chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swallow under left arm in armpit area, felt like a golf ball under arm; Swallow under left arm in armpit area, felt like a golf ball under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2022 15:30 (Lot number: FK9895) at the age of 42 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, product=COVID 19, lot number=ERV0168, administration date=12Aug2021, administration time=05:00 PM, vaccine location=Left arm), administration date: 12Aug2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive"; Bnt162b2 (Dose Number: 2, product=COVID 19, brand=Pfizer, lot number=FD8448 , administration date=02Sep2021, administration time=05:00 PM, vaccine location=Left arm), administration date: 02Sep2021, when the patient was 41 years old, for Covid-19 Immunization, reaction(s): "Covid test result=Positive", "Covid test result=Positive". The following information was reported: AXILLARY MASS (non-serious), LYMPHADENOPATHY (non-serious) all with onset 25Feb2022 08:30, outcome "recovering" and all described as "Swallow under left arm in armpit area, felt like a golf ball under arm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary mass, lymphadenopathy. Additional information: The patient did not receive other vaccine in four weeks and any other medications in two weeks.  No follow-up attempts are possible. No further information is expected.
Initial sore arm with redness, swelling and hot to touch lasting approximately 3 days. On day 9 I woke up with my arm itching at site of injection it was red and became more swollen and hot to the touch as the day progressed. On the 10th day (today) it is still red, hot to the touch and swollen in approximately 3 inch diameter around the injection site.
Information has been received from a registered nurse concerning a 15 year old female with history of syncope who on 16-JUL-2008 was vaccinated with the first dose of GARDASIL (Lot No. 659962/1740U) IM.  After the first dose of GARDASIL, on 20-JUL-2008, the patient experienced a seizure.  The seizure lasted 3 minutes.  The patient went to the emergency room for an evaluation but was not admitted.  Subsequently, the patient recovered.  Upon internal review, seizure was considered as an other important medical event.  Additional information has been requested.  8/26/08 Reviewed ER medical records of 7/20/08. FINAL DX: seizure, conjunctivitis Records reveal patient experienced grand mal seizure lasting approx 3 min & had transient inability to move arms & legs.  Tachycardic in ER otherwise stable.  D/C to home & referred to neuro for outpatient w/u.  9/2/08 Reviewed neurological consult records of 7/21/2008. FINAL DX: none provided Records reveal patient exprienced witnessed passing out at a friends house after a sleep over.  Had generalized tonic-clonic seizure w/foaming at the mouth, cyanosis, bit her tongue & lasting approx 3 minutes.  CT scan reviewed & concurred WNL.  Suggested MRI/MRA of brain & EEG.
This spontaneous report as received from a nurse via company representative refers to a 63 year old female patient with mild asthma, osteoarthritis and seasonal allergies. The patient had no known drug reactions or allergies. On 07-NOV-2014, the patient was vaccinated with a dose of ZOSTAVAX, lot # reported as K0009773 (route and expiration date were not provided). Concomitant therapies included PROTONIX, PROAIR, SYMBICORT and diclofenac. On 08-NOV-2014, the patient experienced headache and feeling unwell. The next day, on 09-NOV-2014, the patient noticed pain on the left trunk and rash and on 10-NOV-2014, the patient went to urgent care and she was diagnosed with shingles on that visit to urgent care. Also on 10-NOV-2014, the patient reported burning sensation around left trunk area to urgent care provider and patient was prescribed VALTREX and gabapentin from urgent care. On 11-NOV-2014, the patient called the physician's office to report an outbreak of shingles but did not come to see the physician until 12-NOV-2014. At the time of the report, the patient's status was unknown. Additional information has been requested.
pt recv vax 8JAN96 & 18JAN96 devel a lesion @ the inj site & on 20JAN96 devel lesions on back;reporter was not sure how many lesions were on the pt back
Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain,  fatigue
11/2/07 1530 SWELLING, REDNESS, HEAT AND THE SIZE OF A GOLF BALL, LIGHT HEADED AND SICK TO STOMACH.11/3/07 0600 SWOLLEN AREA BIGGER, HOTTER AND MUCH LARGER AND STILL VERY PAINFUL. SHOWED IT TO MY NURSE MANAGER AND SUPERVISOR AS WELL AS STAFF FOR ADVICE.  I PUT ICE ON IT BUT NO RELIEF.
BlurredVision, Myalgia, Arthralgia, Fever, red painful eye diagnosed as nodular episcleritis Narrative:  Took Tylenol 500mg, 1000mg BID
Elevated systolic and diastolic pressure well above normal range into the dangerous range. Chills and widespread shaking.
Patient presented to the ED and was subsequently hospitalized for shortness of breath within a week of receiving COVID vaccination. She was diagnosed with acute on chronic respiratory failure with hypoxia.
Rash on cheek/neck area that occurred 2 days after vaccine. Area was itchy  when first popped up and now is just red with bumps
Within 5 minutes, the patient reported a numb tongue, followed by hot flashes and chills.  She took benadryl 25 mg by mouth and sat for monitoring  for about 30 minutes.  She went home when she was bit better.  I followed up in 24 hours and she said she was back to normal.
3/18/19 Had a local reaction to MMRV vaccination erythematous/itching at site w/o other symptoms. Treated with cetirizine with resolution. 3/29/19 fever/rash/and reactivation of local rash. Had URI symptoms so unsure if this was due to virus or separate reaction to the vaccine.
I began to have neck pain and feel achy and nauseous on Friday 8/27. When I woke up Saturday 8/28 I had a fever, more neck pain and diarrhea. On Sunday 8/29, I went to urgent care. While there my blood pressure dropped and my heart rate sky rocketed and I went unconscious, I was transferred to Hospital where they believed something was wrong with my heart. Once they stabilized me they transferred me to hospital to the critical care into on the cardiology floor where I was diagnosed with Myocarditis. I remained on this floor for 5 days.
Admitted 9/24 with right hand and arm cellulitis and pruritis and possible underlying HSV or VZV vesicles. WBC elevated.  Symptoms improving during treatment with antivirals.  During admission on 9/26, flu shot was given right upper arm.  Pt had chills overnight following injection.  Right arm aching 9/27.  MD unsure if r/t flu shot vs cellulitis.  Chills treated with acetaminophen x 1.  Pain covered with ibuprofen x 2 doses.  Antibiotic added 9/27.  Pt discharged on antiviral and antibiotic.
pt recvd vax & awakened screaming & crying; father stated pt had been given APAP; instructions given to taken pt to ER;
Patient presented in our Pharmacy in good health but feeling very anxious about receiving his first in series COVID 19 Pfizer vaccination. Patient was able to ambulate on his own after receiving the vaccine. Patient was sitting with his father and stated to him that he didn't feel right.  Patient then fainted  10 min after receiving vaccine. 911 was immediately called and Epi pen was not administered. Patient was not transported to the hospital.
Mother reports injection site was itchy, red, and swollen to size of softball x 1 wk. MD advised Benadryl, Tylenol, ice. Mother gave Tylenol and applied "cold compresses" and "itch cream".
Severely painful arm pain - lasted all afternoon - evening. Better next day. Got at 11 AM 10/4/16. Patient unable to use arm so painful. First time getting high dose.
2nd dose of PNEUMOVAX 23 given at 11 months instead of 5 yrs, Patient reported fever, cold symptoms, aches and pains which she said was brought on by second shot given way before, she also got a FLU vaccine same day.
Initial information received on 15-Aug-2018 regarding an unsolicited valid non-serious case received from a non-Healthcare Professional. This case involves 13 patients of an unknown demographics who received an expired dose of IPOL lot number not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. The patients received IPOL when it was out of range and expired. It was not reported if the patients experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Heart palpitations, irregular heart beats, chest pain in the heart, nonstop headaches for 4 days, fever, chills, body aches.
Neck pain; Arm pit pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) and PAIN (Arm pit pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced NECK PAIN (Neck pain) and PAIN (Arm pit pain). At the time of the report, NECK PAIN (Neck pain) and PAIN (Arm pit pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were provided. No Treatment information reported.
36 hrs post vax; chest congestion progressed to fever over 101, malaise, anorexia, spacey feeling x 72 hrs;
Pt was hospitalized with ITP 2.5 weeks post immunization. Symptoms started 2 weeks after immunization
mild sore muscle pain at the injection site; headache; This is a spontaneous report from a contactable consumer (patient). An unspecified aged gender patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry dates were not provided), via an unspecified route of administration, on 16Feb2021, as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 26Jan2021, as a single dose for COVID-19 immunization. It was reported that patient had experienced with mild sore muscle pain at the injection site and a mild headache for a couple of days that could as easily be attributed to normal workday stress. Patient do construction work and If Pfizer begin trials to test the efficacy of a booster vaccine against the Covid19 variants, patient would be happy to participate. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Itching, swelling, hot to touch, increasing in size and intensity to 2.5"x4"x1/8" at worst, approximately 36 hours after injection.
Extreme fatigue 1hr after injection, lasting 10 days; extreme muscle aches lasting 48 hours; site pain ongoing (today is 4/2); mild headache beginning 2 weeks after, continuing; loss of energy ongoing; energy at @ 80% of normal; mild muscle aches continued for 3 weeks.
6x8cm area of redness, warmth and swelling to left upper arm, with central bruising.
Menstrual cycle was affected. Last month period started on the 18th. This month it started yesterday on the 7th. That's not even two weeks between her cycles. She had always regular with cycle. Always; A 37 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 08:45 (Lot number: Fc3183) at the age of 37 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Other medical history: No. There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose: 1), administration date: 15Sep2021, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 07Oct2021, outcome "recovering", described as "Menstrual cycle was affected. Last month my period started on the 18th. This month it started yesterday on the 7th. That's not even two weeks between my cycles. I am always regular with my cycle. Always". Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: No other vaccines in four weeks. No other medications in four weeks. No covid prior to vaccination and no covid tested post vaccination. There were no known allergies and no other medical history.  Follow-up attempts are completed. No further information is expected.
DIRECTLY FOLLOWING THESE SHOTS, MY DAUGHTER GOT HUNDRED OF SMALL RED DOTS ON HER NECK, BECAME VERY HOT (FEVER), WAS PULLING ON HER EARS, HAD WATERY EYES, AND DID NOT SEEM LIKE HERSELF AT ALL. DOCTOR EVALUATED AND PRESCRIBED "RN X 2 WKS AFEB" WHICH HAD BEEN SENT TO OUR PHARMACY. WE WERE ALSO ADVISED TO GIVE TYLENOL, WHICH WE DID, AND IT DID NOT SEEM TO HELP OR DO MUCH. SHE SEEMED MISERABLE AND NOTHING WOULD SOOTHE HER OR EASE THE SYMPTOMS. WITHIN 3-4 WEEKS (AFTER MEDICATION) THE SMALL DOT RASH HAD IMPROVED SLIGHTLY BUT SEEMED THAT HER LITTLE BODY COULDN'T FIGHT OFF WHATEVER IT WAS. SHE BECAME SUPER SENSITIVE TO CERTAIN FOODS, SHAMPOOS, LAUNDRY DETERGENTS, ETC. HER SKIN WOULD FLARE UP IN A BAD REACTION , WHICH HAD NEVER HAPPENED TO THIS EXTENT BEFORE. TODAY, SHE STILL GETS THESE DOTS WHEN SOMETHING IS TRIGGERED.
This spontaneous report has been received from a female physician office manager who was also the patient, via a field representative, concerning herself. The patient's medical history, concurrent conditions, drug allergies and concomitant therapies were not reported. On 16-FEB-2018, the patient was vaccinated with PNEUMOVAX 23 with lot # N022303 and expiration date on 01-MAR-2019 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis. On an unknown date in 2018 (reported as "shortly after receiving PNEUMOVAX 23"), the patient experienced injection site swelling which included swelling of the majority of her arm. The patient did not seek medical attention. It was reported that she took TYLENOL for this swelling and it resolved on an unknown date in 2018 (reported as "after several days"). At the time of reporting, the causal relationship between injection site swelling and peripheral swelling, and PNEUMOVAX 23 was unknown. This is one of two reports regarding the same patient. Sender's Comments: US-009507513-1807USA012213.
pt recvd vax; pt had high pitched crying > 3 hrs; severe local rxn; not taken to er;
2nd dose  after 30 mins- dizziness after 3 hours- extreme fatigue after 8 hours  for next 3 nights- severe headache, vivid dreams,  hallucinations, out of body experience, panic, nausea
Initial information received on 11-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves a 18 months old patient (gender not reported) who was vaccinated with a dose of ADACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Caller has been bleeding blood clots out of caller's vagina/Now in the month of Apr and caller is still bleeding blood clots out of vagina.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 09Jan2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 2022, outcome "not recovered", described as "Caller has been bleeding blood clots out of caller's vagina/Now in the month of Apr and caller is still bleeding blood clots out of vagina.". Therapeutic measures were taken as a result of vaginal haemorrhage. Additional information: since the patient received the first dose of the Pfizer covid 19 vaccine, patient had been bleeding blood clots out of her vagina. Now in the month of Apr2022 and patient was still bleeding blood clots out of vagina. She had spent (dollar) 300 dollars on tampons, wipes, and laundry because of this. The patient stated that the blood clots were the size of pancakes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was give an expired dose - she was notified on 8/18/22 and will return for repeat dose, per CDC recommendation - This was her 4th dose -
Sore shoulder and arm, general tired, body aches, chills, slight stomach upset no fever or vomiting;lasted  about 24 hours.
PULMONARY EMBOLISM; THROMBOSIS; COR PULMONALE ACUTE/ DYSPNOEA; HYPOXIA; DIZZINESS; COUGHING; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1120494) concerned a 68 year old female unknown ethnicity.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included amitriptyline for sleep, and zolmitriptan for migraine.  On 07-MAR-2021 08:30, the subject experienced pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing, and was hospitalized (date unspecified). On 12-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) normal, Blood test (NR: not provided) normal, CT scan (NR: not provided) Pulmonary Embolism, Chest X-ray (NR: not provided) normal, Diagnostic ultrasound (NR: not provided) No blood clots or vein thrombosis, Echocardiography (NR: not provided) Increased pressure on the right side of heart due to blood clots, and Heart rate (NR: not provided) elevated. Treatment medications (dates unspecified) included: oxygen, salbutamol, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the  pulmonary embolism, thrombosis, cor pulmonale acute/ dyspnoea, hypoxia, dizziness, coughing was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition); Sender's Comments: V2:Additional version created for MAC update. This updated information does not alter the causality of previously reported events. 20210441745-Covid-19 vaccine ad26.cov2.s-Thrombosis, pulmonary embolism ,Cor pulmonale acute, Hypoxia, dizziness, cough. These events are considered unassessable. These events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
In less than 12 hours, the patient started developing pain in injection region. This morning, patient noticed significant redness and swelling around the site and down the left arm.
Pt was being observed x 30 mins due to sulfa drug allergy. Pt was observed and without complications, after 25 mins her husband stated she was reporting feeling dizzy. Checked her BP 130/65 RA, HR 131, LA 125/75.  Called for assistance from ER, complaints from pt of difficulty breathing. 02 started via nasal cannula, also administered Epi-pen x 1. ER RNs arrived and taken to ER via stretcher with husband in accompaniment.
9/30 at 4:30pm became dizzy at bedtime felt achy on arm. Wednesday noon, cold sweats took 2 ADVIL. Headaches and pressure along with hot and cold sweats. Took 2 more ADVIL. Called Doctor Thursday.
Pain, redness, swelling, and bruising at the injection site. 12 hours later I had chills, fever between 99-101, thigh pain, body aches for 12 hours. Fatigue for 3 days following vaccine. Headache and back pain 5 days after vaccine.
Within 60 seconds of getting my shot, my left wrist and hand had sharp pains in them.  Lasted about 30 minutes or so. Afterwards, had tingling and a little numbness in my left hand.
Information has been received from a physician concerning himself, a 61 year old male patient with a history of pain and vaccine reaction and no known drug allergies who "about 10-12 years ago" received the INFLUENZA vaccine (unspecified), and within a few hours he felt soreness on his left side, where the injection was given. It spread to the whole left side of his body and lasted for about a day. On 16-FEB-2009 patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not provided) 0.65 ml. Concomitant therapy included FLOMAX and SIMVASTATIN. On 18-FEB-2009, "2 days after receiving ZOSTER (Oka/Merck), the patient experienced soreness and hypersensitivity around his lower back and lower stomach. Patient sought unspecified medical attention. Routine labs were performed. Therapy with ZOSTER (Oka/Merck) was discontinued. The patient's soreness hypersensitivity around his lower back and lower stomach persisted. Additional information has been requested.