chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was sore; pounding headache; ear ache; checked her temp and it was 99.8; felt hot and then cold at times; within minutes she felt like she had a knot on her throat; This is a spontaneous report from a contactable health care professional (patient).  A 46-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EH9899) in the hospital via intramuscular route on 23Dec2020 at  13:45 at a single dose on the right arm for COVID-19 immunization. Medical history included seasonal allergy, allergy to latex and an allergic reaction to something she ate and by the time they did the allergy test, they could not find what it was. The patient carried an EpiPen for years. The patient's concomitant medications were not reported.  The patient was not pregnant at the time of the vaccination. The patient was not administered any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that the patient got the shot and within minutes she felt like she had a knot on her throat, the nurse assisted and gave her water.  They kept her for 30 minutes on observation.  She was fine after that and next day, her arm was sore, she had a pounding headache, ear ache and checked her temp and it was 99.8 (unit not specified) and she felt hot and then cold at times all on 24Dec2020 at 13:00.  She took Motrin 600mg and it helped out. The outcome of the events was recovered.  The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19.
Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   The vial was placed in refrigerator on 04-Nov-2021. It was reported that the expired lots were administered due to the confusion with expiry date printed in the carton and the expiration date when the QR code was scanned. The vials did not undergo temperature excursion. The patient did not experience any adverse event.  No treatment medication information was given.
Fever of as high as 101.3,chest pain, and shortness of breath, patient was advised to go seek immediate emergency help.
Fever, chills, sweats, aches and pain, insomnia and fatigue lasting 36-48 hours from injection.
immunocompromised; has recently developed Shingles; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer (patient herself). A 33-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration on 12Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 19Feb2021 (at the age of 33-years-old) as dose 1, single for COVID-19 immunization. In 2021 the patient experienced immunocompromised and has recently developed shingles (medically significant). Therapeutic measures were taken because of immunocompromised and has recently developed shingles. It was reported that the patient called with questions about booster COVID vaccines. Also mentioned that she received her second COVID vaccine in March but has recently developed Shingles. The outcome of the events was unknown.  Follow up(18Aug2021): The new information received, and it includes: In a call, patient asked also asked if the booster dose will be different for the general public in September or will it be the same as the booster dose that is authorized now for immunocompromised individuals. She asked if antivirals (acyclovir, valacyclovir) would have an effect on getting the vaccine. Caller reports she now has shingles and is immunocompromised. Caller wants to know what's the reasoning behind waiting until her shingles cleared before getting a booster dose and also if she were to get the booster dose would it make the shingles worse.  Follow up(18Aug2021): The new information received, and it includes: date, dose and lot number about the first vaccine and treatment given for the shingles. It was reported that the patient was immunocompromised, and she is a teacher that teaches children that have behavioral issues and she have both of her Pfizer Covid-19 vaccine, the second one was back in March, and the teacher has cases shingles right now and she was enquiring that she did some reading, even her doctor said that after the shingles have resolved she should wait at least 2 weeks before receiving the booster. She wants to know if that's true because she goes back to work on Monday. And she wants more information on booster after having shingles. And also, she was on the medication for her shingles, and she received Valaciclovir, she said that she was taking 1 gram 3 times daily. And she was also wanting to know if this medication will affect the efficacy if she has would have the booster as well.  No follow-up attempts possible. No further information expected
8/19 - Developed rash all over body, fever 102 degrees. Saw physician 8/21.
NIGHT OF VACCINATION PATIENT HAD 1 INCH REDNESS AROUND INJ SITE. MONDAY 2/7/22  PT STARTED GETTING SWELLING/BUMP, WARMTH, PAIN AND INTERMITTENT ITCHING AND REDNESS THE SIZE OF A DOLLAR COIN, COUNSELED PT TO TAKE TYLENOL FOR PAIN, APPLY COLD COMPRESS AND CAN TAKE DIPHENHYDRAMINE AND APPLY HYDROCORTISONE FOR ITCH
I had my vaccination on 10/24/2021. On 09/04/2022 I started to experience fatigue and it transitioned into the traditional COVID cough with night chills and fever. I tested COVID-19 positive on 09/07/2022. I took another COVID-19 test PCR at doctor office 09/08/2022. I was told to take TYLENOL as needed rest and fluids. I had residual cough for 2 weeks. I currently feel fine on 10/26/2022 with some fatigue.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) 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, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was reported. Treatment information was not provided.
Pt experienced a woozy feeling, dizziness, cold and flu type symptoms, extreme fatigue, parts of extremities falling asleep, joints sore.
14 x 4 cm area (kidney shaped) Rt upper arm; area at 1" in diameter indurated - at site of injection. Area itchy, reddened, tender. No drainage. No constitutional symptoms. Late onset of symptom: vaccinated 9/22 - symptom onset 9/27. Vaccine given prophylactically secondary skin break.
This spontaneous report as received from a Healthcare Worker refers to unknown patients of unknown age. The healthcare worker reported that an unknown number of doses of MMR II (lot# was not reported) that were exposed to a prolonged peroid of light exposure (2-7 days at the front of a glass door refrigerator, not in boxes) might have been administered. No adverse effect reported. Additional information has been administered. No adverse effectc reported. Additional information has been requested.
very red skin; dry and frizzy skin; asthma attack that could not control it, she gave him Albuterol.; she told that was with ups his brain is asleep; he does not eat and has problems with phlegm for years; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very red skin), DRY SKIN (dry and frizzy skin), ASTHMA (asthma attack that could not control it, she gave him Albuterol.), INSOMNIA (she told that was with ups his brain is asleep) and EATING DISORDER (he does not eat and has problems with phlegm for years) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.    Co-suspect product included non-company product ALBUTEROL [SALBUTAMOL] for Asthma.    The patient's past medical history included Stroke. Concurrent medical conditions included Dementia, Asthmatic attack, Anxiety, Alzheimer's disease and Itching.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ALBUTEROL [SALBUTAMOL] (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (very red skin), DRY SKIN (dry and frizzy skin), ASTHMA (asthma attack that could not control it, she gave him Albuterol.), INSOMNIA (she told that was with ups his brain is asleep) and EATING DISORDER (he does not eat and has problems with phlegm for years). At the time of the report, ERYTHEMA (very red skin), DRY SKIN (dry and frizzy skin), ASTHMA (asthma attack that could not control it, she gave him Albuterol.), INSOMNIA (she told that was with ups his brain is asleep) and EATING DISORDER (he does not eat and has problems with phlegm for years) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs include Anxiety medicines,itching medicine Alzheimer's medicine dementia medicine (2 per day)
Employee complained that she had vomited shortly after vaccine, and that her arm was very sore at the injection site.
injection site pain; arm pain; headache; fatigue; her glands on the left side of throat are swollen; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (Patient) reported that:  A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on 12Feb2021 (54-years-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included tonsil issues from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced injection site pain, arm pain, headache, fatigue and her glands on the left side of throat are swollen. Patient stated that received first dose of Pfizer Covid vaccine 12Feb2021. It was reported that the patient experienced injection site pain, arm pain, headache, and fatigue within the first 24 hours of receiving the vaccine. On an unspecified date on 2021, a week later, she started to experience left neck sided lymph node gland swelling which has continued for 2 weeks. She has an appointment with her ENT MD soon to discuss further. She is due to receive her second dose this Friday 05Mar2021. She wants to know if there is any information on this side effect. After 1st dose, her glands on the left side of throat are swollen and she is wondering if she should take 2nd dose. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1.  3 to 4 inch red raised itchy hive on upper part of same arm as injection about 2 inches from injection site.  2. Migraine Headache with an aura.  Shivering cold during Migraine Headache.
injection site progressively enlarged over the next 72 hours to the size of a "softball" per wife of patient.  Wife reported this to the vaccine administrator on 7/19/2011. Told patient's wife that patient needs to contact the physician.  As per physician (on 7/21/11) the patient was out of town that week and the physician's office referred patient to an immediate care in the town where patient was located. Tried to contact patient on 7/23/11 and 7/25/11 and 7/27/11. Patient will not return phone calls.  Spoke with wife on 7/23/11 and wife said patient applied ice and is fine.
Headache, fatigue, pain in right arm extending into neck, mild right-sided facial swelling. Treated with TYLENOL/ibuprofen and BENADRYL.
Ten minutes after vaccine given, greater than quarter size red area with a 2 by 3 mm wheal at injection site of varicella on left arm. Benadryl 3 ml po given. Within 10-15 minutes redness had diminished and wheal disappeared. Reviewed signs with mom.
Decrease in Creatine/creatine has decreased down to 31 mL/minute; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266 and Expiration Date: May2021), via an unknown route of administration, administered in right arm on 19Feb2021 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing FSGS (focal segmental glomerulosclerosis) a kidney condition, blood pressure, immune system being jeopardized from an unknown date and unknown if ongoing. Concomitant medications included lisinopril taken for blood pressure abnormal, start and stop date were not reported and tacrolimus taken for FSGS (focal segmental glomerulosclerosis) from May2019 and ongoing. The patient previously took first dose of bnt162b2 (Lot number: EL9264 Expiration date: May2021) administered in right arm on 29Jan2021 (at the age of 70-years-old) as dose 1, single for COVID-19 immunisation at around 11:00. Patient reported that, decrease in Creatine could have started in February possible. However, she saw the doctor last week (as reported) and this was when she got the creatine result, 31. She has had issues with the kidney for a couple of years. Back in Aug2020 the doctor started talking about the patient starting a shot called Rituximab infusion, but the doctor did not give at the time due to immune system being jeopardized. She confirmed she was unable to break down what FSGS meant as it's a long name. Since seeing the doctor there has been a protein they have always been watching. Now, the creatine is something they are concerned with for the kidneys. She saw the doctor on Thursday 08Jul2021 and the testing was done and got the creatine level of 31 ml/minute. The doctor mentioned would like to get the patient off Tacrolimus and get a third shot of the COVID vaccination. The case was assessed as non-serious. The patient underwent lab tests and procedures which included blood creatine: 32 ml/min on 08Jul2021, blood creatine: 31 ml/min on 08Jul2021 and on an unknown date. Sars-co-v/2 spike AB, QUANT, S- These antibodies were checked, and level was 46. Outcome of event was unknown.   Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Immediately as the fluid was being injected into my left arm, I felt a sharp pain in my chest/heart.  I didn't mention it to the person administering the dose.  Afterwards just flu like symptoms.  Friend who works for J&J said I should report it for safety.
Joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint; Joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK5730), via an unspecified route of administration on left arm on 17Dec2020 at single dose for COVID-19 immunization. Medical history included wasp venom with anaphylaxis. There were no concomitant medications (No other-vaccine-in-four weeks, no other-medications-in-two weeks). The patient previously Stage 4 breast cancer in remission on Xeloda. The patient experienced joint pain and swelling 3 days after the first dose. Affected joints: right elbow, right wrist and right third interdigital joint on 20Dec2020. All events were reported as non-serious. The patient did not receive treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
Service member had her vaccine at about 0900 on 10/2/2021. By 0935 complains of redness to injection site and constant pain down left arm to 3rd, 4th, and 5th finger. We sent her to the ER to be evaluated.
About two weeks after my vaccine I became very fatigued had blood work done and my thyroid levels went up extremely like they never done before which means I'm running low with my thyroid
Within hours of having his 3rd Pfizer Covid vaccination, patient came down with a severe case of shingles on the right side of his neck, face, and scalp which led to septic shock within 24 hours, requiring admission to the hospital for several days.
Admit to COVID unit 12/5-12/6. Discharged home. Re-admit 12/11-12/23. Mechanically intubated during stay. Expired 12/23/2021
My adverse began 23FEB2023 I started to feel a little sick at work but not bad enough to go home at 6pm I went home and continued to be sick on Friday I did not go to work, Nyquil was very hopeful I started to feel much better. I took a home COVID-19 test which was positive and missed church a play and work. I was back to work by Tuesday. For the next four or five weeks I had a cough and  it is now resolved.
Patient reports that her muscle is "still in pain". Having a hard time lifting objects and is very tender to touch. Also says it hurts when pressure is applied as in when she is sleeping.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender for a "data logger". The patient's medical history and concurrent condition was not reported. The patient may have received an improperly stored dose of GARDASIL 9 (dose and route unspecified)(lot # L014415, expired on 25-MAY-2017). It was reported that the time frame was 1 hour and back in range. There was no previous temperature excursion. The reporter stated that 1 dose of GARDASIL 9 was missing from the box and not sure if the vaccine was administered after the excursion. No adverse effect was reported. Additional information has been requested.
I threw up in the morning of 4/19/21. I have experienced various degrees of severe headache, extreme fatigue and nausea everyday since I received the vaccine (10 days now). I am currently nursing/lactating.
Swelling of the throat and difficulty breathing - 5 minutes after shot, used epipen and benadyrl, did not seek medical attention. Rash on face but not on injection site 1 day later - notified my doctor and took benadyrl, will also be seeing an allergist soon. Blurry vision -  notified my doctor and will be seeing an ophthalmologist soon.
Got their second dose of shingrix just under 4 years after the 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Got their second dose of shingrix just under 4 years after the 1st). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 26-MAY-2023 The patient got their second dose of Shingrix just under 4 years after the 1st dose. The reporter asked were they done with their series. The patient received their first dose at a different pharmacy. Healthcare professional became disconnected from the chat so there were no additional details available regarding the patients or events. It was unknown if follow up was permissible. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.  The case is linked with US2023AMR076149, same reporter different patient.; Sender's Comments:  US-GSK-US2023AMR076149:Original Case : US2023075222
Patients guardian falsified DOB when registering for vaccinations, stating the minor's DOB was . Guardian, consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB which made the vaccine a contraindication.  1st Pfizer vaccination given: 03/13/2021 2nd Pfizer vaccination given 04/06/2021  No known adverse reactions noted.
This spontaneous report was received from a healthcare professional referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M001150 with expiration date 05-JUL-2017 and lot # M022400 with expiration date 01-NOV-2017, for prophylaxis (dose and route were not reported). It was stated that the vaccines were exposed to a temperature between 6 and 14 Fahrenheit degrees with a time frame of 20 minutes and that the diluent for both vaccines did not experienced any temperature excursion. A previous excursion was reported with a temperature between 6 and 14 Fahrenheit degrees with a time frame of 15 minutes. A data logger was used to control temperature. No adverse events were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA006791:
Child fainted, hitting head on agency front door, eased to ground by mother; ice to head and monitoring completed; ambulance summoned; child reported skipping lunch at school. Random sugar and BP checked and WNL; sent home to eat a meal and reported no further concerns when status checked 5/10/18 5:50 PM.
We requested pt wait 30 min due to her hx of severe allergies.  Initially after vaccination, she felt nauseated and looked a little flush.  Gave her cold compress and she felt better and wanted to leave.  We made her wait and around 20-25 post vaccination, she reported feeling itchy all over and then said her throat felt funny.  We were administering the vaccine for a clinic for their hcp staff.  Rather than using our benadryl and ER kit, we walked her down to the ER since we were right in the hospital.
3/4" Swelling, very hard & red, painful, hard for 3 days. after 3 days fever of 100, day 4 better with some swelling and achiness, by Day 5 resolved.
About 48 hours after 2 month imms. patient developed grunting, turned limp, foaming at mouth, and unresponsiveness that lasted approximately 2 hours. Admitted underwent sepsis work up which was negative. EEG normal and normal MRI. Recovered without intervention. No fever documented at or around event.