on an unspecified date. The outcome of the events was unknown.
Patient received .25ml of Moderna vaccine rather than the .5ml vaccination she should have received. Patient received the other half of the full dose (the second .25ml) the following day.
2-day history reported of headache and myalgias primarily leg pain bilateral with office visit on 2/11/2021; subsequent rash 2/12 compatible with shingles right T10 dermatome
Information has been received from a certified medical assistant concerning a 26 year old female patient who on 15-APR-2008 was vaccinated with a first dose of GARDASIL (no lot # provided).  Concomitant therapy included YASMIN.  The patient experienced a hives outbreak 10 days after the first dose was given.  The patient sought medical attention through speaking with the medical assistant.  No further information was available from the medical assistant.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Headaches, body aches, fever (over 101 degrees), fatigue. Fever lasted one day, headaches and body aches for a couple of days, fatigue for 3 days (and counting)
Headache like flu; Headache like flu; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache). At the time of the report, INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported.  No treatments were reported.   This case was linked to MOD-2021-286293, MOD-2021-024366, MOD-2021-024366, MOD-2021-329115, MOD-2021-329194, MOD-2021-329313 (Patient Link).
Chest pain, headache, red dots around the knee,  sweats chills,  temp 104.4, lasted about 36 hours, Pain in sciatica,  Following Wednesday woke up with severe pain in the post op left knee. Following Sunday broke out in a rash left breast, rib cage.  Went to Dr. for the rash and was DX with Shingles.  Patient is now on Valacyclovir 1mg tab every 12 hours for the shingles. Gabapentin for pain. Had 1st vaccine 9/18/2020
This spontaneous report as received from a health care professional refers to multiple unspecified patients of unknown ages and genders. The patients' medical history and concurrent conditions were not reported. On unknown dates in July-2017 (reported as 'in the week of 24-JUL-2017'), the patients were vaccinated with improperly stored ROTATEQ (lot # M041181, expiry date: 31-MAY-2018) (route: oral) (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F (34.4 F) for 15 minutes. The vaccine did not underwent previous temperature excursion. Digital data logger was involved. No other adverse effects reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA001258:
3 doses of PROQU AD were administered to patients at unknown times following a temperature excursion; No additional adverse events or any product quality complaints were reported; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown gender and age. The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (strength was not reported; dose: 0.5 ml, injected, once, lot # was T023918, expiration date was reported as 09-JAN-2022) for prophylaxis following a temperature excursion (product storage error). The previous temperature excursion was 18 Fahrenheit (F) for 1 hour 30 minutes. Temperature was 5.68 F with a time frame of 5 minutes. Digital data logger was involved. No additional adverse events or any product quality complaints were reported in this case.  This is one of 2 reports received from the same reporter.
Two days after the third dose of Prevnar, the pt presented with fever-S. pneumoniae bacteremia and meningitis. Sample to CDC for serotyping.
This case was reported by a physician and described the occurrence of hepatitis B antigen positive in an infant subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). One day after vaccination with ENGERIX B, the subject was tested for hepatitis B antigen and the result was positive. At the time of reporting the outcome of the event was unspecified. No further details were provided. It was reported that this event occurred in 4 infant subjects from different hospital facilities. Linked cases include A0942894A, A0942898A and A0942900A.
This case was reported by a nurse via sales rep and described the occurrence of swelling in a 75-year-old female patient who received Shingrix for prophylaxis. On 9th July 2018, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were recovered/resolved. It was unknown if the reporter considered the swelling and erythema to be related to Shingrix. Additional information received as follows: The age at vaccination was not reported. No other vaccines were given at the same time of Shingrix vaccination. The patient experienced swelling and redness expanding 3 to 4 inches for an estimated 4 to 5 weeks. The patient was instructed to apply compresses to the swelling. The reporter agreed to follow up from GlaxoSmithKline.
Left arm swollen, red, warm hard. Hard red circle below site where given. Swelling started 3/14/07. Still swollen 3/16/07-worsened x 2 days.
Throat tightness, cough, phlegm then bronchospasm hours post vaccine dose.
Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.
Pain/soreness at injection site, followed by body aches, headache, flu-like symptoms overnight.
Redness, itching, warm-to-touch; beginning the evening of the day of vaccination and becoming progressively worse over 24 hours. Self-treated with diphenhydramine oral.
Discharge Provider: DO Primary Care Provider: MD Admission Date: 5/2/2023 Discharge Date: 5/9/23   PRESENTING PROBLEM: AKI (acute kidney injury) (HCC) [N17.9]   HOSPITAL COURSE: 64  Yo male 3 months  s/p bilateral lung transplasnt for COPD presented with complaints of worsening diarrhea. He was sent initially to OSH  ER and found to have profound neutropenia, anemia, AKI with metabolic acidosis and hyperkalemia. CT thorax with new tree-in-bud opacities in RLL. Found to be Covid +. He was transferred to hospital for further management. A bronchoscopy was completed upon admission given CT changes which was positive for staph aureus. Patient was treated with 10d of abx, initially ancef then cefuroxime on dc. Additional his film array was positive for COVID. Given ongoing diarrhea symptoms which was thought to be related to COVID, treatment with remdesivir was completed.  Regarding his severe AKI, this was felt to be likely from a combination of dehydration from diarrhea as well as severely high tacrolimus level also likely from diarrhea symptoms. Tacrolimus was held. AKI resolved completely after initiation of IVF and holding offending agents. Eventually tacrolimus was resumed without issue once kidney injury had resolved  In addition to the AKI patient was severely neutropenic and anemic. He was given 1u RBC and hematology was consulted. After testing it was determined the cause was likely bone marrow suppression from toxic levels of his valcyte and tacrolimus. Patient was given 3 doses of neupogen inpatient and neutropenia recovered. Valcyte was eventually resumed 5/8 after CMV level was checked which was 0. For his anemia, EPO was given 5/7 and hemoglobin remained stable after 1u RBC. Stool occult blood was found to be positive but given stable hemologobin and known colitis on CT which can cause positive occult blood, further GI workup was not completed but this will be followed closely as an outpatient.  Patient was discharged home in stable condition with plans to get outpatient labs 5/11 and be seen in clinic next week.
15 hours after 2nd dose vomiting, intense pain over 3 days, swelling, redness, itching, lump at site, numbness and tingling, low body temp, profusely sweating
generalized itching; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RINVOQ for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RINVOQ (Oral) at an unspecified dose. On 01-Apr-2021, the patient experienced PRURITUS. On 13-Apr-2021, PRURITUS had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Additional information received on 03 Jun 2021 had no new information. On 27-Jul-2021: Follow-up contains No New Information.
patient received 0.2 ml of the vaccine and 0.1 ml of the vaccine was wasted; syringe got stuck; This is a spontaneous report from a contactable other HCP. A elderly female patient with unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated each vial was supposed to produce 6 doses of the vaccine and used syringes such as drop safe 3 ml 23 gauge by 1 inch syringe she only got 5 doses and not 6 doses. Caller would like to know if she could get reimbursed for the lack of dose from each vial? During the administration of the Pfizer COVID vaccine to a patient the syringe got stuck and it is estimated that the patient received 0.2 ml of the vaccine and 0.1 ml of the vaccine was wasted. The outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 35 year old female patient with no medical history reported, who on approximately 01-APR-2008, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL.  On 19-MAY-2008, "approximately two weeks ago," the patient developed redness, swelling, pain and heat at the injection site after receiving her second dose.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
blacking out; Nausea; dizziness, feeling woozy and faint; This is a spontaneous report from a contactable consumer who reported for herself, a 37-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3248), via an unspecified route of administration, administered in the left arm on 24Mar2021 at 12:30, at the age of 37 years old, at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL) and paracetamol (TYLENOL). The patient previously received the first dose of BNT162B2 in the left arm (Lot number: EL3248) on 02Mar2021 at 10:00 AM, at the age of 37 years, for COVID-19 immunization. The patient experienced nausea, dizziness, feeling woozy and faint as well as blacking out, all on 25Mar2021 at 08:00. The events were reported as non-serious. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19, and has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.
patient received an incomplete dose of Fluarix since it leaked; have not attached the needle correctly causing the leakage; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   On 03-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 03-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced incomplete dose administered (Verbatim: patient received an incomplete dose of Fluarix since it leaked) and wrong technique in product usage process (Verbatim: have not attached the needle correctly causing the leakage).  The outcome of the incomplete dose administered and wrong technique in product usage process were 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: 3-Oct-2023 No patient/vaccines identifiers were available. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. The patient received an incomplete dose of Fluarix since it leaked (they had not attached the needle correctly causing the leakage), which led to incomplete dose administered and wrong technique in product usage.