chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection at about 10:15AM, felt slightly light headed about and now later, it continued until about 1:45pm when I collapsed to floor, my head felt dizzy and lightheaded and hot. Witness stated I passed out. But I do not remember losing consciousness.
Pt. reports redness and swelling of (R) arm, pm of 12/6/07. Following am observed hives at (R) shoulder, pain, radiating across back and ribs. Tx=otc Benadryl, Pepcid, Prednisone
Period has been extremely light. Prior to vax I had a medium to heavy flow for 3-5 days. Now I have a 1-2 day light to medium flow.
Pt stated she was nervous.  bp 160/96 15 minutes after vaccination.  Pt stated she was nervous and dizzy.  Had pt sit 10 minutes longer.  retook bp and it was 152/93. referred pt to urgent care.  Next day, followed up with pt. via phone call, pt stated she felt better and did not see md last night.  I recommended pt seek medical attention as soon as possible as uncontrolled high blood pressure can lead to stroke or heart attack.  Pt. agreed to see MD
Aches and fatigue starting 14 hours after injection and lasting 6+ hours. Chills starting 15 hours after injection, occurring on and off for approx. 5 hours. Injection site pain starting at time of injection lasting for 24+ hours.
Runny Nose 3/29/21, muscle aches 3/19 - 3/20.
Initial report received from a non-health care professional (consumer) on 21 October 2013. A female patient who had no illness at time of vaccination, no pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported, had received an Flu vaccine in left arm (lot number no reported) on an unspecified date in 1968. It was reported that on an unspecified date in 1968 the patient's arm was swollen, and red. kept swelling to a point where they thought they were going to have to operate. No treatment was taken. She could eat chicken and eggs but feels itchy of she is around chickens. laboratory investigations were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: None. Follow-up information received on 21 January 2014. The patient date of birth was reported as 17 October 1931. The patient experienced adverse event immediately after vaccination. Patient address, responsible physician address was updated. Documents held by sender: None.
LD swelling, redness, pain, warm to touch. Onset 10-13-8 @ 8:00 PM. L 3 1/2" W 2" C 6 1/2".
Pain at the time of injection with gradually increasing severity, Increased swelling. Ibuprofen and codeine unable to reduce extreme pain. Unable to move shoulder for several  days. Massive swelling (upper arm) subsided after 48hours. Large echymoses appealed
Unable to walk; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative.  A 10-year-old male patient received BNT162b2 (BNT162B2), on 11Jun2022 as dose 1, single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (non-serious) with onset 13Jun2022, outcome "not recovered", described as "Unable to walk". The event "unable to walk" required emergency room visit. It was unknown if therapeutic measures were taken as a result of gait inability. Additional information: It was unknown if the patient had COVID prior to vaccination and if the patient was tested for COVID post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient states she ended up having shingle like reactions about 2 weeks after administration. Had some rashes (pimple, blister) on left arm and back. Her doctor prescribed VALTREX and prednisone as treatments.
product storage error; no adverse event; This spontaneous report was received from a medical assistant referring to a 12 month old male patient. The patient's medical history included Penicillin allergy. No information was provided regarding the concurrent conditions, drug reactions or concomitant medication.   On 08-AUG-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, oka/merck)(VARIVAX) lot # number S005084 in right leg and hepatitis a vaccine, inactivated (VAQTA) lot # S005725 for prophylaxis (dose was not provided). No adverse symptoms were reported.   The vaccine was exposed to a temperature excursion with a total time and lowest temperature below 6°F to 14°F For 11 hours. There was no previous temperature.
immed p/vax lips pale & c/o dizziness VS good & stable 1/2 later VS remain good but cont c/o dizziness @ this time h/a; VS monitored, juice & cookies given in supine position;
Pain at injection site for 13 days, swelling/lump under skin for 12 days , itching at injection site for 10 days, headache for first 24 hours
Patient was given the >12year old product instead of the 5-11 year old product.   Error was recognized after the vaccine was administered when healthcare professional went to document.  Pharmacist that was contacted, recommended to keep child in office and observe for at least 30 minutes.  Advised that likelihood of side effects common but harm not likely.  Advised to treat any fever or symptoms to treat with acetaminophen or ibuprofen. Patient left the office after 30 minutes. No further issues reported.
flushed face mostly on the cheeks  x 1 day   sunburn-like pain on cheeks x 4-5 days
It felt like I was shot with a shot gun in my left arm with immediate soreness and feverish for 4 or 5 days. I had 48 hours of body aching all over, stomach pain that lasted for 3 or 4 days  that was intermitted.  I had left side of the neck and left eye pain.
Swelling throughout whole arm, redness throughout whole arm, tenderness in whole arm and armpit.
STRUGGLING WITH SLEEPING DUE TO THE NAUSEA; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 15-MAR-2021, the subject experienced struggling with sleeping due to the nausea. On 15-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, and struggling with sleeping due to the nausea. This report was non-serious.
Instant reaction to the vaccine; missed second dose-She was advised not to take the second dose of the moderna vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION RELATED REACTION (Instant reaction to the vaccine) and PRODUCT DOSE OMISSION ISSUE (missed second dose-She was advised not to take the second dose of the moderna vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INJECTION RELATED REACTION (Instant reaction to the vaccine) and PRODUCT DOSE OMISSION ISSUE (missed second dose-She was advised not to take the second dose of the moderna vaccine.). At the time of the report, INJECTION RELATED REACTION (Instant reaction to the vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed second dose-She was advised not to take the second dose of the moderna vaccine.) 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.   Patient was advised not to take the second dose of the vaccine.  Patient still wants to be vaccinated, and want s to know is she can take the Pfizer vaccine.  No Concomitant medications reported. No treatment medications reported.
Client in clinic for school immunizations and mother consented to Pfizer/Covid vaccine. Review of patients health history reveals no current issues or complications today.  Menactra and Bexsero given without incident. Pfizer vaccine mistakenly administered 0.5ml instead of recommended 0.3ml at 3:04 PM. Incident revealed to mother and patient of administration error. Patient remained for 45 minutes in clinic, no observation of adverse reactions observed or verbalized. Patient reported minor head lasting approximately 18 minutes. Patient left clinic with mother at 3:52. Mother educated concerning adverse signs and symptom to report immediately and seek medical attention. Mother verbalized understanding. Spoke with mother by phone at 5:45 PM and states  patient reports headache. Reiterated to mother education concerning seeking medical attention if needed. All above information obtained with assistance of Health Department employee/interpreter.
Febrile neutropenia. Patient is currently undergoing chemotherapy for cancer of her ureter.  She was started on broad-spectrum antibiotics and infectious disease evaluated her but she had no further fevers since admission so they felt that antibiotics could be discontinued. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
This is a spontaneous report from a contactable nurse. This nurse reported similar events for 15 patients. This is the 2nd of 15 reports.  A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunization.  The patient medical history and concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter, product, event, different patient.
Red splotchy rash occurs when out in the heat or body temperature is elevated from physical activity.  Slightly itchy occurs all over the body - abdomen, legs, shoulders, arms, but not so much in the scalp, face or feet.  Rahs lasts anywhere from 5-15 minutes and generally dissipates with some slight splotches remaining a little longer.
Approximately 10 minutes after receiving the Moderna vaccine patient started complaining of heart racing. After assessing the patient her heart rate was 117 and irregular, her bp was 172/100. We advised the patient to go to the emergency room for evaluation, she refused transport by ambulance but agreed for her friend to bring her.
pt was sick  as he had it the same as last time so feeling flu like symptoms  called in sick and then worked on the 29th
Client presented to Clinic on 03/21/2022 requesting Janssen booster. Client received Janssen booster Lot # 1855191 at 3:41pm. Client did not report any symptoms during the 15-minute observation period. Client left the vaccination site at 3:56pm with steady gait. At 4:35pm, vaccinator informed lead RN that Janssen vial had passed its beyond use time of 3:05pm. Lead RN submitted a medical consult to COVID vaccine coordinators in regards to how to proceed with incident.  Janssen medical representatives were contacted and were explained the incident. Per the Janssen representative, Janssen has not conducted studies to evaluate the efficacy and safety following administration of expired vaccine or vaccines stored outside of the recommended storage conditions. Janssen representative stated that recommended procedures following incident would have to come from own clinical judgment since no further guidance is available. Vaccine coordinator submitted medical consult to two doctors on staff.  Both doctors stated that revaccination would not be required; however, client has the option to be revaccinated at any time frame with any COVID vaccine. Client was contacted by lead RN. RN explained that we spoke to Janssen manufacturer and two doctors on staff about how to proceed. We offered revaccination at any time frame with any COVID vaccine. Client stated he is not interested in getting revaccinated. COVID vaccination staff were counseled on proper storage and handling of Janssen vaccine. Staff agreed to set an alarm to remind staff 6 hours has passed for when Janssen vial is unusable.
Body Pain; Nausea; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body Pain), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.    Co-suspect product included non-company product NALTREXONE (VIVITROL) injection for Alcohol dependence syndrome.    Concurrent medical conditions included Alcohol dependence syndrome.   On 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and NALTREXONE (VIVITROL) (Intramuscular) 380 milligram once a month. On 02-Jun-2021, NALTREXONE (VIVITROL) (Intramuscular) dosage was changed to 380 mg once a month. In 2021, the patient experienced MYALGIA (Body Pain), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Body Pain), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  No treatment medication was reported.
rash that itches around the neck area; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 10Mar2021 as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity (penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was reported that, Starting yesterday or the day before (Mar2021), the patient was experiencing a rash that itches around the neck area. Patient second injection was scheduled on 31Mar2021, the same day she have some eye surgery scheduled. The patient was asking will that be ok. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
No additional AE's; Caller stated that the PROQUAD that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 27-MAY-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number T035393, expiration date 14-APR-2022) as prophylaxis, that underwent a temperature excursion (product storage error). No additional adverse effects (AE's).  The vaccine underwent a temperature excursion between minus 58 degrees Fahrenheit (F) to 5F (15.2F) for 2 hours, 15 minutes and 0 seconds, as recorded by a data logger. There was no previous temperature excursion.
A week before  9/15/2022, I began experiencing pain in my ankles while walking on the treadmill.  The next day the pain had moved to my calf, a burning sensation.  I went to our local ER and they could not find a cause.  On 09/15 I sever burning pain in my lower legs and feet.   This feeling has begun to move into my arms and face.  I went to the ER and was admitted.  Upon test and spinal taps it was determined I had GBS and was treated with an infusion of IVIG over a five day window.  When  I left the hospital I left having to use a walker to walk and needing day and night assistance once home.  Prior I had lived alone and was very active.  I lost all independence withine a 2 week period.
Patient presented for his second COVID-19 Pfizer dose. Provider failed to check the patient's exact date of birth in the exam room. Second dose administered. Vaccine error identified 24 hours later. Provider contacted the parents. Patient's father reported patient is doing fine, acting normal and with no complaints.
got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An adult female patient (Believe likely age between 23-25) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded
Right arm numbness, 04/15, 5:00pm Facial dropping, 04/18, 12:00pm Right side face paralysis, 04/19, 11:00am Headaches, 04/16, 3:00pm TIA/ stroke, 04/19 11:00am
Gradual onset of chest pain and neck ache and fever resulted in an emergency room visit on October 6 and diagnosis of pericardial effusion and pericarditis. I refused hospitalization because I had to work the next day and was advised to come back Monday for echocardiogram.
!* mo old 18 MONTH OLD CHILD DEVELOPED HIGH FEVER OF 103.6 AND LOCAL SWELLING FOLLOWING IMMUNIZATION.
losing hair in large amounts; Hair was literally falling out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Sep2021 16:45 (Lot number: FE3592) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: OCUVITE [ASCORBIC ACID;RETINOL;TOCOPHEROL]; RED YEAST RICE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 16Feb2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 26Jan2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: HAIR INJURY (non-serious) with onset 18Oct2021 05:00, outcome "recovering", described as "losing hair in large amounts"; ALOPECIA (non-serious) with onset 18Oct2021 05:00, outcome "recovering", described as "Hair was literally falling out". The events "losing hair in large amounts" and "hair was literally falling out" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hair injury, alopecia.  Additional information:   prior vaccination there is no covid, post vaccination there is no Covid test  A few weeks after 3rd dose I started losing hair in large amounts. Hair was literally falling out. At my physical in Nov. I voiced the concern to my doctor. He checked my thyroid & all test results were fine. Went to dermatologist in early December. She had me start Viviscal daily hair supplements and Viviscal shampoo/conditioner. I started drinking protein drinks and was using the above even till now. My hair seems to be slowing down on falling out and I have seen new growth on the top of my head. I never had covid and can't see any other reason why this happened.  No follow-up attempts are possible. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 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 a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Apr-2021 at 4:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 4:07 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 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. The age of patient was provided as 75.67 years. No concomitant medications were reported. Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature 35 degrees Fahrenheit at 09:00 AM .The vial was initially moved to the fridge on 19-Apr-2021 and proposed beyond use date was 19-May-2021. Product moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. On the date of administration from cooler 1, at 09:00 A.M., the temperature recorded was 35 degree Fahrenheit that had been reached by the vial. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. No treatment medications were reported. This case was linked to MOD-2022-566976 (Patient Link).
Increasingly worsening migraine began roughly 6 hours after the shot, sore arm began 15 mins after shot. Mild fever began night of vaccination and lasted 48hours. Migraine continued even till today. I took accetimiphine as acceptable with no aid. I threw up the day after the vaccine and the morning after that again. Nausea for hours. Could hardly eat.