chrisvoncsefalvay/vaers-outcomes huggingface dataset:
experience breakthrough menstrual bleeding; continued taking birth control regularly but was still experiencing bleeding 3 days later; experienced migraine headaches; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 23Mar2021 13:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation; ethinylestradiol, norgestimate (TRI-SPRINTEC), route of administration, start and stop date, batch/lot number and dose were not reported to regulate menstrual cycle. Age at vaccination: 41 Years. The patient medical history was not reported. None known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient regulated her menstrual cycle with birth control pills. She was currently taking ethinylestradiol, norgestimate. At the time of her first vaccine appointment the patient was taking the first week of a new pack. The patient experienced migraine headaches 48 hours after her vaccine appointment. Five days after her vaccine the patient began to experience breakthrough menstrual bleeding. The patient had continued taking birth control regularly but was still experiencing bleeding 3 days later. The bleeding was light, not heavy like a normal period, but appeared dark and viscous. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Action taken of ethinylestradiol, norgestimate was unknown. Outcome of the event was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Left arm painful from fingers to neck, extreme fatigue, headache, fever 100.4, joint& muscle pain throughout body, general weakness, Covid toes, ears ringing, dizziness/lose equilibrium, palpitations, neurological tick/sudden jolts, unable to complete the work day/week
Patient received a vaccine dose, which had been left out from the previous day of work, Thursday 08/25/2022. It was administered on 08/29/2022. Patient contacted and they are fine. I advised to monitor for symptoms. They will be ok to take another dose.
Information has been received from a pharmacy representative regarding a female who on 17-APR-2013, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot #H017759; Expiration: 04-JUL-2014) "on her left hand." It was reported that the patient experienced a side effect, namely, a "cellulite" on the area where the vaccine was administered. The patient experienced fever, redness, and swollen arm. The patient sought medical treatment and was prescribed antibiotics. At the time of reporting the outcome was unknown. Additional information has been requested.
Sore arm; delayed reaction arm itchy; delayed reaction arm red; A spontaneous report was received from a Consumer concerning a  unknown Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events like injection site pain, vaccination site pruritus and vaccination site erythema.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 18-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On  an unknown date, The patient experienced the events like sore arm, itchiness and redness at the vaccination site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 25-jan-2021, the outcome of the events like sore arm , itchy arm and red arm was unknown. At the time of this report, the outcome of the events like sore arm , itchy arm and red arm was unknown.
Case number PHEH2014US025027, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 30-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Information has been received from a 21 year old female with hypersensitivity to yeast who on 3-MAR-2009 was vaccinated with the first dose of GARDASIL. Concomitant vaccination included hepatitis A vaccine (unspecified) and typhoid vaccine (unspecified). On 17-MAR-2009 the patient experienced weak, swollen glands, muscle weakness and flu like symptoms. The patient's weak and swollen glands and muscle weakness and flu like symptoms persisted. No lab diagnostics study was performed. At the time of reporting the patient had not recovered from the above events. No further information is available.
Throwing up for over a month. Been to doctors, urgent care, hospital , and EGD been completed over the course of a month
15-20 mins p/recve vax pt felt nauseated then exp a sz; pt was unresponsive for 1 min; eyes rolled back, pt hyperventilated & was diaphoretic;
nausea, malaise, chills, diarrhea, bone pains & gen weakness lasted approx 48hr;never had gastric sx w/flu shot before;
Flushing/sweating. Benadryl 25 mg PO given. BP readings: 176/61 (pulse 78), O2 sat 100%; 173/71 (pulse 79), O2 sat 100%.
pt recv vax & devel swelling of the face & arm into which vaccine was injected;pt also devel reddened eyes;
5/14/21 12 a.m.  Severe headache, left arm pain 5/14 6 a.m.  Headache, left arm pain, fever of 100.2, chills, sweats, fatigue.  Slept most of the day.  Fever stayed between 98.9 and 99.6  5/15 6 a.m. Headache, left arm pain, chills, fatigue, low grade fever continues.  Lymph nodes in left armpit are greatly swollen and tender.  5/15 2 p.m. All symptoms subsided except for continued low grade fever, sore arm and swollen lymph nodes. 5/16 6 a.m. Temperature returned to normal.  Lymph nodes still swollen and tender.  Arm still sore 5/17  Lymph nodes returned to normal.   Arm slightly sore
feels tingling and swollen right face with tightness/ under her right eye, her upper cheek area she felt a tingling and it felt tight; feel some time a tightness in right side of my face around the cheek area and beneath the cheek; feels tingling and swollen right face with tightness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 24Aug2021 (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: PARAESTHESIA (non-serious) with onset 24Aug2021, outcome "recovering", described as "feels tingling and swollen right face with tightness/ under her right eye, her upper cheek area she felt a tingling and it felt tight"; SWELLING FACE (non-serious) with onset 2021, outcome "recovered" (2021), described as "feels tingling and swollen right face with tightness"; FEELING ABNORMAL (non-serious) with onset 24Aug2021, outcome "recovering", described as "feel some time a tightness in right side of my face around the cheek area and beneath the cheek".  Additional Information: Reportedly, she received her first dose of Comirnaty on 24Aug2021 and within the first minute of getting the vaccine under her right eye, her upper cheek area she felt a tingling and it felt tight. There was nothing visual with her face that you could see just this feeling she had. It lasted 2 weeks and after the 2 weeks it drifted down to under her cheek bone and now about 4 weeks later it is mostly gone but some days can still feel it under her cheek and her upper jaw.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling, itching,  elevated bumps all occuring at injection site 7 days and 4 hrs after first injection applied ice
I've taken all Moderna vaccines and had no reaction other than a sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I've taken all Moderna vaccines and had no reaction other than a sore arm) in a 7-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I've taken all Moderna vaccines and had no reaction other than a sore arm). At the time of the report, PAIN IN EXTREMITY (I've taken all Moderna vaccines and had no reaction other than a sore arm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. Dosage text for suspect drug was reported as unknown. Patient scheduled to get Spikevax in a couple of hours. Patient took all Moderna vaccines and had no reaction other than a sore arm, which she did not consider to be a side effect. Patient did not have Lot information, nor mentioned names of Product.  The treatment medication was not reported by reporter.
He had hives all over his torso and legs,.  Gave him a dose of Benadryl and within a few hours the hives were gone.  He continued to have soreness in his arm and felt achy and not well for two days following the shot.
Swollen lymph node on right side of neck,  swollen spot on back of right side of head, fatigue and headache, chills n
Administered 1st Dose to a 17 Year Old; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st Dose to a 17 Year Old) in a 17-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st Dose to a 17 Year Old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st Dose to a 17 Year Old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up information received on 10-JUN-2021 contains non-significant information.
3 hrs after vaccines pt stopped breastfeeding, turned pale, then became limp and nonresponsive. 911 called ambulance arrived, pt already recovered. Went to ED then to hospital for obs. overnight. (Suspected hypotonic-hyporesponsive episode per MOC and PCP).
Patient states he had hives, fever, sweating, body aches, fatigue, and shortness of breath for 1 month. However, did not come in to be seen till 1 month later, when he needed an excuse.
pt recvd 2 dose of Hep B vax 4AUG92 & 8SEP92 & exp 40# weight loss since beginning series; also c/o nausea, pain in stomach, h/a, stomach cramps, hot & cold flashes p/1st dose & loss of appetite; has not seen MD:
Bilateral left and right pulmonary artery PE's, with development of cerebral aneurysm from blood clot to brain per family members update.
Covid vaccine documentation: PT admitted 10/16/21 - 10/23/21. POC SARS COV2 ANTIGEN POS 10/17/21. PT received Janssen 5/4/21 Lot 1808982.
Patient came to the ED with dizziness and tachycardia and was treated with adenosine 6 mg IVP and metoprolol 5 mg IVP x 3 doses and was sent home.
May or may not be related, but found a soft, non tender, mobile, dime sized lump out of the blue over R clavicle
Tingling in lips, tongue, and face; Tingling in lips, tongue, and face; This is a spontaneous report from a contactable consumer. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 14Mar2021, at 10:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not have medical history The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications. On 14Mar2021 at 11:00, the patient experienced tingling in lips, tongue and face. It was reported as mild, but noticeable tingling in lips, tongue and face about 20 minutes after the injection. It lasted about 20 minutes and was never a worry, but the patient noticed it. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in lips, tongue and face was resolved on 14Mar2021 at 11.20, after the duration of 20 minutes.  No follow-up attempts are needed. No further information is expected.
"A physician reported that a 2 month old female, within 5 days post vax, developed diarrhea which lasted 1 week followed by 3 episodes of bloody stools and then mucus in the stools which lasted 5 weeks. The infant was "fussy or colicky" and was seen by the physician on 8/24/99. On 8/26/99, the mother reported that the infant was more colicky and continued to have blood in her stools."
This spontaneous report was received from a pharmacist refers to a 21 year old female patient. On 03-NOV-3025, the patient was vaccinated with PNEUMOVAX 23 lot # K021881, intramuscular. Concomitant therapies included PROAIR and budesonide, SYMBICORT. On 03-NOV-2015, the patient experienced swelling at injection site region (right arm) from her shoulder and extending to her elbow. No treatment was given. No lab tests were performed. The outcome of the event was reported as not recovered/not resolved. The patient sought medical attention. Additional information has been requested.
SWEATING; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced sweating. On 2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and sweating was not reported. This report was non-serious.
Soreness in left arm, unable to lift or carry weight, pain at night, unable to lift arm straight up or bend it backwards, loss of strength and flexibility, hurts when running (back and forth motion).  Have treated with aspirin, heat and rest.
At approximately 12:15 a.m. on 12/12/2021, I was awaken by a rapid heart rate.  I was wearing a smart watch that monitors heart rate. My heart rate was spiking and not stabilizing. I subsequently called 911 and an ambulance was dispatched to my home.  I was transported, by ambulance, to Hospital in full atrial fibrillation.
did not receive the second / shot and 9 months have passed since the first dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 14th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse reported that the patient did not received 2nd dose which led to incomplete course of vaccination. The reporter consented to follow up.
redness; inflammation, & warmth below site on top of arm; MD examined pt & felt no treatment was necessary;
Pt stated she was hurting on her arm and up into her neck. She had a large whelp in the arm below the vaccination site. She had been to the Nurse Practitioner and she diagnosed her with Cellulitis. She gave her Clindamycin 300 mg 1 bid x 10 days.
His first dose he experienced "feeling off"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (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: FEELING ABNORMAL (non-serious) with onset May2021, outcome "recovered" (2021), described as "His first dose he experienced "feeling off"".  Additional information: Patient is a male consumer who would like to know if the first two doses and the booster dose that he has received were the Pfizer Bio-N-Tech or the Comirnaty vaccines. He is going to be traveling and stated he got vaccinated for this reason. Patient relayed that his lot numbers for his vaccine doses were EN6207, ER8724, and FY1620. He also stated that with his first dose he experienced feeling off for the month of May2021 but that went away. He had no questions regarding side effects.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2014US025030, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 74-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration.
Chest pressure developed in the evening  Elevated heart rate developed in the evening (resting at 90bpm - normally 65-70bpm) Minor arm pain Heat at the site and up the side of my neck on the side of the injection
DEMAND ISCHEMIA ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
Fever (101), chills, muscle aches, fatigue, headache, diarrhea.   Patient resting and taking a Advil
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of COVID after negative. test; Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
received 2 doses of vaccine today; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (received 2 doses of vaccine today) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (received 2 doses of vaccine today). On 14-Apr-2021, INCORRECT DOSE ADMINISTERED (received 2 doses of vaccine today) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No Concomitant product was reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up information received on 20-May-2021 contains non-significant information.
Second dose of Moderna was inadvertently given earlier than the recommended interval. No adverse reactions noted after the event.
2 days post vaccine: left arm swelling, itching, rash from above injection site to the elbow. Treated with OTC Benadryl Cream.
Information has been received from a licensed practical nurse concerning a now 63 year old female patient with sulfonamide allergy, diabetes and hyperlipidemia who on 25-JUL-2008 was subcutaneously vaccinated with 0.65 ml ZOSTAVAX (Merck) (lot# 659410/0412X, exp: 29-JUL-2009). Concomitant therapy included SYNTHROID and CRESTOR. The nurse reported that on an unspecified date "recently", the patient experienced "a case of shingles" around the patient's left eye. Nurse reported that the patient had been to see an ophthalmologist (name unspecified by nurse). The nurse reported that the patient came to see the physician, on 12-AUG-2011. Nurse reported that the patient was experiencing pain around the patient's left eye and the physician prescribed NEURONTIN for the patient's pain. No lab diagnostics study was performed. At the time of report, the outcomes of the adverse events were unknown. Patient was experiencing pain was considered to be significant disability or incapacity by the nurse. Additional information has been requested.
Information has been received from a health professional concerning a 16 year old female who was vaccinated intramuscularly with Gardasil and experienced lymphadenopathy.  The patient sought unspecified medical attention and her outcome was not reported.  Additional information has been requested.
Patient presenting symptoms of bilateral redness and discomfort, reported to have pain on a 0-10 scale , reported a (3) when touch  or scrap on objects.  Patient reports of tender to touch.  Upon assessment patient noted with warm to touch to site. Noted with redness to by lateral arms, measure 40 mm to left arm and 31 mm to right arm .