chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My feet and hands went numb, dizzy, very dehydrated despite drinking fluids, burning sensation, pricking feeling in feet and hands and difficulty moving feet now--potassium low, white count elevated, propriovision off, ankle reflex off, doctor stuck 23-gauge needle in feet and could not feel. We suspect Guillain-Barre Syndrome but as yet not properly diagnosed...it has not shown up on standard tests what is wrong despite many doctor visits...worst symptom is that I am extremely weak--and has gotten progressively worse from January through February. Only think heping is steroids--makes the symptoms almost go away...we are wondering if anyone else has had this reaction to the H1N1 and if so--what was the diagnosis and how do we treat the problem--I have been very sick with a 9 week old baby now and can hardly care for myself....need to know what is wrong with me--what the condition is called and how to treat it if you have seen anything like this with others....
couldn't stop urinating; lost of feeling; she couldn't stand up; fever; Administered fourth dose of 0.05ml; fallen; she had a fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fallen), POLLAKIURIA (couldn't stop urinating), FEELING ABNORMAL (lost of feeling), DYSSTASIA (she couldn't stand up) and PYREXIA (she had a fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O45lz1a and 045LZ1A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Client states has breast Cancer and allergic to suffer.  Concurrent medical conditions included Breast cancer and Allergy (allergic to suffer).   On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .05 milliliter. In 2021, the patient experienced PYREXIA (she had a fever). On 17-Mar-2022, the patient experienced FALL (fallen), PYREXIA (fever) and UNDERDOSE (Administered fourth dose of 0.05ml). On 18-Mar-2022, the patient experienced DYSSTASIA (she couldn't stand up). On an unknown date, the patient experienced POLLAKIURIA (couldn't stop urinating) and FEELING ABNORMAL (lost of feeling). At the time of the report, FALL (fallen) and PYREXIA (fever) was resolving, POLLAKIURIA (couldn't stop urinating), FEELING ABNORMAL (lost of feeling), DYSSTASIA (she couldn't stand up) and UNDERDOSE (Administered fourth dose of 0.05ml) outcome was unknown and PYREXIA (she had a fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the patient stayed at the hospital for 5 hours, went to the emergency room on 01-Sep-2023. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-733273 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2023: Follow up received contains updated dose details, events and narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733273:Linked cases- Monovalent case (MOD-2023-733251) and Bi-balavalent case (MOD-2023-733273)
Pt received vaccine and waited in store for approximately 15 minutes and then went home. He called back about 2 hours after said reported that he experienced an adverse reaction. From his description, he experienced vasovagal syncope. He felt faint, dizzy, lost his balance and fell. He had to get help to get back up and get home.
Moderately severe joint pain and muscle weakness (lower back, left shoulder and elbow, neck, and feet. Results in slowed limited range of movement and painful walking.
Pharmacist administered patient's first dose of Covid vaccine at 4:15pm. Patient claimed he is not feeling well and started to throw up about 5 minutes later. He was also sweating profusely. Pharmacist gave him a dose of Epipen at 4:20 and called 911. Patient started to feel better when paramedic arrive and refused to go to the hospital. We kept patient around for 20 more minutes to make sure he is okay before letting him leave.
My child woke up with muscle discomfort in his neck, they thought it was  it was just a muscle thang in his neck. I took him down to the ER, they did blood draw and found nothing peculiar. He went to rehab. They are now sending him to pediatric hospital to see a neurology. Next week, Wednesday, he is suppose to see a doctor and have botox put in his neck.  ER visit was at : hospital.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On 17-APR-2014 the patient was vaccinated with a dose of VARIVAX, 0.5 milliliter (ml), subcutaneously instead of ZOSTAVAX. The pharmacist reported that on 17-APR-2014 the patient had physician order to be administered ZOSTAVAX but was administered VARIVAX instead. No adverse effects noted by patient. No further information was available. It was also reported that no treatment for the event and the patient did not seek medical attention. It was also reported that therapy discontinued as no. Additional information has been requested.
08/14/2021 the morning after my vaccine, I had a small fever, very tired, took some Tylenol and went through the day. I remember I went home before lunch, my fever had come back, my legs were feeling weak. My right foot heel just didn't feel right. I felt like I had COVID again. I was not short of breath. I went to my primary care and he said that we can go to a neurologist. My right foot has not improved at all since, and after going to the neurologist a month later, where I got a CT Scan of my spine. I had a lesion on my cervical spine. Currently I cannot feel my right heel or right side of my foot and my legs are much weaker than they were prior. I am getting treatment for MS symptoms.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unknown age, gender and race received TRUMENBA at single dose for immunization on unknown date. Relevant medical history and concomitant medications were unknown. On unknown date the patient experienced nausea, body ache, headache. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Caller reports there have been no additional adverse experiences reported; Caller reports that an improperly stored vaccine was administered to a patient; This spontaneous report was received from a physician referring to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction/allergies were not reported.  On 12-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (1 dose, lot #W021743, expiration date: 10-JUL-2024, strength, route of administration and anatomical site of administration were not provided) which improperly stored (product storage error) for prophylaxis. It was reported that it was stored in 10 degrees Celsius for 1 hour 28 minutes. There were no previous temperature excursion. There had been no additional adverse experiences reported (no adverse event).
More redness than a normal post-vaccination reaction; This spontaneous case was received on 21-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-04056) and concerned a patient of an unknown age and gender.  The patient's medical history and concomitant medications were not reported.  On 19-Oct-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number was 283847 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient was treated with Benadryl (diphenhydramine hydrochloride).  At the time of initial reporting on 21-Oct-2020, the patient had not recovered from the event of redness.  The reporter assessed the case as related to Flucelvax QIV.  The reporter assessed the case as non-serious.  This case is linked to cases 202005362, 202005385 and 202005386 (due to the same reporter).  Company comment: A patient of an unreported age was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed erythema. Reportedly, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology.; Reporter's Comments: They reported more redness than a normal post-vaccination reaction.; Sender's Comments: A patient of an unreported age was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient developed erythema. Reportedly, the patient experienced moderate reaction - more redness than a normal post-vaccination reaction. The patient's medical history and concomitant medications were not reported. With information available, causality is assessed as possibly related due to plausible chronology.
Arthralgia, pain and stiffness in joints in hands, shoulders, back, elbows Narrative:
BLISTERS INVOLVING HANDS, ELBOWS BILATERAL, AND HAIRLINE, W/HEADACHES.
Fever and watery green non-bloody mucousy stools developed 3 days post-vaccines/ROTATEQS.
On 12/21/00, this patient had a mild fever, rash to left upper deltoid, swelling, and redness. She was seen by a doctor on 12/22/00, and treated with Hydrocortisone cream. Return to clinic when necessary or sickness increases.
This spontaneous report was received from a nurse refers to a 06-month-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 31-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 10:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 10:23 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.02 for dose administered on 03-Mar-2021 and 67.10 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 014M20A administered on 03-Mar-2021 underwent temperature excursion with temperature range of 34, 35 and 51 degrees Fahrenheit from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 03-Mar-2021. Batch number 030B21A administered on 31-Mar-2021 underwent temperature excursion with temperature range of 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 65-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 8th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 8th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever (serious criteria disability) and injection site pain (serious criteria disability). In March 2018, the patient experienced inability to work, pneumonia (serious criteria disability and GSK medically significant) and respiratory symptom (serious criteria disability). On an unknown date, the outcome of the fever, injection site pain, inability to work, pneumonia and respiratory symptom were unknown. It was unknown if the reporter considered the fever, injection site pain, inability to work, pneumonia and respiratory symptom to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left deltoid. The patient experienced soreness at the injection site. Couple days after vaccination with SHINGRIX, the patient complained that he had pneumonia and respiratory symptoms. Less than a week after vaccination, the patient went to see the doctor and also missed 1 week of work due to these symptoms.
The product wasn't stored according to the labeling and was kept in the refrigerator longer than what the manufacturer requires.
product=COVID 19 Treatment, brand=Paxlovid; product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 05Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). No known allergies. Other medication in 02 weeks was unknown. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Negative on covid tests, on Day 10 of infection, symptoms came back and covid tests are positive again; Negative, notes: Tested Negative on covid tests, on Day 10 of infection, symptoms came back and covid tests are positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course; Adverse event was tested Negative on covid tests, on Day 10 of infection, symptoms came back and covid tests are positive again. start date was 07May2022 and start time was 12:00 PM patient was Recovering.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Swelling to face, lips, throat, difficulty breathing, given Solumedrol in Urgent Care, monitored.
patient experienced jolt of pain immediately upon administration down to elbow and up into jaw, described as very sharp throbbing pain level 9-10, which persisted into night, unable to sleep.  Patient is taking advil, but pain level continues at level 6 and many normal movements cause sharp bouts of pain. Patient is scheduled for doctor visit but has not seen a physician at time of report.
he had experienced pain and discomfort after having received two vaccines: RZV and PPSV23; he had experienced pain and discomfort after having received two vaccines: RZV and PPSV23; This spontaneous report was received from a patient's friend and refers to a male patient of unknown age who reported via social media. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown dates the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, (reported as PPSV23) and with zoster vaccine live (ZOSTAVAX) injection, (reported as RZV), (strength, dose, frequency, route of administration, lot # and expiration date were not reported for both) for prophylaxis.  On an unknown date the patient experienced pain and discomfort.  The action taken, outcome and relatedness between the events and suspect therapies were not provided.
3rd one in October was very similar to 1st one/1st one she felt a little foggy and maybe just a little tired; 3rd one in October was very similar to 1st one/1st one she felt a little foggy and maybe just a little tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "arthritis" (unspecified if ongoing); "left branch bundle blockage" (ongoing), notes: L branch bundle blockage had all her life. takes no medication for this and there is no treatment; "Suffers greatly for anxiety" (ongoing); "has panic attacks for no reason" (unspecified if ongoing); "Asthma" (ongoing), notes: she developed asthma; "Osteoporosis" (ongoing), notes: Diagnosed 7 years ago. Concomitant medication(s) included: XANAX taken for anxiety, start date: 2004 (ongoing); ALBUTEROL [SALBUTAMOL SULFATE] taken for asthma (ongoing); PROLIA subcutaneous taken for osteoporosis. Vaccination history included: BNT162b2 (Dose: 1, lot number: ER2613), administration date: 19Mar2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "1st one she felt a little foggy and maybe just a little tired", "1st one she felt a little foggy and maybe just a little tired"; BNT162b2 (Dose: 2, lot number: EW0153), administration date: 09Apr2021, when the patient was 67-year-old, for Covid-19 Immunization, reaction(s): "2nd one a lot more fatigued". The following information was reported: BRAIN FOG (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "3rd one in October was very similar to 1st one/1st one she felt a little foggy and maybe just a little tired". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information : Covid vaccine: 1st one she had was Oct2021. Clarified she thought first one was 19Mar2021. She had 3 in 2021. March, April and October. All were Pfizer Covid vaccines. 1st one she felt a little foggy and maybe just a little tired. 2nd one a lot more fatigued. 3rd one in October was very similar to 1st one. Then had more, the 04Apr2022. Nothing remarkable about it. A little fatigued and a little soreness at site. Then had another one in May2023 and doesn't recall feeling anything but fatigue. Just felt kinda wiped out and tired.
Tongue swelled a little; Headache; Felt dizzy 1 hour after vaccination, 7 hours later, she got really dizzy/Felt like she was going to faint; This is a spontaneous report from a contactable consumer. An female patient of an unspecified age (reported age: 78, no units reported) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 09:00 as single dose for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient reported she felt dizzy 1 hour after vaccination on 11Mar2021. Then 7 hours later, she got really dizzy, then felt like she was going to faint. She woke up at 2 AM of 12Mar2021 with a really bad headache. Her tongue swelled a little at 4 AM. No treatment was received for the events. She reported that with this being the first shot, she is afraid to get the second. The patient has recovered from the events. The patient has no history of covid prior vaccination. He was not tested for covid post vaccination.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning a female who about a year ago, was vaccinated with a dose of GARDASIL. Three days after the vaccination, the patient developed a swollen lymph node. It was unknown if the patient sought medical attention. It took 3 months to resolve. Additional information has been requested.
Information has been received from a nurse concerning a female patient (the exact age of the patient is unknown) who was vaccinated with a dose of Gardasil and fainted after being given the injection. Unspecified medical attention was sought by the patient. The outcome was unknown. The reporter reported that they had two other patients (ranged from 9 to 11 years) who fainted after being given Gardasil. Additional information has been requested.
Enlarged "left supvraclavicular and infraclavicular adenopathy. Given the reported rapid development and tenderness, the findings likely reflect reactive adenitis."
Patient in clinic 3/17/21. Reports received first COVID vaccine 2/25/2021 at 9:40 am, later that afternoon began having double vision. Reports the night of 2/25/2021 began having severe back pain, numbness to his left foot/toes, burning sensation to right foot, vomiting, and having  hallucinations. Reports was improved by the next day, but has had confusion/disorientation since 2/25/2021. Advised to speak to his primary MD if symptoms persist.
pt recv vax 25NOV97 & 15DEC97 pt exp a T105 lasting 80hr & devel a rash on 21DEC97;possible rxn to MMR vax;
Chills, fever 101, dry cough, upper back pressure, vomiting, no appetite, chest tightness.