chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breast cancer; This spontaneous case was reported by a patient and describes the occurrence of BREAST CANCER (Breast cancer) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In December 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant). The patient was treated with Surgery (Double mastectomy, Lymph node removal) for Breast cancer. At the time of the report, BREAST CANCER (Breast cancer) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered BREAST CANCER (Breast cancer) to be not related.    No concomitant medication was reported.  Patient had breast cancer in both her breasts. Her lymph nodes were removed.  Patient was taking medications for breast cancer, aromatase inhibitor, to prevent a reoccurrence.  Company comment: This is a spontaneous case concerning a 74 years-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) event of breast cancer. The event occurred after a fourth dose of mRNA-1273.222 vaccine. Patient had double mastectomy with lymph node removal. She is on treatment with aromatase inhibitors. No further information disclosed about diagnostic tests performed or treatments received. At the time of the report, the outcome of the event was not recovered. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Rash began on her torso and face. Very small pink dots. Was not raised. The next morning the rash was much worse, Covering all of her face, into her scalp. Rash spread to her arms and legs on day #2 and 3. Slightly raised. She was not bothered by rash, did not have a fever. She still currently has small pink dots that are not as bright pink as on day #2 and Day #3.
Got bronchitis; Was still sick even after Christmas; Freaking cough / would't go away; Freaking / cold would't go away; This case was reported by a consumer via other manufacturer and described the occurrence of bronchitis in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   The patient's past medical history included low blood pressure (Family History) (mother has low BP) and anaphylactic shock. Concurrent medical conditions included metastatic breast cancer, migraine, glossopharyngeal neuralgia (allergies to other substances) and allergy. Concomitant products included gabapentin, montelukast sodium (Singulair), levothyroxine sodium (Synthroid), allergy medication {nos} (Claritin (Allergy Medication Nos)) and oxycodone.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced bronchitis, sickness, cough and cold. The patient was treated with calcium carbonate (Caltrate (Calcium)) and vitamins nos (Vitamins). On an unknown date, the outcome of the bronchitis, sickness, cough and cold were unknown.   It was unknown if the reporter considered the bronchitis, sickness, cough and cold to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient herself. The patient did not receive many vaccines in past. The patient had history of anaphylactic shock. The patient had allergies to other substances. The patient's mother has low blood pressure. The patient concurrent conditions included of metastatic breast cancer, migraine in 2011 or 2012 and neuralgia. The concomitant medication included Gabapentin 300mg for glossopharynx neuralgia , 3 times a day, Singulair 10mg 2 times a day for migraines, Synthroid 112mcg for thyroid, Oxycodone 1 and 1/2 tablets a day for neuropathy and Claritin for allergic to the decongestant. The patient received the dose of Flu vaccine in November 2019 and patient got bronchitis. The patient was still sick, freaking cough and with cold. The patient never complained about her arm hurting. The patient received the vitamins and calcium caltrate as treatment for bronchitis. On 15th April 2021, the patient received the dose Covid-19 pfizer vaccine and experienced events. This case was 1 of 3 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR095136:Same reporter US-GLAXOSMITHKLINE-US2021AMR095212:Same reporter. Flu shot mother's case.
Pt sent home from school with an elevated temp of 101 F.  Pt is also having chills
No complaints on the day vaccines were given 11/21/05. 2/17/06 Death Certificate received which revealed COD as SIDS./ss 2/28/06Autopsy Report received which revealed COD as SIDS/ss
Pain/burning when needle went in 15 min. post injection less pain/still stinging very, very little bleeding
woke up , showered and noted a red band on the arm, there is pain that feels like a bad bruise to the area, area is warm to the area
Hospitalized; A regulatory report was received from a consumer  concerning a female patient who experienced hospitalization.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    The patient received her first of two planned doses of mRNA-1273 Batch number not provided on 11-JAN-2021 for prophylaxis of COVID-19 infection.    The patient received the first dose of the Moderna COVID-19 vaccine on 11Jan2021. On 07Feb2021 she was hospitalized for reasons she didn't want to specify and returned home on 11Feb2021. She missed her appointment for her second dose on 08Feb2021because of the hospitalization. She didn't want a callback because she says that this was not related to the vaccine, so no further information was gathered.  Treatment information was not provided/unknown.    The second dose of mRNA-1273 was temporarily withheld in response to the event.  The event of hospitalization was considered recovered/resolved on 11 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient reports receiving the Moderna COVID-19 vaccine 12/28/20, started noticing itching to left proximal arm with subsequent rash developing to arm 48 hours ago. Patient reports lining rash last night, noted rash extending past lining today. Patient noted some reactive lymphadenopathy, denies any further concerns or complaints.
After 5 days of the injection (2/22/21) had sore arm and then pain in the muscle and also the joint of her shoulder.  She has a sharp pain when she moves her arm in certain positions,.  Goes from a muscle soreness to a sharp stabbing pain.    She went to her doctor and he said that it was from the vaccine and not her rheumatoid arthritis.
Patient remained at the pharmacy for observation period as recommended by the CDC.  5-10 minutes after leaving, while driving home, the patient said her face and tongue started to swell.  She immediately drove herself to the closest urgent care for treatment.  The urgent care dosed her up with benadryl and did not give the patient an epinephrine shot.  The patient states that she remained at the urgent care for most of the afternoon until they released her around 4 pm.
pt recv vax & became sleepier & appetite began to dec;t101 ax;temp cont to rise over next 5 days;quit eating & slept 20hr;finger nails turn blue, lost 2 lbs;fluttering eyes;scream up to & over hr;pain
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash Generalized-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient reported to our store 5457 about a vaccine she got at 5434 last monday. She broke out with a rash the thursday after getting the vaccine and after a few days of vaccine she decided to go to urgent care since the \"burning wasn't stopping\" and it spread to her chest. She was discharged with a script of prednisone and the rash seems to be getting a little better. I will follow up with her in 2 days to make sure it has cleared up.
12 hours post injection developed severe chills, HA, muscle pain and fever of 101.1 along with moderate injection site tenderness with slight itchy rash on arm. Took 500mg Tylenol and went to bed. Felt better in morning fever down to 98.8 with additional Tylenol taken at 0500 am before arising. Moderate fatigue.
Patient was covered in head to toe rash. She tried OTC Benadryl, oatmeal bath and creams. Ended up getting a seriod injection in office and prescription sent to pharmacy
Immunizations were administered without my permission and not needed.  Wrong chart - immunization card in patient's file - it was my other child - he did not need shots either.
achiness; lost of appetite; tired; Headache; rash; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (achiness), DECREASED APPETITE (lost of appetite), FATIGUE (tired), HEADACHE (Headache) and RASH (rash) in a 66-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), DECREASED APPETITE (lost of appetite), FATIGUE (tired), HEADACHE (Headache) and RASH (rash). At the time of the report, PAIN (achiness), DECREASED APPETITE (lost of appetite), FATIGUE (tired), HEADACHE (Headache) and RASH (rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. Rash, headache, fatigue are consistent with the known safety profile of the vaccine.
severe allergic reaction; This is a spontaneous report from a contactable consumer. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced severe allergic reaction after the first dose on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021193923 same patient, different drug/AE
Right Middle Lobe Pulmonary Embolism 12 days after Prevnar 20, shortness of breath, chest pain
Swelling & erythema with 4cm radius, developed 1 wk after vax. Central induration present. Afebrile. Tx'd w/Ibuprofen 800 mg #30.
Pt with parent complaining of hot, red and swollen injection site on left thigh. Rx'd Benadryl po and cold compresses to area per doctor.
fever; developed rash on arm and chest; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and RASH (developed rash on arm and chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017621B) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PYREXIA (fever) and RASH (developed rash on arm and chest). At the time of the report, PYREXIA (fever) and RASH (developed rash on arm and chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication information provided. No concomitant medication information provided.
tested positive for COVID/tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for COVID/tested positive) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (tested positive for COVID/tested positive). At the time of the report, COVID-19 (tested positive for COVID/tested positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive. On 19-Oct-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medication was reported.  The patient stated she received previous COVID19 vaccinations, but she didn't know exactly when. Then she got COVID.  She wanted to know how long she needs to wait before getting the next booster.  Patient took medication on 20-OCT-2022. She was better then.
Pt received left arm SQ injection. Edema and redness noted to arm 48hrs post injections. 2hrs post, pt noted pain to arm, this has now subsided.
Autonomic dysfunction - orthostatic intolerance, dry eyes, dry mouth, palpitations, tachycardia, malabsorption (loss of documented 40 lbs), gastrointestinal motility dysfunction, low blood pressure, new food intolerance, muscle weakness, erectile dysfunction, low testosterone, sweating dysfunction, panic attacks and numbness/tingling of extremities.
This spontaneous report as received from a other health professional refers to a patient of unknown age with prophylaxis. On 25-AUG-2016 the patient was vaccinated with adult formulation RECOMBIVAX HB lot # L035881 dose 1, intramuscular for prophylaxis. On 04-NOV-2016 the patient was vaccinated with pediatric formulation RECOMBIVAX HB lot # L023387 dose 2, intramuscular for prophylaxis. On 25-FEB-2017 the patient was vaccinated with ENGERIX-B (incorrect dose administered, interchange of vaccine products, inappropriate schedule of drug administration). No adverse effects reported.
Pt developed a pruritic rash starting the day after receiving 2nd GARDASIL vaccine.  No work up done.  Rash on torso area.  Treated with TRIAMCINALONE cream 0.5%.
pt recvd vax & 2 wks later exp elevated liver function tests & elevated serum phosphorus; 3MAY94 elevated liver function tests have dec; phosphorus level elevated;
sweaty, lightheaded, fingers tingly, nauseous BP 78/52; BS-102; HR 62; RR 22 juice and crackers improved symptoms when he left his BP was 115/70 left feeling "almost normal"
had chills again today; chills and shaking for 3-5mins yesterday; chills and shaking for 3-5mins yesterday; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (chills and shaking for 3-5mins yesterday), CHILLS (chills and shaking for 3-5mins yesterday) and CHILLS (had chills again today) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A, 030A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced TREMOR (chills and shaking for 3-5mins yesterday) and CHILLS (chills and shaking for 3-5mins yesterday). On 14-Nov-2021, the patient experienced CHILLS (had chills again today). On 13-Nov-2021, TREMOR (chills and shaking for 3-5mins yesterday) and CHILLS (chills and shaking for 3-5mins yesterday) had resolved. At the time of the report, CHILLS (had chills again today) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
no adverse effects; improperly stored VAQTA might had been administered; Information has been received from a registered nurse referring to an unknown number of patients of an unknown age and gender.  The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, (reported as since 16-APR-2016), the patients might have been vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # M003011, expiration date: 15-NOV-2017; dose and route of administration were not provided).  The vaccine was exposed to temperature of 6 degrees Fahrenheit for 7 hours. No previous temperature excursion was reported. No adverse effects were reported. There was no product quality complaint.  On 16- MAY- 2016, a call was placed to the registered nurse. The call was received by another nurse. No additional information including patient identifiers, lot number and expiration date and date of vaccination were available at time of call. This is one of several reports received from the same reporter.  Additional information has been requested. Narrative was updated.; Sender's Comments:  US-009507513-1604USA013742: US-009507513-1604USA014684: US-009507513-1604USA014683:, MERCK1604USA014682:Mfr number
Extreme hives and rash over body. Still occurring. Diagnosis: allergic reaction causing eczema.
12/3/10 (+) Bordetella - had ADACEL (TDAP) 7/17/08.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The Dose administered after 30-day Use By Date or after manufacturer date of expiry Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  Dates of administration of vaccine were reported as 8Apr2022, 12Apr2022 and 13Apr2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contain Non-Significant information.
My arm is swollen and a lump can be felt at the sight of the vaccine.  Still very sore and tender a week later and lump seems bigger.
Breakthrough COVID case. Asymptomatic. Tested during hospitalization be request after partner tested positive. Positive test collected 08/11/2022
Stiff neck, painful to touch with sensation of burning heat. Headache. The painful to touch lasted for 7 days. The unusual stiffness continues as this form is being filled out.
Multiple rashes developed on the upper torso that later spread to other areas touched.  Rashes blistered.  Treated in urgent care on 4/18/2021.  Prescribed oral steroid and topical anti-fungal powder.  Rashes have cleared, but severe scarring remains.
Body aches and head aches started next day  after the vaccine was given.   We recommended to call his Doctor
VERY MILD SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and immunocompromised. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included tofacitinib citrate for rheumatoid arthritis. On MAR-2021, the patient experienced very mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was non-serious. This case, involving the same patient is linked to 20220250779.
Swelling and redness, parents reports looked somewhat purple and bruised.  Used Motrin and ice.