chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer expire vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expire vaccine) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expire vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expire vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. Reporter stated that no treatment was given to the patients.  Reporter stated that vaccine was stored in freezer and took out one to two vials and placed in fridge each day as needed. The pharmacist administered expired modern vaccine that was given as booster shot to the patient. This was among one of the case reported for the 500 patients.
Patient felt dizzy and needed to sit down after receiving Adacel and Havrix.  Patient seemed to lose consciousness, and appeared to convulse as she came to.  911 was called and EMS arrived quickly.  EMS recommended the patient go to the hospital.  Patient's mother returned to pharmacy a few hours later and reported that patient was fine and was told she had a vasovagal reaction.
pt recvd vax;elev INR results;pharmacist rpts that pt Coumadin dose was dec in response to elev in INR;
May 28, 2021: post 2nd vaccine: muscle pain, stiffness, swelling.
This spontaneous report as received from a nurse via a company representative  refers to a 27 year old female patient. The patient's current conditions or medical history were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiration date were not provided). On an unknown date, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiration date were not provided). On unknown date, the patient was vaccinated with the third dose of GARDASIL (dose, route, lot number and expiration date were not provided). On an unknown date in 2014, reported as within the last few days, after the patient had received all three GARDASIL injections she had an adverse experience, the patient had first gone to an unspecified urgent care within the last few days and complained of chest pains, numbness in an unspecified part of her body and a headache. Then on 05-MAR-2014, reported as yesterday, the patient went into the clinic to be prescribed treatment for her adverse experience because the urgent care could not identify what was wrong with the patient. At the time of the report outcome of chest pain, numbness and headache was unknown. Additional information has been requested.
None - The vaccine was expired on 9/5/2022 so the vaccine was subpotent.
Severe itching then hives to chest, arms and face after 45 minutes from injection. Brought to emergency room and given Benadryl 25mg p.o.
Information has been received from a certified medical assistant concerning a 66 year old female with blood pressure high, hyperlipidaemia, rhinitis allergic, penicillin allergy and drug hypersensitivities to morphine sulfate, hydrochlorothiazide (HCTZ), atorvastatin calcium (ATORVASTATIN), ibuprofen, benazepril hydrochloride and gemfibrozil who on 03-APR-2008, was vaccinated IM with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot# 656233/0200U). Concomitant therapy included valsartan (PROVAS (valsartan)). Later that same day, the patient experienced bruising, redness and swelling of the left upper arm injection site. She was treated with aspirin and ice. The area worsened overnight and she went to the emergency room on 04-APR-2008. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 7/30/2008.  Information has been received from a certified medical assistant and medical records concerning a 66 year old female with blood pressure high, hyperlipidaemia, rhinitis allergic, penicillin allergy, gastroesophageal reflux disease (GERD), irritable bowel syndrome (IRS) and drug hypersensitivities to morphine sulfate, hydrochlorothiazide (HCTZ), ATORVASTATIN, ibuprofen, benazepril hydrochloride and gemfibrozil, past surgical history of tonaillectomy, hysterectomy, previous knee surgery and a breast biopsy and a history of endometriosis who on 03-APR-2008 AT 10:30, was vaccinated IM into the deltoid with a first 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 656233/0200U).  Concomitant therapy included PROVAS (valsartan).  Later that same day, the patient experienced bruising, redness and swelling of the left upper arm injection site.  She was treated with aspirin and ice.  The area worsened overnight and she went to the emergency room on 04-APR-2008.  On 04-APR-2008 at 12:30, the patient experienced a local reaction including pain and an urticaria type appearance.  A physical examination done in the ER was reported as left tingling to the distal extremity.  Pulse and perfusion were intact.  There was some splotchy erythema around the area of the upper left arm.  A diagnosis of local allergic reaction was made.  The patient began taking BENADRYL and a prescription for PREDNISONE was given to the patient.  The patient will recheck her arm in 24 hours and if symptoms persist or increase she will return to the ER.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  This is one of two reports from the same source.  Additional information has been requested.
47 yo male complained of generalized chest muscle tightness approximately 16 minutes after receiving Moderna booster. History of similar reaction after last Moderna dose that resolved without medical intervention. Self-reported history of anxiety disorder currently treated with medication. Vitals were taken at onset around 2:20pm: BP 152/98, HR 111, O2 99. Denied shortness of breath or lightheadedness. Breathing was unlabored and he was alert throughout entire encounter. Patient was visibly anxious throughout encounter.  Patient was given an ice pack and encouraged to drink water. He refused crackers and stated that he ate earlier. Laid patient in the supine position which improved his symptoms significantly. He stayed under observation for 1 hour as his symptoms would intermittently improve and then return. Vitals were taken periodically.   Vitals: 2:30pm: 152/98, HR 108, O2 99.  2:50: 152/98, HR 96, O2 99.  3:00: 150/96, HR 99, O2 100 3:10: 138/88, HR 88, O2 99.  3:25: 132/88, HR 86, O2 100.   He was discharged after he reported feeling much better and vitals were stable. Vitals taken before discharge at 3:25pm: 132/88, HR 86, O2 100. Advised patient to continue to monitor symptoms and seek medical attention if symptoms return, worsen, or fail to improve.
Within 12-15 hours of vaccinations with (1) Hep B, (2) DTaP, (3) IPV, and (4) Pneumovax patient had slight rash of race (while later resolved) and aching in both calf muscles of lower legs and didn't want to to go school. Some improved on 8/26/07.
I had shingles, extreme nerve pain and nerve damage. I was treated with gabapentin. I also had an EKG and a echocardiogram which showed minimal cardiac infusion.
pt developed symptoms the same night of given vaccines. took tylenol sunday for pain and icing as well. has not taken any other medicines until today 07/06/23; couseled to continue supportive care of icing and tylenol or advil for the swelling. some itching at injection site. may use benadryl; slight headache this morning 07/06/23 8am;
Information has been received from a registered nurse concerning a female employee who in 1998 was vaccinated with varicella virus vaccine live. Subsequently, a "recent titer failed to detect seroconversion. It was unknown whether the pt sought medical attention. Additional info has been reqeusted.
Information has been received from a physician's assistant concerning a female who about two weeks ago, on approximately 13-JUL-2009, was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). It was reported that after receiving the vaccine, the patient became lightheaded and had to lie down. The patient sought unspecified medical attention. Additional information has been requested.
This reports concern a 65 years old male pt who experienced swollen eyes, itchy rash, swollen lips, temperature elevation and lethargy after receiving the fluvirin vaccination on 11/13/2001. On 11/13/2001, the pt received the Fluvirin vaccination and on 11/14/2001 he developed the symptoms mentioned earlier which lasted 5 days. On 11/14/2001, the pt was administered 10mg Loratadine for 7 days to treat his symptoms. The pt recovered on 11/19/2001. There was insufficient info to determine the reporter's causality assessment. Following internal review on 03/18/2002, this event was upgraded to serious.
I received my vaccine on 05/23/2022. There was no immediate reaction. The following day my arm where I received the vaccine was sore. Each day after I had gotten better. On the morning of 06/19/2022 I woke up around 7 AM with a scratchy throat, minor headache and cough. I went to work did two rapid test which was negative. I then did a PCR and was diagnosed with Covid. I was prescribed PAXLOVID and since taking the medication symptoms have subsided.
Fever 10/30. 10/31 rashes but fever gone and watery blisters. The back covered with lesion. More than 50 lesions.
Shortness of Breath; Swelling; Rash; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of Breath), SWELLING (Swelling), RASH (Rash) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DYSPNOEA (Shortness of Breath), SWELLING (Swelling), RASH (Rash) and FATIGUE (Fatigue). The patient was treated with FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K) at a dose of UNK dosage form. At the time of the report, DYSPNOEA (Shortness of Breath), SWELLING (Swelling), RASH (Rash) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Pt didn't want to provide contact info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Woke up and my lips werecompletely swollen, I have had fillersin the past. Very painful experience forme; Fevers; Tons of pain; I was very sick the first night; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 03Apr2021 at 08:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy to nuts (allergic to cashews and pistachios) and COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), fish oil (MANUFACTURER UNKNOWN) and b vitamins (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was 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 03Apr2021 at 16:00, the patient was very sick the first night, fevers with tons of pain. On 05Apr2021, on Monday morning, the patient woke up and lips were completely swollen, the patient had fillers in the past and had a very painful experience. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of events and included treatment with benadryl and steroid. The clinical outcome of the events pain, sickness, swollen lips and fevers were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician and a certified medical assistant, via a company representative, refers to a male patient of unknown age. No information on medical history, concurrent conditions or concomitant drugs was provided. On an unknown date the patient was vaccinated with ZOSTAVAX; dose, route and site of administration, lot# and expiration date not provided. On an unknown date, two weeks after receiving ZOSTAVAX, the patient developed polymyalgia rheumatica. The patient sought medical attention, via visiting physician's office. The outcome of the polymyalgia rheumatica was unknown. Relatedness between vaccination with ZOSTAVAX and adverse event was not reported. Additional information has been requested.
Woke up with a very swollen arm, arm is firm, and red from the shoulder to the elbow. And very hot. Also experiencing itching.
Patient passed out, complained of being lightheaded and having loss of vision post 2nd COVID-109 vaccine.  EMS was called.  EMS evaluated patient and recommended going to the hospital for observation.   Patient's father denied transfer to hospital and patient left with father to go home.
Moderna COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department with tenderness and increasing redness at injection site. On exam there is no streaking but affected area is hot to the touch. Patient denies itching and hives. Temperature 37.4 degrees Celsius. Patient diagnosed with cellulitis, prescribed antibiotics, and discharged home stable with follow-up in place.
SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (SORE ARM) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Sinus infection (BELIEVED FROM CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM). At the time of the report, VACCINATION SITE PAIN (SORE ARM) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment drugs were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080504:Dose 2
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 6 (booster), single (Lot number: 8679), in left arm and on 28Apr2023 as dose 7 (booster), single (Lot number: gv3268) at the age of 69 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre diabetes" (unspecified if ongoing); "left and right partial bundle branch blocks" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neproxin, reaction(s): "Drug Allergy: neproxin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
5 minutes after shot, pt slid from chair and fell backward; witness said pt suffered from mild seizure; paramedics were called and pt was assessed; pt has no history of epilepsy but did have a fainting episode years ago when giving blood; he also stated he hasn't eaten or drank anything today; he declined transport to hospital but is getting a parent to pick him up; paramedics highly suggested that parent take him to the ER or urgent care
Patient's wife stated that the patient experience reddness, swelling, bruising (black and blue), pain, and site was hot to the touch. Pt went to doctor's office and was prescribed cephalexin since he was told it was infected. Script was filled on 3/2/20.
sore throat; runny nose; feels like a cold; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and NASOPHARYNGITIS (feels like a cold) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concurrent medical conditions included Cholesterol. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and NASOPHARYNGITIS (feels like a cold). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (runny nose) and NASOPHARYNGITIS (feels like a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included 3 blood pressure medications,  for cholesterol and Eliquis- blood thinner
MCV4 vaccine given morning of April 29, 2008 and patient played soccer that evening. Patient presented to school nurse's office April 30th with a raised, pruritic rash on face, neck, face, and legs. Patient indicated that rash started evening of April 29th. Oral Benadryl was given as needed. Patient was not seen by a physician, no diagnosis was given. Rash completed resolved after 1 week.
The patient later tested positive for COVID-19 and requires treatment at a hospital.; The patient later tested positive for COVID-19 and requires treatment at a hospital.; This is a spontaneous report from a non-contactable Consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown, whether the patient was pregnant or not. It was unknown, whether the patient had COVID prior vaccination. On an unspecified date, the patient later tested positive for COVID-19 and requires treatment at a hospital. The patient was hospitalised for event. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient was tested post vaccination. Outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot obtained. No further information is expected.
Patient was administered FLUZONE (lot UT440AA, exp 30 June 2012) and immediately felt ill. The patient began to have difficulty taking breaths and went limp. An EPIPEN Jr. was administered at which point the patient came to but remained lethargic/somnolent. Sent to ER with EMTs.
Information has been received from a nurse practitioner concerning a 25 year old female inpatient with obesity, other unspecified conditions, latex allergy, morphine allergy, and multiple other medication allergies, who on 12/28/2005 was vaccinated subcutaneously in the left arm with a dose of Pneumococcal 23v polysaccharide vaccine (lot unknown) and influenza virus vaccine (unspecified), prior to discharge from the hospital. Patient was in the hospital for an unspecified reason. Nurse reported that the patient was obese and the vaccination was given subcutaneously because the needle was not long enough. Shortly after vaccination, on 12/28/2005, the patient developed injection site itching, chills, shaking and fever of 39.2 degrees C. After discharge, on 1/3/2006, she was seen at the clinic with a 5cm x 3 cm blister. The blister was opened and now the patient has an open wound and big hole. The wound is being packed daily and the patient has received cephalexin (Keflex) and pain pills (unspecified). The patients present status was reported as not recovered. No product quality complaint was involved. Injection site itching, chills, shaking, fever of 39.2 degree C and blister 5cm x 3cm were considered to be disabling and an other important medical event (OMIC). Additional information has been requested.
Pt reported swelling and hardness at site (L) arm of inj, progressed down arm to below elbow. Described as hard, warm, very tender, entire circumference of affected area lasting 5-6 days. Did not seek medical attention while affected.
Red confluent rash with whelts developed about 20 hours from receiving his 4 year old immunizations (DTaP, IPF and MMR). Extremely itchy.