chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a health professional and refers to a 6-year-old female patient. The patients' pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 31-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number U025790, expiration date reported as 19-AUG-2023, and lot number U029496, expiration date reported as 21-SEP-2023, administered for prophylaxis (strength were not provided) (product storage error). The temperature excursion was -14 degrees Celsius (°C) up to -10°C for 3 hours 0 minutes, and  -10°C up to 8°C for 1 hour 30 minutes 0 seconds. No previous temperature excursion was reported. No adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009330: US-009507513-2205USA008004:
Rash over face and body since Aug 07, 2007 afternoon refer to HC and free clinic.
We received our first booster on Sept 25, 2021 and on January 5, 2022 we tested positive for COVID 19.
Event: Heart Arrhythmia, sudden onset of a sinus rhythm with premature ventricular contractions. Treatment: Undergoing study and treatment
Flu like feeling, fever, body aches, nausea, dizziness, weakness, unable to open eyes or stand up. Arm swelled up and turned red, very tender. Lasted until 8/21/18.  Arm redness and tenderness lasted one week.
first dose received 2/2/21. on 7/17/21 I experienced a blackout spot in the bottom left field of my vision. I was then diagnosed with central retinal vein occlusion after a second event on 7/27/21 that lasted approx. 48 hours.
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomittant medications were reported. No treatment information was provided.
Wrong vaccine administered. Patient was 12 years at time of vaccination and received Pfizer 5-11. Should have received 12+
I had really bad reaction to it; the arm hurt,; headache; sore muscles; fever; My muscle, my jaw and my neck were extremely tight.; In my eyes it's almost black like around it.; Dizziness; My muscle, my jaw and my neck were extremely tight.; This is a spontaneous report from a contactable consumer (patient). A 55-years-old non female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EP754), via an unspecified route of administration, administered in Arm Left on 08Mar2021 (at the age of 55-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism. Concomitant medications included thyroid (ARMOUR THYROID). Patient reported that she took the Pfizer vaccine on 08Mar and had really bad reaction to it. On 18Mar2021, her arm hurt, the headache, the sore muscles, the fever she had all that but then it continued. She did not not expect that maybe last a day or 2 but then she continued to had extremely bad headache, and then her muscle, her jaw and her neck were extremely tight and headache was really bad, in her eyes it was almost black like around it, it would not go away and she had dizziness also. She tried all medicine. She took anacin, aspirin, ibuprofen, Tylenol. She took tension headache medicine, migraine medicine. She took muscle relaxers. She took more advanced Ibuprofen extended release that the doctor has given her. She put heat on her, she put ice on her. She went for chiropractor 3-4 times. She tried to exercise like trying to loosen the muscle, she did a lot of stuff for it and then they gave her a shot in doctor's office. She don't know what that was, they supposed to relieve the headache it didn't and then the only thing that relieved her headache finally has been the steroid pack that's the prednisone pack and that was kind of like allergic reaction, like a high information of body allergic reaction, that's why she gave that to her. She went to chiropractor, and they tried to give her a shock to stop her headache that didn't work she thought that using work in 20 minutes, since then, now they finally put her on steroid pack massive a prednisone a pack. She called to asked if she should supposed to get her second shot. She felt like she had really bad reaction to it and she don't feel like I she should get the second shot. The outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
p/recv vax pt devel swelling & redness in arm; quite a sizable area above elbow was swollen & painful to touch; also had real tiredness; pt recovered 10/18 however pt stated the area still feels little hard;
Upper body and hand tremors with blank staring lasting approximately 10 sec. Occurring greater than 48 hours post vax with associated lethargy and anorexia.
Patient first report rash and noticed area swollen. Then patient reported to physician on 10/1/2015 with Shingles like rash near area of injection and noticeable swelling and irritation.
pfizer dose 0.2ml.     patient began to faint after he tried to get up from the sitting position about 2 to 3 minutes after the vaccination.   We laid him flat on floor, elevated his legs, and the patient's face began to have color again.  After about 5 minutes, we had him sit up and gave him a bottle of orange juice about 12 ounces.  He drank about 8-10 ounces. Then, we had him sit in a chair and after about 5 minutes he got up to walk and appeared fine.
Received 1st dose of Moderna COVID-19 vaccine and not received the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of Received 1st dose of Moderna COVID-19 vaccine and not received the 2nd dose 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 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced Received 1st dose of Moderna COVID-19 vaccine and not received the 2nd dose. At the time of the report, Received 1st dose of Moderna COVID-19 vaccine and not received the 2nd dose had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  Administrator of a healthcare facility did not think that any of the patients got COVID after vaccination. The corporate office or someone in the protocol office made a decision to stop the vaccination.
Red patchy hot to the touch rash from injection site radiating towards elbow of left arm. Patient c/o feeling "flu-like" sx. Achy, fever, painful to touch.
Expired Engerix B administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 74EM4, expiry date 20th December 2022) for prophylaxis.   On 28th December 2022, the patient received Engerix B. On 28th December 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt date: 30-Dec-2022. Reporter's Comment: The patient received expired dose of engerix B. The reporter consented to follow-up. Additional Supportive Information: The patient received expired dose which led to expired vaccine used.
High dose influenza caused bruising, warm to touch, itching x2days 2nd day of symptoms, started MEDROL DOSEPAK and advised to take BENADRYL prn.
anaphylactic reaction; Sweating; Slow hands movement; nausea; Body aches; A spontaneous report was received from a consumer who was a 37-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nausea, sweating, body aches and anaphylactic reaction.   The patient's medical history included a previous anaphylactic reaction to her first Moderna Covid-19 vaccine.  .Concomitant medications were not reported.  On 30-DEC-2020,  the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) and on 27-JAN-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly  for prophylaxis of COVID-19 infection.   On 27-JAN-2021, after receiving the second dose of mRNA-1273, the patient reported that she experienced nausea, sweating, body aches, and an anaphylactic reaction that was characterized by slow hand movements and facial swelling.  The patient reported that she would see her doctor on 18-Feb-2021.   Treatment for the events were not reported.  The patient received both doses of mRNA-1273, therefore, action taken with the drug was not applicable.    The outcomes of the events, nausea, sweating, body aches and anaphylactic reaction, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt vaccinated w/HIB/MMR developed temp 103.2 24 hrs after inject, irritable, refused liquids - saw MD 3PM;  4PM started on Ceclor no local reddness or edema at injection site, lymph nodes enlarged in neck area. Also had seizure and vomit.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown demographics. The patient's current conditions or medical history were not reported. On an unknown date, an unspecified number of patients may have been vaccinated with an unknown number of doses of VARIVAX (Merck) (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outside of those specified in the prescribing information. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies and stuffy nose) and NASAL CONGESTION (allergies and stuffy nose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergies and stuffy nose) and NASAL CONGESTION (allergies and stuffy nose). At the time of the report, HYPERSENSITIVITY (allergies and stuffy nose) and NASAL CONGESTION (allergies and stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment information was provided.   Reporter did not allow further contact
A mother reported that her 12 month old son received Prevnar and MMR on 12/8/00. On 12/15/00, he experienced irritability and crying. Additional information received from the physician on 1/17/01, indicated that the pt was seen in the physician's office on 12/19/00 where a physical exam was normal. Follow up info was received from the center for biologics evaluation and research on 09/04/2001. The child received his second dose of Prevnar and his first dose of MMR vaccines on 12/08/2000. On 12/15/2000, he experienced insomnia.
delayed reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (delayed reaction) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (delayed reaction). At the time of the report, VACCINATION COMPLICATION (delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Additional information received - consumer provided her email.
Adverse event: Tinnitus in R ear 16 days after shot (same side as vaccine was administered in R deltoid) Treatment: None Outcomes: Condition is ongoing no resolution to this point
Fever, chills, nausea, headache, fatigue  Fever and chills lasted about an hour at 2am.  Layered up clothes and blankets, but nothing helped. Had to let it run its course.  Headache throughout day, took excederin first time then Tylenol later in day when headache wasn?t as severe.  Fatigue- up with fever and chills in night probably contributed.  Took a 2 hr nap plus went to bed early.
Possible extra dose administered; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced possible extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible extra dose administered was not reported. This report was non-serious.
This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a patient who received Flu trivalent vaccine. On an unknown date, the patient received Flu trivalent vaccine at an unknown dose. On an unknown date, unknown after receiving Flu trivalent vaccine, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. It was unknown if the reporter considered the Guillain Barre syndrome to be related to Flu trivalent vaccine. Additional details were provided as follows: The pharmacist did not provide any patient information. The age at vaccination was not reported. In 2011, the patient developed Guillain Barre after a flu shot. The pharmacist did not know which flu vaccine caused this reaction.
Information has been received from a registered nurse concerning a 63 year old female, with no known allergies, or pertinent medical history, who "about 4 to 6 weeks ago" on approximately 15-JUN-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  On 31-JUL-2007 the patient developed a zoster like rash on her right cheek.  She had about ten lesions or more, and the area was sore, tender, and itchy.  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  There was no product quality complaint involved.  Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a registered nurse concerning a 63 year old female, with no known allergies, sun damage, and a history of non-melanoma skin cancer (previously reported as no pertinent medical history), who "about 4 to 6 weeks ago" in June or July 2007 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck). On 31-JUL-2007 the patient developed a zoster like rash on her right cheek. She had about ten lesions or more, and the area was sore, tender, and itchy. Unspecified medical attention was sought. No lab studies were performed. At the time of this report the patient had not recovered. There was no product quality complaint involved. Follow up information from the registered nurse indicated that no rash occurred at the site of injection or elsewhere within 42 hours of the vaccination. A herpes simplex virus culture of the right cheek was performed with results of none detected. A viral culture of the right cheek was done, no virus was isolated. The patient's pain was a 2 on a scale of 0 (least) to 10 (most). The patient has tried POLYSPORIN and cortisone acetate. The rash are grouped vesicles in an erythematous base. The patient was treated with VALTREX 1 gm by mouth three times a day for 7 days. It was unknown if there was recent exposure to chicken pox or herpes zoster. A DFA was not done. There was no photo taken. On an unspecified date the patient recovered. Additional information is not expected.
Information has been received from an office manager referring to multiple unspecified patients of unknown age and gender. The patients' medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored PROQUAD (rHA, lot # L032760 with expiry date 24-FEB-2017; dose, frequency and route were not reported; data logger involved). The PROQUAD was improperly stored at the temperature of 30.6 Fahrenheit (F) for 6 hours and 30 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
My pulse shot up as high  as 119, it eventually lowered to at or around 86 and now it's back in the 100's again. my arms feel like they're puffed up as tight as they can go. This fatigues.
Arm that shot was administered swelled from shoulder to elbow. It became very warm to the touch and painful. The swollen area also felt hard to the touch.
large red spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (large red spot) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (large red spot). At the time of the report, VACCINATION SITE ERYTHEMA (large red spot) outcome was unknown. Not Provided          Action taken with response to the events are not applicable
Monday (3 days after injection) I noticed a lump on the lower left side of my neck; near my collarbone. Tuesday my primary care physician examined me and said it was likely a swollen lymph node, a possible reaction for the shot. It is tender to the touch but does not affect my day to day activity.
Information has been received from a physician concerning a female patient who was vaccinated IM with a 0.5ml dose of Gardasil.  Subsequently, the patient experienced depression after receiving the vaccine.  Unspecified medical attention was sought.  At the time of this report, the patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
Her arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Her arm is hurting) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISONE and VITAMINS NOS for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (Her arm is hurting). At the time of the report, INJECTION SITE PAIN (Her arm is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided
This spontaneous report as received from a consumer refers to his currently 20 year old male son with no pertinent medical history and no known drug reactions or allergies. On 01-JUL-2013, the patient was vaccinated with the first dose of GARDASIL (route, lot # and expiration date were not provided). On 21-SEP-2013, the patient was vaccinated with the second dose of GARDASIL (route, lot # and expiration date were not provided). On 23-JAN-2014, the patient was vaccinated with the third dose of GARDASIL (route, lot # and expiration date were not provided). On an unknown date, the patient had a patient visit with his physician and the nurse gave him a fourth dose of GARDASIL (route, lot # and expiration date were not provided). Consumer said his son had already complete the three dose series of GARDASIL. The patient did not experience any side effects. There were no laboratory diagnostics studies performed. At the time of the report, the patient's status was unknown. Additional information has been requested.
My son received his second Pfizer vaccination for COVID-19 on 7/9/2022. On about 7/12/2022, he began complaining of chest pains. I had previously had him examined by a cardiologist, who said that his heart was in "perfect" condition, so I didn't think there was anything seriously wrong. I thought that maybe he was just having a panic attack and that he would be okay. He continued complaining of chest pains on 7/13/2022 and 7/14/2022, however. On the morning of 7/15/2022, he collapsed in the shower. I walked into the bathroom and found him unconscious and leaning over the edge of the tub. I got him up, got him out of the shower, set him on the toilet, called 911, and tried to cover him up as much as I could. The ambulance came and checked his pulse and blood pressure. They found that his blood pressure was very low, so they decided to transport him to the ER. When he got to the ER, he underwent various tests, including a chest X-ray, a chest ultrasound, and bloodwork. The doctor told me that my son was diagnosed with myocarditis. He also asked me if my son had received a COVID-19 vaccine. When I answered in the affirmative, the doctor then told me that 3 other young men had been diagnosed with myocarditis that week after receiving the vaccines. My son was not admitted to the hospital, but the ER doctor did call my son's cardiologist to inform him that my son needed a follow-up visit. My son was prescribed a medication to treat the myocarditis. It may have been methylprednisolone, but I'm not sure. The doctor advised us that the myocarditis would eventually go away on its own. My husband and my son went to his cardiologist for the follow-up on or about 7/18/2022. My son underwent an echocardiogram. I don't recall the exact findings of the echocardiogram, but they must not have been serious, since the cardiologist told us that it would be safe for my son to take a plane trip out of state. Since my son received his diagnosis and was treated, he has not complained anymore about chest pains.