chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach upset; Felt Cold; Headache; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Stomach upset), NASOPHARYNGITIS (Felt Cold) and HEADACHE (Headache) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm hurt). On 14-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), NASOPHARYNGITIS (Felt Cold) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm hurt), ABDOMINAL DISCOMFORT (Stomach upset), NASOPHARYNGITIS (Felt Cold) and HEADACHE (Headache) had not resolved.            No concomitant medication reported. No treatment information reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Patient stated that on 14MAR2021 she woke up with stomach upset, head ache, and she felt cold. These symptoms were better on Monday 15MAR2021 however now they are back on 16MAR2021.   This case was linked to MOD-2021-046111, MOD-2021-046111 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up information received on 15-JUN-2021 contains non-significant information.
This spontaneous report was received from a license practical nurse (L.P.N) concerning a patient of unknown age and gender. It was reported that on 16-JUL-2013 the patient was vaccinated with an expired ZOSTAVAX (lot #0242AE, ex. date 01-APR-2013). Concomitant therapy was not reported. No adverse effect reported. Additional information has been requested.
Difficulty breathing; High blood pressure; Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia since 01-Jan-1995. Concomitant products included LOSARTAN from 01-Jan-2014 to an unknown date and ROSUVASTATIN CALCIUM (CRESTOR) from 01-Jan-2021 to an unknown date for an unknown indication.   On 09-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DYSPNOEA (Difficulty breathing), HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Difficulty breathing) was resolving and HYPERTENSION (High blood pressure), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 165/135 (Inconclusive) 165/135. On an unknown date, Body temperature: 102 (Inconclusive) 102. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided.   This case was linked to MOD-2021-009919 (Patient Link).
Body aches Headache Chills Soreness/redness/swelling at site of vaccine tiredness Nausea
Approximately 3 minutes after pt received her injection and was in the post vaccine observation area, she started feeling tightness in her chest, tingling in her mouth and lips and obvious left sided lip swelling and she notified the EMT observer.  The EMT brought the pt inside the building by the vaccine area where I quickly assessed her and administered 0.3mg of EpiPen AutoInjector.  The pt's lips gradually became more swollen, pt was able to talk and breath.  Pt refused 911 or other escort but agreed to go to the ED herself as she was with her husband.  Despite counseling, pt still refused 911. A public Health RN followed them to the ED and assured they were taken back quickly.  Pt was in the ED being seen within 8 minutes of the epi administration.  I called the ED to check on this pt about 60 minutes later and she was stable and planned to be discharged in a few hours.
Sunday (April 18th) I was exhausted and had a dull headache and no appetite.  I took some Tylenol, drank water and slept all day.  Monday (April 19th) I felt fine.  Tuesday (April 20th) the vaccine site was swollen, hot, itching and red.  I used cortisone cream on the site.  Wednesday (April 21st) the site is better but still itching.  I have been using cortisone cream.    Since this is a new vaccine I wanted to report my symptoms, especially since the injection site had a delayed reaction.
Returned to hosp. that day w/chest pain, vision problems, head pains and feeling like worms were crawling around in my veins! They put me on prednisone steroids.
nauseousness; diarrhea; ended up with horrible fever 102 degree Fahrenheit but went away; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported herself that a female patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: unspecified), via an unspecified route of administration on 05Feb2021 (Friday) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She received first dose (Pfizer-BioNTech COVID-19 Vaccine) on Friday 05Feb2021 and ended up with horrible fever 102-degree Fahrenheit on unknown date in Feb2021 but went away; lasted all night long, she felt fine the next day. On 08Feb2021, (yesterday) she had diarrhoea it was bad, just wondering because she has not had nausea like this, it sorts of hit her this morning. On 09Feb2021, (today) had nauseousness. So, should she get the second dose. The outcome of the adverse event "ended up with horrible fever 102-degree Fahrenheit but went away" was resolved on Feb2021, while outcome of the remaining events was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
headache; COVID 19; loss of smell; loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), COVID-19 (COVID 19), ANOSMIA (loss of smell) and AGEUSIA (loss of taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KD0A) for COVID-19 vaccination.     Concomitant products included VITAMIN C [ASCORBIC ACID], ACETYLSALICYLIC ACID (ASPRIN) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (headache), COVID-19 (COVID 19), ANOSMIA (loss of smell) and AGEUSIA (loss of taste). On 10-Jan-2021, HEADACHE (headache) had resolved. In January 2021, COVID-19 (COVID 19) had resolved. On 20-Jan-2021, ANOSMIA (loss of smell) and AGEUSIA (loss of taste) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Entire Rt arm swollen, hot to touch, hurts to touch. Forearm: swollen reddened, anterior and posterior. Blister 2 1/2 cm by 1.5 cm noted, that has ruptured - skin raw. Indurated area, red, 12cm x 7 1/2 cm. Full limb swollen.
Woke up at approximately 02;30 the night of the vaccination with chills and I suddenly had a problem breathing, I could take regular size breaths but it seemed like there was no oxygen in the breaths, which made it like hardly breathing at all. This lasted approximately 10 minutes as I was getting ready to wake my wife up and possibly call 911, thinking I would soon pass out, it began to subside and then ended.
pt recvd vax 3MAY93 330PM; approx 830PM p/nursing returned to crib; w/in few minutes was pale, eyelids blue, tongue swollen; passed out but still breathing;
Developed multiple erythematous maculopapular and vesicular lesions in the trunk and legs
14 days after the 1st dose I was mindlessly scratching my upper left arm (site of injection), then realized it was itchy, so I pulled up my sleeve and saw a red rash. It may have been there a day or two earlier, but I just didn't notice until it started itching enough to notice. (Or it may have just started on Day 14.) It's not very uncomfortable,  just surprising that it happened so long after the injection, which I wasn't expecting. I was reassured after Googling delayed reactions, though my reaction seems delayed even later than most.
Point of injection swollen, red painful to the touch, hot/cold chills, headache, muscle aches, diarrhea, joint pain.
One week after receiving the first vaccine dose I developed multiple arterial blood clots in my right forearm although I wasn't sure of that at the time. I had intense pain in my right forearm which subsided after ~30 minutes. The condition improved, however, my hand would ache and turn pale from time to time. Two days later I was to have a previously scheduled surgery on my right hand. The doctor could not find a pulse and sent me to the emergency room where I had an ultrasound and immediate surgery to remove the clots which was successful. After surgery the surgeon indicated that he believed the clots had been there for a while based on their hardness, and did not think they were related to the vaccine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021 at 9:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 3:44 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.29 for dose administered on 31-Mar-2021 and 69.89 for dose administered on 03-Nov-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021.  Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 05-Nov-2021. Product moved to clinic on 03-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
This case was reported by a healthcare professional and described the occurrence of full body rash in a 65-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 25 September 2010 at 08:50 the subject received unspecified dose of FLULAVAL (.5 ml, unknown, left arm). On 25 September 2010, approximately 5 hours after vaccination with FLULAVAL, the subject experienced full body rash. The subject was instructed by his physician to treat it with BENADRYL. At the time of reporting the outcome of the full body rash was unspecified. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. Follow-up information received on 02 November 2010 indicated that the event of full body rash occurred on 25 September 2010 (the day of vaccination with FLULAVAL) and ended the same day. The event was considered to be resolved. Additionally, it was noted that FLULAVAL was given intramuscularly. Concurrent medications included Ramipril, Metoprolol, Metformin HCl, LIPITOR, ACTOS, TUSSIONEX Pennkinetic, Vitamin B-12, SLO-NIACIN, Multivitamins and Aspirin.
Soreness at injection site, large area of redness and heat at injections site that is still visible today where it was, fever and body aches for 2 days
fainting; chills; fever; This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number AC79X, expiry date 17th October 2021) for prophylaxis.   On 31st January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st February 2020, 1 days after receiving Shingrix, the patient experienced chills and fever. On 2nd February 2020, the patient experienced fainting (serious criteria GSK medically significant). On 2nd February 2020, the outcome of the fainting was recovered/resolved. On an unknown date, the outcome of the chills and fever were recovered/resolved.   It was unknown if the reporter considered the fainting, chills and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 58 or 59 years old at time of vaccination. The patient received Shingrix on left arm and experienced chills and fever. She fainted for a couple of seconds two days after getting the first dose of Shingrix. The patient was concerned about whether she should get the 2nd dose, The reporter consented to follow up.
Patient stated arm was very sore the first week. Patient stated arm/shoulder is achy, arm feels heavy and has discomfort, at times, down to elbow or wrist. Patient denies any decrease in range of motion of arm/shoulder. Arm is not sore to external touch. Patient states sleeping on arm makes symptoms worse as well as the repetitive arm motions she does at work. Patient says OTC meds does not greatly improve symptoms. She says rubbing her arm or massaging it makes it feel some better.  Overall, discomfort in arm has decreased this past week. Patient denies ever having redness, rash, swelling, or tingling of the arm. Patient has a doctor's appointment coming up in a few weeks and will discuss with her doctor if condition is not better
Patient had a big bruise and was sore for days, to this day the bruise is still on the patient's arm but the pain has been gone. Customer is afraid to go back to get her second dose.
patient experienced muscle pain from the shot for 5 to 7 days before it led to shoulder pain with restriction of motion.  Range of motion in shoulder is decreased and pain from arm to shoulder when arm is held in certain orientations.
This spontaneous prospective pregnancy report was received from a 25 years old female consumer regarding herself. Patient had no pertinent medical history and drug reactions or allergies. On 15-NOV-2012, the patient was vaccinated with her first and only dose of GARDASIL (lot#, dose and route not reported). No concomitant medications were reported. Subsequently on 28-NOV-2012, the patient found out that she was pregnant with an LPM of 28-OCT-2012 and an EDD of 04-AUG-13. She was not going to have the second or third shot until the pregnancy was completed. No treatment was given. No laboratory test were performed. Patient sought medical attention (called the Healthcare professional). No adverse reactions were reported. Initial exposure to GARDASIL was at 2 weeks. Additional information has been requested.
18 year old male presents today c/o rash on chest area that has been ongoing for the past 2weeks. Per pt states that he first noted the rash on the nipple and spread slightly to around the nipple area. Pt states that he has noted some itching, intermittent discomfort, however, denies any pain. Pt denies any fever, no body aches, no other lesions elsewhere. Pt did have varicella vaccine placed on 5/22 and about 1 week later rash was noted. Patient currently denies any other complaints or concerns.
Vaccine administered at left leg; MILD BODY ACHES; FATIGUE; This is a spontaneous report received from a contactable consumer, the patient. A 54-years-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206 via an unspecified route of administration in left leg on 18Mar2021, 04:30 PM, (at the age of 54 years old) as a single dose for COVID-19 immunisation. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in right arm on 25Feb2021,16:30, (at the age of 54 years) as a single dose, for COVID-19 immunisation. Medical history of the patient included drug allergy (Allergies to NYSTATIN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Patient received antibiotics within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar 2021 the patient experienced mild body aches and fatigue. The vaccine was administered in left leg (Vaccine administered at inappropriate site). No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events body aches and fatigue was not recovered and vaccine administered at inappropriate site was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
pt recv vax 15JUN95 & pt devel 4-5 lesions;
Urticaria; This non-serious spontaneous case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2317412-1. The original narrative from the sender is as below:  Pt. had the above vaccines, awakened 24hrs later with hives over entire body, went to ER and received steroids and antihistamine. Resolved within 2 days. Mom had also given regular whole milk the same day as shots because of the formula shortage. Possible reaction to milk
No other AE; Improper storage of product in use; This spontaneous report was received from medical assistant and refers to a 14-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent.  On 13-JUN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection, unk, lot #W024971, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 12.45 Fahrenheit degrees (F) for 20 minutes, previous temperature excursion was reported: 42.31 F for 36 hours and 35 minutes.  There were no adverse events reported (no adverse event).  This is one of several reports received from the same reporter.
I have always had normal Blood Pressure 124/78 I now have continual readings of 168/104; Pfizer Dose Number: 1 30Mar2021/ Pfizer Dose Number:2 14Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 at 12:00 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot number: unknown, Vaccine location: Left arm, Vaccine administration time: 12:00 pm), administration date: 30Mar2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Apr2021 at 12:00, outcome "unknown", described as "Pfizer Dose Number: 1 30Mar2021/ Pfizer Dose Number:2 14Apr2021"; BLOOD PRESSURE INCREASED (disability, medically significant) with onset 10Oct2022 at 12:00, outcome "not recovered", described as "I have always had normal Blood Pressure 124/78 I now have continual readings of 168/104". The event "i have always had normal blood pressure 124/78 i now have continual readings of 168/104" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 168/104, notes: I now have continual readings of 168/104; (unspecified date) 124/78, notes: I have always had normal Blood Pressure 124/78; SARS-CoV-2 test: (20Jan2022) Positive, notes: Nasal Swab; Weight: (unspecified date) Normal, notes: I am normal weight and activity. Therapeutic measures were taken as a result of blood pressure increased.  Clinical course: The patient did not have any other medical history or known allergy. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. The patient did not have COVID-19 prior vaccination. The patient was tested for COVID-19 post vaccination which included nasal swab. The patient has always had normal Blood Pressure 124/78. She now had continual readings of 168/104. She was normal weight and activity. This had to be what caused her new issue and need of medication. Now had to take blood pressure meds. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. The case was reported as serious (Disabling/Incapacitating).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt devel rash on back of neck & face, some on rt hand;consulted w/MD pt was taken to office;dx probable flushing of skin secondary to crying per MD