chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a case or orbital cellulitis near left eye. Initial symptoms presented on 6/22, with swelling and fever presenting on 6/24.  Initial treatment with antibiotic ointment on 6/26. Follow up with PCP and specialist on 6/27 resulted in prescription of oral, sulfa-based antibiotic. Swelling and fever resolved within a day, with inflammation continuing for several days. Full course of antibiotic completed on 7/3.
Arm looks red, swollen, warm and it spreads down to her arm; Arm looks red, swollen, warm and it spreads down to her arm; Arm looks red, swollen, warm and it spreads down to her arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Arm looks red, swollen, warm and it spreads down to her arm), VACCINATION SITE SWELLING (Arm looks red, swollen, warm and it spreads down to her arm) and VACCINATION SITE WARMTH (Arm looks red, swollen, warm and it spreads down to her arm) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 16-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm looks red, swollen, warm and it spreads down to her arm), VACCINATION SITE SWELLING (Arm looks red, swollen, warm and it spreads down to her arm) and VACCINATION SITE WARMTH (Arm looks red, swollen, warm and it spreads down to her arm). At the time of the report, VACCINATION SITE PAIN (Sore arm), VACCINATION SITE ERYTHEMA (Arm looks red, swollen, warm and it spreads down to her arm), VACCINATION SITE SWELLING (Arm looks red, swollen, warm and it spreads down to her arm) and VACCINATION SITE WARMTH (Arm looks red, swollen, warm and it spreads down to her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event was unknown.
feel a pain in the middle of her upper stomach that felt "like a rock"; heart was beating fast; little bit weak; feel bad with chills; headache; joint pain; nausea/ Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 01Apr2022 (Lot number: FK9895) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (1st dose, Lot:EN6205), for Covid-19 Immunization; Bnt162b2 (2nd dose, Lot:ER2613), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 02Apr2022, outcome "unknown", described as "feel bad with chills"; HEADACHE (non-serious) with onset 02Apr2022, outcome "unknown", described as "headache"; ARTHRALGIA (non-serious) with onset 02Apr2022, outcome "unknown", described as "joint pain"; NAUSEA (non-serious) with onset 02Apr2022, outcome "unknown", described as "nausea/ Nauseous"; ASTHENIA (non-serious) with onset 03Apr2022, outcome "unknown", described as "little bit weak"; ABDOMINAL PAIN UPPER (non-serious) with onset 03Apr2022 18:00, outcome "unknown", described as "feel a pain in the middle of her upper stomach that felt "like a rock""; HEART RATE INCREASED (non-serious) with onset 03Apr2022, outcome "unknown", described as "heart was beating fast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, headache, arthralgia, nausea, asthenia, abdominal pain upper, heart rate increased. Additional information: on, Friday 01Apr2022. Caller notes this was her third dose of the Pfizer covid vaccine. Caller said she began to feel bad with chills, headache, joint pain, and nausea on Saturday. Caller said on Sunday she began to feel "much better" although a "little bit weak" but that around 18:00 begun to feel a pain in the middle of her upper stomach that felt "like a rock", nauseous, and that her heart was beating fast. Caller said she did not go into work today (Monday, 04Apr), that she started to feel better but then she began to feel the same sensations as Sunday evening this afternoon. Caller is asking if she should go to the hospital or contact her doctor? Consumer stated, "No, I didn't go to any doctor just take Tylenol." Prior vaccination (4 weeks): Consumer stated, "No. I had first dose and second dose, no reaction but this one the third one that's the one I had reaction. " No follow-up attempts are possible. No further information is expected.
Consumer stated he had taken BCG vaccine 5 years ago and had since developed cancer which he attributed to the vaccine.; This spontaneous report was received from a consumer and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2018 (reported as "5 years ago"), the patient started therapy with bcg live (BCG VACCINE ) (formulation defaulted as powder for injection, dose, anatomical location, lot # and expiration date were not reported) for tuberculosis bladder.  On an unknown date, the patient developed cancer which he attributed to the vaccine (neoplasm malignant). The outcome of neoplasm malignant was reported as not recovered/not resolved.  Causal relationship between neoplasm malignant and bcg live (BCG VACCINE ) was unknown.  Upon internal review, the event neoplasm malignant was determined to be medically significant.
ARM SORENESS; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced arm soreness, chills, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness, chills, and fever. This report was non-serious.
Within few minutes I got very slight tingling/numbness sensation in my whole left arm down to my hand and up to my face and the back of my neck and head.  That night I got the chills feeling very cold. The tingling/numbness were gone in the morning but I still felt colder than I normally do.
just a sore arm starting approx 6 hours after injection; This is a spontaneous report from a contactable healthcare professional (patient). A 51-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3249; expiration date: unknown) at vaccination age of 51-year-old intramuscular in the right arm on 15Jan2021 10:00 at a single dose for covid-19 immunization. Medical history included high blood pressure, and allergies to penicillin and sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included unspecified medication. The patient received her most recent COVID-19 in a public health clinic/veterans administration facility. The patient reported that she did no adverse events, she was just a sore arm starting approximately 6 hours after injection (15Jan2021) and lasting about 24 hours (16Jan2021). The event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on 16Jan2021.  No follow up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown age and gender. No current of historical conditions were reported. On 17-MAY-2016 the patient was vaccinated with PEDVAXHIB (lot # L051122, expired date of 12-OCT-2018, dose and route unknown). The vaccines were improperly stored under 9.1 celsius degree for 30 minutes. No previous temperature excursion. Data logger was involved. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
SUPER WEAK; SORENESS FELT ALL OVER THE ENTIRE BODY; RIGHT ARM IS VERY VERY SORE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced soreness felt all over the entire body. On 24-JUN-2021, the subject experienced right arm is very very sore. On an unspecified date, the subject experienced super weak. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness felt all over the entire body, and right arm is very very sore, and the outcome of super weak was not reported. This report was non-serious.
Fever on 9/8/07 100.2 in AM and throughout the day. Alternating Tylenol and Ibuprofen. Woke up middle of night crying and mumbling and jerking. Seizure lasted less than 1 minute. With jerking, choking and no breathing for several seconds. 911 called no other seizures after that. Fever persisted 72 hours with highest temp at 102.
He had a headache, fatigue, severe nasal congestion, a runny nose, cough, sinus pressure in head and ears, sore throat, and a low fever of 99 to 100 degrees. When I took him to the doctors he was told to take Tylenol and ibuprofen. I also gave him some Benadryl. He is feeling better. All those symptoms are improving but today he was short of breath with exertion.
6 episodes of syncope two days after vaccination resulting in hospital admission for what may be an autonomic dysfunction
pt recvd vax;16jan rash on face,legs;p/ eating spitting up food;no tx;16jan red blotches over entire body;no tx required during er visit;17jan rash completely gone;recovered
patient got Covid within a few days of getting the immunization; patient got Covid within a few days of getting the immunization; This is a spontaneous report from a contactable consumer via the Pfizer-sponsored program. This consumer reported similar events for five patients. This is the 3rd of five reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patient got Covid within a few days of getting the immunization. Also, the reporter assumed that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same reporter, product and event; different patient
swelling on her lower lip; felt uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swelling on her lower lip) and VACCINATION SITE DYSAESTHESIA (felt uncomfortable) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included MELOXICAM and IBUPROFEN for Pain.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swelling on her lower lip) and VACCINATION SITE DYSAESTHESIA (felt uncomfortable). The patient was treated with PARAFFIN (PETROLEUM JELLY) at an unspecified dose and frequency. At the time of the report, LIP SWELLING (swelling on her lower lip) and VACCINATION SITE DYSAESTHESIA (felt uncomfortable) 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.
Unable to receive 2nd dose of the vaccine after 45 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to receive 2nd dose of the vaccine after 45 days) 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 April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to receive 2nd dose of the vaccine after 45 days). In April 2021, PRODUCT DOSE OMISSION ISSUE (Unable to receive 2nd dose of the vaccine after 45 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Patient called in to seek assistance regarding second dose. Patient lost the vaccination card. Patient has no contact information of the one who gave it. Patient first dose was somewhere in April (no specific date given), 2nd dose was scheduled to be on May (no specific date given).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: follow up received on 12-07-21 with non significant information.
Day 1- Day 5 "Became red swollen and itchy (4cm diameter) since then." It stayed like that until 8/6 when she noted it was warm and tender. She examined it at that time and noted that a 2-3 cm portion had become cellulitic in appearance (raised, hard, bumpy, well demarcated) and then there was spreading macular erythema surrounding the lesion. 8/9/16 called to see if improvement. Left message on vm.
Patient presented to the vaccination site on 11/13/21. The client notified RN that he received a complete series of COVID vaccine first dose on 12/22/2O and second dose on 1/20/21. RN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Moderna booster. Per CDC guidance, approval to proceed with COVID vaccine Moderna was obtained from medical consult team via text message from , Vaccine Operations Lead . Client received COVID vaccine Moderna Lot#066F21A on 11/13/21. The client did not report any symptoms during the 15 minute observation period.  Vaccinator educated client on possible adverse reactions and when to seek medical care. Client reported no symptoms.
Bloody diarrhea, fever - pneumatonis - necrotizing enterocolitis. Treated conservatively (NPO, IV ASA x 10 days). Did well. No surgery needed.  9/4/07 Received hospital medical records which reveal patient experienced emesis, bloody diarrhea & decreased oral intake.  Seen in ER on 7/15 & d/c to home.  Returned on 7/16 w/continued symptoms.  Admitted 7/16-7/23/07 to ICU & tx w/parenteral nutrition & IV antibiotics.  Received transfusion for Hct 23.  Transferred to another hospital 7/23/07 for long term IV antibiotics. FINAL DX: Necrotizing viral enterocolitis. 9/12/07 Received vax record from pcp which corrected DTaP lot #, otherwise as reported.  VAERS database updated w/same.
Local reaction of redness, slightly raised, warm to touch, roughly 3 inches in diameter. No pain or itching per patient.
sore arm; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-JUL-2022 Reporter's Comments:  The pharmacist mentioned patients experience a sore arm following a dose of Shingrix. The reporter did not consent to follow up.
no adverse effect; Medical assistant reporting an AE for PNEUMOVAX23. Caller reports that on 11/21/2022 a dose of PNEUMOVAX23 was inadvertently administered to a patient who was 2 months old. AE filed for misuse. Caller states the patient was meant to receive PCV-13 va; Wrong vaccine administered; This spontaneous report was received from a medical assistant referring to a 2-month-old male patient. The patient's medical histories, concomitant medications, concurrent conditions and historical therapies were not reported.  On 21-NOV-2022, the patient was inadvertently vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (0.5 mL, product quantity:1, lot #W019639, expiration date: 06-MAY-2024, administered intramuscularly in left thigh) for prophylaxis (product administered to patient of inappropriate age) at private doctor's office/hospital. This was initial use of this vaccine. It was reported that the patient was meant to receive pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (wrong product administered). The operator was a trained healthcare professional. No adverse event was reported at the time of reporting.  Error was identified and reported to doctor, health department and manufacturer. There was no treatment for the patient.
Hospitalization: 1/10/2023 - 1/19/2023 (9 days) Presentation to the ED: SOB COVID + date: 1/30/23 Treatment: methylprenisolone and remdesivir.  Discharge to: SNF EN6199 3/5/2021. ER8730 3/30/2021 FE3592 9/1/2021 FM0698 5/3/2022
02/25/23 presents to ED for "weakness". PMHx of "A-fib, Acute cystitis with hematuria (9/21/2015), Anemia, Aortic valve stenosis, Arthritis"
Patient received second dose of  Pfizer on 4/24 at facility (not our office). She developed tingling to lower half of face/lips on the drive home from the vaccine. Sensation would improve with antihistamines but return. Resolved as of 4/28/21
When I got up in the Morning of the next day of my second shot, I had a fever (100 degrees Fahrenheit) and took Loxoprofen.  I was in my bed all day and my temperature dropped down by the night and I felt getting better.
PATIENT RECIEVED VACCINE, WAS WALKING OUT OF BUILIDING AND FAINTED.
Started having respiratory and sinus issues; took a Home COVID-19 test and it was positive; Called Doctor and was prescribed Paxlovid and Hydrocodone-Chlorphen; Finished course of medications; Retested for COVID-19 14 days later and was negative; Still has a bad cough.
Temperature on weekend, Mom reports infant felt warm on Friday afternoon/evening; Saturday/Sunday temperature up to 101; constant nursing and not sleeping well; had one time episode of "hiccup" breathing. Fever down Sunday am; returned in afternoon. No fever today (Monday).
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT. Patient is 9 years old. Received Pfizer bivalent booster for ages 12+years
8/27/21@4pm, Flushing, Heart palpitations 8/27/21@7pm, Vertigo, N/V 8/28/21@2am-8/29/21 All above  in addition to mild eye Tremors 8/30/21 ALL ABOVE Symptoms started to subside *I remained at home during that time and monitored my symptoms as a RN
6 years old at time of immunization recommended minimum age 12  FYSA:  A group has been requested to enter all COVID vaccines into database. The teams responsible for screening and administering vaccines to the refugees at the mass vax site.   A group is assisting with entering information into database and VAERS.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's concurrent conditions, medical history and concomitant medication use were not provided. On or about 27-FEB-2008 the patient was administered ZOSTAVAX, 1 DF, (lot# and route unknown) at a health department, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 17-SEP-2013, the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 10-DEC-2015, the patient sought subsequent treatment from another physician for ongoing and worsening symptoms of shingles outbreaks. On or about 15-DEC-2015, the patient was treated again by a physician for new and worsening complications of shingles.  The patient has been prescribed VALTREX and ULTRAM for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Member received Flu vaccine during mass influenza line. Only Influenza vaccines were being administered at this time and he went to take a drug test and later threw up several times. Member states that he did not eat anything and appeared yellow and pale when presenting to the clinic.
Broke out in hives within 15 minutes, face red. Treated with BENADRYL immediately, cleared up within 30 min. of BENADRYL dose. Emergency doctor visit after incident to ensure reaction would not progress further.
I received the *Pfizer-BioNTech Covid-19 Vaccine EUA*. I was already not feeling my best that morning symptoms of warmness at home no fever , I checked. No issues with vaccine given approximately 0715, until 1005 am after a very busy morning with nothing but coffee to drink. As I sat down to assist in order entry in our chemo clinic I suddenly became aware of a very rapid heart rate. I realized that I was having a vaso-vagal response and started perspiring lightly and realizing I was having drop in blood pressure. I composed myself removed my mask and breathed slowly and drank cold water while sitting. After a few minutes I was able to slow my heart rate and felt secure enough to leave the pharmacy. I slowly walked and controlled my breathing and continued to drink water. I was able to return to work and continued until the end of the day. I felt somewhat fatigued until bedtime that evening. Slept reasonably well that night and had no other symptoms to my memory the following day.
3 days after flu vaccine and PNEUMOVAX, onset inability to swallow and severe headaches. Hospitalized x 7 days. Extensive work-up completed. Required IV nutrition as could not swallow. IV steroids given and regained some functioning of swallowing. Able to be discharged and can eat and drink but not normally or baseline. Told it was reaction to flu vaccine.