chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL (lot# unknown, 0.5 ml) intramuscularly. The reporter reported GARDASIL were exposed to a lowest temperature of 32F for a total of 1 hour over "four different occasions" and the improperly stored GARDASIL were administered to an unspecified amount of patients. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough case after three vaccines Pfizer 2/26/21 Lot# EN6200;  Pfizer 3/19/21 Lot# ER8727;  Pfizer 10/29/21 Lot# FC3183
Pt reports all-over body itching without any rash or otherwise discrete lesions within hours of receiving the vaccine 4 days ago.  He took Benadryl prn which resolved the itching.  4 days after the vaccine, on the morning this report was filed, he reports large (<2 cm), red, raised lesions over his upper extremities that were only slightly pruritic but then flared with scratching.  The lesions self-resolved within 15-20 minutes and were absent at the time of this evaluation.
The following day, 01/05/2021, I had extreme fatigue, a fever of 100.5, and nausea. The fever subsided by the following day, 01/06/2021
Just after the dose was injected, my face become numbing and I felt tingling sensation.  Right after this it was very hard to swallow and breath. This last around 25 minutes. Then my muscles in my legs got numb.   Pain in the left arm. After 22 hours my face is still partially numb.
Pt had severe crying, irritability and inconsolability for approximately 72 hours post vaccine.
After vaccine 2 weeks, she developed weeping from her hands.  felt like something was growing under her skin.  Very irritating to her hands.
Shingles after dose one; This case was reported by a pharmacist and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) (batch number B334Y, expiry date unknown) for prophylaxis.   The patient's past medical history included cancer and shingles.   On 17th July 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced shingles. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR013246.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR013246:Same reporter.
Shortly after receiving the vaccine I started to experience shortness of breath. The condition worsened over the next few months until I was admitted to the hospital in June of 2022. I was advised to immediately go to an emergency room by Doctor office after the discovery of dual pulmonary embolisms from a previous scan.
positive for COVID again; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 30Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "Bees allergy" (unspecified if ongoing), notes: Bees and insect bites; "prostate cancer" (unspecified if ongoing); "hearing loss" (unspecified if ongoing); "macular degeneration" (unspecified if ongoing); "sinusitis" (unspecified if ongoing); "erectile dysfunction" (unspecified if ongoing); "Insect bite allergy" (unspecified if ongoing), notes: Bees and insect bites; "Barretts Esophagus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Aug2022, outcome "recovering" and all described as "COVID-19"; DISEASE RECURRENCE (medically significant) with onset 13Aug2022, outcome "recovering", described as "positive for COVID again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2022) Positive; (10Aug2022) Negative; (13Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, which included oral Paxlovid from 05Aug2022 to 10Aug2022. Therapeutic measures were not taken as a result of disease recurrence. Clinical course: 05Aug patient started with symptoms and had a positive test Placed on Paxlovid 05Aug (with renal dosing). Patient then tested negative and symptom free on 10Aug2022. Symptoms started again on 13Aug2022 was positive for COVID again. Patient is feeling worse today sneezing, congestion, coughing, muscle/body aches. Rebound symptoms started from 13Aug2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported events drug ineffective, covid-19 , disease recurrence and the suspect drug cannot be excluded.
really bad body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (really bad body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (really bad body aches). The patient was treated with IBUPROFEN ongoing since an unknown date for Ache, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) ongoing since an unknown date for Ache, at a dose of UNK dosage form. At the time of the report, PAIN (really bad body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, COVID-19: negative (Negative) negative. On 10-Mar-2021, Influenza: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.   This case was linked.
stomach issues/diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (stomach issues/diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (stomach issues/diarrhea). At the time of the report, DIARRHOEA (stomach issues/diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Booster; Pain/swelling at the site of the injection; Pain/swelling at the site of the injection; Numbness of the arm all the way through the end and fingers; Extreme fatigue; Selling under the armpit, nera the collarbone on the side of my breast; This was painful in the first few days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Dec2021 16:30 (Lot number: FJ8757) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL; PROGESTERONE; LINZESS. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0176, Vaccine Administration Time: 10:00 AM), administration date: 08May2021, when the patient was 47 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0169, Vaccine Administration Time: 10:00 AM), administration date: 17Apr2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 12:00, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 09Dec2021 12:00, outcome "recovering", VACCINATION SITE SWELLING (non-serious) with onset 09Dec2021 12:00, outcome "not recovered" and all described as "Pain/swelling at the site of the injection"; HYPOAESTHESIA (non-serious) with onset 09Dec2021 12:00, outcome "recovered" (Dec2021), described as "Numbness of the arm all the way through the end and fingers"; FATIGUE (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "Extreme fatigue"; PERIPHERAL SWELLING (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "Selling under the armpit, nera the collarbone on the side of my breast"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 12:00, outcome "recovering", described as "This was painful in the first few days". Therapeutic measures were not taken as a result of immunisation, vaccination site pain, vaccination site swelling, hypoaesthesia, fatigue, peripheral swelling, pain in extremity.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 post the vaccination.  No follow-up attempts possible. No further information expected.
Left arm remains swollen 1 week after vaccine. It feels like a large gold ball is in the arm. Very sore to touch.
Significant loss of hearing in left ear. Tinnitus and pressure in left ear causing equilibrium issues and nausea.
Fever, chills,  nausea, body aches, fatigue,  swollen/smooth fingertips,  swollen face (feels sunburnt)
she got the 2nd shot and it got worse for her; I have read a whole bunch of stuff about gastro issues; people have experienced bloating; lady had same symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she got the 2nd shot and it got worse for her), ABDOMINAL DISCOMFORT (I have read a whole bunch of stuff about gastro issues), ABDOMINAL DISTENSION (people have experienced bloating) and GASTROINTESTINAL DISORDER (lady had same symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she got the 2nd shot and it got worse for her), ABDOMINAL DISCOMFORT (I have read a whole bunch of stuff about gastro issues), ABDOMINAL DISTENSION (people have experienced bloating) and GASTROINTESTINAL DISORDER (lady had same symptoms). At the time of the report, VACCINATION COMPLICATION (she got the 2nd shot and it got worse for her), ABDOMINAL DISCOMFORT (I have read a whole bunch of stuff about gastro issues), ABDOMINAL DISTENSION (people have experienced bloating) and GASTROINTESTINAL DISORDER (lady had same symptoms) outcome was unknown.            No concomitant medications was reported.  No treatment medications was reported.
Approximately 36 hours after I developed a red itchy painful rash below the injection site down my arm.  It also had paresthesias on the skin and swelling.  It is still present.
-I had a stroke three years ago. i did therapy to regain proper use of my right side. after my second dose of the pfizer "vaccine," i was back to three years ago with my right side. it is now generally weaker. it gets fatigued easier. i also have tremors in my right arm. if i try to do anything right handed, it shakes.  -noticeable intolerance to cold temperatures now  -my temper is gone. any little thing angers me now. I was a free-wheeling, fun-loving guy before. now I'm just a ball of rage.
- Vertigo, pallor, nausea x 1/2 hr. - Emergency Technician attended to Pt - offered juice -Pt returned to class approx 1/2 hr after injection.
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) 0.5 ml once underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
He had a secondary infection of bronchitis; positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; sore arm; headache; This is a spontaneous report from a contactable consumer (patient).  A 54-years-old male patient started to receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), via an unspecified route of administration in the right arm on 30Dec2020 14:40 at single dose for COVID-19 immunisation. Medical history included hypothyroidism and blood cholesterol, both ongoing. The patient received the influenza vaccine on 04Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID), eicosapentaenoic acid ethyl ester (VASCEPA). On 31Dec2020 the patient experienced sore arm and headache with outcome of recovered on 01Jan2021. On 02Jan2021 and 03Jan2021 he felt fine. He had a scratchy throat on Monday 04Jan2021. Tuesday 05Jan2021 he felt like he was getting bronchitis which he got sometimes. Later that evening on 05Jan2021 he had a two degree temperature, chills, and achy muscles. He couldn't get in with the doctor on 05Jan2021, so he had to wait until 06Jan2021 when he went to the respiratory clinic. They did the COVID test on 06Jan2021, but the positive result didn't come back until 07Jan2021. He was just now recovering from it. He had a secondary infection of bronchitis and was given an inhaler.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, fatigue Narrative:  Fever 103.4, myalgia, arthralgia, malaise, nausea, headache neck pain; took tylenol; resolved 48 hours.
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age. Approximately in October 2011 ("about 2 years ago") the patient was vaccinated with a dose of GARDASIL (lot#, expiration date, dose, route not reported) and to receive the second dose of GARDASIL on 21-OCT-2013. No adverse event reported. Additional information is not expected.
the patient received moderna as primary vaccines in July 2022 and August 2022-- I failed to verify if they where given Pfizer vs Moderna vaccine and therefore I administer the Pfizer booster rather then the moderna, from which our facility does not have in stock. Mother was informed of this, I contracted the CDC and verified no adverse effect should occur the patient did no exhibit any signs of distress/experience adverse reactions.
Patient reports headach lasting for one week; On 07Jun21 he was diagnosed with temporal arteritis; This is a spontaneous report from a contactable Nurse. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 01Apr2021 as DOSE NUMBER UNKNOWN, SINGLE (at the age of: 71-year-old) for covid-19 immunization. Medical history included hyperlipidaemia, intracranial aneurysm. The patient's concomitant medications were not reported. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. On 07Jun2021 the patient was diagnosed with temporal arteritis. On 25Jun2021 the patient experienced patient reports headache lasting for one week. The patient was hospitalized for patient reports headach lasting for one week (headache) for 3 and  on 07jun21 he was diagnosed with temporal arteritis (giant cell arteritis) for 3 days. Therapeutic measures were taken as a result of patient reports headach lasting for one week, on 07Jun21 he was diagnosed with temporal arteritis. The outcome of event was recovering.; Sender's Comments: Based on the current limited available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events headache and temporal arteritis cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Initial arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Initial arm pain) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Lung transplant (Double lung transplant.).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Initial arm pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg three times a day. At the time of the report, PAIN IN EXTREMITY (Initial arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-215081 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non-Significant Follow-up received on 19-JUL-2021 and contains no new information
Immediate pain in left shoulder; decreased range of motion; pain localized; some what alleviated by IBUPROFEN. Injection given near top of left shoulder. Pain x 8 weeks.
Patient developed a head to toe body rash and facial swelling approximately 48-72 hrs after she received the vaccine. Began on bilateral legs on 15 Sep and progressed to full body by 16 Sep along with facial swelling.
Patient has dried pustules following sciatic nerve and red rash from waist-left buttock following sciatic nerve. Dx shingles-no pain pustules dried.
Pin point rash developed first on wrist and then spread from neck down to the rest of the body.  The rash lasted one week.  Patient did NOT seek medical care but just took OTC Benedryl.
vomiting; Headache; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program Pfizer First Connect. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced headaches and vomiting on an unspecified date. Outcome of event was unknown.    Information on the Lot/Batch number has been requested
I experienced heart palpitations on 4/11/21 after the vaccination. The day after the vaccination I felt faint and weak. I had a fever of 99.6 and bad chills on 4/10/21. I took Aspirin on 5/19/21 as I was experiencing painful heart palpitations.
he has dementia; This is a spontaneous report from a Pfizer Sponsored Program via a non-contactable consumer (patient's wife) reported for a patient (reporter's husband). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Feb2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in Jan2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient had both doses of the Pfizer COVID-19 vaccine. The 1st dose was last Jan2021 and the 2nd dose was last Feb2021. On an unspecified date of 2021, the patient had dementia. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt reports sinus pressure like headache along with fatigue, and upset stomach within 40 mins of vaccine administration. Also pt reported dry cough that started at night, which she stated could be allergies.
Mother called last week to report  that in the car on the way home from our office the patient  report feeling  light - headed and did have a syncopal episode with brief  (a few  seconds) of LOC . No localized site symptoms. No other SX.
patient had seizure and lightheadedness. she was waiting outside to get air before paramedic came. Drank a pedialyte. Paramedic came and took her to hospital
Early the next morning load buzzing in both ears, I still have it to date   11/01/2023.  I had the buzzing in both ears for a short while after the Covid Vaccine and booster before but in about a week it went away.  I have never had any issues before with this.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  No adverse event was reported. The vial had not undergone any temperature excursion issue. The vial was initially placed in the refrigerator on 01-Mar-2022. Many doses were administered from expired lots due to confusion with the expiration date printed in the label.