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 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:35 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.78.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a  traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Concomitant product was not reported. Treatment medications were not reported.
-low Iron levels -constant heart burn -actual hurt pain sometimes lasting longer than 5-10 minutes -2021 September, October and November: ovulation pain that occurred multiple times a month (not normal for me ) -2022 January and February stomach pain, weird stool and intestinal inflammation
periodic headache lasting 7 days periodic high fever that would last up to an hour, and then dissipate for up to 4 hours, than return. This lasted from 2/20 until 2/22. Highest observed temp was 101.9, on 2/20 mid day. observed 99.9 on 2/21 at approximately 5pm.
After getting the vaccine I could feel a high frequency buzzing in my body- as if I had 50 cups of coffee and was just buzzing. I feel as if my fight or flight instincts have turned on but they wont turn off. I now have neuropathy, I also have these strange blood clots that have started happening since the vaccine. I can see them form under my skin and I also feel that there is a tourniquet where ever I can see that blood clot forming and the skin or appendage will turn blue- this has happened about five times. I have not been able to sleep or have stopped sleeping due to the buzzing- I get about three hours of sleep a night. My bowels have been messed up as well since the vaccine- I stopped being able to poop. I have just now started sleeping recently- the buzzing has gotten less and my bowels have been starting to work again.
Sever chills; body/muscle aches; body/muscle aches; This is a spontaneous report from a contactable other Health Professional (the patient). This 36-year-old  male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9263), via an unspecified route of administration, in the left arm on 29Jan2021 at 15:30 PM (at the age of 36-years) as a single dose for COVID-19 immunization. Medical history reported as none.  The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Feb2021 at 10:45 PM, the patient experienced severe chills, body/muscle aches all over for 2 days. No treatment was given. The clinical outcome of severe chills, body/muscle aches was recovering. It was also reported that since the vaccination, the patient had been tested for COVID-19, via Nasal Swab on 05Feb2021, the test result was negative.
patient broke out in hives on his elbows, around his waits and thighs; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (patient broke out in hives on his elbows, around his waits and thighs) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Hives (as per patient he is prone to hives.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (patient broke out in hives on his elbows, around his waits and thighs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Hives, at an unspecified dose and frequency. On 22-Mar-2021, URTICARIA (patient broke out in hives on his elbows, around his waits and thighs) had resolved.  Treatment includes Benadryl.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Extreme dizziness , feeling hot, irritable. Duration 4PM-9PM.  Drank 16 oz water and reclined for duration.
My throat and tongue was itchy. My throat and tongue started to swell up. Then, I got blusters all over my tongue. My throat got tight. Later that night, I wake up and my tongue was swollen even worst. The tightness in my throat was worst as well. I was wheezing. I then went to the ER. They check my throat and mouth. I had to get medicine to open up my throat. They gave me IV medicine and watched me for a few hours. I started to get a little better so they sent me home.
"I got a few hives that evening on my back and on my breasts. When I woke up the next morning they were on my back, breast, legs, arms, and buttocks. The worst areas were my back and breasts. Reports maybe 100 hives on back. They itched and were hot. Applied Calagel with Benadryl and the hives began to improve. The stinging and itching stopped Thursday morning. I continued to apply the gel to the hives. Friday they look like they are drying up and they don't look swollen anymore. They looked very red and puffy before." per patient
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Hypertension-Medium, Additional Details: Patient was taken by ambulance to Hospital.
Developed a fever, sore throat on 7/20/08. Seen on 7-21-08 tested and treated for mono w/ Medrol Dose Pack. Mono test came back neg, condition worsened on 7-23, had severe sore throat and trouble breathing. Was admitted to hospital. 10/16/08-records received for DOS 7/23-7/26/08-DC DX: Pharyngitis, likely viral. Panic Attacks. Presented to ED with C/O sore throat, fever and decreased oral intake, difficulty breathing. Temperature 38.6. Tonsils erythematous with ulcers and white exudate.
I received my 1st dose of Moderna COVID-19 Vaccine on 4/14/21 at 11:30am with the  Fire Department.. After receiving the shot, I notified the individual that administered my shot that I had a metallic taste in my mouth.  They stated that could happened and observed me for 30 minutes.  I left at 12:00 after being cleared and noticed 30 minutes later a red ring forming around the injection site.  I contacted me PCP where she told me to take Tylenol and Benadryl and if symptoms got worse, to proceed to an urgent care clinic.  Wednesday afternoon until Saturday morning, the injection site become extremely painful, hot to the touch and I was having a difficult time moving my elbow and fingers.  I proceeded to the urgent care clinic around 4pm on Saturday 4/17/21 after being diligent about taking OTC medications directed by my doctor as well as ice packs on the injection site.  At the urgent care clinic I was told I was having a non-systemic allergic reaction at the injection site where I was given a steroid shot and also given a prescription for a 5 day course of prednisone.  The area was very hot to the touch, hard and spreading.  Doctor was concerned and  said to contact CDC and that he would be hesitant to take the 2nd shot in the vaccine series after seeing this reaction.
NOSE BLEED; FEVER OF 38.5 CELCIUS 101.3F; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight was 69 kilograms, and height was 66 centimeters. The patient's past medical history included iron deficiency, and concurrent conditions included non alcohol user, non smoker, and sulfa allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received acne medication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced nose bleed. On 09-JUL-2021, the subject experienced fever of 38.5 Celsius 101.3f. Laboratory data included: Body temperature (NR: not provided) 99.5, 101.3 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed on 09-JUL-2021, and had not recovered from fever of 38.5 Celsius 101.3f. This report was non-serious.
The patient was seen on 9/28/22 for a well visit. His vaccine records were not properly transcribed into our computer system and his record was not checked prior to administering vaccines. Therefore, it appeared that the patient was missing doses of varicella and HPV and they were given to the patient even though it was not needed.
experienced headache; experienced body aches; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (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 headache and general body pain. On an unknown date, the outcome of the headache and general body pain were recovered/resolved.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-July-2022 Reporter's comment: The reporter was the patient who stated after dose of the Shingrix vaccine, the patient experienced body aches and headache which lasted for several days. The reporter did not consent to follow up. Additional supportive information: This case had been linked with US2022105572 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022105572:Same reporter
Headache, Myalgia, Fever, chills, fatigue, sweating Narrative:
Severe pain in arm for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in arm for 4 days) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included ATORVASTATINA [ATORVASTATIN] for Cholesterol, METFORMIN and GLIMEPIRIDE for Diabetes.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in arm for 4 days). On 20-Jan-2021, PAIN IN EXTREMITY (Severe pain in arm for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Tylenol used as a Treatment medication, did not help. Concomitant medication was not provided.   This case was linked to MOD-2021-023604, MOD-2021-023581 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient doing fine and declined for further follow up.
Tachycardia HR 118, elevated BP 185/120, flushed face, sweating, nausea - Treated with Benadryl 25mg IM and Famotidine 20mg po, symptom  duration 30 minutes
Patient stated felt "dizzy" after getting a vaccine; was observed for 30 mins - felt normal during observation. Patient did throw up after the observation period was done. Patient also stated that he felt "dizzy" after getting a flu vaccine
FEELING SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling sick was not reported. This report was non-serious.
has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th January 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Shingrix and had not received 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up.
Red, swollen, painful, large  rash  at injection site Fever, chills, headache and fatigue
Patient developed fever (103.1). Nausea. Muscle pains Chills & Cough
4-5 days after dose # 1 she started with heavier than usual vaginal bleeding, passing clots, persisting in the 10-15 days following with dizziness, HA, fatigue, heart racing
headache; pain in the knee; fever; chills; bone pain; back pain/back pain felt like if her back was going to break; hand pain; difficulty to walk; incapable of holding or grabbing things; This is a spontaneous report from non-contactable consumer (patient). A 47-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 for COVID-19 immunisation, and she experienced mild to moderate symptoms like headache, muscle pain and back pain. The patient was being administered with second dose of Pfizer's vaccine on 02Apr2021. After second dose of vaccine she experienced pain in the knee, fever, chills, bone pain, headache, back pain and hands pain. The knee pain provoked her difficulty to walk, pain in hands is so intense that she is incapable of holding or grabbing things and back pain felt like if her back was going to break. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
NIGHT OF VACCINATION, DEVELOPED ARM PAIN, CHILLS, BODY ACHES, AND HEADACHE LASTING 24 HOURS.
Additional information received on 2/10/03 provided an update of the patient's clinical status and results CT scan. A physician reported that a 5 month old female received her second dose of Prevnar at 3 months of age on 12/2/02. The child had no known previous medical conditions. On 2/1/03, she presented to the emergency room with a fever of 101 degrees F, tachycardia, and had seizures. Blood pressure was reportedly difficult to obtain. She was intubated and observed for 2 hours. She was admitted to the pediatric intensive care unit and placed on a ventilator. The reporter stated the child was nonresponsive and her pupils were nonreactive, noting she was doing poor neurologically. A lumbar puncture revealed many organisms, a white blood cell count of 55, and glucose level of 1. Hemodynamics were fine and acid base balance was normal. A diagnosis of pneumococcal meningitis was made. Serotyping was pending as of 2/10/03. the organism was intermediately sensitive to penicillin and sensitive to ceftriaxone. As of 2/10/03, she had yet to open her eyes. Computerized tomography showed an infarct of the brain. Treatment continued with pheonobarbital, ceftriaxone, and penicillin. The reporter considered the child's condition life threatening. The reporter indicated that the child survived with disabilities, noting "the extent of which will be known in the future." Additional information received on 18Sep2003 provided serum antibody titers. Serotyping by the Centers for Disease Control and Prevention laboratory revealed serotype G35, subtype 35B. See laboratory results section.
2 red patches in  arm; injection site pruritus; injection site swelling; injection site red blotch; injection site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warmth), RASH (2 red patches in  arm), INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site red blotch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site warmth), INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site red blotch). On 28-Feb-2021, the patient experienced RASH (2 red patches in  arm). At the time of the report, VACCINATION SITE WARMTH (injection site warmth), RASH (2 red patches in  arm), INJECTION SITE PRURITUS (injection site pruritus), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site red blotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
The patient's face felt numb all over including the forehead; Felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (The patient's face felt numb all over including the forehead) and NAUSEA (Felt nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (patient has a history of mild asthma). Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for an unknown indication.    On 24-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced HYPOAESTHESIA (The patient's face felt numb all over including the forehead) and NAUSEA (Felt nauseous). At the time of the report, HYPOAESTHESIA (The patient's face felt numb all over including the forehead) and NAUSEA (Felt nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  After 15 minutes from vaccination, while the patient was walking out of the facility, the patient experienced the adverse events. The patient wanted to know whether those symptoms were normal or not.
Mid/Upper deltoid pain that still persists over one month after injection combined with weakness and reduced range of motion (difficulty lifting arm over head due to pain).
Client came into the clinic on Wednesday, April 18, 2018 to have a healthcare professional take a look at his arm. He had some noticeable swelling, redness, and felt hot to the touch. Advised client and mother to apply a cold compress to the site several times a day, take ibuprofen/TYLENOL as needed, and RTC by Friday, April 20th in the AM. Client has not returned to clinic.
SYNCOPE 7 MINUTES  POST INJECTION  AND EMESIS IN  THE PARKING LOT 30 MINUTES LATER
Mom reported to physician child had high pitch cry lasting longer than 3 hours.  Family using Tylenol and cool compresses.
On Friday August 6 at 1120 staff gave a Pfizer COVID 19 Immuzation injection Lot number EW0181 to patient in the right shoulder.  Patient is a 43 y/o female.  At 1126 patient became hot and dizzy.  I went to get patient a water and a bag of ice to cool her neck down and she went unresponsive.  Assisted patient to stand and sit in wheel chair.  Pt to cot with assistance.  Vitals taken at 1127 laying down B/P 90/68, 94% SPO2 on room air, RR14 and P60. Vitals supine position at 1140 B/P 106/60, 98% SPO2 on room air, pulse 63, RR12.  At 1145 patient fell asleep while laying down her SPO2 dropped to 86% on room air; RR 10, pulse 60, B/P 90/68.  I woke her up and encouraged her to take deep breaths.   At 1147 sat patient up and Vitals were as follows (112/70, 94%on Room Air, 72 pulse and RR12) At 1149 we did standing vitals 102/66, 91 Pulse, 98% on room air RR 13.  S-Dizzy Hot and syncopal episode.  A-NKDA M- Ginger, P-denies past medical history L- Apple and peanut butter sandwich before coming in for injection. E- 5 months ago patient had COVID 19 with positive test.  Staff assisted patient to parking lot with husband driving.
Patient seen at Immunization Outreach at School requiring 8 vaccines.  Student very nervous before getting vaccines and held her breath during vaccines.  School RN at the clinic helping her get through all of the shots.  At the end was letting head fall forward but didn't faint.  Was escorted to the school nurse's office after the vaccines to be watched by the school RN.  At 12:53 PM, the school RN called the paramedics and she was taken by ambulance to the ER because the school RN said that "she could not keep her awake". Staff spoke with school RN later in day who reported the patient was stable.  No ER note available.
Occasional tingling and temporary numbness starting  from the thumb and indicator finger up to the upper, front part of the left arm. When it happens rubbing or massaging relieves it. However it is getting worse as time goes on.
pt had just completed course of ATB for URI, had febrile sz on 8JAN98
High fever, big knot on R arm, redness, rash, loss of bowel control, trembling, numbness in extremities, tingling, severe nerve pain, partial loss of vision, spasms, cramps, loss of balance, weakness, loss of full respiratory function, hot and cold sweats, sub normal temp 95.4, to high of 104 degrees F.