chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; severe body aches; chills; fatigue; arm pain; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LOESTRIN FE), cetirizine hydrochloride (ZYRTEC) and ibuprofen (ADVIL), all taken for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 09:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. 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. On 06Apr2021 at 01:00, 18 hours after the vaccination, the patient experienced fever, severe body aches, chills, fatigue and pain in arm. Fever and chills subsided after several hours. Fatigue and arm pain continued for about 48 hours after the vaccine was administered. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever and chills were resolved on an unknown date in Apr2021, while that of severe body aches, fatigue and pain in arm were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Terrible pain, pain was awful; Elevated heart rate; Fever 100.7F; Red pin prick marks; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Terrible pain, pain was awful), HEART RATE INCREASED (Elevated heart rate), PYREXIA (Fever 100.7F) and VACCINATION SITE ERYTHEMA (Red pin prick marks) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), BUDESONIDE, XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II), CROMOGLICATE SODIUM (NASALCROM), ASPIRIN [ACETYLSALICYLIC ACID], IPRATROPIUM, ALBUTEROL [SALBUTAMOL], EPINEPHRINE (EPIPEN), IRON, VITAMIN D [VITAMIN D NOS], FOLIC ACID, FAMOTIDINE (PEPCID [FAMOTIDINE]) and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Terrible pain, pain was awful), HEART RATE INCREASED (Elevated heart rate), PYREXIA (Fever 100.7F) and VACCINATION SITE ERYTHEMA (Red pin prick marks). The patient was treated with PREDNISOLONE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Terrible pain, pain was awful), PYREXIA (Fever 100.7F) and VACCINATION SITE ERYTHEMA (Red pin prick marks) had not resolved and HEART RATE INCREASED (Elevated heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: unknown results pending.         Action taken with mRNA-1273 in response to the events was not applicable.
Measles-like rash x 7 days p/inject w/frank urticaria 10 days p/inject; required DPH to treat urticaria; Measles-like rash resolved on its own;
L. Bell's palsy - eyelid drooping, weakness in L cheek and mouth, started about 28 hours after dose #2 of the Pfizer-BioNTech vaccine
This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA001032: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004127.
It was reported that a pt (2 of 3) experienced a local reaction sometime post vaccine.
Pt to ED 6/3 for fall and weakness, COVID+ at home on 5/30. Patient is on 2L NC with an O2 saturation of 95%. Pt in no apparent distress, respirations even & non labored. Pt. awake, alert and oriented x4. 6/4 received MAb  with bebtelovimab on 6/2. Tolerating well. On 2 L nc O2 but uncertain if required, no anti-COVID rx needed at this time. Patient discharged to home, signs stable at discharge on 6/4.
Developed throat tightness followed by chest tightness and then nausea and vomiting.  Blood pressure and pulse remained in the normal range.  She received epinephrine 0.3mg IM and transported to hospital ER.  Felt better by arrival to ER.
Chest pain made worse with any form of exercise also developed throat pain, soreness, dryness. Took a week off work to rest and felt better after doctor prescribed metoprolol and aspirin. Metoprolol for high heart rate and aspirin for chest pain. Went back to work on 6/22/21 and felt fine until around 12AM when chest started hurting again. Have not taken second dose of vaccine due to symptoms. Went to 3 doctors and only one believes me when i say it is because of the vaccine. Have not been able to help or give advice with symptoms aside from the medication I am currently taking.
By night patient was not feeling well. By next evening around 7/8 pm fell down. Felt down 3 more nights. Felt unsteady, had to look ahead when walking otherwise would fall down. Took liquid ibuprofen to alleviate symptoms. Second fall occurred on 7/12. Third fall occurred on 7/13. Fourth fall occurred on 7/17 when walking 1/2 mile to store fell down and had to call a taxi to go back home. Very unusual since walks in general 2-3 miles a day and does 80 push ups/day. During this time legs couldn't really hold up weight. Had to lean against wall in shower not to fall down. Today is 100% back. Had similar episode in Fall 2003 after caught a virus, was weak for 3-5 days.
asthma symptoms; Wheezing; coughing a lot which is not going away; Shortness of breath; Chills; Joint ache; Body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), ASTHMA (asthma symptoms), WHEEZING (Wheezing), COUGH (coughing a lot which is not going away) and CHILLS (Chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced CHILLS (Chills), ARTHRALGIA (Joint ache), MYALGIA (Body ache) and HEADACHE (Headache). On 09-May-2021, the patient experienced DYSPNOEA (Shortness of breath), WHEEZING (Wheezing) and COUGH (coughing a lot which is not going away). On an unknown date, the patient experienced ASTHMA (asthma symptoms). On 08-May-2021, CHILLS (Chills), ARTHRALGIA (Joint ache) and MYALGIA (Body ache) had resolved, HEADACHE (Headache) outcome was unknown. At the time of the report, DYSPNOEA (Shortness of breath), ASTHMA (asthma symptoms), WHEEZING (Wheezing) and COUGH (coughing a lot which is not going away) outcome was unknown.            No concomitant medication information was reported. Treatment included cough syrup, home remedies like tea and honey.
PT CAME TO PHARMACY TO RECEIVE A SHINGLES VACCINE AND ACCIDENTALLY RECEIVED A COVID VACCINE.  THE PT HAD ALREADY BEEN FULLY VACCINATED FOR COVID WITH 2 DOSES OF MODERNA, 2ND DOSE  WAS APRIL 2021.  TODAY RECEIVED A PFIZER COVID VACCINE
large red circle on arm; This case was reported by a consumer via interactive digital media and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received Shingles vaccine. In July 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was not recovered/not resolved.   It was unknown if the reporter considered the localized erythema to be related to Shingles vaccine.     Additional Information: GSK receipt date: 29-JUL-2022 Reporter's comments: This case was reported by a consumer via interactive digital media. The patient had the Shingles vaccine 2 weeks ago from the date of reporting and still had a large red circle on him/her arm. The follow up would not possible since contact details not provided.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. On 14-Oct-2021, the vial was placed in the refrigerator. The vial did not had any temperature excursion and the patient had no adverse event. No Treatment medication reported.
As per MTR (phone call) orange sized pink swelling over right arm (site of Dtap) no fever, Pt acts fine.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-JAN-2013, the patient was vaccinated at a physician's office with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-APR-2016, the patient was treated by at a physician's office for the onset of a rash, which was diagnosed as herpes zoster, or shingles. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Tightness in her chest; Sensation of her heart pounding; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding). On 26-Feb-2021, CHEST DISCOMFORT (Tightness in her chest) and CARDIAC DISCOMFORT (Sensation of her heart pounding) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Two black eyes within 2 hours of shot; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included hypercholesterolemia, hay fever and anxiety/depression. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO) and ezetimibe, simvastatin (VYTORIN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 16:30, within 2 hours of shot, the patient experienced two black eyes for which the patient did not take any NSAIDs. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event two black eyes was recovered on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PATIENT CALLED IN AT AROUND 10AM 05/02/2022 COMPLAING ABOUT ARM SORNESS, SWELLING, AND A LUMP ON HER ARM RADIATING TO HER CHEST. RECOMENDED PT TO CONTINUE TAKING IBUPROFEN PRN. AT AROUND 2PM PATIENT STATES THEY WENT TO URGENT CARE DUE TO PAIN AND WERE PRESCRIBED NAPROXEN.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. In March 2018, less than a year after receiving SHINGRIX, the patient experienced fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema and injection site pain. On an unknown date, the patient experienced general body pain. On an unknown date, the outcome of the fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema, injection site pain and general body pain were unknown. It was unknown if the reporter considered the fever, shivers, nocturnal awakening, muscle pain, fatigability generalized, headache, injection site erythema, injection site pain and general body pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient, who was also a pharmacist experienced the same side effects as his wife, but much less severe. The patient's wife (case US2018GSK046332) experienced the fever fluctuating from normal to 101 and back, severe chills with intense shivering that awoke the patient several times during 3 nights, body and muscle aching, general fatigue and mild headache for 72 plus hours and redness, soreness and mild pain at injection site. The patient's wife commented that it was okay if she had develop immunity to shingles but that left her with two questions. One was what should she expect as side effects from the second dose and what counseling they should give to their patients. They did not want to alarm them but the reporter was a little frightened by her side effects. She further asked if they just warn them of the probable side effects and suggest mild acetaminophen dosing and what if any warnings should they make prior to the second dose especially for herself. The reporter also mentioned that if the first available shingle vaccine was any indication they, as pharmacist, would be giving a great many of these vaccines.
heart palpitations; fainted while using the restroom and woke on the bathroom floor; more like a sore or a strain; more like a sore or a strain; felt more strange; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11May2021 at 11:00 (Lot Number: EW0176, expiration date: Aug2021, at the age of 26-year-old) as 0.3 ml, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Apr2021 about 5:00pm (lot number: ER8731, expiration date: Jul2021, at the age of 26-year-old) as single dose for covid-19 immunisation. When he got the first one, he was fine. The day after he received the second shot, he fainted while using the restroom and woke on the bathroom floor on 12May2021 at 07:30, he was on the floor for a few minutes, 2 to 3 minutes. After that there was no other fainting. Patient had been having heart palpitations since the second dose on 13May2021. Did not particularly remember the time, just that it was in the middle of the day. The palpitations were going away and were less prevalent. He went to the Emergency room (ER) this past Sunday night because it was really working up and he couldn't wait to go to the doctor. Physician office was no. Electrocardiogram (EKG) and blood work were done in the emergency room on unspecified date in May2021 and came back normal. He was supposed to meet with a cardiologist next week. On unspecified date in May2021, he still felt kind of like he senses his heart beating but he didn't usually think about. It felt more strange, than soreness. This was all just so new. Thought it was a sign that he was going to recover and it was going to go away. The palpitations were coming on less and less. Was not so much of an irregular heart beat than last week. On unspecified date in May2021, felt like his heart was getting strong. Felt like his heart was making it's way back and was more like a sore or a strain. It had been going down and he was not feeling his heart in his chest. Treatment was no, not this far. There was not prior vaccinations within 4 weeks. The outcome of the event "fainted while using the restroom and woke on the bathroom floor" was unknown, for other events was recovering.
Left eye lid has been red, swollen, and painful since 7:30 PM on 5/5/21; inside left armpit swollen but not painful since 7:00AM on 5/7/21
Large urticarical welts all over body per RN (noit sure when started, this was when the patient arrived and was treated)
Slight fever and chills starting evening of June 11th approx. 9 PM.   Fever and chills faded by early AM hours June 12th, severe headache started approx. midnight June 11th and persisted until noon June 12th.  Took Excedrin migraine caplet at 8 AM June 12th (250mg Acetaminophin, 250mg Aspirin, 65mg caffeine) to treat headache.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 08-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J001700 and expiry date: 08-MAY-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
(IHB VAECS Case) Patient received SPV(1) and AVA(1) on 26 Mar 2018. 4 Apr, Onset of chest  pain:  about 4 hours after completing work out. Thought maybe it was a  pulled muscle, so "toughed it out".(intensity at onset (5/10). That night, he had difficulty sleeping due to pain. 5 Apr, Substernal chest pain "like a sumo wrestler on chest" continued and became progressively worse (10/10) during the day.  Pain worse with deep breaths . No change with position changes. No radiation. No shortness of breath, palpitations, and pedal edema. By late afternoon, in addition to chest pain, patient was nauseous and had one emesis; his coworkers said he was pale. He went to the local ER where he was admitted. In the ER, patient had abnormal ECG and elevated troponins. He received Toradol with some decrease in chest pain, but pain not resolution. He was admitted and taken for cardiac angiography in cath lab. During procedure, IV NTG was administered under sedation.  Patient remained in the hospital through Sunday, 8 Apr. He was diagnosed with Printzmetal Angina and discharged on Isosorbide  60 mg daily, ASA 81 mg daily, and L-arginine 1000 mg 3x/day. Patient has been asymptomatic since 6 Apr. He is on limited duty x 6 months. Plans are for patient to have follow up with cardiologist.
BODY ACHE; NOT EATEN ANYTHING OR DRINK ANYTHING; CHILLS; FEELING VERY WEAK; FEVER; This spontaneous report received from a pharmacist concerned a 48 year old male. 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 13-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-JUN-2021, the subject experienced body ache. On 13-JUN-2021, the subject experienced not eaten anything or drink anything. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced feeling very weak. On 13-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body ache, feeling very weak and not eaten anything or drink anything was not reported. This report was non-serious.
pain in her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix. In November 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient stated that patient experienced pain in her arm for 3 to 4 days after Shingrix dose.  The patient stated that the pain in her arm was the worst on the first night.  The reporter did not consent to follow up. This case has been linked to the US2022028948 case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022028948:same reporter