chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; My children received a Moderna bivalent booster yesterday; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (2nd dose) in January 2022 and Pfizer COVID-19 vaccine (1st dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 11-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported by the reporter.  The patient's mother was not sure if the patient was eligible to receive a booster dose at this time. Patient was then inadvertently administered a dose of the Moderna COVID-19 bivalent vaccine, instead. Mother was told by the clinic that the Moderna COVID-19 bivalent vaccine just got authorized for use in children 6 and older and that it should not be an issue. The patient is doing okay so far and have not reported any adverse reactions at this time.  No treatment medication was reported.    This case was linked to US-MODERNATX, INC.-MOD-2022-658448 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658448:Patient 2 - BL
NOT THAT MUCH PAIN; SORNESS AROUND INJECTION SITE; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 07-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (NOT THAT MUCH PAIN) and INJECTION SITE PAIN (SORNESS AROUND INJECTION SITE) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (NOT THAT MUCH PAIN) and INJECTION SITE PAIN (SORNESS AROUND INJECTION SITE). On 01-Mar-2021, PAIN (NOT THAT MUCH PAIN) and INJECTION SITE PAIN (SORNESS AROUND INJECTION SITE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Severe deltoid pain followed by restrictive and painful left shoulder movement now with significant sore muscles upper arm and shoulder
They were thinking this was a possible a brain aneurysm; Stroke; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8735; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in left arm on 27Apr2021 given around 8-9AM as dose 2, single for COVID-19 immunization (at the age of 54-year-old). Medical history included kidney cancer from 2020 and ongoing and medical device she has implanted, a Medtronic stimulator device, it couldn't be done (She confirms she had this device for years, about 8-9 years. It is described as like a pace maker but not for her heart but for other things). Cocnomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 06Apr2021 (around 8-9 am) (Lot Number: EP7533; Expiration Date: 31Jul2021) as dose 1, single for COVID-19 immunization (at the age of 54-year-old) and experienced felt really drugged up, dizziness, nausea, headache, loss of vision, and vomiting. No prior vaccinations within 4 weeks. On an unspecified date in 2021, the patient experienced stroke and they were thinking this was a possible a brain aneurysm. The patient was hospitalized for stroke and they were thinking this was a possible a brain aneurysm from 28Apr2021 to 30Apr2021.She was referred to a neurologist. On an unspecified date in 2021, the patient underwent lab tests and procedures which included chest x-ray: normal, CT scan: normal, EKG: normal, EEG: normal and MRI: results unknown. Therapeutic measures were taken as a result of stroke. The patient visited emergency room and no visits of physician office. The outcome of the events was unknown.
Immediate initiation of vomiting and diarrhea within 24 hours followed by protracted GI and feeding distress with eventual evidence of GI inflammation - increased calprotectin, hematochezia and diagnosis of allergic colitis in breast fed infant.
Child had fever increased to 104. On and off for few days. Had went to 102. 9th day after vaccines were given had seizure at 11:30-Sat-AM. Went to "hospital" where test were run for 2 days. Nothing was seen by that test 1st phys. thought no relation to vaccines; #2 Dr. felt it was.  5/2/08 Received hospital medical records for 4/19-4/21/2008. FINAL DX: febrile seizure, possibly viral in etiology & slight otitis media Records reveal patient experienced shaking movements of extremities, discoloration of face & mouth lasting approx 45 secs while in highchair in restaurant followed by period of being 'out of it'. Had intermittent fever since immunizations & developed maculopapular rash all over.  Had been seen by PCP 1 or 2 days after immunizations for otitis media & placed on antibiotics but intermittent fever continued.  Admit exam revealed URI symptoms w/purulent nasal discharge.  No further seizure activity noted & d/c to home on continued oral antibiotics.
rec'd flu shot@ 2 pm About 3 hrs later, had sore throat, then burning eyelids, then severe aches, headache, shivers, retired to bed, totally incapacitated 7.30, lay in a fetal state for 3 1/2 hrs, found an ambien hoarded away, got up at 10 am, still zonked but not aching. I think this happened to me about 10 or more years ago, have not had a flu shot since,guess I won't again!
Nerve sensation (finger, nose, toes); chills; pain at injection site (L); headache; fatigue; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (Nerve sensation (finger, nose, toes)), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (L)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site (L)). On 29-Dec-2020, the patient experienced CHILLS (chills). On 11-Jan-2021, the patient experienced DISCOMFORT (Nerve sensation (finger, nose, toes)). On 01-Jan-2021, CHILLS (chills) had resolved. On 06-Jan-2021, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 07-Jan-2021, VACCINATION SITE PAIN (pain at injection site (L)) had resolved. On 21-Jan-2021, DISCOMFORT (Nerve sensation (finger, nose, toes)) had resolved.        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.   No concomitant medications were provided No treatment information provided   Reporter did not allow further contact
Lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Lymphoma) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination.     The patient's past medical history included Uterine cancer in 2011 and Hysterectomy in 2011.    On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHOMA (Lymphoma) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (Lymphoma) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Positron emission tomogram: abnormal (abnormal) Additional groin lymphoma.         Patient had a medical history of Uterine cancer with hysterectomy since 2011. Patient Chemo therapy will  begin from 06/21/2021. Concomitant medication was not provided. No Treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
sx occurred 3 hrs p/inject throat felt raw; tongue, mouth, lips swollen, eyes bulging, difficulty breathing, anxiety;
Patient presented to the ED and was subsequently hospitalized for hypernatremia, acute kidney injury, and metabolic encephalopathy on 4/25/2021. Patient received second dose of vaccine on 5/17/2021. On 6/4/2021 patient presented to the ED and was subsequently hospitalized for sepsis. These visits are within 6 weeks of receiving COVID vaccinations.
I received the injection and felt fine without any noticeable reactions until approximately 50 minutes later when I developed a strange headache.  It felt as though I had eaten ice cream too quickly and had "brain freeze".  This lasted for about an hour, was fairly mild and I didn't take any medication for it nor did I contact any medical professional.
Pt. reported feeling SOB with exertion 20 minutes after receiving second dose of COVID 19 vaccine. Pt. was speaking in full unlabored sentences without obvious signs of increased work of breathing.  ACC provider was called to assess and ordered MDI albuterol inhaler/ spacer. Pt. ambulated and was able to maintain Sa02 of 97% while ambulating.  Pt. was observed for 60 minutes and discharged home with grand daughter in no apparent distress and reported improvement of dyspnea.   Pt. did report that she routinely has "sudden" onset of SOB with ambulation and this was not unlike previous episodes other than having just had vaccine administration.
Immediately after receiving vaccine patient stated he felt dizzy. Patient BP checked and O2 Sat. Patient stated he felt better after re checking BP.
Patient received the vaccine and started feeling faint. She then became dizzy and a code green was called. RN SUPERVISOR and Paramedics arrived right away. Patient was laid down on a cot and paramedics intervened at the scene.
ADMINISTRATION OF A FILLED  SYRINGE THAT WAS STORED IN  REFRIGERATOR FOR 12-18 HOURS; ADMINISTRATION OF A FILLED  SYRINGE THAT WAS STORED IN  REFRIGERATOR FOR 12-18 HOURS; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's weight was 210 pounds, and height was 67 inches. The patient's concurrent conditions included: asthma, arthritis, alcohol user and smoker and other pre-existing medical conditions included: The patient is taking pro-air inhaler for unknown indication. The patient was previously experienced hives and skin rash when treated with ciprofloxacin for drug used for unknown indication, and drug dependence when treated with aripiprazole, colchicine, fluticasone propionate, escitalopram oxalate, naproxen, omeprazole, paracetamol and diclofenac for drug used for unknown indication, drug dependence when treated with gabapentin and oxybutynin.  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 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 11-AUG-2021, the patient experienced administration of a filled syringe that was stored in refrigerator for 12-18 hours. On 11-AUG-2021, the patient experienced administration of a filled syringe that was stored in refrigerator for 12-18 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of a filled syringe that was stored in refrigerator for 12-18 hours and administration of a filled syringe that was stored in refrigerator for 12-18 hours was not reported. This report was non-serious.
Patient did not receive second dose; Left arm pain; Right arm pain; Received 1st and 2nd dose on the same day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Left arm pain), PAIN IN EXTREMITY (Right arm pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st and 2nd dose on the same day) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 002A21A) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left arm pain), PAIN IN EXTREMITY (Right arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st and 2nd dose on the same day). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 1st and 2nd dose on the same day) had resolved. On 05-Mar-2021, PAIN IN EXTREMITY (Left arm pain) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose) had resolved.        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.   No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.   This case was linked to MOD-2021-036560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received as no new information. On 06-Aug-2021: Follow-up received: added patient middle name and event.
shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a physician office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has 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.
received 3 doses. 3rd dose 12 months after 1st; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 47S82, expiry date 20th May 2024) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.      Additional Information: GSK receipt date: 04-OCT-2022 Reporters comment: The patient received three doses of Shingrix and third dose was administered 12 months after the 1st dose. The first two doses were administered considering the correct schedule. The reporter consent to follow-up. Additional Supportive information: The patient received 3rd dose of Shingrix, which led to extra dose administered.
post menopausal bleeding Narrative: uterine ablation performed 12/2021 due several months of post menopause bleeding.
warm to the touch; redness around injection site; a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of INFUSION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE PRURITUS (a little itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Abscess on 15-Jan-2021, Pruritus on 15-Jan-2021 and Erythema on 15-Jan-2021.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INFUSION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE PRURITUS (a little itchy). At the time of the report, INFUSION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE PRURITUS (a little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
sister woke up from sleep every hour with a fever; sister woke up from sleep every hour with a fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the sister woke up from sleep every hour with a fever. The outcome of event was unknown.  Follow-up attempts are possible. Information on the lot/batch number has been requested.
Itching at injection site upper left arm; Rash on from Mid left upper arm to shoulder; Sore left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left upper arm), VACCINATION SITE PRURITUS (Itching at injection site upper left arm) and VACCINATION SITE RASH (Rash on from Mid left upper arm to shoulder) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, METOPROLOL, ROSUVASTATIN, INSULIN ASPART (NOVOLOG), INSULIN DEGLUDEC (TRESIBA), PARACETAMOL (TYLENOL), METHOCARBAMOL (ROBAXIN), METFORMIN and OMEPRAZOLE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore left upper arm). On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site upper left arm) and VACCINATION SITE RASH (Rash on from Mid left upper arm to shoulder). At the time of the report, PAIN IN EXTREMITY (Sore left upper arm), VACCINATION SITE PRURITUS (Itching at injection site upper left arm) and VACCINATION SITE RASH (Rash on from Mid left upper arm to shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for symptoms: Itching cream application to the area
Office visit 1/30/17.  Left deltoid 3x6 cm raised rash, localized skin erythema at injection site  area itchy & sore to the touch.  Localized skin reaction.  Continue to monitor.  Return if no improvement or gets worse.
Chills, headache and fever between 99.5 and 100.5 (my typical body temp is usually around 97.5) lasting about 18 hours. Pain at injection site and entire left arm, severe after 12 hours then dissipating.
Swollen lymph node left armpit. Tender with arm movement and to the touch. Started on 4/17/21 and still present today, 4/18/21.
This case was reported by a nurse and described the occurrence of rash in an 84 year old female subject who was vaccinated with Engerix-B for prophylaxis. Medical history included renal failure (cause not specified) requiring hemodialysis. On 01 December 2005, the subject received the 1st dose of Engerix-B (20 mcg; lot AHBVB190AA). On 03 December 2005 the subject received another dose of Engerix-B (20 mgc; lot AHBVB190AA) as the completion of the 1st 40 mcg dose of Engerix-B. The recommended schedule for administering 40 mcg Engerix-B from a 20 mcg dose is two 20 mcg doses on the same day. On 03 December 2005, less than one day after vaccination with the 2nd 20 mcg dose of Engerix-B, the subject experienced itching and "a rash that started on her trunk and spread to the entire body." The subject was seen at a physician's office and was treated with Benadryl. The rash and itching resolved on 13 December 2005. The nurse considered the rash and itching to probably be related to vaccination with Engerix-B.
Moderna COVID-19 Vaccine EUA 1/6/21 site of reaction began to itch. Patient did scratch the area and itching persists. Patient looked at injection site where a large swollen (3 inch by 1 inch) reddened and swollen area noted. 1 dose of 25 mg  benedryl taken around 11 PM on 1/6/21. As of today site (5inch by 2 inch) swollen area noted with and torso itchy. 1/7/21 reddened splotchy areas noted on chin chest top of legs and persistent itching all over. Arm continues to be warm to touch. All reactions appear to be on skin. No difficulty breathing or other reactions noted.