chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe body aches; joing pain; shivering, couldn't get warm; arm pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 as dose 1, single (Lot number: EJ1685) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Celiac disease" (unspecified if ongoing), notes: Other medical history: Celiac disease; "Known allergies: Gluten Free" (unspecified if ongoing), notes: Known allergies: Gluten Free. There were no concomitant medications. The following information was reported: PAIN (non-serious), outcome "recovering", described as "Severe body aches"; ARTHRALGIA (non-serious), outcome "recovering", described as "joing pain"; CHILLS (non-serious), outcome "recovering", described as "shivering, couldn't get warm"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm pain"; HEADACHE (non-serious), outcome "recovering", described as "severe headache".
Jan. 25, 2021 - Day17 post vaccination- around 1 am noticed itchy ankles. In the morning I noticed some small papules on the anterior ankles. I donated blood later that day and definitely did not have any rash on my arms. The following morning (Jan. 26, Day 18) I noticed 1 mm papules on my right wrist that were itchy. Over the course of the day I had some increase in papules on the left wrist and also developed some on the right. Are used triamcinolone cream and gold bond anti-itch cream. Over the next two days the rash continued to spread over the dorsum of both hands and feet and up the volar  and posterior surfaces of the forearms to the elbows, as well as up the inner lower legs to the knees. I ended up taking three days of 10 mg prednisone until the itch was controlled. Today, day 26 there is no itch and the rash has almost completely faded.  There was no rash on palms or souls, no rash in the web spaces, no rash on the torso, no other symptoms.  Each papule was 1 to 2 mm and skin colored when I was cool, but red and itchy when I was hot.
No adverse events reported. Advised by DPH to submit to VAERS due to booster given after FDA EUA given to bivalent booster. Bivalent booster was not received in pharmacy until 9/7/2022.
Nausea, extreme fatigue, chills, low-grade fever (99.8) Symptoms began 27 hours after second dose. Dose was 4/9/2021; Symptoms on 410/2021. Note: no symptoms after first dose given on 3/12/2021
splitting headache or bad headache; fever running at 100F; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 as dose 4 (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 (Dose 1, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, manufacturer unknown), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 21Apr2022, outcome "not recovered", described as "fever running at 100F"; HEADACHE (non-serious) with onset 21Apr2022, outcome "not recovered", described as "splitting headache or bad headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that "Yesterday, he received the Pfizer BioNTech COVID-19 vaccine second booster dose" and "now has fever running at 100F and a splitting headache, or bad headache". Caller asked if this had been reported with the vaccine or if it is normal. Headache and fever had been reported as possible side effects with the vaccine" and from CDC: "COVID-19 vaccination helps protect people from getting COVID-19. The patient received the Pfizer COVID 19 Vaccine second dose yesterday, 20Apr2022, and now has a fever which is running at 100 degrees Fahrenheit. Caller is also reporting a splitting headache or bad headache. Caller stated he just wanted to report he had the fever and the headache.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
arm was swollen; arm was sored; big bump at injection site; injection site was hot; injection site was itchy; injection site hurt a little; injection site was red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot) and VACCINATION SITE PRURITUS (injection site was itchy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Patient reported as taking high blood pressure medication) and Hyperlipidemia (Patient reported as taking high cholesterol medications).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE PAIN (injection site hurt a little) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, VACCINATION SITE SWELLING (arm was swollen), VACCINATION SITE PAIN (arm was sored), VACCINATION SITE MASS (big bump at injection site), VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE PAIN (injection site hurt a little) and VACCINATION SITE ERYTHEMA (injection site was red) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had a delayed reaction about eight days after vaccination. My left arm began to itch around lunch time that day and a little bit later I decided to look at my arm. My arm was red, hot to the touch and swollen at the injection site. I put cold compresses on it that afternoon and took a Benadryl for a couple of days and it resolved on its own.
Allergic rash, with blisters,  all over body Still seeking medical care , have been given steroid, benadryl, pepsid hydoxzine,steroid cream, oatmeal baths
groggy; Headache; metallic taste; sweating; shivering; feeling like I was going to either have vertigo spell or throw up; balance unsteady; feeling numbness in left arm; Exhausted/tired; feeling faint; This is a spontaneous report from a contactable consumer reported for herself. A 45-year-old female patient (No Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9267), left arm on 18Feb2021 14:15 at single dose for COVID-19 immunisation. Medical history included overweight, pre-diabetic. The patient did not diagnose with COVID-19. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included multivitamin. Shot on Thursday. No problem on Friday. Headache Saturday morning 20Feb2021 06:30 AM. After dinner on 20Feb2021, she had a metallic taste in her mouth started sweating and feeling faint then started shivering and feeling like she was going to either have a vertigo spell or throw up. Ballance unsteady. Drank water got into bed and then she started feeling numbness in her left arm. Exhausted and tired. Sunday tired and groggy. Monday still tired and groggy. Events were non serious. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the events was not recovered.
Adverse event: PT reports feeling "needles in my arms", as a widespread sensation across both arms. EMTs responded. Denied anxiety, SOB, no rash/hives noted.  Treatment: Assessment by EMTs, vital signs taken, (SPO2 98% on room air, BP sitting 118/84, HR 62).  EMTs brought PT down from bleachers to lay on cot, and received further monitoring from EMTs. Juice provided.  Outcomes: PT reports that he "feels fine now" at baseline, medically cleared by EMTs, exited facility with wife, family to drive home.  Vital signs at release were WNL. (BP 124/84 sitting, SPO2 98% RA, HR 68.)
arm soreness                                                                                     Administered Daptacel to adult patient. Patient should have received Adacel. Daptacel box and vial not marked for pediatric use at time of administration. Error found when new Daptacel box received and new box was marked pediatric.
Moderna vaccine was administered outside of source - reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------- I21.4 ACUTE NON ST ELEVATION MI 2/16/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/16/2023 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Sneezing; Head cold; Little cough; scratchy throat; scratchy sore throat; stuffed nose; Sore arm/pain in her arm; runny nose; chills; Feeling achy; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), MYALGIA (Feeling achy), PAIN IN EXTREMITY (Sore arm/pain in her arm), CHILLS (chills) and NASAL CONGESTION (stuffed nose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Hypercholesteremia. Concomitant products included SIMVASTATIN for Hypercholesteraemia, METOPROLOL and OLMESARTAN for Hypertension.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Low grade fever), MYALGIA (Feeling achy), CHILLS (chills) and RHINORRHOEA (runny nose). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/pain in her arm). On 10-Jan-2021, the patient experienced NASAL CONGESTION (stuffed nose), SNEEZING (Sneezing), NASOPHARYNGITIS (Head cold), COUGH (Little cough), THROAT IRRITATION (scratchy throat) and OROPHARYNGEAL PAIN (scratchy sore throat). The patient was treated with PARACETAMOL (TYLENOL) on 07-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses at night); PARACETAMOL (TYLENOL) on 08-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses) and PARACETAMOL (TYLENOL) on 09-Jan-2021 for Adverse event, at a dose of UNK dosage form (2 doses). At the time of the report, PYREXIA (Low grade fever), MYALGIA (Feeling achy), PAIN IN EXTREMITY (Sore arm/pain in her arm), CHILLS (chills), NASAL CONGESTION (stuffed nose), RHINORRHOEA (runny nose), SNEEZING (Sneezing), NASOPHARYNGITIS (Head cold), COUGH (Little cough), THROAT IRRITATION (scratchy throat) and OROPHARYNGEAL PAIN (scratchy sore throat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Body temperature: 99.5 °F (High) low grade fever (99.5F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had plan to test to undergo COVID test soon.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1 week later, a large rash, approximate 8cm in diameter appeared at vaccine site. Not raised, no itching, no pain.
Began screaming and crying 2 hrs after receiving vaccines.Continued this behavior for 3 additional days and was instructed to go to ER. At no time did she have a fever
back is hurting; headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back is hurting) and HEADACHE (headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B1A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced BACK PAIN (back is hurting) and HEADACHE (headache). At the time of the report, BACK PAIN (back is hurting) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Dizziness upon rising 7am Nov 4, 2am Nov 5, 8am Nov 5, 7am Nov 6, Dizziness lying down 10am Nov 7
IMMEDIATE SWELLING AFTER VACCINE ADMINISTRATION, REDNESS, WARM TO TOUCH
Patient immediately went pale after injection of the HPV 9 vaccine, pt c/o tunnel vision and seeing black spots. He broke out in a full body sweat and breathing became rapid. He also c/o abdominal tightness. This nurse talked patient through breathing techniques and applied a cool clothe to forehead and back of neck. The patient laid on the floor for about an hour recovering and under continuous observation. Vital signs within normal limits taken twice.   No emergency medications administered. Pt left the clinic with c/o a headache.
yeast infections; blurry vision; inflammation; This is a spontaneous report from a contactable other hcp (patient). A 43-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247) via intramuscular, administered in right arm on 26Jan2021 at 13:15 (at the age of 43-year-old) as dose 2, single for covid-19 immunisation at hospital. Medical history included covid-19 and allergy to unspecified drug from an unknown date and unknown if ongoing. Patient received no medications within 2 weeks of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot No: EL0142) via intramuscular, administered in right arm on 05Jan2021 at 13:00 (at the age of 43-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 30Jan2021 at 12:00, the patient experienced yeast infections, blurry vision and the doctor said it was due to inflammation. The adverse events resulted in visit to emergency room visit and physician office visit. No prolonged hospitalization was reported. Patient gone to numerous doctors and they can't figure out the cause and she have been on multiple treatments. Outcome of the events was not recovered at the time of reporting.   Follow-up attempts are completed. No further information is expected.
PATIENT WAS GIVEN PDRX AND PREVNAR ON 3/11/2008 AT 11:00 AM AND ON 3/13/2008 MOM CALLED OFFICE AT 4:00 PM STATING THAT PATIENT WAS HAVING SEIZURE LIKE SYMPTOMS WITH NO FEVER. ADVISED MOTHER TO CALL EMS. PATIENT WAS TRANSPORTED TO  HOSPITAL VIA PERSONAL AUTOMOBILE.
Severe injection site pain, redness, hard, swollen lump. Hard to use arm through Sunday (shot on Thursday). Site was warm to touch, doubled in size on Saturday.  Mild headache Friday. Saturday migraine with congestion. Sunday +9 pain scale migraine with dizziness. Sunday evening major fibromyalgia flare with neck & shoulder spasms especially on the right. Insomnia all night into Monday from pain.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on unknown dates, the patients were vaccinated with improperly stored doses VAQTA  lot # N005274 with expiration date of 03-APR-2018, for prophylaxis (dose, route and frequency were not reported).  No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 hours and 20 minutes (worst case). Previous temperature excursion was reported as 47 to 77 degrees Fahrenheit for 40 minutes. The call was because of a "data logger".  This is one of several reports from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1706USA008789: US-009507513-1707USA000697: US-009507513-1707USA000698:
blackout (falling to the floor and unable to get up on my on); weakness; blackout (falling to the floor and unable to get up on my on); sweats; Chills; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FD0809, on 31Aug2021 08:15 at single dose in left arm (at the age of 63-year-old) for COVID-19 immunization. Medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medication included unspecified medication. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 lot number= FC3180 on 10Aug2021 10:45 AM in left arm for COVID-19 Immunization. The patient previously received olmesartan medoxomil (BENICAR) and experienced allergy. On 31Aug2021, the patient experienced Chills on the day of second vaccine. The following morning (01Sep2021 02:30), the patient experienced weakness, blackout (falling to the floor and unable to get up on her on), sweats. No treatment was received for all events. The outcome of all events was resolving.
Exactly three weeks after vaccination, patient woke with a fever and sore throat on March 4th. Fever subsided through the day. Mild sore throat persisted. Patient suspected he was dealing with a lingering cold given that COVID test was negative. Patient took the week off work to be careful in case the COVID test was a false negative.  March 15th, the sore throat became much worse and patient became very exhausted.. March 17th, the sore throat make it difficult to talk and patient was even more exhausted. After calling the health insurance company, a representative send patient to the emergency room. There, patient was tested for strep (negative) and mononucleosis. The Infectious Mononucleosis Screen  (Monospot) collected on 3/17/22 was positive.  As of 3/23/22, patient responded to predisone prescription and throat feels better. Patient's spleen is still swollen.
Narrative: 88yo female patient with PMHX: Htn, Hld, Hearing loss, Osteporosis, Allergic rhinitis,MDD, Osteoporosis died on 7/1/2021. No information given on cause of death. Pt had received covid vaccines on 1/19/21 & 2/22/21. This death is likely not related to the vaccinations due to patient's advanced age, and length of time from vaccine administration.
received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose of a vaccine from an expired vial) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose of a vaccine from an expired vial) outcome was unknown.        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.   Treatment and concomitant medicines were not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-122781, MOD21-089636, MOD21-089642, MOD21-089644, MOD21-089646, MOD21-089650, MOD21-089653, MOD21-089655, MOD21-089658 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122781: MOD21-089636: MOD21-089642: MOD21-089644: MOD21-089646: MOD21-089650: MOD21-089653: MOD21-089655: MOD21-089658:
Information has been received from a nurse practitioner concerning an 8 year old female patient who was vaccinated with a dose of varicella virus vaccine live. On 6/21/04, the patient presented with chicken pox all over her body, including in her mouth. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of fibromyalgia worsened in a 75-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included SHINGRIX (1st dose received on 1st June 2018 and did not report any issues). Concurrent medical conditions included fibromyalgia. Concomitant products included tramadol. On 12th December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fibromyalgia worsened, feeling queasy and pain. On an unknown date, the outcome of the fibromyalgia worsened, feeling queasy and pain were not recovered/not resolved. It was unknown if the reporter considered the fibromyalgia worsened, feeling queasy and pain to be related to SHINGRIX. Additional details were provided as follows: The patient told that the 2nd SHINGRIX vaccination aggravated her fibromyalgia. The patient still had the events at the time of reporting. It was stated that, the patient takes Tramadol for her fibromyalgia, and the pharmacist thought she might had had to take more Tramadol after her 2nd SHINGRIX vaccination. The pharmacist did not had lot number, expiration date, injection site, or other details at the time of initial report.