chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MULTIPLE MINI STROKES; This spontaneous report received from a patient via a company representative concerned a 5 decade (around 41 years) old male of unknown 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 not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple mini strokes. The timing between the vaccine and the stroke was unknown, and that the patient still had troubled speaking today. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from multiple mini strokes. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211112429-Covid-19 vaccine ad26.cov2.s-Multiple mini strokes. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fever of 103 x 5 days 1 wk p/immun administered; treated w/appropriate dose of APAP;
HOSPITAL COURSE: The patient was admitted to the hospital with acute respiratory failure secondary to COVID pneumonia
Headache; Nausea; Upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced headache, nausea and upset stomach. On an unknown date, the outcome of the headache, nausea and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the headache, nausea and upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient was having headache, nausea and upset stomach five days later. The patient knew it was not common, but could that be happened. Additional supportive information: The follow-up would not possible, as no contact details were available.
Patient's date of birth was calculated incorrectly. Patient received a moderna booster  (which was requested) instead of another pfizer
This case was reported by a healthcare professional and described the occurrence of Hepatitis B antibody negative in a 24-year-old female subject who was vaccinated with Hepatitis B vaccine and ENGERIX B. On 23 September 2004, the subject received 3rd dose of Hepatitis B vaccine, to complete the The second dose of ENGERIX B was given on 19 March 2004, and the 1st dose of ENGERIX B was given on 20 February 2004. On 12 June 2007, approximately three years after receiving the 3rd dose in the Hepatitis B  vaccination series. the subject had a titer drawn that was Hepatitis B antibody negative. At the time of reporting the outcome of the event was unspecified.
PATIENT RECEIVED VACCINE ON 5/17/21 AT 1234 WHILE AT HIS OFFICE VISIT.  AT 1438 WIFE CALLED IN SAYING PATIENT WAS HAVING DIFFICULTY BREATHING AND CHEST DISCOMFORT.  WIFE WAS ADVISED BY NURSING STAFF THAT PATIENT NEEDED TO GO TO THE ED FOR EVALUATION.  WHEN NURSING DID A FOLLOW UP CALL THIS MORNING THEY WERE TOLD BY THE WIFE THAT THE PATIENT EXPIRED AT 0609 ON 5/18/21.
FEELING SORE; ACHY JUST LIKE GETTING THE FLUE; RASH COVERNING BODY; LOW GRADE FEVER; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (FEELING SORE), INFLUENZA (ACHY JUST LIKE GETTING THE FLUE), PYREXIA (LOW GRADE FEVER), RASH (RASH COVERNING BODY) and HEADACHE (HEADACHE) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Foot surgery in january). Concomitant products included Torvistatin, LEVOTHYROXINE, ALLOPURINOL and sulfamethoxazole TMP BS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (FEELING SORE), INFLUENZA (ACHY JUST LIKE GETTING THE FLUE), PYREXIA (LOW GRADE FEVER), RASH (RASH COVERNING BODY) and HEADACHE (HEADACHE). The patient was treated with IBUPROFEN at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. On 08-Mar-2021, PAIN (FEELING SORE), INFLUENZA (ACHY JUST LIKE GETTING THE FLUE), PYREXIA (LOW GRADE FEVER) and HEADACHE (HEADACHE) had resolved. At the time of the report, RASH (RASH COVERNING BODY) outcome was unknown.        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.   Treatment details included Patient took Benadryl and ibuprofen to help relieve symptoms..
Dizziness, Headache, Diarrhea, NauseaVomiting, arm pain with mild swelling, fatigue Narrative
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, pain, chills, hives and pruritus. On an unknown date, the outcome of the pain in arm, pain and chills were recovered/resolved and the outcome of the hives and pruritus were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, pain, chills, hives and pruritus to be related to SHINGRIX. Additional details were provided as follows: The reporter was wife of the patient. The patient experienced sore arm, aching and chills for 3 to 4 days and then those events resolved. A few days after the dose, the patient began experiencing hives and itching. The hives would show up, lasted for about an hour and then go away and the later would show up in a different area of the body and then go away. This was still occurring with the patient, at the time of reporting. The reporter did not consent to follow-up and declined the prescriber follow up.
Trouble breathing and tinnitus; Trouble breathing and tinnitus; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced trouble breathing and tinnitus on an unspecified date. It was reported that Caller had called to report on her experience with the 1st dose of Pfizer Covid 19 vaccine and had been seen at an emergency clinic for trouble with breathing and tinnitus. It was reported that while she was in the emergency clinic there was a woman there 1 hour before her that also got Pfizer and had the same issue as she did. No further information was obtained or provided. The outcome of events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be requested.
Accute deep vein thrombosis of popliteal vein of right lower extremity.
No aditional AE info; Physician calling reports patient was given a 3rd dose of PEDVAX HIB. First dose was given DEC 10 2021 at 2 months, second dose given FEB 11 2022 at 4 months and third dose given APR 15 2022 at 6 months. No additional AE info. No PQC.; This spontaneous report has been  received from physician and refers to a 6-month-old female patient.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On 10-DEC-2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, first dose, a second dose was received 2 months later on 11-FEB-2022, and a third dose 2 months later on 15-APR-2022 administered for prophylaxis (strength, lot number, expiration date, and route of administration were not provided) (product use issue). No additional adverse event were reported.
Narrative:  PATIENT PASSED AWAY DUE TO COVID-19. HE WAS HOSPITALIZED AND HAD RECEIVED THE COVID-19 VACCINE.
Woke up around 5am the morning after my second dose of the Pfizer with severe chills and headache. I was sweaty when I woke up but also feeling cold at the same time. Around 7am the same morning, I began having body aches specifically in the back of my neck and low back. I slept most of the day and still felt run down when  throughout the entire day. The chills and headache we?re  the worst in the middle of the day around 1pm.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reaction and allergies were not reported. On 25-AUG-2014, the physician reported that the patient was vaccinated with a dose of M-M-R II, subcutaneous (dose and lot number were not reported), which expired vaccine on 25-JUL-2014 and was inadvertently administered to a patient. No adverse effect was reported. Additional information has been requested.
Dull, throbbing nerve pain shooting down arm of injection into wrist, up through shoulder and to back.
He got at the injection site 2 blisters; This is a spontaneous report from a contactable consumer. A male patient (son) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 21Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 22Aug2021 08:00, the patient experienced he got at the injection site 2 blisters. Patient did not any AE(s) require a visit to emergency room. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Service number received the 2nd dose of MMR. About 3-4 weeks later started to experience tremors, muscle aches, pain and became shaky. Also noticed a rash in groin area. Went to the doctor but not able to determine if symptoms are due to vaccine. Recently diagnosed with influenza and pneumonia.
Information has been received from a pharmacist concerning a 21 year old female patient with no pertinent medical history and no allergies who was vaccinated with GARDASIL vaccine (yeast). There was no concomitant medication. The patient has been experiencing "spotting" during menstrual cycle. The pharmacist did not know the history of the "spotting". The patient is not known to be on birth control. The patient's spotting during menstrual cycle persisted. No further information is available.
pt recv vax & exp nausea, chills, hot flashes & dizziness (onset date unspecified);sx lasted approx 1wk;
Information has been received from a physician concerning an approximately 5 year old female who in November 2007 (when she was 4 years old), was vaccinated with her second dose of MMR II (Lot # not reported). Concomitant therapy included DTaP (manufacturer unspecified) (Lot # not reported) received in October 2007. In June 2008, the patient had a "twilight" seizure where she was going "in and out" of her sleep cycle. It was originally thought that she had sleep apnea. The patient had seen an ear, nose, and throat (ENT) specialist and a neurologist. Last month (approximately July 2008) the patient had another seizure. The patient sought medical attention and went to the emergency room and was put on an unspecified seizure medication but the patient did not react well to it (unspecified reaction). On an unspecified date the patient had a magnetic resonance imaging (MRI) which was normal, a computed axial tomography (CT) scan which was normal, and an electroencephalogram (EEG) which was abnormal. No product quality complaint was involved. Upon internal review, "twilight" seizure and seizure were considered to be other important medical events. No further information is expected.
I had the 1st shot in June can I get the second shot/Beyond 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had the 1st shot in June can I get the second shot/Beyond 35 days for 2nd dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had the 1st shot in June can I get the second shot/Beyond 35 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had the 1st shot in June can I get the second shot/Beyond 35 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received: first dose date updated, consent obtained. On 01-Sep-2021: Follow-up received on 01-sep-2021 having no new information
COVID Arm - Dime-sized red splotch on arm directly under the injection site; sore to touch; arm soreness and feeling of pressure on upper arm
Resident had an emesis, complaints of cough, congestion, and headache, increased respiratory rate, tachycardia,  and fever.
June 10th, I went to doctor's office (had to see a different doctor) on June 11th. I had a rash on my forehead and kind of a headache. He determined it was Shingles. He put me on medication for 10 days. I took Valtrex; or the generic for it. It went away in about two weeks. It healed up. I had the 2-shot Shingles' vaccine already (the year before). He said I was a breakthrough case.
Myalgia, Fever, Diarrhea, Nausea Vomiting, FATIGUE, CHILLS Narrative:
Information has been received from a health professional concerning a female in her mid 60's who on approximately 10-NOV-2005 was vaccinated in the deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Subsequently, the patient experienced fever, erythema and edema at injection site.  Subsequently, the patient recovered.  No further information is available.
light heart palpitations; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (light heart palpitations) 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.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Dec-2021, the patient experienced PALPITATIONS (light heart palpitations). At the time of the report, PALPITATIONS (light heart palpitations) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Information has been received from a 73 year old female patient with previous history of 4 different cancers, including breast cancer that she had 8 years ago who on approximately 05-AUG-2011 (3 weeks ago) was vaccinated with ZOSTAVAX (Merck) (lot # not provided). Caller stated she was not experiencing any problems post vaccination. However. caller stated her breast cancer had metastasized to cancer in her femur in August. MRI,  PET Scan, x-ray and bone scan had been performed without providing results. Consumer stated she began chemotherapy on 26-AUG-2011 (this past Wednesday), and would be scheduling radiation treatments soon. Upon internal review, "breast cancer metastasized to cancer on femur" was determined to be an other important medical event. Additional information is not expected.
Patient attended an immunization clinic hosted by pharmacy. Because I was not at the event, I am unsure if patient had a previous covid card. When attempting to bill the vaccine at the store the next day, a rejection came up showing plan limitations exceeded. Patient already received the bilavent Pfizer vaccine on 9/11/22, which means a second bivalent booster was administered at this clinic. Patient is not answering the phone to check in, but a message was left. The event was reported in our internal reporting system.
About 2 hrs after giving the varicella vacc she started with nausea and then vomiting. No fever. I saw her again at the office and gave Benadryl. Her vomiting persisted. Admitted to the hospital for observation.
Erythema, edema, induration at injection site (Lt leg). Systemic symptoms of headache, nausea, vomiting. Subjective fever.
Redness and swollen at injection site, patient states feels like bee sting, symptoms started per patient after 48 hours. Advised patient to apply ice and take acetaminophen or NSAID. Advised patient if persists to contact primary care provider.
Area of vaccine was turning very red, hard to the touch, and tender and was quickly spreading the length of her arm. Over the next 24 hours the area affected expanded from the top of her shoulder down to her elbow. ROM was affected. Child was also very lethargic and tired and would not eat. 48 hours after time vaccine was give the redness and hardening expanded from her shoulder to her elbow and wrapped around her entire arm. Arm was also 2+ times larger in size than normal size.
Information has been received from a physician concerning a female (age unspecified) with unspecified history of drug reaction/allergies and no pertinent medical history who on an unspecified date was vaccinated with Gardasil vaccine (yeast) (lot# not reported) 0.5 ml by injection. Concomitant therapy was not reported. Subsequently, the patient experienced a seizure after the injection of Gardasil vaccine (yeast). Medical attention was sought. At the time of reporting, the patient had recovered. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information has been requested.
childhood leukemia; Initial information regarding an unsolicited valid serious case was received from a pharmacist (Reference number- 00434394) and transmitted to Sanofi on 18-Jan-2021.  This case involves a 4-year-old patient (unknown gender) who experienced childhood leukemia (leukaemia), while the patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, past medical treatment, family history and concomitant medication were not reported.  The patients past vaccination included HIB vaccine for prophylactic vaccination (reported as preiously received a full series of Haemophilus influenzae type b (Hib) vaccine).  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (batch number and expiration date were not reported) via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, the patient experienced childhood leukemia (leukaemia) (latency: unknown) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. This event was assessed as medically significant.  The reporter asked if Pentacel had ever been implicated as a potential cause of childhood leukemia and any side effects were anticipated if a 4-year-old patient received one dose of Pentacel after previously receiving a full series of HIB vaccine.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the events was reported as unknown.  Information about batch number requested.; Sender's Comments: Sanofi company comment on 22-Jan-2021: This case concerns a 04-year-old patient who experienced leukaemia after vaccination with PENTACEL. The time to onset is compatible. Further information regarding medical condition at the time of vaccination, previous vaccinations and laboratory investigations excluding alternative etiologies is needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Redness, itching, pain, swelling in right leg spreading previous reaction to shot/immunization but was not sure which shot was given in which leg (occurred at another clinic).
I got my shot Friday afternoon at 1pm, around 8pm the following Sunday night my left foot started tingling out of no where. Then my right foot started tingling off and on all day. My right had also started to tingle some (but not as much). It is now Wednesday (5 days post shot) and the tingly has subsided, but is still there. My feet also seem like after they tingle a lot they get sweaty.
pt recv vax & devel an inj site rxn characterized by pain, redness, & induration;
Still have redness at injection site-and yesterday woke up feeling exhausted, gi upset- no vomit or diarrhea but definitely nausea- didn't really eat anything until dinner-just took sips of water and Sprite-  and took 2 naps- which is something I only do ONCE a year if at all! Not something I ever do unless early pregnant (which I'm not!) or have the flu etc. Today i am feeling  85% - no nausea- still redness. Flu shot first week of Oct- can get details if need.