chrisvoncsefalvay/vaers-outcomes huggingface dataset:
multiple patients were vaccinated with improperly stored VAQTA on multiple dates; no adverse effect; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-OCT-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
swollen lymph nodes; migraine; severe fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 18:45 (Lot number: 59267-1000-01) at the age of 57 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's disease" (unspecified if ongoing), notes: Other medical history: Hashimoto's disease, hypertension; "hypertension" (unspecified if ongoing), notes: Other medical history: Hashimoto's disease, hypertension. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 21Aug2021 06:00, outcome "not recovered", described as "swollen lymph nodes"; MIGRAINE (non-serious) with onset 21Aug2021 06:00, outcome "not recovered", described as "migraine"; FATIGUE (non-serious) with onset 21Aug2021 06:00, outcome "not recovered", described as "severe fatigue". Therapeutic measures were not taken as a result of lymphadenopathy, migraine, fatigue.  Additional Information: Patient did not receive other vaccine in four weeks and medications in two weeks. Patient did not tested covid prior vaccination. No any Known allergies.  Follow-up attempts are completed. No further information is expected.
MILKY PRESENCE IN THE VACCINE; FATIGUE; This spontaneous report received from a patient concerned an 83 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced fatigue. On an unspecified date, the subject experienced milky presence in the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue on 07-MAR-2021, and the outcome of milky presence in the vaccine was not reported. This report was non-serious.
not clear if interval between doses is correct and not clear if eligible for third dose booster; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not clear if interval between doses is correct and not clear if eligible for third dose booster) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not clear if interval between doses is correct and not clear if eligible for third dose booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not clear if interval between doses is correct and not clear if eligible for third dose booster) had resolved.            No concomitant medication reported. No treatment information was provided
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment medications were not provided by the reporter.
Headache starting the evening of vaccination and approximately every other day since vaccination. Headaches were very rare prior to vaccination.
This spontaneous report was received from a registered nurse and refers to a 5-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB) lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient). Sender's Comments: US-009507513-1901USA000071.
Local erythema, induration upper 1/2 of upper arm.  No treatment needed.
On 11/02, I started to have vaginal bleeding. I called my provider and they said that it can be normal. On 11/04, I was still bleeding and had cramping as well. They did an ultrasound and told me that the gestational length was showing 6 weeks, but it should have been at 8 weeks. We went over options about the possibilities of what could be happening. I was supposed to have my HCG blood levels checked on 11/06 and 11/08. I did not have this test performed because on 11/05, I passed a lot more blood and the gestational sac. I ended up having a miscarriage. The baby was due 06/16/2022. I have one daughter, who was a healthy birth and is now 1 1/2 years old. I did not have any issues during my pregnancy with her.
Patient had a seizure which brought her into the hospital and required intubation following inability to protect her airway. She was resumed on her Keppra, after being seen by Neurology and having an EEG. The seizures were due to an aneurysm that she had coiled years ago. She was also noted to have an elevation in her troponin. She was found to have an echo with an EF of about 40%. She had a Left heart cath which showed no evidence of CAD. While here she was treated for pneumonia which cleared up quickly after 7 days of treatment. She was discharged on the new medications of Keppra, Coreg, ASA, Lasix and her losartan was changed to 25 mg po every day. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt came to clinic on 11/13/15 for follow-up.  MD ordered pneumococcal conjugate 13-valent vaccine (Prevnar 13) and nurse gave the 0.5ml vaccine IM in the left deltoid at 1149 per documentation (Wyeth-Ayerst lot # M13068, NDC # 0005-1971-01.  Patient returned to clinic on 11/16/2015 for follow-up and nurse noted mild redness at the injection site.  Pt reported that it has been red for several days with mild reaction.  Pt stated that she had no fever or chills.  The site was not warm or painful to touch on 11/16/15.
Sudden onset of symptoms on 5/11/2021. Symptoms include dyspnea, dizziness, fatigue, brain fog, and high heart rate. Symptoms are episodic and last an hour or so at a time.  Dyspnea gives a feeling of not having enough air flowing to the belly. Patient attempts to take fuller breaths and complains of not achieving a satisfying full breath every time during these episodes.  Patient complains of dizziness and having a difficult time keeping the head and neck up. High heart rate and palpitations are often the worst after getting out of bed in the morning, with bpm hitting 135. Patient complains of a racing heart upon waking up. Patient's resting heart rate is consistently 85-100 bpm. Oxygen saturation always above 95%.  Patient has experienced these episodes previously for a few days at a time but these incidents self-resolved after a few days. No headaches. Sharp chest pain experienced twice, both times under the left breast. First time while running on the treadmill, the second time the chest pains awoke patient from sleep.  Negative Covid test as of 5/14/2021. Second Covid vaccine (Pfizer) administered 5/4/2021, may be mild myocarditis. Patient recovering but not back to normal yet.
This spontaneous report as received from a medical assistant refers to a 3-year-old male patient. The patient's concurrent conditions were not reported. The patient's medical history included swollen lymph node. The patient had no concomitant medications. On 14-MAR-2016, the patient was vaccinated with the first dose of VARIVAX (Merck) subcutaneously, in the left thigh, lot# L037561, expiration date: 29-SEP-2017 (dose was not reported). On the same day, the patient was accidentally vaccinated with the first dose of PROQUAD (Merck) recombinant human albumin (rHA) subcutaneously, in the left thigh, lot# L046509, expiration date: 17-MAY-2017 (dose was not reported) instead of regular M-M-R II. The patient received double Varicella dose. At the time of the report, it was unknown if the patient would receive anymore VARIVAX (Merck) or PROQUAD (Merck). Additional information has been requested.
Caller would like to know  if the vaccine inflamed  her already existing conditions; Felt pain in both hips, spine and very tip of her tailbone; Felt pain in both hips, spine and very tip of her tailbone; Caller has a history of arthritis, which was worse in one side than the other (left) side, osteoporosis and degenerative disc disease./arthritis flare-up; Felt a little sleepy; This is a spontaneous report from a contactable consumer or other non hcp.   A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported, expiry date: unknown) as dose 2, single for COVID-19 immunization. Medical history included, arthritis, osteoporosis, intervertebral disc degeneration (degenerative disc disease). The patient's concomitant medications were not reported. On 03Mar2021 the patient experienced felt a little sleepy. On an unspecified date patient reported caller would like to know if the vaccine inflamed her already existing conditions, felt pain in both hips, spine and very tip of her tailbone, and caller has a history of arthritis, which was worse in one side than the other (left) side, osteoporosis and degenerative disc disease./arthritis flare-up. She went to the doctor, x-rays confirmed it as an arthritis flare-up. The right side and tailbone feel better, but the left hip still hurts. She was put back on Naprosyn after being off it for 1 year. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
dull and goes on and off and is only in the arm between elbow and wrist; muscle soreness; leg pain also started on 30Mar2021; lower back ache; tenderness in the left arm for 4 days; lower back pain; pain in right limb and buttocks with a little bit of pain on left side but more on the right side; soreness inthe left arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), PAIN (pain in right limb and buttocks with a little bit of pain on left side but more on the right side), PAIN IN EXTREMITY (soreness inthe left arm), PAIN IN EXTREMITY (leg pain also started on 30Mar2021) and BACK PAIN (lower back ache) in a 33-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.     The patient's past medical history included No adverse event. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BACK PAIN (lower back pain), PAIN (pain in right limb and buttocks with a little bit of pain on left side but more on the right side), PAIN IN EXTREMITY (soreness inthe left arm), BACK PAIN (lower back ache) and TENDERNESS (tenderness in the left arm for 4 days). On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg pain also started on 30Mar2021) and MYALGIA (muscle soreness). On an unknown date, the patient experienced DISCOMFORT (dull and goes on and off and is only in the arm between elbow and wrist). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever and Chills, at an unspecified dose and frequency. On 27-Mar-2021, PAIN IN EXTREMITY (soreness inthe left arm) and TENDERNESS (tenderness in the left arm for 4 days) had resolved. At the time of the report, BACK PAIN (lower back pain), PAIN (pain in right limb and buttocks with a little bit of pain on left side but more on the right side), PAIN IN EXTREMITY (leg pain also started on 30Mar2021), BACK PAIN (lower back ache), MYALGIA (muscle soreness) and DISCOMFORT (dull and goes on and off and is only in the arm between elbow and wrist) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       CONCOMINANT DRUG WERE NOT USED.  IBUPROFEN WAS USED AS TREATMENT DRUG, LAB DATA AND ALLERGIES WAS NOT GIVEN
Immediate sharp pain and burning at the injection site radiating down to right fifth digit.  Continued intermittent pain, burning, numbness, aching and radiation since injection with certain arm movements (lifting arm over head, moving arm across body to left side).  Intermittent numbness to right fifth finger associated with above movements.  Tenderness to touch at injection site.   Intermittently relieved with ibuprofen.  Exacerbated with passive stretching and movement. x2 months
Patient received 2 vaccines containing varicella; PROQUAD and Varicella. Each vaccine gave in opposite legs (right and left).
First shingles shot 2019, second in 2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st shot of Shingles vaccine in 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient was reporter's brother. The age at vaccination was not reported. The patient had his second Shingles shot in 2022 later than the recommended interval, which led to lengthening of vaccination schedule. The reporter asked should the patient take a 3rd dose of Shingles vaccine. The follow-up would not possible as no contact details were available.
Low grade fever; Sore mouth; Sore throat; still so weak; This is a spontaneous report from a contactable nurse (patient).  This 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EK5730), via an unspecified routed of administration, on 31Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 30-years-old. Medical history was none. Concomitant medications included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient just wanted to know how long a low grade fever is in the patients, it's been like three days now she still has low grade fever, mouth sore, sore throat and she is still so weak. The patient was treated with Tylenol. Outcome was not recovered.   The reporting nurse considered the events related to the vaccine because the events started after that.
HCP administered expired vials but she doesn´t remember how many; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered expired vials but she doesn´t remember how many) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered expired vials but she doesn´t remember how many). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (HCP administered expired vials but she doesn´t remember how many) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter  Treatment information was not provided
Extreme pain from head to toe, Loss of proprioception, stabbing, burning pain in and around spine. Tremors in hands, blue feet.  No reflexes.  Severe headaches, vomiting, choking & nausea.  Difficulty walking and holding items without dropping them.  Difficulting getting dressed (needs help from wife).  Inability to sit comfortably.  Constant spine, head neck and right shoulder pain.  Hiccups.  Inability to sleep comfortably.  Chills/Sweats/blurred vision.  Inability to drive or work (disabled).  ICU in Nov 2021 - almost died from choking and not breathing - Hospitalized 7 days.
Information has been received from a nurse concerning a female patient who 2 weeks ago, on approximately 06-NOV-2008, was vaccinated with a dose of GARDASIL.  The patient experienced syncope and seizure-like symptoms after receiving the vaccine.  The patient experienced the symptoms while she was still at the physician's office.  The patient sought medical attention through an office visit.  Subsequently, the patient recovered.  Upon internal review seizure-like symptoms was determined to be another important medical event.  Additional information has been requested.
Immediately felt a stiff neck (left side) that slowly over the course of hours spread to my Left shoulder and became extremely painful muscle spasms. Even my lips throbbed. At 6 am on 10/1702020 I was so debilitated, I could hardly move a muscle. I felt like I was having a stroke or blood clot. We waited for the walk in clinic to open at 9am, but since I?d been up all night in extreme pain I laid down and slept a while. I felt like the symptoms had let up a bit so decided to convalesce at home unless it got worse. At the peak of the pain I was running a temperature of 99.4. I?m usually 97,6. My bloodpressure and heartbeat were normal.  Then ever so slowly the pain has pulled back and reduced in area affected so that by 6 PM Sunday, 10/18/2020 I could only detect some residue pain in my neck ( left side) where it all started.  I did not expect a reaction since I took this vaccine last year. But there must be a difference that blew me out of the water this time. It was so painful and horrible. A 10 on the pain scale.
THE PATIENT REPORTED LARGE SWELLING OF LYMPH NODES NEAR THE BREAST AND REDNESS AROUND THE BREAST. INJECTION SITE WAS VERY SORE.
Fevers to 102.6, severe arthralgias, malaise, palpitations
renal vasculitis following COVID-19 vaccination; This is a literature report.   A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL VASCULITIS (medically significant), 4 weeks after the suspect product(s) administration, outcome "unknown", described as "renal vasculitis following COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: Positive. Therapeutic measures were taken as a result of renal vasculitis.  Clinical Course: Reported cases of renal-associated AAV induced by COVID-19 vaccination. Despite the substantial benefits of the COVID-19 vaccine, autoimmune processes, particularly AAV, have been highlighted post-vaccination. AAV is a rare and life-threatening complication, and the objective of our case is to inform the clinicians to encourage the hasty recognition and diagnosis of vasculitis in timely correlation with the COVID-19 vaccine, a complete workup including imaging modalities of possible concurrent triggers, as well as timely appropriate management once found.; Sender's Comments: Based on the available information and on the compatibility with the drug's known safety profile, the company considers that a causal relationship between the reporter event -Renal vasculitis and suspect drug BNT162B2 cannot be excluded. 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
Headache, Myalgia, Arthralgia, NauseaVomiting, Chills Narrative:
Moderna vaccine given from outside other than facility- reported by patient  CHRONIC HYPOTENSION 7/29/2021 GANGRENE OF RIGHT FOOT    ULCER OF LEFT LOWER LEG, UNSPECIFIED SITE AND DEPTH CHRONIC HYPOTENSION 7/29/2021 GANGRENE OF RIGHT FOOT CHRONIC HYPOTENSION 7/29/2021 ATHEROSCLEROSIS OF AORTA CHRONIC HYPOTENSION 7/29/2021 DM 2 W PERIPHERAL VASCULAR DISEASE CHRONIC HYPOTENSION 7/29/2021 DM 2 W PERIPHERAL VASCULAR DISEASE CHRONIC HYPOTENSION 7/29/2021 HYPERKALEMIA CHRONIC HYPOTENSION 7/29/2021 PRERENAL UREMIA SYNDROME CHRONIC HYPOTENSION 7/29/2021 ATRIAL FIBRILLATION, UNSPECIFIED