chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; tingling/buzzing/numbness/swelling in face and lips; swelling in face; swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 28Dec2020 03:30 PM at single dose (lot number: EH9899) for COVID-19 immunization. Medical history included asthma and known allergies to medications, food, or other products. Concomitant medications include Estradiol received in two weeks. No other vaccine in four weeks. The patient was not pregnant. The patient experienced lightheaded; chills; tingling/buzzing/numbness/swelling in face and lips; rapid heart rate; flushed neck, upper chest, and face-a red rash here that resembled sunburn, but was not painful; on 28Dec2020 04:00 PM. The patient took antihistamine (Claritin) and rest as treatment. All events were reported as non-serious. The patient had no Covid prior vaccination, no Covid tested post vaccination. Outcome of all events was recovering.
The adverse event began with a sudden rash on the face, arms, neck, ears, chest and back, accompanied by a mild headache, dizziness, aching at the injection site, and a sub-dermal "burning" sensation in the skin and upper extremities. There was no rash that presented below the waist. The rash was accompanied by a low-grade fever of 99 to 100 Fahrenheit and lasted for over an hour from the time the adverse event presented.  Once the low-grade fever dissipated, the rash symptoms and low-grade fever dissipated as well.
was administered with an engerix-B expired dose; This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 5397F, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 14th December 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Engerix B, which led to expired vaccine used. The reporter consented to follow up.
21 yo male received AVA, APV, typhoid vaccine--all initial doses--on 6/6/2011. On 6/21/2011 he was admitted with fever and mental status changes. He had a seizure leading to unconscious state. Admitted to hospital with PE that noted weak upper extremities and movement of lower extremities. Laboratory data reveal a wbc of 24 K, CSF elevated protein 128? And cell count 3 wbc. Radiographic: evidence of cervico-thoracic demyelination. Multiple viral studies pending at this time. Has been treated with one dose of Cidofovir and corticosteroids. Current status: Afebrile, with some weakness and minimal balance difficulties. URI symptoms on 6/17/2011.
Seen for persistent myalgia and fatigue. Labs showing mild rhabdomyolysis. No evidence or symptoms of decreased urine output. Electrolytes and renal function within normal limits. Started on IV fluids and with follow up the next day.
Occurring for 2 days.  Red area on anterior thigh 10 x 13 cm and going into the left groin.  Has a hard movable mass in the left groin.  Has increased warmth and tenderness with palpitation.  Amoxicillin - Pot clavulanate 600 - 42 9mg/5ml.  7.5ml BID - 10 days.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 9:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:54 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 27.67.  Concomitant medication of the patient was not reported.  Batch number 027L20A underwent temperature excursion on 07-Jan-2021 with unknown temperature. These vials were moved to fridge on an unknown date and beyond use date for the vials was not reported. The vaccines moved to clinic on an unknown date. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.
Fever of 103.8, chills, headache, left arm redness, swelling and hot to touch.
mild headache; mild nausea; face and eyelids are swollen; face and eyelids are swollen; sore throat; shortness of breath; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (mild headache), NAUSEA (mild nausea), SWELLING FACE (face and eyelids are swollen), SWELLING OF EYELID (face and eyelids are swollen) and OROPHARYNGEAL PAIN (sore throat) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (mild headache), NAUSEA (mild nausea), SWELLING FACE (face and eyelids are swollen), SWELLING OF EYELID (face and eyelids are swollen), OROPHARYNGEAL PAIN (sore throat) and DYSPNOEA (shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) on 16-Apr-2021 at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 16-Apr-2021 at an unspecified dose and frequency. At the time of the report, HEADACHE (mild headache), NAUSEA (mild nausea), SWELLING FACE (face and eyelids are swollen), SWELLING OF EYELID (face and eyelids are swollen), OROPHARYNGEAL PAIN (sore throat) and DYSPNOEA (shortness of breath) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 100.4 (High) 100.4.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported .
Patient reported a 5 inch, red raised area around injection site.  Pharmacist on duty recommended tylenol and antihistamines. Told patient if persisted to contact her physician.  Patient did go to a doctor, and was diagnosed with 'covid arm'.  She was given the same directions, tylenol and antihistamines.
Dizziness diagnosed as vertigo, meds prescribed. Thursday following admitted to ER for feeling upside down. Dehydrated & vertigo. Spent day in ER on IV. Hospital offered to keep me overnight. I declined. Have not experienced same since.
arm burning, like pins and needles; numbness; muscle is stiff, firm, hard to move; he can not sleep on the arm goes to sleep if he sleeps on it; upper respiratory symptoms; coughing a lot; yellow phlegm; wheezing; felt like a fire from injection down elbow,his arm, it was burning; hard to move; This spontaneous case was reported by a non-health professional and describes the occurrence of PARAESTHESIA (arm burning, like pins and needles), HYPOAESTHESIA (numbness), MUSCULOSKELETAL STIFFNESS (muscle is stiff, firm, hard to move), LIMB DISCOMFORT (he can not sleep on the arm goes to sleep if he sleeps on it) and RESPIRATORY SYMPTOM (upper respiratory symptoms) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol (Cholesterol medication) and Blood pressure high (High Blood pressure medicine). Concomitant products included IBUPROFEN for Back pain.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (arm burning, like pins and needles), HYPOAESTHESIA (numbness), MUSCULOSKELETAL STIFFNESS (muscle is stiff, firm, hard to move), LIMB DISCOMFORT (he can not sleep on the arm goes to sleep if he sleeps on it), RESPIRATORY SYMPTOM (upper respiratory symptoms), COUGH (coughing a lot), SPUTUM DISCOLOURED (yellow phlegm), WHEEZING (wheezing), VACCINATION SITE WARMTH (felt like a fire from injection down elbow,his arm, it was burning) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to move). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (arm burning, like pins and needles), HYPOAESTHESIA (numbness), MUSCULOSKELETAL STIFFNESS (muscle is stiff, firm, hard to move), LIMB DISCOMFORT (he can not sleep on the arm goes to sleep if he sleeps on it), RESPIRATORY SYMPTOM (upper respiratory symptoms), COUGH (coughing a lot), SPUTUM DISCOLOURED (yellow phlegm), WHEEZING (wheezing), VACCINATION SITE WARMTH (felt like a fire from injection down elbow,his arm, it was burning) and VACCINATION SITE MOVEMENT IMPAIRMENT (hard to move) outcome was unknown.            Concomitant medication information also included Cholesterol medication, High blood pressure medicine.
Large red spot about 4 inches in diameter. Onset approximately 24 hours post vaccine. Continues to be red, inflamed, and warm to the touch 48 hours post vaccine. From what I've read being called "COVID arm" only presenting in patients receiving the Moderna vaccine. Apparently rare so I thought I should report it in the event those who get it have other issues down the road.
Extreme radiating pain from injection side down arm all the way into elbow and then fingers. Pain also radiated into axillary area towards breast and into the back toward scapula.
Red rash that is about the size of her palm/Rash is red and warm to the touch; Rash itches a lot; Rash is red and warm to the touch; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. The patient had a regular routine appointment to the HCP on Monday. The patient medical history and concomitant medications were not reported. The patient noticed every day she had a red rash that was about the size of her palm. Rash itches a lot. Rash was red and warm to the touch. The patient wanted to know should she be concerned and what to do to get rid of it or should she ignore it. She did not think she was going to die, it just kept continuing. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
pt recv vax 16APR96 between 930-11AM & MD office states pt exp poss rxn to DTP-non stop crying >3hr w/t99.6 desires Td only in future;mom states very high pitched screaming type crying for long periods-MD gave APAP & DPH
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 13-JAN-2014, the patient was vaccinated with expired PROQUAD (Merck) injection (lot # H015641, Expiration Date 06-JAN-2014) (dose, units and route unknown) in error. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and administration date 25Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid".  The lot number for bnt162b2 was not provided and will be requested during follow up.
S/P HPV injection 6/12/12. Hives all over body since taking BENADRYL without relief. Rx'd MEDROL dose pack 06/27/12.
Reaction has spread out; Reaction at the injection site that is hard; Reaction at the injection site that is itchy/Scratching at the injection site; Reaction at the injection site that is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reaction has spread out), VACCINATION SITE INDURATION (Reaction at the injection site that is hard), VACCINATION SITE PRURITUS (Reaction at the injection site that is itchy/Scratching at the injection site) and VACCINATION SITE ERYTHEMA (Reaction at the injection site that is red) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION (Reaction has spread out), VACCINATION SITE INDURATION (Reaction at the injection site that is hard), VACCINATION SITE PRURITUS (Reaction at the injection site that is itchy/Scratching at the injection site) and VACCINATION SITE ERYTHEMA (Reaction at the injection site that is red). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Symptomatic treatment, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency and URTICA DIOICA ROOT (STINGING NETTLE ROOT) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Reaction has spread out), VACCINATION SITE INDURATION (Reaction at the injection site that is hard), VACCINATION SITE PRURITUS (Reaction at the injection site that is itchy/Scratching at the injection site) and VACCINATION SITE ERYTHEMA (Reaction at the injection site that is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Tdap given per MD order to pt. Came to HD, immunization given - stayed in dept app 15 minutes talking with staff and RN. Pleasant alert and oriented. App 5 min. later wife runs into HD and states her husband was not responding. This RN ran down to car - no respiratory effort occurring. No pulse noted. Compressions performed - 3 agonal like breaths occurred. Deputy sheriff on scene - defib 2 shocks then ambulance arrived on scene and took over pt's care. Was transported to local hospital - heart rhythm came back as well as respiratory effort, but remained unresponsive. Transferred to another hospital. Had flu shot at clinic on 11/06/18. Pt received (.5mg) IV into (R) forearm (venous) during resuscitation (but doubt if this perfused to core) -> app 7 min into resuscitation efforts. Not completely sure vaccine was cause of collapse - had walked up 2 flights of stairs and down after receiving vaccine -> 85.5 yrs old.
Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ED7533), via an unspecified route of administration in the right arm on 31Mar2021 at 14:30 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient did not have any history of allergies to medications, food, or other products. Concomitant medications included finasteride (MANUFACTURER UNKNOWN), pentoxifylline (TRENTAL), omeprazole (MANUFACTURER UNKNOWN) and chondroitin sulfate; glucosamine hydrochloride (OSTEO BI-FLEX). 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 vaccination. On 09Apr2021 at 06:00, the patient experienced dizziness and nausea. No therapeutics measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dizziness and nausea was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Son missed his second Moderna vaccine that was scheduled for 4-19-2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Son missed his second Moderna vaccine that was scheduled for 4-19-2021) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Son missed his second Moderna vaccine that was scheduled for 4-19-2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Son missed his second Moderna vaccine that was scheduled for 4-19-2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up information was received and contains no new information.
mild flu like symptoms; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (mild flu like symptoms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Injury (Injury 11-12 years ago (maybe in 2006 or 2007)).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (mild flu like symptoms). In January 2021, INFLUENZA LIKE ILLNESS (mild flu like symptoms) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (mild flu like symptoms) to be possibly related.    No Concomitant medications were reported.  No Treatment information was reported.  The events lasted for 48-72 hrs.   This case was linked to MOD-2021-385888, MOD-2021-385889 (Patient Link).
URI, bronchitis, bronchiolitis, allergic rhinitis, atypical pneumonia, community-acquired pneumonia, asthma exacerbation, COPD exacerbation
Itching at injection site that began 7days after the injection.  A red puffy area developed the next day.  It is oval shaped about 2 inches by 1.5 inches and is itchy.   I have used one application of topical Benadryl and it has not helped.
shortness of breath, sore throat and mild cough for approximately 9 days, yesterday developing worsening shortness of breath
Information has been received from a medical assistant refers to a 4 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date the patient was vaccinated with a 2 ml dose of ROTATEQ (lot # 668036/0594Z, Exp date 23-MAR-2012, oral). There were no concomitant medications. On unspecified dates, it had been tested with positive for Rotavirus. Medical assistant reported that on 04-MAR-2015 the patient was seen in the nurse practitioner's office after experiencing diarrhoea, nausea and vomiting. A stool sample was collected and did test positive for Rotavirus. Medical assistant reported that a basic metabolic panel, complete blood count and a stool test for Clostridium difficile was also performed on the child without result provided. The patient sought medical attention and the child was treated with oral fluids. The outcome of nausea, vomiting, diarrhoea and rotavirus test positive was unknown. This is one of the several reports from same reporter. Additional information has been requested.
Savere headache,savere fever, chills, Avery joint hurt,no appetite, and broke out into hives/rash. Almost a week later started with headaches.
Patient received 2nd dose of Pfizer vaccine 7 days after receiving 1st dose from a different provider.
Patient had a seizure.  He was hospitalized.  NOTE: The patient has had two Pfizer shots and two boosters. He continue to have seizures and altered memory.
fatigue, headache, nausea that started 1 day after; redness, swelling and pain to injection site that started yesterday
2/2/11 noted swelling redness at injection site 2/3/11 seen in office - Ice & MOTRIN prescribed 2/7/11 seen in office - had scattered zoster like lesions. Placed off work given prescription for ZOVIRAX 2/14/11 seen in office - no new lesions - old lesions are scabbed over.
Headaches, body aches, and a red, hot, inflamed upper arm. This lasted for several days.
On 11/21/2001, at 8 am, patient's parent reports that his child's left arm was warm to the touch and swollen. When they came into the clinic around 12:50, patient's arm was noted to be warm to the touch and red from the shoulder to about two inches from his elbow.
Local reaction with significant underarm swelling, soreness, and tenderness. The area surrounding the vaccination site was also swollen, red, and bumpy. Treatment: Continue careful care of the site, and hydrocodone as needed for pain.
pt recv vax 31JUL96 & 1AUG96 felt sick, stomach cramping, jittery, felt weak;
Pain in left shoulder and arm upon movement. Decreased range of motion; injection given near top of left shoulder. Pain x 8 weeks.
pt recvd vax & w/in 24hrs post vax exp hives & pruritic lesions on legs & buttocks;tx DPH