chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case previously recorded as MA2009-4590. Initial case report received from a physician on 17 NOV 2009. A patient 3-year-old or younger was vaccinated with FLUVIRIN 2009/2010 i.m. on 13 NOV 2009. No adverse effect was reported. Reference no:NA09-008308.
This case was reported by a consumer via call center representative and described the occurrence of itchy legs in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced itchy legs. On an unknown date, the outcome of the itchy legs was unknown. It was unknown if the reporter considered the itchy legs to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The patient experienced itching at one spot on his left thigh. No further details were provided.
ABDOMINAL PAIN; LEG PAIN; HEADACHE; BLOOD CLOT IN THE RIGHT FEMORAL VEIN IN THE RIGHT THIGH; This spontaneous report received from a consumer concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 03-APR-2021 to right deltoid for prophylactic vaccination. Concomitant medications included valsartan 40mg. On 20-JUN-2021, the patient experienced blood clot in the right femoral vein in the right thigh which was found through computerised tomogram which was done when the patient had visited the doctor about the other symptoms of abdominal pain, leg pain and headaches. The health care professional had intended to visit another health care professional specialized in blood clot related issues. Laboratory data included: Computerised tomogram scan (NR: not provided) Blood clots observed in right femoral vein in the right thigh. On an unspecified date, the patient experienced abdominal pain, leg pain, and headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in the right femoral vein in the right thigh, leg pain, headache and abdominal pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210654370-COVID-19 VACCINE AD26.COV2.S-blood clot in the right femoral vein in the right thigh. 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).
Dizziness, Tachycardia, menstrual bleeding started Narrative:  menstrual bleeding started same day as vaccine injection and has continued to bleed slightly as of 2/23/2021  Other Relevant History:
Redness, swelling, itching, warm to the touch radiates out greater than 6 cm from injection site.
High fever; Nausea; Diarrhea; muscle/body aches; muscle/body aches; horrid headaches; large red spot size of softball where injection given; This is a spontaneous report from a contactable other health care professional reported that a 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection); first dose (lot number: eh9899) via an unspecified route of administration on 18Dec2020 09:00 at SINGLE DOSE at right arm, and second dose (lot number: EL1284) via an unspecified route of administration on 08Jan2021 09:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included depression, anxiety, and migraine. The patient has Known allergies with lisinopril, morphine, vancomycin, albuterol. On 09Jan2021 12:00, the patient experienced High fever, nausea, diarrhea, muscle/body aches, horrid headaches, large red spot size of softball where injection given. The outcome of the events was recovering. The patient did not receive treatment for the events.
04/29/2021 PM-Queasy stomach, very sore arm at injection site, headache 04/30/2021 AM-Headache/chills all night.  Fever 101 about 9AM. Queasy stomach, very tired..  Continued through day.  Did not retake temperature but may have increased. headache beg an to ease overnight 4/30-5/1 05/01/2021-Light headache AM.  Queasy stomach and fatigue all day. 05/02/2021 to 05/03/2021-All symptoms gone except fatigue which continued through 5/3/21
had an episode of vomiting & severe stomach pains 3 days following vax; similar bouts on 13MAY, 15, 20 & 22; 4JUN to ER returned to MD 5JUN hosp x 2 days; dx gastroporesis;
A few hours after vaccine was given, my entire left arm ached, especially at the joint areas (elbow and wrist); I could barely use that arm. That night, my entire body ached and I developed a bad and consistent headache that lasted throughout the night. I also experienced chills and a fever and was unable to sleep. I took TYLENOL over two days and symptoms eventually went away.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt fainted after vaccine, hit head on nearby object.  sustained approx 2 cm laceration to scalp with moderate bleeding. applied saline wound wash and gauze. bleeding stopped. VS normal BP110/72, P90,RR14,O297%RA. Pt revived after1-2 min. She sat up and was able to walk. Mom at work. Mom called neighbor to pick up pt. Mom agreed to have FM take pt to ER/urgent care.
First menstrual period after shot was delayed by about 10 days,  subsequent periods have been very heavy with large clots and increasing each time
PT first noted itching, erythema around 3:30 or 4pm went to church then took BENADRYL 25mg after church Sx's increased so pt returned to office today She will start fexofenadine 180mg QD and Prednisone 20mg BID for 3 days then one QD for 3 days She will return to the office if any increased Sx's or to the ER if any anaphylaxis Sx's.
REPORTED FEELING THROAT TIGHTNESS, SKIN FLUSHING AND LIGHTHEADEDNESS POST VACCINE, SIMILAR TO DOSE 1 WHICH RESOLVED SPONTANEOUSLY AFTER ABOUT 2 HOURS.. TODAY, S/S BEGAN/OCCURED WITHOUT CLINICAL FINDINGS. NO THROAT EDEMA/ERYTHEMA NOTED. VSS. ESCORTED TO EXIT WITH NO ISSUES AT 1621. 1605 LYING BP 148/76 HR 78 RR 12 SATS 99% 1615 SITTING BP 133/82 HR 71 RR 12 SATS 98% RA
An expired Covid-19 pfizer vaccine was administered to the patient on 4/23/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient on 5-11 and she will consider getting revaccinated.
Progressively sore shoulder following vaccination impaired range of motion reaching overhead, behind back in following weeks. Saw GP, who suspected tenonitis went to orthopedist on 2/2-diagnosed with frozen shoulder. Injected and oral steroids and PT.
soreness and redness where given the injection; soreness and redness where given the injection; Fever; Headache; Chills; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date not reported), via an unspecified route of administration at the left arm on 20Jan2021 17:30 at single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, thyroid disorder and COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications (unspecified) in two weeks were given. On 21Jan2021 15:00, the patient experienced soreness and redness where given the injection, fever, headache, and chills. No treatment was received for the adverse events. Clinical outcome of the events was recovering.
Itching all over body and tingling of lower lip. Hives all over top half of back within the first four hours of injection.  Headaches for three days and off an on for a week after that.  Leg pain and cramping of both legs for over a week and still going on.
Per patient, he developed enlarged lymph node 2 days after his vaccination.  He indicated that he has been hospitalized 3 times and that twice his lymph node "has been drained" by his physician.  His condition has not resolved as of 5/18/21.  He is still under care of his physician.   Hospitalization info was not provided to me.
pt recvd vax & 15NOV92 pt exp soreness in entire lt arm & transient arthritis & arthralgia in hands, lt foot, rt elbow, rt hip; seen by MD & placed on therapy w/Relafen;
PT REPORTED MILD DIZZINESS APPROX 10 MINS AFTER VACCINATION. REPORTS ONLY EATING A PROTEIN BAR AND KOOL-AID AT APPROX 1 PM AMBULATED WITH BRISK STEADY GAIT IN OBSERVATION AFTER GIVING SUGARY DRINK AND CRACKERS
fatigue; body aches; a low grade fever; This is a spontaneous report received from contactable reporter(s) (Other HCP), Program ID.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6198) at the age of 67 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "a low grade fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown".   Additional information: Caller dose not sees any prior vaccinations (within 4 weeks) in patient's chart. No family medical history and relevant tests was reported.
Extreme seasonal allergy - rhinitis that seems to be somewhat resistant to both over the counter and prescription meds
No additional AE reported; administration of an expired MMR II; This spontaneous report was received from a medical assistant and refers to a patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-MAY-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T016198, expiration date: 11-MAY-2022, administered for prophylaxis (strength, and route of administration were not provided). The reporter confirmed the vaccine was stored within the recommended storage range until administration. Also, the reporter was provided with the appropriate disclaimer per the post expiry memo. There was no additional adverse event (AE) reported.
Sore throat starting 2:00 pm the next day.  Better at night with Tylenol then recurred 2nd day at noon.
"Bad pain" on arm from elbow to shoulder along with fever and chills, sweating, h/a - lasted 12 hrs then resolved without Tx after 24 hrs. Arm was "sore for several days" - both doses in same arm.
Small red mark at vaccine site. Rash started in deltoid then disappeared 24 hrs later. Second rash appeared in the front of the arm near bicep.
In Nov. I had cold issues and it stayed until Dec. 9 when it got much worse. I have yet to get a CoVid test because of complications, so I self quarantined up until today.  Talked with my psychologist and other medical professionals. Was advised to rest at home until fully recovered to be seen.
swelling in the muscle; rash; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SWELLING (swelling in the muscle) and RASH (rash) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MUSCLE SWELLING (swelling in the muscle) and RASH (rash). At the time of the report, MUSCLE SWELLING (swelling in the muscle) and RASH (rash) outcome was unknown.        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.   Concomitant medications include a medicine for cholesterol, blood pressure, and anxiety, not otherwise specified. No treatment details were provided.
Rash started, rash is the size of a small saucer; Red; Became itchy; Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Became itchy), VACCINATION SITE PAIN (Arm sore), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Rash started, rash is the size of a small saucer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history were reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm sore). On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Became itchy) and VACCINATION SITE ERYTHEMA (Red). On 12-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash started, rash is the size of a small saucer). On 08-Jan-2021, VACCINATION SITE PAIN (Arm sore) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Became itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE RASH (Rash started, rash is the size of a small saucer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment drug calamine-pramocaine hydrochloride was administered to treat itchiness.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored (in 30.7F for 3 hours and 30 minutes and in 57.9F for 11 hours and 45 minutes) doses of PNEUMOVAX 23 (lot # L018503, expiration date 16-MAR-2017; dose and route of administration were not reported). No adverse effects were reported. The call was made because of the data logger. This is one of two reports received from the same reporter. Additional information has been requested.
mom rpt axillary fever of 104 since vax inject, given tylenol & motrin, fever has not decreased, pt is listless & just laying around.
From telephone correspondence on 7/2/02 and faxed correspondence received on 10/9/02, it was reported that a 37 year old adult female was vaccinated with TD ADS ADULT, lot # U0527AA on 6/28/02. Patient experienced severe pain and extreme swelling of the arm, and ran elevated temperatures for several days. The swelling and pain remained for approximately a week. Patient recovered.
This spontaneous report was received from a pharmacist and refers to a 64 year old female patient. The patient historical medications included BACTRIM. The patient was allergic to BACTRIM. The patient's concomitant medications included fluvoxamine maleate and quetiapine fumarate. On 02-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, (0.65, subcutaneous, lot # and expiration date were not reported). On an unknown date, unspecified time after receiving the ZOSTAVAX, the patient developed red patches at the injection site. The patient sought medical attention by calling the pharmacist. The outcome of red patches at the injection site was reported as recovery/resolving. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
large red rash that hurt, itched; large red rash that hurt; was hot to the touch on arm where shot was given; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm right on 27Apr2021 at 08:00(at the age of 76-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported she has allergy to several things. Concomitant medications included allergy shot - armsB taken on 17Mar2021and others(Yes, but more than will fit in this space) were reported but name not specified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm right on 06Apr2021 at 08:30(at the age of 76-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Apr2021 the patient experienced tiredness, headache, muscle and joint pain, fever, feeling unwell, dizziness, large red rash that hurt, itched, and was hot to the touch on arm where shot was given and nausea. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of adverse events that included treatment with steroid cream, Benadryl. The clinical outcome of the events  tiredness, headache, muscle and joint pain, fever, feeling unwell, dizziness, large red rash that hurt, itched, and was hot to the touch on arm where shot was given and nausea were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Ongoing body ache; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 29Mar2021 at 10:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. No relevant medical history was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included daily intake of multivitamins (MANUFACTURER UNKNOWN). The patient had no allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 08Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced body ache, chills, and headache. The patient did not receive any treatment for the adverse events. The events did not result in a doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events body ache, chills, and headache were resolving at the time of this report.   No follow-up attempts are needed. No further information expected.
vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022; No other adverse reaction; Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.), PRODUCT STORAGE ERROR (vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022) and NO ADVERSE EVENT (No other adverse reaction) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AS1416B) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022) and NO ADVERSE EVENT (No other adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.), PRODUCT STORAGE ERROR (vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022) and NO ADVERSE EVENT (No other adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No other adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric patients received Moderna Covid-19 vaccine 30 days past its beyond use date.) and PRODUCT STORAGE ERROR (vaccine was initially stored in refrigerator on 5Aug2022 and administered on 6Sep2022).    No concomitant drug information was provided.  Vaccine was administered on 06-Sep-2022 from  09:15 to 09:45. It was confirmed that the vial had not undergone any temperature excursion issue. No adverse events were reported post vaccination of both the Moderna doses.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-642057, US-MODERNATX, INC.-MOD-2022-642060, US-MODERNATX, INC.-MOD-2022-642052 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2022: Follow-up received, Suspect drug information and narrative was updated. Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642060:Same reporter US-MODERNATX, INC.-MOD-2022-642057:Same reporter US-MODERNATX, INC.-MOD-2022-642052:
Hot to the touch and swollen at injection site. The next morning turned bright red with increased swelling. Exact same symptoms as last time she received the DTAP vaccine. Swelling at that time took 8 weeks to resolve.
Arm hurts and has a knot. Has gotten worse ever since vaccination. Has not seen a doctor for this condition yet.