chrisvoncsefalvay/vaers-outcomes huggingface dataset:
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  Patient age was reported as 66.03  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was  9A and 10 A, temperature was 37 and 34, vaccine was not frozen prior to administration. Vaccine moved to fridge on 09-Mar-2021 and moved to clinic on 20-Mar-2021. 19 vials were sent to the clinic. BUD date was 08-Apr-2021. Vials only punctured right before administration.  Vaccine was stored in Cooler 1 on 20-Mar-2021.   Treatment medications were not reported.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information regarding her medical history, concurrent conditions or concomitant medications was provided.  On or about 23-APR-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose and route of administration were not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient inoculation, on an unknown date, the patient experienced shingles, due to which she was hospitalized and treated. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would 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 would continue to suffer such losses, and damages in the future. The outcome of the event was determined to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Soreness of arm the next day and then that night tingling of the arm and numbness of the hand.  Then complete left side tingling with burning pain of the lips and hand.; that night tingling of arm; and numbness of hand; with burning pain of lips and hand; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 73-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (A-Fib) and high blood pressure. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN), amiodarone (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO) and amlodipine (MANUFACTURER UNKNOWN) all from unknown date for unknown indication. On 06Mar2021 (the next day), the patient experienced soreness of arm and then at that night tingling of the arm and numbness of the hand. Then complete left side tingling with burning pain of the lips and hand. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of events soreness, tingling of arm, numbness of hand and left side tingling and burning pain of lips and hands. The patient underwent magnetic resonance imaging (MRI) test on an unknown date and result was negative for stroke. Since the vaccination the patient had not been tested for COVID-19.  The clinical outcome of the event soreness, tingling of arm, numbness of hand and left side tingling and burning pain of lips and hands was not recovered, at this time of report.   No follow-up attempts are needed. No further information is expected.
pt recvd vax & had inflammed lymph behind R ear; neck stiffness; t 99.6; slept 19 hrs straight; severe headache & pain in eye balls; face flushed & pt noticed rash on body & face;
Injection site pain; This is a spontaneous report from a contactable consumer (patient) received from Pfizer sponsored program. An 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration in Feb2021, as single dose for COVID-19 immunisation. The patient's medical history included cancer and had surgery 2 weeks ago. Concomitant medications were not reported. In Feb2021 (2 weeks ago from reporting date), the patient experienced injection site pain. The patient wanted to know if she will still get the 2nd dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Pt receiving bivalent booster.  During admin, pt moved away at the end causing about 1/4th of the dose not being administered.  Provider recommended revaccination, however parent decline re-administration at this time.
Rash developed on bilateral legs & arms 1 day after receiving TDAP vaccine & PPD. Treated on 24 Feb 2011 with prednisone. The patient is a 42 year old male. 1. c/o skin rash on legs, arms, lower abdomen x 4 days, started on Sat 19 Feb. Not on any medications, but he received PPD and TDAP on Fri 18 Feb. Using OTC lotion for sx's. No shortness of breath/wheezing/facial swelling. States had similar rash in 3/2010 but was localized to left leg at that time, was treated with steroid cream.
first dose given 05/15/19 and second dose given 06/25/2019. 30 days later.  too soon for protocol
5/24/17 pt states: -raised red bump at site of injection (about $ inches down arm) -"density at site of injection -not a lot of heat at touch but looks and feels bruised -slight pain/tender to the touch (feels like hard deep bruise) on 5/25/17 at phone follow up with pt. pt states: - trending better -faiding in redness and pain is better than yesterday -site of injection is less density and less swollen -reports no fever.
2/13 Vaccine given in left arm. On 2/14 arm became getting swollen and red from the arm to the wrist. On 2/15/Pt went to ER were was prescribed with PREDNISONE and strong antihistaminic for 5 days, after 5 days swelling decreased and redness. On 2/23 swelling - redness are gone.
Painful at initial injection time. Sore arm that night. Worked the next day. Arm was sore all day. Didn?t feel good, tired. Large red spot swollen about the size of a baseball. Got chills then hot and chills then hot and had night sweats all night couldn?t sleep. Still large red spot at injection site warm to the touch two days after. Swelling went down, those still noticeable.
20 minutes after moderna vaccine pt reported flushing and dizziness, and then 5 minutes later she broke out in hives on her face.
Information has been received from a nurse concerning a 19 year old female who on 25-JUL-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL vaccine (yeast). The nurse reported that on 30-JUL-2008, "today", the mother called the office and reported that her daughter had been nauseous since receiving the first dose. At the time of this report, the patient was still nauseous. The patient's mother called the office to seek unspecified medical attention. Additional information has been requested.
Patient first mentioned that her tongue "felt funny."  She described it as NOT tingling, she just became aware of its presence in her mouth & it felt funny.    This progressed to a a slight swelling of the tongue, and then some emotional panic. Within 30 seconds she was calmed & her initial panic was diminished. Upon examination, & true to her new description, only the very center of her tongue was swelled. She was able to breath & swallow with ease. She took 2 Benadryl 25mg capsules & remained at the pharmacy for an additional 30 minutes.  Her tongue had returned to normal & was counselled on what to do if any sign of the the problem rebegan. No further issues have occurred.
Headache, Myalgia, Fever, c/o fatigue. told to see primary care physician if no improvement Narrative:
Pt developed hard lump and redness at site of HIB vaccination. No fever or other symptoms. Apply compresses, lump 3-4cm with erythema, mild warmth.
This report describes joint soreness and aching in a 50 year old female who received Lyme disease vaccine recombinant OspA (lymerix). This report was resolved from the vaccine and has not been verified by a physician or other healthcare professional. The medical history and concurrent conditions were not very specified. Concurrent medications included unspecified headache medications. "Approximately four years ago ", the vaccinee reportedly received the three-injection series of Lymerix On 06/07/02, she reportedly developed a fever of 102 degree F and her joints were achy and sore. Her fever reportedly increased when she lay down to go to sleep. The vaccinee stated that she went to her physician who tested her for Lyme disease and "other conditions caused by ticks.". She reported that her physician prescribed doxycycline in case she did have Lyme disease. The adverse event "joint pain' dose not meet serious criteria, but is being submitted as an expedited report by special FDA report per the 06/28/00 letter.
Vomiting, diarrhea, stomach cramps. Rx Phenergan, clear liquids.
Patient's family reports that the patient received COVID vaccine at Dr. office, 3 weeks prior to admission to ER. 2 days ago, she began with a cough. She went to the restroom at 0400.  At 0630, family activated EMS for unconcious status.  Paramedics found patient to be in PEA. ACLS, CPR, Defibrillation, Meds administered prehospital as well as in ER.  Time of Death called at 0750.
Adverse event NOS; dizzy for 2-3 seconds; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy for 2-3 seconds) and ADVERSE EVENT (Adverse event NOS) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIZZINESS (dizzy for 2-3 seconds). On an unknown date, the patient experienced ADVERSE EVENT (Adverse event NOS). At the time of the report, DIZZINESS (dizzy for 2-3 seconds) and ADVERSE EVENT (Adverse event NOS) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products was reported.   No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Outcome of event updated
feels tiredness; back ache; Rash and Itches, broke out, wrist going away; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8733 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 27Apr2021 at 10:30 (Age at vaccination was 67 years) as dose 2, single for covid-19 immunisation. Medical history included ongoing seasonal allergy (patient states had sneezing but that is going away), herpes zoster from an unknown date and unknown if ongoing (he has had the shingles shot before, and he was supposed to be due for the second one, but they said to wait a month after the last Covid vaccine. Patient states his first shot from the shingles vaccine, he noticed that it wore him out too because they gave him the virus and he was tired for a few days). The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0150 and expiration date were not reported), via an unspecified route of administration, on 01Apr2021 as dose 1, single for COVID-19 immunization. The patient experienced rash and itches, broke out, wrist going away on 29Apr2021. Patient noticed that he developed some rash in right hand, left wrist and behind his knee in right leg about 3-4. On 30Apr2021, the patient experienced feels tiredness, back ache. He says about the tiredness that he could be in bed all day and he does not feel like doing some morning exercise and about the back pain, he feels like a back spasm that has given him problems in his golf (he missed yesterday course) and washing his car. Patient also states he doesn't remember injuring his back. Patient states it was severe last night, but it comes and goes. States when he was sitting still it goes away but it was still there when he bends over to the left and right, he had muscle soreness. States he was lethargic and could sit in the chair all day and not move. Patient states he was hoping it didn't effect his kidneys, it was on the lower right side. The patient did not perform any relevant test. Patient had Laser treatment on his back because he thought it was a muscle, but they don't seem to be doing much and Aleve was also took. Therapeutic measures were taken as a result of back ache (back pain). The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Adverse event the following week of vaccine I had a heart attack. I had 90% blockage left side and put a stent in and then 3 days later later I had Right stent put in where I had a 70% blockage. Now I'm on all kinds of medicine and still have lack energy I can't hike or dance anymore more than an hour and I use to dance 10 hours a week.
This report was received from Sanofi Aventis concerning a patient who on an unknown date was vaccinated with PNEUMOVAX (site and route of administration was not reported). On an unknown date the patient experienced allergy to PNEUMOVAX. The outcome was not reported. Additional information is not expected.
Tenderness at site of injection, right arm; Pain in non-injected left arm,Pain in non-injected left shoulder; Pain down left chest,Pain down left back; Cannot move non-injected left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness at site of injection, right arm), MYALGIA (Pain in non-injected left arm,Pain in non-injected left shoulder), PAIN (Pain down left chest,Pain down left back) and MUSCLE SPASTICITY (Cannot move non-injected left arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Gabapentin) and Drug allergy (Phenergan).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at site of injection, right arm), PAIN (Pain down left chest,Pain down left back) and MUSCLE SPASTICITY (Cannot move non-injected left arm). 05-May-2021, the patient experienced MYALGIA (Pain in non-injected left arm,Pain in non-injected left shoulder). At the time of the report, VACCINATION SITE PAIN (Tenderness at site of injection, right arm), MYALGIA (Pain in non-injected left arm,Pain in non-injected left shoulder), PAIN (Pain down left chest,Pain down left back) and MUSCLE SPASTICITY (Cannot move non-injected left arm) outcome was unknown. Not Provided          concomitant medications include anti depressant medications, anti anxiety medications and pain medications.   This case was linked to MOD-2021-110036 (Patient Link).
Redness swelling x 2 days pt itching at site: RT. Dexamethasone 10 mg given in office (LT). Q-DRYL 7.5 mL orally, every 6 hrs, 5 days.
Information has been received regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 16-JUN-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but instead the patient contracted a persistent strain of shingles. On or about 15-JUN-2015, the patient was treated for the onset of a severe vesicular-patterned rash and was prescribed VALTREX for management of her painful symptoms. On or about 09-JUL-2015, the patient was treated for follow-up of her painful rash and the onset of post-herpetic neuralgia and was prescribed gabapentin and oxycodone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Can't Walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Can't Walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Can't Walk). At the time of the report, GAIT DISTURBANCE (Can't Walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
I don?t know what hep b they gave him just that it was the hep b shot. His records are closed right now. He died exactly a week later on the 31st of May. We had some people say to report his death to you just in case. He didn?t have any other symptoms so I have no idea if it?s related. As of now we are being told it was sids.
Soreness at injection site- 6 hours Severe swollen axiliary lymph node, armpit on same arm as vax-10 hours Fatigue- 10 hours Myalgia-12 hours Fever 101.5F- 34 hours Vomit-40 hours
Information has been received from a registered nurse concerning a 22 week old infant who was vaccinated on 28-SEP-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint was involved. Additional information is not expected.
Very sore arm; swelling of arm; horrible headache; fever between 101-103; very tired; chills and achy muscles.
Muscles pain, back pains, legs, shoulder, fingers, upset stomach, joints hurt so much.
Numbness on face; Feeling thirsty; Nausea; Stomach upset; Cluster headache; Itchiness; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer of an unspecified age reported for herself who received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered on 17Mar2021 as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. In Mar2021, the patient experienced several adverse events like numbness on face, feeling thirsty, nausea, stomach upset, cluster headache, itchiness. Subsequently, she took Benadryl last night. She wants medical advice for the adverse events she's experiencing. The outcome of all event was Unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recvd rubella vax approx 01JUN91 & approx 11JUN91 pt devel swollen lymph glands under the arm opposite inject site & presented to MD; PE of pt noted splenomegaly; tx ATB;
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that his or her physician told him or her that if he or she had chickenpox as a child then he or she would not got shingles as an adult. The reporter stated that he or she know the patient who received Shingles vaccine and shortly after that experienced shingles. The patient reported that it was sounds like another fear inspired cash cow for certain chemical companies. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR064963 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR064963:Same reporter
COVID + test 10/21/2021.  53 year old female with chest pain for months on and off, increased in intensity with SOB yesterday and presented to the ED. She stated her "lungs felt cold" while going up the stairs and felt the chest pain radiate to her jaw and back of her head. She admits to excessive BMs though no nausea, vomiting, diarrhea.Dx:  dilation of thoracic aorta, Pneumonia due to COVID-19 virus. D-dimer 1,758.  Discharged to home.
Patient received a influenza vaccination (Fluad 65+, 2020-2021 Quad) on 10/27/2020 and began to have adverse event the same day. Patient experienced body aches and soreness, and 10 days following the vaccination, he developed headaches lasting all day. Headaches were moderate in pain but did not resolved with Tylenol. Patient is unable to use NSAIDS because of renal complications.