chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hardness in arm; soreness to the touch in arm; tiredness; headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (hardness in arm), INJECTION SITE PAIN (soreness to the touch in arm), FATIGUE (tiredness), HEADACHE (headaches) and PAIN (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M208) for COVID-19 vaccination.     Concomitant products included SERTRALINE and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE REACTION (hardness in arm), INJECTION SITE PAIN (soreness to the touch in arm), FATIGUE (tiredness), HEADACHE (headaches) and PAIN (body aches). At the time of the report, INJECTION SITE REACTION (hardness in arm), INJECTION SITE PAIN (soreness to the touch in arm), FATIGUE (tiredness), HEADACHE (headaches) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Chest pain while exercising.  Excessive shortness of breath right after exercise.  Exercise intolerance.  Exercise fatigue.  Still not feeling as "fit" since vaccination.  Headaches that I'm still suffering from.  Fatigue, ongoing.
lower back felt like it was breaking; inside my stomach felt really hot [after third dose], burning; fever; chills; aches and pains all over my body; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back felt like it was breaking), DYSPEPSIA (inside my stomach felt really hot [after third dose], burning), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back felt like it was breaking), DYSPEPSIA (inside my stomach felt really hot [after third dose], burning), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body). At the time of the report, BACK PAIN (lower back felt like it was breaking), DYSPEPSIA (inside my stomach felt really hot [after third dose], burning), PYREXIA (fever), CHILLS (chills) and MYALGIA (aches and pains all over my body) outcome was unknown.            No Concomitant medication was provided.  No treatment medication was provided.  Company comment: This case concerns a 76-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected events of back pain, dyspepsia and non-serious expected events of pyrexia, chills and myalgia. The events occurred  on unknown date after third dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-390522, MOD-2021-390656 (Patient Link).; Sender's Comments: This case concerns a 76-year-old, female patient, with no relevant medical history, who experienced the non-serious, unexpected events of back pain, dyspepsia and non-serious expected events of pyrexia, chills and myalgia. The events occurred  on unknown date after third dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 15-APR-2015, the patient was vaccinated with one dose of improperly stored ZOSTAVAX (19400 PFU, dose, route of administration, lot# and expiration date were not reported). The patient's concomitant therapy was not reported. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Patient reports within 1 day of administration at outside facility (pharmacy) having expected swelling at deltoid area of vaccine administration but within about 8 days developed marked swelling of the left hand and fingers; did recall sensation of inflammation progressing down along arm but without swelling to degree observed of the hand
This spontaneous report was received from Pfizer Inc and was assigned manufacturer report number (2017048505) for PREVNAR 13, concerning a male patient of unknown age. This was originally reported by a patient's wife. The patient's concurrent conditions, medical history and concomitant medications were not reported. In January 2015, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot number, expiration date were not reported) for prophylaxis. After receiving pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the blood test was done and there was no reaction on data. The reporter stated that her husband did not have any protection from pneumonia. The dose of vaccine did not work (Vaccination failure). The titer was less than 4 (unit not provided) (Antibody test negative). Product quality complaint was involved. The outcome of the events was not reported. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA008462.
Severe tinnitus started March 8 and is ongoing as of May 13. Two doctor's visits and one hearing test (March 24, April 6, and April 16). I have an appointment with an ENT specialist on May 25.
DTaP immunization administered to left deltoid IM, with ETOH prep to site before each immunization was administered. The patient was restrained properly by his mother to prevent patient from moving and getting possibly scratched by the needle. No incident occurred during administration of immunizations. Mom brought patient in 01/12/05 with redness and swelling to left deltoid, warm to touch. No fever measured at time of visit.  Doctor examined patient and indicates doing well on 01/13/05.
9:15am, pt felt weak, face red, B/P 170/110, Pulse 80. Pt unreactive to voice stimulation for 1-2 mins "low blood sugars". 9:25, B/P 160/96, Pulse 82. 9:40, B/P 120/80, Pulse 80-regular. Taken to DR as precaution. Tx'd for hypoglycemia.
Fatigue, chills, whole body muscle aches, tender right arm, and headaches for 2 full days after the injection.
adverse symptom after a dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse symptom after a dose of Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse symptom after a dose of Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (adverse symptom after a dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
On 18OCT91, pt called to report very sore lt arm following shot on 11OCT91; 21OCT91 lt arm was "very achy", felt miserable all over; no fever; area of induration approx 3" in diameter; swollen tender lymph nodes under lt arm;
Information has been received from a licensed practical nurse concerning a 67 year old female with hypercholesterolemia and hypothyroidism and no drug reaction/allergies who on 25-JUN-2010 was vaccinated subcutaneously her left upper arm with a first dose of ZOSTAVAX (Merck) (dose not reported, lot # 665309/1173Y). Concomitant therapy included simvastatin and SYNTHROID. On 04-NOV-2010 the patient was diagnosed with shingles. The patient was evaluated at a local emergency room on 04-NOV-2010 and was prescribed VALTREX 1 g three times per day for 10 days. The distribution of the lesions was the right upper arm and shoulder. The patient was scheduled to be seen in the office on 12-NOV-2010. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Presented c/o vomiting, fever, myalgia, shortness of breath and cough as well as fever.Dx: COVID-19 pneumonia. Patient was found to be hypoxic and he was placed on oxygen supply. Treated with IV antibiotics/steroids;  patient was offered tocilizumab as well as remdesivir but he declined both. Patient's symptoms improved gradually and we were able to wean of his oxygen to 2 L and he was discharged home on home oxygen and to continue steroid course at home.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: 053D22A) at the age of 65 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10May2022 as dose 4 (booster), single (Lot number: FJ4989), in right 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: "Mild heart disease" (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 Apr2023, outcome "recovered" (17Apr2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not received other medication in 2weeks. It was reported that patient was treated with Paxlovid from 11Apr2023 to 15Apr2023. Took the full course of Paxlovid. Tested 2 days after completion and tested negative.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166762 same reporter/patient, different drug/AE;
TESTED POSITIVE, 14 DAYS AFTER RECEIVING THE 2ND DOSE OF COVID VACCINE
Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose; tightness in the chest; Headaches; lethargic behavior; Chills; extreme shaking; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 12:00 as dose 3 (booster), single (Lot number: GJ5342) at the age of 44 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TESTOSTERONE. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19,, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=EN6206,, Prev dose lot unknown=False,, Prev dos dose number=2,, Prev dose vaccine location=Left arm,), for Covid-19 immunization, reaction(s): "Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose"; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer,, Prev dose brand unknown=False,, Is bivalent=False,, Prev dose lot number=EL3249,, Prev dose lot unknown=False,, Prev dose dose number=1,, Prev dose vaccine location=Left arm), for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered"; HEADACHE (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "Headaches"; LYMPHADENOPATHY (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose"; TREMOR (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "extreme shaking"; LETHARGY (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "lethargic behavior"; CHEST DISCOMFORT (non-serious) with onset 15Nov2022 at 22:00, outcome "not recovered", described as "tightness in the chest". Therapeutic measures were not taken as a result of lymphadenopathy, chest discomfort, headache, lethargy, chills, tremor.  Additional information: The patient did not receive other vaccine in four weeks. He was not diagnosed with covid-19 prior to vaccination and not positive for Covid-19 after vaccination. The patient had no known allergy. Other medical history: None. It was reported that Lymph node was very swollen underneath left armpit. Significant bump remained for two weeks after the second dose and I'm currently have the same after the third dose. Great deal of tightness in the chest. Headaches and lethargic behavior. Chills with extreme shaking approximately 12 hours after the third dose.  No follow-up attempts are possible. No further information is expected.
AFib; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 62-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EN6201) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, Batch/lot number: EL3302, Anatomical Location: Left Arm), administration date: 21Jan2021, when the patient was 61 years old, for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Jan2022, outcome "not recovered", described as "AFib". The patient never had it before and does not take any medication. She was diagnosed with Afib in Jan2022, diagnosed at her physical appointment in Jan2022. The event "afib" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of atrial fibrillation.
approx 5 pts recvd Engerix-B between the dates of 4MAY92 to 6MAY92; exp nausea, loss of memory & felt bad;
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender (patient identifier: 7751316). On an unspecified date the unspecified patient was administered RECOMBIVAX HB  (Lot# H010380, expired date: 18-NOV-2014) dose, frequency, route and location unspecified was stored improperly (first exposed to 9C for 30 minutes and then exposed to 8.3C for 1 hour). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
injection site soreness; Mild cough during evening of injection; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL 3247), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:00 (at the age of 37years) as dose 1, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and Allergies: Mussels. Concomitant medications included montelukast sodium (SINGULAIR); ergocalciferol (VIT D); paracetamol (TYLENOL); and Medicated Nasal Spray; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced injection site soreness and mild cough during evening of injection on 10Mar2021 17:00. There was no treatment received for the adverse events. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
arm turned into a pinkish color and had a light pink and black ring around the vaccination site (right upper arm). Swelling inches below the vaccination and down to the elbow; Hardness inches below the vaccination and down to the elbow.; redness 2 inches below the vaccination and down to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (arm turned into a pinkish color and had a light pink and black ring around the vaccination site (right upper arm).), VACCINATION SITE SWELLING (Swelling inches below the vaccination and down to the elbow), VACCINATION SITE INDURATION (Hardness inches below the vaccination and down to the elbow.) and VACCINATION SITE ERYTHEMA (redness 2 inches below the vaccination and down to the elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced VACCINATION SITE DISCOLOURATION (arm turned into a pinkish color and had a light pink and black ring around the vaccination site (right upper arm).), VACCINATION SITE SWELLING (Swelling inches below the vaccination and down to the elbow), VACCINATION SITE INDURATION (Hardness inches below the vaccination and down to the elbow.) and VACCINATION SITE ERYTHEMA (redness 2 inches below the vaccination and down to the elbow). At the time of the report, VACCINATION SITE DISCOLOURATION (arm turned into a pinkish color and had a light pink and black ring around the vaccination site (right upper arm).), VACCINATION SITE SWELLING (Swelling inches below the vaccination and down to the elbow), VACCINATION SITE INDURATION (Hardness inches below the vaccination and down to the elbow.) and VACCINATION SITE ERYTHEMA (redness 2 inches below the vaccination and down to the elbow) outcome was unknown. Concomitant medication details were not provided.Treatment details were not provided.
got poison ivy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Lot number: EN6207) 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: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "got poison ivy". The event "got poison ivy" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dermatitis contact.  No follow-up attempts are possible. No further information is expected.  Follow-up (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. A  female consumer (patient) reported for herself that: she was scheduled for her second shot on Friday 02Apr2021. The caller got poison ivy really bad, she went to the local clinic here and they gave her prednisone to take. The caller has not taken the prednisone yet. The caller was calling to see if she can receive the second vaccine.  No follow-up attempts are needed. No further information is expected.
On 4/1/2023, patient presented to the emergency department via ambulance in severe respiratory distress. Patient was placed on BiPAP which improved his respiratory status; He was also given an albuterol nebulized treatment and IV Solu-Medrol. Patient had been ill over the past week with cough, congestion, fatigue and weakness; He was given a COVID-19 NAA test which resulted positive; His chest x-ray showed pneumonia with interstitial opacities in RUL/RLL. Patient had also fallen and hit his head prior to arrival, so a CT head was done which was unremarkable. His heart failure was treated with IV Lasix; He was started on Decadron and remdesivir to treat the COVID infection, and IV antibiotics to treat bacterial pneumonia.  Patient was diagnosed with acute hypoxic respiratory failure, COVID-19 pneumonia, severe sepsis, bacterial pneumonia, acute on chronic diastolic heart failure, leukopenia in the setting of recent chemotherapy, and metastatic adenocarcinoma of left lung. He was admitted to ICU at the hospital for further evaluation and treatment. His condition progressively worsened, and he developed encephalopathy. Patient was placed on hospice care and died on 4/8/2023 at the hospital. His death abstract listed immediate cause of death as Severe Sepsis due to or as a consequence of Bacterial Pneumonia, and COVID-19 Pneumonia.  Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital
Case previously recorded as MA2009-4203. Initial case report received from a medical assistant via MedCom on 10 NOV 2009. A patient 3-year-old female was vaccinated with 0.5mL S-OIV FLUVIRIN (batch no. 102046P1) once i.m on 05 NOV 2009. No adverse event was reported. MedCom reference no.: NA09-007859.
Dizziness - 7 wks muscle weakness 2 wks. Cluster headaches (left) 4 wks.
Headache, fever, nausea, chills.  3am 5/4 to 3pm 5/5
Patient reported feeling itchy. Liquid Benadryl 25mg/10ml resolved the issue.
Patient developed palpitations and chest tightness/pressure that worsens with laying down and deep inspiration. EKG consistent with pericarditis.
first vaccine feb 27th was scheduled on march 20th and couldnt make appointment; he had fallen; couldn't hardly walk; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (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: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "first vaccine feb 27th was scheduled on march 20th and couldnt make appointment"; FALL (non-serious), outcome "unknown", described as "he had fallen"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "couldn't hardly walk".  Additional Information: A patient received first vaccine 27Feb was scheduled on march 20Mar and couldn't make appointment because he had fallen and couldn't hardly walk. Wanted to schedule a second appointment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.