chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pemphigus; Hives in the back; This is a spontaneous report from a contactable physician (patient). An 82-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL 1284), via an unspecified route of administration, on the left arm, on 30Dec2020 at a single dose for Covid-19 immunisation. Medical history included glaucoma, age-related macular degeneration (AMD), arrhythmia. The patient has no known allergies. The patient did not receive other vaccine in four weeks. The patient has no Covid prior vaccination and not Covid tested Concomitant medications included nebivolol hydrochloride (BYSTOLIC), rosuvastatin calcium (CRESTOR), and timolol.  On an unspecified date, the patient developed hives in the back within a week after 1st shot and broke out in blisters over upper body 3 wks after 2nd shot of vaccine. Skin biopsy (Bx) done to confirm Pemphigus. Treatment for the events was Kenalog 60 mg IM/ also 3 wks later prednisone po. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Pemphigus cannot be completely excluded given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a consumer via call center representative and described the occurrence of abnormal sensation of limbs in a female patient who received Herpes zoster (shingrix) for prophylaxis. Co-suspect products included amoxicillin trihydrate (Amoxicillin) unknown for tooth extraction. The patient's past medical history included tooth extraction. On 26th December 2021, the patient received the 1st dose of shingrix. On an unknown date, the patient started Amoxicillin at an unknown dose and frequency. On an unknown date, less than 3 weeks after receiving shingrix and unknown after starting Amoxicillin, the patient experienced abnormal sensation of limbs, neck pain, enlargement of lymph nodes and stiff neck. Amoxicillin was continued with no change. On an unknown date, the outcome of the abnormal sensation of limbs, neck pain and enlargement of lymph nodes were not recovered/not resolved and the outcome of the stiff neck was unknown. It was unknown if the reporter considered the abnormal sensation of limbs, neck pain, enlargement of lymph nodes and stiff neck to be related to shingrix and Amoxicillin. Additional details were provided as follows: The patient self-reported this case. The patient stated she had been experiencing lymph node swelling, stiffness in the neck, neck pain, and her arm feels funny too, since receiving the vaccine. The patient stated she was currently taking amoxicillin for a scheduled tooth extraction. The patient was inquiring if Amoxicillin was causing these side effects or was it the shingrix vaccine. The patient was also inquiring if the vaccine was causing these side effects, what should she did about the second dose. The medical advice disclaimer was provided. The reporter did not consent to follow up.
RECTAL BLEEDING/BLOOD IN STOOL.  CHILD HOSPITALIZED WITH INTUSSUSCEPTION ON 3/7/2010.
This spontaneous report as received from a licensed nurse practitioner regarding multiple patients of unknown age and gender. The patients' medical history, current conditions and concomitant medication were not reported. On unknown dates the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and expiry date were not reported). The vaccine was exposed to a temperature of 34 Fahrenheit for a time frame of 50 hours. There was no data logger and no previous excursions. No adverse events were reported. There was no product quality complaint involved. This is one of the several cases reported by the same reporter. Additional information has been requested.
Sore arm; Felt like there was knot inside; Left arm started to swell at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Felt like there was knot inside) and VACCINATION SITE SWELLING (Left arm started to swell at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 PAIN IN EXTREMITY (Sore arm), VACCINATION SITE INDURATION (Felt like there was knot inside) and VACCINATION SITE SWELLING (Left arm started to swell at the injection site). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and VACCINATION SITE INDURATION (Felt like there was knot inside) and VACCINATION SITE SWELLING (Left arm started to swell at the injection site) had resolved.            Other treatment details included rubbed alcohol on it. Concomitant medication were not provided by the reporter.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-JUL-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 22-JUL-2022).    Concomitant medications were not reported.  Patient received half dose. They administered the vaccine to 346 patients after the 30 days by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
This spontaneous report as received from a nurse refers to a male patient of "around 25 years old", who was the son of a physician's friend. Medical history and concurrent conditions were not reported. On an unknown date, reported as "many years ago when he was a young child", the patient was vaccinated with 2 doses of (Oka/Merck) VARIVAX. Dose, route, lot number and expiration date were not reported. On an unknown date, "recently", the patient was diagnosed with shingles. The outcome of shingles was not recovered. The friend's son was not a patient of physician. Additional information has been requested.
Pain in arm was much more than expected almost immediately. Within 2 hours area around injection site had swollen and become painful and hot to touch. Muscular and joint pain started and I had fever of just under 100F. Within several hours, fever had risen to almost 102F. Flu-like symptoms of intense fatigue, muscle and joint pain, headaches, weakness, and loss of appetite set in before the end of the night. These symptoms lasted for 5 days causing me to miss work for most of the following week. Fever persisted at 101-102 for most of the time, dropping to just under 100 by late the following Tuesday and to 99 on Wednesday - by evening it was normal and I went to work the next day, Thursday, for the first time since the prior Friday.
Chills, sweating, extreme fatigue, weakness, short of breath, exacerbation of asthma.
approx 8mos p/vax pt lab eval revealed neg varicella titers. no further info avail
11/14/2007 - Seizure. Confirmed by EEG. Begun using DEPAKOTE. CBC and LFT's - within nml limits.
The patient had chils, temperature of 101, headache, muscle aches, weakness, fatigue for 2 1/2 days. Prescription: Ibuprofen and rest
Patient experienced dizziness, lightheadedness, and vision that was in and out within 5 minutes of administration of Moderna Covid-19 shot. Patient was advised to lay down with feet propped up to prevent fall due to lightheadedness. At about 10 minutes after administration patient felt nauseous and was vomiting. Patient was given a cold compress and water.
Flu-like symptoms; chills; Fatigue; Nausea; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th January 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, fatigue and nausea. On an unknown date, the outcome of the influenza-like symptoms, chills, fatigue and nausea were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, fatigue and nausea to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in the left deltoid and experienced flu-like symptoms, nausea, fatigue and chills later that evening which lasted through the weekend. The reporter did not consent to follow up. The reporter declined to provide any medical doctor information.
This spontaneous report as received from a registered nurse who was the patient's mother, refers to a 16 year old male patient (reporter's son), with no pertinent medical history or drug reaction allergies. On 14-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported) since "the doctor recommended it". There was no concomitant medication. On 02-JUL-2013, reported as 2 and a half weeks after 14-JUN-2013, the patient developed a cluster of plantar warts broke out on his unspecified foot. The patient sought medical attention, went to a physician who burned/froze the plantar warts last week. Laboratory diagnostics studies were not performed. At the time of the report the patient's outcome was recovering. This case is related with MARRS 1207USA012821 and 1307USA012822. Additional information has been requested.
Rash the next morning. Gradually got worse with pain/redness and fever. On the 3rd day had problems breathing and went to her work site health clinic. They gave her oxygen and called 911. 911 came, gave her Benadryl and IV ? and took her to ER. ER did EKG.
fever; headaches; body aches; sore throat; cough; congestion; runny nose; fatigue; illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: el3247) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: asthma. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ADVAIR. Vaccination history included: Bnt162b2 (Dose Number:01, Pev dose lot number : el3247, Prev dose vaccine location: Left arm), administration date: 28Jan2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "headaches"; PAIN (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "body aches"; OROPHARYNGEAL PAIN (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "sore throat"; COUGH (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "congestion"; RHINORRHOEA (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "runny nose"; FATIGUE (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "fatigue"; ILLNESS (non-serious) with onset 05Nov2021 15:00, outcome "unknown", described as "illness". The events "fever", "headaches", "body aches", "sore throat", "cough", "congestion", "runny nose", "fatigue" and "illness" were evaluated at the physician office visit.  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination.Since the vaccination the patient has not been tested for Covid-19. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Device Date : 08Nov2021.  No follow-up attempts are possible. No further information is expected.
The pt developed wheezing, desaturation and generalized urticaria, within 5 minutes, post vax. Rx'd with epinephrine, Benadryl and steroids.
One week after the first Moderna shot on 1.28.21, I experienced severe upper body pains, aches on shoulders, arms, fingers, continuing to date: 4.13.21.  My concern is that the Moderna vaccine stimulated an underlying & unknown arthritic condition, diagnosed via xray on 4.8.21.  The disabling pain continues, even after the 2nd shot, 3.4.21, which I listed in item 4, so that I could include the first shot as happening one month prior in item 22.
ringing in ears that sounds like outdoor night in spring  with tree frogs. No treatment.  hoping it will go away with time.  Been this way 2 1/2 months
Shortness of breath; Difficulty breathing; Heaviness in chest; Went to ER and had chest x-rays and CT scan of my lungs. Found out I had numerous pulmonary embolisms in all 5 lobes of my lungs. They did a COVID test and it was negative. They did an EKG and sonogram on my heart and it was fine. They checked for blood clots in my legs. There were none. They checked for signs of cancer. There were none. They started a heparin drip through my IV and the dissolved the largest clot with an embolectomy. I'll be on blood thinners for 6 months.
Patient reported nausea, dizziness, and shortness of breath at 0950. Declined epinephrine. Requested IM benadryl. 50 mg IM benadryl given at 1005 am in the left deltoid. Patient got a driver to take her home. Symptoms resolved within 30 minute observation period after benadryl was given.  Declined ED visit.
ACUTE HYPERCAPNIC RESPIRATORY FAILURE 9/3/2022 ACUTE HYPERCAPNIC RESPIRATORY FAILURE
I received the flu vaccine for employment purposes. I am not sure which flu vaccine it was. Metallic taste in mouth. Soreness at the injection site
Received 2nd dose of hepatitis A vaccine 6/27/08.  2 days later went to ER for "rash" (was urticaria).  Given prednisone 30mg/day for 3 days.  On next day.  Trunk, legs, & face were involved.  Played outdoors.  Waded ankle deep in river seen in office 7/2/08 & 50 MEDROL given (60mg) then prednisone.
24 hrs after vaccine "I" had a low grade fever.; 24 hrs after vaccine "I" had a low grade fever, chills; 24 hrs after vaccine "I" had a low grade fever, chills, body aches; 24 hrs after vaccine "I" had a low grade fever, chills, body aches, tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 24Apr2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021 at 12:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 25Apr2021 at 12:00, 24 hours after vaccine, the patient had a low grade fever, chills, body aches and tiredness. On the same day, the patient underwent body temperature test and the result was not reported. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, chills, body aches and tiredness were resolved on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Fatigue, Tired feeling, Headache, Muscle pain, Decreased appetite, Pain on the left arm, swelling,  tenderness, hard lump, chills, fever for 2 nights (Saturday 28th & Sunday 29th), drowsiness, sleepy, fatigue.
No additional adverse effects; four pediatric patients received the adult formulation of VAQTA; This spontaneous report was received from the office manager and refers to an unspecified pediatric patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 22-NOV-2019, the patient was vaccinated with the adult formulation of hepatitis a vaccine, inactivated (VAQTA) 50U/1.0ml, 1 milliliter, once,  lot # S012250 expiration date on 07-JUL-2020 (route and anatomical location were not provided), for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA003828: US-009507513-1912USA011815: US-009507513-1912USA011816:
right sided body paresthesias, unclear to me that this is related to vaccine given time course but pt wanted this reported as possible; began 2/26 am when awakening, has improved but persistent a few days later; NOT on the side vaccine was given
burning rash; After 8 days new rash like hives on face and neck; touches it and it burns; This spontaneous case was reported by a consumer and describes the occurrence of RASH (burning rash), URTICARIA (After 8 days new rash like hives on face and neck) and BURNING SENSATION (touches it and it burns) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 027A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 NOS, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) and VITAMIN D NOS for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced URTICARIA (After 8 days new rash like hives on face and neck) and BURNING SENSATION (touches it and it burns). On an unknown date, the patient experienced RASH (burning rash). The patient was treated with PREDNISONE from 04-Apr-2021 to 11-Apr-2021 at a dose of 20 mg once a day; FAMOTIDINE from 04-Apr-2021 to 11-Apr-2021 at a dose of 40 mg once a day and HYDROXYZINE (ATARAX [HYDROXYZINE]) from 04-Apr-2021 to 14-Apr-2021 at an unspecified dose and frequency. At the time of the report, RASH (burning rash), URTICARIA (After 8 days new rash like hives on face and neck) and BURNING SENSATION (touches it and it burns) 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.   Other concomitant medication included Sarno, Benadryl.   This case was linked to MOD-2021-089496 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up was received  Vaccine lot numbers, patient  info, concomitant products, AE outcome was added
Extreme amount of pain. Patient could barely lift her arm the next morning. It resolved in less than 48 hours.
chest pain, troponin of 36.6ng/dl, ST elevation in lateral leads. treated with ibuprofen and 1 dose of methylprednisolone. troponin downtrended to 3.49 on 6/13
Big red ring around injection site, raised red/pink spotted rash on back, back of neck up ears around hair line, on the face ( face swollen) down to chest. Instructed to tKe Benadryl by Dr seen on 10/15/2019. Feeling weak with muscle aches.
Sick; This is a spontaneous report from a contactable consumer via medical information team and a Pfizer sponsored program. This consumer reported similar events for 2 patients. This is 1st of 2 reports.  A 70-years-old female patient (reporter's cousin) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, Expiry date: was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Patient's medical history and concomitant medications were not reported. Reporter stated that patient received the 1st dose of the Pfizer COVID 19 vaccine and patient got really so sick on an unspecified date. Reporter wants to know if that was normal and how long it lasts and reporter also stated that seniors who take the vaccine were 80% effective and don't have to take the second shot, is that true, with the Pfizer. It's terrible they telling people to get vaccinated, people getting sick. Outcome of event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.