chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caused misscarrage; Vaccine exposure during pregnancy; Based on the current case data, this case has been classified as invalid. This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Caused misscarrage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (Caused misscarrage) (seriousness criteria medically significant and congenital anomaly) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). At the time of the report, ABORTION SPONTANEOUS (Caused misscarrage) outcome was unknown and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported.  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.  This is a case of product exposure during pregnancy with associated AE.   Reporter did not allow further contact; Sender'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.  This is a case of product exposure during pregnancy with associated AE .
sweats; chills; Head Rush immediately following the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included tuberous sclerosis. The patient had no known allergies to medications, food, or other products. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 26Mar2021 at 15:15 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021 at 14:30, the patient experienced head rush immediately following the injection. On 17Apr2021 at 02:00, the patient experienced chills and at 11:00 experienced sweats. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events head rush immediately following the injection, chills and sweats were resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
red skin, itching, injection site pain, dizzines. Given 25mg PO benadryl, and then 25mg more benadryl after symptoms continued. After the second dose of benadryl, s/s subsided enough for the staff member to go home.
Heart rate, 113; Feel on and off like I can not feeling like too well; Mild headache that comes and go; Muscle ache; Sensation in my stomach, like my stomach burn, sort of like heart burn sensation sort off; Sense of anxiety; This is a spontaneous report received from a contactable consumer. This 36-year-old male consumer (patient) reported for himself. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection lot number was not reported) via an unspecified route of administration in arm right on 23Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing I had asthma as a child, but I think I cured out of it as a guy as I grow older. Concomitant medications were not reported. On 23Jul2021, it was reported by the patient that that I had symptoms that still kind off lingering around that mild headache that comes and go, sort of like muscle aches and then I had been through like sensation in my stomach, like my stomach burn, sort of like heart burn sensation sort off, I did not had any of that I was so, feeling a sense of anxiety and checked saturation and heart rate last night when I got home from work and wanted to check my heart rate, 113 for my heart rate and my saturation was fine, I can just feel on and off like I cannot feeling like too well. Treatment received was Tylenol and Ibuprofen, use for muscle ache. The patient underwent lab tests and procedures which included heart rate resulted as 113 on 29Jul2021, saturation resulted as fine on 29Jul2021. The clinical outcome of the events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fatigue, Inability to sleep, Fever, Chills, Aches/Pains, Lightheadedness, Nausea
Immediately after Menactra vaccine was administered patient experienced sudden syncope and fell forward from her seated position on the exam table striking her head on the floor and receiving a small L lip laceration. She had a brief 1-2 minute tonic-clonic seizure with bladder incontinence. Seizure was followed by some confusion. Patient was transported to Medical Center by EMS.
arm was sore/arm pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore/arm pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles, Colonoscopy in February 2021 and Abdomen CT. Concomitant products included CHLORHEXIDINE GLUCONATE (ORAL C) for an unknown indication.   On 05-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced INJECTION SITE PAIN (arm was sore/arm pain). At the time of the report, INJECTION SITE PAIN (arm was sore/arm pain) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information as not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Primary Reporter Email  address added
Numbness on the right side of body/Numbness remains in right side foot in her toes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 2, single (Lot number: EN6204) at the age of 77 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EM9809, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 06Feb2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious) with onset 05Jul2021, outcome "recovered with sequelae", described as "Numbness on the right side of body/Numbness remains in right side foot in her toes". The event "numbness on the right side of body/numbness remains in right side foot in her toes" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia.  Additional information: After the dose received on 07Mar2021, Name (withheld) experienced numbness on the right side of body (around Jul2021). PCP did workup for stroke (brain CT) and no signs of stroke. Numbness remains in right side foot in her toes. With recent (withheld) reporting of potential stroke in 65+ Name (withheld) wanted to report to Pfizer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19.
At the time of vaccination, the patient expected to receive the Moderna vaccine for dose 1 of COVID-19 vaccination series. The technician administering the vaccine unknowingly mixed pre-filled syringes of both Pfizer (lot EN6201, exp 6/2021; diluent lot 401817, exp 9/22) and Moderna together in the same container to bring into the vaccination room.  The technician believed she was providing the Moderna vaccine but unknowingly administered 3 total vaccinations before the mix-up was discovered, and 2 doses of Pfizer vaccine were unaccounted when discovered by the pharmacist on duty. All 3 patients within this time frame of 3 vaccinations given were notified that they potentially received the Pfizer vaccine, as there was no way to confirm with certainty using store camera footage which syringe had definitely been used on each patient.
Patient went to the clinic on Friday, January 8th, to receive the COVID-19 vaccine. The nurse allegedly administered the vaccine in the patients shoulder joint and not in the muscle. Patient is currently experiencing extreme pain. She is unable to move her arm.
Microscopic blood found; Crohns disease flare up; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Microscopic blood found) and CROHN'S DISEASE (Crohns disease flare up) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced HAEMORRHAGE (Microscopic blood found) (seriousness criterion medically significant) and CROHN'S DISEASE (Crohns disease flare up) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (Microscopic blood found) and CROHN'S DISEASE (Crohns disease flare up) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient experienced a microscopic bleed and flare up of Crohn's disease.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in Company comment-This spontaneous case concerns an elderly female patient of unspecified aged with relevant medical history of Crohn's disease reported, who experienced the unexpected serious (medically significant) events of Crohn's disease (Crohn's aggravated) and Haemorrhage that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns an elderly female patient of unspecified aged with relevant medical history of Crohn's disease reported, who experienced the unexpected serious (medically significant) events of Crohn's disease (Crohn's aggravated) and Haemorrhage that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the events was not known at the time of report. Relevant medical history remains a confounder to the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement
2-3 days p vaccine developed respiratory symptoms of cough, increased sputum , no T. on 11/14 seen by PA for symptoms. WBC 17,000. (Has hx of COPD, heavy smoker.)RX with antibiotic and prednisone. ON 11/19 seen for same symptoms plus weakness, "shaky".  Similar had occurred years before related to her Cardizem, so dose decreased.  11/21-continued weakness, seen by HCP, no motor deficits, CT scan nl.  12/6 still weak and dizzy, comes and goes, consider Guillan-Barre, to have neuro consult. 12/13/07-records received for DOS 10/31-12/11/07-C/O feeling tired , cough congestion, weak and shaky. Legs feel weak.  Impression: probable viral illness improving. Has had significant workup for weakness and tremor which appear to be an intention tremor. Unknown etiology could be stress. On visit day of vaccine C/O numbness to feet, feel like asleep.
It was reported that a female patient received a rabies vaccination on 21-Jul-2000. Reportedly that same day, the patient complained of swelling, warmth and redness, wrist to elbow. This was the second dose in the series and was administered in the forearm.  From additional correspondence received on 28-Sep-2000, additional patient, vaccine and responsible physician information was provided. No further information is expected, this case is closed.
chest pain that comes and goes; shortness of breath; pain in both lower legs; has no energy; feels so cold in her feet; abdominal distension; lost her appetite; Headache; nausea; extreme fatigue; back pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy) and PERIPHERAL COLDNESS (feels so cold in her feet) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Patient is allergic to some pain medication like dilaudid.).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BACK PAIN (back pain). On 04-May-2021, the patient experienced CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy), PERIPHERAL COLDNESS (feels so cold in her feet), ABDOMINAL DISTENSION (abdominal distension), DECREASED APPETITE (lost her appetite), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (extreme fatigue). On 02-May-2021, BACK PAIN (back pain) had resolved. At the time of the report, CHEST PAIN (chest pain that comes and goes), DYSPNOEA EXERTIONAL (shortness of breath), PAIN IN EXTREMITY (pain in both lower legs), ASTHENIA (has no energy), PERIPHERAL COLDNESS (feels so cold in her feet), ABDOMINAL DISTENSION (abdominal distension), DECREASED APPETITE (lost her appetite), HEADACHE (Headache), NAUSEA (nausea) and FATIGUE (extreme fatigue) outcome was unknown.            Concomitant medication included an unspecified cholesterol medication.   Treatment for the events included paracetamol and ibuprofen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
playing then fell over eyes rolled back, shaking 2-5mins, turned blue, slept afterwards for 10min; pt taken to ER T100.3; neuro exam
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 17-MAR-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # M033209, expiration date 09-JAN-2018, albumin status recombinant human albumin (rHA) (dose, route and site of administration were not reported). No adverse effects reported. Administered vaccine experienced the temperature excursion of -14.4 Celsius degrees for 54 minutes. There was no previous temperature excursion reported. Data logger was involved. This is one of several cases received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA004113: US-009507513-1611USA011831: US-009507513-1705USA009742.
She had swelling and redness on the arm; asthamtic shortness of breath Nurse came after incidence, examined her and no treatment was given. Pt has a f/u appointment the next week.  Currently  using albterol inhaler, some sort of steroid diskus.
Headache, Arthralgia, Fever, chills Narrative:  Other Relevant History:
Arthralgia, UrticariaPruritus, Diarrhea, see next section for narrative report Narrative: Dose # 1 immediate mild itching scalp, armpit; day #2 itching, pain at injection site, diarrhea; day# 3 menstrual spotting; day #4 menstrual cramps; day #5 (May1) stiff fingers RIGHT hand, hurt when make a fist, which have continued to present; Dose # 2 felt tired for the week following. Dose #2 fatigue the week after. As of today, Right hand fingers still stiff. Employee states that they took tylenol after dose #2 and took it easy for 4-5 days post-vaccine.
This is a spontaneous report from a contactable consumer (patient's wife). A 82 years old male patient received PREVNAR 13 on an unknown date in Oct2017, at single dose, in arm, for immunization. Medical history included ongoing diabetes since 10 or 12 years and ongoing regular arthritis. Ongoing concomitant medications included insulin glargine (LANTUS) at 40 (unknown unit/frequency) in little syringe, for diabetes and insulin aspart (NOVOLOG) at unknown posology, depending on his blood sugar, for diabetes. On an unspecified date in Oct2017 in the morning, the very next day after vaccination, the patient could not raise his arm to put his shirt on, hands were swollen huge, big swollen hands, had pain and could not make a fist. The patient wife waited a day or 2 to call doctor because he said it might go away, it didn't. So for about 3 months nobody knew what it was and the patient tried some prednisone 2.5 mg (expiry date : 08Nov2018) that did not help. It will be finished in two days but he did not get relief and he had gone to a rheumatologist. It was not rheumatoid arthritis. Nobody knew how to treat this. The patient underwent blood work on an unspecified date, he just got  5 or 6 vials done and they send it to the rheumatologist who said his blood work was good and to come back in 6 weeks. He was still in pain at the time of report (still when he went to push himself out of the chair or move he had pain). The outcome of the other events was unknown. Information on the batch number has been requested.
Information has been received from a medical assistant referring to a 4 years old patient of unknown gender. Information about concurrent condition, drug reactions/allergies, concomitant therapies and medical history was unknown. On 27-NOV-2017, the patient was vaccinated with a dose of improperly stored VAQTA (lot # N017094 with expiration date 31-FEB-2018, 1 dose, strength unknown) intramuscularly for prophylaxis ((incorrect product storage)). No adverse effect was reported. The vaccine was exposure at the temperature of 55.2 Fahrenheit (47 to 77 Fahrenheit) for 2 hours and 41 minutes. There was no previous temperature excursion. A data logger was involved. This is one of 4 reports received from the same reporter.; Sender's Comments: US-009507513-1711USA012903: US-009507513-1712USA005650: US-009507513-1712USA005649:
Leg pain; Neck pain; Fibromyalgia; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Highly sensitive to medicines" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "Leg pain"; NECK PAIN (non-serious) with onset 2021, outcome "unknown", described as "Neck pain"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Fibromyalgia"; HEADACHE (non-serious) with onset 2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of fibromyalgia.  Additional information: The patient indicated she called on Saturday. Created a DSU report. Was instructed to call back and choose option three. Received Injection (first dose) 30Nov2021. "Tuesday. Saturday night a lot of leg pain, Sunday still hurt. On Tuesday much worse. Wednesday really bed. Medicines that will call to have leg pain. Not tried anything new. Vaccine on Tuesday. The patient was not able tell if her leg was hurting her. Her leg had been hurting her ever since. Born (DOB), 53 or 54 years of age. HCP went ahead and ordered her ultrasound to make sure she did not had any blood clots. She did not. Battle neck pain and some headaches. Seemed like it was more consistent than what it was. Naproxen and Parafon Forte for Fibromyalgia. Her leg pain had not gotten any better. Worked for HCP. Wanted her to get it. When was her leg pain going to stop. She was so highly sensitive to medicines that it scared her. HCPs indicated to get. They were not going to handle the pain."  Indicated she will reach out to Rheumatologist.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mother reports child started with rash on 01/12/00. Rash is now widespread over body. Advised to see PMD, Wa sseen in 1/13/00 infirmary,  Dx as vaccine related rash