chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature-non-study case was reported in a literature article and describes the occurrence of ISCHAEMIC STROKE (Acute ischemic stroke) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: First report of COVID-19 vaccine included flare of compensated congenital thrombotic thrombocytopenic purpura. Blood Coagul Fibrinolysis; 33(1). 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 ISCHAEMIC STROKE (Acute ischemic stroke) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (Acute ischemic stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ISCHAEMIC STROKE (Acute ischemic stroke) to be related. No concomitant medication was reported. No treatment medication was reported. Company Comment: This is a Literature-non-study case, concerning a 50-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant), and AESI of Ischaemic stroke. The event occurred on an unknown date after a dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a Literature-non-study case, concerning a 50-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant), and AESI of Ischaemic stroke. The event occurred on an unknown date after a dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Slight sore throat; Feel achy; Tired; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 14Apr2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included parkinson's disease and blood pressure high. Patient had no known allergies. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), carbidopa; levodopa (CARBIDOPA/LEVODOPA) and rasagiline (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 14:30 (at the age of 49-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 14Apr2021 at 20:30, the patient experienced felt achy and tired with slight headache. On 15Apr2021, the patient experienced felt achy, worse headache, tired and that evening had slight sore throat as well. The events did not result in doctor 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 felt achy and tired with slight headache, slight sore throat was recovering.  No follow-up attempts are needed. No further information is expected.
Approximately 36 hours following vaccine, I experienced a hypomanic episode lasting about 18 hours. My bipolar II disorder has been successfully regulated for more than 10 years, with very rare depressive breakthrough. My last manic episode was more than 5 years ago. I notified both the pharmacist and my psychiatrist. Because the episode resolved in less than 24 hours, no further medical intervention was required.
Fever, chills, muscle aches, rapid heart rate, pain in rib cage, pain at injection site Lasted for about 48 hours
Rabies vaccine round #2 Wed 3/28/12 approximately 1000, urinary incontinence approximately 1700 (also Thurs 3/29/12 x 2, Fri 3/30/12 x 1, Sat 3/31 x 1) Sun 4/1/12 round #3 approximately 1000, incontinent of urine approximately 1700. Seen Mon 4/2/12 negative UA and exam normal (no weakness, normal DTRs, etc.)
-Dosing error; adult dose given to pediatric patient for Hepatitis B -no adverse event experienced -Nursing error resulting in pediatric patient receiving adult dosing of Hepatitis B vaccine. Error identified after    administration. Patient did not exhibit or experience any adverse event from the dosing error. Mother contacted by this    clinician regarding error and discussion with local health department on forward progress.
Had a flu vaccine #2 yesterday-last night irritability and crying throughout night fever 100, soft stools x3 (so far), positive drinking formula and Pedialyte.
Patient left elbow locked. She cannot fully extend, She receive the shot on 8-23-23 Started feeling adverse reaction 08-25-23
Marked swelling, induration, tenderness @ inject site; 4-5cm diameter w/ 2 0.5cm vesicles;
First Shot 2/15/21: Full Body Itchiness, Went after prednisone.  Second Shot 3/15/21:  joint inflammation, muscle pain. Still reoccurring since 1 week after 2nd shot.
Felt very warm/hot within a few hours after the shot followed by chills at night and general body aches without a fever. Since Sunday April 25 to date I have kept on feeling an itch (without rash or hives) underneath my skin, mostly in between fingers and toes but also in stomach, back, chest.  There's nothing visible in my skin, just this itchy sensation.
Scratchy throat, cough, throat tightness improved with Benadryl 25mg oral. Observed for 15 minutes, able to drink water. Lungs CTA (B).
Information has been received through the Merck pregnancy registry for GARDASIL vaccine from a registered nurse concerning a 20 year old female patient with juvenile diabetes and no known allergies who on 19-May-2008, was vaccinated with the first dose of GARDASIL vaccine (LOT # 658222/0927U) 0.5 ml IM. On 29-JUL-2008, was vaccinated with the second dose of GARDASIL vaccine (LOT # 659653/1448U) 0.5 ml IM. Concomitant therapy included insulin (manufacturer unknown). The patient was now pregnant. The last menstrual period was on 01-JUL-2008. On an unspecified date, pregnancy test was performed and resulted positive. No other symptoms were noted. The patient called the doctor for medical attention. Estimated date of delivery on 07-APR-2009. Follow-up information received from the registered nurse revealed that the patient had delivered a baby boy in March 2009 (exact date not known). She mentioned that the baby did have some "heart trouble"; the patient was told that her baby had a "rapid heartbeat". The baby was treated with INDERAL (additional details not known). The registered nurse reported that the patient was told by her doctor that her baby's rapid heartbeat was related to the patient's juvenile diabetes. It was reported that the patient did continue to wear an insulin pump. The reporter stated that she had seen the baby and he did "look normal". She confirmed that the patient had no congenital anomalies. Additional information was received from the nurse the next day. She reported that the baby was born on 18-MAR-2009. The nurse stated that she had said the baby's heart trouble as a "rapid heartbeat" was listed as an "enlargement heart" and was being treated with INDERAL. She had no further information to provide. This is one several reports from the same source. Additional information has been requested.
Product temperature excursion issue; Expired vaccine used; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Nov-2021 and was forwarded to Moderna on 10-Nov-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.
This spontaneous case reported by a consumer, describes the occurrence of ageusia (loss of taste), arthralgia (joint pain) and pain in extremity (arm pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concomitant products included clonazepam, gabapentin and Wellbutrin (bupropion hydrochloride). On Apr 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 16, 2021, patient experienced arthralgia (joint pain). On Apr 17, 2021, patient experienced ageusia (loss of taste). On an unknown date, patient experienced pain in extremity (arm pain). Patient treated with Tylenol (paracetamol) ongoing since an unknown date, 1 dosage form once a day; and codeine ongoing since an unknown date at a dose of 1 dosage form once a day. At the time of the report, ageusia (loss of taste), arthralgia (joint pain) and pain in extremity (arm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: not applicable. No concomitant medication or treatment information reported.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Additional Details: PT EXPERIENCE LITTLE DIFFICULTY SWALLOWING/BREATHING SO GAVE BENADRYL. PT SAT FOR 30MINS AND EXPERIENCE TINGLING IN LEFT SIDE OF ARM/NECK, TEMP WENT FROM 97 TO 98F, MUSCLE ACHES.
Pt recvd 2nd dose of vax on 7FEB92 & MAY92 devel blurred vision; seen by Ophthalmologist who changed contact lenses 3 times then stated pt had swollen optic nerve;
onset of probable measles rash on 19MAR94 @ 630AM treated w/DPH in ER: f/u clinic visit on 21MAR; rash remains;
Abdominal pain, fever, chills, myalgia, vomiting 24 hours after receiving vaccine - Rx Phenegran.
I tested positive on 22May2022; I tested positive on 22May2022; 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 67-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 17Feb2021 as dose 2, single (Lot number: EM9809), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: EW1062), in left arm and on 28Apr2022 as dose 4 (booster), single (Lot number: FH8027) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "GERD" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Avelox, reaction(s): "known allergies: Avelox Allergy", notes: known allergies: Avelox Allergy. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22May2022, outcome "not recovered" and all described as "I tested positive on 22May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: I tested positive on 22May2022; (06Jun2022) Positive, notes: I tested positive again on 06Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had not taken other medication in 2weeks. Anti-viral details: Product COVID 19 Treatment, Brand-Paxlovid, Treatment start date-25May2022, Treatment stop date-29May2022, indication=Treatment of COVID-19. Adverse event: He tested positive on 22May2022. Extremely sore throat. Started Paxlovid on 25May, finished 29May. Sore throat diminished about 3 days after starting Paxlovid. Continued to have excess phlegm and coughing for another few (maybe 2 or 3) days. Did not have any symptoms but he tested positive again on 06Jun. The reason he did the test was his wife tested positive on 06Jun also. Her story: She first tested positive on 18May2022. Slightly elevated temperature and sore throat. Started Paxlovid on 19May. Her symptoms diminished about 3-4 days after starting Paxlovid regimen. Somewhere around 03Jun, maybe 04Jun, she developed congestion in her chest with a cough. She decided to do a home test on June 6 and tested positive. He also did the test, but only because she tested positive, he had no symptoms. Of course, he don't know if he might develop symptoms going forward. We isolated for 10 days after testing positive the first time and will do the same this 2nd time. Adverse event start date: 06Jun2022, If patient recovered: Recovering, If treatment ae: No.
Later that day I started getting pain in the hip/groin area of my left leg preventing me from putting pressure on it or walking.  The acute pain diminshed after about 3 hr and I could walk again but the hip flexor area remained tender and felt like a sore muscle had been pulled for about 3 days.  About 5pm I developed really bad chills which lasted about 24 hrs and was really intense about the first 6hr.  About 11pm I developed a severe headache preventing me from sleeping which lasted about 9hrs.  4/10 I had occassional chills, the headache had subsided a little but had a nagging tension feeling and I was really fatigued and really wiped out the remainder of that day.  My Gynecologist advised I stopped taking my Birth Control for the next month to lower my risk of blood clots.
Primarily it was headache, fatigue, gut pain, it was higher in my abdomen centralized like around gallbladder, random body pains in my back back, legs , shoulder, my arm wasn't sore the first 2 days about day 3 it started getting sore for about week, the rest of my symptoms lasted till the end of month. Saw my primary care doctor.
Information was received on 15-FEB-2019 from a lawyer regarding a case in litigation regarding a female patient, history not specified. On or about 05-NOV-2015, at age 66, the patient was prescribed and administered ZOSTAVAX at a pharmacy for the prevention of shingles and zoster related conditions. On an unspecified date the patient was treated by a physician at an urgent care for the following injuries resulting from ZOSTAVAX use: shingles. The outcome of shingles was not specified.   Additional information has been requested.
Sudden vestibular neuritis currently treated with prochlorperazine after going to hospital.
Varivax was expired 9/9/23 but administered on 11/3/23. No apparent harm to vaccine recipient.
she and her Husband got a common cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: Unknown; , Manufacturer: Unknown), for Covid-19 immunization. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "she and her Husband got a common cold".  Additional Information: The reporter would like to cancel their appointment for the 2nd booster dose of the vaccine. Because the patient mentioned that she and her Husband got a common cold.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Joint Pain, 2-3x worse than her normal joint pain, her arthritis is noticeably worse, knees, lower back, large joints, and her hands are the worst; Left arm instantly hurt the second she got it, it hurt before she even got out of the parking lot.; Fever; Headache; Liver Failure; Body Aches; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164; Expiration Date: 31Aug2021) via an unspecified route of administration in left arm in Apr2021, as single dose for COVID-19 immunization. Medical history included Cushing's syndrome from 2007 to ongoing, Adrenalectomy (Right) in Dec2007, ongoing Osteoarthritis (joint pain), hypersensitive to chemicals, ongoing Arthritis (joint pain), short memory. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks) were None. Previously patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8732; Expiration Date: 31Jul2021) in right arm in 2021 (at age of 53-year-old) for COVID-19 immunization and also took avalox and experienced tachycardia which almost killed her (years ago). Patient stated after the second shot she had fever, body aches, headache and all the list of horrible side effects for 2 days all in Apr2021. Left arm instantly hurt the second she got it in Apr2021, it hurt before she even got out of the parking lot. Patient states what has not subsided was the joint pain. Patient states she had arthritis, Osteoarthritis caused by her Cushing's Syndrome. Patient states her medications that she uses to manage her arthritis are not stopping the joint pain. Patient stated her joint pain was 2-3x worse than her normal joint pain and also bad as it was before the vaccine and her arthritis was noticeably worse, knees, lower back, large joints, and her hands are the worst and her hands and she usually doesn't feel it much in her hands. Patient states she tested and tested to see if it was the weather and no it wasn't her joints are significantly worse and her usual treatment isn't very effective. States she was pretty sure it was from the vaccine. Patient states anyhow, she reported that her joint pain was worse after having Covid. Patient states the achiness and pain in her joints lasted and never got better, her pain was 2-3x what she was normally used to and the medicine was not making a dent in the pain level. Treatments were Occasional Tylenol. CBD (cannabidiol) and THC (tetrahydrocannabinol), but they are not working. Patient stated she rarely takes Tylenol in case of Liver Failure in Apr2021. Patient states her body rejects chemicals and she has to eat organic food. The outcome of event liver failure was unknown, joint pain and arthritis aggravated were not recovered, while remaining events were recovered in 2021.   Batch/Lot number was obtained. Further information has been requested.
Initial and follow up information has been received from a health professional concerning a 20 year old female patient who on 16-AUG-2007, at 09:00 AM was vaccinated IM in to left deltoid with a first dose of Gardasil lot #658094/0524U.  The reporter reported that about 2 minutes after at 09:05 AM she became dizzy with a near syncope episode.  She became pale and her skin became clammy.  She was assisted to put her head between knees and applied a cool compress to her forehead and back of the neck.  She regained color.  Patient mentioned that she felt "normal".  Additional information is not expected.
Pt informed us today, 1-15-21, that he tested positive for COVID-19. He was tested on 01-08-21 and failed to inform us during his vaccine checklist questions. He answered no to all questions and was afebrile.  He is remaining at his residence now.
Immediately after injection felt warmth and pain in arm. Stood up then felt like couldn't breath, "like worst asthma attack of my life" and flushed and dizzy. HR rapid initially to 3P<, O2 sat 98%, BP 130/70 and rash with hives at injection site. Lungs clear, no wheeze.
LOCAL REACTION LEFT DELTOID:  SWELLING , REDNESS, WARMTH, PAIN WITH MOVEMNT
Visual disturbances, flashes in left eye periphery (no impact on right eye), did not worsen after second dose, slow improvement over time but persisting.
second dose planning to be given today (Feb 22nd 2021) / 29 days apart /first dose (Dic 26th 2020).; circumstance or information capable of leading to medication error; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 22nd February 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: Age at vaccination was not reported. The patient received 1st dose of shingrix on 26th December 2020.  The reporter was looking for guidance on administration of Shingrix second dose and was planning to give on the day of reporting, which was only 29 days apart from 1st dose and led to shortening of vaccination schedule. No further information available. The reporter consented to follow up.   Follow up information was received from pharmacist on 16th April 2021: Since in the initial reporting, it is stated that the reporter reconstituted the vaccine and was in hurry but was not clearly stated if dose was given or not. Therefore event circumstance or information leading to medication error was added. The reporter said that there were no further details to share and requested no further contact.
A few minutes after vaccination patient had a scratchy throat and metallic taste in her mouth, as well as a headache.  She received Benedryl and was released home.
This morning I woke up with a  tenderness,  swelling,  pain in the same arm of the vaccine, left shoulder. I also developed fatigue, headache, chills and fever of 104.00.