chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching; Big burn; Skin is dry and rough; Big old bruise burn back of the leg; Big old mark; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Skin is dry and rough), CONTUSION (Big old bruise burn back of the leg), PIGMENTATION DISORDER (Big old mark), PRURITUS (Itching) and THERMAL BURN (Big burn) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced PRURITUS (Itching). In September 2021, the patient experienced DRY SKIN (Skin is dry and rough), CONTUSION (Big old bruise burn back of the leg), PIGMENTATION DISORDER (Big old mark) and THERMAL BURN (Big burn). At the time of the report, DRY SKIN (Skin is dry and rough), CONTUSION (Big old bruise burn back of the leg), PIGMENTATION DISORDER (Big old mark), PRURITUS (Itching) and THERMAL BURN (Big burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided. Patient reported adverse events that are skin was dry, big old bruise burn back of the leg, skin is rough, big old mark, big burn, itching. The location was clarified left kneecap, where she bend her leg. Patient states the itching started the night of the vaccination.
In less than 24 hours after vaccination pt developed urticarial lesions diffusely over body- oral antihistamines/ He blockers / cool compresses. Still with urticaria at this time.
Got very weak, chills, had a temperature, upset stomach, headache, arms and legs felt like I was beat up didn't do anything just waiting for it to wear off.
Initial report was received from another manufacturer on 25 September 2013 who received the report from a healthcare professional under service request number 1-8545372237. A female patient (age and date of birth was not reported), who was 20-years-old at the time of the report, had received an injection of unspecified Pertussis Vaccine (manufacturer, lot number, route, site and date of administration not reported) when she was a child. Vaccine was also reported as DAPTACEL but DAPTACEL was not licensed at the time of vaccination. An unspecified amount of time later, the patient experienced convulsions after vaccination. No additional information was provided. Outcome was not provided. Documents held by sender: None.
Syncopal episode within 1 minute of injection, seizure like active posturing, unresponsive.  Alert and oriented by the time she was transferred to ER.
Patient was given shingrix vaccine by mistake, was supposed to get COVID booster; upon speaking to him approximately 3 hours after mistaken administration he denied any adverse events. He completed the shingles series in January of 2021 and doesn't recall having any AEs at that time, but we reviewed the typical AEs for the shingles vaccine and to call his MD if any severe symptoms develop; he has no questions/concerns at this time.
On Friday morning woke with a rash on my left shoulder. It has since gotten worse and has progressed across chest, up neck and cheek and right shoulder. Also have patecheia on my legs. Went this morning .. was prescribed something for the rash.
The employee was given the TDAP as a service on 9/5/2017 as the previous TDAP had been recorded in 2006. The injection was given by RN, Employee Health Service, in the left Deltoid after all the EPIC questions were reviewed. The employee was instructed that her arm may be sore for a few days after the injection. When the Employee called, she states that the pain in her left deltoid has not improved and she continues to have 8/10 pain in that muscle with movement. She did a "hall consult" with an orthopedic surgeon and was told she may have developed a "syndrome" R/T the injection and that it should be reported. The employee's arm is not swollen and she doesn't report any markings, just C/O pain in the muscle area to where it wakes her up at night when she rolls on the shoulder and has difficulty with ADL's. She called me wanting to have it documented in case the pain did not go away.
in such pain she cannot walk with her left leg; severe joint pain in her left leg knee; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (in such pain she cannot walk with her left leg) and ARTHRALGIA (severe joint pain in her left leg knee) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fractured femur (excl neck) (Fractured left femur). Concurrent medical conditions included Arthritis (End stage arthritis in both knees and is going through nerve blocking things and before that she was given pain pills.) and Osteoarthritis.    On 19-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced GAIT DISTURBANCE (in such pain she cannot walk with her left leg) and ARTHRALGIA (severe joint pain in her left leg knee). At the time of the report, GAIT DISTURBANCE (in such pain she cannot walk with her left leg) and ARTHRALGIA (severe joint pain in her left leg knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Nausea lost 25 lbs from intermittent vomiting, random muscle twitches,  chills less common, brain fog, fatigue and I've never had COVID twice a week testing, all these symptoms keep randomly reoccurring, the brain fog has affected my memory it may render me disabled as I can't retain info now
Received Flu vaccine, PENTACEL, PREVNAR, ROTATEQ, HEP B 11/29/10 --> developed rash 11/30/10.
redness around injection site; itchiness around injection site; Initial information received on 08-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to cases 2019SA281762, 2019SA281763 and 2019SA281764 (same reporter).  This case involves five patient who experienced redness around injection site (vaccination site erythema) and itchiness around injection site (vaccination site pruritus), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6656KA, expiry date: 30-Jun-2020 via unknown route in unknown administration site.  On an unknown date, the patient had redness around injection site (erythema) and itchiness around injection site (pruritus) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was vaccination site erythema and vaccination site pruritus.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for vaccination site erythema and vaccination site pruritus.  List of document held by sender: none.
pt recv vax 18JUL95 & 19FEB96 pt broke out in full blow chicken pox;no further details were provided;
Adverse reaction to right deltoid after Tdap administered "started two days after the shot was given." (Hep B immunization was administered to patient to the left deltoid approximately 24 hours after the Tdap; no right arm adverse events noted at that time or until reported on 05/04/09.) Described adverse reaction as "had softball size raised [area] with redness and it was warm to touch..." Patient did not know if she had an elevated temperature, "I don't have a thermometer." Patient also reported, "I had an IV when I had my daughter about 8 years ago and had to be hospitalized for 6 days with antibiotics. So, I wanted to get on top of it." Patient, who works in the Emergency Dept, stated, "I showed one of the doctors who gave me a prescription for Keflex." Area assessed, no redness, swelling or redness observed; however, patient complains of tenderness upon light palpation. In addition, patient reports a lump to the right lateral neck, just below the ear (lymph node area). This area was palpated, approximate 3 cm raised area felt. Patient encouraged to seek medical care for follow-up. "I don't have a regular doctor. I just go to clinic."
(L) arm cellulitis. Clindamycin 11/05/15 x 1 day changed to cephalexin 11/06/15.
pt recv vax & devel vaccine-associated paralytic poliomyelitis;it was later determined that the pt had severe immun deficiency;the child died 4 or 5 year ago d/t the immunodeficiency;MD stated this event may have been reported to CDC;
Itching at vaccine site an allergic reaction?; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient reported that, he/she got the Shingrix vaccine 3 days ago and had the normal reactions, but there was some itching at the vaccine site.  The patient asked, was this considered an allergic reaction.
2nd shot at 9:00 am,  approximately 5:00 pm - injection sight was painful, gave 220 mg-1 tablet (NSAID) - a medicine that patient had prior times without side effects.  At 5:40  * patients throat was closing up and having difficulty breathing -  taken to ER for evaluation.  It was determined to be an allergic reaction.  Given a single dose of prednisone, benadryl, and pepsid.  Released after approximately 3 hours.
Pt's rt arm red & sore w/slight swelling on 01NOV91 p/recving DTP; by 02NOV91 rt arm reddened from deltoid to elbow w/sl swelling & much soreness; by 04NOV91 redness almost gone along w/swelling & pain; area did have some scaly skin;
EXTREMELY SICK; BODY ACHES; HEADACHE; FATIGUE; SEVERE INJECTION SITE PAIN; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced extremely sick, body aches, headache, fatigue, severe injection site pain, and fever. The action taken with covid-19 vaccine  was not applicable. The outcome of the extremely sick, headache, fatigue, severe injection site pain, fever and body aches was not reported. This report was non-serious.
The pt developed an injection site reactions characterized by a large area of redness and itching. She recovered.
No adverse effect reported; one patient received an improperly stored VARlVAX; This spontaneous report was received from a nurse and concerns to a 5 year old patient of unknown gender. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included sterile diluent.   On 21-AUG-2019,  the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(dosage schedule, route, anatomical location were not reported)(it can not be determined with which lot number was vaccinated the patient (R026722 and expiration date 17-MAR-2020 or R023499 and expiration date 13-FEB-2020)) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 8 hours as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.; Sender's Comments:  US-009507513-1909USA002960: US-009507513-1909USA006332: US-009507513-1909USA006333: US-009507513-1909USA006330: US-009507513-1909USA006334: US-009507513-1909USA006329: US-009507513-1909USA006328: US-009507513-1909USA006341:
She had an burning, "fire" sensation at the time of time of the injection. The surrounding area turned red right away and it was swollen and hot feeling. She came in on 9/9/2018 and her arm was still a little swollen and slightly red. The surrounding area looked bruised. She said she had been having headaches and was having trouble sleeping. Not sure if that was an adverse reaction to the injection.
spells of dizziness; sweats; her hands are frozen; fatigued; pain on the injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (spells of dizziness), HYPERHIDROSIS (sweats), FROSTBITE (her hands are frozen), FATIGUE (fatigued) and VACCINATION SITE PAIN (pain on the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (spells of dizziness), HYPERHIDROSIS (sweats), FROSTBITE (her hands are frozen), FATIGUE (fatigued), VACCINATION SITE PAIN (pain on the injection site) and CHILLS (chills). At the time of the report, DIZZINESS (spells of dizziness), HYPERHIDROSIS (sweats), FROSTBITE (her hands are frozen), FATIGUE (fatigued), VACCINATION SITE PAIN (pain on the injection site) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No specific follow-up information recorded.
4/13/21 extremely swollen lymph nodes in neck, difficulty swallowing, generally not feeling well - urgent care doctor ran labs for mononucleosis and strep - positive mono diagnosis, patient (teacher) advised to work from home until 5/10/21, along with rest fluids and OTC pain relievers 5/25/2021 Symptoms flared - again swollen lymph nodes in neck, sore throat,  contacted primary care physician/nurse practitioner who ran a second strep test and a Covid test. Covid test was positive. Primary care physician also ran labs for possible auto immune disorder. Physician to consult with immunology doctor.
All of a sudden, day 3 after the vaccination, her right eye is swollen.   Eye lid was red and swollen,  She went home and applied ice to the eye.  Three hours later the swelling had gone down.
Thickening of injection site within 10 min Nauseous  Headache  Hugely enlarged lymph nodes on left side (painful and very noticeable swelling) Severe joint and muscle pain Fatigue  No previous reaction to first two COVID vaccine. Just on the 3rd booster.
Large swollen area (8.5 cm) after receiving 2 injections the day before. Dx with cellulitis. Rx: SEPTEA 200 mg 40 mg/5ml BIX x 10 days.
fever, chills, total body severe muscle ache, fatigue--lasted 36 hours--took a vicodin for pain at 5 AM on the 27th, was only conscious a few hours on the 27th. Woke up on the 28th feeling much better.
Rec'd injection on 3/19/2021 in the afternoon. By that night, patient reports she started to run fever and had a sore arm. Reports she also developed a rash from the injection site that went up to her shoulder. Reports rash was very warm to touch and "splotchy" looking and very red. Prior to injection she was having issues with bradycardia. After injection she began to have palpitations and her heart rate increased with noted chest discomfort and dyspnea on exertion.
couldn't eat anything/could eat cereal and maybe some ramen noodles, he couldn't eat anything; tired; sweating; This is a spontaneous report from a contactable consumer(patient). This 65-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN0158) at single dose on 13Apr2021 13:30 via an unknown route in left arm for Covid-19 immunization.  Medical history included Type 2 diabetes and high cholesterol, both ongoing. He had probably had Type 2 diabetes a lot longer than he thought. He was diagnosed with Type 2 diabetes in 2001 or 2002. He said his high cholesterol was pretty much in check because he stays on his pills. He says he has no clue how long he has had this condition, 39 years all over a year, that he probably had it while he was in Korea. His dad died of a heart attack. Concomitant drugs included metformin for cholesterol and had been taking this probably since '99 (as reported), gliclazide (GLIZIDE)(reported as "extra large (XL)") for type 2 diabetes taking this since probably about the time they discovered he had type 2 diabetes, atorvastatin calcium been taking this since the same as gliclazide for type 2 diabetes, and sitagliptin (JANUVIA) from Mar2021 for type 2 diabetes, all ongoing. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208) on 23Mar2021 10:30 AM in left arm for Covid-19 immunization and had no issues or side effects. History of all previous immunization with the Pfizer vaccine considered as suspect was reported a "NA". No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations (within 4 weeks) and no AE(s) following prior vaccinations. He received his second vaccine dose on 13Apr2021 and on 15Apr2021 he began experiencing sweating. He stated he had been sweating up a storm, changing clothes 3 times a day. He said that didn't happen before the second shot. He denies fever and chills. Patient also experienced tired from 16Apr2021 and couldn't eat anything from 17Apr2021. Reporter seriousness for the events sweating, tired and couldn't eat anything was unspecified. Sweating happened 1 day right after he got the shot, which was probably "Wednesday" night, then it went away, then "Friday, Saturday, Sunday, last night" he had to change clothes 3 times. He still had to change clothes last night (as of 19Apr2021).  He was so tired he couldn't even eat, he could eat cereal and maybe some ramen noodles, he couldn't eat anything, he didn't feel like it. He was tired "Friday" afternoon. His grandkids got up and he felt like bleh. He said some days he gets up and feels fine, then he sweats, then he felt fine. On 19Apr2021 he got up and felt fairly decent. "Saturday" morning he couldn't eat anything, bacon and eggs he can't eat, he made a bowl of cream of wheat. No Emergency Room or Physician Office visit due to the events. No relevant tests performed. Outcome of tired was unknown. Outcome of the other events was not resolved.  Follow-up attempts are completed. No further information is expected.
Severe pain,  swelling and redness, headache, muscle and joint pain, diarrhea, and fatigue, lasting  1 week+ after vaccination. Used ibuprofen, acetaminophen, and Benadryl for symptoms but they still persisted.  All symptoms are tapering off but continue over this last week.
On 04/12/2021, midday, I noticed significant ringing in my left ear, significant to Tinnitus. We were in lockdown, so I did not seek care. Once I was released from work, I mentioned it as a part of my current conditions. It continues to persist.
Excessive crying, sleeplessness, trouble with sleeping, unable to sleep, runny nose, cough, sneeze, nasal congestion, chest congestion, diarrhea, mood swings including head banging, loss of appetite.
Leg pains; Severe exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pains) and FATIGUE (Severe exhaustion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic fatigue syndrome and AFib.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pains) and FATIGUE (Severe exhaustion). At the time of the report, PAIN IN EXTREMITY (Leg pains) outcome was unknown and FATIGUE (Severe exhaustion) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that her second dose was due on 03/Jun/2021 and also was not functioning normal. The patient had leg pains for almost the whole month a couple weeks after the vaccine, severe exhaustion started and it had not gone away. Concomitant and treatment medication were not provided.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included flank pain. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced shingles, rash and feeling bad. On an unknown date, the outcome of the shingles, rash and feeling bad were unknown. The reporter considered the shingles, rash and feeling bad to be unrelated to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of the patient. The age at the vaccination was not reported. It was reported that while experiencing flank pain the patient received second dose of SHINGRIX. A day later he was diagnosed with Shingles. he patient had what she described as an atypical rash that does not have blisters, did not itched or burn and he just felt bad. She indicated that she believed her husband was getting shingles prior to receiving the second dose of the medication and does not feel that SHINGRIX was responsible for causing this episode. The reporter did not consent to follow-up.
The patient reports that the following day of the vaccine administration, she saw a rash all over her body. The next day she had painful hives and urticaria that were like burns. The next day she had edema in her tongue, she could expand her lungs but could not remove saliva from her mouth. She had pain in the thorax posterior area. She also had fatigue and tiredness, dizziness that persists to this day.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 29-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (strength, dose, route of adminstration were unknown) with lot # N008825 and expiration date of 12-SEP-2018 for prophylaxis which was stored in a temperature from 6 Fahrenheit degrees (°F) to 14 °F for 24 hours. There was no previous temperature excursions. Morevoer, it was reported that the temperature excursion was not detected by a data logger. No adverse effects were reported.
Patient hospitalized for supervision of labor and delivery within 6 weeks of receiving COVID vaccination. She had an uncomplicated postpartum course.