chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash on Elbows and Knees.; This is a spontaneous report from a contactable consumer. A 65-years-old-male patient received dose 1 as single of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201,) (at the age of 65-years-old)  on 23Feb2021 and 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) on 17Mar2021 at 03:30 PM, both doses via an unspecified route of administration into left arm for COVID-19 immunisation. Medical history of the patient includes bladder cancer, renal cell carcinoma, heart disease and chronic kidney disease from an unknown date. No concomitant medications were reported. The patient had an allergy towards Egg yolk. Prior to vaccination and since the vaccination the patient had not been diagnosed with COVID-19. The patient experienced rash on elbows and knees on 07Mar2021.The outcome of the event patient was not resolved. No follow-up attempts are possible, no further information is expected.
Patient stated left arm has gone numb around the shoulder area spreading up the neck.  Vaccine site was red
Patient came in with 2 other family members. Questions were all answered "no" on COVID vaccine consent form, and reviewed by writer.  Writer asked if patients had any questions. Son interpreted. There were no questions. Vaccine was administered, and then the son asked " Does this interact with the Johnson & Johnson Vaccine? We all got it about a month ago." They did not make this known until the vaccines were already administered. Writer contacted nurse for guidance. Told to report this as an incident, as the patients received two brands of vaccine. No adverse affects have been noted.
lack of efficacy; diagnosed with Covid 19 virus; occasional cough that wasn't terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) on 28Feb2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) on 21Mar2021 and third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) on 22Aug2021 via an unspecified route of administration, administered in left arm (at the age of 60 years) as a single dose for COVID-19 immunisation. The patient's medical history included Multiple sclerosis, Chronic obstructive pulmonary disease, Overweight, immune compromised, and Supraventricular tachycardia from an unknown date and unknown if ongoing. The patient's concomitant medication included METOPROLOL taken for a Supraventricular tachycardia, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Oct202 the patient experienced occasional cough that was not terrible and on 04Oct2021 the patient diagnosed with Covid 19 virus. Patient was diagnosed with the Covid 19 virus, and she was wondering if Pfizer was keeping track of people who had breakthrough cases of the Covid 19 virus. Patient had her Covid 19 vaccine booster also. When probing medical history and concomitant medications patient took a betablocker for supraventricular tachycardia so she did not really know if she had high blood pressure or not because the betablocker helps with that. Patient took the betablocker for a long time. The betablocker is Metoprolol 50mg daily. The patient went and had the Regeneron treatment. She did not know the dosage and stated it was a small IV bag, much smaller than the big fat normal IV bag. The Regeneron only took about 20-22 minutes to drip. Patient had the Regeneron treatment. Patient had been around about 10 people in the last week and contacted them all and so far, only one woman had tested positive for the Covid 19 virus, and that woman was asymptomatic. As far as the reporter knew only the reporter and the other woman have had positive results. The patient did let everyone know that she had tested positive for the Covid 19 virus. Reporter reported that the patient had left her house in 20 months and this time she wasn't as careful. The patient underwent lab tests and procedures which included Covid 19 virus PCR test on 03Oct2021 and resulted positive and Covid 19 virus Rapid test was performed on 04Oct2021 and resulted positive. The outcome of the events was unknown.  Follow-Up (07Oct2021) attempts are completed. No further information is expected.
At approx. 1015 pt began to seize in chair and fell off chair. Pt continued seizing after fall. Another pt sitting next to pt placed pt onto left side during seizure. Nurse assumed care at approx. 1015. Nurse observed tonic-clonic seizure lasting  approx. 30 seconds total.  After seizure ended, pt had unlabored breathing and appeared foggy for approx. 10 seconds. Patient was then AxO x4. Pt reported 7/10 pain on left side of head and feeling tired. Pt reported no Hx of seizures and no blood thinners. 911 activated at approx. 1016. Pt denied taking any meds and any chronic medical conditions. Paramedics arrived and assumed care at approx. 1024. At approx. 1026, pt left facility via ambulance and transported to ER for further care.
I took 1 Advil 2 hours after vaccination (at 3pm on Sat 3/27). and then 2 more Advils at 11p that same day when I started feeling the side effect -- body ache, left arm soreness where I was vaccinated,  and chills for about 4hours.  It made it really hard to sleep.  I woke up the next day on 3/28  feeling extremely fatigued with a bit of body ache.  I then took two more Advils that day.  By the 3rd day on 3/29  I was back to normal, with the exception of a tingly sensation on my left-hand (note i received the shot on my left arm/shoulder area).
Information has been received from a registered nurse who reported that unknown number of patients was vaccinated with GARDASIL doses outside of recommended dosing schedule. Follow-up information has been received from the registered nurse who reported that sometimes she had patient came in and state they did not receive the third dose and she had called to doublecheck if she could go ahead and give the third dose to the patient and did not think to keep track of their names. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, hospital name (if applicable), healthcare provider name and contact information. No further information is available.
On 4/10/2021 the evening of her vaccine she had fever, chills, headache, and fatigue.  6-7 days later she said her right arm started swelling, rash, itching and painful for about 6-7 days.
pressure behind right eye; annoying headache, which comes now and then usually when he wakes up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, OCULAR DISCOMFORT (pressure behind right eye) and HEADACHE (annoying headache, which comes now and then usually when he wakes up) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  No relevant concomitant medications were reported.   Other treatment information included, prescription eye drops was provided.  Patient stated that ophthalmologist was draining his eye in every visit.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up information received on 17-JUN-2021 contains no new information.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient admitted to hospital for two syncopal episodes soon after immunization. No arrhythmias identified on telemetry and TTE unchanged from previous TTE. Monitored, no additional syncopal episodes, and patient discharged to home medically stable.
Large local reaction - 5x3cm erythematous, warm, non tender, swollen
Pt sent to hospital by public health office, she has two red areas on left deltoid. RN suggested she be seen by ER physician, patient refused exam or treatment. States she will see a primary care physician.
pt. received vaccine past the 12 hour expiration. MD contacted pt. no adverse events. Pt. declined revaccination.
Approximately 24 hours after receiving kindergarten boosters, left arm started to get red, swollen, warm and hard to the touch. She may have had a slight fever, but her temperature was not taken. The swelling went from the elbow to the shoulder with the deltoid having a red hard induration 2+ inches across. Mother applied cold compresses. By 72 hours the swelling had gone down considerably and she was playing and seemed to be doing fine.
Patient admitted to hospital with COVID detected PCR. Provider discharge note "Patient is a 90 YO F with history of HTN, HLD, anxiety/depression, who presented with symptoms of orthostasis in setting of poor PO intake and viral syndrome. She was found to have COVID-19 infection and AKI due to dehydration. She was treated with IV fluids and supportive care. Symptoms and AKI resolved overnight and patient reported she felt back to her baseline. Sh was able to eat and drink a regular diet prior to discharge. Will continue holding indapamide and lisinopril on discharge and recommend PCP follow-up in 1 week for repeat BP check and labs. Consider resumption of one or both HTN medications at that time. "
Conjunctivitis- pink eye; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199), via an unspecified route of administration in the left arm on 09Mar2021 at 12:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medications were not reported. 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 COVID-19 vaccination. On an unspecified date in Mar2021, the patient experienced conjunctivitis- pink eye. The patient reported that this event occurred for both the doses of the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event experienced. The clinical outcome of the event conjunctivitis- pink eye was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
I had a severe reaction to my 2nd Pfizer shot with projectile diarrhea for 3+ days! This seems unlikely since it occurred 9 days after the shot but there's no other explanation. This left me so dehydrated that I went into AFIB and had to visit Emergency Room.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an expired dose of PNEUMOVAX 23, lot # M003027, expiration date: 28-JUN-2017 (dose and route of administration was not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
sore left injection site arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm after first dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm after first dose). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication  was reported.  No treatment medication  was provided for the event happened after first dose.   This case was linked to MOD-2021-387747 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received contains no new information.
No additioanl AE details available; Vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a Medical Assistant, referring to a 12 month old patient of unknown gender. Information regrading the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.      On 13-OCT-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), with lot # T032932 and expiration date on 28-SEP-2022 (route was not provided) for prophylaxis, after the vaccine experienced a temperature excursion (product storage error).  Varicella virus vaccine live (oka/merck) (VARIVAX) was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit (8.5F), for 0 hours, 18 minutes 0 seconds and 6 degree Fahrenheit to 14 degree Fahrenheit (11.9F) for 1 hour 0 minutes 0 seconds. Cumulative timeframe of the exposure was 1 hour and 18 minutes.  The vaccine was not exposed to any other previous temperature excursion. No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA007447:
Muscle cramps; This is a spontaneous report from a contactable consumer (patient). This consumer reported for self that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiration date: 06Feb), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced muscle cramps on an unspecified date. The outcome of the event was reported as unknown.  Information about Batch/Lot number has been requested. Follow-up attempts are completed. No further information is expected.
Tightness in chest; A racing heart; Dizziness; Still feel a little off; Flu like symptoms; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Tightness in chest), PALPITATIONS (A racing heart), DIZZINESS (Dizziness), FEELING ABNORMAL (Still feel a little off) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHEST DISCOMFORT (Tightness in chest), PALPITATIONS (A racing heart), DIZZINESS (Dizziness), FEELING ABNORMAL (Still feel a little off) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, CHEST DISCOMFORT (Tightness in chest), PALPITATIONS (A racing heart), DIZZINESS (Dizziness), FEELING ABNORMAL (Still feel a little off) and INFLUENZA LIKE ILLNESS (Flu like symptoms) 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.   Concomitant medications taken by the patient were not provided. Treatment activities for event was unknown.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
within 10 minutes of vaccinations, went into anaphylactic shock.  Brought back to pediatrician's office when the EPIPEN was administered and he was taking by ambulance to the ER
This case was reported in a literature article and described the occurrence of fall in a 86-year-old female subject who received Hz/su + AS01B for prophylaxis. On an unknown date, 6 hrs after receiving Hz/su + AS01B, the subject developed fall. Serious criteria included death. The outcome of fall was fatal. The reported cause of death was fall. An autopsy was performed. The investigator considered that there was a reasonable possibility that the fall may have been caused by Hz/su + AS01B. Additional information was provided. This case was reported in a literature article and described the occurrence of fall in an 86-year-female who was vaccinated with SHINGRIX (GlaxoSmithKline) for prophylaxis. The patient was a part of a Centre for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) began safety monitoring of recombinant zoster vaccine (RZV; Shingrix), in the Vaccine Adverse Event Reporting System (VAERS) for the period between 20 October 2017 and 30 June 2018. No information on patient's family or medical history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received SHINGRIX (administration route and site unspecified; dosages unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, between 6 hours and 6 weeks, the patient died due to a fall. Autopsy was performed on unspecified date (results not available). [In this study, according to autopsy reports, death certificates, or medical records, the median decedent age was 65 years (range = 61-86 years), and the interval from vaccination to death ranged from 6 hours to 6 weeks]. This case has been considered serious due to death. The authors commented, "CDC and FDA will continue to closely monitor the safety of RZV. Whereas the initial safety data for RZV are reassuring, the vaccine is still in the early uptake period. Understanding of the safety of RZV will advance as use increases and additional data become available from VAERS and from near real-time sequential monitoring in CDC's Vaccine Safety Datalink."; Reported Cause(s) of Death: fall.
I was standing outside after walking my dog less than 2 miles which is nothing compared to the average 10 we do daily and I started to feel light headed and I wasn?t able to hear anything. I was able to get to the floor and eventually everything came back but it was like going through a tunnel.
Chills for several hours, dry mouth, sweating, slammimg headach on top of head and pounding behind eyes, dizziness. Fell to floor when going to get water.
Patient started adverse events on 11/1/20 body aches,chills and swelling where the vaccination was administered on 11/2/20.
received vaccine on 1/5/2021,  on 1/12/2021 noted swelling  and tenderness in left axilla. On 1/13/2021 noted entire jaw was itchy. on 1/14/2021 noted entire face was Hot, red and swollen.  I am the provider that gave the injection,  I saw Pt on 1/14/2021 and noted her entire face, ears, neck, and chest had erythema and edema.
After shots client became flush and c/o nausea. Client then vomited while sitting in chair. Cold compress to forehead v/s normal. B/P 100/70 after sitting for 20 more minutes client states still feeling fine and no nausea. Client states she ate a very greasy hamburger earlier, but feels fine now. Denies any s/s of light headness or nausea. Told mother to take number to call and let them know how she is feeling and explained to mom to take her to doctor  or ER if any more s/s occur.
Four days after my vaccine I had swelling at the injection, but it went away within a day or two. About three days later the swelling came back. Ten days later I went into the doctor's office to make sure it wasn't infected, but everything looked normal. Three days later the swelling went down, and the doctor suggested that I get my second shot on my right arm, and everything was fine (no swelling).
p/vax pt exp SOB, pain under rt arm & across back, numbness in arms & fingers, back spasms & nausea;pt said it felt as if someone beat her;tx w/DPH & Toradol;pt recovered w/in 24hr;
Completed a full course of Paxlovid and on day 8 COVID symptoms began to re-appear; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Completed a full course of Paxlovid and on day 8 COVID symptoms began to re-appear) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Name of drug not reported).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2022 at 8:00 PM, the patient experienced COVID-19 (Completed a full course of Paxlovid and on day 8 COVID symptoms began to re-appear). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Completed a full course of Paxlovid and on day 8 COVID symptoms began to re-appear) had not resolved.            Concomitant product use was not provided by the reporter.  Device date was reported as 24-May-2022. Company comment: This spontaneous case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The exact date of administration of third dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. It has been reported that patient completed the treatment regimen of Paxlovid but the symptoms recurred after 8 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The exact date of administration of third dose of mRNA-1273 was not specified in respect to the onset of the event, hence latency could not be assessed. It has been reported that patient completed the treatment regimen of Paxlovid but the symptoms recurred after 8 days. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.