chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 37-year-old female 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 POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 digital data logger, they would need to treat this issue as a temperature excursion. The data logger 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 State at this time. It was reported that, no adverse reactions were reported by the patient.  No treatment medication was provided.
SIRVA. Patient developed severe left shoulder/arm pain and weakness 48 hours after receiving Pfizer vaccine.
Vaccine was administered after it had been open for more than 12 hours; Vaccine was administered after it had been open for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after it had been open for more than 12 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Vaccine information updated.
coughed; This is a spontaneous report received from a contactable consumer (patient) from a Pfizer Sponsored Program. A patient of unspecified age and gender received 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) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. During the call, the patient coughed and stated he/she didn't have Covid because he/she got the Pfizer vaccine. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Covid arm; Fever; Severe body aches; Joint aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), PYREXIA (Fever), MYALGIA (Severe body aches) and ARTHRALGIA (Joint aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), PYREXIA (Fever), MYALGIA (Severe body aches) and ARTHRALGIA (Joint aches). At the time of the report, VACCINATION SITE REACTION (Covid arm), PYREXIA (Fever), MYALGIA (Severe body aches) and ARTHRALGIA (Joint aches) outcome was unknown.            No relevant concomitant medications were provided.  No treatment information was provided.   This case was linked to MOD-2021-409912 (Patient Link).
I was 5 weeks postpartum and still trying to establish breastfeeding/milk supply. After my second dose of the COVID vaccine, I woke up with intense chest pain. Over the course of a few hours, I realized that the lymph nodes in my chest/breasts were inflamed. This caused extreme clogging of my milk ducts, and my milk supply dropped dramatically. I was primarily pumping breastmilk at the time, so I could see the exact output, and I was pumping about 1/2 to 2/3 of my usual output. The clogs were extremely painful and persistent. It took about 5 days for them to fully resolve and over a week for my milk supply to get back up to capacity. I?d recommend that any breastfeeding individuals wait until after 12 weeks postpartum (generally when milk supply is regulated) to get vaccinated in the event that their milk supply is affected like mine was.
Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; lack of strength; This is a spontaneous report from a contactable other hcp (patient himself).  A 57-year-old male patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL1284, expiry date not reported), via an unspecified route of administration on 08Jan2021 12:00 at a single dose on right arm for covid-19 immunization.  Medical history included hay fever. Prior to vaccination patient was not diagnosed with Covid-19.  Concomitant medication included melatonin taken within 2 weeks of vaccination on unspecified date for unspecified indication. On 15Jan2021 (also reported as 17Jan2021-pending clarification), it was reported that patient had stuffed nose, developed after 7 days of vaccination. Nose became painful to touch. Light chills, light headache and lack of strength. Patient received treatment of TYLENOL and decongestant. Since the vaccination the patient has been tested for Covid-19. On 11Jan2021, patient had PCR and nasal swab, and both were negative. The facility where the most recent Covid-19 vaccine administered was in a hospital.  The outcome of events was recovering.
Mistakenly given a second Pfizer Bivalent Booster on 2/15/2023 at 1:27pm AST. The original Pfizer bivalent booster was given in October of 2022.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was placed in refrigerator on 20-Nov-2021 Vial did not undergone to any temperature excursion. No adverse event was reported. No treatment medications were reported.   This case was linked to MOD-2022-491837 (Patient Link).
Customer received flu shot without incident. Shortly thereafter, he fell in one of the aisles. He stated he felt dizzy. He was taken to local hospital for observation.
Moderate/severe injection site pain with active movement peaked at 9-15hr mark; Elevated temperature 99.5-100.0; Insomnia; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration, administered in the left arm on 17Feb2021 11:30 (at the age of 31-year-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not have other vaccine in four weeks and did not have covid prior to vaccination. On 17Feb2021 at 05:00 pm, the patient experienced moderate/severe injection site pain with active movement peaked at 9-15hr mark and elevated temperature at 99.5-100.0 in the evening, responsive to 325mg acetaminophen (TYLENOL). The patient also experienced insomnia on the night of 17Feb2021, and no treatment was given in response to the event. The events were reported as non-serious. The patient was not tested for covid post vaccination. The patient recovered from all the events on an unspecified date.   No follow up attempts are possible. No further information is expected.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild.
Positive COVID-19 PCR test with symptoms, cough, congestion runny nose. post vaccination
My daughter and I went for her to get the Covid Vaccine and was given  Moderma.  I was about to walk away when she called me back and said she didn't feel well.  I was trying to ask was she ok but she just had a blank stare and then  her eyes went back and she started to  convulse.  That lasted about 10-15 seconds.  When she came through she was disoriented and she had red circles under her eyes and her lips were discolored also she started to sweat profusely and had an intense headache.  I was calling for help from the pharmacy staff but I couldn't get them to respond, until another gentleman that was there also for the vaccine started shouting for then to help.  Someone finally came and asked would we like for her to call 911, to which I asked her to please.  I was going to take her to the ER, but she said she couldn't walk.  The EMS got there about 30 minutes later and did and EKG and some other check.  At that time  they  advised my daughter against going to a hospital because of long wait times and the high amount of Covid cases, so she declined.   They also advised her to see a neurologist.  At that time I took her home and have been monitoring her.
About 2 weeks after second shot slowly began to be out of breath doing all activities, tightness in chest, heart racing. by April 14th I was admitted to hospital with multiple bilateral pulmonary embolism.
10 minutes following injection began to have pain at site and tingling down arm. Aching pain has continued. no redness, edema at site
pt tolerated immun well during administration w/o incident-walked w/sibling & father out of exam room gait steady alert;pt returned to peds appointment desk by father stating pt had fainted while father stopped to use public restroom;
Received shot in am, by that night noticed her hand was itchy.  Then the next day whole body started itching,  woke up in the middle of the night extremely itchy and noticed she was red all over her body, kind of like hives.  She took benadryl and it helped some what.  Now Monday, is doing much better, can still see mild rash that has faded, not nearly as bad.   Also had a headache for the 1st couple of days, and also had chills, and fatigue.
2 days after the Flu shot - I called not get out of bed by myself, nor could I lift myself from toilet. Husband lifted me up - my shoulders and arms were paralyzed.
approx 10 days post vax pt devel blisters on hands and ankles. Pt was hospitalized and treated w/ meds
Fussiness. Pain. Erratic behavior. Completely changed child's personality w/in one week. Resulted in permanent disability. Violent behaviors never before seen. Biting, tantrums, inconsolable. Regressive in speech. Complete withdrawal of social interactions, social inability to play.12/14/07-records received for DOS 5/20/02-6/20/05-include well and sick visits.Fever times 2 days, cold symptoms with frequent stools on 9/29/02-Congested, fever vomited on 1/12/03-. Vomiting and increased fatigue on 2/13/03. Achieving milestones 6/20/03. Fever vomiting and shaking 6/26/03. Drooling, fever runny nose congested 10/14/03-upper respiratory infection.
Initial report was received from a health care professional on 21 October 2011. A 27-year-old female patient had received an Intradermal (ID) injection of FLUZONE (lot number and site of administration not reported). On an unspecified date, the patient developed a hot red patch from shoulder to elbow and the wheals have been the size of a softball. They have stopped giving the intradermal injection because several patients a day have been calling due to reactions. No further information was available at the time of the report. The patient outcome was not reported. Document held by sender: none. The follow-up information received on 21 May 2012: The outcome of the event was amended from not reported to recovered.
A physician reported that a female pt who on 1/6/00, was noted that the pt had been "constantly asking for drinks" for the past few months.  The pt was to return to MD in 1 month for follow-up on ear infection but on 1/10/00, the pt's parents notified the MD that the pt was fussy and was given Advil. On 1/16/00, the parents called the MD's after hour service about the fussiness and rash. On 1/18/00, the pt returned to MD's office with what was reported as a "chickenpox-like rash". It was described as a "bump-like", scattered rash with some vesicles, on the pt's chest and abdomen. The lesions were "red, raised and solid". During the visit, the pt was noted to have nasal congestion and a fever of 99.1F. On 1/19/00, the pt's parents called the MD to report that pt was very lethargic and had a rectal temperature of 102.5F during the night. The pt was also fussy, cranky and had been having several "runny bowel movements" a day for the past few days. On 1/20/00, the parents called the MD's office to report that the pt was doing better and was more alert. Additionally, she had a "swollen ankle", which was treated with Benadryl. On 1/21/00, the pt was seen in the MD's office for a follow-up visit for her ear infection and rash. The pt was continuing to do well and no additional problems were reported. Additional information has been requested.
Anaphylactic reaction; Blood pressure high; Could not breathe; Pain in his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERTENSION (Blood pressure high) and DYSPNOEA (Could not breathe) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0031b21a) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COPD. Concurrent medical conditions included Allergy (receives four shots a week for his allergies).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm). On 05-Apr-2021, the patient experienced DYSPNOEA (Could not breathe) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion hospitalization) and HYPERTENSION (Blood pressure high) (seriousness criterion hospitalization). The patient was hospitalized on 06-Apr-2021 due to ANAPHYLACTIC REACTION, DYSPNOEA and HYPERTENSION. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), HYPERTENSION (Blood pressure high), DYSPNOEA (Could not breathe) and PAIN IN EXTREMITY (Pain in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment of the events included steroids and blood pressure medication.  Additional information:Patient stated he had some pain in his arm. Patient states on 4-5-2021 he could not breathe. Patient states on 4-6-2021 he went to emergency room. Patient stated he was in the intensive care unit for 3 days. Patient stated he was given steroids and blood pressure medicine because his blood pressure was high. Patient stated he was told he had an anaphylactic reaction. Patient stated that the doctor thought it was something he ate. Patient state he has a history of COPD and allergies and receives four shots a week for his allergies. Patient stated he will get itching around his mouth from eating chicken but doesn't believe his symptoms was from food.  Company comment:Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Odd feelings in his head; He has had 2 EEG's one was a 24 hours test which showed Abnormal activity on the left side of his brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 2 (orange cap), single (Batch/Lot number: unknown) at the age of 10 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (ORANGE CAP), SINGLE, Batch/Lot number: FL8094), administration date: 25Feb2022, for COVID-19 immunisation. The following information was reported: ELECTROENCEPHALOGRAM ABNORMAL (non-serious) with onset Mar2022, 4 days after the suspect product(s) administration, outcome "unknown", described as "He has had 2 EEG's one was a 24 hours test which showed Abnormal activity on the left side of his brain"; FEELING ABNORMAL (non-serious) with onset Mar2022, 4 days after the suspect product(s) administration, outcome "not recovered", described as "Odd feelings in his head". The patient underwent the following laboratory tests and procedures: Electroencephalogram: (unspecified date) Abnormal activity on the left side of his brain.; (Mar2022) Abnormal activity on the left side of his brain. Clinical course: 4 days later patient complained of odd, feelings in his head, to this day 03Jul. He still experienced the odd feeling in his head which had affected his school work, and his general daily ability to be a kid. He had 2 EEG's one was a 24 hours test which showed Abnormal activity on the left side of his brain.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
bleeding at the injection site; he did not receive the full 0.25 mL booster dose of the Moderna COVID-19 vaccine due to bleeding at the injection site, in the patient's left arm/patient believes did not get full dose of booster; The pharmacist was able to find the information that she needed and then  repeated another half dose (0.25mL) of the Moderna COVID-19 vaccine in the right arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), UNDERDOSE (he did not receive the full 0.25 mL booster dose of the Moderna COVID-19 vaccine due to bleeding at the injection site, in the patient's left arm/patient believes did not get full dose of booster) and EXTRA DOSE ADMINISTERED (The pharmacist was able to find the information that she needed and then  repeated another half dose (0.25mL) of the Moderna COVID-19 vaccine in the right arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), UNDERDOSE (he did not receive the full 0.25 mL booster dose of the Moderna COVID-19 vaccine due to bleeding at the injection site, in the patient's left arm/patient believes did not get full dose of booster) and EXTRA DOSE ADMINISTERED (The pharmacist was able to find the information that she needed and then  repeated another half dose (0.25mL) of the Moderna COVID-19 vaccine in the right arm). On 25-Oct-2021, EXTRA DOSE ADMINISTERED (The pharmacist was able to find the information that she needed and then  repeated another half dose (0.25mL) of the Moderna COVID-19 vaccine in the right arm) had resolved. At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding at the injection site) and UNDERDOSE (he did not receive the full 0.25 mL booster dose of the Moderna COVID-19 vaccine due to bleeding at the injection site, in the patient's left arm/patient believes did not get full dose of booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was not immunocompromised.   Concomitant medication of the patient was not reported.  The reporter mentioned that it was at least six months following the first two doses of the Moderna COVID-19 vaccine of the patient (the exact dates not available at this time).   No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Follow up received on 26-OCT-2021. New events, patient details and vaccination details were added. Event description was updated.
Pt said that she slept most of today, but woke up this afternoon with left arm swollen to elbow, hot to the touch and painful. She said she could lift arm and that swelling has not worsened since she woke up. I advised her to continue her anti inflammatory medicine, take a couple of Benadryl and to place cold compress on left arm. I also advised her to have a family member or friend with her over next few hours and to contact doctor or go to ER if swelling worsens or dose not get better by the next day.