chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Symptoms began 2 hours after dose, including headaches, myalgias, and lower extremity weakness. Tried Tylenol with no relief. Symptoms progressively worsening. Fell and hit head the following day, denied loss of consciousness. Never had a reaction to vaccine before. No response to first dose. No lightheadedness/presyncope prior to falls.  Came to ED after fall (evening of the day after receiving the vaccine). Found to have elevated troponin. CK elevated, aggressive fluid repletion initiated, determined to be in rhabdomyolysis. Hypokalemic. Patient improved with fluids and electrolytes, determined to be stable for discharge after 2 days.
delayed onset injection site reaction; sleeping a lot more than normal; feeling groggy upon waking up; soreness on arm (left arm from the first shot); Itchiness; rashes on arm below injection site for 8 to 9 days (from first shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up), PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)) and PRURITUS (Itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Shingle shot in December 2020.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced PRURITUS (Itchiness) and VACCINATION SITE RASH (rashes on arm below injection site for 8 to 9 days (from first shot)). On an unknown date, the patient experienced VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up) and PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)). On 04-Mar-2021, VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up), PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)), PRURITUS (Itchiness) and VACCINATION SITE RASH (rashes on arm below injection site for 8 to 9 days (from first shot)) had resolved.            Treatment information were not provided.   Received  first vaccine Feb 20 and experienced oval shaped rash and itchiness 1.5 to 2 inches below the injection site on Feb 28th and she also mention rashes disappeared and sleeping a lot more than normal and feeling groggy upon walking up.   This case was linked to US-MODERNATX, INC.-MOD-2021-110250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded. On 05-May-2021: significant changes updated On 12-May-2021: Dose two information and after dose two events updated ( fatigue and tiredness ).
On days 1-3, Fever, malaise, long lasting unilateral headache, body aches, fatigue, and minor tinnitus.   On days 8-12, Anxiety, panic attacks, waking up in a panic, POTS (postural orthostatic tachycardia syndrome) like symptoms, dizziness when standing long and tachycardia, minor shortness of breath, and exercise intolerance.
Six days of increasing arm soreness s/p anthrax vaccine.  Incision and drainage of skin abscess deltoid area.  Keflex 500mg TID.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 09:15 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sarcoidosis" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again; Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient experienced nausea, diaphoresis and dizziness immediately after getting Flumist dose. Patient was offered juice, food, and put on stretcher. Recovered in 30 minutes.
He had Bell Palsy, severe joint aches (still to date) severe migraines and we are worried about the possible birth defects in children. He was forced to take the vaccine 3 (three) times.
shortly after the vaccine, I had flu like symptoms.  In the past I was always tired after the previous vaccines with body aches and headaches. this vaccine symptoms progress and I was short of breath with heart palpations.  I called my doctor for follow up.
Patient states that she was given both shots in the upper right arm. Both were given through the same inject safe barrier bandage. Next morning patient's arm was red, hot and swollen, area of swelling and erythema continued to expand over the next 24 hours with pain extending up into shoulder and axilla, today a new area of erythema on shoulder and fever of 101. Being tx with clindamycin for cellulitis. Patient is allergic to cephalosporins. Concern that injection given through a bandage and both injections given in same arm it will be impossible to determine cause of the cellulitis. Patient had injections at pharmacy. Pharmacist there was called, very rude and we were not given the lot numbers and expiration dates. This is the second case of cellulitis I have seen in urgent care in less than a week. Both cases have had quadrivalent flu and PNEUMOVAX 23 given the same day. Both done by pharmacies.
Red rash and itching covering entire back, along incision from back surgery and wrist, and under breast.
Redness/Swelling/rash 4/11/19 at injection site. Pt. reports itching at the site, along with above rash/Swelling and Redness
Patient was given the first Pfizer COVID19 vaccine around 5:36pm. While waiting her 15 minutes patient states that she is itchy, has blotchy skin, swelling in her feet and hands, and tingling in her face and lips. She is immediately brought back into theimmunization room for observation. Patient declined ice pack. After no signs of anaphylaxis and since patient was conscious and coherent, gave 25mg of diphenhydramine around 6:00pm.  Told patient to remain seated for observation. Checked patient's bloodpressure at 6:12pm and it was 144/96 with pulse of 90. Patient states her blood pressure normally runs below 120/80. Brought patient back into immunization room for more monitoring.  Patient states that symptoms are not improving. Recheck blood pressure at approximately 6:25pm and it was still elevated at 151/86 with pulse of 96.  Patient declined ambulance ride and wanted to continue to be observed at the pharmacy. Continued to monitor patient and call pharmacy manager and market manager.  Patient states that she has taken Benadryl and Zyrtec in the past for a previous allergic reaction and it did not lessen the symptoms.  Discussed taking hydroxyzine and went over possible adverse reactions especially extreme drowsiness before giving to patient.  Patient's husband was with her and would be driving her home. Gave hydroxyzine hcl 25mg approximately at 7:25pm and observed patient for additional 15 minutes.  Patient felt comfortable enough to leave and go home with her husband. She stated that she has an epi pen and blood pressure monitor at her house and will continue to monitor symptoms and her blood pressure.  Agreed if worsening symptoms to seek medical attention. Patient left pharmacy approximately at 7:40pm.
Multiple Sclerosis; immune system is weaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, MANUFACTURER UNKNWON), for COVID-19 immunisation. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system is weaker". Clinical course: patient stated he can relate because he was initially diagnosed with Multiple Sclerosis. It meant his immune system is weaker than normal.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized w/ pneumonia. Vaccination took place on 1/27/09. According to physician relationship is 'None'.
Patient received booster of Moderna (025ml) on 10/25/21. According to modernatx website specific lot number has an exp of of 10/24/21. LOT 026C21A. I reached out to manufacturer for guidance if patient should receive an additional booster dose -still waiting on contact from manufacturer.
20AUG97 2PM recv vax by 830PM had rash (red dots) on forehead, cheeks, both sides of neck, no other sx;c/o leg pain from shot;mom gave motrin;mom called clinic to report on 21AUG97;rash never spread;
Injection site warm and stiff. Painful to lift arm past 45 degrees from side. Lymph node on neck (right side) tender, pain radiates to ear causing dull headache.
PATIENT STATED THAT SHE STILL FEELS LITTLE ITCHING AND LITTLE PAIN AT THE INJECTION SITE.
Fever 104, shaking, babbling, Tyenol given, lasted approx. 7 hours then fever broke.
This is a spontaneous report from a contactable consumer. This 37-Years-Old female consumer reported that. A 37-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 03Feb2021 02:00 PM (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 13Jan2021 02:00 PM (Batch/Lot Number: EL 3248) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Smart Pants Women's Multivitamin and fluoxetine hydrochloride (PROZAC) 10mg. On 05Mar2021 02:00 PM a month after completing the treatment of the second dose of the vaccine, the patient tested positive for the virus. She was prompted to get a test after she lost sense of taste and smell. The patient underwent lab tests which included sars-cov-2 test (nasal swab): positive on 05Mar2021. Patient tested positive for covid post vaccination. Patient did not have covid prior vaccination. Events were not treated. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Moderna COVID-19 Vaccine EUA. There is a severe Red Rash on the left arm near the site of injection. It started after 1 week of injection and is causing lot of itching, red spots across the arm. Started taking Over the counter - Claritin non-Drowsy on 3/20/2021 and will monitor for 3-4 days. if doesn't improve then will visit Dr.
2-27-07 Patient stated "I had redness in my right arm that went down to right hand and knuckles, then it started in left arm and hand it was very itchy. Started 30-45 min after injection given.
Mild body aches; Fatigue; Headache; Maternal Exposure During Pregnancy, first trimester; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 07Apr2021 at 08:30(at the age of 37-years-old) as a single dose for COVID-19 immunisation. The last menstruation period was on 14Mar2021. The patient had no medical history. The patient was pregnant at the time of vaccination. The last menstruation period was on 14Mar2021. The patient had no allergies to medications, food, or other products. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), paracetamol, diphenhydramine hydrochloride (TYLENOL PM) and caffeine, mepyramine maleate, paracetamol (MIDOL); all for unspecified indication and from an unknown start date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 08:30(at the age of 37-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 07:00, the patient experienced mild body aches, fatigue and headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events mild body aches, fatigue and headache were resolved on an unknown date in 2021.   No follow-up attempts are possible. No further information is expected.
Redness and swelling of left leg at the site of Pentacel and Hep B vaccinations which were given at 1:15pm. Inconsolable fussiness. Symptoms resolved after antihistamine was administered orally.
No adverse event; Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced UNDERDOSE (Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient administered with 0.25 instead of 0.5 mL dose of bivalent vaccine).    No concomitant medication details was reported. It was reported that patient did not had any adverse events. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654894, US-MODERNATX, INC.-MOD-2022-654906, US-MODERNATX, INC.-MOD-2022-654905 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654906:Patient No. 3 US-MODERNATX, INC.-MOD-2022-654894:Patient No. 1 US-MODERNATX, INC.-MOD-2022-654905:Patient No. 2
6 mt old received 6 month vaccine - DTaP, Hib, IPV, Prevnar IM in right leg anteriolateral thigh and developed swelling chills still?? with swelling at the inject site.
Day 2 post vaccination: Tinnitus. Ringing in ears, ears feeling plugged, hearing diminished, and every sound seems to echo around me.
Itchy skin rashes, looking like raised mosquito bites. Appearing at different times all over the body. Continued until 2 weeks after the second vaccination shot.
Yellow color around the area of injection for 11 days now.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 13:45(at the age of 63-years-old) as a single dose for COVID-19 immunisation. The medical history included no spleen and allergic to wasp. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 13:45(at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Apr2021 at 13:45, the patient experienced yellow color around the area of injection for 11 days now. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event yellow color around the area of injection was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Woke up from sleep around 1215AM with chills, unable to get warm.  Woke up again around 0215 with sweats, nausea, vomiting, body aches and diarrhea.  Lasted until approximately 0730 when I took a dose of Phenergan to stem the nausea.
Within 5 minutes the patient had a headache, became dizzy, and chilled.  The first dose of the vaccine she stated that she had these symptoms that were later accompanied by chest pain and abdominal pain
Received flu shot  10/30/06. On 10/31/06 patient stated about 6 hours after the flu shot his head "filled up" and "had nasal congestion" and was "stuffed up" and had a sore throat. Stated his temp was 101F, took aspirin and rested. Stated his glands on both sides of his throat are swollen and edema has now gone down with only residual tenderness. No other adverse symptoms. States injection site without redness or swelling. Decline offer of throat culture. On 11/1/06, states he is doing better and that he had a throat culture done which was normal.  Stated sore throat was gone and lymph nodes no longer sore.
emesis x 1 10 mins p/vax start of h/a mins later;h/a described as rt sided sinus h/a not sharp or dull, constant w/some throbbing; neg assoc photophobia;started to resolve p/30 mins
Less than 24 hours later - When I woke up, I had back pain on left side of buttock severe when in motion and some nausea. Took OTC pain meds and put ice on area of the most pain. By dinner time, I had chills and other arm aching by the evening.
Patient had a syncopal episode within 10 minutes of having her vaccine. She was standing at the check out desk having her information entered into our state system and she passed out. She had no warning it was coming. She fell backwards and hit her head. She was aroused to sternal rub. She was emotional when she aroused. She new where she was and that she had a vaccine. Her vital signs were normal. Her significant other was contacted. Do to hitting her head we advised she be evaluated through an emergency department. She was called the next day. She had a brain CT which was normal and she was released. On follow-up she was feeling well.
Child (2 mo.) adm. expired dose of ROTATEQ on 12-21-10; per order from Dr. - parent to be called for redose of child - 4 wks from previous dose on or after 1-21-11.
Flushing of skin. No itching or raised hives. No shortness of breath.
pt recv vax in 1983 & a few years later pt expired from neurologic problems;no further info was provided;
Swelling on arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling on arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling on arm). At the time of the report, PERIPHERAL SWELLING (Swelling on arm) outcome was unknown.      No concomitant medications were reported.   No treatment information was provided.
Information was received on 20-APR-2017 from an attorney in the from of an initial legal complaint regarding a male patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 14-FEB-2009 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-JUL-2014 the patient was treated for a painful rash that was diagnosed as shingles. 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 suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  Additional information has been requested.
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 77 years old female patient who experienced throat was sore and fever was 100, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included was injection site warmth and pruritus. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site. On an unknown dtae, the patient experienced a non-serious throat was sore and fever was 100 two days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included was blood test done that was negative for infection. Final diagnosis was fever was 100 and throat was sore. The patient was treated with ADVIL 12HOUR for Product used for unknown indication and KEFLEX for Product used for unknown indication. On 15-Oct the patient visited for urgent care. On an unknown date, the patient was recovered for fever was 100 and unknown for other event. List of documents held by sender: none.
Partial dose of vaccine (less than 1/2 dose) given in error and repeat dose has been rescheduled per Guidelines. No adverse events reported by patient.