chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 82 year old male patient. The patient's pertinent medical history was none and drug allergies were unspecified. Approximately in 2009 (reported as about 6 years ago), the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were unspecified). Concomitant medications were unspecified. On 21-JAN-2015 (reported as 6 years later), the patient had a rash which was diagnosed as zoster on his right arm. The patient sought medical attention and the treatment received was unspecified. The outcome of zoster was reported as not recovered/not resolved. The causality of zoster was not reported. Additional information has been requested.
A nurse reported the occurrence of a possible allergic reaction in a 5 year old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received the fifth injection of Infanrix (lot DTPA586B9). Subsequently, on 4/9/03, the subject developed injection site swelling measuring greater than 4cm and injection site redness. The subject was seen by the physician, who almost admitted the subject to the hospital, because he thought that the subject may have been experiencing an allergic reaction to Infanrix. The possible allergic reaction resolved on 4/17/03. The reporting nurse considered the possible allergic reaction to be related to Infanrix administration.
This spontaneous report as received from a registered nurse (R.N.) refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unspecified dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot # L043213, expiration date: 29-AUG-2017 (dose and route of administration were not specified). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a 7 unspecified patients of unknown ages and genders. Pertinent medical history or concurrent conditions were not provided. On an unspecified dates, the 7 unspecified patients were improperly stored doses of GARDASIL 9 (lot # L011846, expiration date 04-MAR-2017, dose and frequency were not provided). Concomitant medications were not provided. No adverse experiences were reported. Additional information has been requested.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concurrent medical conditions included Drug allergy (Sulfa allergy), Penicillin allergy and Allergy. Concomitant products included DIPHENHYDRAMINE, ZOLPIDEM TARTRATE (AMBIEN), FISH OIL, PROBIOTICS NOS and TURMERIC [CURCUMA LONGA RHIZOME] for an unknown indication.    On 22-Jan-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 IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Treatment information was not provided.   This case was linked to MOD21-050623, US-MODERNATX, INC.-MOD-2021-041005 (E2B Linked Report).; Sender's Comments:  MOD21-050623: US-MODERNATX, INC.-MOD-2021-041005:
This is a spontaneous report obtained from a contactable pharmacist. A female patient of an unspecified age received on 10Oct2018, PREVNAR 13 on an unspecified date, in the arm, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On 18Oct2018, the patient experienced pain in her arm (where injection was given). Treatment was received. Clinical outcome of the adverse event was unknown at time of this report.
Extreme fatigue; Sore arm at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient 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 07Apr2021 at 09:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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 07Apr2021, the patient experienced extreme fatigue and sore arm at injection site ( vaccination site pain). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of extreme fatigue and sore arm at injection site were unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
20 second sz; related to fever;probable febrile sz (temp of 103 R @ time of sz);described as tonic-clonic sz by mom;pt was referred to hosp for eval;blood, urine & CSF culture were obtained pt was given Ceftriaxone & discharged
The pharmacist accidentally administered the MONOVALENT booster instead of the BIVALENT booster
Flu like symptoms, fever, chills, spiking temp. Note: Pt is a merchant seaman and is being treated aboard vessel at present time.
Pt recvd 1st dose of Hep B on 18APR91 & immediately following vax pt exp pain in lt forearm & thumb, a salty taste in mouth, t99; also devel flushing in face & 2 in red area around inject site; h/a;
Administered with vaccine refrigerated for 33 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine refrigerated for 33 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine refrigerated for 33 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine refrigerated for 33 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  The vial was initially stored in the refrigerator from 23-Jan-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by the reporter.
At the site of injection, redness 6 cm X 4 cm, induration 6 cm X 6cm later of the day injection given.  Treated with AUGMENTIN 600es 1 1/2 teaspoon twice a day for 10 days.
Mild itching near injection site; Mild redness near injection site; Red round rash at injection; Mild swelling near injection site; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm), VACCINATION SITE PRURITUS (Mild itching near injection site), VACCINATION SITE ERYTHEMA (Mild redness near injection site), VACCINATION SITE RASH (Red round rash at injection) and VACCINATION SITE SWELLING (Mild swelling near injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concomitant products included FISH OIL (OMEGA 3 [FISH OIL]), ASCORBIC ACID (ESTER-C [ASCORBIC ACID]) and MAGNESIUM GLYCINATE for an unknown indication.    On 30-Mar-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little sore arm). On 06-Apr-2021 at 6:00 PM, the patient experienced VACCINATION SITE PRURITUS (Mild itching near injection site), VACCINATION SITE ERYTHEMA (Mild redness near injection site), VACCINATION SITE RASH (Red round rash at injection) and VACCINATION SITE SWELLING (Mild swelling near injection site). The patient was treated with HYDROCORTISONE (topical) for Itching and Redness, at an unspecified dose and frequency. On 01-Apr-2021, PAIN IN EXTREMITY (Little sore arm) had resolved. On 08-Apr-2021, VACCINATION SITE PRURITUS (Mild itching near injection site), VACCINATION SITE ERYTHEMA (Mild redness near injection site), VACCINATION SITE RASH (Red round rash at injection) and VACCINATION SITE SWELLING (Mild swelling near injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list also included My Kind Organics Women's Once Daily Vitamins, 1 per day, oral for daily maintenance.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter contact details were updated, patient demographics were updated, re and de challenge fields were updated, vaccine facility details were updated, new event; developed red round rash at injection site was added and event outcomes were updated from unknown to recovered/resolved.
Presents for AMS & disorientation, found to be hypoxic, hypotensive, & in acute renal failure. Admit for COVID pneumonia & septic shock. Tx: levophed, dexamethasone, abx, O2. DC to SNU.
low grade fever, and severe chills - shaking all over.... lasted about six hours, went to ER early morning next day; tested for covid and flu a & b - both negative... remained in ER for about 3 hours and then released.
12/20/21 presents to ED for "nausea vomiting and diarrhea" "generalized abdominal pain and progressive weakness". PMHx of "CHF, anxiety, arthritis, A. fib"
Redness and warmth showed up 1 day following injection. Patient reported 3 days following injection to show to pharmacist and it appears as cellulitis, but recommended to see doctor to treat appropriately. Erythema covered most of patient's upper arm, approximately 5 inches x 3 inches. Patient reported no pain or itching.
Patient received covid vaccine x 2. Last dose on 1/27/21. Admitted to Hospital on 8/9/2021 with covid symptom and tested positive for COVID 19 upon admission. Case expired at hospital on 8/17/2021.
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The caller stated that they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use and the doctor at the office wants to know if what else should be done. The office manager stated that they called ever patient the following day and no adverse events were noted, and they performed an antibody test on all of them and the patients antibody numbers were in the 800-900 range.   This case was linked to MOD-2021-415889 (Patient Link).
Employee states swelling to tongue and throat, hives, itching, and now bruises easily. She went to emergency room where she was given Benadryl, Medrol dosepak, and Pepcid.  The only remaining symptom is bruising easily.
Itching, hives started 45 mins after injection, given BENADRYL IV, Simvastatin in ED.
This is a spontaneous report from a contactable consumer. A 79-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on unknown date. Medical history included chemotherapy. The patient's concomitant medications were not reported. The patient experienced localized reaction on left arm and swelling on left arm on an unspecified date with outcome of unknown. Follow-up (19Dec2014): Follow-up attempts completed. No further information expected.
This spontaneous report as received form a consumer refers to her approximately 20 years old son, who was vaccinated with dose 1 GARDASIL (lot# and dose not reported) about a year ago, approximately in 2012. The consumer stated she was told her son only needed one "catch up shot" because of his age. No adverse event reported. The patient did not seek medical attention. Additional information has been requested.
pt recvd vax 12SEP95 & 13SEP95 pt awoke from nap w/fever of 103 & astham like breathing;lab eval revealed inc WBC count & pt was placed on therapy w/Ceftriaxone sodium (Rocephin);tx motrin
Onset of symptoms on 3/26/01 with sore throat and rash. On 3/29/01 had joint swelling, arthralgia but no fever.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administration date 26Oct2021 (Lot number: FD0810) at the age of 45 years as dose 3 (booster), single, administration date 18Mar2021 (Lot number: El3247) as dose 2, single and administration date 25Feb2021 (Lot number: El3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Mar2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Mar2022) positive.   No follow-up attempts are possible. No further information is expected.
Received small pox vaccine on 11/06/2005. Went to ER on 11/26/2004 for retrosternal chest pressure that had begun 11/24/2004. Felt as if someone were sitting on his chest, No nausea, vomiting, or diaphoresis. Symptom: chest pain start 11/24/2004. Comment: retrosternal radiating into arms, no nausea, vomiting, or diaphoresis. 2/15/06 -  Discharge summary reviewed. It states admission date was 11/26/04 and d/c date was 11/27/04. Discharge diagnoses were listed as myocarditis and pericarditis.  He presented to ER with chest pain of sudden onset with associated mild SOB. D/C meds included ASA daily, Lopressor daily, Motrin X 10 days, and Protonix X 10 days. Per information from 60 day follow up, recovery status unknow loss to F/U.
Chronic cluster headache/migraine, nausea/vomiting, appetite loss. One day after, with some relief after over the counter medicines then symptoms returned on October 15 days before second vaccine. After second vaccine series symptoms have not ceased for over 2 months with little relief.
Breakthrough case admission after 2 vaccines ; Pfizer 1/21/21 Lot# EL3249;  Pfizer 2/1/21 lot# EL9267
I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; I had an allergic reaction after the first dose, swollen face, itchy body and face. Headache.; This is a spontaneous report from a contactable consumer (Patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date: was not reported ), dose 1 via an unspecified route of administration, administered in Arm Right on 19May2021 at 13:30 ( Age at vaccination: 50 years) as dose 1, single for covid-19 immunisation. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. The patient was previously diagnosed with COVID-19, and since the vaccination the patient tested for COVID-19. Concomitant medications were not reported. The patient previously took Penicillin, Codeine phosphate (CDOEIN) and acetylsalicylic acid (ASPIRIN E.C) and had Drug allergy. It was reported that she had an allergic reaction after the first dose, swollen face, itchy body and face and headache on 19May2021 at 17:00. The patient underwent lab tests and procedures which included sars-cov-2 test which was negative on 06Apr2021 Nasal Swab. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Injection side paresthesia and numbing,  spreading from injection site (upper left arm) to neck and face, and down arm to fingers.
Injection site (thigh) swelled up and turned bright red. Redness started to spread and lasted over 7 days. Child complained of extreme leg pain and itchiness. Parent was instructed to give child benadryl and cephalexin. Improvement did not begin until day 11 post vaccine.
Presented to ER with CP and just not feeling well - 3 days after getting vaccine - general myalgia. Treated CHF, ruled out MI and encouraged to drink fluids.  Information recieved from medical records states thrombocytopenia.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: unknown (Positive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
RECEIVED BOTH DOSES OF PFIZER COVID19 VACCINES ON 01/30/21 & 02/20/21. ON 02/21/21 WENT TO urgent care COMPLAINING OF DIZZINESS BEGINNING THIS AM EKG THERE SHOWED SINUS WITH 1ST AV BLOCK. ON 02/21/21 WENT TO ER COMPLAINING OF DIZZINESS. DIAGNOSED WITH VERTIGO AND ABNORMAL CTA OF NECK. DISCHARGED AND INSTRUCTED TO FOLLOW UP WITH PCP IN 2 DAYS.
This case was reported by a nurse practitioner and described the occurrence of dizziness in an adult female pt who received hep A vaccine inactivated (Havrix). On 05May04, the pt received a dose of hep a inactivated and hep B recombinant vaccine (Twinrix); dose number not specified). At an unspecified time following the administration of Twinrix, on an unspecified date in 2004, the pt developed dizziness. The outcome of the event resolved on an unspecified date. The relationship to Twinrix was not reported. On 16Jun04, the pt received the first dose of Havrix (lot VHA786A4). Although it was the first dose of Havrix, the dose number in the hep A immunization series was not specified. On 16Jun04, the same day as the admin of Havrix, the pt experienced dizziness and felt out of it. On 17Jun04 the pt experienced a rapid heartbeat and blurred vision. The pt sought medical attention. The events resolved on an unspecified date. The nurse practitioner considered the events to possibly be related to vaccination with Havrix.
12AUG91 mom states pt has severe h/a, holding head & crying; warm to touch-no temp taken; pt taken to ER; 12AUG91 mom reported pt was admitted, t39.4, unresponsive, hard to arouse & limp, pain, vomit; MD felt allerg react to Pertussis;
Patient is a 19 year old military personnel;  on 09/24/2021 received his first dose of Covid-Pfizer at our clinic, on 10/19/2021  the patient went to a local  to finish his covid vaccine series. On 10/21/2021 the patient brought his vaccine records to be updated in the immunization tracking system.  I noticed that the patient records stated that he received Moderna instead of Pfizer for his second dose.  Patient states he felt body aches after receiving his second shot.
Noticed next morning upper arm (shoulder to elbow) red and swollen. Not a noticeable reaction at specific injection site. Swelling was more towards inner arm and elbow than on site of immunization.
Almost immediately, my arm began to throb at the site of injection. Then the pain began to go down my arm to my hand. And my head began to throb. Within the next hour, I had pain from my jaw, down through my neck, and all the way down my arm to my fingertips. It was sharp piercing pain. This pain lasted for 2 days. I began to get more tired as the day went on and I could not lift my arm at all.  I slept most of the day and could not eat or drink very much. I woke up the next morning with a 102 fever, severe nausea (to the point of not being able to eat or drink for almost 3 days). I was on the verge of vomiting. The 102 fever lasted 24 hours, then the fever hovered around 100 to 100.5 for the next 24 hours. On the third day when the fever broke, I had hives. Along with all the symptoms, I had a severe headache on the right side of my head by my right eye and at the base of my skull on the right side. This headache began minutes after the vaccine and continued to get worse. On the third day after the vaccine, Monday, May 23, I went to bed with such a severe headache and a numbness on the tight side of my face below my eye. I honestly thought I would dies of a clot in my sleep. It is now May 330, 10 days later and I still have the headache around my right eye that comes and gos in severity.
flu like symptoms, body ache, temp, naseau, upset stomach, weakness, fatigue, fluctuating blood pressure, lawer face swelling
Information has been received from a licensed practical nurse concerning a 65 year old male consumer who on 27-MAR-2008 was vaccinated IM with 0.65mL of zoster vaccine live (Oka/Merck) (lot # 659326/1824U). Concomitant therapy included allopurinol, ACCUPRIL, THEO-DUR, ezetimibe (+) simvastatin (MSD), and MOBIC. Subsequently, after the vaccination the patient developed pain at the injection site. Medical attention was sought in the office. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
A pre-diluted grey-top Pfizer covid vaccine vial (adult) was further diluted with 1.8 mL of normal saline. Subsequently an over-diluted 0.3 mL vaccine was administered to the patient for his first vaccine. The patient was notified of this, and informed that the CDC recommendation is to receive an additional dose of the vaccine immediately. He returned to the clinic on the same day and received the correct dose/concentration of the vaccine. There were no adverse events or clinical consequences reported.
ON 11-17-2017, AREA AROUND INJECTION SITE WAS SWOLLEN AND RED, WITH NONE HIVES AND TEMP OF 100F. ON 11-20-2017, MOM STATES HIS ARM HAD SWELLING FROM THE INJECTION SITE TO HIS WRIST, DESPITE ELEVATION AND COLD COMPRESS OVER THE WEEKEND. TODAY IS IMPROVED WITH ONLY SLIGHT ITCHING BUT REDNESS AND SWELLING HAS GONE AWAY.