chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got exposed to the sun a lot; arm where she got the shot was getting red and hot; arm where she got the shot was getting red and hot; arm where she got the shot was getting red and is now moving down her arms along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; Right now her arm is puffy, swelling, hot, and the redness is moving down the arm along with the heat; soreness is going out. It is just a little sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number was not reported) via an unspecified route of administration administered in Arm on 22Jul2021 as dose 2, single dose for covid-19 immunization (at the age of 70-years-old). The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization and had no issues. It was reported that on 22Jul2021 (on Thursday) the patient received the second dose of vaccine and stated that on Sunday 25Jul2021, patient got exposed to the sun a lot and her arm where she got the shot was getting red and hot and was now moving down her arms along with the heat. Patient was trying to know if it was normal. The patient further stated that she set in the sun and she didn't know that the heat was goanna bother her arm. Right now on an unspecified date in Jul2021 her arm was puffy, swelling, hot, and the redness was moving down the arm along with the heat. She wanted to know if this was normal. She stated that she had first shot and had no issues. She then said it started Saturday night when she put ice on it. It just seems like the red and hot was moving down her arm. She was just trying to find out if it was normal. On an unspecified date in Jul2021 the soreness was going out and It was just a little sore. The outcome of the event pain in arm was recovering and outcome was unknown for rest of the other events.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium
Fever, reddened area size of fifty cent piece. Started 24 hours after injection. Seen in office 02/07/05 for reaction to injection.
I had cough, headache, congestion, sore throat, and a weird taste.  These symptoms are still ongoing since Jan 15th.  I went to urgent care on Jan 17th, for a Covid-19 test, positive results.
Moderate sore arm; Took two naps; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Took two naps) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 025J20-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced SOMNOLENCE (Took two naps). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Took two naps) outcome was unknown.            No concomitant medication were reported.   This case was linked to MOD-2021-307981, MOD-2021-308039 (Patient Link).
sometimes she can´t even walk due to the pain; awful pain in the joints; awful pain in muscle; Muscle pain; joint pain; she has slow movements; she is laying on the bed her whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), ARTHRALGIA (joint pain), BRADYKINESIA (she has slow movements), PAIN (she is laying on the bed her whole body hurts) and PAIN IN EXTREMITY (sometimes she can´t even walk due to the pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0521-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history is provided and concomitant drugs are provided.  Concomitant products included cholesterol medication and blood pressure medication for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (joint pain), BRADYKINESIA (she has slow movements) and PAIN (she is laying on the bed her whole body hurts). On an unknown date, the patient experienced PAIN IN EXTREMITY (sometimes she can´t even walk due to the pain), ARTHRALGIA (awful pain in the joints) and MYALGIA (awful pain in muscle). At the time of the report, MYALGIA (Muscle pain), ARTHRALGIA (joint pain), BRADYKINESIA (she has slow movements), PAIN (she is laying on the bed her whole body hurts), PAIN IN EXTREMITY (sometimes she can´t even walk due to the pain), ARTHRALGIA (awful pain in the joints) and MYALGIA (awful pain in muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: TCR
Muscle ache,  Throbbing pain and 10/10  on pain scale. Took Ibuprofen,  Tylenol,   Aspirin , Votaren,  Lidacaine and they are all ineffective.
Arm red swollen from shoulder to elbow on left arm (cellulitis). Given cetirizine for swelling and cephalexin for infection.
This spontaneous report as received from a registered nurse refers to a 0 day (neonate) old male patient. On 12-JUL-2014 the patient was vaccinated with the first dose of a RECOMBIVAX HB lot # J012520, intramuscular. The storage temperature of RECOMBIVAX HB was between 0 and 1 degrees, on 18 different episode between 14-MAY-2014 and 21-JUL-2014. The registered nurse reported that it was no possible to identify how long the temperatures were down because it was not documented accordingly since all recorded temperatures at morning and at night were within 2 and 8 degrees. It was reported that the vaccine was removed once the problem was identified and it had not been used after 21-JUL-2014. There were no adverse events reported. This is one of several reports received from the same source. Additional information is not expected.
A nurse reported that a female inadvertently received a subcutaneous injection of flu Shield on 11/27/2001 and two days later, developed a red mar, the size of a coffee cup at the injection site. As of the date of this report, no further info was available.
shot throat started closing up; couldn't breathe; Fever day one day two 1.5 days into shot throat started closing up couldn't breathe. Went to er everything checked out except I was in anaphylaxis from a allergy.; Fever; This is a spontaneous report from a contactable nurse (patient). This non-pregnancy 35-year-old female patient received bnt162b2 (Brand=Pfizer), dose 1 via an unspecified route of administration, administered in arm left on 25Aug2021 10:00 (Batch/Lot Number: Fa7485) as dose 1, single for covid-19 immunisation. Medical history included chronic pain depression. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: paracetamol. Known allergies: No true allergies just adverse side effects like clarithromycin (MACROBID) vomiting trazadone weird dreams varenicline tartrate (CHANTIX) we. The patient experienced anaphylaxis and fever on 25Aug2021 13:00, shot throat started closing up couldn't breathe on 26Aug2021.  Fever day one day two 1.5 days into shot throat started closing up couldn't breathe. Went to ER everything checked out except she was in anaphylaxis from an allergy. No new meds or foods eaten. No new allergens introduced except vaccine. Never had a true allergic reaction in my life only side effects from certain meds like vomiting with clarithromycin for instance. Her throat still felt like it was trying to close up about once a day and she had to take more benedryl. The adverse event result in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received for the adverse event included Iv steroids famotidine and benedryl. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Covid rapid at work on 19Aug2021: Negative (Nasal Swab). The outcome of event shot throat started closing up was not recovered. The outcome of other event was unknown.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
PATIENT RECEIVED FULL DOSE OF MODERNA AS BOOSTER TO JANSSEN VACCINE RECEIVED 03/2021 -- DECEIVED PROVIDER INTO THINKING  IT WAS FIRST DOSE IN SERIES THEN ULTIMATELY ADMITTED PRODUCT WAS HER BOOSTER AND WANTED TO RECEIVE FULL MODERNA SERIES SINCE "J&J PRODUCT WANES OVER TIME." NO FURTHER DOSES WILL BE ADMINISTERED AFTER DATE OF SERVICE.
Patient received 1st dose of Moderna in October. Instead of giving the patient a second dose (0.5 mL) of Moderna, I accidentally gave 0.25 mL (booster dose) assuming it was a booster shot since it was far out from his first dose. Patient was alerted and notified.
Within 3 minutes of administering HPV & Tdap (BOOSTRIX), patient's eyes rolled back and patient fainted. Came to within 1-2 minutes. Doesn't remember episode. States she saw lights and was dizzy. Episode happened after 2nd shot (HPV) given. Pt. stated it hurt and arm felt achy just before fainting
Information has been received from a physician concerning an approximately 6-week-old female who was vaccinated PO with the first 2.0 mL dose of Rotateq (lot number not provided). The physician reported that, two weeks after being vaccinated, the patient developed a small circular ulcer, 4 mL in diameter, on her soft palate characterized by a red border with a clear center at the back part of her throat. The physician noted that it looked like ring worm. Unspecified medical attention was sought and the patient was treated with nystatin. The patient subsequently recovered while on therapy. The physician considered the patient's ulcer to be an other important medical event as she was treated with nystatin. This is one of several reports received from the same source. Additional information has been requested.
Fever 102.2 F since 2:45 p.m until now the time of report 9:45 p.m. Sneezing, congestion, heavy eyelids, red cheeks.
IPV given 2:11 pm 8/15/11. In the middle of the night had fever of 103 & headache. No other symptoms.
FEELING UNDER THE WEATHER; FEVER; COULDN'T FALL ASLEEP AND DIDN'T REST VERY WELL; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced couldn't fall asleep and didn't rest very well. On 26-MAY-2021, the subject experienced feeling under the weather. On 26-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.3 degrees Fahrenheit. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from couldn't fall asleep and didn't rest very well, fever, and feeling under the weather. This report was non-serious.
No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 30-MAR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (No lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005629: US-009507513-1904USA005628: US-009507513-1904USA005631: US-009507513-1904USA005627:
Her arm was swollen, red, bumpy and itchy and about a size of orange; Her arm was swollen, red, bumpy and itchy and about a size of orange; neck pain; arm pain; Her arm was swollen, red, bumpy and itchy and about a size of orange; she got an allergic reaction at site; Her arm was swollen, red, bumpy and itchy and about a size of orange; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain) and INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain), INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE HYPERSENSITIVITY (she got an allergic reaction at site) and INJECTION SITE PAPULE (Her arm was swollen, red, bumpy and itchy and about a size of orange). At the time of the report, INJECTION SITE SWELLING (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE ERYTHEMA (Her arm was swollen, red, bumpy and itchy and about a size of orange), NECK PAIN (neck pain), PAIN IN EXTREMITY (arm pain), INJECTION SITE PRURITUS (Her arm was swollen, red, bumpy and itchy and about a size of orange), INJECTION SITE HYPERSENSITIVITY (she got an allergic reaction at site) and INJECTION SITE PAPULE (Her arm was swollen, red, bumpy and itchy and about a size of orange) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol, Antihistamines and Hydrocortisone cream.; Sender's Comments: This case concerns a 32-year-old female with a nonserious unexpected event of injection site hypersensitivity, injection site papule, pain in extremity, neck pain and expected injection site pruritus, injection site erythema, injection site swelling. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on 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.
UNCONTROLLABLE VAGINAL BLEEDING; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included intestinal surgery, and concurrent conditions included severely overweight, stomach issues, and severe scarring. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported .The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was hospitalized with uncontrollable vaginal bleeding, that would not stop without surgical intervention. As of 16-APR-2021, the patient was still hospitalized. The current condition and whereabouts of the patient is unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of uncontrollable vaginal bleeding was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210438280-covid-19 vaccine ad26.cov2.s-Vaginal bleeding. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
food allergies/ Allergic to eggs, avocados; intense gut allergies; Allergic to gluten; Allergic to dairy; Making my quality of life miserable/Ever since the day I got my vaccine life has not been the same; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Jul2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. The following information was reported: FOOD ALLERGY (disability) with onset 24Jul2021, outcome "not recovered", described as "food allergies/ Allergic to eggs, avocados"; HYPERSENSITIVITY (disability) with onset 24Jul2021, outcome "not recovered", described as "intense gut allergies"; GLUTEN SENSITIVITY (disability) with onset 24Jul2021, outcome "not recovered", described as "Allergic to gluten"; MILK ALLERGY (disability) with onset 24Jul2021, outcome "not recovered", described as "Allergic to dairy"; IMPAIRED QUALITY OF LIFE (disability) with onset 24Jul2021, outcome "not recovered", described as "Making my quality of life miserable/Ever since the day I got my vaccine life has not been the same". The events "food allergies/ allergic to eggs, avocados", "intense gut allergies", "allergic to gluten", "allergic to dairy" and "making my quality of life miserable/ever since the day i got my vaccine life has not been the same" were evaluated at the physician office visit and emergency room visit. No other vaccine in four weeks and no other medications in two weeks. After receiving vaccine patient have developed a long list of food allergies and intense gut allergies she had never had prior to the vaccine. For two months after getting the vaccine, she was bed ridden. She was now allergic to gluten, eggs, dairy, avocados, as well as other items but these are the main. This health complication had led her to hospital visits, countless blood tests, and making her quality of life miserable. Doctor literally told patient he did not know what was wrong with patient. Ever since the day she got her vaccine life had not been the same. The patient underwent the following laboratory tests and procedures: countless blood tests: unknown result; Nasal Swab: negative. Therapeutic measures were not taken as a result of food allergy, hypersensitivity, gluten sensitivity, milk allergy, impaired quality of life. The lot number for bnt162b2 was not provided and will be requested during follow up.
Swollen lymph nodes (very painful); Red, swollen, raised rash at injection site; Red, swollen, raised rash at injection site; Red, swollen, raised rash at injection site; Fatigue; Deep sweat; elevated heart rate; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the arm left on 30Apr2021 at 08:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sambucus nigra (ELDERBERRY), allium sativum, ganoderma lucidum, lentinus edodes, hericium erinaceus, inonotus obliquus (MUSHROOM IMMUNE SUPPORT), benzalkonium chloride, sodium chloride (ALIVE) and multiv; all from unknown date for unspecified indication.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the arm left on 10Apr2021 at 08:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation and Penicillin on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021 at 01:30, the patient experienced swollen lymph nodes (very painful), red, swollen, raised rash at injection site, fatigue, deep sweat and elevated heart rate. The clinical outcome of the events swollen lymph nodes (very painful), red, swollen, raised rash at injection site, fatigue, deep sweat and elevated heart rate was not resolved.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Information regarding concurrent conditions and medical history was not provided. On 17-MAR-2016 the patient was inadvertently vaccinated with an expired dose of (Merck) VARIVAX (with lot # and expiration date K002920 and 26-FEB-2016, respectively) (dose and route of administration were not provided). Concomitant medications were not provided. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a registered nurse concerning her daughter who was vaccinated with the third dose of GARDASIL.  Four days after the third dose the patient experienced bleed in her arm.  It did not happen with the previous dose.  At the time of reporting, the outcome was unknown.  It is unknown if the patient sought medical attention.  Additional information has been requested.
"Given Tdap, developed cellulitis. Treated with Keflex." Information entered through hospital's internal adverse event reporting system; available documentation inadequate to differentiate if this is truly a bacterial cellulitis versus a common injection site reaction. Patient was treated with cephalexin (Keflex).