chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.; She states that no adverse reactions have been reported by any patients; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 13 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Chills; Soreness; Pain in throat under chin; Hurts when he swallows; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (Soreness), OROPHARYNGEAL PAIN (Pain in throat under chin) and DYSPHAGIA (Hurts when he swallows) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (Chills), PAIN (Soreness), OROPHARYNGEAL PAIN (Pain in throat under chin) and DYSPHAGIA (Hurts when he swallows). At the time of the report, CHILLS (Chills), PAIN (Soreness), OROPHARYNGEAL PAIN (Pain in throat under chin) and DYSPHAGIA (Hurts when he swallows) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment medication were reported.
t104, red local rxn to shot site w/in 24 hrs of shot; 27JAN92 office visits cellulitis shot site tx Ceclor;
patient had vaccine and was a bit nervous at time of vaccination . patient has epilepsy and has not had seizure in 7 months , about 15 minutes after vaccination patient went into a seizure and 911 was called and supportive measures given. patient refused medical treatment and about 45 minutes later was ok
Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074562 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074562:2nd dose
Patient had their first injection over a year ago; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first Shingrix injection over a year ago and the reporter enquired if patient had to restart the series or just get the second injection. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow-up could not be possible as no contact details were available.
Headache, rash/swelling at site. 9/22/14 developed shortness of breath, dizziness, heart irregularity; took Prednisone and symptoms gradually subsided.
Patient became dizzy and generally not feeling well and laid down on the floor. The Pharmacist came out to check on her. She was awake so he called store management over to bring her some juice and he checked her blood pressure.  After a few minutes the patient was able to stand up and was ok to leave with her guardian.
Hospitalized 1/14/22-1/20/22 Dyspnea, chest heaviness and tightness, hypoxia, pulmonary effusion, elevated D-dimer, resp. failure, PNA, PE
positive covid test; Inappropriate schedule of vaccine administered; positive covid test; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3248 and expiry date was not reported), via an unspecified route of administration, on 09Mar2021, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 23Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had sore throat, body aches, low grade fever, cough, nose congestion, and nausea and these symptoms were first noticed the night of 04Aug2021. On 07Aug2021, the patient had positive covid test and inappropriate schedule of vaccine administered. Event took place after use of product. Outcome of the events was unknown.
Initial report received on 04 January 2007 from a health care professional. A 59-year-old male patient, with no illness at the time of vaccination, had received a first dose, subcutaneous, left arm injection of YF-VAX, lot number UE944AA; and an intramuscular, left deltoid injection of Typhim VI, lot number Z0664-4; on 03 January 2007. The next day, the patient experienced "blood in his urine" and planned to see his family physician. At the time of this report, the patient had not recovered. Follow-up information received on 21 February 2007. It was not known if the patient had any illness at the time of vaccination. The doctor did a full work up on the patient including endoscopy. All tests were negative. The problem resolved - unknown etiology. The patient recovered without treatment.
Patient presented to the ED with 10/10 chest pain.  Two days prior, he'd gotten his second COVID-19 pfizer vaccine.  He denied any fever, congestion, cough, vomiting, diarrhea, or other signs of infection recently; no sick contacts.  On arrival to the ED, he had normal vital signs,  but physical exam was notable for sternal/epigastric pain. Laboratory evaluation, including CBC, CMP, CRP, urinalysis, urine culture, high sensitivity troponins, and lipase were obtained and notable for HS troponin of 303 pg/mL with a 2 hour repeat of 291 pg/mL. CRP was 3.5 mg/dL. His EKG had diffuse ST elevations. CXR was obtained with no evidence of cardiac border or consolidation. RUQ ultrasound showed no evidence of cholecystitis or other abnormality. Patient was admitted for presumed COVID-19  vaccine-induced myopericarditis. Echocardiogram showed  normal biventricular function and no pericardial infusion. He was treated with IV toradol, with resolution of chest pain. HS troponins reached the 400s, with downtrend to the 300s prior to discharge. He was discharged on PO ibuprofen with follow-up  cardiac MRI and labs.
Information has been received from a health care professional concerning a 15 year old female patient who on 08-JAN-2007 was vaccinated in her right arm with a first dose of Gardasil, lot #654389/0961F. Subsequently the patient developed nausea, headache, dizziness, cramping and soreness. The patient's outcome was unknown. Additional information is not expected.
Information has been received from a medical assistant concerning multiple, unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (strength, frequency and route not reported, lot # L032044 with expiration date 24-AUG-2017). The vaccines were exposed to 11.7 degree Celsius for 84 minutes. There was no previous temperature excursion. The temperature was back in range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given Pfizer Bivalent as a 3rd dose instead of the Moderna Bivalent. No treatment neede and no signs or symptoms at this time.
nausea; chills; fever; 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 71-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "She does have a lot of allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, single), for COVID-19 immunization, reaction(s): "high blood pressure/ after the first shot it went up to 159/85", "heart palpitations", "PVCs"; Bnt162b2 (Dose:2, single), for COVID-19 immunization, reaction(s): "Chills", "Nausea", "fever". The following information was reported: NAUSEA (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller had AEs to the five previous doses of the Pfizer COVID vaccines, attempted warm transfer to DSU, but accidentally blind transferred due to needing to click several times. She is calling about the new one that was just released but no where has it yet. She had a different reaction to each vaccine but would like to stick with Pfizer because that is what her body is used to. She does have a lot of allergies. The first shot she had a very severe reaction to. She developed high blood pressure, and she had always had low pressure. Her blood pressure was usually 100/60 and after the first shot it went up to 159/85 she thinks. It was like that for quite a while, until right before she had to get the second shot and it got better.  She called the Pfizer reaction line and they told her that its happening to people but its temporary and if you already deal with that issue the shot could make it worse, but she never had that issue before.  So she went to the heart hospital to go get checked out. She was having heart palpitations and PVCs bad. She could feel them. She always gets them but doesn't feel them. But she didn't have that strong of reaction again like she did to the first dose of the Pfizer COVID vaccine.  When she went to see the doctor and told her about it, the doctor, who is thin like her, said she got the Moderna COVID vaccine and she also was having heart palpitations. The subsequent doses it was always the nausea and the chills and things like that, fever.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300612 Same reporter, patient, product,  events different dose;US-PFIZER INC-202300300609 Same patient/ reporter, product, Different dose/ events;
It's got heat to it; Iiches; swelling in her injection site; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A2/A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE WARMTH (It's got heat to it), VACCINATION SITE PRURITUS (Iiches), VACCINATION SITE SWELLING (swelling in her injection site) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information were provided by the reporter     This case was linked to MOD21-056467, US-MODERNATX, INC.-MOD-2021-048101 (E2B Linked Report).; Sender's Comments:  MOD21-056467: US-MODERNATX, INC.-MOD-2021-048101:Reporter case: wife
Redness, swelling and satellite (vesicles) small in size and number, close to area of injection.
Patient is a 67-year-old male with past medical history of tobacco use who initially presented to the hospital on 7/27/2021 due to complaints of shortness of breath and worsening leg swelling ongoing  and progressing for around 6 weeks and was found to have new onset heart failure.  He was vaccinated for covid 19 on 3/8/21 and otherwise has had no medical care or blood work in a long time. He was transferred to another hospital for further cardiac evaluation. He was diagnosed with. New-onset systolic and diastolic heart failure -TTE done 7/27/21 showing EF of 45% with global hypokinesis.  LVH with significant diastolic dysfunction. Troponin negative. BNP >1900 -Received diuresis with IV Lasix 40 mg IV daily with improvement in shortness of breath and LE swelling.  Subsequently held diuresis when Creatinine  trended up -Status post Right heart catheterization on 7/30 which showed normal filling pressures and borderline mild pulmonary hypertension. -Cardiology recommended Left heart catheterization but both patient and son wanted to do conservative/medical management for now due to significant kidney dysfunction and risk for being on dialysis. -He was startd on aspirin and high intensity statin. along with Toprol, Hydralazine, Imdur.  -Renal ultrasound showing medical renal disease.  Urine protein to creatinine ratio showing some proteinuria.  Anemia -likely of Chronic renal disease. hemoglobin was stable. He was discharged on 7/31/21 home to follow up with nephrology and cardiology  Pt was also complaining of new hemoptysis and cough.
15 minutes, post vax, pt had generalized urticaria, eyelid edema with excessive tearing and sneezing plus wheezing and shortness of breath. Pt was given, epinephrine X 1, albuterol nebulizer X 2 and PO prednisone. Pt was transferred to the hospital via ambulance in much improved condition.
Post Vaccnation symptoms. Muscle aches, injection site pain,  chest pain continues third day at same intensity, headaches, nausea, weakness, chills.  All symptoms started following morning after vaccination and majority disappeared by day 3 except for chest pain left side chest and mid sternum under left breast and left arm pain with on and off numbness.  Underarm dwelling one side only.
Had shingles after getting the shots/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles after getting the shots/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2023 This case was reported by a patient friend via  interactive digital media. The reporter reported that his or her friend as suggested received Shingles vaccine and experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case was 1 of 4 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR054618:Same Reporter US-GSK-US2023AMR054624:Same Reporter US-GSK-US2023AMR054627:Same Reporter
Initial report received from a healthcare professional on 09 October 2013. A 61-year-old male patient had received a dose of FLUZONE ID, (batch number- UT4721BA) intradermally in left deltoid on 07 October 2013. The patient denied any illness at the time of vaccination and had no pre-existing physician diagnosed allergies, birth defects, medical conditions. On 07 October 2013, same day after vaccination, the patient presented with redness (6cm), swelling and pain at injection site. Laboratory details were not reported. The patient was treated with ice compresses, hydrocortisone cream and bacitracin ointment to the injection site. At the time of this report, the outcome was unknown. Documents held by sender: none.
cold; joint pain/severe joint pain; severe joint pain; chills; nausea; diarrhea; This is a spontaneous report from a Pfizer-sponsored Program from a contactable consumer (patient)   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced cold (non-serious) on an unspecified date with outcome of unknown , joint pain/severe joint pain (non-serious) on an unspecified date with outcome of unknown , chills  (non-serious) on an unspecified date with outcome of unknown , nausea  (non-serious) on an unspecified date with outcome of unknown , diarrhea  (non-serious) on an unspecified date with outcome of unknown. She wanted  to know if that was normal and confirm if was safe to get the second.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
I95.9 HYPOTENSION 11/7/2021 ARTHRITIS I95.9 HYPOTENSION 11/7/2021 PARTIAL SMALL BOWEL OBSTRUCTION I95.9 HYPOTENSION 11/7/2021 LIVER ABSCESS
After shot pt started itching in arm, the following day patient started itching from head, neck, arms, and torso and MD said to use BENADRYL. Itching went away for 1.5 hours then came back and started feeling bugs crawling on skin. Recommended CLARITIN.
Information has been received from a registered nurse concerning an 8 year old female with no known allergies or medical history who on 02-DEC-1999 was vaccinated SC with a first dose of Varivax (lot # 630683/0439J). There was no illness at the time of vaccination. There was no concomitant medication. On 12-FEB-2007, the patient presented to the office with chickenpox. There were 50 to 75 scattered papules with pimple-like centers, and right posterior auricular lymph node. Symptomatic treatment was provided. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that on 12-FEB-2007, the patient was seen in the office with a one day history of 50 to 75 scattered red papules. There were no clear blisters or vesicles. The right posterior lymph node was over riding the mastoid bone and was palpable and tender but not red, warm or swollen. The patient recovered on 15-FEB-2007. No further information is expected.
2 days after vaccination:  Muscle pain in both thighs - difficult to sit, squat, get out of a chair, difficulty climbing stairs Hip, pelvis, and butt pain in the muscles, hip bones as well Right arm, shoulder, back, neck pain Swollen joints in hands, stiffness especially in the morning Prescribed Prednisone for pain, 30 MG gradually weaned over 5 months.  Still extreme pain and difficulty performing daily tasks - weaned due to it being only a short term solution.  Overall arthritis-like symptoms in joints  that never experienced arthritis before, either from age or injury.
Flu shot administered within 15 minutes c/o tingling in jaws bilaterally & feeling feverish. No SOB or breathing problems. Went to the ER & symptoms progressively worse. Hospital unknown.