chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; lightheaded; weak; not eating or sleeping right; not eating or sleeping right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; DIZZINESS (non-serious), outcome "unknown", described as "lightheaded"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; DECREASED APPETITE (non-serious), INSOMNIA (non-serious), outcome "recovered" and all described as "not eating or sleeping right".  Additional Information: He got the shot on a Thursday. He mentioned he was not sure if it was from working long hours and not getting any sleep or if from the vaccination. Now he's hesitant to get the second Covid 19 vaccine. Not eating or sleeping right only lasted about two days, then it went away. He was wondering if he should just get that second dose. Caller declined to file safety report, no further information was provided or obtained.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
slightly swollen red rash on the site of the injection the size of her hand, not itchy; slightly swollen red rash on the site of the injection the size of her hand, not itchy; slightly swollen red rash on the site of the injection the size of her hand, not itchy/Rash on the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slightly swollen red rash on the site of the injection the size of her hand, not itchy), VACCINATION SITE ERYTHEMA (slightly swollen red rash on the site of the injection the size of her hand, not itchy) and VACCINATION SITE RASH (slightly swollen red rash on the site of the injection the size of her hand, not itchy/Rash on the right arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (slightly swollen red rash on the site of the injection the size of her hand, not itchy), VACCINATION SITE ERYTHEMA (slightly swollen red rash on the site of the injection the size of her hand, not itchy) and VACCINATION SITE RASH (slightly swollen red rash on the site of the injection the size of her hand, not itchy/Rash on the right arm). At the time of the report, VACCINATION SITE SWELLING (slightly swollen red rash on the site of the injection the size of her hand, not itchy), VACCINATION SITE ERYTHEMA (slightly swollen red rash on the site of the injection the size of her hand, not itchy) and VACCINATION SITE RASH (slightly swollen red rash on the site of the injection the size of her hand, not itchy/Rash on the right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.  The patient's weight was provided as 168 (units not specified).  The rash on the patient's right arm, she was advised to take the second shot in her left dominant arm.  No treatment information was provided.   This case was linked to MOD-2021-227801 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Patient demographics were updated. Information was received stating the patient received her second dose. Action taken with suspect product was updated. Additional event information was provided. On 25-Jul-2021: No new information was received.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 28 Jun 2023, 5 doses were administered at administration site 2. No treatment medication reported.   This case was for the 40th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:MASTER CASE
Shortness of breath and tightness of chest for a week and several palpitations.  Autoimmune response similar to Hashimoto's attack with severe inflammation in heart and body, migraine headache, fever, chills, body aches intermittently over three weeks.  Hands and feet hurt three weeks.   Could not make a fist.
Headaches; no taste or smell; no taste or smell; This is a spontaneous report from a non-contactable consumer.  A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on an unspecified date for covid-19 immunisation. Medical history included barretts esophagus. The patient's concomitant medications were not reported.  The patient experienced headaches on 30Jan2021, no taste or smell on 30Jan2021. No treatment received. The events outcome was recovering. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report as received from a 51 years old female medical assistant who is the patient with a lot of unspecified allergies. In July 2012, about two weeks ago, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The patient told the representative that she was given ZOSTAVAX and later that day the arm she got the vaccine in became "hard and swollen" from her shoulder to her elbow. The patient verified that there was no rash. The patient also told this representative that she had the same reaction to an unspecified flu vaccine about 10 years ago. No treatment was given. The patient recovered from the arm she got the vaccine in became hard and swollen" from her shoulder to her elbow 5 days after the vaccination. No additional information was provided. Additional information has been requested.
he had a problem with his heart; neck pain/his neck on the left side, when he turn his head to the left side it hurts; muscle pain is from neck down to upper shoulder; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On 28Jan2021, patient experienced neck pain; further reported as his neck on the left side, when he turn his head to the left side hurts and patient also experienced muscle pain from his neck down to the upper shoulder. It was also reported that the patient had a problem with his heart on an unspecified date. Outcome of events was unknown.   Information on the lot/batch number has been requested.
Patient ended up hospitalized 3 days later with severe pneumonia he was hospitalized on 9/25/14 and placed in ICU. He signed out AMA on 9/26/14 and died of self inflicted gun shot.
Patient complains of shortness of breath beginning 1 week after receiving his 2nd covid vaccine.  The complaints started after traveling in a car to another state (long car ride).  Patient is started on heparin drip and admitted to CCU.  Patient is transitioned to apixaban and is discharged after 1 night stay.  Patient to follow up with vascular as an outpatient.
Patient was administered 0.5ml instead of 0.25ml booster dosage, patient was called on 1/18/2022 and denies any problems since vaccination. A letter was sent to the patient informing the dosage given
Rash 1 week after vaccine given. "Dew drop on rose petal rash".
Patient only received PENTACEL vial. Staff didn't combine with Hib diluent.
red blotch at injection site, sore,  hot to touch ongoing through 01/21/2021 Date of Onset: 01/11/2021
Patient received the vaccine on 11/10/18 and reports that sometime late the next evening and into the next day (11/11/18-11/12/18) she began to experience a tingling paralysis that started in her toes then moved up to her shoulders and neck and then down to her leg (started on her left side). She reports being unable to move, not even to lift the sheets from her bed, and could not call 911 or anyone for help. She did regain functionality and was able to see her internist and rheumatologist several days later and was put on Prednisone (she has been taking for 3 weeks now). She still reports feeling tired and some joint stiffness/pain but is 90% back to normal. She states her physicians conclude she had a reaction to the vaccine in which the proteins accumulated in her joints. Patient reports she had never had a reaction to the flu vaccine in the last 20 years.
muscle spasms between the breast plate while lying in bed in horizontal position but stopped in vertical sitting up/ standing; left arm hurt wihtin 2-3 hours; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm hurt wihtin 2-3 hours), CHILLS (chills) and MUSCLE SPASMS (muscle spasms between the breast plate while lying in bed in horizontal position but stopped in vertical sitting up/ standing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (left arm hurt wihtin 2-3 hours) and CHILLS (chills). On 30-Mar-2021, the patient experienced MUSCLE SPASMS (muscle spasms between the breast plate while lying in bed in horizontal position but stopped in vertical sitting up/ standing). On 30-Mar-2021, CHILLS (chills) and MUSCLE SPASMS (muscle spasms between the breast plate while lying in bed in horizontal position but stopped in vertical sitting up/ standing) had resolved. At the time of the report, VACCINATION SITE PAIN (left arm hurt wihtin 2-3 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Body temperature: 93.8f (Low) temperature dropped to 93.8F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment drugs were reported
Patient complaining of pain upon injection that ran all the way down arm to the fingertips. Pain has persisted until today's date (2 weeks) after vaccination.
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 08-SEP-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX 19400 PFU lot # L015417/expiration date 01-AUG-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
PAINFUL, SWELLING, REDNESS 3  1 INCH IN DIAMETER.
Baby is having episodes of seizure activity. Has been to another hospital but not dx'd as seizures or attributed to vaccines. Vaccines have not been given since.
Her Legs swelled up again today and it has gotten worse; This is a spontaneous report from a contactable consumer (patient). This contactable female consumer (age not specified) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: unknown) through an unspecified route as a single dose on 24Apr2021 (age at vaccination: unknown) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot: unknown) and had legs swelled up this lasted for 3 or 4 days and then resolved. After getting her second dose on 24Apr2021 her legs swelled up again today and it had gotten worse. She could not put on shoes or slip-ons. The outcome of event was reported as not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Symptoms: low-grade fever (2-3 degrees elevated), muscle aches, joint aches, headaches, chills, malaise. Treatment: 24 hour Quarters (bed rest), Motrin 800mg 3 X day by mouth with food.
Mother reported excessive itching at site of vaccine admin on left upper arm 2 days later. Arm became swollen to level of mid lower left arm and very reddened with child c/o pain in arm 2 days later also.
PATIENT FELT FAINT/DIZZY UPON STANDING AFTER IMMUNIZATION. PATIENT PRESENTED TO PICK UP WINDOW STATING THEY WERE LIGHTHEADED. RPH ASSISTED THEM IN LOWERING TO THE GROUND. PATIENT WAS COHERENT AND RESPONDED TO THEIR NAME. PATIENT WAS ASSITED TO RPH TO A SITTING POSITION. PATIENT STATED THEY HAD NOT EATEN BREAKFAST AND WAS PROVIDED AND DRANK ORANGE JUICE WHILE SEATED IN THE WAITING AREA.  PT WAS OBSERVED FOR 15 MINUTES WHILE SEATED. PATIENT STATED NO ADDITONAL DIZZINESS/LIGHTHEADEDNESS/ONGOING PROBLEMS OR CONCERNS AND LEFT WITHOUT FUTHER ASSITANCE.
See medical tests. Minor tenderness in armpit but was not reported to doctor. The test were because of my annual mammogram.
smalls hives, extreme itchyness. starting in palms then migrating to any and all parts of the body that undergo any sort of physical abrasion. eg scratching with fingernails, rubbing on a blanket, picking things up.
PT CALLED AND SPOKE TO PHARMACIST ON DUTY, ON 5/19/2021 AND SAID HE'S BEEN TIRED AND WEAK SINCE HIS SHOTS A MONTH AGO OR MORE. SEEN DR AND THEY RAN TESTS NOTHING COMING BACK AS WRONG WITH HIM. JUST WANTED TO LET US KNOW... ON 4/25/23 I GOT A CALL FROM COORDINATOR, INDICATING THAT PATIENT HAS BEEN COMPLAINING OF RINGING IN EARS SINCE HE GOT THE COVID SHOTS.
parent states that 3-4hr p/vax pt was crying inconsolably w/high pitched cry, had a dec appetite & had an episode where eyes rolled back;states there was no fever;
This is a 44y.o. male with a past medical history of asthma, gout, morbid obesity and obstructive sleep apnea presenting to the emergency department today with increased shortness of breath and chest pain. Patient states that he was positive for Covid about one week ago. Patient is vaccinated for Covid. Patient is known door saying that over the past 2 days he has been increasingly short of breath. Patient states that he is on oxygen at home but has been increasing his requirements and is currently requiring 4 L with oxygen saturation in the low 90s. Patient also is endorsing chest pain. Chest pain is diffuse and worse with deep inspiration. Patient states that he also has been coughing which is productive of a foam-like substance. Patient endorses fever earlier today for which she feels improved after taking Tylenol. Patient also admits to an episode of nausea earlier which resolved on its own and did not have any vomiting. Patient denies chills, current nausea, vomiting, abdominal pain, lower extremity edema, and changes in bowel or urinary habits.
Client experienced stomach upset, intermittent headaches, throbbing pain in arm, fatigue, and body aches for approximately 5 days following her second COVID-19 booster which was Pfizer. The Client previously had only received Moderna COVID-19 vaccine and reported she had no side effects. Client reports a personal and family history of non-specific inflammatory conditions.
8/13/21: patient presents to ED with a chief complaint of cough, weakness, and shortness of breath for the last 7 days. states tested positive for COVID 19 on 8/10/2021. Upon initial evaluation on ED VS:  hypoxia 88% upon walking in the room at room air. admitted.  Note: previously received COVID-19 Pfizer vaccine: First dose: 01/29/21 Lot Number EL8982; Second dose: 02/24/21 Lot Number EL9265. Diagnosed with covid 19 pneumonia, acute hypoxic respiratory failure. 8/20/21: patient discharged
Information has been received from a physician concerning a 13 month old male with no medical history or drug allergy who on 31-DEC-2008 was vaccinated with single dose of series of VARIVAX (Oka/Merck) (660669/1381X) and PREVNAR (lot # C71975). On 20-JAN-2009 the patient came into the office with a Varicella rash from head to toe. The physician reported that the patient had recovered and was unsure if they would give the booster of VARIVAX (Oka/Merck). The patient did not perform any lab diagnostics study. Follow-up information has been received from a health professional concerning the patient who on 31-DEC-2008 at 11:30 AM was vaccinated with the first dose of VARIVAX (Oka/Merck) (660669/1318X, SC) and the fourth dose of PREVNAR (lot # C71975, IM in the left thigh). The patient was seen with vesiculopapular rashes. Rashes developed on 16-JAN-2009 (previously reported on 20-JAN-2009) on neck, torso and spread to the extremities. Some of the rashes were drying out and scabbing over, while others were still developing. It was reported the patient did not have any illness at time of vaccination and no pre-existing allergies, birth defects, or medical conditions. At time of the report the patient was recovered (also reported as unknown).
The Pfizer vaccine was given as a booster.  First dose of Covid vaccine was J & J on 05/18/2021.  Incident: Patient, and father of patient (RN) reported that patient frequently faints when receiving any vaccine.  Patient declined lying on the exam table and preferred to sit in a Phlebotomy chair that has an arm restraint , for the vaccine.  Very quickly patient c/o dizziness and experienced a "sudden loss of clarity".  Sp)2 @ 98%, pulse 68 and regular.  BP 118/75; RR 12.  Lung fields clear.  Skin clammy.  EMT called in @ 11:33.  Patient was seated and supported by dad.  Initially unresponsive & mildly diaphoretic.  Patient regained alertness to be able to swallow and was given a juice box.  Continued to recover and was held for 30 minutes.
Pfizer-bioNTech COVID-19 vaccine EUA..symptoms include vomiting,  chills and injection site pain/sore
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding his 6 year old son who received a dose of vaccine and experienced flu-like symptoms. Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was not provided.  Concomitant medications were not reported.  The pt experienced flu-like symptoms (influenza like illness) immediately following receipt of vaccine (date unspecified).  His "flu-like" symptoms lasted about one week.  No additional information was available at the time of this report.
Being crushed underneath a train car for 4 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HAE-type 1" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovered", described as "Being crushed underneath a train car for 4 days".  Additional information: The patient reported had HAE-type 1 and had all vaccines and boosters. It was reported that second vaccine reaction was like being crushed underneath a train car for 4 days. Hope this info/data was of some value.The patient was afraid to get another booster. The patient didn't had knowledge to knew if could become a fatality.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The pt experienced a rash around the neck within one week of vax. The pt also experienced faintness, erythema, splotchy. Was treated with Claritin. Symptoms have resolved.
Fever  101 deg F,  chills and shaking, body aches, arm sore at injection site, fatigue; Symptoms lasted about 24 hours after onset with gradual decrease in intensity.  Asprin helped reduce symptoms
Pt received two doses of Engerix-B and c/o occasional severe headaches since the first dose. Seen by her family physician.  No treatment given.
Headache, nausea and chills starting at 5:00pm on 10/4/20, lasting four days Pain felt at injection site on 10/4/20, then throughout body in muscles for four days Dizziness, lethargy, fatigue for one week after injection on 10/4/20