chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea; It felt like a neurological issue.; It felt like a neurological issue.; Right now, the only problem is that the muscle occasionally locks up; can't lift my arm without maneuvering it to try to get it to loosen up.; my arm started to ache; I Felt ill; Nausea; pulling sensation on face,lip, and leg; pulling sensation on face,lip, and leg; pulling sensation on face,lip, and leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm started to ache), MALAISE (I Felt ill), DIARRHEA (Diarrhea), FACIAL DISCOMFORT (pulling sensation on face,lip, and leg) and ORAL DISCOMFORT (pulling sensation on face,lip, and leg) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced MALAISE (I Felt ill), FACIAL DISCOMFORT (pulling sensation on face,lip, and leg), ORAL DISCOMFORT (pulling sensation on face,lip, and leg), LIMB DISCOMFORT (pulling sensation on face,lip, and leg) and NAUSEA (Nausea). On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm started to ache), DIARRHEA (Diarrhea), NEUROLOGICAL SYMPTOM (It felt like a neurological issue.), FEELING ABNORMAL (It felt like a neurological issue.), MUSCLE DISCOMFORT (Right now, the only problem is that the muscle occasionally locks up) and HYPOKINESIA (can't lift my arm without maneuvering it to try to get it to loosen up.). At the time of the report, PAIN IN EXTREMITY (my arm started to ache), MALAISE (I Felt ill), DIARRHEA (Diarrhea), FACIAL DISCOMFORT (pulling sensation on face,lip, and leg), ORAL DISCOMFORT (pulling sensation on face,lip, and leg), LIMB DISCOMFORT (pulling sensation on face,lip, and leg), NEUROLOGICAL SYMPTOM (It felt like a neurological issue.), FEELING ABNORMAL (It felt like a neurological issue.), MUSCLE DISCOMFORT (Right now, the only problem is that the muscle occasionally locks up), HYPOKINESIA (can't lift my arm without maneuvering it to try to get it to loosen up.) and NAUSEA (Nausea) was resolving.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-061044 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Updated Patient's AE outcome details, New events added, Patient also provided details about her husband's AE outcome.; 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.
Patient called in the pharmacy on 12/10/2021 at 4PM with concern of redness and swollen around the vaccination area, stating 3-4 inches in diameter. The swelling and arm ache was observed on 12/7/2021 (day of administration). She observed the redness only on 12/10/21, when she became concerned and called the pharmacy. After listening to her concerns, we recommended to go to Urgent Care or call provider, and take Tylenol or NSAID, per CDC recommendation. After more research on her situation, we told patient she might be one of the individuals experiencing "COVID arm", experiencing rash like symptoms a few days after the vaccination.  We followed up with the patient on 12/13/21. Cont next page.
Information has been received from a physician concerning a 16 year old female who in June 2008, about two months ago, was vaccinated with the first dose of GARDASIL vaccine (yeast). The patient experienced dizziness after vaccination. The patient sat down for a while and was given an "epi pen" just in case of an allergic reaction, but then recovered and was able to leave. The physician also reported that the patient has received the second dose of GARDASIL vaccine (yeast) and no adverse experienced occurred. The patient sought medical attention and saw physician. This is one of several reports from the same source. Additional information has been requested.
Immunization: COVID-19 Moderna, External Administration  J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 LOBAR PNEUMONIA, RUL J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 LOBAR PNEUMONIA, RUL J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 LOBAR PNEUMONIA, RUL R09.02 HYPOXIA 4/19/2022 LOBAR PNEUMONIA, RUL J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 HYPOXIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 HYPOXIA J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 HYPOXIA R09.02 HYPOXIA 4/19/2022 HYPOXIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 LUNG CANCER, RIGHT UPPER LOBE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 LUNG CANCER, RIGHT UPPER LOBE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 LUNG CANCER, RIGHT UPPER LOBE R09.02 HYPOXIA 4/19/2022 LUNG CANCER, RIGHT UPPER LOBE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 BILAT GLAUCOMA SUSPECT J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 BILAT GLAUCOMA SUSPECT J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 BILAT GLAUCOMA SUSPECT R09.02 HYPOXIA 4/19/2022 BILAT GLAUCOMA SUSPECT J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 HTN (HYPERTENSION) J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 HTN (HYPERTENSION) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 5/18/2022 HTN (HYPERTENSION) R09.02 HYPOXIA 4/19/2022 HTN (HYPERTENSION)
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022) in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Feb-2022 at 1:59 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Feb-2022 at 1:59 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient received vaccine past its 30-day expiry date on 20-Feb-2022 at 1:59:45 PM.  Vaccine went into 2 to 8 degree Celsius thaw state on about 24-Dec-2021. The vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
Pt called on 2-3-18 indicating a swollen, warm, itching, and painful area at the site of injection. She states it start a couple of hours after injection. Advised pt to take ibuprofen, BENADRYL and cold therapy at the site. Followed up w/pt on 2-5-18 for which she confirms the pain and swelling has resolved with ibuprofen. Advised pt to continue therapy and contact RX or MD should symptoms worsen and do not get better.
Joint muscle pain, all over body aches , swollen joints , have trouble climbing stair & going down stairs & getting up from the floor , I feel like all my bones will break , having headaches , gait is unsteady, depressed, fatiguedswollen glands
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: EN6202), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FL3184), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 72 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no other medication in 2 weeks. The patient was treated for COVID-19 with Paxlovid from 12Aug2022 to 16Aug2022. The patient previously received a COVID-19 Vaccine. Symptoms were significantly diminished from original infection which began 11Aug2022. Original infection symptoms were headache, sore throat, muscle aches and nasal discharge. No known allergies.
rash @ site of inject & on face & abdo 24 hrs p/vax; DPH administered by parent;
Patient received FLUZONE high dose 9/29/13. Patient died 9/30/13, family believes the death is due to advanced age, not the vaccination.
COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Unknown result, notes: Rebounding Covid symptoms after initial symptoms disappeared for 2-3 days after paxlovid completion. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received other medication in 2 weeks. Covid was treated. Anti-viral details: Treatment start date was 06Sep2022 and treatment stop date was 11Sep2022. Indication- Treatment of COVID-19. Adverse event: Rebounding Covid symptoms after initial symptoms disappeared for 2-3 days after paxlovid completion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Menstrual cycle was disrupted. Period was expected on April 14th, but started a week early on April 7th. Cramps and fatigue were significantly worse than normal. Next period was normal, even though dose 2 was received April 22nd.
81 year old female presents to the urgent care with a raised red rash to her left arm. States she received her COVID-19 vaccination on 1/23, denied having any symptoms except for a subjective fever about 36 hours following her vaccine. Patient stated on 1/31 she noted a coin sized red spot to her left arm, then placed vitamin A ointment to arm, then throughout the week it has continued to grow and feels that it has started to "swell". Patient denies fever, difficulty breathing, pain, itching, or fluid from red area on arm.
Patient complained of extreme pain in the arm 'extending all the way down to hand', general malaise, runny nose, sneezing, waking up at 3am and being unable to sleep.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a male patient of unknown age.  Medical history and concomitant medications were not provided.  On or about 14-JUN-2014, the patient was vaccinated with ZOSTAVAX at a county health department as recommended for routine health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-NOV-2015, the patient was treated at a Family Practice for a painful rash that was diagnosed as shingles. On or about 20-NOV-2015 (note this is same date as before), the patient was treated at the same facility for worsening symptoms. He was prescribed acyclovir, MEDROL and capsaicin cream for management of his symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome was unknown. Additional information has been requested.
This spontaneous report was received from a nurse practitioner concerning to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date, ROTATEQ was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. At the time of the report if was unknown if the vaccine was applied to patients. This is one of several report from the same source. Additional information has been requested.
Pt called clinic at 13:45 stating he developed a cough around 11:40 after leaving clinic, then began to notice slight swelling on the left side of his mouth. Pt denied any difficulty breathing. He stated he also began to notice a small 1/2 of a penny-sized lump on his left lower anterior forearm as well as the same lump on his anterior abdomen. He denies any itching at the sites. He stated the swelling, lumps, and cough were seeming to ''go away'' at time of call to clinic. I advised pt to go to nearest ER/ contact nurse triage line (provided pt w/ number)
Anxiety induced. vital signs obtained and monitored. Patient denies any chest pain, SOB, dizziness, nausea and vomiting. Skin color, temp., condition appeared normal. patient described his feelings as "wonky".  Patients anxiety subsided after drinking water.
Patient had vasovagal reaction. Fainted. Was able to communicate and give his mom's phone number. Nurse, pharmacist and customer physician tended to the patient. He was still faint after 10 minutes so 911 was called and the squad took over patient care at that time.
Suspected vaccination failure; Had ONE SHINGLE erupt; Extremely painful; Erupt with fluid, circle of eruptions around; Formed tough scab; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2021, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, eruption and scab. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, eruption and scab were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, eruption and scab to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he/she got Shingle vaccine years ago and last month in August 2021 had one shingle erupt on his/her back spine area. The patient said, it was extremely painful with a center filled with fluid and then a circle of eruptions developed around the center, it drained finally and formed a tough scab that finally fell off after about a month. 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 and laboratory confirmation for shingles were unknown at the time of reporting. For the first outbreak of the shingles, refer case US2021AMR190793, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190793:Same reporter.
This spontaneous prospective pregnancy report as received from a physician refers to a 33 year old female patient with diabetes, high cholesterol, unspecified allergies (no drug allergies), asthma and patient had difficulty getting pregnant. On 03-DEC-2013 the patient was vaccinated with ZOSTAVAX lot # J000447 (expiry date April 2014), subcutaneous. The patient did not use any concomitant medication. The patient was administered ZOSTAVAX since a coworker of hers had developed shingles. On 20-DEC-2013 the patient returned to physician's office stating that she was pregnant (first trimester exposure) and her last menstrual period (LMP) was on unspecified dates during the second week of November 2013. No treatment was given. No lab diagnostics studies were performed. The pregnancy outcome was pending. Additional information has been requested.
received the covid vaccine and then developed blood clots; received the covid vaccine and then had strokes; This is a spontaneous report from a non-contactable consumer (family member) from a Pfizer sponsored program regulatory authority. This consumer reported similar events for three patients. This is the second of three reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that a member of his family received the Covid vaccine and then developed blood clots and then had strokes. The reporter was wondering about FDA approval and how many deaths happened from the Covid vaccine and also wondering about vaccine shedding. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101211991 Different patients, same reporter/drug/events;US-PFIZER INC-202101211993 Different patients, same reporter/drug/events
Pt received FLUARIX Quad 2014-15 yesterday (9-17) at approx 14:30. She called today (9-18) at 12:39 reporting vomiting, shivering, nausea and decreased appetite. She was going to f/u w/ MD.
Pt presented to pharmacy 7 day post-administration with injection site redness/inflammation approx 3 inch diameter complaint of itching.
pt recv vax 16OCT97 & exp pain @ inj site;13NOV pt cont to exp pain w/certain motion;pt has not been seen by healthcare provider & has not tried any tx for pain;this is 1 of 2 pt from this facility to exp pain @ the inj site p/vax
punctate keratitis in her right eye; Pain soreness and redness in her left eye diagnosed with corneal edema; herpes zoster on her lower back; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 30-JAN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, Shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered pain, soreness and redness in her left eye and was diagnosed with cornel edema. Pt also suffered punctate keratitis in her right eye and herpes zoster on her lower back. It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, punctate keratitis was considered medically significant. The events were considered to be disabling.
Pt given TD next day lt arm was sore seemed OK p/that; Then on 7APR91 lt arm was swollen & warm to touch & red; Seen by MD, tx Silveane cream to lt arm;
temperature excursion at 1 degree C for 43 minutes due to unknown reasons with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid non-serious case received via Lab manager. number: 01286865   This case reports temperature excursion of vaccine IPV (VERO) [IPOL] at 1 degree c for 43 minutes due to unknown reasons with no reported adverse event.  This case is linked to cases 2022SA391587 and 2022SA391920.   On an unknown date, Lab manager reported temperature excursion of Ipol (Lot: V1B901M, expiry: 03-Jun-2024, lot: V1A022M, expiry: 17-Jun-2024, Lot: V1A121M, expiry: 15-Jun-2024) at 1 degree c for 43 minutes due to unknown reasons with no reported adverse event (product storage error) at unknown latency. Caller verified none were used post excursion.  This situation is reported as a temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data and is due to unknown reasons.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown.   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.