chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had clots; prolonged menstruation/menstrual bleeding that is non-stop; not feeling good; her psyche was screwed up; from a physiological aspect it was screwed up every single day; sick with allergies and other things; start to say this hurts, that hurts; she has the sniffles; Zero Energy; This is a spontaneous report from a contactable consumer (patient's husband). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 18Jan2021 16:10 (Lot Number: EL1283; at the age of 45-years) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included influenza vaccine (FLU VACCINE VII) for immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; at the age of 44-years), first dose on 28Dec2020 4:10 pm (lot number: EJ1685 expiration date: unknown), administered in arm, but does not know which arm for Covid-19 immunization and experienced zero energy. The husband was calling on behalf of his wife. He wanted to know who is liable for the side effect his wife is experiencing. In 2021 ( a month or two), the patient had prolonged menstruation and was not feeling good. The husband is almost positive the vaccine effected his wife's menstrual cycle. She had menstrual bleeding that is non-stop. She had clots. The patient almost had a month or two straight of bleeding. It screwed everything up. The timing was screwed up, her psyche was screwed up, and from a physiological aspect it was screwed up every single day affecting his life and their livelihood for their family. She has been sick with allergies and other things. She would start to say this hurts, that hurts, she has the sniffles with zero energy. He stated that she falls asleep immediately after work when comes in. The events did not result to emergency room and physician office visit. He also reported that the patient's mom got the COVID vaccine and had hives. Outcome of prolonged menstruation/menstrual bleeding that is non-stop was recovered in 2021, while the other events was unknown.  Follow-up attempts are completed. No further information is expected.
Breakthrough case admission after 4 vaccines Moderna 3/15/21 Lot# 023M20A;  Mderna 4/12/21 Lot# 040B21A;  Moderna 11/3/21 Lot# 039F21A;    Moderna 4/26/22 Lot# 056A22A;
It was discovered after the vaccine was administered, that the lot used had a beyond use date of 8-19-21.  Moderna was contacted for clinical information and stability guidance to help determine if the dose would be considered valid.  The response received from Moderna's medical information department:  The vaccine administered on August 30, 2021 from lot number 026A21A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Acute COVID-19 infection Patient admitted to the hospital Continue Decadron IV Continue remdesivir IV Continue ceftriaxone IV/azithromycin IV Will start the patient on budesonide nebulizer breathing treatment Will start the patient on formoterol nebulizer breathing treatment
1) Body aches, fever, flu-like symptoms 6 days after vaccine.   2) Arthritic-like symptoms on hands, wrists, arms, knees, shoulders and ankles 8 days after vaccine and continue.
I started feeling faintly, experienced headaches, flashing blackness in my eyes and head. I also had blurry vision , extreme fatigue, nausea and diarrhea. I sat down for 10  minutes  to be monitored and then I went home.    To this day I still have headaches that come and go and I have no energy whatso ever and still have nausea that comes and goes.
Shot given 7-7-12. Within 12 hours redness a 1 1/2" deep hard lump that extended about 6" x 5:". Nausea and diarrhea within 12 hours. Chest pain within 24 hours intermittent light headed.
The night of the vaccine I could not sleep due to terrible joint pain. Starting in my knees and eventually working up to my hips and lower back. Symptoms became worse in right hip and lower back where a previous (dormant) injury had occurred 12 years earlier.
Patient received a Pfizer Covid booster on 12/19/21. She had received a two dose Moderna vaccine prior, so this was her 3rd covid vaccine but the 1st Pfizer shot. Symptoms were visible to family members around 12/25/21, however may have started earlier. Symptoms started as neurological in nature (mimicking stroke symptoms) weakness in hands especially the left hand, overall body weakness and fatigue, trouble seeing, trouble swallowing and clearing throat. By 2/14/22, her symptoms continued to become more extreme in nature when she returned to the doctor's office. Her left arm had lost almost 100% function, her left side weakness had increased leaving her unable to get up by herself, her right eye was drooping, her throat and swallowing disfunction was causing her to choke even on water and she was unable to eat solid food. She went to her primary care, who then sent her to the neurologist and they ran an initial CT thinking she had a full stroke. After CT, MRI with and without contrast, and extensive medical testing there was no evidence of stroke found and no other underlying diseases that would cause these symptoms other than the vaccine.
Bruising on both inner arms (not outer arm where vaccine was given),  about 3 inches from armpits, looking like a series of several dots in a cluster about 2 inches long.
expired Ipol dose was given to a child with no ae; Initial information regarding an unsolicited valid non-serious was received from a Physician via Medical Information (Reference number- 00620475) and transmitted to Sanofi on 28-May-2021.  This case involves a 7 years old male patient who received a expired dose of suspect IPV (VERO) [IPOL] (lot R1B251M and expiry date: 12-Mar-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 28-May-2021.  The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.   The reporter asked how to proceed.  It was an actual medication error case due to expired vaccine used (latency: same day).  At the time of reporting, the patient experienced no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a Licensed Practical Nurse (L.P.N.) concerning unspecified patients who on an unspecified date were vaccinated with improperly stored GARDASIL. The patients were not experiencing any unknown symptoms. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Pt states he was eating on Saturday, Sep 25, when his smallpox bandage fell off his arm and landed in his food.  Pt continued eating.  Around Sep 30, pt began experiencing a sore throat and notice white pus pockets in the back of his throat.  Pt came into clinic for evaluation by a family physician.  The family physician determined the pus pockets to be satellite lesions from the primary smallpox site.
for approximately 12 days after the injection, I couldn't think clearly...a minor "brain fog." For example I had trouble with word choices, thinking through the day to plan multiple events. I've never experienced that after a Covid vaccine or booster, just this SpikeVax.  And I have never had problems with word choice or planning my day, this was quite unusual.
Hospitalized 01/13/2022; COVID-19 positive 01/13/2022; Fully vaccinated   BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: DO Admission Date: 1/13/2022 Discharge Date: 01/25/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus COVID-19   HOSPITAL COURSE: Patient is a 94-year-old male who presented to the emergency department with shortness of breath.  In the emergency department, patient was found to be hypoxemic on room air and required supplemental oxygen.  Chest x-ray showed patchy mild right pulmonary opacities consistent with atelectasis and/or pneumonia.  Patient was found to be positive for COVID-19.  He was admitted to the Internal Medicine service and started on Decadron and remdesivir.  Endocrinology was consulted for steroid induced hyperglycemia.  Patient was started on an insulin drip and transitioned to BBI. He had some morning hypoglycemia, so this was adjusted to just corrective insulin. His oxygenation improved and remained stable.  Physical & occupational therapy recommended subacute rehab, but the patient's daughter wanted to take him home.  He was set up with the COVID at home program, but ultimately given continued somnolence, his advanced age, and illness, the patient's daughter asked to be set up with Hospice. Patient was discharged home with Hospice.
Light headed 30min after injections. Approximately 4 hours later - developed extreme gout-like flare in toes, ankles and finger joints (no prior gout except in big toes). Chills, stomach pain, aching muscles. Sore fissured tongue, short episodes of racing heart beat, also itchy and weeping spots on scalp. Side effects subsided in 48 hours.
The patient felt faint and reported almost passing out. EMS was called and evaluated the patient. EMS after monitoring the patient and consulting with an ER physician allowed the patient to go home.
This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown demographics. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of PROQUAD (dose and route were not reported) lot # M014304 and expiry date: 22-SEP-2017. The vaccine was exposed to a temperature of 23.5 Fahrenheit for a time frame of 63 hours. The call was received because of a data logger. No previous temperature excursions were reported. There were no adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Patient called and had some redness and swelling at vaccination site. It was on the left arm and was raised and hot to the touch. Over the weekend the redness and swelling spread down towards her elbow. The patient took Tylenol PM to help with the pain so they could sleep.
Positive puncture erythematous papules over B/L anticubital spaces, elbows RLQABD, Axilla, Atarax PRN
Face became flushed and puffy about 2 hours after vaccine. Eight hours later, I had nausea, headache, wooziness and still flushed and puffy face. Injection site pain began. Woke from sleep throughout the night with racing heart. Next day, still nauseous, headache and extremely fatigued. Face remained puffy but redness gone. Frequent and urgent urination and bms. Next two days symptoms faded, but lips and hands were on and off numb and tingly. R ankle became swollen. Symptoms gone by the 7th, 5 days after vaccination.
Pt was given flu shot at 15:07 and was asked to wait so after that, after 30 minutes she left and returned approx 15 minutes after and said she was feeling warmness on left arm at chest. BP 200/104. She was monitored for 20 mins and B/P was rechecked and reading 150/102, advised to call her Dr and notify of reaction. She called DR office and office nurse told her to take Benadryl. Pt stated she was feeling better, was also checked by school nurse.
lower abdominal pain, diaphoresis, pale, nauseated, lightheaded, dizzy, bradycardic
low-grade fever chills tightening in chest headache pain at injection site In addition, I had a mammogram and a bilateral ultrasound on 4/6/21.  I didn't know anything about waiting 8-10 weeks.  None one at the Center told me that I should wait.  They did, however, ask me when I had my second vaccine.  I told them 4/1/2021.  They still proceeded with the mammo and ultrasound.  My right breast at the 10:00 position (right adjacent to the injection) showed a tiny mass with benign properties (according to Dr.).  She told me that I should have it biopsied.  the mass wasn't there last year.  I have an appointment for a biopsy tomorrow, 4/13/2021.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills) and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. Concurrent medical conditions included diabetes. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills), nausea, confusional state (being confused) and headache. At the time of the report, pain in extremity (soreness of arm), fatigue (fatigue/was tired), hyperhidrosis (sweating), chills (cold chills), nausea, confusional state (being confused) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Patient presented to facility with syncope, neck pressure, decreased appetite, chills, fevers. Pt was admitted to facility.
Rheumatoid arthritis symptoms worsened; pain increased in knuckles, fingers, and feet; pain is bad; Feeling discouraged or depressed worsens; Feeling discouraged or depressed worsens; This is a spontaneous report from a contactable healthcare professional and a consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Numbers were not reported), via unspecified routes of administration, in Aug2021 (at the age of 56 years), as dose 1, single, and then in Sep2021, as dose 2, single, for COVID-19 immunization. The patient's medical history included depression, discouraged, and rheumatoid arthritis, all were ongoing. The patient's concomitant medications included tofacitinib citrate (XELJANZ XR) from 2019 and ongoing for rheumatoid arthritis and an unspecified medication for depression. The patient had COVID-19 vaccines in Aug2021 and Sep2021. Tofacitinib citrate was held for 1 week following both vaccines. In 2021, rheumatoid arthritis symptoms worsened following held doses; pain increased in knuckles, fingers, and feet. Symptoms have not returned to baseline following missed doses. The patient generally agrees that generally it's been hard to cope with rheumatoid arthritis and sometimes felt discouraged and/or depressed. Prior to start of therapy, she is treated with medication for depression. Feeling discouraged or depressed worsens when the pain is bad (2021); received treatment for these events. The patient was advised to update physician with new or worse symptoms. The patient had not recovered from the events.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Rheumatoid arthritis (aggravated) and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Passed out 15 seconds after giving injections. Was out for 10-15 seconds.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On 20-JUN-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L040442 and expiry date: 15-JAN-2017). Concomitant medications were unknown. The pharmacist reported that a patient may have been administered a dose of ZOSTAVAX via the intramuscular route instead of the subcutaneous route. The patient experienced itching and redness at the injection site shortly after administration. The outcome of the events was not reported. The causality of the events was not provided. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
I developed Tinnitus after the first two doses; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 (Lot number: EW0171) at the age of 48 years as dose 2, single and administered in arm left, administration date 08Apr2021 (Lot number: ER8737) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Relapsing Remitting Multiple Sclerosis" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Droperidol, reaction: "Allergy". The following information was reported: TINNITUS (disability) with onset Jun2021, outcome "not recovered", described as "I developed Tinnitus after the first two doses". The event "i developed tinnitus after the first two doses" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus including Course of high dose steroids.  Follow up information has been requested.
Hive like rash that itched at injection site about the size of a regular sized hand. Back pain that felt like going through labor for 3 days straight. Also pain in the lower pelvic area that felt like a UTI where I constantly had to goto the bathroom, but went to see MD no sign of a UTI and constant headache.
In July 2021, I felt like I pulled something in my left shoulder or shoulder blade.  Over the next 3 months my shoulder and arm became more painful and harder to move.  I went to an orthopedic surgeon's office in November 2021 and they ordered an MRI.  The MRI did not show any damage, just AC joint arthrosis and a moderate joint effusion.  8 weeks of physical therapy was prescribed for me and I did see improvement in strength and movement as well as a lessening of pain.  I am continuing to do the physical therapy exercises at home and hoping to see additional improvement over time.
PATIENT WAS GIVEN SECOND DOSE OF ROTOTEQ AT 11 MONTHS OF AGE
Information has been received from a registered nurse concerning a female with arthritis who "about six months ago" in approximately November 2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified therapy for arthritis. In approximately November 2007, "about six months ago" the patient developed redness swelling and a blanched area at the injection site and some aching...., which the patient noted may be related to her arthritis. The patient obtained medical attention, which included an office visit. At the time of reporting the patient was recovered (date unspecified). There was no product quality complaint. Additional information has been requested.
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown ages and genders. On unknown dates, the patients were vaccinated with ROTATEQ (lot # reported as N005617, expiry date: 03-OCT-2018), that was improperly stored (incorrect product storage). The vaccine was stored at a temperature of 32°F to 35°F (34.8F) for 1 hour and 15 minutes, at 32°F to 35°F (35.4F) for 4 hours and 24 minutes, at 32°F to 35°F (35.4F) for 4 hours and 12 minutes, at 32°F to 35°F (35F) for 4 hours and 36 minutes, at 32°F to 35°F (35F) for 4 hours and 18 minutes, at 32°F to 35°F (35F) for 4 hours and 42 minutes, at 32°F to 35°F (35.4F) for 2 hours and 30 minutes, at 32°F to 35°F (35.4F) for 3 hours and 18 minutes, at 32°F to 35°F (35.2F) for 4 hours and 54 minutes, at 32°F to 35°F (35.2F) for 4 hours and 42 minutes, at 32°F to 35°F (35.2F) for 4 hours, at 32°F to 35°F (35.4F) for 2 hours and 24 minutes, at 32°F to 35°F (35.4F) for 2 hours, at 32°F to 35°F (35F) for 4 hours and 6 minutes, at 32°F to 35°F (35F) for 5 hours and 24 minutes, at 32°F to 35°F (35.2F) for 5 hours and 6 minutes, at 32°F to 35°F (35.2F) for 5 hours and 18 minutes, at 32°F to 35°F (35.4F) for 3 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse symptoms reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA011555: US-009507513-1707USA011601: US-009507513-1707USA011419: US-009507513-1707USA011615:
Pt. states that after receiving the 3rd Booster dose of Moderna 11/05/2021, started experiencing symptoms 11/06/2021 of fainting (shortly after waking, fainted resulting in 3 hours unconsciousness). Unknown status of symptom. No noted Primary visit/communications.
On 12/31/2020 I had a headache and I was tired.  Over then next two days my arm was very sore.  That subsided by 1/02/21.  On 1/07/21 I woke up around 8 AM with my arm being sore again and at ejection site I had a red circle. The ejection site was also swollen. I took a benedryl and the pain subsided but the red circle continued to grow.  On 1/08/21 the circle got even bigger (even with taking two 25 mg tablets of benedryl before bed) and it?s warm to the touch.    Also on 1/07/2021 at around 6 pm I began menstrual spotting (this would be in the dead middle of my usual cycle). It continued into today ,1/08/2021. This is unusual for me as I have never experienced spotting in the middle of my cycle.   Also on today 1/08/2021 my arm soreness has returned as the red circle is  growing bigger around the ejection site (approximately 3 1/2 inches by 2 inches). I?m also experiencing extra tiredness and a headache.
pt recv vax & devel an inj site soreness & body aches which were occasionally severe;pt devel a fever up to  38C;pt devel rash w/approx 30 lesions;