chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient experienced chest pain and palpitations. On an unspecified date the patient was vaccinated with a second dose of GARDASIL (lot number, injection site and route not reported). The patient's chest pain and palpitations got worse after the second dose. The patient's primary care provider referred the patient to the reporting physician. The outcome of the patient's events was unknown. No further information is available.
This spontaneous report was received from a pharmacist who was told about the event by patient's friend. The report refers to a patient of unknown age and gender with a history of epilepsy. Current conditions and drug allergies were not specified by the reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of administration, lot# and expiration date were not specified). Concomitant medication was not specified by the reporter. On an unknown date, the patient experienced shingles of the brain which caused the patient's death on an unknown date. It was not specified whether any treatment was given for the adverse event and whether the patient sought any medical attention. Laboratory test were not specified by the reporter. It was also reported that the deceased person had never had the chicken pox and the pharmacist asked if a patient who had never had the chicken pox can be vaccinated with ZOSTAVAX. The physician correlated the death to receipt of the ZOSTAVAX without having a prior case of the chickenpox. No product quality complain (PQC) was filed. Additional information is not expected, because the reporter did not wish to be contacted.
improperly stored administered PROQUAD; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's medical history and historical drugs was not provided.   On 15-SEP-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD), lot #T013540 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 6 degree Fahrenheit (°F) to 14°F (11.7°F) for 25 minutes as recorded by a data logger. There was no previous temperature excursion reported.  Lot No. T013540 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD), expiration date reported and verified as 17-OCT-2021.
My lips and tongue became number 30 minutes after the shot.  They stayed numb about 6 hours.
Headache, sinus congestion, thick nasal secretions lasting two weeks. Then constant sneezing runny nose. Treated with decongestant Tylenol and Zyrtec.
Chest tightness, Throat tightness.  Patient was given 50mg via IM of Benadryl at 10:20 AM. Pt was then given dexamethasone 10mg IM at 10:44 AM after the initial Benadryl did not improve patient symptoms
This spontaneous report as received from a 65 year old female patient refers to herself. The patient stated that she had a history of shingles. Drug reaction/allergies included an unspecified reaction to an unspecified medication used to treat gout. On 10-DEC-2012 the patient was vaccinated with a dose of ZOSTAVAX (lot #, strength, dose, frequency and route unspecified). Concomitant medication included blood pressure medication. Consumer stated that since vaccination, she developed shingles 3 times starting in June 2013 (reported as 6 months after vaccination) and another one in approximately 2014 (reported as "not long ago"). Upon developing shingles, consumer was prescribed ACYCLOVIR bu the consumer stated that ACYCLOVIR did not work. No lab diagnostics studies were performed. The patient sought medical attention via contacting physician. No product quality complaint (PQC) involved. The outcome of shingles was unknown. Additional information has been requested.
LEFT-SIDED FACIAL NUMBNESS 5 MINUTES FOLLOWING INJECTION, NO PARALYSIS NOTED, HAD NOT RESOLVED BY THE TIME HE LEFT CLINIC 30 MINUTES LATER
Second shot produced red rash in area opposite of injection site on same arm, first shot with no rash reaction, but first shot caused feeling under the weather/achey x 2 days, no achiness with second shot, just red rash, raised area, about 2 days later to present
A report has been received from a Pharmacist concerning a 55 year old, Female patient, who had been receiving Nasal FLUMIST quadrivalent. FLUMIST quadrivalent was given to the patient on an unknown date. The pharmacist reported, that they gave accidentally FLUMIST to 55 year old patient on 21-Aug-2013. The outcome of the event of accidentally gave FLUMIST to 55 year old was unknown. The report was considered to be non-serious by the reporter.
Right arm was very sore; right hand felt numb; itchy on the right side of her back and her right arm; Itchy on the right side of my back; Rash with bumps; This is a spontaneous report from a contactable healthcare professional (patient). This 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiry date unknown), via an unspecified route of administration on 22Jan2021 15:00 at a single dose on the right arm for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included unspecified birth control pill. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On day 2, 23Jan2021 17:00, the patient's right arm was very sore, right hand felt numb, itchy on the right side of her back and her right arm. The patient started to develop rash with bumps. Rash went away as soon as she took Benadryl. On Day 3, she was back to normal, no soreness, no numbness and no itchiness. The events were reported as non-serious. Outcome of the events was recovered on 24Jan2021.
Chills, fatigue, muscle aches, fever with period of sweats, swollen neck lymph nodes, dizzy, diarrhea,  pounding headache. Symptoms have started to occurr on 12/28, until now jan 1st, 2021. It consumes my whole body, to eve. Get up from bed or even walk 10ft to the bathroom. Its very difficult,  I am a single mom with 3 kids.
Mild Red and itchy skin at injection site. Slight salty or metallic taste similar to what I experienced the day of the injection.    This is 8 days later. Have used topical benadryl.
p/vax pt flus sx & asthma-like sx;chest tightness, trouble breathing & frequent chills;attempted to treat/over the counter but no results;decided to see MD dx bronchitis;
Information has been received from a 28 year old female registered nurse who in 1997 had a pre-vaccination titer drawn for varicella which was negative.  In December 1997 and in 1998 the patient was vaccinated with a first and second dose of varicella virus vaccine live.  It was unknown if there was illness at time of vaccination.  In 2000 the patient had a post-vaccination titer drawn which was negative.  On 06/06/2004 the patient broke out in shingles.  On 06/07/2004 the patient went to see a nurse practitioner and was diagnosed with shingles.  She had an itchy rash over a band on her right side with millions of bumps.  She was treated with valacyclovir hydrochloride (Valtrex).  On 06/09/2004 the patient reported that she was feeling somewhat better.  It was reported that the patient was recovering with sequalae.  No product quality complaint was involved.  Follow up information received from medical records indicated that on 06/06/2004, the patient noticed that she had pain on the right side of her chest wall when washing her car.  That night, she noted that it itched quite a bit, and on the morning of 06/07/2004 she presented to the physician's office with a vesicular rash similar to zoster.  The patient was not aware if she had previously had the chickenpox.  It was noted that on 10/08/1997, a varicella-zoster AB (IGM) was normal and a varicella-zoster AB (IgG) was negative.  No diagnostic tests were performed or ordered.  The patient was diagnosed with zoster, and was treated with valacyclovir hydrochloride (Valtrex) 1, 3 times a day for 7 days and danekonat solution.  The patient declined pain medication.  The outcome was reported as recovered.  No further information is expected.
Pfizer Pediatric (5-11) dose given to adult aged >18 years in lieu of Moderna Booster intended. No adverse reaction. Client was informed of error and CDC's clinical considerations for COVID Vaccine errors and revaccination was reviewed. Provided second dose of Pfizer Pediatric (5-11) dose per CDC recommendations.
awful nausea occurred; Restless legs and couldn't stop shaking; Restless legs and couldn't stop shaking; Diarrhea once as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Raynauds Syndrome (circulation deficiency)" (unspecified if ongoing); "B12 deficient" (unspecified if ongoing); "facial paralysis/concussion" (unspecified if ongoing); "facial paralysis/concussion" (unspecified if ongoing); "Known allergies: Gluten allergies" (unspecified if ongoing), notes: Gluten allergies. The patient took concomitant medications. The following information was reported: NAUSEA (non-serious), 4 hrs after the suspect product(s) administration, outcome "recovering", described as "awful nausea occurred"; RESTLESS LEGS SYNDROME (non-serious), TREMOR (non-serious), outcome "recovering" and all described as "Restless legs and couldn't stop shaking"; DIARRHOEA (non-serious), outcome "recovering", described as "Diarrhea once as well". Therapeutic measures were not taken as a result of nausea, restless legs syndrome, tremor, diarrhoea.  Additional information: Age group: Adult (18-64 Years). Other medication in 2 weeks: Yes. COVID 19 Treatment started on 11May2022 with Anti viral brand Paxlovid stopped on 11May2022 via Oral route. Dose 2 date 21Mar2022. Adverse event: 4 hours after taking 1st dose, awful nausea occurred. Restless legs and couldn't stop shaking. Diarrhea once as well. Adverse event start date: 11May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Presents with abdomen pain and diarrhea. COVID + not overtly symptomatic. Once stable pt discharged home.
This study case was received from the investigator in a trial on 29 January 2014. A male subject (date of birth not reported), with no medical history, experienced a slightly elevated troponin lab result, considered mild in severity, 15 days after he received an injection of ACAM2000, lot number, route, site and side not reported) on 14 January 2014 and concomitantly, an injection of TYPHOID (manufacturer, lot number, route and site not reported) and ANTHRAX, other manufacturer, (lot number, route, site and side not reported) on 14 January 2014. On 29 January 2014, 15 days post vaccination the Troponin I result was reported as slightly elevated, 0.12 ng/mL. On 29  January 2014, electrocardiogram (ECG) was reported as normal. According to the reporter, if the ERT report says otherwise or more information becomes available, a follow-up report will be submitted. The subject did not require any medical treatment. The patient's outcome was reported as still present, not recovered. According to the investigator, the event of elevated troponin was considered other important medical event and possibly related to the trial product. Documents held by sender: None.
Mother states that student was 'just lying around' after school. She took student to the ER that night and states he was diagnosed with strep.
One week after first Moderna vaccine, experienced dizziness and tinnitus. Symptoms persist at present time.
Vaccinated on Tuesday.  Fever of 100.4 on Wednesday morning, took 2 Tylenol every 6 hours the day after the vaccination.  Woke up Thursday with no fever. Achy joints on both Wednesday and Thursday, feel normal on Friday. Had "COVID arm" after the first vaccination about the size of a softball and noticed it coming on last night around 7pm.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received a dose of ACT-HIB diluted with the MMR diluent. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant medications included DTAP; and PREVNAR. On 08-Mar-2019, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number: UI921AAA and expiry date: 09-Nov-2019) (dose and dose in series was not reported) via intramuscular route in the left thigh. It was a case of actual medication error due to inappropriate reconstitution technique as the patient was administered ACTHIB diluted with the MMR diluent. It was not reported if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a physician concerning an approximately 60 year old pt who in approximately October 2002, were vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (lot# 642722/0165M). Concomitant therapy, that same day, included a dose of influenza virus vaccine in the opposite arm. Within hours of vaccination, in approximately October 2002, the pt developed a "big time reaction" from the deltoid to the elbow. The reaction persisted for 3 to 5 days. The pt received palliative treatment. The physician reported that the pt had prior vaccination with pneumococcal vaccine 23 polyvalent over 5 years ago. The reporter expressed a concern with the lot. The records of testing prior to release of this lot have been checked by GMP compliance and found to be satisfactory. The lot complies with the standards of the CBER and was released. The pt sought unspecified medical attention. Additional information has been requested. This is one of a total of four patients. Three other patients had similar reactions after vaccination with pneumococcal vaccine 23 polyvalent (WAES 0210USA02060, 0306USA2764 and 0306USA02765).
30 mins after shot face felt numb and body felt heavy. Left work and started to feel better till around 10pm. Back started to hurt and couldn't get comfortable. Then the whole body started to ache. Quickly the whole body and skin hurt and food and drink tasted bad. Started becoming cold and had to wrap a blanket around. Went to bed and had to take Tylenol every four hours to sleep. Woke up and body aches and feeling cold continued the rest of the day. There was also nausea and headaches on and of the whole day. Went back to work the following day but felt heavily nauseous for most of the day and couldn't eat or drink much of the day.
2 BLOOD CLOTS IN BRAIN; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. Dose number series was 1. 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 an unspecified date, the patient experienced 2 blood clots in brain, and was hospitalized (date unspecified). The reporter stated that "reporter's ex-girlfriend who had 2 blood clots in brain after the shot and was in the hospital for 3 months. This company has hurt more then just her".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 2 blood clots in the brain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211215117-COVID-19 VACCINE AD26.COV2.S- 2 blood clots in brain. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Onset of area on (L) thigh that looked liked a bug bite that progressed to vesicles over the next several days.
6JAN93 pt states felt like wasp sting when inject was done lasted only seconds; 7JAN93 830PM pt felt like had fever but did not check; c/o chills; arm @ inject site sore, redness; face felt hot to touch; 8JAN93 9PM chills, face felt hot
I began to feel itchy, but didn't think anything of it until my entire body started swelling up by Friday. My blood sugars were getting higher and not going down.
Extreme neck stiffness; Neck pain; Pain in injection site; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 20Apr2021 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), Sjogren's disease and allergy to gluten, wheat and sesame. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced pain in injection site for first two days. On 23Apr2021, on 4th day(as reported), the patient experienced extreme neck stiffness and pain. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in injection site, extreme neck stiffness and pain was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Welts over my chest and back as well as neck and face.; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL1283; expiration date not reported), via an unspecified route (administered on left arm) at the age of 59-years-old, on 22Jan2021 01:00 PM as single dose for COVID-19 immunization. Medical history included childhood asthma from an unknown date and unknown if ongoing which the patient has out grown. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medication included simvastatin taken for an unspecified indication, start and stop date were not reported. The patient didn't take any vaccine within 4 weeks prior to the Covid vaccine. The patient experienced welts over his chest and back as well as neck and face on 22Jan2021 02:00 PM. The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event included Benadryl 125 mg over 6 hours. The outcome of the event was recovered.   No follow-up attempts are possible. No further information is expected.
She developed left shoulder pain at site of injection. Pain worsened so that lifting her left arm was very painful in the shoulder.
7/21/2021  - 30 minutes after injection - dizzy, rapid heart beat  - 11:00 PM-  7/28/21 - Severe pain, swelling and redness around injection site  7/22/2021 - Swollen and tender lymph nodes on face, neck, armpit, groin 7/22/21 - Present - Swollen lymph node in left armpit.  Frequent swelling of other lymph nodes. / Joint pain especially in left knee and ankle that makes walking difficult and has resulted in falls.
High pitched tinnitus mostly affects left ear; left atypical/tonic pupil; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 10May2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not available. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for unspecified indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 10:00, the patient experienced high pitched tinnitus mostly affects left ear and left atypical/tonic pupil. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events high pitched tinnitus mostly affects left ear and left atypical/tonic pupil were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Two days after customer received vaccination, she noticed her arm was sore and a "thumbnail" sized pink spot at the injection site. Two hours later, the site was warm to the touch and swollen. The pink spot was now a "quarter to half dollar "size. She called the pharmacy. It was recommended for her to take on antihistamine and contact her doctor. She took an ALLEGRA and she was feeling better within 10 minutes.