chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nursing staff manager is calling to report a temperature excursion; No adverse event; There was only 1 person whom received the vaccine from this lot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Nursing staff manager is calling to report a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (There was only 1 person whom received the vaccine from this lot ) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Mar-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (There was only 1 person whom received the vaccine from this lot ). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Nursing staff manager is calling to report a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Nursing staff manager is calling to report a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (There was only 1 person whom received the vaccine from this lot ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Nursing staff manager is calling to report a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (There was only 1 person whom received the vaccine from this lot ).    No concomitant drug information was provided.  Reporter reported that from a Bivalent - Lot no. AS7170B, unknown number of vials and doses- a temperature excursion was reported, time frame was for 2 hours and 12 minutes. Temperature dropped to 28-8-degree Fahrenheit - average temperature should be 39.6-degree Fahrenheit. It was reported that 4 Bivalent vials of Moderna COVID-19 vaccine experienced excursion in the refrigerator. On 23Mar2023, an adult patient received 1 Bivalent booster dose. At the time of excursion the vials were refrigerated and intact cartons. The vial size was 2.5 ml. Maximum temperature 42.2F and minimum temperatures 28 (Average: 39.6F) Excursion duration was reported as 2 hours and 12 minutes.  vial was moved from freezer to refrigerator on 28FEB2023. Upon the visual inspection, a vaccine state change was noted.   Treatment medication information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2023: Follow-up received, updated narrative.
A couple of week after the vaccination I gradually started seeing small, red bumps on my knuckles,  and it progressively started getting worse and it continues. I saw doctor in April and he prescribed a treatment that did not help. The bumps have increased overtime and now my face has redness, my neck, chest, left elbow have redness that look like a rash.  My hands have red bumps on my knuckles and my cuticles, they are tender and sore. I am now taking prednisone 5 mg that I took for 2 weeks and it did not do anything for me. Methotrexate 2.5 mg, 4 tablets 1 x week. The doctor said it was slow acting and I have not seen any results. Dermatologist feels strongly that the vaccine caused the flare up because I never had a reaction like that before the vaccine.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reaction/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX (lot # M010212 with expiration date 21-JAN-2019; dose and route were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Red swollen rash developed around the upper arm. Rash had localized pain and itching. Pain lasted 2 days and was treated with Tylenol, Motrin and Benadryl tablets.
Tight lungs and instant migriane headache followed by diarrhea, I could not sleep and then today I am vomiting and sore body. These symptoms are not on the site and I have 2 children 2 year old and 3 year old. They are not able to get the vaccine until Dec. 5th, due to other vaccines. Is my symptoms contagious? What if I give my kids the Swine Flu? I got vaccinated because I have past of respiratory issues and I also did not want them to get sick. I did the nasal spray rather than the shot, I wonder if the shot would have made me this sick?
developed sore left and right shoulders; knee started hurting; Shoulders had rotator cuff tendinitis; Knee had bad inflammation; Can not sleep; Limping; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Mar2021 at 13:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included prior arthroscopic surgeries on right shoulder and knee. The patient was allergic to penicillin. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously took erythromycin and experienced drug allergy. 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 23Mar2021, at 16:00, within one day of first vaccination, the patient developed soreness in left and right shoulders. On an unknown date in 2021, within 2 weeks, the patient's knee started hurting. On an unknown date in 2021, at 4 weeks, the patient went to the doctor who informed that both the shoulders had rotator cuff tendinitis and knees had bad inflammation. On an unknown date in 2021, the patient also experienced lots of pain, could not sleep and was limping. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of all reported events and included treatment with prednisone. The clinical outcome of the events sore shoulders, rotator cuff tendinitis, knee inflammation, lots of pain, could not sleep and limping were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow-up.
Approximately 10-15 minutes after injection was administered, pt. had episode of syncope. Pt's. father sat pt. up in chair, pt. was alert but reported lightheadedness. Nursing and provider arrived and vitals were taken - initial BP 74/44. Laid pt. on the floor for 3-4 minutes. Pt. then sat up for a minute. BP increased to 104/67. Pt. reported feeling better, provider reinforced teaching to pt. and father that vasovagal syncope can be common with HPV vaccination.
LGF, tactile  temp, runny nose, headache, stuffy nose, cough.  No SOB or chest pain.  Less energy and less active than normal.  All started day after vaccine and progressively gotten worse over the next couple of days.
Fever (up to 101°F) Muscle and general body aches Stomach pains and bloating Lethargy/weakness over entire body
Information has been received from a physician concerning a male patient who in October 2006 or November 2006 was vaccinated with a dose of Zostavax. Subsequently the patient experienced a "severe case of shingles". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
t101.5; rt leg swelled real, real red very sensitive non-stop screaming-crying;
CVA isolated; Diplopia (left eye); Left with a palsy; Inability to walk confidently; Left cranial nerves VI, and III show deficit's; Cannot see out of left eye; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (CVA isolated), DIPLOPIA (Diplopia (left eye)), PARALYSIS (Left with a palsy), GAIT DISTURBANCE (Inability to walk confidently), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) and VISUAL IMPAIRMENT (Cannot see out of left eye) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Obesity (BMI 45-45.9).    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (CVA isolated) (seriousness criteria hospitalization, disability, medically significant and life threatening) and DIPLOPIA (Diplopia (left eye)) (seriousness criteria hospitalization, disability and medically significant). On 12-Apr-2021, the patient experienced PARALYSIS (Left with a palsy) (seriousness criteria disability and medically significant), GAIT DISTURBANCE (Inability to walk confidently) (seriousness criteria disability and medically significant), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) (seriousness criteria disability and medically significant) and VISUAL IMPAIRMENT (Cannot see out of left eye) (seriousness criteria disability and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (CVA isolated), DIPLOPIA (Diplopia (left eye)), PARALYSIS (Left with a palsy), GAIT DISTURBANCE (Inability to walk confidently), CRANIAL NERVE DISORDER (Left cranial nerves VI, and III show deficit's) and VISUAL IMPAIRMENT (Cannot see out of left eye) 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.   The Patient was Treated with  Lovenox, Coumadin, Brimonidine eye drops.The patient has been taking High Blood Pressure Medication,Severe Obesity medications and Hyperlipidemic Medications.The patient has no known Allergies.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE EXPIRED DUE TO TEMPERATURE EXCURSION; This spontaneous report received from a pharmacist concerned a 50 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: 207A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the patient experienced administration of vaccine expired due to temperature excursion. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine expired due to temperature excursion and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915661, 20210916910, 20210915719, 20210916300, 20210916697, 20210916959, 20210916965, 20210917160, 20210916808, 20210915646, 20210915623, 20210916715, 20210917163, 20210916907, 20210916553, 20210916768, 20210917515, 20210917226, 20210915852, 20210916658, 20210917500, 20210915731, 20210916228, 20210916312, 20210916455, 20210916520, 20210916129, 20210916415, 20210916498, 20210916465, 20210916849, 20210916811, 20210915748, 20210917603, 20210913164, 20210915852, 20210917074 and 20210916401.
no adverse effects; patients received improperly stored doses, exposed to a temperature of 34.5 Fahrenheit for 100 minutes; This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
My daughter came to for the holidays in December 2019. She was sick when she arrived. I became ill with the same symptoms three days later. We had all the symptoms of COVID and I was on an study for which I sent three blood samples. I believe I was an early adopter of COVID, and have since had FIVE vaccinations. EACH TIME I FELT LIKE I HAD COVID. I feel like I have COVID now. I just took a COVID test. It was negative, but I like science, especially self-science. BUT TELL THAT NEGATIVE RESULT TO MY  BODY because I feel like I have the start of a cold and tremendous fatigue (I am normally very energetic and rarely take naps), and I feel like I have a fever. But I also live in  City, so.... Anyway, I am just reporting in because I think others need to know that reactions to the vaccine might mimic the disease and they could be in for a few days of discomfort as well as redness (inflammation) at the site of the injection. Thank you. May whomever reads this stay well and hearty and hale.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 (at the age of 68-Years-old) (Batch/Lot Number: EW0169; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 02Apr2021 (at the age of 68-Years-old) (Batch/Lot Number: ER8733; Expiration Date: 31Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. On 24Apr2021, 2 days after the vaccination, the patient experienced Diarrhea. The patient reported that patient had diarrhea for the last 2 weeks and she is asking is it something that we have been hearing about or not. The patient was taking care of it and wanted to inform that this was happening to her. It was reported that patient went to the Mini Clinic and they prescribed 3 probiotic, one after every meal and she did a bland diet. This was not the prescription it was OTC 3 billion CFU of probiotics and daily digestive probiotics. This was all she took. That's all. That was the strength they recommended to patient. Therapeutic measures were taken as a result of diarrhoea. At the time of this report, the outcome of diarrhoea was unknown.  No follow-up attempts are needed. No further information is expected.
Dry cough; A bump on his armpit; Swelling at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), AXILLARY MASS (A bump on his armpit), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced COUGH (Dry cough), AXILLARY MASS (A bump on his armpit), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (Dry cough), AXILLARY MASS (A bump on his armpit), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            Treatment medications also included a cream. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-101728 (Patient Link).
05/15/2022, I had a slightly runny nose and a slightly itchy nose. I took a COVID test on 5/14/2022 because my partner had tested positive. It was negative. On 5/16/2022, I had a COVID test at the pharmacy and it was positive. My symptoms never worsened. On 5/17/2022, I contacted my Rheumatologist to ask if I should stop taking my immune suppressive medication, Xeljanz. She said to stop for 5 days. She prescribed Paxlovid. I took Paxlovid for 5 days. My runny nose went away in about 2 days. I have recovered.
It was described as a full body rash that resolved without permanent effect. It was recommended to not get next dose based on symptoms. A licensed physician present during the clinic agreed not to receive the next dose at this time.
Patient presents to PCP for routine physical. Patient reports palpitations after COVID booster in 11/22. Noted multiple resting HR in the 140s and one time in the 180s sustained for several minutes at rest. Felt unwell, flushed but no chest pain or SOB, nausea, or dizziness. PCP believes temporally related to COVID shot and recommended avoiding further boosters. Has seemingly resolved and hasn't felt ill since November. Some elevated HR readings on smart watch but patient isn't sure if related to working out or not.
body aches; chills; runny nose; coughing; sneezing; This is a spontaneous report from a contactable consumer (patient). This 28-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that last week he received BNT162B2 and yesterday (as of 16Mar2021) he started feeling body aches, a lot of chills, a runny nose, coughing and sneezing. The patient inquired if he could go to the doctor or what he should do. The clinical outcomes of body aches, chills, runny nose, coughing and sneezing were unknown.   Batch/Lot Number has been requested.  Follow-up attempts are completed. No further information is expected.
After receiving the PFIZER Booster shot in right arm, 20 minutes later I started having Sharp, painful, jabbing pain in my supraclavicular lymph nodes on the right side. Hours later my lymph nodes in my right armpit and along the side of my right breast were swollen as well.  The swelling and the pain lasted for 4 days.
12/25/21: Pt admitted at 2043 to the hospital due to SOB, chest pain, generalized body aches and cough. Onset of symptoms occured 12/22. Also reports fever/chills (pt report Tmax 104F), also nausea with 1 episode of vomiting. COVID diagnosed 12/25. Pt took tylenol 500 mg at 2000 with minimal improvement.  12/26: PRN tylenol for fevers and tessalon for cough. Pt was eligible for monoclonal Ab infusion but currently unavailable at pharmacy. Pt was discharged at 0743 since she was stable and not requiring o2.
Sore arm, extreme nausea, fatigue. Extreme headache. Fever.
PENTACEL dose # 2 and PREVNAR dose # 2 inadvertently given 2 weeks after 1st dose. Informed mom of event. Spoke with mom next day. No adverse reaction. Pt. doing well. Treated with TYLENOL.
Patient admitted to hospital several times within 6 weeks of receiving COVID vaccination for infective myositis of left lower leg.
Flu like symptoms; slight fever; Arm pain; Unexpected therapeutic effect; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included attention deficit hyperactivity disorder.   On 12th November 2021, the patient received the 1st dose of Shingrix. On 12th November 2021, several hours after receiving Shingrix, the patient experienced influenza-like symptoms, fever and pain in arm. In November 2021, the patient experienced unexpected therapeutic effect. On 13th November 2021, the outcome of the influenza-like symptoms, fever and pain in arm were recovered/resolved. On an unknown date, the outcome of the unexpected therapeutic effect was unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient had shingrix vaccine and experienced flu-like symptoms, a slight fever, and arm pain a few hours after the dose. All symptoms began at the same time and all symptoms resolved at the end of the day on 13th November 2021. The patient had ADHD and experienced the unexpected benefit of mental clarity on 14th November 2021, which patient reported had not experienced in over 2 years. It resolved at the end of the day on 15th November  2021. The reporter did not consent for follow-up.
A non-serious spontaneous report of fever has been received from a parent concerning her four-year-old female child, subsequent to Flumist. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The patient's medical history and concomitant medications were not reported. The patient and her brother (MEDI-0009049) received FluMist on 08-Oct-2009. On 10-Oct-2009 the patient and her brother both developed a fever. The outcome of the event fever was unknown. Required follow-up attempts have been performed, requested information unable to be obtained.  22-Feb-2010.
Abnormally sore arm for 2+ weeks post-vaccination (March 26). -- No treatment; resolved on its own Intense chest tightness starting during late night on April 6th; continued through April 8th; dissipated April 9th. -- No treatment sought, as no dizziness nor shortness of breath accompanied chest pain; resolved on its own Hemiplegic episode April 7th. -- No treatment sought, as episode was very brief and resolved quickly