chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; I just get shingles again today/Several years ago I got shingles; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Zoster vaccine at an unknown dose. On an unknown date, less than 3 months after receiving Zoster vaccine and an unknown time after starting Valacyclovir, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Zoster vaccine.  Additional details were reported as follows: The age at vaccination was not reported. Several years before the reporting date, the patient got shingles for the first time regardless of already having Zoster shot in earlier two months. On the day of reporting, the patient again had shingles and was puzzled. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided. The patient got prescription of Valacyclovir medicine but the patient asked if this medicine was a right kind that help to fight off shingles and was really a good medicine. The patient also asked about the ineffectiveness of Zoster vaccination.
Vaccine given 1-20-10. Severe pain "bone deep" on 1-23-10. Reported 1-25-10 to nurse. Is taking 800mg ibuprofen 2x day. "Is helping." Cannot use L arm still.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 48-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). On 1st March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling, injection site erythema and malaise. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and malaise were recovering/resolving. The reporter considered the injection site pain, injection site swelling, injection site erythema and malaise to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The nurse practitioner came to the pharmacy to inject the vaccine to the patient. The patient had SHINGRIX sometime in March 2018. The patient experienced injection site reactions consisting of redness, pain, swelling and bumps at site. For further tolerance to next dose, refer case US2018GSK087683. This case is also linked to cases US2018077566 and US2018GSK087683, reported by the same reporter.
Child was given DTAP (Left leg), IPV, HIB (right leg), MMR at about 4:20.  Child was given Benadryl at 4:25.  Mom stated child had a red rash.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of ZOSTAVAX (Lot# 670038/0761AA, expired date 09-APR-2012, dose and route not reported) on 02-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. It was not known if the patient sought for medical attention. No adverse effect reported. Additional information has been requested.
Painful cramping and very heavy flow period with clotting. All abnormal for me. This lasted 4-5 days.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 11-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 11-JAN-2022, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220121562.
he has a hearing and memory problem; he has a hearing and memory problem; Very bad headache; Fatigue; Dizziness; This is a spontaneous report from a contactable consumer. A 95-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient has a hearing and memory problem. He later clarified the main thing is he wanted to know if he can continue with getting the second COVID vaccination. He wanted to continue but wanted to know if these symptoms will prevent him from continuing with getting the COVID vaccination. He confirmed he has no problems around the injection site. However, this is the second day and in Jan2021, he had dizziness. On 11Jan2021, last night he had a very bad headache and fatigue. This morning he is feeling better, but he still has slight dizziness. He is still three weeks away from getting the next vaccine. He wanted to know if he would be able to still take it. He wanted to be immune and to know if there would be any reason why he cannot take the second dose of the vaccine. He then mentioned these symptoms that he is speaking of are general symptoms and he assumed other people have reported them along with him because it is listed on the information sheet. Outcome of the events of dizziness, fatigue and headache was recovering, other events was unknown.    Information about batch/lot number has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Oct2022 as dose number unknown, single at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient took Paxlovid as treatment from 24Sep2023 to 28Sep2023.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300317356 same reporter/patient, different drug/event;
I was given the injection on 01/27/2021 in the left arm at approximately 08:30 am. At around 08:00 pm I started to get really cold and had the worst case of the chills I have ever had. I was shaking so hard my body hurt. At around 10:30 pm I went to bend and started to get a low fever of about 101.4* and could not get warm. I started to get a bad headache and my body hurt. It was so bad I had to call in sick the next day for work. On 01/28/2021 I stayed home and had sever body aches, bad headache, the chills and I felt nauseas. From my left hip to my left knee it felt like I had a bad charley horse. That night I got another low grade fever of about 100.1*. I woke up in the middle of the night sweating and still had a headache. I took some Aleve and went back to sleep. I called in sick again the next day and that day I was a little better only had a headache, a little nauseas and body was only a little sore. I went to bed and am fine today. A note I have never tested positive to COVID-19 and I test weekly.
Appoximately 10-15 minutes after patient received the Flu vaccine, she began having swelling in mouth and throat. 4:25 PM She was given Benadryl 50 mg per Dr's order. Swelling increased and throat felt tight. 4:35PM SoluMedrol 125mg IM given per Dr's order. 4:50PM Chilling, but she states she feels a little better. BP 110/58. 5:15PM Since patient was still feeling discomfort in throat, Dr. ordered an EpiPen which was given at 5:20PM. patient started having an increase in swelling and was then sent to Emergency Department.
Nausea; Dizziness; vomited once; Chills/her left hand, where she got the shot, it does not feel right. It feels chilled.; soreness and pain at the vaccine site; Tiredness; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via intramuscular on left top upper arm where the muscles are below shoulder on 24Dec2020 at single dose for prevention because she works in hospital (COVID-19 immunisation). The patient medical history included high blood pressure. Concomitant medication included Hydrochlorothiazide started a year ago in 2019 at 12.5mg, once daily for High blood pressure. A later response of symptoms including nausea, dizziness, and vomited once. The patient got the COVID vaccine last Thursday, 24Dec2020. That day she had chills on 25Dec2020 06:00. (PENDING CLARIFICATION) She did not have any more problems with that. The second day, 25Dec2020 00:00 she had soreness and pain at the vaccine site. Then, it was ok but sore that day and then this morning. She is having dizziness, nausea and vomited one time at 07:30 on 29Dec2020. Started on 10:00 25Dec2020, her left hand, where she got the shot, it does not feel right. It feels chilled. On Monday, she was completely fine. She did not leave. At work on Sunday. No discomfort. Today morning, she has chills and started getting all the symptoms. Her left hand is not normal. She cannot say it is weak though. The left hand is chilled. She would like to know if Pfizer has reports of others with similar issues. She also would like to know if she should get the second dose and if she should see a physician about any of these. She works at the hospital and they were giving out to employees. There was no prescriber. It was not mandatory. Her daughter got it on 20Dec2020. She is a doctor and did not have any issues. Lots of people in her family got the vaccine. No further details provided. Regarding the first day she got chills, it was like an all over body chill. The chill described on her left hand went away on 25Dec2020, and today is feeling it again. Left hand is not bad cold, just chilly. She was still tired. She is not dizzy but didn't feel all that good. Outcome was provided as persisting but improved. She was tired the day she got the vaccine at night time on 24Dec2020, she went to bed early, slept all night and Friday morning she was also tired. By Friday afternoon, she felt better and was doing better until this morning and it started again. She did not feel this bad when she got the vaccine. Today, it is worse. She is nauseated, dizzy and tired. She never had a flu vaccine. This is the first time in her life getting a vaccine. The outcome of the events chills and left arm sore and painful was recovering and the outcome of the other events was unknown.
large red area lower than the vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE ERYTHEMA was resolving. Not Provided      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 were not provided by reporter. Treatment medications included Antibiotics.
Information has been received from a medical assistant concerning an 18 year old female patient with no medical history and a penicillin allergy and a sulfonamide allergy who on 30-JUL-2007, was vaccinated IM into the left deltoid with a prefilled syringe of Gardasil (Lot# 658282/0929U). Concomitant therapy included PROZAC and LOESTRIN 24 FE. Subsequently, the patient experienced dizziness after the first dose> on 19-SEP-2007, the patient received a second dose of Gardasil (Lot# 654539/0742U). Fifteen minutes later after leaving the office, the patient broke out in hives and a fever. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On an unknown date, the patient recovered. It was reported that the third dose of the vaccine will not be given. No product quality complaint was involved. Additional information has been requested. Information has been received from a medical assistant concerning an 18 year old female patient with no medical history and a penicillin allergy and a sulfonamide allergy who on 30-JUL-2007 in the "PM", was vaccinated IM into the left deltoid with a prefille dsyringe of HPV vaccine (Lot# 658282/0929U). Subsequently, the patient experienced dizziness after the first dose. On 19-SEP-2007 in the "PM" the patient was vaccinated IM into the left deltoid with a second hose of HPV vaccine (lot # 65439/0742U). Fifteen minutes later, after leaving the office, the patient broke out in hives and a fever. Unspecified medical attention was sought. No laboratory diagnostic studies were performed. On 29-NOV-2007, at an office visit, the patient recovered. It was reported that the third dose of the vaccine will not be given. No product quality complaint was involved.
This spontaneous report as received from a Licensed Vocational Nurse (L.V.N.) refers to unspecified number of unspecified patients of unknown age and gender. The patients were administered an unspecified number of improperly stored doses of VARIVAX (Merck) (subcutaneous injection, dose, frequency, lot# and expiration date were not reported) on unspecified dates since 01-FEB-2015. No adverse effects were reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
tingling in her lips; numbness in her tongue; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  She had the first Pfizer vaccine in the morning and about 30 min later noticed some tingling in her lips and partial numbness in her tongue. The outcome of the events was unknown. Information on the lot/batch number has been requested.
No additional adverse effects reported.; On 01-JUN-2020 a patient was administered an improperly stored dose of MMR II.; This spontaneous report was received from an administrator refering to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions/allergies were not reported.  On 01-JUN-2020, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) (lot number S014430, which has been verified to be valid, expiration date reported and validated as 09-MAY-2021) (vaccination scheme, anatomical injection site, and route of administration were not reported) for prophylaxis (product storage error). No additional adverse effects reported.  The administered vaccine was exposed to an unknown temperature excursion for 20 hours. No data logger involved. There were no previous excursions reported.
This spontaneous report was received from a pharmacy technician, who referred to a 22-year-old male patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 11-JUL-1995 and 14-SEP-1995, the patient was vaccinated with Hepatitis B vaccine (manufacturer unknown), dose 1 and 2 respectively (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 14-SEP-1995, the patient was also vaccinated with Haemophilus Influenzae B vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. The pharmacy technician reported that on an unknown date, the patient had an unknown test done, which showed that his levels were insufficient. It was also reported that the patient was also Human Immunodeficiency Virus (HIV) positive since an unknown date and was treated with an unknown medication. The reporter did not clarify whether the patient was born HIV positive or whether the patient became HIV positive after receiving the vaccinations. The outcome of the reported events was unknown. No product quality complaint was involved. The relatedness between the events and the suspect therapy was not reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 1:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 1:32 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) 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 66.41 on 13-Feb-2021 and 67.13 on dose given on 03-Nov-2021. Concomitant products were not provided.  On 13-Feb-2021, excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021, 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. On 03-Nov-2021, excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021, 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Gave MMR SC in left leg and varicella SC in right leg. About 40 seconds later, I noticed redness around each of injection site about 3 inches in diameter. Notified NP immediately; baby had been given Tylenol 10 minutes before. PMD was called and informed. Patient sent to be seen by PMD.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (on weekends) and Marijuana use (Occasional). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 31-Jan-2020 to an unknown date for Pregnancy.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 14-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2020, Ultrasound scan: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a 34 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving mRNA-1273 vaccine approximately 2 months after she had a positive pregnancy test. No adverse events were reported.
Received my vaccination on July 5th and I was scheduled for my infusion on July 6th.  I receive infusions of Simponi Aria  for my RA.  I called my rheumatologist to see if it was safe for me to get the infusion directly after the vaccine and I was advised that it was fine.    I woke up on Tuesday, July 6th and I had a slight sore throat and headache but it wasn?t significant so I went for my infusion.  By Tuesday evening my symptoms were worsening.   On Wednesday I had more symptoms, and actually felt like I had Covid-19 again.  Sore throat, runny nose, body aches, low fever, stomach issues, and very fatigued.  I even developed a little cough.  So on the 14th of July, I got a COVID test.  As the aforementioned symptoms start to subside, I developed a rash on my arms and neck, itchy palms and feet as well.  I thought it was hives but nothing I did got rid of the rash and itching.  Called my primary physician on the 19th of July I believe.  He prescribed some medication that did not help the problem.  I am still dealing with the rash and itching today.