chrisvoncsefalvay/vaers-outcomes huggingface dataset:
knot above her collar bone; like a node just above my collar bone and half inch from my neck and the swelling that was around it; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received second 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 left arm on Feb2021 (at the age of 68-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included diabetes mellitus and hypertension. The concomitant medication(s) included atorvastatin 10 mg, metformin 1000 mg, hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) 37.5 mg half per day, pantoprazole 40 mg and mometasone furoate monohydrate (MOMETASONE FUROATE) 15 mcg nasal spray 2 squirts a day. The 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 on an unspecified date (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient reported on Feb2021, next night around 19:00 following vaccination, I noticed like a node just above my collar bone and half inch from my neck and it's still there and the swelling that was around it has gone down from what I can hardly tell swelling was there but the little node as still there. So I need to know what I should do, if that has come from the vaccine and it's on the left side which was the left arm where I got the injection. The patient underwent lab tests and procedures which included glycosylated haemoglobin of blood work AIC with unknown results on unspecified date and HTC with unknown results on an unspecified date.  Patient took Tylenol for the event. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Immediately following administration of the vaccine, the patient reported lightheadedness, tinnitus, and paresthesia of extremities. Patient experienced these symptoms within 15 seconds of vaccine administration. Symptoms persisted for approximately 15 minutes.
Chronic loud tinnitus began a few days after the first dose and had continued until today; Vaccine administered at inappropriate site; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right leg on 02Apr2021 at 12:30 (at the age of 64-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 27Apr2021 at 16:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. 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 COVID-19 vaccine. Concomitant medications were not reported. On 02Apr2021 at 12:30, the patient experienced "chronic loud tinnitus began a few days after the first dose and had continued until today". The event resulted in doctor or other healthcare professional office/clinic visit. 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 "chronic loud tinnitus began a few days after the first dose and had continued until today" was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse concerning a 24 year old female with a history of panic attacks who on 07-Nov-2006 was vaccinated with a 0.5 ml dose of Gardasil vaccine (yeast) (lot#653938/0954F). Concomitant therapy included Asacol. On 07-Nov-2006 later that night, the patient experienced tachycardia and difficulty breathing. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/16/2007.  Information has been received from a nurse concerning a 24 year old female data assistant with Crohn's disease and allergies to CLINDAMYCIN and CODEINE a history of panic attacks who on 07-NOV-2006 at 14:30 was vaccinated into the right deltoid with first a 0.5 ml dose of GARDASIL (lot # 653938/0954F).  Concomitant therapy included ASACOL.  On 07-NOV-2006 later that night, the patient experienced tachycardia and difficulty breathing.  No other symtoms were noted.  Unspecified medical attention was sought.  On 08-NOV-2006, the patient recovered.  No product quality complaint was involved.
Per patient develop body rash with pruritus day of flu vaccine injection 9/27/11 at home evaluated 10/5/11 body rash throughout body.
Information has been received form a 75 year old female patient with no pertinent medical history and drug reactions/allergies reported who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml injection (route and administrating site not reported). There was no concomitant medication. On 14-JUN-2008 the patient developed shingles. The patient's shingles persisted. The patient did not seek medical attention.
11:30 am 11/17/06 pt reported pain at left deltoid shooting down left arm, no redness, swelling, induration noted. No resp distress observed. 11:40 am left message Dr office stated will give message to Dr when he calls 12:30 pm 11/20/06 spoke to pt by phone arm feels much better and every day getting better. Has been applying ice to arm per Drs instruction, states he called her on Friday.
After 1st dose of vaccine experienced headache and extreme fatigue. Began about 2 hours post-injection. Headache lasted 8 hours. After 24 hours the fatigue was moderate and persisted a total of 36 hours. Blurred vision occurred 8 hours post-vaccine and  has persisted +72hours. Twitch in right eye-lid persistent with blurred vision from squinting.
He came down with covid-19 and was hospitalized; He came down with covid-19 and was hospitalized; pneumonia in both lungs; he had 3 blood clots in his lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, DOSE NUMBER UNKNOWN, primary series completed.), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), SUSPECTED COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "He came down with covid-19 and was hospitalized"; PNEUMONIA (medically significant), outcome "unknown", described as "pneumonia in both lungs"; PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "he had 3 blood clots in his lungs". Clinical course: Caller knows of 2 cases: one was a cardiologist who had his primary series and was boostered. He came down with covid-19 and was hospitalized, pneumonia in both lungs and also he had 3 blood clots in his lungs." Caller also says she knows people who had the booster who got very sick and some people didn't get sick at all.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache; Joint aches; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 31Mar2021 at 10:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the arm left on 10Mar2021 at 11:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 01Apr2021 at 06:00 the patient experienced headache and joint aches. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not received any treatment for the adverse events. The clinical outcome of the adverse events headache and joint aches were resolving.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a Doctor of pharmacist refers to a 79 year old male patient with no drug reactions or allergies. On 18-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # H0199996, expiration date 02-FEB-2014), subcutaneously. The pharmacist reported that almost immediately upon administration of the vaccine on 18-MAR-2013, the patient developed a raised, pale yellow, circular bump around the injection site. There were no lab diagnosis or studies performed. The outcome of raised, pale yellow, circular bump around the injection site was reported as not recovered/not resolved. Additional information has been requested.
6/8/10 at 0130 Awakened with some difficulty breathing and swallowing. Took prednisone 20mg. 6/8/10AM She called PA-C. He told her to increase take prednisone 60 mg. Continued having difficulty with swallowing and breathing intermittently so contacted her neurologist. 6/10/10 Saw doctor-he sent her to hospital ICU to receive prednisone 100 mg IV, then they sent her home telling her to take an additional 30 mg that evening and then to take 50 mg daily. Some days symptoms would be absent, but some days they would be back. She was feeling very weak and worn out during all this. 6/15/10 Saw a neurologist (she already had this appointment for another matter) and told her all of these things that had been going on since the immunization. This neurologist told  her to start decreasing the prednisone by 10 mg per week and when she gets to 20 mg she is to call for there for further instructions. 6/21/10 Pt reported all this to us at Health Dept. 6/22/10 At this time, pt is supposed to be taking 40 mg prednisone daily-states some days symptoms return. Today she is feeling very weak but breathing and swallowing are good.
Some irritation in my nose/on the inside of his left nostril; Runny nose; Little pain in the arm; Some minor pain at the COVID-19 Vaccine injection site; Headache; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 20Jan2021 (09:00) at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 20Jan2021, in the evening, the patient had a little pain in the arm; some minor pain at the COVID-19 vaccine injection site; and headache. The patient had received paracetamol (TYLENOL) as treatment for the headache. On 21Jan2021, the patient had some irritation in the nose/on the inside of his left nostril; and runny nose. The outcome of the events, 'little pain in the arm', 'minor pain at the vaccine injection site', 'headache', 'some irritation in the nose/inside of left nostril' and 'runny nose', was unknown.  Information about lot/batch number is requested.
Fussiness. Temp to 100 (normal temp) decrease PO intake, vomiting, viral gastroententis
severe case of shingles including enteric shingles; heart palpitations; rash; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (severe case of shingles including enteric shingles), PALPITATIONS (heart palpitations) and RASH (rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HERPES ZOSTER (severe case of shingles including enteric shingles), PALPITATIONS (heart palpitations) and RASH (rash). At the time of the report, HERPES ZOSTER (severe case of shingles including enteric shingles), PALPITATIONS (heart palpitations) and RASH (rash) outcome was unknown.            No concomitant medications were provided by the reporter.  The patient stated she was unable to get any antiviral medications because she had just been vaccinated. 6 weeks passed and she began to feel better.   This case was linked to MOD-2021-040781 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains  No NewInformation
Approximately 6 hours after receiving the vaccine, I started feeling feverish and having body aches. Over night, I woke up with a low grade fever, severe body aches, and a severe headache. Those three symptoms lasted throughout the day, 4/8. I woke up at approximately 7:15am on 4/9, and my symptoms were mostly gone, with some lingering muscle soreness. Today, 4/10, I am feeling nearly 100% again
Patient complained of a rash that showed up about one week after the administration of the vaccine.  He also complained of some numbness on his arm.  Called the manufacter and let them know and they did not send me a copy of VAERS statement.  Phone number on file is not getting any return call backs so unable to contact patient.
Bright red circle 2 inches in diameter where the shot was given; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Bright red circle 2 inches in diameter where the shot was given) and MYALGIA (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History Information was Reported.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Bright red circle 2 inches in diameter where the shot was given) and MYALGIA (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (Bright red circle 2 inches in diameter where the shot was given) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication Information was Reported Contact information was updated. Caller confirmed side effects previously reported. Some information was lost due to system crashing.   This case was linked to MOD-2021-067622 (Patient Link).
VARIVAX Vaccine was given intramuscularly not subcutaneously as directed by package insert. The vaccine manufacturer was notifed and told there should be no issues.
Reports his throat was swelled, he had chest pain in which he took nitro for, tired, sweating both morning and night, and had an upset stomach.
Pt had second COVID vaccine 11 days ago, and is still not feeling well.  Pt is very tired, nausea, body aches, brain fog, cold then hot temp(~100), no appetite.  Pt states she can hardly get out of bed.
She had symptoms of shingles last Sunday; She noticed burning and tingling on the left side of her head; She noticed burning and tingling on the left side of her head; Shingles was reported as worsened; This is a spontaneous report from a contactable consumer (patient herself) via Medical information team. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL0140) via unknown route of administration on 12Jan2021 14:00 PM at single dose in left arm for COVID-19 immunization at nursing home. Medical history included ongoing high blood pressure. Ongoing concomitant medication included metoprolol orally at 50 mg, once a day taking for 10 years and hydrochlorothiazide orally at 25 mg, once a day taking for 3 years both for high blood pressure, mecobalamin (B12) orally at 1000 ug, once a day taking 6 years for low b, colecalciferol (D3) orally at 100 ug, daily (50mcg; take two daily by mouth) taking for 6 years for low d. Patient received the first dose of the Pfizer covid vaccine on 12Jan2021 and her second dose was scheduled 02Feb2021. She had symptoms of shingles last Sunday on 29Jan2021 and was given famciclovir and was advised to not take the scheduled second dose of the vaccine. The next time that the vaccine will be given in their facility is on 22Feb2021-23Feb2021, and she wants to know if she can get the vaccine despite having shingles. However she came down with shingles. Adds she is being treated with Famciclovir 50mg; take three times daily by mouth. Her doctor recommended she not get the next dose of the Pfizer COVID 19 vaccine on 02Feb2021 so she stayed home and did not get it. Should she get the second dose? She noticed burning and tingling on the left side of her head in Jan2021 and then shingles on 29Jan2021 on the left eyebrow and hairline. Also shingles was reported as worsened in 2021. Adverse events required a visit to physician or ER was reported as Urgent care but not to the hospital. No Prior Vaccinations (within 4 weeks). The outcome of events shingles and condition worsened was not recovered, while for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Case number PHEH2015US021219, is an initial spontaneous report from a health care professional received on 19 Oct 2015. This report refers to a 14 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly on 15 Oct 2015. The case was assessed as non-serious. No adverse event was reported.
Migraines returned after 2 years, but with increased duration than usual. Sharp stabbing pains located in two spots of scalp. Pain level 9. ER visit 3 days in a row to minimize pain, but never fully treated. Lasted 3 intense days with 4 lingering days of pain level 5. Also had fever for 3 days with chills. Along with a kidney infection that occurred on the same day.
Chills around 3am night of vaccine, moderate myalgia, specifically in neck and lower legs day after vaccine. Resolved completely 2nd day. No fever noted.
blood clot in her leg; severe leg pain and cramps; severe leg pain and cramps; she can't even stand long enough to brush her teeth; my sister continually cries from pain and frustration; This is a spontaneous report from a contactable consumer. A female patient of unknown  age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration at unknown dose single for COVID-19 immunization. No medical history reported. No concomitant medication reported. The patient start experiencing blood clot in her leg, then severe leg pain and cramps, continually cries from pain and frustration. The outcome of Events was unknown.  Information about lot/batch number has been requested.
Lymphnode in Left side of neck swelled up.  Sought care at Health Services, but none could be provided.  Painful for a time.  Went away after about three months.  Came back with third dose of HPV vaccine.  Has not yet gone back to normal completely.  It has been three months. 8/15/07-records received from clinic. Diagnoses for DOS 10/10/06-2/8/07- include pelvic pain with C/O menstrual type cramps. Abdominal pain with C/O abdominal cramping. Enlarged lymph node left neck. Painful. HX of mono. Neck hurts less but has some nasal congestion. Bilateral rib pain. Lymphadenopathy. Lump in neck first appeared around 10/28/06-Lymphadenitis. Cold few days prior to first vaccine
FLUBLOK being administered to 12 year old with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA402510(CLUSTER).  This case involves a 12 years old female patient who was administered Influenza Quadrivalent  Recombinant Vaccine [Flublok] at inappropriate age with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Immunisation.  On 14-Sep-2022, the patient of 12 year received Influenza Quadrivalent Recombinant Vaccine at dose of 0.5 ml, once (formulation, strength: unknown) (lot UJ887AA, exp date: 09-Jun-2023) via intramuscular route in the left deltoid for Immunization with no reported adverse event (product administered to patient of inappropriate age).  Action taken not applicable.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
35 minutes after flu shot had TIA like symptoms. Experienced strange sensation through my body then Limbs felt heavy and weak. Lasted about 5 minutes. Blood pressure 189/88. Followed up with cardiologist and schedule for several cardio tests. Also seeing neurologist in January.
After I received the shot within 10 minutes, my heart rate skyrocketed. I was monitored by the EMTs for 45 minutes. I was pale and it took a few days for my heart rate to come down.
Woke up the next morning and the third digit on my left hand was swollen and could not bend finger at all. Over the period of the next few months I experienced numbness, tingling, swelling and pain in several fingers palms, wrist and toes, left knee with pain radiating up both arms. Hands were incredibly cold to the touch though felt like they were on fire. As of today I still have swelling, pain in multiple joints and cannot bend fingers or put pressure on joints because of the pain and cannot perform my job fully as a graphic artist. I was seen by my primary doctor on 5/5/2015 who ordered blood work and recommend I see a rheumatologist. She was very helpful in getting me in to a rheumatology office right away. I went to a rheumatologist, but saw a nurse practitioner, who prescribed a 7 day treatment of Prednisone, x-rays of hands and knee, and more blood work. Will start the prednisone treatment tomorrow.