chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from Other health professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298622, 2018SA298644, 2018SA298649, 2018SA298631, 2018SA298611, 2018SA298692, 2018SA297575, 2018SA298495 and 2018SA298603, same reporter. This case involves Elderly patient (gender unknown) who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AB, expiry date 20-Jun-2019 via intramuscular route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that there was possible temperature excursion, the staff was unaware that the temperature report from the refrigerator showed that the FLUZONE HD was frozen at some time. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
This is a spontaneous report from a contactable consumer (patient). A 52-year-female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8734) via an unspecified route of administration on 20May2021 (at the age of 52-years-old) as 2nd dose single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date in Apr 2021 for COVID-19 immunization. On unknown date (reported as after second dose), the patient had an allergic reaction on her skin and had to go to the emergency room. A week after her second dose (exact date unknown), the patient felt a pain in her chest and a rash next to the chest. Rash was a little better but the same rash she was on her body, she was now seeing on her fingers. On an unknown date, three weeks ago, went to the emergency room. Before she went to the emergency room patient went to urgent care and went twice and because she felt something like temperature and something coming up to her brain. Patient was treated with steroids and cortisone for rash. The treatment medication has affected her stomach, hairs falling out, and her skin was dry- clarifies the medication they gave her for the rash. Reporter seriousness for allergic reaction on her skin, rash on chest, pain in chest was unspecified. The outcome for all events was not resolved. Follow-up attempts are needed. Further information is expected.
I have a double kidney infection after my vaccine. I went to the ER, they did a urine sample and also did a microscopic culture. They also started me on antibiotics and fluids and then sent me home with a medication that turned my pee orange. I am still having my symptoms today and will touch base with my PCP. I have a lot of pain in my back and I thought I had a kidney stones and all my lower back is swollen from the infection.
On 08/06/2013 I had chills, fever (39.9 C), hematoma (unable to lift up my arm) on the injection site. Took the following medications, Hydrocodone and Tylenol. I did not attend work for 2 days due to the pain.
Nausea; tiredness; leg cramp; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 13Apr2021 at 12:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included fibromyalgia, tachycardia, dysrhythmias. The patient's allergies included sulfonamide allergy, penicillin allergy, pollen allergy, amoxicillin allergy, dairy allergy, grass allergy, trees allergy and mold allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 16:30 the patient experienced nausea and tiredness and leg cramp. The patient had the worst leg cramp from the top of the leg right up into the groin, they continued all the way down to my ankle. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. The patient did not receive any treatment for the adverse events. The clinical outcomes of the events nausea and tiredness and leg cramp were recovering at the time of reporting.   No follow-up attempts are possible. No further information is expected.
Starting on morning of Day after vaccine, experienced very SEVERE fatigue, headache, and nausea. Also low grade fever with sweats and mild sore throat.  Arm was mildly sore at injection site for several days.  Headache and fatigue continued for three full days. On 5th and 6th day after vaccine, had diarrhea.  Was told by doctor at vaccine event not to take any anti-inflammatories for 3 to 5 days.  He said Tylenol was ok.  Took Tylenol day after vaccine when adverse effects were the worst and it did not help at all.  Finally took Advil on day 4 and it relieved headache.  Now 7 days after vaccine still have intermittent headache.
Swollen arm, throbbing pain with swelling in shoulder up into my neck region on the right side where the shot was given.  The pain is getting worse as the days go by - weird I know.
Pt recv vax on 9/21/98; on 9/22/98 pt exp local rxn, fever, nausea, malaise, arthralgia
NKA from patient. Patient in at 1553 and out at 1608. Hx of chronic rhinitis and asthma. Patient presented with vitals of 163/105, HR 67, SP02 94% (sitting). VS at check out were 145/88, HR 64. Patient reported with hunger, flushed, diaphoretic, and pale. there was no SOB or dizziness reported. Patient provided juice and snack. Patient returned to normal and released.
Subsequent to receiving one dose of varicella virus vaccine live in April, 1998, the pt experienced a rash on 4/26/99. The rash was not believed to be extensive. No further information is available.
when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots; when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FD0809), via an unspecified route of administration in right arm on 14Sep2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included amlodipine taken for high blood pressure; losartan taken for high blood pressure. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217), via an unspecified route of administration in right arm on 24Aug2021 (at the age of 45-years-old) as dose 1, single for COVID-19 immunization and experienced menstrual cycle has been unbalanced; It has been on and off and menstruation was three weeks delayed. The patient experienced when menstrual cycle came on 10Sep2021, it was like a light period and then today it was like a normal period, heavy cycle with heavy blood clots on 27Sep2021. It was reported that patient received second dose of Vaccine on 14Sep2021 but ever since she received the first dose, her menstrual cycle has been unbalanced. It has been on and off. So, basically, she got the first vaccine on 24Aug2021, the same day when her menstrual cycle was about to start, and it was three weeks delayed. And then when it did come, it was not a normal cycle. Like normally her cycles are heavy but they were light. The cycle was started on 10Sep2021. And on the day of this report, it was like a heavy cycle with heavy blood clots. So, it was like starting like the first day of menstrual. Patient talked to the doctor on the day of this report, and today patient should monitor it for 7 days and so, she said that it sounds like it is just starting like a fresh menstrual. So, patient will wait for 7 days and if still is happening then patient need to come and re-seen and then if she is using more than like a pad or the tampons fill with up the blood within an hour. Then patient need to go to the urgent care of the hospital. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
chest pain; tachycardia; cold sweats; shakes; This is a spontaneous report from a contactable other health professional. A 20-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 20-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Batch/Lot number was not reported) administered in arm left on an unspecified date for COVID-19 immunisation. The patient ended up in the hospital with chest pain, tachycardia, shakes and cold sweats, 5 hours after receiving second dose. The patient underwent lab tests and procedures which included SARS-COV-2 test: unknown results on an unspecified date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of chest pain, tachycardia, shakes and cold sweats due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
10 minutes post-vaccine.  Tingling throat and tongue, tongue was mottled.  Elevated heartrate and blood pressure.  Due to heartrate and elevated pulse, epi-pen was not used.  Claritin pills were administered and I waited 30 additional minutes until blood pressure and heartrate/pulse came back down.
A few hours after receiving the 2nd dose, my toes on my right foot became tingly (pins/needles feeling). It?s the feeling when a part of your body falls asleep but only in my right toes. It has not gone away since receiving this vaccine.
Patient stated developed painful red spot on forehead that was oozing and draining day after ZOSTAVAX vaccine given. She claims it was a shingle. But not diagnosed by a physician.
Unsteady - 2 staff members accompanied resident to ambulate, resident was immediately lowered to sitting position in chair as resident experienced a change in LOC- approx. 5 sec. T- 99.3 O2 at 90% and pulse 44. Regained orientation X 2, began vomiting and diarrhea,. 911 transported to hospital, Family aware
itchy eyes; This spontaneous case was reported by a pharmacist and describes the occurrence of EYE PRURITUS (itchy eyes) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PRURITUS (itchy eyes). At the time of the report, EYE PRURITUS (itchy eyes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided
On May 27th 1999 the pt experienced chicken pox, very mild with 12-15 lesions so far. The pt was treated with diphenhydramine hcl and colloidal oatmeal.
Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). It was reported that the patient got the ZOSTAVAX (Merck) shot and then got shingles, but much less severe outbreak. It was unknown if the patient had shingles before or if the severity was based on shingles in general. At the time of reporting, the patient's status was not provided. Patient sought unspecified medical attention. Additional information has been requested.
was on the phone then loss conscious and collapsed; was on the phone then loss conscious and collapsed; This is a spontaneous report from a contactable consumer(patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EP7534) via an unspecified route of administration into the left arm on 20Mar2021 08:30 as single dose for COVID-19 immunisation. Medical history included heart disorder and blood pressure abnormal. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EN6203) via an unspecified route of administration into the left arm on 26Feb2021 02:30 PM as single dose for COVID-19 immunisation. On 21Mar2021 12:00, patient was on the phone then experienced loss conscious and collapsed. The patient was brought to the emergency department and was given treatment (unspecified). Outcome of events recovered on an unspecified date.
Information has been received from a nurse concerning a 129 year old female patient who was vaccinated with the first dose of GARDASIL vaccine (no lot # provided) intramuscularly. "Patient received two other unspecified vaccines in her opposite arm". Subsequently the patient experienced pain underneath her arm and into her chest. Subsequently, the patient recovered from pain underneath arm and pain into her chest. patient sought unspecified medical attention. At the time of the report the patient's symptoms had resolved. Additional information has been requested.
Patient was hospitalized on 11/11/2021 with weakness, urinary frequency, and dizziness. Patient tested positive for COVID-19 in the ER.  Patient did not have a fever when he presented to the hospital but his daughter said he could have potentially has one at home. This was not confirmed with a thermometer. The patient was admitted to the COVID Med floor (not critical care) for observation.
woke up next morning with hearing loss....in one ear and pressure in both....tried ear drops, nothing happened
Patient started with small bump last pm and woke up this morning with large welts on most of her body.
pt began crying, held head @ temples, t103.4 ax, leg swollen & red @ site of inject; pt crying & irritable, settle down @ 11PM was given APAP every 4 hrs p/initial inject; awoke between 1AM & 2AM; projectile vomiting;
covid test result: Positive; covid test result: Positive; dry cough; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from regulatory authority.  An adult male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 03Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "covid test result: Positive"; COUGH (medically significant) with onset 12Jan2022, outcome "unknown", described as "dry cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive. It was unknown if therapeutic measures were taken as a result of covid-19, cough.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events and cough The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Narrative:  COVID positive following COVID vaccine 04/08 COVID vaccine dose 05/18 symptoms began: confusion, headache, and fatigue 05/19 presented with symptoms after exposure to COVID positive co-worker, tested positive, symptoms: cough, fatigue, headache, loss of taste or smell, myalgia 05/22 same symptoms with addition of fever and infrequent dyspnea 05/23 reports productive cough, fatigue, loss of appetite, fever, myalgia 05/24 reports diarrhea, cough (improving), fatigue (improving), afebrile, myalgia, feels better today
This spontaneous report as received from a licensed vocational nurse refers to an unknown number of patients of unknown age and gender. The patients medical history and concurrent conditions were not provided. On unknown dates since 23-JAN-2015, the patients were vaccinated with ROTATEQ, per oral (lot # and expiration dates were not provided). Concomitant medication information was not provided. On unknown dates since 23-JAN-2015, the patients had been administered ROTATEQ which underwent supported temperature excursions. No adverse effects were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Broke out in "hives all over" at 3:00 AM. Was given Benadryl with good effect.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 34-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was an internal medicine manager.  Concomitant medication of the patient was not reported.  The reporter reported that because their facility had not been able to download the digital data logger, they had been put on hold at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the state was made. There had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, this issue was treated as a temperature excursion. The reporter was unable to download the data logger for the months of December 2021, January 2022 and February 2022. The reporter was filling out a temperature excursion assessment.  The reporter mentioned that the patient had been administered dose while the temperature excursion assessment was ongoing. The reporter also reported that, no adverse reactions were reported by the patient.  No treatment information was provided by the reporter.
Rec. vaccination 12-29. On 12-31  had peri-orbital swelling, facial edema and conjunctivitis lasted 4 to 5 days.