chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she noted of "every" joint & body was aching & after receiving first dose covid 19 vaccine (pfizer); she feels achy; This is a spontaneous report from a Pfizer- sponsored program. A contactable other healthcare professional and a contactable consumer (patient) reported that a 47-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from 21Jan2021 and ongoing, at 11 mg, 1x/day for rheumatoid arthritis. Medical history included thinning of nail, recurring bad acne, rheumatoid arthritis, and depressed. Concomitant medication included benzoyl peroxide (MANUFACTURER UNKNOWN) for acne and methotrexate (MANUFACTURER). The patient reported that after exercising for a few days on an unspecified date, she noted of "every" joint & body was aching & after receiving first dose covid 19 vaccine (Pfizer), she feels "achy" (unknown if this is muscle/joint), resolved after two days. MD was aware. The action taken in response to the events for tofacitinib citrate was unknown. The patient recovered from the events on an unspecified date.    No follow up attempts are needed. Further information of lot/batch number not obtained.
TORN ROTATOR CUFF; VERY PAINFUL NEAR INJECTION SITE; BLACK AND BLUE AREA TO THE TIP OF THE SHOULDER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021, the subject experienced black and blue area to the tip of the shoulder. On 09-MAR-2021, the subject experienced very painful near injection site. On 10-MAR-2021, Laboratory data included: Sonogram (NR: not provided) NEGATIVE (units unspecified). On an unspecified date, the subject experienced torn rotator cuff. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very painful near injection site, and black and blue area to the tip of the shoulder, and the outcome of torn rotator cuff was not reported. This report was non-serious.
red itchy rash appeared under my right underarm about 2 weeks after the 2nd injection; 4 month later it is still there and has now spread to the left underarm
Pt stated she went to ER the day after the vaccination (on 6/22/21) complaining of headache, fever, rash, and shortness of breath.  She went to the ER a second time on 6/24/21 again complaining of shortness of breath.  In pharmacy she stated she was concerned about blood clots because she has family history with them.  She was prescribed albuterol inhaler and prednisone.  She has an appointment to see her primary care physician.
7day p/vax pt noticed increase in amount of hair pt was losing p/pt washed & brushed hair. better since no more treatment
Experience heavy vaginal bleeding 72 hours after final dose of vaccine. This is not menstrual bleeding.
I've had the same reaction to GARDASIL on both shots. The first shot I initially forgot about, on account of I was injected with three vaccines at once. The second shot I had today at 4:30 ish, and my symptoms began around 9:00. I began to have severe diarrhea until I began to have an absence of stools, and began to just have pure water in my bowel movements. It has continued for at least five hours, and shows no signs of stopping. I also have severe cramping in my abdomen, and seem to have a high fever. I cannot hold water or slight food in my stomach; it makes it worse to even drink. So now, I feel very faint and have a hard time sitting and standing. The first shot was much of the same. I was up all night with watery stools, and was told to report this adverse effect to the FDA.
Left arm erythema, possible Allergic reaction to vaccine. Improving redness on left arm and anterior chest. Cultures neg. Abx narrowed to doxycycline per ID.
pt had a positive COVID test on 12/31/21 in the nursing home; pt passed away in the facility; per death certificate, the causes of death were:  2019-nCoV Acute Respiratory Disease and Acute Respiratory Failure
napping; cried out-seizured for 15-20 mins; transported by ambulance to ER; given Motrin & IV's; home by about 6PM: played this AM & last evening w/o further problems; MD advised DT next immun;
rash on arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm) in an adult patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 RASH (rash on arm). At the time of the report, RASH (rash on arm) outcome was unknown. Not Provided          Reporter did not allow further contact
A spontaneous report (United States) was received from a 74-year old, female nurse, who was also a patient, who received Moderna's COVID-19 vaccine and experienced a little soreness in her left arm.   The patient's medical history was not provided by the reporter. Products known to have been used by the patient, within two weeks prior to the event, included pregabalin.   On 28 DEC 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 309K209) intramuscularly in the Left Arm for prophylaxis of COVID-19 infection.   On 28 DEC 2020, the patient stated that she had a little soreness in her left arm that began approximately five hours after receiving the vaccine. She had no other reported symptoms, and stated that her and her husband are both doing well and pleasantly surprised. The patient confirmed with her orthopedic surgeon that she would be receiving a cortisone injection in her knee on 29 DEC 2020.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event a little soreness in her left arm was not reported.   The reporter did not provide an assessment for the event a little soreness in her left arm.; Reporter's Comments: This case concerns a 74-year old, female nurse. The patient's medical history was not provided. The patient experienced the NS expected event of pain in arm. The event occurred the day the first dose of mRNA-1273 (Lot number: 309K209) was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Prolonged menstrual bleeding; Irregular menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Prolonged menstrual bleeding) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OLIGOMENORRHOEA (Prolonged menstrual bleeding) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding). At the time of the report, OLIGOMENORRHOEA (Prolonged menstrual bleeding) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Her blood pressure spiked to 220/180 and she ended up in the Emergency Room.; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration in right arm (at the age of 65-years-old) on 17Mar2021 at 14:59 as single dose for COVID-19 immunization. Medical history included ongoing high blood pressure. Patient's family history reported as none. Concomitant medication(s) included losartan (LOSARTAN) 25mg, one tablet daily for hypertension from Feb2021 and ongoing and hydrochlorothiazide (HYDROCHLOROTHIAZIDE) 12.5mg once daily for hypertension from Feb2021 and ongoing, patient did not provide lot number for Losartan and Hydrochlorothiazide. Patient did not receive any other vaccine prior four weeks of vaccination. On 17Mar2021, patient had an incident of high blood pressure right after the vaccine. Her blood pressure spiked to 220/180 on 17Mar2021 and she ended up in the Emergency Room. She had a band aid on right arm. When the patient was in the ER test and blood work were conducted, but she was not sure what that was. Her blood pressure came down that same evening. Patient wanted to know if she should still get the second vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: 220/180 mmhg on 17Mar2021 High. The outcome of the event was recovered on 17Mar2021.
On 10/22/21, resident noted with unclear, jumbled speech, nausea and vomiting. Sent to local ER. Returned at family request. Family declines aggressive treatement including MRI.
Received Prevnar on 7/15/15 and Pneumovax on 9/16/15 recommended by doctor due to being severely IGA deficient even though I have multiple auto immune diseases.   On 9/28/15 started with cough, sleepy, slobbering and heavy chest.  Taking Robitusin & Mucinex DM with no results.  Oct 11, 2015 doctor prescribed Benzonatate and Methylprednisolone.  Renewed Benzonatate on Oct 20 & Nov 24 with still no relief.  Dec 1, started with fever.  Missed work on Dec 2, 3 & 4th.  Sleeping in recliner, persistent cough, fever for 6 days, squeaky door sound breathing.  Dec 7, doctor prescribed Dexcycycline Hyclate after chest xray and not sure of results but treating as pneumonia.  Jan 5, recheck xray and results still same and to get CT scan.  No airflow and cannot blow nose, nothing coming out.   Diagnosed as interstitial lung disease.  Jan 15, 2016  diagnosed as bronchial asthma and prescribed Advair and Fluticansone.  Also took Mucinex D with no results.  Feb 5, 2016, appt with pulmonologist.   4/8/19 diagnosed with Acute Bronchitis and lung nodule.   Prescibed ventolin first time in life and steroid.  Never had lung issues before these 2 vaccines.
Onset of pain, fever, non-rigorous chills 36 hrs later; inject site extremly tender w/no overlying erythema or SQ crepitous; several erythematous urticarial papules w/surrounding erythema on ant chest & abd;
Patient received her flu shot on 10-29-22. On 10-30-22 she noticed a lump at the site of injection.  Once the band aid was removed, a clear tannish discharge was noticed by the patient from a blister that had formed at the injection site. Patient was concerned it was the vaccine itself being discharged.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unspecified dates during the time period of 06-DEC-2016 to 13-DEC-2016, the patients were vaccinated with improperly stored M-M-R II (lot # M016233, expiration date: 31-MAR-2018; lot # L040961, expiration date: 19-OCT-2017; lot # M002419, expiration date: 12-JAN-2018; lot # M022408, expiration date: 02-MAY-2018; dose and route were unknown) (rHA) for prophylaxis. The detail of the storage was a temperature excursion of 53.4 Fahrenheit for 2 hours 24 minutes for the refrigerated vaccine M-M-R II. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as follow up with the reporter is not permitted. Sender's Comments: US-009507513-1701USA001926: US-009507513-1701USA001927: US-009507513-1612USA007495.
Mom states had a fever of 103 approx 3 hrs p/vax; Fever remained @ 103 for greater than 48 hrs; mom states pt also vomited; taken to MD who instructed mom that pt receive only DT;
Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-Sep-2020 and the estimated date of delivery was 04-Jul-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2020, Pregnancy test: positive (Positive) Positive. In February 2021, Ultrasound scan: single umbilical artery (Inconclusive) Positive Pregnancy test and Single Umbilical artery.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Complications or acute illnesses during pregnancy includes Single Umbilical artery.  Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medication were reported.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow Up received on 15-JUN-2021.  Updated Reporter Contact Information.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 02Sep2022 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: 5 days later symptoms come back and I am testing positive again; (25Dec2022) Positive, notes: I tested positive for COVID with a home test on Christmas morning; (30Dec2022) Negative, notes: Tested negative, 30Dec and 31; (31Dec2022) Negative, notes: Tested negative, 30Dec and 31; (07Jan2023) Positive, notes: Still positive on 07Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: Patient tested positive for COVID with a home test on Christmas morning. Patient did a tele-visit with the Clinic and the doctor gave me Paxlovid. Symptoms were scratchy throat and mild cough. Patient finished the 5 days, no worsening of symptoms. Tested negative 30Dec and 31. 5 days later symptoms come back, and patient was testing positive again. Same sore throat and mild cough. Saw doctor again, said no more Paxlovid. Using OTC to treat symptoms. Still positive on 07Jan. No AE treatment and no known allergies. No, other medication in 2 weeks. Yes, reported about covid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
his serum Creatinine has risen from 1.23 to 1.48; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Transitional Cell Renal Cancer" (unspecified if ongoing); "Nephrectoimy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD CREATININE INCREASED (non-serious) with onset 2021, outcome "unknown", described as "his serum Creatinine has risen from 1.23 to 1.48". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed Red swollen, hot area 24 hrs after shot, in (R) arm, Kinrix. Seen at Urgent Care & diagnosed w/cellulitis, started on Keflex. Seen 12/16/19 w/continued severe localized reaction.
Herpes zoster. No history of varicella. Had varicella vax. Currently still has herpes zoster.
At 3pm on 9/21/2021 burning rash on face developed. also left arm and hand but not at the injection site.
A large welt (1" x 3" as described by pt) developed at injection site after ZOSTAVAX injection.
Patient was given PNEUMOVAX 12/4 and presented in office 12/7/15 with 4 x 3" erythema at injection site with warmth. Treatment with cold packs and ibuprofen as directed.
pt was nervous 15 minutes after vaccination.  bp was taken as a precaution. bp was 141/77. pt was asked to sit, sip water and have a low sodium snack.  at 8:56p.m. bp was  121/76, pt was feeling better and smiling.  pt's morale had improved and pt was ready to leave.  Advised if any other side effects, to advise employer of needing time off
I was 34 weeks, 5 days pregnant at the time of vaccination (due date 3/26/2021). The next day at 10pm my water broke and I went into early labor. I had my baby on Friday in the early morning. Prior to this, I had no risks or warning signs of early labor (e.g. preeclampsia, gestational diabetes, etc) and was generally following a routine pregnancy path.
shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 05-MAY-2015, she was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for the long-term prevention of shingles and zoster-related conditions, by a healthcare provider. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, she had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Blood pressure had gone up; Her injected arm hurts on and off; got real dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (got real dizzy), HYPERTENSION (Blood pressure had gone up) and PAIN IN EXTREMITY (Her injected arm hurts on and off) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 0045A21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included high blood pressure for Blood pressure, ATENOLOL for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced DIZZINESS (got real dizzy). On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (Her injected arm hurts on and off). On an unknown date, the patient experienced HYPERTENSION (Blood pressure had gone up). At the time of the report, DIZZINESS (got real dizzy), HYPERTENSION (Blood pressure had gone up) and PAIN IN EXTREMITY (Her injected arm hurts on and off) outcome was unknown. Not Provided          blood pressure started going up on 17Apr2021. Consent to follow up by email by safety team   This case was linked to MOD21-083320, US-MODERNATX, INC.-MOD-2021-094953 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Significant follow-up.Product tab: Added product batch information along with the administered date.Event tab: Added an event of arms hurting.; Sender's Comments:  MOD21-083320: US-MODERNATX, INC.-MOD-2021-094953:
Nausea, insomnia, abdominal pain, fatigue/exhaustion, fever, chills, overheating, dry eyes, muscle aches and joint pain (more/different than usual related to health condition)
Had red round site come up on my vaccination site, 3 weeks after receiving the vaccine. The area around the site itches.
Patient was administered Pfizer COVID-19 vaccine on 5/9/21 when the patient was eligible for their second dose on 5/11/21.