chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office manager refers to a unspecified number of patients of unknown age and gender. Approximately in August 2014, reported as after 18-AUG-2014, the patients were vaccinated with (Oka/Merck) VARIVAX. Dose, route, lot number and expiration date were not reported. Approximately in August 2014, reported as after 18-AUG-2014, improperly stored (Oka/Merck) VARIVAX was administered. No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
HAIR LOSS ON THE SCALP (STARTED ON THE LEFT SIDE OF THE SCALP AND IN DIFFERENT AREAS AND STRETCHED TO THE BACK OF THE SCALP, THE RIGHT SIDE OF THE SCALP NOT AS BAD AS THE LEFT SIDE); This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: pain here and there, non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced hair loss on the scalp (started on the left side of the scalp and in different areas and stretched to the back of the scalp, the right side of the scalp not as bad as the left side). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hair loss on the scalp (started on the left side of the scalp and in different areas and stretched to the back of the scalp, the right side of the scalp not as bad as the left side). This report was non-serious.
Pt received 2 vaccines (pfizer bivalent and 1st Shingrix). After I gave her Pfizer vaccine she said she was feeling dizzy. Then about 5 seconds later she fainted. I moved myself in front of her when she said she was dizzy. I caught her in a hug and slowly lowered her to the ground. I proceeded to elevate her legs and within 5-10 seconds she came to. She was able to then slowly get up into a chair and we kept her feet elevated and gave her some cold water. I offered to call an ambulance but she said she was feeling better. We checked her Blood pressure multiple times while she was sitting for a while. Started at 95/65 and last check was 114/80. She had her mother come pick her up so she didn't have to drive home. By the time she left she was feeling much better.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 18-OCT-2011 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient have serious internal complications and to contract a persistent strain of herpes zoster. Shortly after being vaccinated the patient was hospitalized for kidney issues at which time she was evaluated by a team of Internal Medicine specialist who deducted that her kidneys were spotted with unusual nodules and vesicles, which was likely a complication of the vaccine or an internal outbreak of zoster. The patient continued to experience health issues and zoster complications. On or about 01-SEP-2017 the patient was treated by a physician for shingles outbreaks that were diagnosed as severe herpes zoster that had spread into her genitals, resulting in excruciating pain and impossibility of topical treatment or relief. The patient has been prescribed VALTREX and pain medication for management of her ongoing and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. She also presented to the ED on 4/1/21.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.    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 COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative- for 2 days. and positive (Positive) Positive.         It was reported that the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Paxlovid relapse. Tested negative for 2 days, then started having symptoms again and tested positive again.  On 29-May-2022, the patient had COVID- 19 relapse after Paxlovid treatment. Device Date was reported as 01-Jun-2022.  Company comment: This spontaneous case concerns a patient (age and gender unspecified) with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving mRNA-1273 vaccine as 3rd dose. The patient had received a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days and tested negative for two days after this. The symptoms recurred and the patient was tested positive again. The outcome was reported as resolving. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of previous Covid-19 vaccines was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender unspecified) with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving mRNA-1273 vaccine as 3rd dose. The patient had received a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days and tested negative for two days after this. The symptoms recurred and the patient was tested positive again. The outcome was reported as resolving. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. Details of previous Covid-19 vaccines was not provided. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Acute onset of more severe vertigo at 0100 the night after receiving vaccine. Slowly resolving when she sent me a message to report at 0719. Pt has a hx of BPPV but previously had been management.
pt recv vax & c/o pain in rt arm;pt states did not feel painful 23APR99;upon exam rt arm noticed sl redness approx 2in in width & length, area was warm to touch w/o swelling noted;mom states pt was given motrin day of vax but none p/vax;
Information has been received from a physician concerning a patient, with congenital muscle disease, who was vaccinated intramuscular on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient experienced a break through of varicella (less than 50 lesions). At the time of the report the patient's status was unknown.  A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
About a week after my vaccination, the initial red swelling that appeared, reappeared after being gone for four days. It is hot to the touch, and red with a couple of small purple spots. I feel fine, all other initial symptoms are otherwise gone.
EXPIRED VACCINE ADMINISTERED. Vaccine expired on 06/19/2022 and administered in error on 06/22/2022
Headache, Fever chills, body aches (unspecified) Narrative:  Other Relevant History:
Pain, swelling left upper arm 9cm long and 7cm wide. Redness, warm to touch, induration. Ibuprofen 2-3 tablets every 6-8 hours as needed for pain and swelling. Cool Compress. Return to clinic for s/s infection.
lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was on fire; trouble breathing; face felt like it was on fire; headache; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19May2021 09:00 (age at vaccination: 60 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing multiple allergies. She has had allergies her whole life. Concomitant medication included rosuvastatin calcium (CRESTOR OD) taken for blood cholesterol increased which she has taken it for 15 or 20 years; fenofibrate (LIPOFEN) taken for blood cholesterol increased, which probably she has taken it for 15. On 19May2021, she experienced multiple symptoms 15 minutes after initial vaccination including, trouble breathing which started maybe an hour after she had the vaccine, face felt like it was on fire which lasted for 2 or 3 days, headache, felt really tired and her whole face and neck was really red and felt like it was on fire; on 21May2021, the patient lost sense of taste. Her sense of taste is back now. She thinks her tiredness has gone away. The adverse events did not require emergency room visit or a physician's office visit. The patient did not get other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient feels hesitant about getting her second dose of the vaccine tomorrow and would like some guidance, asking if she should get her second dose or not. The outcome of the event dyspnoea was reported as not recovered; burning sensation, erythema was unknown; headache was recovered on 24May2021, Ageusia was recovered on 23May2021 and tiredness was recovered on May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Headache and mod to severe pain at injection site by 4 hrs followed by bad muscle and whole body aches and increased skin sensitivity by 10 hours after injection Feel terrible. Took Tylenol but didn?t help. Took Tramadol 50 mg this morning which seems to be helping. Have never had this reaction to a vaccine. And not sure that I am willing to get the second dose. I am a retired health care provider who believes in the value of vaccinations.
Erythema nodosum;seen in office 06/03/2002 with 2 week history of painful leg lesions, ie, approximately 2.5 weeks after getting immunizations
Shivering, Chills, Headache, nausea, dizziness, Muscle Spasms. Lasted about 2 hours. No lasting side effects.
THIS WAS MY 2ND OF 3 DOSES IN THE SERIES. I RECEIVED THE 1ST DOSE ON APRIL 4, 2021 AND THE 2ND ON APRIL 21, 2021. NEXT DOSE AFTER THE 2ND DOSE, I SUDDENLY DEVELOPED AN EXCRUCIATING HEADACHE (THE TYPE THAT I HAD NEVER HAD IN LIFE BEFORE AND SINCE AFTER THAT DAY) AND AT THE SAME TIME MY LEGS JUST GAVE UP ON ME THAT I COULD STAND OR WALK AND HAD TO CALL FOR ASSISTANCE FOR PEOPLE TO SUPPORT ME TO A CHAIR. THE SYMPTOMS RESOLVED AFTER A FEW MINUTES BUT SINCE THAT DAY OVER TWO YEARS AGO NOW, I HAVE BEEN HAVING PROGRESSIVELY WORSENING MUSCLE WEAKNESS/FATIGUE, CRAMPS, DEEP PAIN, AND OCCASIONAL PARESTHESIA IN THE MUSCLES OF MY LEGS FROM MY BUTTOCKS DOWN TO MY FEET.
Patient was given second Pfizer Covid 19 vaccination at 11:08 am.  Within 45-60 seconds had a blank stare, then became limp, then stiffened arms and legs indicative of a brief seizure.  After a few seconds with a cool cloth on her forehead, she responded appropriately to questions of name, birth date.  Stated "I feel a little dizzy"  Then, stated "I'm ok"  Left ambulatory with  mother at 11:17. Brother had stated that she only ate a gogurt this morning.
Generalized aching starting at 5pm day of H1N1 injection with temp to spike 100.6 spx 24 hrs. Event reported to Medical Clinic 01/05/10.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022, beyond 30 days duration) and PRODUCT STORAGE ERROR (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 017E21A, 010A21A and 042L20A) for COVID-19 prophylaxis. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022, beyond 30 days duration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022, beyond 30 days duration) and PRODUCT STORAGE ERROR (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with freezer expiration date 20-May-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug reported. Moderna vaccine lot 033K212A manufacturer expiration date was reported as 10-July-2022 and was taken out of freezer on 20-Apr-2022. There were 13 booster doses in 1 vial. The vial was initially stored in the refrigerator on 20-Apr-2022. Out of freezer expiration date was reported as 20-May-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
more warm to the touch; left arm was sore,; red / that the arm was more red / are of  redness is approximately 6 inches; This case was reported by a pharmacist via call center representative and described the occurrence of skin warm in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 3F3FP, expiry date 30th April 2022) for prophylaxis.   On 25th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 27th August 2020, 2 days after receiving Shingrix, the patient experienced skin warm, pain in arm and erythema of extremities. On an unknown date, the outcome of the skin warm, pain in arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the skin warm, pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and noticed the left arm was sore, red, and warm to the touch.  The patient stated the changes were that the arm was more red and more warm to the touch.  The pharmacist described the area of redness was approximately 6 inches and this was on day 3 after the injection. No HCP information was obtained.
A legal complaint was received from an attorney alleging that a male plaintiff received a series of Hib-TITER vaccines and Acel-Imune vaccines as well as DPT and Haemophilus influenzae b from 5/21/99 through 10/4/99. It is alleged that as a result of exposure to thimerosal contained in the vaccines, the plaintiff sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. These events were considered medically important (OMIC) MANUFACTURER'S COMMENT: The reporter indicated that the patient received Hib-TITER vaccine lot number 450253A and Acel-Imune vaccine lot number 464364: however, these are not valid lot numbers.
Information has been received from a physician concerning an adult female who was vaccinated with the first and second doses, respectively, of Varivax. The physician reported that a varicella titer revealed the patient did not seroconvert. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
A lot of itchiness and developed a rash 4 days or so after I received the 1st dose.  It felt like an allergic reaction, much like my latex allergy. I used hydrocortisone to alleviate. I took Tylenol for some relief. It spread from my right arm over to my back. The rash ended up going away after 2 weeks.
Hives lasting 5 days.  Took Benadryl for itching.  ***Note   Patient also got a spray tan at 6PM the same night.  This was her first ever spray tan.  She has had Flu shots for the past 5 years without any reactions.
Swelling left arm - nausea 24 hours  after vaccine - resolved 48 after edema X 1 day - 12 vesicles on chest.
Chest pain/pressure; Flushing; General fatigue; Presyncopal event; Migraine; Left arm tingling; Chest pain/pressure; This is a spontaneous report from a contactable nurse reporting for self. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3302), intramuscular on 20Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included coeliac disease, polycystic ovaries, migraine, drug hypersensitivity to Sulfa. Concomitant medication included clarithromycin (MACROBID [CLARITHROMYCIN]). The patient experienced flushing and general fatigue. Presyncopal event and migraine on day 3 without prior indication 23Jan2021. Left arm tingling and chest pain and pressure. Therapeutic measures Motrin were taken as a result of flushing and migraine. Patient had Covid test type post vaccination on 23Jan2021 with negative result. Outcome of events was recovering. All events resulted in emergency room visit.
New onset Atrial fibrillation with RVR diagnosed September 27, 2022
Ran fever of 103 degrees.  Moaning and whimpering in sleep.  twitching in sleep.  Next night, still high fever, had convulsions in sleep.  Still keeping watch on him.  Seems to be better after 48 hours.
pt devel immed tightening in chest-diff breathing became flush & had to sit down;
Expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HBV (Engerix B) (batch number M4KE9, expiry date 29-APR-2023) for prophylaxis.   On 09-MAY-2023, the patient received Engerix B. On 09-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose of Engerix-B was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2023 The medical assistant reported that an expired dose of Engerix-B was administered to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Increased SOB while at Dialysis and had to discontinue dialysis.  SOB/CHF warranted admission to the hospital- diuresis and supplemental oxygen.
Very heavy period within 24 hours of getting the vaccine; This is a spontaneous report from a contactable consumer(patient). A 14-years-old female patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration in the arm left on 14Jul2021 16:45 (at the age of 14-years-old) at single dose for covid-19 immunisation. The patient was not pregnant. The patient was not pregnant at time of vaccination. The patient medical history was reported as none and had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient concomitant medication was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced very heavy period within 24 hours of getting the vaccine on 15Jul2021 12:00 PM. The event did not result in Emergency Room Visit nor Physician Office Visit. No treatment was received for the event. The patient had not tested positive for COVID-19 since the vaccination. The outcome of the event was recovering.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium.
Headache, coughing, sneezing, sore throat, congestion, grogginess.
Elevated heart rate; High blood pressure with a headache; High blood pressure with a headache; Dose received: 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jan2022 at 12:00 (Lot number: FE3594) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EL0140; Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EL3246; Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 14Jan2022 at 12:00, outcome "unknown", described as "Dose received: 3"; HEART RATE INCREASED (non-serious) with onset 15Jan2022, outcome "not recovered", described as "Elevated heart rate"; HYPERTENSION (non-serious), HEADACHE (non-serious) all with onset 15Jan2022, outcome "not recovered", and all described as "High blood pressure with a headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, hypertension and headache.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.