chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller is a patient who reported receiving PNEUMOVAX 23 vaccine on 26MAY2022 and reports that 4 hours after administration, she experienced reaction to the vaccine  which included redness, itching and swollen arm.; Caller is a patient who reported receiving PNEUMOVAX 23 vaccine on 26MAY2022 and reports that 4 hours after administration, she experienced reaction to the vaccine  which included redness, itching and swollen arm.; swollen arm. Some symtomps went down all the way to the elbow; Patient's body temperature was "fine" at 97.7F but experienced fever and chills.; Patient's body temperature was "fine" at 97.7F but experienced fever and chills.; This spontaneous report was received from a female consumer of unknown age referring to herself.  The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date (reported as in the past), she received a dose of pneumococcal vaccine conj 7V (CRM197) (PREVNAR) without experienced any symptom; and 2 doses of tozinameran (PFIZER BIONTECH COVID-19 VACCINE) (also reported as Pfizer's COVID-19 vaccine) that cause a little soreness but no other issue.  On 26-MAY-2022, the patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (valid lot #U034712, expiration date: 30-JUL-2023) in an arm (unspecified) (also reported as ''too shallow'' administration) (strength and route of administration were not provided) as routine vaccination.  Then, on the same date, after 4 hours of the administration of the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the subject experienced a reaction to the vaccine which included redness (vaccination site erythema), itching (vaccination site pruritus) and swollen arm (vaccination site swelling). Some symptoms traveled down to the elbow and she "could not move her arm". Furthermore, it was reported that her body temperature was "fine" at 97.7 Fahrenheit (F) but experienced fever (pyrexia) and chills. Consequently, the patient's nurse advised her to took paracetamol (TYLENOL), diphenhydramine (BENADRYL) and use ice packs to help to alleviate or improve some symptoms related to itching, however not all the symptoms went away. At the reporting time, the subject was recovering from all the events.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events vaccination site erythema, vaccination site pruritus and vaccination site swelling, was considered as related, and regarding the events pyrexia and chills the causality was not provided.
Three days after the vaccine I woke up and the back of my throat and my tongue really hurt. My throat and tongue and soft palate were covered in blisters. They were very painful and it was hard to swallow. She recommended seeing my dentist. They both thought it was a viral infection. I was prescribed a mouth rinse Chlorohexidine and recommended combination of Mylanta and Benadryl.  After almost two weeks I just have one blister left on the side of my tongue but the rest are healed up. I have no more pain.
From initial information received on 08/31/2004 from a physician regarding an adverse event occurring in the USA, it was reported fever, injection site swelling, injection site inflammation, injection site induration.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 21-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant product use was not provided by the reporter.  Staff gave patients vaccines past the use date of 18-Jun-2023.  On 28-Jun-2023, 9 doses were administered at administration site 1.   Treatment information was not provided.  This case contains information for the 22nd patient out of 47 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received suspect vaccine details added, iNarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
she received her 3rd dose of pfizer covid vaccine; she received her 3rd dose of pfizer covid vaccine; soreness; swelling ar the injection site; little redness at the injection site; 'itching like crazy'; hard to the touch; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 72-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on 31Aug2021 (Batch/Lot number and Expiration date was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) for covid-19 immunisation. On an unspecified date, the patient experienced she received her 3rd dose of pfizer covid vaccine, soreness, swelling at the injection site, little redness at the injection site, itching like crazy and hard to the touch. The patient stated that she received her 3rd dose of pfizer covid vaccine on tuesday (31Aug) and yesterday developed soreness, swelling and a little redness at the injection site. Also reported that the area was hard to the touch and was 'itching like crazy'. States today symptoms remain the same. She was wondering what to do and if this is normal. Stated that she called last night and spoke to an agent however the agents language was broken, and she was not sure how much information was captured. It was explained to her that we are unable to provide tx recommendations and referred to hcp if it persists or become concerning. The clinical outcome of the events was unknown.  Information about Lot/Batch number has been requested.
Left armpit and left lateral armpit swelling and pain began 3/29/22 morning. Continued for the next 3 days. No fever. Applied ice prn for comfort. Gave Children?s Ibuprofen 10ml on 3/29/22 at 2100 and 3/30/22 at 0800 and 2100 Contacted Dr. to report these symptoms on 3/29/22 1900.
mild runny nose; This is a spontaneous report from a Pfizer-sponsored program. A contactable 34-year-old female nurse, who is also the patient, reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient experienced mild runny nose. The patient reported also that her son was just diagnosed with COVID and she just took a test on an unspecified date but was negative. She was still experiencing a mild runny nose. At the time of the report, the patient had not recovered from the mild runny nose whereas the outcome of the exposure to COVID-19 was unknown.  The Information on the lot/batch number has been requested.
Swelling at vaccination site; my arm was sore; hotness where shot was given; red rash encircling the area where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of   in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     Concurrent medical conditions included White blood cell abnormalities.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
lightheadedness 3d after vax and desquamating bilat hand rash 6d after vax
Patient called stored stating that after she received BOOSTRIX shot her arm was very painful to the point she cannot move it and has to go to the doctor.
Mother reports "severe/projectile vomiting" 30 min. after vaccines given. Pt. vomited 15 times and 1 diarrhea diaper. Afebrile.
Client was vaccinated with Pfizer vaccines for Covid on 3/7 and 3/29, 2021.  Symptoms started 10/5 - continuous coughing.  Had monoclonal antibody infusion at Hospital on 10/9 with symptom improvement 24 hrs. later.  Reported as a case of breakthrough Covid in a fully vaccinated person.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 02-AUG-2013, patient received improperly stored VARIVAX dose 2, from batch/lot # H018451 (expiry date, dose units, route and anatomical location were not specified). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M040412, expiration date 30-JUN-2019 (single doses; dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 degrees Celsius for 8 hours and 26 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA012921.
On March 7, 2009, I noticed a rash on my back (right side).  Two days later, the rash was spreading with blisters and itching.  Saw doctor, confirmed I had the worse case of shingles he had ever seen!!  Continue to deal with - and permanent scaring.
Patient was screened and stated he did not receive the COVID vaccine and the MD ordered the Moderna vaccine (per hospital supply). Patient was consented and given the vaccine dose.  Then it was discovered that the patient already had completed the COVID-19 vaccine series having received 2 doses of Pfizer on 4/12/2021 and 5/3/2021. Patient did not have any adverse effects noted.
Difficulty breathing; Dizziness; heart beating fast; Heart racing; Legs shaking; Blurred vision; Red rash patches on left hand, right hand and knuckle; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), HEART RATE INCREASED (heart beating fast), PALPITATIONS (Heart racing) and TREMOR (Legs shaking) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (TRI ESTARYLLA) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), HEART RATE INCREASED (heart beating fast), PALPITATIONS (Heart racing), TREMOR (Legs shaking), VISION BLURRED (Blurred vision) and RASH ERYTHEMATOUS (Red rash patches on left hand, right hand and knuckle). On 14-Apr-2021, DYSPNOEA (Difficulty breathing), DIZZINESS (Dizziness), HEART RATE INCREASED (heart beating fast), PALPITATIONS (Heart racing), TREMOR (Legs shaking) and VISION BLURRED (Blurred vision) had resolved. On 21-Apr-2021, RASH ERYTHEMATOUS (Red rash patches on left hand, right hand and knuckle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (unknown route and strength) lot # K009953 with expiry date of 03-APR-2016 or lot # K004989 with expiry date of 14-NOV-2015. No adverse effects were reported. The nurse confirmed that no vaccines were administered after the labeled expiration dates. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Speech difficulty and bilateral lower extremity tingling and numbness after COVID-19 vaccine administration. Symptoms improved at ED with IV Hydration
Chills, fever, nausea, headache, out of breath, foggy, and exhaustion just hours after receiving second dose of moderna vaccination.
pt varicella antibody titer was 1.24, was subsequently exposed to individual who had been vaccinated w/ varivax;pt devel chicken pox on 14dec95;
Headache, Myalgia, Fever fatigue Narrative: Employee reported fever, myalgia, and fatigue. Resulted in unable to work 3/4 and 3/5/2021.
1/26/2021:  Fatigue, Soreness & headache; Severe chills (0120 a.m.); Body aches, joint pain, nausea/vomiting, pale/cool/diaphoretic skin, chest tightness and lightheaded/Dizziness. Bed rest for remainder of day. 1/27/2021:  Continued fatigue, soreness, more lightheaded/dizziness, onset of sustained Ventricular Tachycardia around 1400 hours,Tx at work with Advanced Cardiac Life Support, Emergency Transport to Emergency Room, Amiodarone Drip/Oxygen/IV-TKO,EKG. Emergency Room-Continue Cardiac Care with continued IV drip and Amiodarone. Echo-Cardiogram and admit to Hospital. 1/28/2021:  Cont. Hospitalization-Cardiac Cath,monitoring on ICC floor. Hospitalization stay 1/27/2021-02/03/2021. Transfer to another hosp by ambulance. Transferred to Hospital (1/30/21). Further treatment and monitoring. Cardiology tests and procedures (Cardiac MRI, Electro-Physiological Study and defibrillator insertion). Discharged on 2/3/2021. Still under doctor's care during recovery for next 5 weeks and ongoing into the future.
WRONG DOSE GIVEN- SHOULD HAVE RECEIVED AGE 5-11, RECEIVED AGE 12+ DOSAGE AND FORMULATION.
Redness at injection site of MMRV. Redness developed the day after the vaccine 2.5 cm x 3.75 cm.
Headache, Myalgia, Arthralgia, Fever, eyes burning, fatigue Narrative:  Low grade fever off and on x2 days, body aches, joint pain, fatigue, headache (has history of migraines but states this was different), eyes felt like they were burning, vision was not impaired, also had a decrease in appetite. Did not take any medications.
pt recvd flu vax 4NOV93 @ 3AM; 5NOV93 underside of lt arm inflammed; seen by MD;
Case number PHEH2014US004437, is a spontaneous initial report from a nurse received on 03 Mar 2014, with a follow up received on 10 Mar 2014. This report refers to a 20-year-old female patient. Past medical history and concomitant medications were not reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: not reported) without being reconstituted with MenA, intramuscularly on 18 Dec 2013. No adverse event was reported following the administration error. Follow up received from nurse on 10 Mar 2014: Updated patient demographics (date of birth, age and gender) and date of vaccine administration.
Rash on left upper arm around injection site and up to shoulder.  Rash is itchy and warm to touch.    Raised area under skin adjacent to injection site.
Woke up at 1 AM shivering so bad, hardly could put on a pair of socks for my cold feet. Shivered for 3 hours, then fell asleep. Woke up at 4 AM with 102 fever, took Tylenol. Fell asleep woke up at 6:30 could hardly get out of bed, to take dog outside.  Took me three days to get back to normal.
Patient transferred from hospital with fever and rash. Patient got flu shot 1st time 4 weeks prior. Patient developed cough. Antibiotics given. Approximately 1.5 weeks PTA, patient noticed lesions on right hip and pruritic area on back of right arm. Patient on prednisone. Systemic vasculitis 2 hours to flu vaccine. Still rash on 12/6/02. Nurse follow up on 05/26/04: "fever, systemic lupus erythematosus, Cough." Medical records state purpura, anemia. msv
I have been diagnosed with ulcerative colitis.  Before my Covid vaccine shot, I had never had one symptom.  I get my shot and I start having lower back pain, blood in my stool and alot of blood when defecating.  Now I have to take Mesalamine everyday.  Side note:  I was sick with Covid January 8th-28th, not hospitalized, recovered normally.  Healthy afterward and no long hauler symptoms.  The ulcerative colitis issues started after the first shot.
Nausea, headache, fatigue, hot flashes-(no actual fever), diarrhea. No treatment required.
Fever started on 1/7 at around 7:00am, highest was 100.2, Took tylenol Nausea, headache, body aches as well
The patient stated they had previous experiences of 'passing out' from vaccinations. Shortly after receiving both vaccinations ( roughly 5 minutes), the patient stated they felt like they were going to pass out. The patient did pass out, but was breathing and became conscious shortly after. Their blood pressure was taken, and EMS was contacted. EMS did an evaluation of the patient, at which point the patient refused transportation to the emergency room for further evaluation. The patient remained in the pharmacy after the incident for > 30 minutes. A family member was with them and saw that they got home safely. The patient has no prior pertinent PMG; i.e. history of seizure, TBI, etc.
His son having back to back seizure; His son having back to back seizure; This is a spontaneous report from a contactable consumer (patient's father).   A male patient of an unspecified age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included seizure (son already had a history of seizure). The patient's concomitant medications were not reported. On an unspecified date patient received 1st dose of BNT162B2 for covid-19 immunisation. On an unspecified date reporter son having back to back seizure after getting the second shot of Pfizer Covid Vaccine. Patient got VNS prior to getting shot. Son already had a history of seizure. The caller is asking does this medicine cause more seizure. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
VERTIGO, IMPAIRED BALANCE ON WALKING, MOVING. NAUSEA, WEAKNESS IN LEGS, FATIGUE
Hours after administration (Fri afternoon)-Body aches, chills  Next morning (Saturday)-body aches, chills, itching hives, chest pressure, SOB, light headed, fatigue (Sunday/Monday)-body aches, chills, itching hives, chest pressure, SOB, light headed, fatigue
Day after shot, same arm developed a large red patch, I then got sore throat cough & runny nose, all this lasted 10 days. Am just about to get well.
Cough, body aches. Pt given antibiotics by another primary care physician, inhaler.
Tested positive for COVID-19; unknown vaccination schedule, might have been outside of window; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown vaccination schedule, might have been outside of window) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown vaccination schedule, might have been outside of window). On 06-Nov-2021, the patient experienced COVID-19 (Tested positive for COVID-19). In September 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (unknown vaccination schedule, might have been outside of window) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 06-Nov-2021, SARS-CoV-2 test positive.      No Concomitant and Treatment medication were reported. This case of inappropriate schedule of product administration concerns a 49-year-old, female patient with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The event occurred at least 1 month after the second dose of Moderna COVID-19 vaccine (exact day of second dose unknown). The rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Information has been received from a 60 year old female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient received vaccine for shingles and arm got very hot and bruised.  No medical attention was sought.  No further information is available.