chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MUSCLE ACHE WHEN WALKED UP HILL; FELT TIRED/FATIGUE/FEELING TIRED; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (MUSCLE ACHE WHEN WALKED UP HILL) and FATIGUE (FELT TIRED/FATIGUE/FEELING TIRED) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    There was no reported medical history.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (MUSCLE ACHE WHEN WALKED UP HILL) and FATIGUE (FELT TIRED/FATIGUE/FEELING TIRED). At the time of the report, MYALGIA (MUSCLE ACHE WHEN WALKED UP HILL) and FATIGUE (FELT TIRED/FATIGUE/FEELING TIRED) had resolved.            The patient did not taken any concomitant drug.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of muscle ache when walked up hill and felt tired/fatigue with Skyrizi (Risankizumab) was a reasonable possibility.  Treatment medications were not reported.
his son's arm will be swollen; This is a spontaneous report from a contactable consumer (parent) from a Pfizer-sponsored program. A male patient of age 16 (unit reported as unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), second dose via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was swollen on an unspecified date. Reporter wanted to know how many days that his son's arm will be swollen, because every day the pain was increasing. Clinical outcome of event was unknown.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Fever 102.9 approximately 14 hours after vaccine, nausea, severe all over body pain and headache, ear pain, throat pain, developed wet cough, back pain. Poor PO - saltines, applesauce, ice chips.
Initial and follow up information has been received through a physician and a nurse for the Pregnancy Registry for GARDASIL regarding a 17 year old female, with attention deficit/hyperactivity disorder, and no known previous pregnancies, who on 21-MAY-2007 was vaccinated with her first dose of GARDASIL (Lot # 657621/0387U; route and site not reported).  On 09-JUL-2007, the patient was vaccinated with her second dose of GARDASIL (Lot # 658490/0802U; route and site not reported).  On 22-OCT-2007, the patient was vaccinated with influenza virus vaccine (unspecified).  On 26-NOV-2007, the patient was vaccinated with her third dose of GARDASIL (Lot # 659437/1266U; route and site not reported).  Concomitant therapy included FOCALIN and FOCALIN XR.  On 31-DEC-2007, the patient was diagnosed with scabies and treated with ATARAX and ELIMITE cream.  On 03-JAN-2008, the patient had an ultrasound due to an enlarged abdomen.  The results of the ultrasound showed that the patient was pregnant (33.7 weeks gestational age).  The patient's LMP was reported as November 2007.  On 23-JAN-2008, the patient gave birth to a normal baby girl (5 lbs, 13 oz and 18 in).  There were no congenital anomalies.  There were no complications during labor and delivery.  It was reported that the patient had no prenatal care.  No additional information was provided.  No additional information is available.
This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a adult female patient who received HAVRIX. On an unknown date, the patient received HAVRIX 1440 at an unknown dose. On an unknown date, 12 hrs after receiving HAVRIX 1440, the patient experienced anaphylactic reaction (serious criteria GSK medically significant and life threatening) and generalized urticaria. On an unknown date, the outcome of the anaphylactic reaction and generalized urticaria were unknown. It was unknown if the reporter considered the anaphylactic reaction and generalized urticaria to be related to HAVRIX 1440. Additional details were provided as follows: The patient experienced generalized hives 12 hours after receiving HAVRIX adult. On allergy testing it was revealed that the occurrence of hives was actually an anaphylactic reaction. No other information was available.
Pt received a light dose of the Pfizer covid 19 vaccine. 0.8mls of NS was used to dilute vaccine not 1.8 mls.  A dose of 0.3 was removed from that vial then another 1 ml of dilute was added. That diluted vaccine dose was then given to this pt. Pt contacted and awaiting call back.
Heart palpitations everyday for 11 days straight starting the day after 1st vaccine dose, now with occasional palpitations
About 5 minutes after the shot, I developed a sudden sharp pounding headache at the top of the head & near the temple. I also got clammy/sweaty in my neck & the back of head. My hair got damp at the scalp. At nurse took my BP & it was 142/88 which is very high for me. I usually average a low BP. This reaction slowly subsided within 30 minutes. I was able to drive home.  I felt nothing more on this day other than soreness in the injection site. On 2/23/21 I woke up with stomach cramping & had looser stools than usual. I also had fatigue & lethargy all day, which got stronger towards the evening. This lasted until 2/25/2021.
Patient was admitted to the hospital with acute kidney injury (AKI) and possible colitis with hematochezia.
Patient received Moderna second dose at 4:45 pm and began complaining of a racing heartbeat at 4:55. I administered two ice packs to the back of his neck. He stated he was nervous about receiving the vaccine. At 5:00 he was still complaining of a racing heart, tingling in his arms and in his stomach, and he was visibly agitated and nervous. He asked for an ambulance to be called and the pharmacy called a code white. His blood pressure was taken in between this time and it 122/96 and his pulse was 137. The ambulance arrived at 5:10 and EMS checked his pulse and BP. They told him it was likely anxiety induced and offered to take him to the hospital if he wanted to go. He stated he wanted to go but wanted his girlfriend to drive him. EMS left the store and the patient left with his girlfriend.
Moderna Covie-19 Vaccine EUA   I had extreme left arm soreness for 24 hours and got progressively better taking advil.  I was more tired than normal, sleeping 10 hours at night for 2 nights.  I had some head pain the next day that resolved.
Patient received a second FLUAD shot in October because she did not realize that she had already received the flu shot in August. Patient reported no adverse events and had no signs or symptoms of a reaction upon receiving the additional dose in October. Patient felt normal.
Patient received the two vaccines, after about 10-15 minutes after the vaccine he came back to the pharmacy counter in excruciating pain spasming and pain in the low back that was radiating up his right arm and shoulder. The patient was having trouble speaking through the pain and quickly started complaining of a headache along with the lower back spasm and pain. The patient agreed to an epipen shot due to this reaction and within 2 minutes the headache and radiating pain had subsided. The patients lower pain was still spasming for about 5 more minutes and he did not want 911 or an ambulance called. He called his wife because he did not want to drive home. By the time he left at 12:15 all of his symptoms were gone. He will be following up with his primary care and will also call the pharmacy tomorrow with a follow up.
Narrative:  A 76yo male with PMH of Tobacco use disorder, HTN, Hyperlipidemia, Malignant Neoplasm of the prostate, Carcinoma of the Prostate, Heme +ve Stool, Bladder Carcinoma, CHF and PE Per Nurse's documentation, he received JSN Covid - 19 vaccine per policy and protocol on March 20, 2021 it's documented to have been administered without complication No ADE was reported Per PCC telephone note on March 24, 2021 , reviewed patient's lab by the physician indicated, he was in renal failure with sr cr of 2.7 and GFR of 22, was advised to go to the ER but patient refused, reporting he is doing well His torsemide dose was decreased to 10mg by the physician and fluid restricted to 1.5 L per day, due to CHF He was also advised to follow up with Cardiology clinic and private nephrologist April 1, 2021 note indicated he was experiencing more Fatigue, Dyspnea and Edema but refused recommendation by his nephrologist to see cardiologist. April 12, 2021 Cardiology F/U note included documentation of patient being admitted to Hospital due to HF exacerbation System showed this patient passed away on April 28, 2021
Within 1/2 a day of injection patient experienced soreness, redness and swelling over an area with a 2 in diameter below the site of injection.
HIVES - BENADRYL (LIQUID SUSPENSION) 5O MG - HIVES GONE WITHIN 2 HOURS
Received vaccine 9 AM 6/10/05. 6/11/05, developed fever 101-102, severe myalgias, headache. Responded to Tylenol over 24-36 hours. Known adverse effect but was severe.
rash; A spontaneous report was received on 16 Feb 2021, from a consumer concerning a patient  (age and gender unknown) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, rash.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, rash, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a physician and refers to a 1 year old male patient. The patient did not have any pertinent medical history, drug reactions, allergies or concomitant therapies. On 23-JUN-2016, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # L049534, expiration date, exact dose and route of administration were not reported). On 08-JUL-2016, the patient developed a persistent generalized rash following administration of (Oka/Merck) VARIVIAX. The physician stated that the rash was continuing to evolve. The patient sought medical attention, he visited physician, but no treatment was given for the event. No lab diagnostic studies were performed. The outcome of the events was reported as not recovered. The relatedness between the event and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Patient came to office on 5/29/2018 for suture removal related to a self inflicted cut to Right Arm.  Health Maintenance regarding the need for BEXSERO and GARDASIL 9 was offered and patient accepted. Patient returned in 2 months, 7/9/2018 after a positive pregnancy test. She then reported that her last menstrual period was in February between Depo Injections. Patient also reported she started taking OCP last month but has since stopped due to the positive pregnancy test.  on 7/9/2018 it is thought that patient was 6/7 weeks along.
FEVER; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-JUL-2021, the subject experienced fever. On 06-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and headache was not reported. This report was non-serious.
Temp 48 hours after inj 99-100 8/21/07 - severe pain in left arm and shoulder un-able to raise above her head - saw Orthopedic doctor with MRI to follow. Not resolved as of 10/12/2007.
Nausea and metallic taste 7/23/15. Rash from injection site toward elbow 7/27/15.
fizer vaccine was administered outside of our facility - reported by patient  G47.33 OBSTRUCTIVE SLEEP APNEA 9/13/2021 MOOD DISORDER, UNSPECIFIED TYPE
Information has been received from a nurse referring to two unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L010145, expiration date 24-MAR-2017, dose, route and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient also had COVID after COVID Vaccine; 102 degree temperature; Patient had the vaccine he experienced achiness and soreness for 3 day; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient also had COVID after COVID Vaccine), PYREXIA (102 degree temperature) and VACCINATION SITE PAIN (Patient had the vaccine he experienced achiness and soreness for 3 day) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Immunisation.    Co-suspect products included non-company products DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Immunisation.    Concurrent medical conditions included Atopic dermatitis.   On 17-May-2017, the patient DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 600 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form., DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient also had COVID after COVID Vaccine), PYREXIA (102 degree temperature) and VACCINATION SITE PAIN (Patient had the vaccine he experienced achiness and soreness for 3 day). At the time of the report, COVID-19 (Patient also had COVID after COVID Vaccine) and PYREXIA (102 degree temperature) outcome was unknown and VACCINATION SITE PAIN (Patient had the vaccine he experienced achiness and soreness for 3 day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degree.         No concomitant medications were provided.  Patient had been on Dupixent for 6 or 7 years and never had a reaction. It was reported that the last time the patient had the vaccine he experienced achiness and soreness for 3 days and had a slight temperature. He reported he had 3 Moderna COVID vaccines and for each injection he was in bed all weekend with a 102-degree temperature. He reported additional potential for COVID vaccines. He also had COVID after the COVID vaccine. It was reported that at the time of the report, the Dupixent was ongoing.  Treatment medications were not provided.
Injection site soreness, headache, fever to 101 F, myalgia, fatigue Duration of symptoms 18 hours Back to normal 48 hours after injection
dose of expired Pentacel was given to a patient with no reported adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 months old female patient who had dose of expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past vaccination(s) included VAXELIS with previous three doses in the series against DTaP, IPV, and hib. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20) for Immunisation.  On 26-Oct-2023, the patient received an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ791AA, expiry date- 10-OCT-2023) via unknown route in the left thigh for Immunization with no reported adverse event (expired product administered) (latency- same day).  Reportedly, reporter asked, What information do you have for a Pentacel dose that was expired at the time of administration. This was the fourth dose in the series for the patient's vaccination against DTaP, IPV, and hib. The patient received Vaxelis for the previous three doses in the series. The dose was administered by a nurse.  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.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number reported as L044475 and expiration date 12-MAY-2017, dose and route of administration were not reported). The temperature and the time frame of the excursion were 12.3 Celsius degrees for 83 hours and 40 minutes and -3.4 Celsius degrees for 105 hours and 50 minutes. There was no previous temperature excursion and it was stated it was a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On Wednesday following vaccine child had 1 episode of tongue clicking in conjunction with spontaneous head rotation and shoulder lift. On Thursday the child played with friends and went swimming, she stated that she felt cold and noticed that the tongue clicking and head rotation and shoulder lift occurred spontaneously until she felt warm. She experienced these symptoms throughout the weekend whenever she felt chilled. Per parents report she was seen my natural path physician 6/22 and a 24 hr urine is being collected. She has slept better approximately 13 hrs through Monday night until today. She denies HA, fever, N/V/D or stomach pain.  Parents state that she rotates her head different directions and lifts different shoulders, the child states that she doesn't have control over these episodes. The parents deny that she has seizure or loss of consciousness. No loss of bowel or bladder control.
Diagnosed with Paroxysmal supraventricular tachycardia; This is a spontaneous report from a contactable consumer (patient) communicated to Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on unspecified date as dose number unknown single for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that after use of product patient was diagnosed with paroxysmal supraventricular tachycardia on unknown date. The outcome of event was unknown.   Information about lot/batch number has been requested.
After the first dose, I had a ?Light? bout of hives localized to my legs that worsened at night. After the second shot, the hives became more pronounced and began appearing on my arms, neck, hairline and finally my face. It has been a month since my second dose and things are not getting better even with daily doses of antihistamines and two courses of prednisone. They are getting larger, redder, itchier and more difficult to control. I have had hives daily/nightly for two months now.
This initial spontaneous report was received from a physician referring to a 3 month old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015, at 15:16 hours the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
12/19/22 presents to ED for "abdominal pain, SOB". PMHx of "metastatic breast cancer, hx PE on AC"
-low grade fever -chills -muscle aches -nausea Symptoms began approximately 12 hours after second dose of vaccine. Symptoms resolved approximately 36 hours later. Treated with tylenol and ibuprofen.
7 patients devel large welt (approx 1 1/2inches), redness, swelling, & pain @ inj site;all employees had negative allergy history to eggs;
This spontaneous report as received from a pharmacist via a company representative refers to 4-5 patients seen in hospital obgyn (obstetrician/gynecologist) clinic who were of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of PNEUMOVAX 23(lot number, expiry date and route were not reported) 0.5 milliliter (ml) (reported as standard dose) in the leg. On an unknown date, the patients developed swelling and phlebitis. One of the patient had a reaction severe enough to seek attention in emergency room. It was unknown if the other patients sought medical attention or received treatment. The outcome of phlebitis and swelling was unknown. Follow up information has been received from the pharmacist who called back and reported that the 4 or 5 OB patients were administered PNEUMOVAX 23( in the thigh after being given an epidural and after delivery of the baby. He noted that these 4 or 5 OB patients have complained of severe pain in their legs and have not been able to walk after being given PNEUMOVAX 23( and also have needed to come back to the emergency room for unspecified treatment. He provided PNEUMOVAX 23 ( lot reported as H018441 with unspecified expiration date. "Lot check requested" by the pharmacist. At the time of report, the outcome of patient was unknown. Unable to walk was considered to be disability. Additional information has been requested. This is one of the several reports from the same source.