chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nodule under left armpit, very painful; nodule under left armpit, very painful was reported as worsened.; nodule under left armpit, very painful was reported as worsened.; states it keeps growing and growing and is now the size of a quarter, states it has developed like a head on it, like a cyst; hard time breathing; Fatigue; tender breasts and under left armpit; tender breasts and under left armpit/ arm pits were starting to hurt; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0198), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jun2021 (at the age of 48 years) as dose 2, single for COVID-19 immunisation. Medical history included ongoing asthma diagnosed over 15 years ago. There were no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot# EW0186), dose 1 via an unspecified route of administration in Left arm on 20May2021 (at the age of 48 years) for COVID-19 immunisation. Consumer stated, on 30Jun2021, the next day consumer was fatigued and her breasts were really tender and arm pits were starting to hurt. On an unspecified date consumer developed a small nodule under left armpit a few days later, it kept growing and growing and now the size of a quarter and it has developed like a head on it, like a cyst, today it had a whitehead on it, stuff started coming out of it, put some peroxide and Neosporin on it and it hurts really bad and also taking Aleve and Ibuprofen every 6 hours and was applying cold compress and warm compress to the site. Consumer stated that consumer was having a hard time breathing after second dose and treated with nebulizer, hydrated and was told that consumer could be fatigued. Consumer thought the cyst was from her skin rubbing. The outcome of event painful nodule and breathing difficult was not recovered and for all rest events was unknown.  No follow-up attempts are possible. No further information is expected.
HEACHE; PHOTOSENSITIVITY REACTION NOS. Information has been received concerning a patient who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). Concomitant therapy that day included a dose of measles-mumps-rubella vaccine (MSD). Subsequently, the patient developed a headache and light sensitivity. Unspecified medical attention was sought. Additional information has been requested.
Within 6 hours of vaccinations had an acute reaction of dystonic muscle spasm causing head to twist to her right shoulder and extreme irritability. She was unable to move her head for minutes, this improved but then recurred and resolved. Associated with high fever.
Developed Deep Vein Thrombosis. Diagnosed 30Apr2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 14:30 (Batch/lot number: EN8207) as 2nd dose, single for COVID-19 immunisation. Medical history included Diabetes, High Blood Pressure and High Cholesterol, all from an unknown date. There no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in Arm Left on 11Mar2021 11:45 AM (Batch/lot number: EP7533) at the age of 59-year-old for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient developed deep vein thrombosis since 07Apr2021, which was diagnosed on 30Apr2021. Therapeutic measures were taken as a result of deep vein thrombosis which included Prescribed Xarelto. The adverse event result in Doctor or other healthcare professional office/clinic visit. The outcome of event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
After vaccines administered, patient said she felt dizzy. Within seconds patient passed out, eyes rolled in head and teeth clenched on a lollipop she was eating. Patient started to moan, and came to after 15-20 seconds. Color very pale, sweaty, shakey, pupils pinpoint. Upon patient coming around she said she felt like she had a dream. She knew her name and where she was. I elevated her feet and got a cool compress to her head. She drank 10 oz of ginger ale and sat for 20 minutes while her color returned to normal and she said she was feeling much better. Mom said her daughter gets weak at the sight of blood. After 20 minutes 1 had her sit for 10 more minutes with her feet down before being driven home by mom. Patient said she felt almost like herself. I followed-up and called mom's cell phone 90 minutes later and she said patient ate all her lunch and was doing fine. I advised mom to keep a good eye on her and keep activity minimal for the day. Asked to call own DM if symptoms worsened. Vitals: 98/72 right after fainting, 80/56 2 minutes later, 104/68 10 minutes Pulse 76. 108/66 just prior to going home
Ringing in my left ear; This is a spontaneous report from a contactable healthcare professional, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 14:30(at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not did not receive any medications within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Apr2021 at 14:30(at the age of 51-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 12:00 the patient experienced ringing in her left ear. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ringing in her left ear was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse refers to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 15-AUG-2016, the patient was vaccinated with improperly stored VARIVAX (Lot # M023379 and expiry date 11-MAY-2018). This dose of VARIVAX had had a temperature excursion of 4 hours at 27.5 F. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No information about medical history, drug reactions and allergies was specified. On 22-SEP-2014, patient was given the ZOSTAVAX (lot#, dose, route not reported). No concomitant medications were reported. The field representative reported that the pharmacist called in to report the events. The pharmacist reported that on 23-SEP-2014, the patient experienced adverse events of - site of injection swelling, redness, itchiness and soreness. The patient is now starting to have "tingling in other parts of her body" (the "other parts of her body" was unspecified by the field representative). She was unsure of where the tingling was located. The pharmacist said she recommended the patient to see her doctor and the patient will go in to see her doctor today. There was no product quality complaint. The outcome of the events was reported as not recovered. The causality of the events was not specified. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of lymphangitis in a 64-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received SHINGRIX. In June 2018, immediately after receiving SHINGRIX, the patient experienced lymphangitis (serious criteria GSK medically significant). On an unknown date, the patient experienced granulomatous thyroiditis. On an unknown date, the outcome of the lymphangitis was resolved with sequelae and the outcome of the granulomatous thyroiditis was unknown. It was unknown if the reporter considered the lymphangitis and granulomatous thyroiditis to be related to SHINGRIX. Additional information was received as follows: At the time of reporting, the patient was 64 years old. The age at vaccination was not reported, however, it could be 63 or 64 years. The physician stated that the patient received SHINGRIX in the middle of June. The physician reported that the patient developed lymphangitis which resolved after 4 to 5 days. The patient later showed signs of subacute granulomatous thyroiditis. The physician was out of office at the time of call and did not have additional information.
Fever 101f, chills, nausea, lethargy, malaise  all for 36 hours
Was perfectly normal until I laid down for bed.  Got very dizzy and took blood pressure with a cuff and it reported 95/47.  Hypotension, shakiness and mild nausea.  I've never had this symptom in my life and have taken 3mg melatonin before bed for years.  (3mg, not 4mg as reported on the previous page).  I was back to normal after ~10 minutes and woke up perfectly normal. Also, minor shoulder pain.
Patient received PNEUMOVAX and Flu shot in same arm. On 10/15/2010 received the immunizations. On 10/18/2010 noted with localized pain and erythema.
Numbness in right leg below knee that went down to her foot.  Sometimes this also occured in left leg.  Woke up 11/9 stating she could hardly walk.  Seen by MD who reports no impaired motor function.  12/07/09 Clinic progress record for DOS 11/09/09. DX: Leg numbness Patient presented with c/o leg numbness x 4 days. Felt weak upon waking this morning. Weakness now resolved. Leg numbness began within 15 min after receiving vaccination. Numbness below knees towards ankles. On examination, numbness reported at top of shin area below R. knee down toward ankle, but not the foot. Has normal strength, balance and reflexes.
Strong metal taste; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Mar2021 10:30 (Lot number: ENW99) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). Concomitant medication included: PLAQUENIL. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The following information was reported: DYSGEUSIA (non-serious) with onset 19Mar2021, outcome "not recovered", described as "Strong metal taste".  No follow-up attempts are possible. No further information is expected.
The patient fainted; This is spontaneous case, initially reported by physician via Merck via Communications (reference number: SEQ19-07021) on 25-Nov-2019, concerning an 17-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 09-Nov-2019, the patient was administered the second dose of Gardasil 9 [hpv vaccine vlp rl1 9v (yeast); dose, route of administration, anatomical location, batch number and expiry date: not reported] for an unknown indication.  On the same day, the patient was also administered INN Flu Vaccine [Influenza vaccine; dose, route of administration, anatomical location; batch number and expiry date: not reported] for an unknown indication.  On the same day, after vaccination, the patient fainted.  The patient recovered after a few minutes and was given juice. The patient was observed.   The event of faint was considered serious due to the criterion of medical significance (the event is on IME list).  The reporter did not provide causality assessment.  Company Comment: The patient experienced syncope after vaccination with the suspect product, INN Flu Vaccine. Chronology is plausible. Causality was strongly confounded by use of co-suspect product Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant); No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as possibly related.; Sender's Comments: The patient experienced syncope after vaccination with the suspect product, INN Flu Vaccine. Chronology is plausible. Causality was strongly confounded by use of co-suspect product Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant); No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as possibly related.
Patient received Pneumovax 23 on 11/18/2016.  Patient had site reaction on 11/19/2016, it progressed to swelling and warmth to the touch of the upper left arm.  On 11/21/16 the doctors office stated patient possibly developed cellulitis and started the patient on oral antibiotics.
At 4 AM woke up during night with nausea. Then during next day 10/22 felt light headed and difficulty concentrating and just felt weak and "not well". Then on 10/23 developed localized reaction red, raised area on arm approx 2.5mm and developed cough. No fever or any other symptoms.
Patient states he was unable to move arm after having vaccine. Presented to office 1/11/18 reports he has pain right arm, entire right shoulder blade, right back, has muscle soreness in right upper chest. "Pain is increasingly getting worse". Patient reports he has taken Motrin and muscle relaxers "not helping pain". RN referred patient to Physician for further evaluation. Recommended ROM exercises, icing/heating on/off, continue taking anti-inflammatory medication. Patient verbalized understanding. Scheduled appointment with Physician for the afternoon of 1/12/18.
Patient began feeling hot, "head pounding",  facial flushing, and developed red rash all over her anterior chest wall. She was then transferred to the medical evaluation area and  examined. She was evaluated and given Benadryl 25mg . Her vitals were within normal limits. A few minutes after taking Benadryl, her symptoms started to diminish and she was no longer feeling flushed or having pounding in her head. The rashes on her anterior chest wall remained. Patient denies any any shortness of breath, chest pain, wheezing, or having tingling in her tongue or lips. Her vitals within normal limits. Patient felt stable upon leaving the facility and advised to follow up with her PCP and an allergist for further care. Patient refusing to be transferred and evaluated by ER facility
1st dose 31-JAN-2022, 2nd dose on 3/22/2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 22nd March 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The health care professional reported that she had received the 2nd dose of Twinrix later than recommended interval. The patient asked that she will be able to get her 3rd dose now. The reporter consented to follow-up via email. Additional supportive information: The patient received 2nd dose of Twinrix later than recommended interval, which led to lengthening of vaccine schedule.
Sore right arm and shoulder for approximately 64 hours. Sore especially when lifting arm up to side. No medical treatment sought.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs; "Rheumatoid Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Negative; (24Jun2022) Positive, notes: a faint positive test; (25Jun2022) Positive, notes: the test was very positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID 19 Treatment: Paxlovid from 15Jun2022 to 19Jun2022, Adverse event Rebound infection after testing negative. Congestion and sore throat returned on 24Jun2022 followed by a faint positive test.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2105, the unspecified number of patient were administered unspecified doses of improperly stored RECOMBIVAX HB (lot # K014697 and expiry date: 04-FEB-2016). No adverse effects were reported. No product quality complaint (PQC) was reported RECOMBIVAX HB. This is one of the several reports form the same reporter. Additional information has been requested.
Pt got their shot on 4-7-21 and was fine, until today 4-16-21.  She said that she woke up with a very sore arm. a red "dot" and swelling at the injection site.  I recommended she go to her doctor, which she didn't have one, so I told her it was important to be seen today, so she is going to an urgent care.  I don't know the treatment or outcome.
Child appeared to expierence a complex partial seizure which lasted approx. 20 seconds.  Vitals were within normal range 911 was notified  blood sugar was 127 she had not eaten parents were recommended to take her to her doctor  mother stated that this has happened before with shots.
Fever, chills, body aches began around 10 PM. Reached peak at 2:30 AM at 101.6. No treatment. Around 8:30 AM fever was 99.6 with body aches. Treated with Ibuprofen 600mg and symptoms cleared up around 10:00. No further reaction.
She got sick, pain in the arm and neck the day after the vaccine.  I called her doctors office on the 19th of Feb and I did not get a call back.   She was sick to her stomach, really tired and lost her appetite.   On the 22nd I called her doctor again... no response, on the 23 I called again.  On the 24th finally someone spoke to me.. they stated they had called my mom and spoke with her.  They are suppose to call me, my mom could not remember by the time she would hang up.  They said to let her rest and give her electrolytes and Vit. B6.  On the 26th when I called the doctor and said she is lethargic they said to take her to the ER.  She flat lined at the hospital and her body went into shock.  She ended up having Kidney, Heart and Liver Failure.  She was still driving and doing all of her cooking, banking, shopping, showering, walking every day on Feb 18th.  She died on March 5th.
progressive shortness of breath following vaccination starting on day of 2nd shot, resulting in hospitalization 3/11, normal CT pulmonary angiogram, elevated troponin, echo with EF 48% and focal hypokinesis, normal coronary angiogram, and Cardiac MRI showing myocarditis
Pt received PNEUMOVAX & flu vaccine in (R) deltoid. Developed redness, swelling and itching later that night.
typical vaccine side effects; burning sensation in my internal organs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation in my internal organs) and VACCINATION COMPLICATION (typical vaccine side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced BURNING SENSATION (burning sensation in my internal organs). On an unknown date, the patient experienced VACCINATION COMPLICATION (typical vaccine side effects). At the time of the report, BURNING SENSATION (burning sensation in my internal organs) and VACCINATION COMPLICATION (typical vaccine side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not reported.  Treatment details was not reported .
Swollen lymph nodes under arm of vaccine site. Tissue of underarm in normally concave area adjacent to breast observed to protrude approx 2 inches. Area tender to touch.  Duration: ~1.5 weeks Decreased stamina ~ 2.5 weeks
Gave Pfizer vaccine rather than the Bivalent booster dose. vial is same color. No harm to patient.
death Narrative: Patient received Moderna covid vaccine # 1 on 2/26/21. Per scanned records on 3/18/21, he presented to the ER with reports of shortness of breath and was subsequently admitted and treated for acute CHF, NSTEMI and sepsis (ceftriaxone and azithromycin). He later developed AKI and surgery was consulted for placement of a Trialysis catheter. After placement of this catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue. Autopsy reports not available. 22 days from date of vaccine to date of death.
Patient complained that it was given too high and her arm is continuing to hurt even now. She is going to make a doctor appointment.
MO reports welps on abd, chest and under arms on 11-15-08 went to health services in city.  Clinical impression acute allergic reaction. Resolved with BENADRYL & PRELONE