chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The next morning feeling tired and headache; The next morning feeling tired and headache; My left arm feeling sore after 10 hours of injection; dose received 3/dose number = 3; This is a spontaneous report from a contactable other healthcare professional, the patient. A 31-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via intramuscular route of administration in the left arm on 22Nov2021 at 11:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications with 2 weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Other vaccines  within 4 weeks prior to COVID vaccine included influenza vaccine (FLU) on15Nov2021 for immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via intramuscular route of administration in the left arm on 18Mar2021 at 10:15 (at the age of 30-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an intramuscular route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 22Nov2021 at 22:00, (also reported as after10 hours of injection, the patient experienced left arm feeling sore; the next morning on 23Nov2021, the patient was feeling tired and had headache. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events left arm feeling sore after 10 hours of injection, the next morning feeling tired and headache were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Headache, wrist pains, knee pain (arthralgia). Sx controlled on meds.
swelling of both wrists; difficult for him to make a fist; difficult for me to make a fist; headache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling of both wrists), MOBILITY DECREASED (difficult for him to make a fist), ARTHRALGIA (difficult for me to make a fist) and HEADACHE (headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica (Had been treated with prednisone.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swelling of both wrists), MOBILITY DECREASED (difficult for him to make a fist), ARTHRALGIA (difficult for me to make a fist) and HEADACHE (headache). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 month. At the time of the report, JOINT SWELLING (swelling of both wrists), MOBILITY DECREASED (difficult for him to make a fist) and ARTHRALGIA (difficult for me to make a fist) was resolving and HEADACHE (headache) outcome was unknown.            Concomitant product was not provided by the reporter.   This case was linked to MOD-2021-294353 (Patient Link).
This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On 15-MAY-2014, the patient was vaccinated with a dose of ROTATEQ, oral (dose number, dose, frequency and lot number were not specified), 1 vial, which was stored outside the temperature ranges specified in the product information (PI) (exact temperatures and dates not specified). Concomitant medications were not specified. No adverse effects were reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 78-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Illness at time of vaccination included pruritus (About 1 month before the vaccination with SHINGRIX). On 19th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, 7 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were received as follows: About 7 months after the case of shingles, the patient vaccinated with the SHINGRIX vaccine. About 1 month before vaccination with SHINGRIX, the patient had some itching. But since the patient never had itching with shingles before, the patient did not associate it with shingles. The pharmacist reported that the patient presented with shingles one week after vaccination with SHINGRIX. One week after getting SHINGRIX, the shingles vesicles broke out where she had the itching.
Information has been received from a nurse practitioner concerning a 14 year old female with allergies to sulfonamide, CEFTIN and SUPRAX and no pertinent medical history who on unspecified dates was vaccinated with the first, second and third dose of GARDASIL (routes and lot numbers unspecified). There was no concomitant medication. The nurse practitioner reported that the patient received the second dose of GARDASIL but was told it was invalid due to incorrect storage. The patient then received a third dose. After the patient received the third dose of GARDASIL the patient experienced numbness and tingling of her hands that lasted for one month. It was noted that the sensations were worse at night. Medical attention was sought, the patient was seen by her primary physician. There were no laboratory tests performed. At the time of the report, the patient recovered on an unspecified date.  Additional information has been requested.
she tested positive for Sars-CoV-2 infection; she tested positive for Sars-CoV-2 infection; getting sick; got the chills; This is a spontaneous report from a contactable consumer (also mentioned being a Physical Therapist Assistant). A 60-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Batch/lot number: EN6203, Expiry Date: Jun2021, in Pharmacy/Drug Store, via an unspecified route of administration, in left arm on 26Feb2021 at 12:00, at 60 years of age, as single dose for COVID-19 immunization. Medical history included SARS-CoV-2 test positive in Nov2020 (COVID-19 Virus throat swab test was used), also reported as COVID-19 infection in Nov2020 with no symptoms, except a slight sore throat and gingival disorder from an unknown date. On 26Feb2021 the patient had no symptom, saying she felt great. She reported she worked out and was in great shape for her age. She said she was not the typical 60 year old. On 09Mar2021 in the evening the patient felt like she was getting sick and got the chills and she had never had that happen before, and didn't know if her symptoms were from the 2 pills of  an herbal supplement she used for periodontal issues to strengthen her gums she had ordered online (she never saw the product in a store) and that she had taken on the same day; moreover she tested positive for SARS-CoV-2 infection on 11Mar2021 with a COVID-19 Virus 24-hour nasal swab test done at her work. The events didn't require visit to Emergency Room or Physician Office. It was reported that the patient was scheduled to receive her second dose of vaccine 19Mar2021 and the patient wanted to know if this is possible with her current diagnosis and how likely it is this is a false positive test for SARS-CoV-2. No treatment was administered for the reported events. At the time of the report the outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
SORE THROAT; MILD-SEVERE COUGHING; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAR-2021, the subject experienced sore throat. On 11-MAR-2021, the subject experienced mild-severe coughing. On 11-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sore throat and mild-severe coughing was not reported. This report was non-serious.
Pfizer-BioNTech COVID-19 Vaccine EUA.  On Friday morning, at 6-7am, less than 24 hours from the time I received my vaccination, I was experiencing chills and could not get warm. I tried to go to work...well, I did go to work. When it became apparent that I was not going to get warm, I left work. When I got home, my wife made me breakfast between 8:30 & 9:00am. After i eat, I slept under a sheet and two blankets...fully dressed for 5 hours. When I came to, it was the first time all day that I felt some warmth.
This is a spontaneous report from a contactable physician. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (deltoid injection) on 22Jan2021 09:30 at SINGLE DOSE for covid-19 immunization.  Medical history included HBP (high blood pressure).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included amlodipine, furosemide, lovastatin, losartan and niacin. On 24Jan2021 08:00, the patient experienced severe ipsilateral back pain extending to mid axillary line. Negative evaluation for renal stone, rib fracture. CPK pending. Symptoms started within 48 hrs of deltoid injection and have lasted for 13 days and have been severely activity restricting. Tentative diagnosis of myositis (CPK results pending). The patient underwent lab tests and procedures which included blood creatine phosphokinase: unknown   on   Tentative dx of myositis(CPK results  pending) , chest scan: negative   on   Negative evaluation for renal stone, rib fracture , renal function test: negative   on   Negative evaluation for renal stone, rib fracture.  The outcome of events was reported as 'recovering'. The patient did not receive treatment due to the events. Follow-up attempts are completed. The following information on the batch number has been requested.
Fatigue, weight gain,  depression after years of complaining I was found to have a thyroid disorder.
Information was received from a physician via a company representative concerning a female patient of unknown age. No information was provided regarding the patient's medical history or concomitant medications.  On an unknown date, the patient was vaccinated with ZOSTAVAX injection (lot number, dosage, route of injection not provided).  The patient developed shingles on an unspecified date after receiving ZOSTAVAX.  The patient sought medical attention by her physician (no treatment information reported).  The outcome of the shingles is unknown. No further information was reported. Additional information has been requested.
red blotchy rash all over his back; Worst headache of his life, a "thunder cloud headache"; This spontaneous case was reported by a consumer and describes the occurrence of THUNDERCLAP HEADACHE (Worst headache of his life, a "thunder cloud headache") and RASH (red blotchy rash all over his back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     Concurrent medical conditions included Pain in foot (It was reported patient  had pain to his foot from the vaccine but caller stated that he never had pain in his foot from the vaccine. He said it has been ongoing for years from neuropathy).   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THUNDERCLAP HEADACHE (Worst headache of his life, a "thunder cloud headache"). On 22-Apr-2021, the patient experienced RASH (red blotchy rash all over his back). At the time of the report, THUNDERCLAP HEADACHE (Worst headache of his life, a "thunder cloud headache") and RASH (red blotchy rash all over his back) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Computerised tomogram: normal (normal) normal.         No concomitant medications information was reported. No treatment medications were provided   This case was linked to MOD-2021-085673 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: significant follow-up appended medical history added; Sender's Comments:  MOD-2021-085673:2nd Dose Case
AFTER PATIENT RECEIVED THE VACCINE HE STARTED GETTING AN ITCHY TONGUE AND THEN ITCHY HANDS. GAVE 2 BENADRYL 25 MG CAPSULES AND WAS MONITORED FOR 2 HOURS. ONCE HE FELT BETTER THEN HE WENT BACK HOME.
stridor, wheezing, urticaria w/in 15min of vax;severe resp distress;given epi, DPH, steroids;observed x 1hr;still w/stridor adm x 24hr;
This spontaneous report was received from an office manager refers to a 11 year old patient. No information about the patient's pertinent medical history, concomitant medications or drug reactions or allergies was reported. On 26-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # M044717, expiry date: 19-JUL-2019) (dosing details were not reported) for prophylaxis. The administered dose of GARDASIL 9 underwent a temperature excursion at 35 degree Fahrenheit for 5 full days. No adverse effects reported. No previous temperature excursions reported.  This is one of several reports reports received from the same reporter. Additional information is not expected as no further information is available.; Sender's Comments: US-009507513-1708USA002323: US-009507513-1708USA005405: US-009507513-1709USA012713:US-009507513-1709USA012714:
I got the 1st dose Pfizer vaccine on 11/11. I had normal headache and tiredness 24 hr post vaccine. I developed minor cold symptoms later that week. On 11/20, I was laying down in bed at night watching a movie and felt slightly congested so I used some Flonase. 30 min later I got a weird head rush feeling, felt jittery and hot, hands and feet had some tingling, heart palpitations/racing. Originally I thought maybe these symptoms were attributed to the Flonase. The episode took about 2 hr to calm down enough to fall finally lay down and relax/fall asleep. The next day on 11/21 that night I had the same symptoms of feeling weird and heart palpitations. Since the initial start of these symptoms I was having intermittent episodes of heart palpitations, chest tightness, feeling like I can't take a deep breath, headaches, and random tingling sensations in my left shoulder blade. I went to the ER for these symptoms because I was woken up out of sleep feeling like my heart skipped a beat and needing to gasp for a breath and then followed with a really fast HR (low 100s - my baseline HR was normally in upper 50s to lower 60s) , cardiac workup was normal at that time but got referred to cardiology. I am currently wearing a Holter monitor. I had these symptoms for a total duration of 3 weeks. The symptoms started to subside/improve last Tuesday on 12/14. I am still waiting on results from the Holter monitor.
TDap given in error. Patient was to receive famotidine but was given tdap iv in error.
EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue. This report was non-serious.
Vaccine administered 2/3/16 - later in evening pt developed swelling/redness at injection site. Over two day area expanded despite ice, BENADRYL. Seen 2/5/15 w/11 x 19 cm warm, indurated erythematous plaque wrapping around arm. Rx: Prednisone, BENADRYL.
This spontaneous report as received from a registered nurse refers to a 65 year old male patient. On 31-MAR-2014, the patient was vaccinated with a 0.5 ml single dose vial of PNEUMOVAX 23 (Lot # J010332, expiration date 14-JAN-2015) intramuscularly that was exposed to 77 F (25 degrees C) for 66 hours. No adverse effects were reported. Additional information has been requested.
ON EVENING OF RECEIVING VACCINE, STARTED WITH FEVER TO 102 DEGREE, FEVER CONTINUED FOR 5 DAYS.  HE WAS ALSO CONGESTED, NO COUGH. ALSO VOMITED.  PATIENT LOOKED GREAT.  POSSIBLE VACCINATION REACTION-WITH PROLONGED FEVER VS. UPPER RESPIRATORY INFECTION.
Patient reports feeling short of breath since receiving COVID  vaccine in March. In September had a syncopal episode and had some chest discomfort, was hospitalized and diagnosed with myopericarditis. Patient feels this is related to her COVID vaccine. Resolved within 24 hours with pericarditis therapy.
11:01 blotchy rash on L neck w/ pulsing sensation L neck. Anxiety, sense of impending doom. BP 167/98. Cap refill slow (recorded at 45 seconds).  11:05 25mg benadryl PO  11:09 mild chest pressure without SOB, no throat tightening or difficulty swallowing.  11:25 new R neck itching/rash and chest rash 11:30 another 25mg benadryl PO 12:00 increased rash across torso and back, BP 173/80  Presented to urgent care by 1:00PM, BP 157/96, increasing chest pressure, rash improving. EKG 12-lead completed (NSR w/ sinus arrhythmia). Instructed to take PO Benadryl 50mg every 4hrs.
This spontaneous report was received from a Licensed Practical Nurse via a Company Representative and refers to an 11-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date in 2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The patient left the nurse's office feeling fine, however, later that day, she did not feel well and did not eat dinner on the night she was vaccinated. On the next day, the patient woke up with swollen lips and swollen right eye and went to an emergency room, where she was administered epinephrine as a treatment for the events. The patient recovered from the events on an unspecified date. The relatedness between the events and GARDASIL was not reported. Upon internal review, the events of swollen lips and swollen right eye, requiring an emergency room visit and treatment with epinephrine were has been upgraded to medically significant.
Chills, nausea, tiredness, body aches.  Treated with electric blanket, chicken noodle soup, aspirin/tylenol, antacids and rest. Chills lasted approx. 3-4hrs. Nausea etc. lasted apprx. 12hrs.
Felt mild soreness in arm within few hours after but no other symptoms occurred until about 2am the following morning. Fever, chills, entire body was achy and sore, headache and neck pain.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypotension and flushing of face skin hot to touch-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Additional Details: slight improvement after 1 dose of epipen, EMS was immediately activated and pt was transported to ED via EMS, she was awake alert and oriented at time of transfer.
Patient was given vaccine at 11 years of age, which is younger then the recommended age for the Pfizer vaccine. Talked with mother of patient and she states that patient had no side effects from receiving the first dose and understands that her daughter can not receive the second dose until she turns 12 years old on 9-3-21.
Patient called today and states that around 7pm last night, 4 hours post vaccination, she started to feel ill. She reports chills/aches/feverish/sweating and overall body aches. She reports joint and muscle ache over her entire body. She states that she did not take her temperature as she did not have the strength to find her thermometer. She reports taking ibuprofen for her symptoms and resting.
Began shaking all over & began turning blue in color; P/shaking episode pt remained dusky but was breathing "OK"; temp 104.3;
COVID vaccine myocarditis (myopericarditis). Began with chest pain 6 hours after vaccine, continued for 4 days, at which time he presented to the hospital for further care
Within 6 hours of the injection, he developed a fever lasting several days.  Wednesday/day of injection: patient developed a fever ranging from 101.6 - 102.  He was very tired and felt unwell.  He developed a cough.  He also vomited twice and experienced diarrhea.,  Thursday/day after injection: Fevers of 101.3 persisted throughout the day.  He still felt unwell and still had a cough. He also vomited twice and experienced diarrhea. Friday/2 days after the injection: Fevers of 102.4 persisted throughout the day.  He still felt unwell and still had a cough.  Saturday/3 days after the injection: He experienced fevers although I did not document the exact temperature.  He still had a cough and felt unwell.  His fever persisted unbroken from Wednesday - Saturday.  He also experienced chills on and off the entire time.  Sunday he woke up with no fever, and feeling well.
Patient requests reporting of chest discomfort and hand swelling for 2+ weeks after receiving vaccine.