chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anaphylaxis; Burning sensation in the arm; This spontaneous report  was received from a consumer who was a 39-years-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and experienced an immediate burning sensation in the arm and anaphylaxis.   The patient's medical history was not provided. Concomitant Medications were not reported.  On 13 Jan 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 intramuscularly in the left arm (Lot number: 025L20A). She immediately felt a burning sensation in the arm, dizziness, and developed hives on her arm, face and chest. The hives on her face were itchy. She presented to the Emergency Department and was treated for anaphylaxis. Treatment included intravenous diphenhydramine and intramuscular epinephrine.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, burning sensation in the arm and anaphylaxis, were considered resolved on an unknown date.; Reporter's Comments: This case concerns a 39-year old female patient with unknown medical history and concomitant medications. The patient experienced an unexpected event of Anaphylaxis that was considered medically significant. Additionally, the patient experienced expected non-serious event of Burning sensation in the arm. The events occurred immediately after receiving their first of two planned doses of mRNA-1273 (Lot number: 025L20A). Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Prior to the administration of the COVID 19 vaccine, the nursing home had an outbreak of COVID-19.  Patient was vaccinated and about a week later she tested positive for COVID-19.  She had underlying thyroid and diabetes disease.  She died as a result of COVID-19 and her underlying health conditions and not as a result of the vaccine.
The pt experienced itching on 10/21/00, no hives. 10/22/00 told mother hives on extremities and on body. Seen at a walk-in clinic. MD ordered arthritis screen, metabolic panel and CBC. All labs were negative per mother with the exception of Sed Rate that was elevated. The pt was treated with Prednisone, Zyrtec and Vioxx. Was advised to consult a rheumatologist. It was felt that the symptoms were due to the vaccine.
This case was reported by a dentist via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 71 or 72 years old. The reporter stated that his friend experienced sore arm for several days and then he recovered. No further details were provided. This case was one of the 4 cases, reported by same reporter.
2 Hours after receiving HPV injection patient reported hives covering body swelling of wrists, knees, feet.
Fever, hives, eczema flare-up to which at this point I was under the impression that these were normal reactions for him. Patient had gastritis and/or stomach pain prior to the appointment these symptoms worsened. We removed dairy from his diet completely.
SWELLING IN BOTH FEET; CAN NOT WALK; HEART RACING; BURNING IN BOTH HANDS THAT STRETCHES FROM FINGER TIPS TO THE  ELBOW; HURTING IN BOTH HANDS THAT STRETCHES FROM FINGER TIPS TO THE  ELBOW; NUMBNESS IN BOTH HANDS TO THE ELBOW; BOTH FEET BURNING AND TINGLING; This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, non alcohol user, irregular heart beat (arrhythmia), and atrial fibrillation, and other pre-existing medical conditions included: Patient had no known allergies and did not had any drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included apixaban for atrial fibrillation.  On 16-APR-2021, the patient experienced swelling in both feet. On 16-APR-2021, the patient experienced can not walk. On 16-APR-2021, the patient experienced heart racing. On 16-APR-2021, the patient experienced burning in both hands that stretches from finger tips to the elbow. On 16-APR-2021, the patient experienced hurting in both hands that stretches from finger tips to the elbow. On 16-APR-2021, the patient experienced numbness in both hands to the elbow. On 16-APR-2021, the patient experienced both feet burning and tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both feet burning and tingling, swelling in both feet, can not walk, heart racing, burning in both hands that stretches from finger tips to the elbow, numbness in both hands to the elbow, and hurting in both hands that stretches from finger tips to the elbow. This report was non-serious.
Several hours after vaccination patient came to the pharmacy and presented with angioedema of her upper lip, hives on thighs and inner arms.  No complaints of any breathing difficulty or swelling of the throat.  Her face felt tingly "like I just went to the dentist."  I advised patient to either go to the emergency room to be evaluated or immediately follow up with her current provider and have them advise her next actions. Patient did not feel bad enough to go to the emergency room and preferred to stay at work, which is at our facility. Patient took 50 mg diphenhydramine and called her provider, who scheduled the soonest televisit to follow up with her.  She was prescribed prednisone 40 mg x 5 days as well as cetirizine 10mg daily for urticaria.  She has a scheduled follow up in person with her provider.
Fever and full body rash consistent with viral exanthem including palms and soles with some blisters onset 30 hours after vaccine
Within 24 hours of receiving vaccine, pt developed fever, headache, puffy eyes, cough and congestion, post tussive emesis noted, fever present for 5 days with temp high 102. Symptomatic care.
Arm pain; Fatigue; Chills; Flu like symptoms; Chest fluttering; Sweats; Itchy rash stared on both forearms, then chin line, forehead, back of neck; both lower shins; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GW0170), via an unspecified route of administration in the left arm on 26Apr2021 at 14:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received shellfish for an unknown indication on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8T34), via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 61-year-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 vaccination. On 27Apr2021, during the first 24 hours after vaccination, the patient experienced arm pain, fatigue, chills, sweats, flu like symptoms, chest fluttering. On an unspecified date in Apr2021, which the patient reported to be the second or third day, the patient experienced a very itchy rash which started on both forearms, then the chin line, forehead, back of neck and both lower shins. The clinical outcome of the events arm pain, fatigue, chills, sweats, flu like symptoms, chest fluttering and itchy rash was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Fever to 103, nausea, vomiting approx 8-10 hours after vaccination
- Injection site pain started about 30 minutes post-injection, continued for a week.  - Diarrhea started approximately 2 hours post-injection, continued for 2 days - Chills started 2 days post-vaccine at bedtime, stopped by morning - Temp of 100.4 started 2 days post-vaccine, afebrile by next day.
Shortness of breath, fever, shaking, chills that started the day after receiving Moderna and influenza vaccine.
Body aches, chills, fatigue, nausea-began on 1/15/21 at 0700 and continued through the day. All these symptoms were gone when I woke up on 1/16/21. I developed a baseball sized lump in my left axilla on 1/15/21 at 1700 and this continues to be present today.
The child was given immunizations by the nurse and shortly after receiving them she went limp in her grandmothers arms, her eyes rolled back and she appeared to lose consciousness.  The child quickly regained consciousness, her blood pressure and pulse were stable and she was afebrile.  Her mother reported that she had not eaten or drank since breakfast that morning.  Mother also reported that the child did not know she was going to receive vaccines that day until the nurse came into the room with them.  Mother also states that the child sometimes holds her breath when upset or angry.
pt recv vax 26SEP96 & 29SEP96 pt exp perfused sweating;sore throat;tiredness;lethargy;
First and second day after administration: Pain and swollen arm at the sight of injection, body aches, chills, sweats, 102.6F temperature. Third day and up to date (2-14-20): hives at various sights on my body (arms, legs, behind ears, neck). Urgent care Dr. prescribed prednisone 20mg and benadryl for 5 days.
Received Gardasil on 5-3-07. Also was provided prescription for Elimite cream. Cream applied on the pm of 5-3-07. Child awoke w/diffuse hives on 5-4-07.
Heart beating irregular, fast and noticeable - 2:30 a.m. - 2:30 p.m July 27, 2021; Intermittent heart palpitations daily every day through today.
High fever; headache; myalgia ; inbility to smell or taste;  fatigue on 22nd; hAD THOSE SYMPTOMS FOR ABOUT A WEEK; tested positive for COVID on Dec 26.   haven't recovered inablity to smell or taste; fatigue - still have that, too;
Test: Home Ag/Positive; Test: Home Ag/Positive; cough; congestion; ST; myalgia; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 25Feb2021 as dose 2, single (Lot number: EL3247) and on 23Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "exposed to someone 31Mar  who later tested positive" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 or not. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 01Apr2022, outcome "unknown", described as "HA"; OROPHARYNGEAL PAIN (non-serious) with onset 01Apr2022, outcome "unknown", described as "ST"; NASAL CONGESTION (non-serious) with onset 01Apr2022, outcome "unknown", described as "congestion"; COUGH (non-serious) with onset 01Apr2022, outcome "unknown"; MYALGIA (non-serious) with onset 01Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Apr2022, outcome "unknown" and all described as "Test: Home Ag/Positive". The patient had + covid test on 06Apr2022 but had classic COVID symptoms starting 01Apr2022 cough, HA ,myalgia ,congestion and ST. He was exposed to someone on 31Mar2022 who later tested positive and he found out about it 06Apr2022 so tested. He did not feel that he has had covid for a week. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Apr2022) Positive, notes: COVID test type post vaccination: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, cough, nasal congestion, oropharyngeal pain, myalgia, headache.   No follow-up attempts are possible. No further information is expected.   ; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of covid-19 and vaccination failure.
It's been 5 days after my 2nd dose of Pfizer, and I still have a headache in the back of my head and feel on/off nauseaous . I had arm pain for first few days but that has subsided.; It's been 5 days after my 2nd dose of Pfizer, and I still have a headache in the back of my head and feel on/off nauseaous . I had arm pain for first few days but that has subsided.; It's been 5 days after my 2nd dose of Pfizer, and I still have a headache in the back of my head and feel on/off nauseaous . I had arm pain for first few days but that has subsided.; This is a spontaneous report from a contactable consumer (patient herself). A 50-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: FC3180; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 13Aug2021 15:30 (at age 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included sertraline (SERTRALINE), vitamin d (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0196; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 21Jul2021 14:00 (at age 50-years-old) for COVID-19 immunization. Patient had previously received codeine and experienced drug hypersensitivity. 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. On 13Aug2021 the patient experienced it's been 5 days after my 2nd dose of pfizer, and I still have a headache in the back of my head and feel on/off nauseaous. I had arm pain for first few days but that has subsided. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of event it's been 5 days after my 2nd dose of pfizer, and I still have a headache in the back of my head and feel on/off nauseaous. I arm pain for first few days but that has subsided (Pain in extremity) was resolving while it was not recovered for all other events.  Follow-Up (27Aug2021): Follow-up attempts are completed. No further information is expected.
Per mother's report awaiting records from ER. 6/4 rash. 6/5: low grade fever and nausea 6/6: increase temperature. 6/7: to ER temp 101 Lumbar puncture and CT performed (neg per mom's report). Mom states he had pustules in mouth, severe sensitivity to light, extreme itch. She feels he had nausea.
Vaccines administered 10-2-12; patient states arm was extremely sore; on morning of 10-4-12 she noticed a red swollen area on arm, warm to the touch located 12 inches below the injection sites; no irritation at injection sites, but continued pain treating w/Ibuprofen.
Nausea; Diarrhea; This spontaneous case was received on 22-Sep-2022 from other healthcare professional (nurse) (reference number: SEQW22- 03395) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported. It was reported that some of patients were diabetic, however, it was not specified whether this patient was diabetic.   On 20-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration and anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza. The batch number reported was 346341 and expiry date was 28-Apr-2023.   On 21-Sep-2022, during the night, 18 to 24 hours after receiving Fluad Quadrivalent, the patient experienced nausea and diarrhea. Nurse Practitioner claimed that as they were nauseated, they gave the patient 7up and an acid. Also, couple of patients did receive anti-diarrhea pills.  On the same day, the patient recovered from both events. The patient no longer had these symptoms.  The reporter did not provide causality assesment.   The case was assessed as non-serious.  This case is linked with the cases 202204733, 202204734, 202204736, 202204737, 202204738, 202204739, and 202204740 (the same reporter).  Company comment: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Sender's Comments: The events of nausea and diarrhea are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
This spontaneous report was received from a consumer referring to her husband, a male patient of unknown age. The patient's concurrent conditions, concomitant medications and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, (concentration, dose, frequency and anatomical place of vaccination were not reported), for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date, the patient developed shingles (herpes zoster). At the time of the reporting, the outcome of herpes zoster was unknown and the reporter did not provide a causality assessment between ZOSTAVAX and herpes zoster. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003161: US-009507513-1709USA004175.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-APR-2015, the patient was vaccinated with an improperly stored dose of COMVAX (lot number J013884; expiration date 19-AUG-2016) 0.5 ml "SDV;PK/10" (route of administration and anatomical location were not reported). On an unspecified dates, the COMVAX had five temperature excursions: 304 hours, 72 hours, 40 hours, 712 hours and 48 hours. The lowest recorded temperature was 28 F (-2.222222222 Celsius) while the highest recorded temperature was 47 F (8.333333333 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
itching on back; itching on scalp; itching on arms; bouts of itching all over their boby; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on back), PRURITUS (itching on scalp), PRURITUS (itching on arms) and PRURITUS (bouts of itching all over their boby) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOLAZONE, ALLOPURINOL, DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE/TIMOLOL ACTAVIS), BRIMONIDINE, TRAVOPROST (TRAVATAN), AMLODIPINE, TRAMADOL, FERROUS SULFATE, UBIDECARENONE (COQ-10), FISH OIL (OMEGA XL), AGATHOSMA BETULINA HERB, VACCINIUM MACROCARPON JUICE (CRANBERRY & BUCHU), MULTIVITAMINS & MINERALS PLUS LUTEIN and ACETYLSALICYLIC ACID (BAYER ASPIRIN) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 PRURITUS (itching on back), PRURITUS (itching on scalp), PRURITUS (itching on arms) and PRURITUS (bouts of itching all over their boby). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching on back), PRURITUS (itching on scalp), PRURITUS (itching on arms) and PRURITUS (bouts of itching all over their boby) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR added contains patient says feeling fine.
Limited information. Child was taken to the ED where he was admitted for observation. Child had an episode of pallor and being limp during the evening/night which prompted the parent to take the child to the ED as a precaution. The ED reported the admit to the provider in our office this AM and stated the child had been stable since arriving at the facility.
Measle type rash at neck area; This is a Spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID19 VACCINE, Lot#:EP7534), via an unspecified route of administration in arm left on 15Mar2021 12:00 at age of 73-year-old as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient's concomitant medication included atorvastatin calcium (LIPITOR) from 2021. Prior to vaccination, the patient was not diagnosed as COVID-19. The patient was not pregnant at time of the vaccination. In 2021 following first dose after vaccine, the patient experienced measle type rash at neck area. The adverse event measle type rash at neck area resulted in visiting doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse enent measle type rash at neck area and included treatment with Steriods. Since the vaccination, the patient had not been tested for COVID-19. The outcome of adverse event measle type rash at neck area was not recovered.    No follow-up attempts are needed. No further information is expected.
I developed hives all over my body and dermatographia.  Intense itching everywhere - wrists, ankles, neck, scalp, palms, chest, back, legs, etc.  Zyrtec helps the hives but not the dermatographia. I have prominent red marks all over my body any time there is pressure (think a waist band from clothing) or contact.
-Flu like symptons started about 8 hours after and lasted for 36 hours. - Injection sight very sore (nothing with first vaccine) and developed hot red rash which increased in size for 48 hours then slowly disappeared