chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 01-MAY-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as " in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Fainted without warning while attempting to take second dose of Extra Strength Tylenol. Had a fever and chills and severe arm soreness.
After Tdap vaccine in right arm, blurred vision and flashes of bright lights in right eye, then floaters.  Vision is blurry and a gray film is still over in the right eye
First day sore throat, second day stuffy nose, third day hives over the face and low grade fever , fourth day persistent cough
Temp of 103 off and on for 4 days. Very fussy, no appetite, no URI symptoms, no rash.
Patient was well until 7/31 when she developed low grade temps.  She spiked to 103.5 on 8/1 and was seen on 8/2 complaining of emesis on 7/31 and rhinorrhea x 2-3 days.  She was diagnosed with a right OM and was started on amoxicillin.  She appeared better late on 8/2 and seemed fine on 8/3 in the morning.  She had a temp of 101 when the mother left for work around 9 AM.  By 12 PM the patient was noted to be somewhat lethargic.  She began to develop some cyanosis of her hands and feet as well as what were probably rigors.  By 1 PM the patient's caregiver took her temp and noted it to be 107.6 rectally.  EMS was called.  The patient arrived in the ER obtunded, with a temp of 107.5, BP of 60's/20's, O2 saturation of only 90% on 100% by mask.  She was intubated in the ER and started on dopamine.  Initial CBC showed WBC=2 with ANC=390, Hgb approx 8.5 and plt approx 60.  Broad spectrum antibiotics were begun and blood, urine, and CSF cx were obtained.  All cultures have been negative.  An MRI obtained on 8/7 revealed changes consistent with ADEM.  Steroids were begun on 8/6 following a CT scan that was also suggestive of ADEM and IVIG was given starting on 8/7.  The patient has become more responsive since the steroids and IVIG although she is still intubated and sedated.  She does have left ptosis and left abducens nerve palsy as well as hypertonia of her lower extremities bilaterally. 02/27/07-DC report received: DX:ADEM complicated by spasms and diffuse neurologic sequelae. R/L Hydronephrosis, UTI resolved. Respiratory distress Intubated 8/14 and extubated 8/18/06. Ophthalmology consult 10/20/06-observed series during exam. 60 day Follow-up Information 13-NOV-2006: Possible seizure disorder, Glosal developmental delay (Several ADEM
bullous type rash on bilateral lower extremities, which appeared as a large fluid-filled blister; pemphigoid-like reaction/ could be a bullous pemphigoid; This is a spontaneous report from a contactable nurse. A 47-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07May2021 08:10 (Batch/Lot Number: EW0170) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing morbidly obese, blood clot in one of legs that resolved. The patient's concomitant medications were not reported, patient was not currently on any medications. No prior vaccinations within 4 weeks. Patient had the first dose of bnt162b2 on 16Apr2021 with lot: EW0158. The patient received the second vaccine on 07May2021 and he noticed the rash starting that night and really noticed it progress on 08May2021. On 11May2021, patient with a bullous type rash on bilateral lower extremities, which appeared as a large fluid-filled blister, a pemphigoid-like reaction. Patient had had no new soap, clothing, or detergent. He has had nothing new. The reporting nurse say this is medically significant because she is concerned it could be a bullous pemphigoid which could be life threatening if that is the case. No emergency room or physician office visit. The events outcome was not recovered.; Sender's Comments: Based on the available information and known product profile, the potential causal relationship between the reported events and use of BNT162B2 is cannot be fully excluded. The case will be assessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 virus test was positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter.    No treatment information was provided.
Right Shoulder was sore starting evening of 17 April and most of the day on 18 April.  Rash developed today (26 April) approximately 1.5 to 2 inches diameter (red dots).
Immediate and sudden numbness and tingling in left hand/fingers 8/15/2021 Extreme pain in left arm, left  armpit, side of left neck , numbness and tingling in left elbow and hand/fingers 8/18/21 Extreme Pain in left side of chest, left arm , left armpit, and left side of neck 8/25/21 Extreme pain in the left arm, left shoulder, and  left side of neck
Rash on his abdomen, penis, cheek, side of neck. Now the rash is spreading to his legs.; Rash on his abdomen, penis, cheek, side of neck. Now the rash is spreading to his legs.; Appears to be urticaria; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the parent.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 01Jul2022 as dose 3 (booster), single (Lot number: FL8094) at the age of 8 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, lot number=FK5618, Intramuscular, Left arm), administration date: 07Dec2021, when the patient was 8-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, lot number=FK5127, Intramuscular, Left arm), administration date: 16Nov2021, when the patient was 7-year-old, for COVID-19 immunization. The following information was reported: URTICARIA (medically significant) with onset 02Jul2022, outcome "not recovered", described as "Appears to be urticaria"; RASH (medically significant), PENILE RASH (medically significant) all with onset 02Jul2022, outcome "not recovered" and all described as "Rash on his abdomen, penis, cheek, side of neck. Now the rash is spreading to his legs.". The events "rash on his abdomen, penis, cheek, side of neck. now the rash is spreading to his legs." and "appears to be urticaria" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of rash, penile rash, urticaria, included Benadryl, Zyrtec, and prednisone.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
Body got a little achy. Noticed I had a slight fever the next day so I took an ibuprofen tablet.
Patient stated that following flu vaccine, she passed out due to fatigue and slept most of the day. In the middle of the night, she had nausea, vomiting, and diarrhea up until 3 am on 9/18/18. She stated she did not eat anything after the vaccine because she did not feel good. She is sweating and possibly running a fever so she took three 81mg aspirins. She is chronically taking oxycodone 5 mg twice daily for pain as well. Patient was counseled to rest and stay hydrated. She was told to monitor her symptoms and to reach out to her PCP to follow up. She was also told to go to urgent care/ER if symptoms continue to worsen (nonstop vomiting/diarrhea and if temperature doesn't go down with 24 hours).
Dizzy, fuzzy headed, headache, (L) foot and bilateral hands fuzzy 9/28/07-records received from neurologist for DOS 8/22/07 and 8/31/07-Seen for C/O lightheadness and tingling in her hands and toes one day after receiving a miningococcal vaccination, 9 days prior to this evaluation. Has also had occasional headaches and feels a little confused and weak all over. Headaches everyday which is atypical for her. More thirsty lately. Denies difficulty ambulating, speaking for swallowing. No fever. PE: WNL.
Initial and follow-up information has been received from a Nurse Practitioner (N.P.) concerning a 16 year old female patient with Attention Deficit Hyperactivity Disorder (ADHD) who on 29-MAR-2007 was vaccinated with a first dose of Gardasil. The patient was upset and crying prior to the first injection, because of fear of vaccination. The patient said that when the injection was administered it felt as if they were injecting fire into her arm. The injection site immediately developed an erythematous raised area about 3 inches in diameter. The raised area was red and warm to touch. The patient's mother reported that there was a red area on the chest wall in addition to the reaction at the injection site. The nurse practitioner did not see the chest wall reaction. The patient was kept in the office and was given Benadryl 50 mg and ice was applied to the injection site. On 29-MAR-2007 the reaction subsided and the patient recovered. Additional information has been requested.
Had a miscarriage (due date was 12/02/21)  Have had high blood pressure which required er visit since getting vaccine
Brain stroke; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Brain stroke) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, SIMVASTATIN, LISINOPRIL, OMEPRAZOLE and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Brain stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Brain stroke) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) medial occipital and temporal lobes affected..     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 of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "SVT" (unspecified if ongoing), notes: Other medical history: SVT; "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: METOPROLOL TARTRATE, start date: 01May2014; ATORVASTATIN, start date: 01Sep2020, stop date: 27Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Treatment Drug (PAXLOVID), from 28Oct2022 to 01Nov2022 for covid-19 treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A few days after receiving the vaccine I started to get chills. I developed mouth sores all over my tongue, and soft palate. I also had blisters that were all over my lips. I went to see my Doctor on they prescribed me an antibiotic 1 dose and oral topical lidocaine to help treat the blisters and sores. The sores lasted for about 2 months
About 48 hours after vaccination, I developed tender and swollen lymphadenopathy from my axilla down the bottom of my arm to my elbow on my right side. This is the same side the injection was given. The injection site is no longer tender to touch but it is difficult to raise my arm and hold it straight due to discomfort. My arm is visibly swollen compared to my left arm. I can feel shotty lymph nodes down my arm.
stiff neck; toe infection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck) and LOCALISED INFECTION (toe infection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Diabetes and High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, CEFALEXIN (CEPHALEXINE) for Infected toe.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and LOCALISED INFECTION (toe infection). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) and LOCALISED INFECTION (toe infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event include muscle cream.
This spontaneous report as received from a nurse refers to unspecified amount of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date these unspecified amount of patient were vaccinated with a dose of GARDASIL (Lot number J015378, expiration date 09-APR-2016, dose, route not reported) that underwent a temperature excursion. Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pain in the neck; pain in the teeth; Arm where she received the vaccine is very painful, she can not move it; pain in the shoulder; Area in the arm where she received the vaccine is very painful; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Vitamin D.).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful). At the time of the report, NECK PAIN (pain in the neck), TEETHING (pain in the teeth), MOBILITY DECREASED (Arm where she received the vaccine is very painful, she can not move it), ARTHRALGIA (pain in the shoulder) and VACCINATION SITE PAIN (Area in the arm where she received the vaccine is very painful) had not resolved.            The patient was not on any concomitant medication. The patient have not received other vaccines within 1 month prior to Moderna. The patient tested positive for COVID on 24 Dec 2021 and some more times but not remember the dates. Patient received booster dose on 13 Dec 2021 or 14 Dec 2021 reporter was not sure. The patient did not experienced similar event in the past. Patient  went to the doctor because it was very painful.Patient had never taken painkillers and at the time of reporting patient was on painkillers.Patient received physical therapy and acupuncture .   This case was linked to MOD-2022-511800, MOD-2022-511845 (Patient Link).
runny nose; sore throat; diarrhea; fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer-Sponsored-Program. A female of an unspecified age received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Mar2021 the patient experienced diarrhea, runny nose, sore throat and fever, on Friday (02Apr2021) caller went to the doctor and had a strep test and COVID-19 test, both were negative. The outcome of the events were unknown and fever stopped yesterday (recovered on 04Apr2021).   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a doctor of pharmacy concerning a 16 year old female patient who on 04/23/2003 was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M).  Within hours on 04/23/2003, the patient developed severe pain and swelling in the arm of the injection.  Unspecified medical attention was sought.    The reporter also mentioned three other patients that had adverse experiences post vaccination with pneumococcal vaccine 23 polyvalent (Lot # 645249/1196M) (WAES # 0304USA02307, 0304USA02519, 0304USA02521).  The reporter expressed a concern with the lot.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.
BLOOD PRESSURE FLUCTUATION; DIZZINESS / LIGHT HEADEDNESS; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension sad, non-smoker, and social alcohol drinker, and other pre-existing medical conditions included no known allergies. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included amlodipine, bupropion hydrochloride, and lisinopril. On 09-APR-2021, the subject experienced blood pressure fluctuation. On 09-APR-2021, the subject experienced dizziness / light headedness. On 09-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine  was not applicable. The patient recovered from injection site pain on 10-APR-2021, and had not recovered from blood pressure fluctuation, and dizziness / light headedness. This report was non-serious.
Large red patch around injection site. About 3x5 inches in size. Flat not raised. Mild itching. Appeared 3 days after shot. Lasted about 3 days. Disappeared no further problems.
30 hrs p/vax pt had 10min episode of hypotonia & was pale fine p/30 mins;
04/05/2016: Follow up information received om 05-APR-2016. Lot number L006805 is an invalid lot number for ROTOTEQ. Additional information has been requested. Narrative was updated.  This spontaneous report as received from a healthcare worker regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 25-MAR-2016, the patient was vaccinated with expired dose of ROTATEQ dose 1, 2 ml, oral, lot number L006805, expiration date- 24-MAR-2016, (expired product administered). No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Large blotchy rash (5" long, 4" wide) on arm at site of the injection, sensitive to touch and feels warm.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 60-year-old male patient who received SHINGRIX (batch number J4D5J, expiry date 8th February 2021) for prophylaxis. On 5th September 2018 18:00, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a month after receiving SHINGRIX, the patient experienced headache, diarrhea, general body pain and fever. In September 2018, the outcome of the headache, diarrhea, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the headache, diarrhea, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient reported to the pharmacist that his symptoms lasted 7 to 10 days.
Mother has reported patient had fever 100.0  x 1 week and poor sleeping , irritability  x 2 weeks , no other symptoms reported.
Headache, Myalgia, Fatigue, chills Narrative:  Other Relevant History:
Immunizations 1/21/03: DTP #4, Hib #2, Prevnar #4, OPV #3, MMR #1, HBV #3. 1/29/03 Seizure with babysitter. Second witnessed 1/29 at ER. By 1/31/03 returned to clinic.