chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sinus headache for the past 2 weeks; My upper jaw is aching; I have a little bit of an earache; Earlier on I had fatigue.; It's a dull headache with no fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.). At the time of the report, SINUS HEADACHE (sinus headache for the past 2 weeks), HEADACHE (It's a dull headache with no fever), PAIN IN JAW (My upper jaw is aching), EAR PAIN (I have a little bit of an earache) and FATIGUE (Earlier on I had fatigue.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication reported. No treatment information was provided.
sweaty; clammy; blurred vision; His left eye had no peripheral vision; it was like he had spider webs in both eyes; headache; left chest muscle was sore and kind of hurt; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VISION BLURRED (blurred vision), VISUAL FIELD DEFECT (His left eye had no peripheral vision) and EYE DISORDER (it was like he had spider webs in both eyes) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No relevant medical history was reported.  Concomitant products included DOXYCYCLINE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced HEADACHE (headache) and MYALGIA (left chest muscle was sore and kind of hurt). On 11-Aug-2021, the patient experienced HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), VISION BLURRED (blurred vision), VISUAL FIELD DEFECT (His left eye had no peripheral vision) and EYE DISORDER (it was like he had spider webs in both eyes). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPERHIDROSIS (sweaty), COLD SWEAT (clammy), HEADACHE (headache) and MYALGIA (left chest muscle was sore and kind of hurt) outcome was unknown and VISION BLURRED (blurred vision), VISUAL FIELD DEFECT (His left eye had no peripheral vision) and EYE DISORDER (it was like he had spider webs in both eyes) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) found no tumor, brain bleed, stroke, neurological, or cardiac disorder..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient also had an ekg and blood draw and spent about 7 hours in the ER. The emergency room doctor did say that when multiple sclerosis affects vision it lasts for days or weeks.
Platelets are at 20 & normal is 150-400; Has mild asthma; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; CBC shows the following are slightly low: RBC, Hgb, & Hct; slightly elevated RDW SD; 16May2021 1:30am dyspnea - can't get satisfying deep breathe; bronchial inflammation on chest X-ray; Bloody nose 9:30am next day; This is a spontaneous report from a contactable consumer. This 15-year-old male consumer (patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 16:15 (at the age of 15-years-old) (Batch/Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Asthma, migraines, small right sinus, ear tube hole in left eardrum and allergic to Weed, cat, dust, tree nuts, (nasonex, nasacort, dimetapp, topamax, amitriptyline, cyproheptadine) drug allergy from an unknown date and unknown if ongoing. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), ibuprofen (MOTRIN [IBUPROFEN]) 2x, sodium alginate (GAVISCON [ALGELDRATE;SODIUM ALGINATE]) 1x and flinstone gummy taken for an unspecified indication, start and stop date were not reported. The patient had mild asthma. 14May2021 Bloody nose 9:30am next day, 16May2021 1:30am dyspnea - can't get satisfying deep breathe, 16May2021  Urgent Care  - bronchial inflammation on chest X-ray, 4 puffs Albuterol followed by Decadron 16mg, then 2 more Albuterol puffs. No improvement. CBC shows the following are slightly low: RBC, Hgb, & Hct. Following are slightly elevated RDW SD. Platelets are at 20 & normal is 150-400 (medically significant). Alert & stable but tires easily going up/downstairs. Dr visit scheduled to recheck platelets on 20May2021. Patient underwent lab test chest X-ray which showed bronchial inflammation on 16May2021. CBC showed slightly low: RBC, Hgb, & Hct, Platelets are at 20 & normal is 150-400 and slightly elevated RDW SD on unspecified date. The patient had not received any other vaccine in four weeks, the patient took no treatment for events except bronchial inflammation. The patient prior to this had not received any covid vaccine, patient had not done covid test post vaccination. Outcome of the events CBC shows the following are slightly low: RBC, Hgb, & Hct, slightly elevated RDW SD, and Platelets are at 20 & normal is 150-400 was unknown. The outcome of other events was not recovered.
The patient did not have an adverse reaction. The plunger in the vaccine was slightly stuck and wouldn't depress. I had to remove the need from the patients arm, express a very small portion of the vaccine and re-adminster the vaccine to the patient. The patient did not experience any side effects from having to be injected for a second time.
fell cold symptoms; running nose; pain in arm at injection site; felt feverish, slight temperature of 99; Headache; feeling tired; Sneezing; Nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing), NASAL CONGESTION (Nasal congestion), RHINORRHOEA (fell cold symptoms; running nose), VACCINATION SITE PAIN (pain in arm at injection site) and PYREXIA (felt feverish, slight temperature of 99) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Hypertension and High cholesterol. Concomitant products included METOPROLOL for Blood pressure high, CALCIUM for Calcium supplementation, ATORVASTATIN CALCIUM (ATORVASTATINE [ATORVASTATIN CALCIUM]) for High cholesterol, VITAMIN D3, PROBIOTICS NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced SNEEZING (Sneezing), NASAL CONGESTION (Nasal congestion), VACCINATION SITE PAIN (pain in arm at injection site), PYREXIA (felt feverish, slight temperature of 99), HEADACHE (Headache) and FATIGUE (feeling tired). On 24-Jan-2021, the patient experienced RHINORRHOEA (fell cold symptoms; running nose). The patient was treated with PARACETAMOL (TYLENOL) 22-Jan-2021 for Headache, at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) 24-Jan-2021 for Runny nose, at a dose of 1 dosage form. On 28-Jan-2021, SNEEZING (Sneezing), NASAL CONGESTION (Nasal congestion), RHINORRHOEA (fell cold symptoms; running nose), VACCINATION SITE PAIN (pain in arm at injection site), PYREXIA (felt feverish, slight temperature of 99), HEADACHE (Headache) and FATIGUE (feeling tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 99 (High) high.         This case was linked to MOD-2021-113500 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional info-1 :ADR form with updates to concomitant medications and medical history. More details about the events from dose 1
Fever after 1 day and a rash after 4 days, post vax.
Presented to ER with intermittent left sided chest pain that moves / radiates in arm and axilla after vaccination day prior.  Also reported some left arm tenderness, wrapping around to back.  No SOB, but does report some chest heaviness.  Exam noted no acute distress; reproducible left sided chest wall tenderness.  Per provider, non-toxic but concerning for potential reaction to vaccine.  Reproducible chest wall tenderness and small reactive lymph node in left axilla likely from vaccine.  Discharged for outpatient workup of atypical chest pain most likely as result of vaccine reaction.  Patient was to take home supply of NSAIDs and report to sick call in am. 9/23 sick call encounter noted the EC labs and EKG were WNL and notes it appears to be most like muscle soreness and noted the swollen lymph node that was TTP but ordered echo to rule out cardiac causes.  Patient put on profile.  Echo ordered with routine priority from cardiology clinic. 9/28  patient returned to clinic with chest pain 6 days post vaccination.  Encounter noted that he was improving but woke up at 0300 in morning with periodic "squeezing" chest pain.  Also noted that left arm pain not present anymore.  Patient had not had echo at this point per note.  Repeat labs ordered, although there was low suspicion of myocarditis; suspected MSK.  Ordered Ibuprofen 800 mg.  Given temporary profile. 10/5 patient seen in cardiology for echo.  Report to be emailed to provider.  Not available at time of report
Needle was not fully screwed in place and most of the vaccine leaked on administration. Since exact dosage was unknown. DR Ordered that the vaccine be re-administered. No adverse reaction noted that day or since.
Vestibular symptoms, hearing loss, vertigo, balance problems. Started 4-13-21. Treated in patient at hospital. Released 4-15-21. Currently under care of primary care dr, ent, pt, and waiting neurologist consult.
pain in shoulder iridin to back; had sore arm that 3 or 4 days more chronic pain in left arm (injection); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (had sore arm that 3 or 4 days more chronic pain in left arm (injection)) and ARTHRALGIA (pain in shoulder iridin to back) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's medical history was not reported.  Concomitant products included LEVETIRACETAM (KEPPRA), AMLODIPINE, PRAVASTATIN, PARACETAMOL (TYLENOL REGULAR) and IBUPROFEN for an unknown indication.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (had sore arm that 3 or 4 days more chronic pain in left arm (injection)). On an unknown date, the patient experienced ARTHRALGIA (pain in shoulder iridin to back). The patient was treated with PREDNISONE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and LIDOCAINE, PRILOCAINE (COMPOUND LIDOCAINE) for Pain, at a dose of UNK, bid. At the time of the report, VACCINATION SITE PAIN (had sore arm that 3 or 4 days more chronic pain in left arm (injection)) and ARTHRALGIA (pain in shoulder iridin to back) outcome was unknown.            Additional treatment medication included unspecified muscle relaxing.   This case was linked to US-MODERNATX, INC.-MOD-2021-048391 (Patient Link).
Day 4 -Itching torso Day 6-contained raised itchy  rash on right side of torso Day 8-vaccine site itchy right arm Day10-scattered raised rash on back, rash on left side, vaccination site pink Otherwise feeling fine. Extra tired at times.
2 weeks after recieving vaccination has tremendous pain in arm (same as injection site) seeing doctor on 11/20/12.
This spontaneous report was received from a 62 year old female patient, referring on herself. The patient was allergic to codeine, sulfur and iodine. The patient did not have any medical history. On 23-FEB-2016, the patient was vaccinated with a dose of ZOSTAVAX one time (dose, frequency, route (reported as vaccine), lot # and expiration date were not reported) (reported as shingles). Concomitant therapies included clonidine (reported as clonadine), BENICAR (reported as BENACAR) and hydrochlorothiazide. On an unknown date in February 2016 (reported as 12-15 hours after receiving the ZOSTAVAX), the patient started experiencing redness on injection site, itchy and fever. No treatment was given to the patient. No laboratory diagnostic studies were performed. The patient did not seek any medical attention. No product quality complaint was involved. At the time of the report, the outcome of injection site erythema, pyrexia and injection site pruritus was unknown. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
PATIENT CALLED 9/23/09 STATING SHE IS STILL IN EXCRUCIATING PAIN. SAID SHE WAS VERY PAINFUL ON ADMINISTRATION AND IS STILL VERY PAINFUL 2 WKS LATER.
Four hours post vax, the pt's mother reported increased stridor, fever of 102, and cough.
is having bad side effects from booster; she is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (is having bad side effects from booster) and VACCINATION COMPLICATION (she is not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION COMPLICATION (is having bad side effects from booster). November 2021, the patient experienced VACCINATION COMPLICATION (she is not feeling well). At the time of the report, VACCINATION COMPLICATION (is having bad side effects from booster) and VACCINATION COMPLICATION (she is not feeling well) had not resolved.            No concomitant medication was provided  Treatment medication was not provided by the reporter  It was stated that She asked is it true that you are not supposed to take pain killers.
Mom bottle fed at 0330 on 4/9/03. Placed on couch with mom at 0400. Mom fell asleep on couch with him at 0430. She awoke at 0630 to discover he was not moving. Some swelling in lower extremities noticed. CPR started at 0630 and continued until rescue arrived at 0705.
Narrative: Admission Date: Aug 11,2021 Discharge Date: Sep 7,2021 Condition of patient at discharge: Deceased 92 yo male initially admitted for bacteremia likely secondary to urinary source (E. faecalis/pseudomonas UTI). Pt clinically improved with Zosyn. Plan was to discharge home with Zosyn through PICC line, however, patient acquired COVID during hospitalization despite being fully vaccinated with Moderna COVID vaccine on 1/12/2021 and 2/9/2021. Desaturations with minimal exertion and conversation. Required 8L oxymizer to maintain SpO2 >90%. Transferred to ICU on 8L oxymizer. Oxygen increased to 45L 75% FiO2. Pt maintained O2 sats well. Mental status waxed and waned throughout ICU stay. Dexamethasone and remdesivir were continued. He was eventually transferred out of ICU on high flow nasal canula 50L/85%. Following transfer to floor, patient had persistent O2 requirement that ultimately worsened to high flow nasal canula 50L/100%. Repeat CXR revealed worsened total opacification of left lung field and US confirmed effusion. Procal was elevated and hospital-acquired pneumonia coverage was started with vancomycin/cefepime. Unfortunately, patients O2 requirements failed to improved and he passed away peacefully on 9/7.
Patient was vaccinated with Meningococcal Conjugate vaccine in her left arm on 8/14/12. On 8/20/2012 she came to clinic complaining of rash and itching that started Sat. 8/18/12 in the morning, 8-10 hives noted on her Rt upper arm. 3-4 on her left arm & back BENADRYL given.
PATIENT DEVELOPED SWELLING AND DISCOLORED RIGHT ARM AND FEVER ON 10/21/2019
After having Janssen COVID 19 vaccine less than one month developed a DVT (extensive) throughout right lower extremity from common femoral vein through the calf veins. Patient was seen and given eliquis (blood thinner).
Parent stated child had PCV-7 on Friday (2/28) and Saturday afternoon they noticed petecchiae and bruising on face and trunk. No fever noted. Symptoms worsened and family took baby to pediatrician. Baby was hospitalized. He was found to have low platelet counts. Child was hospitalized and then transferred. Child received artificial platelets and immune globulin serum. Per father, hospitalized for 5 days. Today 3/10, child is ok. He is to return to MD on 3/11 for follow up blood work. 3/11/03 TC from father stating concerns about liability and was given vaccine compensation phone number. States child is to follow up with hematologist. The follow up received on 7/14/03 states new connection to box 13 (reverts to original VAERs report info). New correction to box 14 OMIT Prevnar. Child did receive the other 4 vax.
soreness in the arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in the arms). At the time of the report, PAIN IN EXTREMITY (soreness in the arms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication use was reported.   This case was linked to MOD-2021-423760, MOD-2021-423679 (Patient Link).
Stroke; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke".  Clinical information: It was reported that the patient's wife of was unwilling to receive a COVID-19 vaccine because she stated that her husband (age unknown) had a stroke after getting his vaccine and now she had to care for him as he could no longer work. This anecdotal report was made to navigator during a call on RN. This was a patient of her sister, a nurse practitioner and did not know if it had been reported already. RN agreed to get additional details as she agreed to having Pfizer contact her. The event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported event cerebrovascular accident. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
17 year old was immunized at a mass vaccination event but the minimum age is 18 years old
Feverish with chills and sweats. Every joint hurt when standing.  Fatigue.  Mild headache, deep in my head only. Extreme flu symptoms.  Off and on frequent urination.
UNABLE TO SLEEP; PAINFUL FEET; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included patient does not have history of reactions to vaccines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. 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 02-APR-2021, the subject experienced unable to sleep. On 02-APR-2021, the subject experienced painful feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from painful feet on 03-APR-2021, and the outcome of unable to sleep was not reported. This report was non-serious.
Suspect vaccination failure; got them after my second vaccine/still have them under my left arm and breast; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In March 2021, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. 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 Shingles vaccine and Shingles vaccine.  Additional details were provided as follows. The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still had them under his/her left arm and breast, and it was horrific. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This case had been linked with case US2021AMR151371, reported for the patient's husband.
Pt was under 18 years old when received vaccine.  Patient was 16 years old when receiving this vaccine, improper age screening, system allowed her to make an appointment anyway. No adverse event reported.
Swollen injection site at first. Then redness surrounding injection site. Then red blotchy patches on cheek area of face 2 days later. Then increased redness on cheeks the next day and spreading across bilateral arms.