chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to three patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. On 15-MAY-2015, first patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot number, dose and route were not reported) and a dose of improperly stored M-M-R II (lot number, dose and route were not reported). On 20-MAY-2015, second patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot number, dose and route were not reported) and a dose of improperly stored M-M-R II (lot number, dose and route were not reported). On 28-MAY-2015, third patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot number, dose and route were not reported0 and a dose of improperly stored M-M-R II (lot number, dose and route were not reported. Concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
feels terrible; hasn't slept since receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels terrible) and INSOMNIA (hasn't slept since receiving the vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FEELING ABNORMAL (feels terrible) and INSOMNIA (hasn't slept since receiving the vaccine). At the time of the report, FEELING ABNORMAL (feels terrible) and INSOMNIA (hasn't slept since receiving the vaccine) outcome was unknown.            No concomitant medications or treatment details reported.
paralyzed; ALS; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "autoimmune disease" (unspecified if ongoing), notes: she had an autoimmune disease. The patient's concomitant medications were not reported. The following information was reported: AMYOTROPHIC LATERAL SCLEROSIS (medically significant) with onset Jan2021, outcome "unknown", described as "ALS"; PARALYSIS (disability, medically significant) with onset Jan2021, outcome "unknown", described as "paralyzed". Therapeutic measures were taken as a result of paralysis, amyotrophic lateral sclerosis. The clinical course was reported as follows: the patient had the Pfizer vaccine and was now paralyzed and on breathing tubes and the Doctor had no idea what was going on and diagnosed her with ALS and related to the Pfizer Covid-19 vaccines. The patient had two kids and she was suffering significant neuromuscular issues. She was a young wife and seen several Doctors across the country and had done testing. The patient first experienced issues in Jan2021. Treatment reported as follows: over the past year she had been seen by several Doctors in the country. EMG, MRI, X-rays, spinal taps etc. She first experienced drop foot in Jan2021 and weakness in right leg and weakness in the left leg and confined to a wheel chair and unable to walk. Now she was experiencing weakness in her core, hands and arms and that was before and now she was paralyzed. The effects on her hands were devastating and there was no specific treatment was available and intravenous immune globulin (IVIG) treatment may be done at discretion. She was being treated at the top hospital. The patient was 39 or 40 years old and after the symptoms started post vaccine and she had an autoimmune disease that did not surface until the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This initial spontaneous report was received from a Nurse Practitioner (NP) via a company representative and refers to a patient of unknown age and gender. Medical history and concurrent medications were not provided. In August 2017 (reported as about two months ago), the patient was vaccinated with GARDASIL 9 (dose and route not provided.)  It was unknown which dose in the series the patient received. While waiting at the office 15 minutes after receiving the vaccine, the patient passed out and hit their head. It was noted that two other patients also passed out after receiving the vaccine (see case # 1710USA007830). Two of the three injections came from the same lot # (lot # not provided). The patient went to the Emergency Room. It was unknown if hospitalization ensued. The outcome of the events were unknown. The NP did not provide causality assessment. The NP stated that a lawyer has contacted their office for this patient. Upon internal review, passed out was considered medically significant. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1710USA007830:
I'm reporting a rash beginning 3 days after the vaccine, but am giving my lead-up symptoms as well. I'm not sure of the brand of flu shot we got at the Pharmacy.  Had no intense responses to the prior three COVID vaccines ? maybe a little achy/brain foggy but nbd  9/28/22 ? within 2 hrs of vaccine took a hot bath (then learned googling in-bath that might spike IL-6, oops) 9/29/22 ? next day woke feeling achy all over, flu-like, fever of 100.4 throughout the day, chills 9/30/22 ? basically feeling better unless I drink a very hot drink, then I get a hot flash (not typical for me, at first I thought it was fever) 10/1/22 ? ditto 9/30/22 but I itched my left (COVID vaccine arm) elbow and noticed a bunch of little bumps there; not too itchy for now, although my collarbone is a little itchy too
Chronic pain in area of flu shot administration. Pain has continued and has caused limited mobility, trouble laying/sleeping on it. Have needed to take Motrin daily to help with pain.
I got stiffness in my lower legs. Just my legs, from my waist up I was fine. Pain in my left leg. I went to the urgent care, they told me I had a Baker's Cyst in my left leg. I have a compression brace to wear on my left knee. That is helping with my symptoms, my leg is still sore though. I do have an appt scheduled for ortho, if it isn't cured by 11/02/2021. They will do a needle aspiration if needed.
Pt recv vax on 1/21/99; on same day pt exp hives on stomach, vomiting 3x, swollen face; tx= Epinephrine SC x3
Swelling of the lips; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Jun2021 at 11:45 (at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL) from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jun2021 at 12:45, the patient experienced swelling of the lips.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of the lips was unknown at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Received the vaccine at approx 8:45 am on 8/27.  Spent the day at the house with his son and claimed to be feeling totally fine throughout the day.  Was last seen alive by his son at 2:30 pm and advised that he felt fine at that time.  He was found deceased at 4:00 pm by his son sitting in his workshop with his tools still in his hands and sitting upright.
This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. On 10-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # K011562, expiration date 08-APR-2017) (strength, dose and route were not provided). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Side effects; This case was reported by a consumer and described the occurrence of adverse event in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than 9 months after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. In mid or late November 2019, the patient received 1st dose of shingle vaccine and annual flu shot and experienced side effects. The patient stated that healthcare professional refused to give patient the 2nd dose within the 6 month range because of CDC guidance on Covid 19 and potential side effects similar to Shingles vaccine side effect. The patient wanted to know How effective was just the first dose of the shingles vaccine versus both doses in clinical trials and also what was the longest interval between dose 1 and dose 2, beyond 6 months, where the second dose can still be given and still effective. No other information was reported.
Left eye swelled red and puffy. Gave patient 2 - BENADRYL 25 mg capsules told her to take one every 4 hours and she called her primary care doctor. She had taken EXCEDRIN 15 minutes prior to flu shot. She has allergy to ibuprofen.
This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M041083, expiration date 04-APR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Vaccines were reconstituted with properly stored sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA005086: US-009507513-1705USA005094:
rash; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comments:  The pharmacist mentioned that one of their employees developed a rash after having been vaccinated with Shingrix.  She did not state whether this was after 1st or 2nd dose. The reporter did not consent to follow up.
Raised area of redness over (R) upper arm. Blotchy skin over UES, upper chest - no frank hives
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 07Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 75 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 included: "Other medical history: HBP" (unspecified if ongoing); "Other medical history: Interstitial lung dis" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid from 24Jan2023 to 29Jan2023.
The patient reported filling dizzy within a few minutes after vaccine. I instructed her to put her head between legs. She sat back up and said she felt hot so I got her some water. She said she was feeling better so I asked her to stay seated by her husband and I would give her a minute to see if she improved. He called me bac to the room because she passed out and was leaning on him. She was speaking but very weakly. She asked to be put on the floor. We lowered her down to the floor. I applied cold packs around her head and got a fan. We called EMS. Her pulse was normal and when a nurse arrived her blood pressure was okay. Ems took her to the hospital.
This case was reported by a consumer via call center representative and described the occurrence of dystonia aggravated in a adult patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included dystonia and neuromuscular disorder nos. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken. On an unknown date, the outcome of the dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken were unknown. It was unknown if the reporter considered the dystonia aggravated, ill feeling, fatigue extreme, difficulty in walking, bone pain, muscle pain and hard to awaken to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient's symptoms were well managed for many years before the shot. The patient was extremely ill with the dose of SHINGRIX vaccine. The patient's neuromuscular disease and generalized dystonia much get worsen after the dose of SHINGRIX. At the time of reporting, the patient still had extreme fatigue, difficulty walking, difficulty getting up, pain throughout bones and muscles from the 1st week in September until the reporting date. The patient's neurologist told to not to get the second shot. The case had been logged accordingly in CRS with corresponding issue.
couldn't lift arm or lay on it; red hematoma at injection site for weeks; burning from head to toe; Arm hurt; Neuropathy and Small Nerve Fiber Neuropathy; worst headache; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 05May2021(at age of 60 years old) (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation.  Medical history included Hashimoto's, Fibromyalgia, Small Nerve Fiber Neuropathy, surgeries for defective veins and valves, poor circulation problems and kidney infection 10 years before shortly after undergoing cath lab procedure. The patient's concomitant medications were not reported.  Consumer call with questions regarding " I had side effects after the first dose of the vaccine.  Should I get the second dose?" Side effects included "worst headache on 05May2021 for 2 days continued for weeks, couldnt lift arm or lay on it, red hematoma at injection site for weeks, burning from head to toe." Caller also reported that her arm hurt after the vaccine. Also reported she had to receive prednisone (her doctor put her on steroids) after first vaccine dose, also reported that her doctor gave her Methylprednisolone, which she took for 6 days, the medication did help somewhat with her symptoms, specifically, the burning from her neuropathy, headache and she couldnt lift her arm, the medication was not a miracle drug, but she did have some relief. She tapered the medication, she had less relief of her symptoms. The symptoms have subsided somewhat and it has taken several weeks. Caller just wanted to ask a medical professional if that ingredient (propyl ethlene glycol as provided and spelled by Caller) contributes to Small Nerve Fiber Neuropathy, Patient reported she went on vacation in January of 2020, after returning home she was very sick but was never diagnosed with Covid-19.  Caller reported that she had some type of neuropathy that had come back after she got the first vaccine, she had a splitting headache within 30 minutes of getting the vaccine, and it was really bad, for two days after the vaccine. Caller was concerned to take the second vaccine, because of her previous bad reaction, and her doctor told her to take her second dose and Second dose of vaccine scheduled for 10Jun2021, 36 days after the first dose of vaccine. Outcome for events was recovering.   Information regarding the lot/batch number has been requested.
Was very tired and wanted to stay in bed from short time after receiving the vaccine. Experienced some chest pain.  Was found deceased in house at night 14 days later.
Patient stated that she started itching on 10/18/20 and her arm felt sore.  Patient came in to pharmacy on 10/19 and I examined her arm.  Swollen, red area was between elbow and shoulder (not the deltoid).  Patient stated that she received the immunization at that site, but the pharmacist that gave the immunization stated that they were confident it was administered in deltoid area.  Physician was informed on 10/19 at 1:30pm.  He said he would follow up with the patient.  I expressed to him that she wanted to be seen.
This spontaneous report has been received from a medical assistant referring to a female patient of unknown age. The patient's medical history included unspecified allergy to neomycin. On 29-JAN-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, route and lot # were not reported). The reporter reported the patient experienced swelling of the skin and throat closing up while in the office. The patient was administered EPIPEN while in the office. The reporter did not verify if the patient was sent home or a hospital. The outcome of adverse events was unknown. Upon internal review, the adverse events treated with EPIPEN were considered as other medically significant events. Additional information has been requested.
Was given 2-3 times the recommended dose. At the time of reporting no adverse reactions yet.
No adverse drug reaction or adverse patient effect. Administered one day past manufacturer expiration. Per Moderna, vaccine maintained activity at time administered.
This spontaneous report as received from a nurse refers to an unspecified adult patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported. On 21-DEC-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis instead of M-M-R II (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. Product quality complaint (PQC) was not involved. Additional information is not expected because there was no consent to contact physician.
Headache; lymph nodes in neck swollen on left side; Brightness in vision; chills; Nausea; sorenes in arm; This spontaneous case was reported by a patient and describes the occurrence of VISUAL BRIGHTNESS (Brightness in vision), CHILLS (chills), HEADACHE (Headache), NAUSEA (Nausea) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in neck swollen on left side) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced CHILLS (chills), NAUSEA (Nausea) and INJECTION SITE PAIN (sorenes in arm). On 15-Feb-2021, the patient experienced VISUAL BRIGHTNESS (Brightness in vision). On 16-Feb-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in neck swollen on left side). At the time of the report, VISUAL BRIGHTNESS (Brightness in vision), CHILLS (chills), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE LYMPHADENOPATHY (lymph nodes in neck swollen on left side) and INJECTION SITE PAIN (sorenes in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
EAR RINGING; FATIGUE; This spontaneous report received from a consumer concerned a 90 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified medical issues, and fatigued.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On 14-MAR-2021, the subject experienced ear ringing. On 14-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, and the outcome of ear ringing was not reported. This report was non-serious.
The pt woke up on 4/22 with severe pain and numbness in both hands, unable to close hand to make a fist, fingers very difficulty to move. Could not feel objects in hand, pain remained excruciating, went to the ER. MD could not make a diagnosis, was admitted to continue testing. Treated with Percocet and then high doses of ibuprofen. Neither gave relief. Discharged on Vioxx for 3 weeks, no help, symptoms persist. The 60 day follow-up states that there is still some intermittent, minimal numbness in the three middle fingers of the left hand and middle finger only of the right hand, only at finger tipps and only occasionally.
01/14/22 presents to EC ED for "Dyspnea, Chest Pain and x1 Syncopal Episode ". PMHx of "Morbid Obesity, HTN, Asthma, OSA, and recently COVID-19 positive x2 weeks ago"