chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Greater than 1-month between HEPLISAV-B dosing; Initial Report Received on 05-Jan-2021  A pharmacist reported that a 20 year-old female (race and ethnicity not provided) received her second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization greater than 1 month after the first dose.  No medical history was reported.   No concomitant medications were reported.  On 18-Sep-2020, the patient received the first dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021 and NDC # 805181463558) to the left deltoid at an unknown facility.  The flu vaccine was administered concomitantly.  The patient reported no adverse reactions.    On 05-Jan-2021, 110 days (greater than 1 month) after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot # 933625, expiration date 12-Sep-2021 and NDC # 805181463558) to the left deltoid at a pharmacy.  At the time of the report, the patient reported no adverse reactions to either injection.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Hives started approximately 5:00 PM, persisted for 3+ days after injection, spreading across torso to extremities.
Our daughter began dropping her head to her chest randomly the evening after her hib shot. She would be playing and just drop her head several times (almost like she lost muscle tone briefly) in the space of a couple of minutes. This happened multiple times a day, every day for weeks. It still happens occasionally, though not nearly as frequently.  We are down to about 1 or 2 times a week.  She was sent to a neurologist who said it could possibly be drop seizures, but her EEG came back normal. She was referred to a chiropractor who has helped some.
Intensely pruritic papules on left anterior forearm, contralateral to injection site.  Over course of 12 hrs, bilateral arm 'welts', spreading to buttocks and groin also bilaterally. 20 hrs after onset, shaking chills w/ fever of 101.7---ibuprofen taken. Woke 2 hrs later at ~2AM on 12/29/21 with pruritic papules of the posterior scalp, serous yellow discharge from excoriation sites at the posterior scalp, and diffuse anterior and posterior subcutaneous edema. Symptoms of dysphagia had also been occurring throughout the day. Admitted to hospital @9AM. Welts coalescing and flattening, more clearly diffuse urticaria. Discharged on steroids, antibiotics 12/30/21 after improvement in edema, urticaria.   Readmitted to hospital 1/1/22 after nausea and vomiting overnight; I was unable to keep steroids, antihistamines down.  Worsening  esophageal symptoms continuing to worsen, feeling like esophageal spasms, worse when lying flat for a few hours and waking me up in considerable discomfort. EGD performed at hospital 1/2/22 showed no visible signs of pill esophagitis, esophageal ulcers, or strictures related to Eosinophilic Esophagitis history.
No adverse effect reported; patients received an improperly stored dose of MMR II on unspecified dates; This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and previous drug reaction, and allergies were not reported. The patients' concomitant therapy included sterile diluent injection.  On unspecified dates, the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II) of lot # R028382, expiration date reported as 02-OCT-2020 but upon internal validation established as 10-MAR-2020 (therapy type: rHA; exact dose, dose number and route of administration were not reported) for prophylaxis (product storage error). The sterile diluent injection used to reconstitute the vaccine was stored in the recommended temperature range. On an unknown date, the vaccines administered to the patients were exposed to the temperature excursion of -58 degree Fahrenheit and +46 degree Fahrenheit (35.1 Fahrenheit (F)) for 30 minutes, and at highest temperature above 47.1 degree Fahrenheit (47.1 F) for 30 minutes. There was previous temperature excursion at -58 degree Fahrenheit and +46 degree Fahrenheit (-35.8 F) for 30 minutes. There was no adverse effect reported (no adverse event). Digital data logger was involved. No product quality complaint was involved.  This is a non-valid report due to lack of patient identifiers.  Upon receipt of follow-up information from nurse practitioner on 26-MAR-2020, it was determined that this case is now valid as patient identifier was reported. The case is regarding a 18-years-old male patient. On 28-AUG-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA010101:
Pain; Swelling; This spontaneous case was received on 31-Aug-2020 from other non-health professional via agency (reference number: SEQW20-01068) and concerned a female patient of unknown age.  The patient's medical history and concomitant medications were not reported.   The patient's past vaccines included unspecified flu vaccines after which the patient experienced pain and swelling (see case 202004353).   On an unspecified date, the patient was vaccinated with INN Seasonal flu vaccine [influenza virus vaccine polyvalent; dose, route of administration, anatomical location: not reported] for flu prevention.   The batch number was not reported.  On an unspecified date in 2019, an unknown amount of time after receiving INN Seasonal flu vaccine, the patient experienced pain and swelling.   The outcome of events was not reported.  The reporter did not provide causality assessment.  This case is linked to case 202004353 (the same patient).  Company comment: The patient developed pain and swelling on an unknown date and unknown amount of time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. No information regarding concomitant medication and medical history was provided. Based on this information, causal relationship for both events is assessed as unassessable.; Sender's Comments: The patient developed pain and swelling on an unknown date and unknown amount of time after vaccination with the suspect product, INN Flu Vaccine Seasonal. Chronology is unclear. No information regarding concomitant medication and medical history was provided. Based on this information, causal relationship for both events is assessed as unassessable.
couldn't see out her central eye/lose total vision; some bleeding and or blood clot over her left eye, retina; blood clot over her left eye, retina; This is a spontaneous report received from a non-contactable reporter consumer from medical information team. The reporter is the patient. A female patient of an unspecified age received BNT162B2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "TIA" (unspecified if ongoing), notes: on Plavix from TIA "years ago". Concomitant medication(s) included: PLAVIX taken for transient ischaemic attack. Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: unknown), for COVID-19 Immunization. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "couldn't see out her central eye/lose total vision"; EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "some bleeding and or blood clot over her left eye, retina"; RETINAL VASCULAR THROMBOSIS (medically significant), outcome "unknown", described as "blood clot over her left eye, retina". The events "couldn't see out her central eye/lose total vision", "some bleeding and or blood clot over her left eye, retina" and "blood clot over her left eye, retina" were evaluated at the physician office visit. Reporter stated that 6-7 hours after the 2nd dose of the Pfizer BTC vaccine (12 and older formula, purple cap) she noticed some bleeding and or blood clot over her left eye, retina, she couldn't see out her central eye. She went to her regular eye Dr. and he dilated her eyes and then referred her to the specialist. After her eyes were dilated the blood made her lose total vision in her eye until the specialist operated on her eye and her peripheral vision came back. He stuck a needle in the white part of her eye. She had been on Plavix from TIA "years ago" and her primary Dr said it was up to the eye Dr. to stop the PLAVIX and the eye specialist said it was her primary HCP's responsibility because he knew her medical history much more in depth than the eye Dr. of the DRs told her to get the booster dose and this was not a reaction. It was too soon to be a side effect. She was a Medicare patient and they just want her to get the booster for the better of the country and not for the better of her health. Therapeutic measures were taken as a result of blindness, eye haemorrhage, retinal vascular thrombosis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Head cold (congestion and tired); Head cold (congestion and tired); Head cold (congestion and tired); Feeling flu like; Complete loss of taste within 24 hours; Leg muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date were not reported), via an unspecified route of administration, in Left arm on 27Mar2021 at 11:00 AM (at the age of 44-years-old) at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included aripiprazole(ABILIFY), fluoxetine hydrochloride (PROZAC), Valsartan and methylphenidate hydrochloride (RITALIN). The patient was not pregnant. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. The patient experienced head cold (congestion, tired), feeling flu like, complete loss of taste within 24 hours, leg muscle pain and joint pain from 27Mar2021 at 14:00. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  Information on lot/batch number has been requested.
One week after first Pfizer vaccine, awoke with severe right eye pain and light sensitivity. The eye and peri-orbital area was extremely painful, swollen and red. The ophthalmologist said the the urea and surrounding tissues were severely inflamed and the eye pressure was increased. He stated this could have been a delayed inflammatory response to the covid vaccine and advised to refrain from having the second dose. Took steroid eye drops every one hour for several days and have had three follow up ophthalmology visits.
Mother reports patient developed redness, warmth to injection site and pt also developed small cluster of vesicular like lesions anterior deltoid. No treatment given by mother. Healthcare provider (writer) saw pt today and observed warm, mildly erythematous left deltoid area, non tender to touch, child has full range of motion, <1cm cluster white vesicular like lesions anterior deltoid.
BAD COLD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included bruising, and anemic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bad cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bad cold. This report was non-serious.
My arm is like really sore at the vaccination site, on my right arm; It is still sore;; My whole right arm is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 (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: VACCINATION SITE PAIN (non-serious) with onset 10May2021 12:00, outcome "unknown", described as "My arm is like really sore at the vaccination site, on my right arm; It is still sore;"; PERIPHERAL SWELLING (non-serious) with onset 10May2021 12:00, outcome "unknown", described as "My whole right arm is swollen".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After the first injection there was a localized reaction. After the second vaccine at about 3am I experienced severe chills, fever, body aches and fatigue. I took Tylenol 500mg,2 tabs every 4 hours .
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: patient was given shot. about 5 minutes after she was complaining of chest tightness and difficulty breathing. i took BP at 208pm 177/22 - pulse 99. I spoke to the patient't nephrology nurse, she said patient has many allergies and to start our protocol. At 223pm BP was assesed with a manual device and still high at 170/120, patient still complaining of difficulty breathing and chest tightness, 1 dose of epinephrine 0.3mg was administered intramuscularly in left thigh.
PATIENT DEVELOPD A BALL OF PHLEGM IN HER THROAT THAT WOULD NOT GO AWAY AFTER DRINKING 8 OUNCES OF WATER, PATIENT WAS GIVEN 25MG (10ML) DIPHENHYDRAMINE AND 16 OUNCES MORE OF WATER AND SYMPTOMS WENT AWAY
Initial information received on 13-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA389639 same reporter. This case involves a 74 years old male patient who experienced stuffy nose, strong cough with mucus, chest pain, headaches and got sick after a day of vaccination, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Diabetes mellitus and Hypertension. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Notes: Patient had vascular surgery. In end of September 2018, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious stuffy nose, strong cough with mucus, chest pain, headaches and strong cough with mucus, with chest pain, stuffy nose, at night couldn't sleep- it comes from the chest and got sick after a day of vaccination following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data.) Final diagnosis was got sick after a day of vaccination, headaches, chest pain, strong cough with mucus and stuffy nose. The patient was treated with TYLENOL for Product used for unknown indication and NYQUIL for Product used for unknown indication. The outcome of the event was not reported. Documents held by sender: none.
Employee called Emp Health with request for exemption from mandatory influenza vaccine due to symptoms experienced with last year's vaccination. A review of encounter with another provider indicated employee complained of developing extreme sleepiness, fatigue, myalgia & temp of 99.4 degrees within hours of receiving vaccine. Symptoms resolved within 2 days.
Shortly after the patient received the vaccine and left the pharmacy, she started experiencing severe headache and radiating left-sided neck pain. The pain continued throughout the day and morphed into head, neck, and sinus pressure. The next morning, the patient noticed a ruptured blood vessel in her left eye, causing redness. Symptoms lasted for approximately 1 week.
product is opened she noticed leakage in the pouch.; No additional AE; Doses from the same box have been administered to multiple patients; This spontaneous report has been received from a nurse regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  It was reported that the nurse notice that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ ) was open and she noticed leakage in the pouch (Product leakage), then on 16-MAR-2023, the patient was vaccinated wit Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ ) oral liquid, at a dose of 2 milliliters (ml), orally administered, for prophylaxis (lot number W026137, which has been verified to be valid, expiration date reported and established as 05-FEB-2024)(Poor quality product administered) (strength, and vaccination scheme frequency were not provided).  No additional adverse events were reported in the patient.
Sore arm; Mild body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 05-Feb-2021, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Mild body ache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-053200 (Patient Link).
Patient developed flat non-itchy rash immediately after first dose of COVID-19 vaccine. Per mom, she is unfazed as this has happened with multiple vaccines, including pneumococcal. She received 25 mg Benadryl and flushing / non-itchy rash is improving. No VS changes. Feeling systemically well. Advised taking normal dose of cetirizine tonight
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Additional Details: Rph noticed pt didn't look well as she waited after the shot. pt said she was not feeling well and rested head on RPH shoulder & passsed out. Rph with assistance of another Rph lower pt to floor. pt regained consciousness but still seemed out of it. We called 911. kept her feet elevated, covered her with blanket since body temp dec to 93.2, she was able to answer questions. paramedics took bp & bs and said bs low. pt had had smoothie before shot . Went to hosp in ambulance
Patient is a 80 y.o. female with past medical history of seizure disorder, who presents to the Emergency Department with chief complaint of as mentioned above.   The patient has arthritis of the right knee, which has been affecting her walking for long time.  The patient has been having some chest congestion and cough for last few days.  3 days ago, she had a third Covid vaccination shot.  She has some mild fever after the booster shot and some cough nonproductive cough.  Today the patient had difficulty with walking, her right leg gave out on her and she also was confused and has some dysarthria at that point.  The symptoms gradually resolved spontaneously.  She denies exposure to patient with Covid infection, loss of taste or smell.  She has no urinary complaint.  Onset of the condition was gradual with moderate symptoms.  Ambulation, exertion aggravate the condition and resting helps
24 hours after red and painful approximately 6 inch diameter; circular started to reduce in size 2 days after spontaneously.
MOP states the patients arm is swollen from the Shoulder to the elbow and warm to the touch, started approx. 24 hours after injection.
near syncope episodes, unstable heart rate, palpations, skipped beats.   Heart racing more than usual during excercise
Very large lymph nodes in armpit with swelling, pain and itching  over lymph nodes. Pain was 8/10 with Advil and alternating with Tylenol.  Pain radiated down arm/radiculopathy.
Sore arm; weakness/I was weak; fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm on 26Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the patient experienced sore arm, weakness/I was weak, fever. Patient pharmacy told her to call regarding her side effects. Transferring agent stated, I have a consumer on the line, she is calling about side effects that she received from the first dose of the Pfizer Covid 19 vaccine- patient is a 44-year-old female who received the first dose on 26Jul2021 this year. She began having sore arm started around midnight in the same arm, the night she received the vaccine in the arm she was vaccinated in. Symptom has resolved. However she has developed weakness and fever in the morning that started yesterday and continued into today. Are these normal symptoms from the vaccine. Patient wants to know if the side effects can start that long after receiving the first dose. Patient stated, No, I called because my pharmacist told me to call, says you guys can help me. The lady before you said, It's normal. She said, You will experience it for 7 days. This is my 4th day. When, I got fever and I was weak. It must broke my fever in the morning. I was fine all day. All day all, before the morning. I was fine, even in the first week, I have another fever wake up in the morning, now weak again. Patient stated, No I don't have to transfer that. I don't need that. I cannot spend a week like that. She, If, told me, I am experiencing this until 7 days then it can extend up to 6 months with the second dose. Outcome of the events sore arm was recovered on an unspecified date in Jul2021 and outcome of remaining events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-Up (PRD/SRD 23Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous case initially received from other health care professional (nurse) on 19-Oct-2018, concerning a 33-year-0ld, adult, female patient. On an unspecified date, it was reported that, the fridge had never gone out of range between 2 and 8 degrees for 10 months. On 15-Oct-2018, at 8:23 AM, the tracker thermometer cloud was disconnected until 17-Oct-2018 at 9:34 AM and they did not have any temperature recordings between that time, which was considered possible temperature excursion. On 16-Oct-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 272676, expiry date: not reported] which underwent possible temperature excursion. At this time of report, no adverse event was reported after the vaccine administration. The reporter assessed this case as non-serious.