chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 12:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 12:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 51.47 for dose administered on 13-Feb-2021. No concomitant medications were reported.  Batch number 031L20A administered on 13-Feb-2021 underwent temperature excursion with temperature of 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Patient received Moderna COVID vaccine on 2/21/21 (lot # 012M20A), 3/3/21 (lot # 029A21A), and 11/23/21 (lot # 013F21A). On 5/28/22, patient admitted to our inpatient facility with generalized weakness with frequent falls and COVID-19 infection (diagnosed 5/25/22 using home test and confirmed positive in our facility on 5/30/22). Patient was admitted to our med/surg unit and discharged home on 5/31/22.
This spontaneous report as received from health care worker via company representative refers to a patient of unknown age. There were no pertinent medical history, concurrent conditions and drug reactions/allergies reported. On an unknown date the patient was vaccinated with ROTATEQ orally, (frequency, dose number, lot # not reported). No concomitant medication reported. The health care worker stated that an increased number of patients seem to be spitting out partial doses of ROTATEQ with greater frequency than before. No patient specific information available. No adverse effects reported. Additional information has been requested.
This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent or medical conditions were not reported. On an unknown date, the patient was vaccinated post supported temperature excursion with VARIVAX (Merck) 0.5 ml, subcutaneous, lot # reported as K000794 with expiration date 30-JUN-2015 and lot #K010339 expiration date 22-JUL-2016. No adverse effects noted. Lot number K000794 is an invalid lot number for VARIVAX (Merck). This is one of several reports received from the same source. Additional information has been requested.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Apr2021 11:00 (Lot number: ER8731) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia", start date: 2020 (ongoing); "osteoarthritis" (ongoing); "Rheumatoid arthritis", start date: Mar2021 (ongoing); "Migraines" (unspecified if ongoing); "Acid reflux", start date: 2020 (unspecified if ongoing); "inflammatory arthritis", start date: Mar2021 (ongoing); "COVID-19", start date: 2020 (unspecified if ongoing), notes: Verbatim: Caller reported that she had Oovid-19 last year in 2020. Concomitant medication(s) included: PREDNISONE taken for arthritis, start date: 27Mar2021, stop date: 17Apr2021; PREGABALIN;PF-00489791 taken for fibromyalgia, start date: May2020 (ongoing); PANTOPRAZOLE taken for gastrooesophageal reflux disease, start date: Aug2020 (ongoing); TOPIRAMATE taken for migraine, start date: Jun2020 (ongoing); PROPRANOLOL taken for tremor, migraine, start date: Nov2020 (ongoing); HYDROXYCHLOROQUINE, start date: Apr2021 (ongoing); DOXEPIN HYDROCHLORIDE taken for fibromyalgia, sleep disorder, sleep disorder, start date: Apr2021 (ongoing); DULOXETINE DR taken for fibromyalgia, start date: 2020 (ongoing); VITAMIN D3 taken for blood iron abnormal, start date: Apr2021 (ongoing); VITAMIN B12 & FOLIC ACID, start date: Dec2020. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Apr2021, outcome "recovering", described as "Sore arm".  Additional information:It was reported that she had previously taken Topiramate for migraines and stopped taking it when she had surgery because she didn't want to take a whole lot of medication. She took 4 tablets of prednisone, then 3 tablets, then 2 tablets, and then 1 tablet until the medication was completed. She was diagnosed with migraines, maybe 15 or 16 years ago. It might have been longer than 15 or 16 years since she was diagnosed with migraines. Patient did not required emergency room or physician office. No prior vaccination within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Had the Pfizer booster felt my finger feel a little numb on 12/11/2021 when I got the shot, but I thought that would go away. Then the next day my arm hurt where I couldn't lift it too high, and I had an excruciating back pain like it was going to break. So painful that Tylenol didn't help.
This spontaneous report as received from a nurse refers to her 65 year old male husband without drug reactions/allergies. The patient had history of shingles, right hip replacement in 1990's, radiation for malignant lesion of right 1997 and hemochromatosis. On 30-OCT-2014 (also reported as 30-NOV-2014), the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiration date not reported). Concomitant therapies included PROTONIX, UROXATRAL, ibuprofen, baby aspirin and omega-3 marine triglycerides (reported as fish oil). Nurse reported that patient experienced being confused and unable to speak on 07-NOV-2014, after receiving ZOSTAVAX on 30-OCT-2014. Patient was taken by ambulance to a hospital, computerised tomogram (CT) scan showed a left frontal bleed and patient medevaced to another hospital on 07-NOV-2014. Left frontal lobe bleed affected patient's right side and speech. Patient was on life support. Nurse reported that patient had no use of his right arm and cannot speak. Nurse reported patient was now off ventilator, feeding tube remained in place; however, patient was advancing to a soft diet. Nurse reported patient was transferred to step down unit on 13-NOV-2014, and anticipated start of rehabilitation. The outcome of the events was recovering. The events were considered by the reporter as requiring intervention to prevent serious criteria, significant disability or incapacity and life threatening. Additional information has been requested.
pt recv vax 12DEC95 & later that day pt devel an inj site rxn characterized by redness & tenderness inferior to the inj site;sx lasted 4 days & were resolved as of the date of this report;
A fast heartbeat; Dizziness and weakness. Went to ED - "Patient is an 82yo male with a history of chronic Afib on Eliquis, HTN, and bradykinesia (thought to be PD) who presented to the ED with a CC of weakness after receiving 2nd dose of COVID-19 vaccine. He also had low-grade fever and difficulties ambulating. In the ED he was febrile at 38.5C and HR 159bpm. EKG revealed Afib RVR. BP was stable. He was given Cardizem 10mg IV x1. Basic labs were unremarkable. COVID negative. CXR negative. He was given Tylenol for fever and admitted under observation. He remained afebrile and heart rate remained controlled with home Cardizem dosing. Cardiology was consulted who will refer him to their clinic to establish routine care with their service. PT/OT recommended home with home PT/OT. The patient overall felt much improved compared to admission and felt ready for discharge. He was discharged home in stable condition.
COVID/First positive test was 06Jun; COVID/First positive test was 06Jun; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1,single (Lot number: EN6198), on 02Apr2021 as dose 2, single (Lot number: ER8732) and on 19Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "asthma" (unspecified if ongoing); "migraine headache" (unspecified if ongoing); "peanuts" (unspecified if ongoing); "mangoes" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01Jan2022, stop date: 16Jun2022; SPIRONOLACTONE, start date: 01Jan2022, stop date: 16Jun2022; TOPAMAX, start date: 01Jan2022, stop date: 16Jun2022; MELATONIN, start date: 01Jan2022, stop date: 16Jun2022; SUMATRIPTAN, start date: 08Jun2022, stop date: 10Jun2022; ALBUTEROL [SALBUTAMOL], start date: 06Jun2022, stop date: 08Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "not recovered" and all described as "COVID/First positive test was 06Jun". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) Positive, notes: First positive test was 06Jun; (14Jun2022) Negative, notes: Tested negative 14Jun; (16Jun2022) Positive, notes: Tested positive again 16Jun. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Information:No other medication were received in 2weeks. Anti viral details.Product: COVID 19 Treatment, brand: Paxlovid.Treatment start date 06Jun2022,Treatment end date 10Jun2022.Indication:Treatment of COVID-19.
Pain where vaccine was injected, tiredness, headache,  muscle pain, chills, fever, sweating
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-JAN-2016 the patient was administered with  a dose of improperly stored ROTATEQ (lot # L008996 and expiration date 01-DEC-2016, dose, dose # and route not reported) and RECOMBIVAX HB (lot # L027733 and expiration date 13-SEP-2017, dose, dose # and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected since there was no consent for follow up contact.
Massive rash down arm; Rash is hot and raised; Rash is hot and raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Massive rash down arm), FEELING HOT (Rash is hot and raised) and RASH PAPULAR (Rash is hot and raised) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced RASH (Massive rash down arm), FEELING HOT (Rash is hot and raised) and RASH PAPULAR (Rash is hot and raised). At the time of the report, RASH (Massive rash down arm), FEELING HOT (Rash is hot and raised) and RASH PAPULAR (Rash is hot and raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported.  No Treatment information was provided.  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.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 20-MAR-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
I was eating food that I normally eat and I looked down at my right arm and saw decent amount of hives. Then I check the rest of my body and found more. I took benadryl and zyrtec on the 5th and then feel asleep. I woke up in the middle the night to see that they had doubled eone in my private parts. I went to urgent care and they gave me a steroid injection, prescriptions for pepcid, a steroid pack and told me to continue to take the benadryl and zrytec. The hives have gone down, but I feel very weak and tired. It occured around 8:30 Friday night (2/5) and I am sorry I didn't fill out the form last night. i got the shot this morning at 8:30 am. I had a slight fever this morning.
Sudden feeling of lightheadedness; Heart started racing; This is a spontaneous report from a contactable consumer, the patient. A 20-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left  arm on 02Apr2021 at 14:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Patient medical history was provided as no. The patient did not have any known allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN). 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 02Apr2021 at 16:15, the patient had a feeling of light-headedness and patient's heart started racing, which lasted for about a minute or two. The adverse events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic treatment was taken for the reported events. The clinical outcome of the events feeling of lightheadedness and heart started racing was recovered on 02Apr2021.  No follow-up attempts are needed. No further information is expected.
Patient received his 1st COVID-19 vaccine from Pfizer at his school today. Within 15 minutes, he developed mouth tingling and a bad taste in his mouth. He was evaluated by the school nurse who gave him benadryl, which helped. He did not have any rash, wheezing, face swelling, trouble breathing, abdominal pain, vomiting, or diarrhea. He was then evaluated at the PCP's office where vitals were normal but he had some lingering mouth tingling. Advised to continue Benadryl for the next 48 hours.
Within three hours I experienced stiffness in my left knee which escalated to incapacitating pain and inability to support my weight, this lasted for three days with 2nd day being the worst pain and discomfort.  Also had a headache for most of the day on the second day.   Four days following vaccine I started to notice the injection site was getting itchy, then on day Five it was increasing and started getting red, swollen, hot and itch increased.  Day Six it is still itchy, red, hot and swollen.  Red site is about the size of an orange. As of Day Six, No fever, headache or other symptoms and knee has returned to normal discomfort.
11:40 AM- Patient reported pain in the left shoulder. Redness and swelling were present around the vaccination site and into the left shoulder area. The redness progressed along the upper arm chest and neck area. The areas were warm to the touch. Patient reported a feeling of being 'hot.'  No reported shortness of breath or itching. Patient was able to communicate and remained alert. Initial BP 153/85 P 80; Repeat BP 155/92. Benadryl 50 mg oral dose was given. Repeat BP at 12:05 PM 146/92 P 80.  Patient was instructed to take Benadryl 50 mg PO every 4 hours as needed. She stated that she had Benadryl at home. She was given a work release for one day. She was instructed to call 911 if she experienced any further symptoms.  Patient was called at 3:53  PM for followup. She reported that the redness was gone but she was sleepy from the Benadryl. She was instructed that if any further redness or swelling returns or severe symptoms, then she should take the Benadryl again and call emergency services.
Vaccine was titrated in small doses and injected in very small amounts with appropriate waiting periods in between injections until entire vile was used. This was to allow my allergic body time to adapt as each dose entered. Metal taste immed. after injections - disappeared after leaving office. Next day, swelling from elbow to shoulder - iced both arms. Took 2 wks for swelling to really decrease. Arms remained hot and stinging for 4 wks after vaccine. Now 6 wks and arms still sting off and on each day - feel bruised, but there is no injection site mark. It is internal. So glad I could find tetanus only. Imagine if I had taken "Td" shot you keep pushing on the public. Nausea - 10 days total. Loose bowels - 11 days total.
On 14FEB92 pt woke up w/rash over inject site of both legs; rash worse over DTP site; pt seen by MD tx DPH; rash spread over all extremities;
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (Family History) (everyone in patient's family had chickenpox, there was 12 people).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the family member of the patient. The age at vaccination was not reported. The reporter stated that only the patient in their family had a shingles, who had the Shingles vaccine.  The reporter stated that, there was 12 of them in their family, so no thanks. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Pt c/o extremely sore arm, tenderness at injection site, and inability to lift arm above head since receiving 3rd Gardasil injection. Injection was given 5/05/08 and patient continued to c/o symptoms 5/20/08. Patient tried ice and ibuprofen with very minimal relief.
About 11 p.m. that night I got extreme chills and some aches in my upper back. I was in bed the next day until about 7 p.m. that night when the symptoms ceased. I just found this reporting site or I would have sent this sooner.
CHILLS AND BAD SHAKES DAY 2&3. SWEAT AND CHILLS, SLIGHT HALLUCINATIONS DAY 2-5, LIGHT HEADED AND BODY PAIN DAY 2-5, STILL SOME LIGHT HEADED AND DIZZINESS DAY 5-8.
none accidentally gave dtap instead of tdap.  it was in the wrong part of the fridge and this fnp mistook the vaccine for the correct one.
Extreme cold (temperature was 98.3). Trouble breathing (but pulse-oximeter read 99%). Extreme tiredness. Doctor consulted by phone recommended using albuterol inhaler (hadn't used it in at least 9 months), drinking plenty of fluids and getting in bed. Temperature reached 99 by 6 PM. All symptoms ended by 2 AM.