chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knot in the left arm about the size of a golf ball; pain in arm; Warm to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-May-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Knot in the left arm about the size of a golf ball), PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE WARMTH (Warm to touch) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, the patient experienced PERIPHERAL SWELLING (Knot in the left arm about the size of a golf ball), PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE WARMTH (Warm to touch). At the time of the report, PERIPHERAL SWELLING (Knot in the left arm about the size of a golf ball), PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE WARMTH (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, the patient was taking some other unspecified medications. Treatment details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-138301 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-138301:crosslinked
Slight soreness at injection site, slight nausea. tiredness. headache.  general achiness
Vaccines given 7/6/04. Fever noted later that day. Pt awoke with a red maculopapular serpiginous like rash on 7/7/04. Rash began on legs and arms then migrated to trunk. Both checks later that PM/ early AM 7/8/04. Afebrile on 7/8/04.
He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got; He could hardly walk; Lightheaded and dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue). On 22-Mar-2021, the patient experienced ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) (seriousness criterion hospitalization) and GAIT DISTURBANCE (He could hardly walk). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to ANAEMIA. At the time of the report, ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got), GAIT DISTURBANCE (He could hardly walk), DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included blood transfusions. Concomitant product use was not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I formed a series of blood clots in the sinus veins on the surface of my brain.; This is a spontaneous report from a contactable consumer (patient). This 25-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in left arm in 2021 at the age of 25-year-old for COVID-19 immunization. The first dose was on 27Feb2021 04:00 PM in left arm at the age of 25-year-old. Patient had allergies to hydromorphone hydrochloride (DILAUDID) in the past. Medical history was not reported. Concomitant medications received within 2 weeks of vaccination included omeprazole; drospirenone/ethinylestradiol (LORYNA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Nasal Swab SARS-CoV-2 RT-PCR was negative on 31Mar2021. The patient formed a series of blood clots in the sinus veins on the surface of her brain on 28Apr2021 08:00. She began having headaches on 28Apr2021 08:00 and was admitted to the hospital on 04May2021 after the headaches wouldn't subside and a CT scan revealed the blood clots on 04May2021. She was treated with anti-coagulants during a 9-day ICU stay. A thrombectomy was performed on 11May2021 to relieve the pressure on her brain and prevent a brain bleed. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The seriousness criteria were hospitalization and life-threatening illness (immediate risk of death from the event), not results in death, not disabling/incapacitating, not congenital anomaly/birth defect. Hospitalization duration was 9 days. The treatments were anti-coagulants and thrombectomy. The outcome of event was not recovered.  The information on the lot/batch number has been requested.
A five-year-old male patient with no reported medical history, had received a subcutaneous left thigh injection of Yellow Fever Vaccine, lot number UFO45AA and an intramuscular left thigh injection of Typhim Vi, lot number Z0443-2 on 21 June 2007 and one day later complained of not feeling well, abdominal pain, stomach pain, pallor and tiredness. The patient had received a Hepatitis A vaccination at their pediatrician's office, date of vaccination reported to have occurred within the previous four weeks. The patient had been scheduled to be evaluated by their pediatrician on 23 June 2007. The reporter stated that the patient had not recovered at the time of this report. Follow-up information received on 27 September 2007 from a health care professional. Hepatitis A vaccine not administered by this reporter's clinic. For the reporter, the symptoms resolved.
The pt developed erythema multiforme rash on 5/18/01. The rash resolved over a 5 day period.
Pt recv vax on 9/28/98; on 9/29/98 pt exp fever (100-102)x 48 hr; tx=Motrin, Tylenol
Headache fever cramping neck legs nausea  tired slept about 18 hrs on the twelfth miserable since vaccination
Pain all over; Joint pain; This case was reported by a nurse via sales rep and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received on 20th July 2020, for tolerance of 1st dose refer case US2021252028).   On 19th October 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain and joint pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the pain and joint pain to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and in 2020, less than 2 years after receiving vaccine, the patient had experienced pain all over and joint pain. It was unknown if the adverse events occurred after the first dose of Shingrix or the second dose of Shingrix. The pain all over and joint pain have lasted for months after the Shingrix was administered.  The physician had ruled out rheumatoid arthritis and other auto-immune diseases.  As of 8th December 2021, the patient continued to experience pain all over and joint pain. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252028:Same reporter
After receiving vaccine his arm became swollen and difficult to move being treated with ibuprofen and hydrocodone/APAP.
chills; My son was given the ohizer booster at 9:30 am at 2 am in the morning my son was screaming his head hurts; heart racing/Palpitations; started vomiting profusely; He had a fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Phizer, administration date: 30Dec2021, when the patient was 16 years old; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, No adverse event), when the patient was 16 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, No adverse event), when the patient was 16 years old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "My son was given the ohizer booster at 9:30 am at 2 am in the morning my son was screaming his head hurts"; PALPITATIONS (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "heart racing/Palpitations"; VOMITING (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "started vomiting profusely"; PYREXIA (non-serious) with onset 31Dec2021 02:00, outcome "recovering", described as "He had a fever". Therapeutic measures were not taken as a result of chills, headache, palpitations, vomiting, pyrexia.  Follow-up attempts have been completed and no further information is expected.
Patient called on 7/17/18 complained fever (101F) and very tired. She mentioned last night she had soreness on her right arm and rash around the injection site. She also had swollen gland on her right armpit on 7/16/18 night, but not showing on 7/17/18 anymore. I have advised patient to take TYLENOL or ALEVE to reduce fever and see her doctor if necessary.
Pt called this afternoon at 430pm stating this morning about 8am (appox 12 hours after vaccination) she began to feel week, lethargic and had a slight fever that peaked at 100.4 degrees. These symptoms were consistent with expected adverse events of the vaccine. Patient stated that as the day has gone one, she has felt a little better in regards to those symptoms. However, patient also stated that pustules/bumps began forming on her torso this morning. This symptom was not consistent with reported adverse events and is believed to be a possible allergic reaction.  Patient stated it has not spread beyond initial area. Advised patient to take oral BENADRYL and will follow-up with her to see how she is feeling.
Vaccine given 10/15/12. Developed (L) arm pain & paresthesias two days later. Ultimately diagnosed w/ Turner Parsonage Syndrome.
7 days after receiving the first shot itching and red ring/rash around injected arm. After second shot, fatigue, chills, sweating, for two days. 10 days after receiving the second shot on March 25, developed shingles on stomach , abdomen and back. It?s been two weeks and I still have shingles.
Narrative:  Patient required 24/7 observation after the vaccine due to severe lethargy and confusion.
arm necrosis; This serious case was reported by a consumer via call center representative and described the occurrence of necrosis in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced necrosis (Verbatim: arm necrosis) (serious criteria GSK medically significant). The outcome of the necrosis was not resolved.   It was unknown if the reporter considered the necrosis to be related to Arexvy.     It was unknown if the company considered the necrosis to be related to Arexvy.   Additional Information: GSK Receipt Date:13-NOV-2023 Consumer reported that the arm was necrotic after RSV injection. The reporter stated that medical attention had been sought which included several emergency room visits. The reporter stated that she was given permission to go on a cruise by her doctor and when she returned her arm was very necrotic. Consumer reported that she saw doctor on Thursday and bloodwork was okay. The patient followed all medical guidelines and it was still necrotic. Follow-up would not be possible as no contact details were available.
pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck; She felt very tired; She felt weak; lethargic; She had diarrhea as well; Her right hand has not healed, it feels swollen and tight; Her right hand has not healed, it feels swollen and tight; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic) and DIARRHOEA (She had diarrhea as well) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) and MUSCULOSKELETAL STIFFNESS (Her right hand has not healed, it feels swollen and tight). At the time of the report, PAIN (pain in her right hand/ pain in hips, hands, neck/ pain in back/ felt like she got hit by truck), FATIGUE (She felt very tired), ASTHENIA (She felt weak), LETHARGY (lethargic), DIARRHOEA (She had diarrhea as well), PERIPHERAL SWELLING (Her right hand has not healed, it feels swollen and tight) and MUSCULOSKELETAL STIFFNESS (Her right hand has not healed, it feels swollen and tight) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medication details was reported. No treatment medication details was reported.
Child developed bilateral otitis media within 3-4 days of both Prevnar injections.
79 y.o. male with past medical history of systolic and diastolic heart failure, chronic hypoxic respiratory failure on 2 L, AICD placement, type 2 diabetes, RA on hydroxychloroquine and coronary artery disease with most recent stenting 2012 who presents to the ED with worsening fatigue and shortness of breath. Of apparently was in his normal state of health until yesterday evening when he slept poorly. This morning he was more weak and his wife states that he took a 5 hour nap. After waking up he developed rigors but his temperature was only 98.9.  He was somewhat more short of breath as well. Therefore he was brought to ED. In the ED upon arrival vital signs were as follow: Heart rate 124, BP 147/76, respiratory rate 28, T 103.2° with saturations of 88% on his normal 2 L. These did improve to the mid 90s on 4 L. present labs include a BNP 15000 (12,000 last month), CRP 4.7, procalcitonin 0.17, creatinine 2.25 (roughly baseline), D-dimer 3121, WBC 13.1. He did have a positive COVID-19 PCR test. A chest x-ray showed bilateral pulmonary infiltrates right greater than left. He received dexamethasone and was subsequently admitted to the hospitalist team. When I arrived he is resting comfortably in bed with his wife at bedside. He feels that improved slightly. Otherwise he continues to feel fatigued. He denies vomiting, diarrhea, chest pain or worsening swelling. He does admit to having no appetite. He received the J&J vaccine and had COVID in Nov 2020.
Constipation; Hard stools; Right arm soreness; This spontaneous case was reported by a patient and describes the occurrence of CONSTIPATION (Constipation), FAECES HARD (Hard stools) and PAIN IN EXTREMITY (Right arm soreness) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced CONSTIPATION (Constipation), FAECES HARD (Hard stools) and PAIN IN EXTREMITY (Right arm soreness). At the time of the report, CONSTIPATION (Constipation), FAECES HARD (Hard stools) and PAIN IN EXTREMITY (Right arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included stool softener.   Reporter did not allow further contact
pt recvd vax 7JUN95 & the same day pt's sibling devel chicken pos; 19JUN95 pt devel non-vesicular rash w/red, itchy bumps over head, face, neck, trunk & extremities;25JUN95 pt recovered;No further details were provided;
This spontaneous report as received from a healthcare worker (Certified Medical Assistant (CMA)) refers to a patient of unknown age, gender and ethnicity. On 26-JAN-2015, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot # J009833, expiration date 25-JAN-2015 (dose, route of administration and indication were not provided). No adverse effect was reported. Additional information is not expected. The reporter did not wish to participate in adverse event (AE) report.
This spontaneous report was received from a Registered Nurse (R.N) concerning multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (Lot # N008823; expiration date 26-MAY-2018) for prophylaxis (dose and route not reported).  The temperature was 9°C to 25°C for 210 hours and there was no previous temperature excursion. The call was made because of a data logger. Adverse effects reported and there was no PQC involved. This is one of several cases from the same source.; Sender's Comments: US-009507513-1708USA003628: US-009507513-1708USA003629: US-009507513-1708USA003635: US-009507513-1708USA011937: US-009507513-1708USA003632: US-009507513-1708USA003633: US-009507513-1708USA003634: US-009507513-1708USA003627: US-009507513-1708USA003630:
feeling really dizzy and light headed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: DIZZINESS (non-serious), outcome "unknown", described as "feeling really dizzy and light headed". Additional information: The patient stated to be perfectly fine before getting the vaccine and wanted to know if an appointment with a primary doctor was needed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A 37 year old male presents for his Moderna COVID vaccine booster (0.25 mL). Vaccine was administered at 3:15PM. At 3:25 PM, patient flagged down the PA on staff. Patient appeared in distress, diaphoretic, and pale. He reported dizziness, nausea, tunnel vision, tinnitus, tingling down the left arm, diaphoresis, weakness, and lightheadedness. He denied chest pain, shortness of breath, swelling, fever, chills, syncope. Patient reports allergy to Penicillin causing hives. He denies chronic illness and medication use. Denies family history of heart disease and diabetes. Reports family history of depression and suicide. Patient reported similar event in the past. Once with his first dose of the Pfizer COVID vaccine and once as an adolescent after a venipuncture. Based on acute signs, symptoms, and recovery, likely diagnosis is vasovagal shock.   Vitals taken at 3:30PM by RN; HR 68, RR 18, Pulse Ox: 99%, Temp: 98.2 Physical exam by RN: Heart: regular rate and rhythm Lungs: Clear to auscultation bilaterally  Romberg test at 3:45PM negative Patient expressed improvement and demonstrated cognition and ability to ambulate without support. Patient reassured of low risk of complications and to avoid potential triggers and to minimize risk during future injections and venipunctures. ER Precautions given and suggested to walk home or call for a ride instead of driving home.  Patient left clinic at 3:50 PM.
Headache Fever Exhaustion Nauseous Pain at injection site Extreme fatigue Muscle pain Generally feeling unwell
Right away, site of vaccination became very red, puffy, watery, swollen; baby very irritable, screeching crying. Doctor said it happens; recommended Tylenol. During the rest of the day, baby was breathing really fast (like wheezing), turned light pale, stopped feeding. At 9 AM, 1/15, baby taken to the doctor who directed them to the ER. She was hospitalized for 48 days. She was diagnosed with respiratory failure, septic shock, meningitis, suffered from seizures. A CAT scan revealed global swelling on left side of brain, right lung collapsed. Her blood platelets count was low so she had some transfusions. She had 2 surgical procedures to remove tissue at site of vaccination that was infected. On the second operation, they extracted more tissue because the fever and seizures continued.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On an unknown date, the patient was orally vaccinated with improperly stored dose of ROTATEQ (dose, frequency, and indication were not reported, lot # (L048854 with expiration date: 31-AUG-2017). Concomitant medications were not reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. states that after receiving the 1st dose of Moderna 09/26/2021, started experiencing symptoms 09/28/2021 of arm muscle spasms (right), tingling in the lip, double-vision, 3rd &4th toes numbness, (left) arm extreme pain, (left) shoulder pain, Heart Rate (110) Resting (90), hands and wrist cramping and spasms, intense neck pain (right side), memory loss, and joint pain.  Primary visit 10/07/2021 Blood Work (Normal), EKG, (recommendation for Nerve Study) Muscle Relaxers, 10 day Steroid regiment Prescribed. Emergency Physician suggested Lymph noid counter reaction. Primary visit scheduled for 11/4/2021, recommendation for MRI Imaging. Still continuing to experience symptoms.