chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Pfizer vaccine administered to the patient had expired 3/17/2022 and was administered to the patient on 3/24/2022. The patient did not experience any adverse events
Administered pfizer covid-19 updated booster for 5-11 yo and patient was fine for a minute, stood up and fainted. Mother half caught her and was unsure if she bumped her head. Mother stated she has had vasovagal syncopy in the past but never with an immunization. We put patients Legs above her head and gave her an ice pack and some cold water. She had eaten prior to the appt. Within 5 minutes after fainting event, she was doing okay and walking again.
Pt called office states (L)arm is swollen red warm to touch. Instructed to come to office for Dr to check arm. Comments: Pt. had pneumovax administered l deltoid yesterday during office visit.
28OCT98 day of vax later @ home exp rash/redness @ site of inj;also hives on chest & back lasted for 3 days;behavior-hyperactive;30OCT98 vomiting;taken to MD on 31OCT98;
About 5 min after orient got vaccinated. Pt complains of lightheaded, nauseous, felt faint and felt like she?s about to pass out. Patient requested to have her vitals taken. Paramedics responded. Vitals stable.
Approx 3hrs post vax pt had shrill cry, became limp & pale but was alert; Some extremity twitching but not rhythmically; Observed overnight in Hosp;
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effects reported
Sweet taste in her mouth/ salty taste/ metallic taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), outcome "unknown", described as "Sweet taste in her mouth/ salty taste/ metallic taste".  Additional Information: Caller received the covid vaccine and within 5 minutes had a Sweet taste in her mouth. Then it switched to a salty taste and now a metallic taste. Caller would like to know how long this will last. Provided number to PMI and transferred to Pfizer DSU but more than 7 calls holding so transferred to PMI but transferred to hold queue due to long hold time from support. Any unaddressed medical questions were not referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Most abnormal one was dizzy spells, still lasting about 48 hours later.  I just feel light headed every time i stand too long or make subtle movements. Also continue to feel short of breath. Like lung movement is restricted
patient had covid shot on 3/18/21 then had known exposure on 04/06/21, tested positive for covid on 4/8/21, was admitted on 4/9/21, then died on 4/27/21.   there is no indication the vaccination had anything to do with her death, but wanted to report.
This spontaneous report was received from a consumer and refers to an unspecified number of male patients (reportedly described as "boys") of unknown ages. No medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, dosage number, route of administration, anatomical location, lot # and expiration date were not reported). No concomitant medications were reported. Subsequently, on unknown dates, the patients presented themselves with "new physical and psychological problems". The outcome of these psychosexual disorders and nonspecific reactions were unknown. The reporter did not explicitly state any causal relationship between the events and vaccination with the suspect vaccine. This is one of the several reports received from the same reporter. Additional information has been requested.
35 patints exposed to vaccine from which vial may have been punctured more than 20 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times). On 04-Nov-2021, PRODUCT ADMINISTRATION ERROR (35 patints exposed to vaccine from which vial may have been punctured more than 20 times) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 4:16 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 4:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna COVID 19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer or refrigerator, otherwise it was maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported.   This case was linked to MOD-2021-402935 (Patient Link).
FINGERS AND TOES WER ON FIRE; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (FINGERS AND TOES WER ON FIRE) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (FINGERS AND TOES WER ON FIRE). At the time of the report, BURNING SENSATION (FINGERS AND TOES WER ON FIRE) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant product has been reported.  Patient experienced lack of efficacy with Skyrizi (Risankizumab).  No treatment drug has bene provided.  The reporter causality for events extremities burning sensation of was not provided  and lack of drug effect was reasonable possibility. It was not known if the patient was involve in Covid-19 vaccine clinical trial. Primary reporter's contact for the lot number is not available.
Severe arm ache at injection site.   Headache. Slight Fever Tired Could not sleep General poor feeling All took place early morning right after shot
Redness. Area around injection 4" X 3 to 3 1/2", pain in arm - warm to touch, rash, itching, left arm. Redness continues 12/9/09 - Pain at sight continues 12/9/09.
Headache, Sedation, Arthralgia, Poor sleep, Low back pain Narrative: Received injection at 10:30 am on 2/3/21 and at 7:00 pm day of injection noted onset of headache. Headache worsened that evening, and developed arthralgias in knees leading to poor sleep. Next day noted after severe fatigue, low back pain, headache and persistent bilateral knee pain. Symptoms resolved by 2/5/21. Missed work x 1 day. No known prior COVID infection.
This vaccine was stored at room temperature outside of 2 hours. The vial was opened around 1115AM and the vaccine was administered around 245PM. I did not realize this was incorrect until 11/5/21. I have contacted my managers and the manufacturer who did not have stability data past 2 hours and advised to use clinical judgement.
seen by MD c/o itching palms w/mild swelling, erythema @ inject site; t99.7, P92, BP 138/82; given Medrol; c/o rapid heart rate & difficulty breathing; c/o lethargy on following day;
This spontaneous report was received from a nurse via Pfizer (2017481808) refers to a 60 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dosing details, strength, route, frequency and indication were unknown). The co suspect medication included PREVNAR 13. On an unknown date, after receiving the vaccine the patient started breaking out in a rash, more or less hives, to her upper body and upper chest. Her face was red, swollen and warm to the touch. The patient did not mention the time or length of the event (urticaria, drug hypersensitivity, feeling hot, swelling face and erythema). The outcome of urticaria, drug hypersensitivity, feeling hot, swelling face and erythema were unknown. The reporter considered drug hypersensitivity to be related to PNEUMOVAX 23.
The patient came in the next day following her vaccine to ask if her response was normal and based on the location of the reaction and the patients statement it was discovered that the immunization was given in the subcutaneous tissue. The patient had an extremely red, raised, large area on the back area of her arm. Based on the patients allergies and the fact that the patient didn't want to go to the hospital as the primary care physician recommended she took zytrec and upon follow up the patient saw improvement. She did mention that the morning of the 30th (2 days after the vaccine) she experienced some nausea and upset stomach but said that had improved as well.
Pt c/o feeling warm, has a hx of syncope after giving blood. Noted to have "passed out" for approximately 3 seconds about 10 minutes after receiving the vaccine.  She was observed for 30 minutes and was fine.
The week prior to 1/19/2022 I was not feeling well- no specific symptoms- I was tested for COVID and test was negative.  On 1-19-2022 I experienced exteeme thirst, frequet urination and did not feel well.  I went to an Urgent Care clinic.  Mh blood sugar was over 600.  They sent me to Hospital Emergency Room.  I was treated for new onset diabetes and admitted.  Six months prior my A1C was 5.4- now it was 8.7.   I had been seen by my doctor every three months with lab tests and this was the first onset of symptoms with abnormal lab work.
Woke up in AM with flu like symptoms: headache, myalgia, joint pain, general malaise, slight nausea, slight cough...by 10:00 AM, symptoms intensified, additional fatigue, developed chills and low grade temperature. At 1:30 pm, developed generalized macular papular rash at MD office. Flu test and Strep test were negative. MD diagnosed allergic reaction and administered Decadron injection (6 mg, IM).  Began antihistamines and oral Medrol Dose pack next morning.  Continued with myalgia, fatigue, and dermatological symptoms into late afternoon, early evening with chest appearing sunburned or scalded....also developed itching. By 7 or 8 pm, myalgia, headache, chills reduced and gradually improving. In 24 hours, energy level improved, myalgia, headache, joint pain gone...continued with uticaria and skin appearing scalded, sunburned....this lasted about 4 or 5 days....gradually resolving.
Sudden onset of severe intractable right arm pain. Not responding to oral or IV pain medications. No signs of local irritation or infection.
Patient received vaccination around 130pm, then went out to eat with friend afterwards. Around 430pm, patient called pharmacy to report redness developing from neck up and then redness spreading down arms as well as an increased heart rate. As per patient, no specific local reaction was observed around injection site but both arms was turning red. Patient was advised to take Benadryl and head to closest emergency room right away.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that there had been no power outages that would have impacted the Moderna vaccine.  However, the Healthcare professional reiterates that because her facility was unable to download the data base, they would need to treat this issue as a temperature excursion. The data base was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the RA at this time. It was reported that no adverse reactions were reported by any patients.  No treatment medication was provided.
Patient did not have card.  He stated that his first shot was Phizer. Was discovered later that his first shot was Moderna. Patient waited 30 minutes in the pharmacy and reported that he felt well and had no side effects.
Information has been received from a medical assistant concerning a 2 month old male infant with no pertinent medical history who on 18-DEC-2009 was vaccinated orally with the first 2 ml dose of ROTATEQ (lot # not reported).  Concomitant therapy included "other routine 2 month of age vaccines".  On 18-DEC-2009 the patient "vomited" after receiving the dose of ROTATEQ in the physician's office.  No diagnostic laboratory test was performed.  At the time of the report, the patient's status was unknown.  No further information is available.
This is a spontaneous report received from a Pfizer-sponsored program. A other healthcare professional reported that a 62-year-old female patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: unknown), via an unspecified route of administration on 25 Feb 2021 (received at the age of 62-years-old) at a single dose for COVID-19 immunization; and started to receive tofacitinib citrate (XELJANZ XR, 11 mg prolonged-release tablet), orally, from Oct2020 to an unspecified date at 11 mg, 1x/day for rheumatoid arthritis. Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient reported being off medication (tofacitinib citrate) for about 8 days, as instructed by MD (doctor). When she got her covid vaccine (BNT162B2) on 25Feb2021, she was supposed to be off her medication for almost 2 more weeks. She reported that while being off tofacitinib citrate she saw an improvement in symptoms. Her normal symptom with rheumatoid arthritis affected her left elbow and arm. Since being off of tofacitinib citrate she has less stiffness and pain to the left elbow. It wasn't until one day after getting the vaccine, she started having increased pain and swelling in the elbow again; she was unsure if it is from the vaccine or her rheumatoid arthritis. The action taken in response to the events for tofacitinib citrate was post-therapy. Outcome of the events was unknown. Information on the lot/batch number has been requested.
Heart Attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 at 16:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 39 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: moderna (Dose Number: 3, Batch/Lot No: 071F21A, Location of injection: Arm Left), administration date: 22Oct2021, when the patient was 38-year-old, for COVID-19 immunization; moderna (Dose Number: 2, Batch/Lot No: 016M20A), administration date: 10Feb2021, when the patient was 37-year-old, for Covid-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 012L20A), administration date: 13Jan2021, when the patient was 37-year-old, for COVID-19 immunization. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 02Oct2022, outcome "recovering", described as "Heart Attack". Therapeutic measures were taken as a result of myocardial infarction.
Patient presented to our clinic accompanied by her mother, to receive her booster dose Pfizer-BioNTech for age 5-11 years. However, patient walked to the table for doses to be given for patients 12+ years of age. The patient is 150 lbs and received the incorrect dose for her age. The mother was advised within 5-10 minutes of administration. The mother was not worried about the dosage mistake given the fact of her larger stature. I apologized for the vaccine error and provided my contact information incase of any adverse reactions. Advised her to report and/or seek medical attention if she felt her daughter had symptoms post vaccine.
Rec'd vaccine 9/11/07; 9/16/07 pruritus, 9/17/07 urticarial rash beginning at left upper arm- site of injection, was diffuse and self treated. Patient denied any fever and was afebrile at 1st office visit 9/21/07 following sx.
dizzy/lightheaded experienced at the end of the 15 minute waiting period- treated with additional sit time/rest for  an additional 15 minutes, also ate a pack of mini muffins - felt better after eating, asked if she wanted tus to call spouse to drive home, pt denied and left after feeling "much better"
One secondary scab by primary and satellite lesion imitation of mosquito bites on vax arm. Inflamed, some wheeping. Reaction to bites vs mild generalized vaccinia.
Information has been received from a licensed practical nurse (LPN) concerning a 73 year old white female with an allergy to sulfamethoxazole (+) trimethoprim, erythromycin and penicillin vk, and a history of 2 prior vaccinations with pneumococcal vaccine 23 polyvalent who on 10/15/02 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent (lot # 641130/1161L). Immediately after the administration of the vaccine, the patient developed a huge red and swollen area that extended all the way around her arm and into her armpit. The LPN reported that the area was hot and painful. In follow up, the LPN reported that the patient developed left axillary tenderness, as well as redness, swelling with pain at site, and that it continued around the patient's whole arm (orange size). The LPN also reported that the patient sought unspecified medical attention, and that, as of 10/17/02, the patient's reaction had not resolved. In follow up, the LPN reported that the patient's experience was considered to be an other important medical event, which required medical treatment. A concern was expressed regarding the lot number. Additional information has been requested. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
I did not have an adverse reaction to the vaccine. I have had asthma for many years, and it was under control. On my ride home on 12/22/2022, my asthma starting again. As of today, I am still recovering for that episode.
Sudden onset vertigo, hearing loss in left ear, diaphoresis, shortness of breath, and confusion.
pt recv vax;exp tingling in feet that spread to hands&progressed to numbness in feet;pain in hands;vaccinee seen by neurologist who stated symmetric sensory loss in extremities;no tx given yet;series discontinued;
Patient received PREVNAR 13 injection in right arm on Monday September 14 2015 at 11:25am. He noticed this morning (Wednesday September 16 2015) that he had a rash approx. 2x3 inches on his right arm and it was warm to the touch. Patient presented to pharmacy at approx. 12:45 pm to report reaction. Recommended that patient apply cool compress, use BENADRYL cream or hydrocortisone cream if itching is present. He mentioned he had a second generation antihistamine at home so I recommended that he take one antihistamine daily. Recommended that patient monitor reaction and verify that it resolves within 1-2 days. Told him to call me if reaction worsens or does not go away.
Pt recvd vax & 24 hrs p/2nd inject exp a sz; pt was seen by MD;