chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6-16-10 pt awoke with sore arm got up took 2 Advil, went to work, had to take more Advil at work, noted (L) arm injection site swollen, red, warm to touch and sm. White pimple at injection site. 6-17-10 -No better called HD at 430/PM to report. Instructed pt to go to ER for eval and call HD 6-18-10. Called 6-18-10 415 talked with MD. Pt went to ER. was too full will try to go back today after 330/pm. Pt went to work 6-19-10 went to E.R.- Rx Naproxin, Thamedol (Cellulitis).
Palpitations & HYPERtension Narrative:  Palpitations 2/2/2021 @ 1100 10 min follow dose. 172/103, 86,  99% RA. Hx anaphylaxis prior allergy test, no other relevant PMH. Observed  30 min, symptoms resolved, v/s normalized 126/85, HR 65.   Other Relevant History:
multiple outbreaks of herpes zoster; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a patient (pt) of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot #, and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care at the time of reporting. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), 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. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not resolved. The reporter determined the event to be related to zoster vaccine live (ZOSTAVAX).  The event of multiple outbreaks of herpes zoster was considered to be disabling by the reporter.
Blurred vision, list of vision, intense shivering and tingling. Peripheral neuropathic tingling in feet and fingers. Patient reported similar incidents when younger.
11SEP95 pt vaxed w/Hep B #1 dose; sx of upper resp infect 25, 26th; Protein CSF inc; sx for CT of brain r/o bleed; ? meningitis per ct; ? edema from an inflammatory infectious process this subtle area of dec attenuation in the lt frontal
Began with aches and chills, and lymph node under arm became swollen.  The second day, aches and chills persisted, as well as underarm pain.  Third day, lymph started to return to normal, but fever increased, aches & chills persisted, and a large appeared at the injection site. Fourth day, redness & swelling at site continues to grow, but aches & chills have lessened.
neuropathy; post-herpetic neuralgia; anxiety; depression; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose,  lot #, expiry date, and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   On an unknown date, the pt experienced post-herpetic neuralgia, neuropathy, anxiety, and depression. As a result of these symptoms, the pt was seen and treated by medical provider.  As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had sustained severe and permanent personal injuries, including but not limited to: 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 pt also had suffered and incurred damages, including medical related expenses, the loss of accumulations; and other economic and non-economic damages as a result of these injuries.  By the time of this report, the pt had not recovered from shingles. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of neuropathy was considered to be medically significant.
Fever, chills, body aches, lethargy, nausea and vomiting and diarrhea. Heart palpitations started after first vaccine but have gotten worse since second one.
Light headache. 9/2/18 Patient is feeling better over time. Called at 2:30PM.
Reaction/catch something; Feeling like the flu; Feeling lousy; runny nose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction/catch something), INFLUENZA LIKE ILLNESS (Feeling like the flu), MALAISE (Feeling lousy), RHINORRHOEA (runny nose) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction/catch something), INFLUENZA LIKE ILLNESS (Feeling like the flu), MALAISE (Feeling lousy), RHINORRHOEA (runny nose) and HEADACHE (Headache). At the time of the report, VACCINATION COMPLICATION (Reaction/catch something), INFLUENZA LIKE ILLNESS (Feeling like the flu), MALAISE (Feeling lousy), RHINORRHOEA (runny nose) and HEADACHE (Headache) outcome was unknown.            Patient received 2 doses of the vaccine and the booster dose, patient had a reaction when she received the flu shot at the same time.  Patient had an emergency and she was taken by an ambulance.  No Treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Nov-2021: follow up received has no new information(NNI).; Sender's Comments: This is a case of a female patient with unknown age , who experienced Non-serious , unexpected events of Vaccination complication , Inlfuenza like illness , malaise, rhinorrhea and expected event of headache after vaccination with unknown dose number  of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . It was reported that these events occurred after vaccination together with vaccination with  Influenza vaccine ( C0-suspect ) .  The patient was taken to the hospital via ambulance because  of the said events however outcome was not reported. The dates of the vaccination were not reported and based on the report it is not clear on what particular dose number  of the mRNA -1273 vaccine  ( Moderna Covid 19 Vaccine ) the patient developed the said events.   It was only reported that the patient had 3 doses of the mRNA -1273 vaccine . The re-challenge for this case is not applicable since the outcome of the events is unknown and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine is not affected by this report.
Cough, SOB with worsening SOB in the last 24 hours, fever and congestion, had nausea. Possible vomiting unsure.
I received my third dose, about two after the vaccine. I started to feel tired and disoriented. I could hardly stand and was fatigued. I went home and went to sleep, a couple hours after I awoke with a fever and severe muscle ache all over my body. I did have a rash around the injection site on my left arm. But nothing appeared to be a allergic reaction. I was unable to sleep after that, I did take Tylenol for the muscle ache and fever Saturday morning. It helped but not that much. On Saturday I was fever disoriented and fatigued, and dizzy. I was drinking water a lot. Saturday I was able to sleep okay and then Sunday morning I woke up with the same symptoms but less severe. I was extremely dehydrated with headache, still disoriented and dizzy. I sleep excessively that night and on Monday I went to get up and experienced flushing in my body with rapid strong heartbeat. The rapid heartbeat would not go away, It was so bad I was unable to breathe. I was weak and unable to move, I thought I was having a heart attack and called 911. The paramedics arrived and placed in me two iv catheters; my heart rate was 180. The administered medication to slow my heart rate. They were unable to and were going to shock me, but then i did respond to the medication. I was transported to the hospital were they stabilized and sent to the hospital. I was diagnosed with Supra-ventricle Tachycardia. I was given fluids and injections, the discovered my potassium level was very low. It was possible I sustained cardiac injury from this event. They suspect underlying heart disease or adverse reaction to the vaccine. After that visit I was discharged and experienced a similar event again and went back to the hospital on my own the same evening Tuesday morning. Tuesday they basically did the same thing and gave me a potassium supplement and beta-blocker to take at home as well. They recommended cardiac follow-up. Present day since then I have been exhausted and have continued pressure in my chest. My second dose I felt well but did not result in heart issues. I have never had a history of heart issues in my life. Because I have asthma I was told I am immunocompromised the gave me a full dose of the vaccine instead of the half dose.
High fever (102 F) starting 3/6/14 evening into 3/7/14. Still febrile today (3/10/14). Behavioral changes beginning 3/6/14; confusion 3/7/14. Cervical adenopathy.
Covid symptoms started on 05/10/22; tested positive on 05/12/22. Tuesday night, I was cold and shivering with most likely a fever, and that started at night. I was very tired at work on Tuesday, so I had fatigue and was feverish. Wednesday, I woke up feeling just almost incapacitated and was exhausted and I didn't think of Covid because I wasn't coughing. I was achy, felt like I had a head cold, and then starting around mid-day all the way through 5 PM I was coughing at work. It wasn't a productive cough but it felt like my lungs were dry and my throat hurt. Then, I had a terrible sore throat and that was my main symptom on Friday and it was just awful. I'm still tired. I feel a lot better today and I would say the symptoms were from 05/10-05/15/22. I had a phone appointment with Doctor and he recommended not to take the medication but to ride it out.
15 minutes after receiving the vaccine, I was feeling light-headed. Upon having my vitals checked, my heart rate was at 110bpm. By the next morning my whole body was sore, especially at the injection site, and I was feeling flush and was sweating. I also have experience lost of appetite, fatigue, and shortness of breath.
elevated blood glucose levels about 210; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 15Mar2021 at 12:00(at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included depression and type 2 diabetes mellitus. The patient received unspecified medication within 2 weeks of vaccination. The patient had allergies to unknown medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient underwent blood glucose test on unknown date and the result was 210 unknown unit. On 17Mar2021 at 00:00 the patient experienced elevated blood glucose levels about 210 for 3 weeks. No therapeutic measures were taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event elevated blood glucose levels about 210 was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Information has been received from an office manager and a physician concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates in October 2016 (reported as "since 01-OCT-2016"), the patients were vaccinated with improperly stored GARDASIL 9 (dose and route were unknown; lot # L026602 with expiration date 19-OCT-2017, lot # L036301 with expiration date 20-DEC-2017 and lot # M004116 with expiration date 12-OCT-2017). The vaccines were exposed under temperature of 30.6 degrees Fahrenheit for 29 hours 30 minutes. There were no previous temperature excursions. Data logger was involved. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided.   On 29-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
Given Moderna vaccine 6 month to 5 years instead of Pfizer 5  11 years.
I received my first Pfizer booster for COVID-19 on 11/8/2021. On 7/26/2022, I woke up feeling ill with a fever, body aches, and a headache. I didn't get out of bed that day, and I ended up pretty much staying in bed for three days. The fever lasted for three days and fluctuated in the 100s, with 101 being the highest temperature. After the fever went away, I developed a nagging dry cough that hung on for about six weeks. At one point, I also experienced a partial loss of taste. I took an antigen test on 7/29/2022 and got a positive result. On or about 8/2/2022, I went to the clinic and received monoclonal antibodies. I had body aches and fatigue until about 8/4/2022. During my illness, I just took TYLENOL to treat the symptoms. The cough was very persistent. I took DAYQUIL and NYQUIL to help treat the cough, though they didn't help much. However, the NYQUIL did help me get to sleep.
I couldn't stay awake for 5 days after that; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on (22Mar2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a 64-year-old female patient started to receive tofacitinib citrate (XELJANZ XR 11mg) via an unspecified route of administration from an unspecified date to an unspecified date at unspecified dose and frequency from an unspecified indication and BNT162B2 Solution for injection from an unspecified date to an unspecified date via unspecified route (Lot number-unknown) as dose number-unknown, single for COVID-19 immunization and he patient's medical history and concomitant medications were not reported. The patient was completely out of medication as of today because her shipment did not arrive to her as stated for 09Jan2017. Upon follow-up on 22Mar2021, inbound call from patient to schedule refill. The patient stated, "I got the COVID vaccine. Does this medication interfere with it because I couldn't stay awake for 5 days after that." The patient was prescribed tofacitinib citrate 11mg tablets. The action taken in response to the event for tofacitinib citrate and the outcome of the event were unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up (25Jan2022): This is a follow-up report to notify that the case 2017022503 and 2021330703 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2017022503 . The new information reported from a contactable consumer (patient)  includes suspect product BNT162B2 and clinical information  No follow-up attempts are needed.No further information is expected.
?Moderna COVID-19 Vaccine  Rash all over body, does not itch but will not go away.
Right thigh redness and swelling/macular patch occurred within 1 hour of immunization. Pt. was completely asymptomatic.
she got at 8 am on a Sunday. At 5pm that same day, she couldn't move.; She had to lay down. She was so nauseous.; She wasn't eating. She never vomited.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 08:00 as dose 2, single (Lot number: EN6198) at the age of 68 years for COVID-19 immunization. The patient's relevant medical history included: "underactive thyroid" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Hot flashes" (unspecified if ongoing), notes: She had issues with hot flashes; "menopause" (unspecified if ongoing); "Hormone replacement" (unspecified if ongoing). Concomitant medication(s) included: FUROSEMIDE; LEVOTHYROXINE taken for hypothyroidism; LOSARTAN taken for hypertension. Past drug history included: Prempro for hot flashes, reaction(s): "Off label dosing", notes: she takes it every other day not every day. Vaccination history included: BNT162b2 (First dose, Lot-EN5318), administration date: 31Jan2021, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 21Feb2021 at 17:00, outcome "unknown", described as "She had to lay down. She was so nauseous."; MOBILITY DECREASED (non-serious) with onset 21Feb2021 at 17:00, outcome "unknown", described as "she got at 8 am on a Sunday. At 5pm that same day, she couldn't move."; DECREASED APPETITE (non-serious) with onset 2021, outcome "unknown", described as "She wasn't eating. She never vomited.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She does get a reaction to Pfizer's COVID shots though. She was fine after her first covid shot. Her second one three weeks later she got at 8 am on a Sunday. At 5pm that same day, she couldn't move. She had to lay down. She was so nauseous. She was in bed for 3 days. She wasn't eating. She never vomited. She just was unable to get out of bed for 2 days. And then she was fine.
very sleepy/had to sleep the whole day; felt like someone with low pressure who can't breath; felt like when someone has low blood pressure; very tired/felt like body was down/felt body tired; muscle aches; a little bit of a headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired) and MYALGIA (muscle aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history were provided.  Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes, METFORMIN, FAMOTIDINE, LISINOPRIL, GABAPENTIN and MELOXICAM for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired), MYALGIA (muscle aches) and HEADACHE (a little bit of a headache). At the time of the report, SOMNOLENCE (very sleepy/had to sleep the whole day), DYSPNOEA (felt like someone with low pressure who can't breath), HYPOTENSION (felt like when someone has low blood pressure), FATIGUE (very tired/felt like body was down/felt body tired), MYALGIA (muscle aches) and HEADACHE (a little bit of a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Information were provided by the reporter
Red itchy rash about the size of an egg on the left arm. Not at the injection site and started a week after the shot. Has not appeared anywhere else on my body at this point.
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Loss of conciousness for less than 1 minute-Medium, Additional Details: The patient lost conciousness within a minute of receiving vaccine. Rph notified and immediately ran to patient. Rph tapped on patients shoulder and asked \"are you okay\" and patient regained conciousness immediately. Patient was confused and did not realize he lost conciousness. Patient felt oaky after regaining conciousness, but Rph helped patient lay down and elevated feet. Vital signs were monitored and were normal.