chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle soreness; slight headache; fatigue.; feeling bloated and gas; feeling bloated and gas; This is a spontaneous report from a contactable other healthcare professional, the patient. A 39-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in the left arm on 25Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and known allergies reported as none. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via intramuscular route in the left arm on 28Feb2021 at 14:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 16:00, the patient had experienced muscle soreness, slight headache and fatigue. He was feeling bloated and gas since he received the shot which was most significant side effect. At the time of report which was second day and he was still gassy and little pressure in his abdomen but when he passed the gas it went away but then he was geeked with more gas. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events of muscle soreness, slight headache, fatigue, feeling bloated and gas was not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient stated that he right arm was red and swollen following the FLUZONE HD vaccine administration on 11-9-2015. The symptoms resolved within 2 weeks without drugs.
An 81 year old female received RSV vaccine or Placebo and influenza vaccine in the RSV 11 study on 10/15/02; and on 7/16/03 died at home of congestive heart failure, 274 days after vaccination. The subject had been placed on hospice for severe CHF not responding to treatment. The pt was hospitalized 3 times in February 2003, May 2003 and June 2003 for CHF, atrial fibrillation and ischemic cardiomyopathy. A death certificate and other pertinent record will be sent as soon as available. The investigator assessed the events as unrelated to the study products. Additional info received 10/7/03. There is no hospital summary since subject died at home. Copy of certificate of death received. Cause of death: congestive heart failure-approximate interval between onset and death-5 years. Secondary cause: atrial fibrillation-approximate interval between onset and death-2 years. Other significant conditions contributing to death but not resulting in the underlying cause given-breast cancer. No autopsy performed. A 15-day follow up report received 10/23/2003 adds: No further info is expected. Case is closed.
fever/Her dad was running a fever of a 102.9; tiredness; cough; headache; muscle pain; chills; joint pain; her father was feeling unwell; my dad was feeling nausea too; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's daughter) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9262), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, caller mentioned that both her parents got the first dose of the COVID-19 vaccine and afterwards they got fever, tiredness, cough, headache, muscle pain, chills, joint pain, and her father was feeling unwell on an unspecified date in 2021. She wanted to know how many days do these side effect would last and also how to treat them. She was aware that this has been reported in the clinical trials. She has already got doctors but got no answers. This is the first case out of two cases. Transferring agent stated, "I have a caller on the line. She was calling about her parents. Her parents received the dose of Pfizer COVID vaccine on 20Jan2021. Her dad was running a fever of a 102.9 and her mother was running a fever of 101 on an unspecified date in 2021. So, she was kind of wondering how long this might last. I did give her the medical information department phone number, but I am getting her over to you to record the fever." When paraphrased the concern, reporter stated, "Yes, and what was the procedure to prevent it because they had the Pfizer vaccine and they have all the symptoms to them except not injection site redness and nausea. But my dad was feeling nausea too on an unspecified date in 2021." The outcome of the events was unknown.
This spontaneous report as received from a 68 year old male patient refers to himself. The patient was with gout, allergic to morphine, penicillin and iodine. The patient's medical history included shingles. 6 years ago, approximately in October 2008 the patient was vaccinated with a dose of ZOSTAVAX (route and lot# not reported), 1 vaccine. It was reported that in first part of September of 2014 the patient had a flare up of shingles. Medication prescribed for the treatment of the event. Electrocardiography (EKG) was performed (unspecified result). Blood work for double hip replacement surgery (unknown adverse event with unknown onset date) would be done on 13-OCT-2014. The outcome of the adverse event was unknown. The outcome of shingles was reported as improved. The patient sought unspecified medical attention. Upon internal review, the event of Blood work for double hip replacement surgery (unknown adverse event with unknown onset date) would be done on 13-OCT-2014 was considered to be medical significant event. Additional information has been requested.
Pt was seen 1 week after Flu and H1N1 vaccine with vision changes. Sent to ER discharged with F/U ophthalmologist
Stroke; Blood clots in his brain; Limited motion on the left side of the face and arm; Turned my life upside down; A spontaneous report was received from a consumer concerning a 73 -year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported events blood clots in brain/ cerebral thrombosis, stroke/ cerebrovascular accident, turned life upside down/loss of personal independence in daily activities and limited motion on the left side of the face and arm/mobility decreased.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  The patient received the first of the two planned doses of mRNA-1273 (lot/batch number: 041L2A) on 08 Jan 2021. On 05 Feb 2021, prior to the onset of the events, the patient received their second of the two planned doses of mRNA-1273(lot/batch: 01020A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 26 Feb 2021, the patient experienced blood clots in brain, stroke and he patient woke up in the morning with limited motion on the left side and was subsequently hospitalized for two days. The patient's life upside down. Treatment information included blood thinners, small dose of acetyl salicylic acid, rosuvastatin, CoQ and Vitamin D3.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events blood clots in brain, stroke, turned life upside down and limited motion on the left side of the face was not reported.; Reporter's Comments: This case concerns a 73 -year-old, male patient, who reported  cerebral thrombosis, stroke, loss of personal independence, and mobility decreased. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Mom became agitated. Would not sleep. Stayed continuously awake for approximately 40 hours.  Could not be redirected. So tired she was swaying on her feet, but could not be convinced to lay down.  After 2 days we were able to get 50 mg Trazadone from our doctor.  After sleeping for 6-8 hours she then did another 24 hours awake. We upped the dose to 100 mg.  By this point the event had started to pass.    During this time we also noticed mom was running a low fever in the morning. 99.5 - 100.5. It would go away in the afternoon.  During this time mom was hallucinating - having conversations with people who were not there.  Mom's hearing declined during the event as well.   As of 2 days ago mom's temperature seems to be back to normal in the morning.  This "event" has impacted mom's mental and physical decline.  She seemingly overnight now needs help showering and toileting, and sometimes dressing.  (This kind of decline is common for dementia.  Each time over the past 5 years that mom has had some physically stressful even such as hurting her foot or getting a bad stomach virus,  she has come out the other side degraded)  The reason I'm reporting this is that the behavior changes were sudden, seemed to peak, and then subside.  There is a correlation with the second moderna shot, and so I though it was important to report.
Mar 5-2:30pm: arm began to feel sore. Mar6-12:00am  I can barely lift my left arm above chest level. The soreness has traveled from the injection site down to my wrist and fingers. The injection site is slightly pink, not really noticeable, and warm to the touch. I start to feel a little nauseous and also starting to get body aches and chills. From 12:00am-4:00am i constantly wake up because of arm soreness and body aches. At 4:00am, I woke up  to use the restroom and realized even the bottom of my feet hurt with every step I took. Took my temperature and it was at 101.5.  I went back to bed and fell asleep even though I kept waking. At 7:00am, the migraine started. I was trying to avoid taking meds just to be able to get a clear picture of how my body responds to the vaccine, But by 9:30am (22hrs post vaccine) I ended up taking Tylenol for severe migraine. It feels like someone is stabbing my temples with a very sharp object. Turning or even slightly moving my head strengthens the migraine. My arm is still so sore that I can barely move it!  Tylenol brings temperature down to 100.7°. 10:30am I began with extreme fatigue. By 12:30pm I went back to bed because I couldn?t stand my body aches and migraine. I slept until 4:00pm woke up feeling a little better. Migraine was still there but not as bad. At 8:00pm I began to feel pressure on my chest. That pressure slowly turned into pain. By 9:20pm I was in excruciating pain, I was in tears and I literally thought I was going to die. It hurt to breath. I checked into the ER by 9:30pm the pain was sharp and it would come, last a few minutes, then slowly ease off a bit. On a scale of 1-10 if was definitely a TEN!!!! The ER said it wasn?t cardiac so they sent me home. The DR did say that the chest pain could have possibly been caused by the vaccine, as many have seen different symptoms and everyone has reacted differently. I was home by 1:15am. The pains continued until 3:00am. By 8:30am on Sunday Mar 7, the only thing I was suffering from was soreness in the arm and my chest was sore from the pain. The pain in my chest was a 1 or 2 compared to the 10 that it was when I went to the ER, And that pain/discomfort has lingered all day.  I?m currently 22weeks 4days pregnant with a boy and expected to deliver July 7th. I?ve been pregnant 19 times have 4 living children and suffered 14miscarriages.
Within 24 hrs of vaccine, she was dizzy, tired, had poor balance, memory problems, stuttering, headaches, muscle weakness, tight feeling in arms, numbness around mouth & at left arm.
My son received the varicella vaccine on 10/17/07 and began to break out with bump/blisters on 10/25/07.  I had to take him to the ER with a fever of 104.3 on 10/27/07 since that day I could not get it to go down below 103.0 with meds.  I also noticed on that day that i had a few bumps breaking out I went to my physician on 10/29/07 with bumps/blisters, who stated that this could be or is chicken pox.  She said she was unsure what to do since I did have the disease as a child.  I have checked around and the vaccine that my son received was dead and therefore he should not of been able to transmit that disease to anyone else.  They are stating that this is a adverse secondary infection and I was thinking that it would be a good idea to report this to the CDC since this should not be something that happens after a child receives a dead vaccine.  The vaccine was given to my son as part of his 12 month vaccination.  He also received that day a few other vaccines that I have also given you the manufacturer and lot number for.  Also he had a very large red raised area around the injection site that is still is their on 11-1-07 but it looks as if it is finally starting to fade the size of the redened area would be about the size of a nickel.  I have also called and asked that his physican note this reaction in his chart.
Patient reports large, red, rash on vaccinated arm approximately 2 weeks after vaccine administered.
Site: Pain at Injection Site-Severe, Systemic: shooting pain up her neck-Severe, Systemic: Unable to Sleep-Medium
At approximately  10:30 AM, Hep B was ordered, but HPV-9 was given. Dr. was made aware immediately. Mom was then informed.  This vaccine was given outside of test range.
Thrush; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CANDIDA INFECTION (Thrush) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CANDIDA INFECTION (Thrush). At the time of the report, CANDIDA INFECTION (Thrush) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-075307, MOD21-074672 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information received on 21 JUL 2021 contains significant information updated that the doctor earlier misdiagnosed with thrush patient has no adverse event.; Sender's Comments:  MOD-2021-075307:Wife case MOD21-074672:
Tiredness starting one hour after the injection and lasting an hour.  Injected arm experienced soreness when raised for two days, injected arm experienced soreness to touch for two days, injected arm experienced general soreness when not moving or touching it for one day.  Experienced some hot and cold flashes on first day starting about half an hour after the injection.  Some full body shaking 15 hours after injection, but only lasted an hour.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for 5 days 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 was not reported. Concomitant medication(s) included: SINGULAIR; LOSARTAN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEVOTHYROXINE; SPIRONOLACTONE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.  clinical course: patient had no Known allergies, patient received Other medication in 2weeks.  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 and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
5" x 5" area of erythema on proximal anterior left thigh surrounding injection site and small 2 cm excoriation. BENADRYL PRN.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Within 10 minutes of vaccination patient c/o numbeness and tingling similar in nature to the sensation that his wife was experiencing after her vaccination occurring a few minutes after him. The patient reported to be experiencing the non-focal generalized ipsilateral numbness and tingling on the left side of his body of which he was vaccinated
her mother is very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). A female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine - manufacturer unknown (Dose: 01), for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine".  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "her mother is very sick".   Additional information: Patient does not have covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Evening post vaccine - Fever & chills (x 2 days), HA (x 5 days) & joint pain (x 3 weeks). Tylenol prn. Flare up of oral neuropathy & inflammatory pain peaked at 3 days post vaccine: - extreme sensitivity and burning, pulsing pain to teeth and gums, unable to talk due to pain - burning pain to arms, neck, and back (increased Lyrica, 50% relief) - joint pain (hips & legs) - continued for 3 weeks until 1 week after prednisone started 10/25/21 - started prednisone pulse/taper therapy.  Mouth/teeth burning, pulsing pain is continuous, unresponsive to prednisone, topical lidocaine and topical benzocaine. Unable to talk or work since vaccine.  Disability filing 11/8/21.
sore arm at site of injection; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 13:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included dupuytren's contracture, and allergies: Latex. Concomitant medications included acetaminophen; and colecalciferol (VITAMIN D 3); taken for unspecified indications, start and stop dates were not reported.  The patient experienced sore arm at site of injection on 17Feb2021 17:00. The patient did not receive treatment for the event. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Pt developed sudden onset of hard mass in left lateral thigh, 3 weeks, post vax. Observation originally used, mass continued to enlarge. Hot packs applied. Abscess opened on 10/14/00. Low-grade temperature noted.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; 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 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022 at 3:50 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 3:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). 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 'vaccine administration date'). 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 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient had received the booster dose.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and lot number was no longer possessed.  No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Vomited multiple times 5 minutes after receiving the vaccine. Also felt dizziness, tingling, and throat tickle.
pericarditis reported in pt who received Fluogen 10 days earlier, pt diabetic, Hospitalized, recovered
fever of 102F; Inflamed arm described as pink and puffy; Inflamed arm described as pink and puffy; inflamed arm; arm became sore; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 2nd November 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 3rd November 2020, the patient experienced fever, tissue puffing, erythema and inflammation. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever, tissue puffing, erythema, inflammation and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, tissue puffing, erythema, inflammation and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix in right deltoid and that evening arm became sore.  On 3rd November 2020, the patient waking up with a fever of 102F and a sore and inflamed arm. Inflamed arm described as pink and puffy. Consumer reports taking Tylenol this morning and fever dropped down to 99.7 F. The reporter consented to follow up.
1 week after 1st dose (delayed reaction), I had a red/raised area on injection arm. Was tender/hot and itchy. Resolved in 1 day