chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced swelling, redness, heat to injection site and pain, headache, body aches, joint, pain, and weakness that made me feel unsteady when walking that began on 06/24/2022. These symptoms lasted through the weekend. Monday 06/27/2022 evening I had swelling and pain in my chest, clavicle, right shoulder, which went all the way down through my right arm, which lasted for 24 hours initially. I had a second episode of swelling and pain in the same area that lasted for about 6 hours that began late Tuesday on 06/28/2022. I saw my nurse practitioner on Wednesday on 06/29/2022 and she had labs, EKG, and chest x-ray done for me; also she told me of other patients she's seen with these issues after vaccination. My Nurse Practitioner told me she believed this was an allergic reaction to the immunization pending any lab results. I was not speaking clearly to my kids, and fell multiple times while experiencing my reactions. I do not feel fully recovered from my reaction yet.
He hasn't had a nose bleed since he was a young teen. Pt took the injection on the 27th of August. The morning of Sept 4, 2021 at approx. 6:30am he suffered a 15 min long nose bleed. That the end result was a large blood clot that he was able to get out. We have documentation of it. The morning of Sept 5, 2021 at approx. 4:11am  he suffered another nose bleed that lasted about 5 min. After  a couple of medium sized blood clots came out the the bleeding stopped. Then, the nose bleed started again  at 8:40am where a few smaller clots came out proceeded by him spitting a clot out through his mouth. We have video and pictures.
sore; impossible to sleep; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), INSOMNIA (impossible to sleep) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (sore), INSOMNIA (impossible to sleep) and HEADACHE (headache). At the time of the report, PAIN (sore), INSOMNIA (impossible to sleep) and HEADACHE (headache) outcome was unknown.            No concomitant information was provided. Treatment information was not provided.
Information has been received from a physician concerning his "about 6 or 7 year old" son with no known drug reactions or allergies or pertinent medical history who in approximately 2000, was vaccinated with the second dose of VARIVAX (Merck). The physician reported that his son developed a mild case of chickenpox in first grade, after being immunized a year prior, with the second dose of VARIVAX (Merck). Physician reported that this happened nine years ago (approximately in 2001), and that on unspecified date, the patient had recovered. No lab tests were performed. The patient sought unspecified medical attention. It was reported that on an unspecified date, the patient had recovered. No further information is available.
Initial report received from a healthcare professional on 24 September 2013. This case is for 59/60 employees who were given FLUZONE ID had various site reactions. Patients (demographics) details were not reported), whose medical history and concomitant medications were unknown, had received a dose of FLUZONE ID, (lot number: UT47719AA, Exp. date: 01 April 2014, site of administration was not reported) on an unspecified date. On unspecified date, it was reported that the patients had various site reactions. The reporter stated that it was her first time using this vaccine and she was not happy with it. She said out of all the vaccines she gave she had a 95% severe reaction and one employee (nurse) who had to go to the emergency room for pain. Complementary investigations and laboratory data were not reported. Documents held by sender: none.
LEG PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced leg pain. Laboratory data included: Diagnostic ultrasound (NR: not provided) Blood clot was ruled out. The action taken with covid-19 vaccine was not applicable. The outcome of leg pain was not reported. This report was non-serious.
Feb 3, 21 I was at work, around 8:20 PM I was standing at my computer, all of a sudden my legs felt aches and pains, it was so excruciating that my legs collapsed. My supervisor had to hold me, assist me to my car and leave work. While I was driving my sciatic nerve down to my legs and toes tingling, burning sensation, pain radiated. My arms,  hands and fingers went numb and tingling. Trigeminal neuralgia.
Pain in shoulder movement becoming severe by nighttime and lasting through the next day, inability to lift affected arm, inability to sleep normally due to pain.
Large lump under both injection sites, redness, swelling, warmth. Ice pack,  ibuprofen. Currently continuing treatment
I got sick the following days like most people. But haven't gotten better and have broke out with a rash all over my upper body. Along with congestion, sore throat, off and on low grade fever.
Slight fever, chills, shivering, weakness, headache, severe heartburn. Duration from 6:30 in evening to noon the next day. Flu like symptoms without nausea and without tingle in sinuses. More runny nose than usual.
Suspected drug or drugs: Flu and PNA vaccine.  Drug start and stop dates: early October.  Description and date of reaction: Transverse myelitis vs dural AVF, any association with vaccines? A 61yo admitted on 11/19 for slowly  progressive paraplegia over 3 months and patient reports getting the flu  shot and pneumococcal vaccine in early October and after that he had left lower extremity edema and was given lasix and states he had acute onset of  lower extremities weakness. .   Of note, patient had  previously received multiple times of Flu and PNA vaccine in the past  years (last documented pneumonia vaccination was in 2017).  Relevant medical history: N/L knee severe osteoarthritis, Afib on  warfarin, Morbid obesity with BMI of 52, HFrEF.  What was used to treat this reaction? PLEX, steroids, IVIG, Rituximab, and  apheresis.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 43-year-old female patient (not pregnant) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3182), at the age of 43, in right arm, on Aug 27, 2021, at 11:30, single dose, for COVID-19 immunisation. Medical history included thyroid disease (unspecified if ongoing); and COVID-19 (unspecified if ongoing), notes: COVID-19 prior vaccination: Yes. Concomitant medication included synthroid. Vaccination history included 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FA7485), at the age of 43, in left arm, on Aug 4, 2021, at 04:15 pm, single dose, for COVID-19 immunisation. The patient experienced menstrual disorder (menstruation - following a full cycle only a few days before), onset Aug 29, 2021, at 11:00, with outcome of not recovered. Therapeutic measures were not taken as a result of menstrual disorder. Additional information: Patient had COVID-19 prior vaccination. Patient not COVID-19 tested post vaccination. No other vaccine in four weeks. No follow-up attempts possible. No further information expected.
I had tested negative on 5/24/2021. I got my second/last shot on 5/25/2021. That night when I lay down to sleep, my entire body was riddled with pain and each time I stood up to go to the bathroom I urinated on myself. The next day I was find?! I'm still extremely tired.
hands, feet itching, burning, became fiery red, numbness in lips, fine rash over body;occurred 30-40mins p/vax;seen by MD, DPH caps x 2 & DPH inj; Medrol dose pack started
On the night of the vaccination, I didn't have any symptoms of being thirsty. When I got up the next day, I had a headache, my heart was racing, I had diarrhea for what continued for four months, and my face got very blotched with red spots, and my eyelids were extremely red, and I also thought I had a sty on one of my eyes. This persisted to get worse and then I contacted my doctor and diagnosed me with acute post allergic vaccine syndrome, I had bloodwork ordered and was given a low dose of cortisone to see if the symptoms would abate. After Seven days my symptoms came right back. I still felt subpar until November December. I still currently have small blotches of red appearing on my face. Whenever I get exposed to something I seem to get a red cyst that is on my eyeball. polyethylene glycol seems to be the triggering factor and one of my liver enzymes is still elevated.
passed out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out". Clinical course: Caller also added his mum's friend also passed out, so it could not be related to their genes because "millions of Americans are dying from the vaccine."  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300225285 same reporter/vaccine, different patient/event;US-PFIZER INC-202300225283 same reporter/vaccine, different patient/event;US-PFIZER INC-202300225069 same reporter/vaccine, different patient/event;
Body aches, back aches, chills, shivering, fever. Sore muscle at injection site. Little to no sleep first night. Symptoms began approximately 12 to 14 hours following injection. Took tylenol. 2 every 6 hours.  Fever gone in about 12 hours. Still some body aches and sore injection site but greatly reduced at 48 hours following injection.
injury on her spinal disk; not receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of SPINAL CORD INJURY (injury on her spinal disk) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included None.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SPINAL CORD INJURY (injury on her spinal disk) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose). At the time of the report, SPINAL CORD INJURY (injury on her spinal disk) and PRODUCT DOSE OMISSION ISSUE (not receiving 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication provided.  Patient received a treatment steroids for an injury she had following vaccination on her spinal disk.  Company comment: This case concerns a 51-year-old male patient with no relevant medical history reported , who experienced the non serious unexpected event of  DISC DISORDER after the first dose of  mRNA-1273, time to onset is unknown. Rechallenge is not applicable, since the patient didn´t get the second dose.  The benefit-risk relationship of the product is not affected by this report.; Sender's Comments: This case concerns a 51-year-old male patient with no relevant medical history reported , who experienced the non serious unexpected event of  DISC DISORDER after the first dose of  mRNA-1273, time to onset is unknown. Rechallenge is not applicable, since the patient didn´t get the second dose.  The benefit-risk relationship of the product is not affected by this report.
Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient).  A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol.  Concomitant medication included rosuvastatin calcium (CRESTOR).  The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue".  The patient also reported that she had a herpes simplex virus that was dormant unless she  get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She  stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.
Very red and swollen, hot to touch. Treatment plan; Tylenol, Motrin and ice pack as needed.  Follow up in office with any worsening symptoms.
PATIENT HAS SJS. DEVELOPED RASH ON THE ARM OF VACCINE 2 HOURS AFTER GETTING THE JANSSEN VACCINE.   PATIENT TOOK BENADRYL AND WENT TO THE ER ACROSS THE STREET FROM HER HOUSE AND IS HER PLACE OF WOR.  SHE WAS DISCHARGED AND NOTIFIED US. THE DOCTOR PRESCRIBED STEROIDS.  PT CALLED AT 09/23 4:36PM
Patient got the second Shringrix shot on September 21 around 6 p.m. at our local pharmacy where we got the first one on June 21, 2019. On Sept. 22, his arm was sore, but he did not take off his Tshirt or notice if it was red at the time. On Sept. 23, he went to see a physical therapist in the morning and when she saw his arm, she told him to go to an ER immediately because it was red, hot to the touch and in a rectangular shape. She thought it was either cellulitis or MRSA. We went to the ER around 1 p.m. and the PA there, sent patient home with a cellulitis diagnosis and a prescription for Cephalexin 500 mg four times a day for seven days. Today is Tuesday, and he has taken the antibiotic five times. His upper arm is still red and warm to the touch, but the redness it seems to have faded a tiny bit. He had a low grade fever on Sunday but not now.
Following vaccination the pt's family noticed a sudden onset of confusion and mental deterioration in 1/99. A rapid progression from short-term memory loss to death in March 2000. A diagnosis of paraneoplastic disorder was given. Further information is requested.
Area had become itchy; axillary lymph nodes were very swollen; Left arm area started turning red, red area is currently 2in x 2in area; left arm area was slightly raised; Sore Arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE MASS (left arm area was slightly raised), VACCINATION SITE PRURITUS (Area had become itchy), LYMPHADENOPATHY (axillary lymph nodes were very swollen) and VACCINATION SITE ERYTHEMA (Left arm area started turning red, red area is currently 2in x 2in area) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to sulfa products).    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 08-Jan-2021, the patient experienced VACCINATION SITE MASS (left arm area was slightly raised), LYMPHADENOPATHY (axillary lymph nodes were very swollen) and VACCINATION SITE ERYTHEMA (Left arm area started turning red, red area is currently 2in x 2in area). On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Area had become itchy). At the time of the report, PAIN IN EXTREMITY (Sore Arm), VACCINATION SITE MASS (left arm area was slightly raised), VACCINATION SITE PRURITUS (Area had become itchy), LYMPHADENOPATHY (axillary lymph nodes were very swollen) and VACCINATION SITE ERYTHEMA (Left arm area started turning red, red area is currently 2in x 2in area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 04-Jan-2021, patient received a TB skin test in the left arm.. Patient thought that this may have contributed to the reaction.   No concomitant medications were reported. Patient has not taken any treatment.; Reporter's Comments: This case concerns a 29-year-old female who had NS events of unexpected pain in extremity, vaccination site mass and expected vaccination site erythema, vaccination site pruritus, lymphadenopathy.  Event onset Day 1 after first dose mRNA-1273, with further events on Day 7. She had TB skin test on Day 3. Treatment and outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Vaccination site on Right deltoid a circle of erythema the size of a half dollar. Area is warm, firm, tender. Vaccination 10/17/2016 - Redness noted that evening.
11 days after the vaccination, I developed hives all over my body that itch and flare up as raised bumps. I am still experiencing these hives more than 48 hours after they first appeared.
pt seen in ER by MD 12DEC for temp 102 ax & rash on hands, face, feet;temp cont to 14DEC w/rash on & off;pt can't move cries when moves so stays very quiet;
Whole body achy, muscles hurt and chills - day after vaccine right upper arm w/ localized reaction of erythema, visible lesions.
pt recvd vax 8FEB93 & MAR93 started to feel cramping in rt foot;was not very painful, but by JUN93 was unable to walk on rt foot;x-rays were neg;devel migratory hot spots of redness & pain lasting a few hrs;tx for arthritis;pain
Swelling and erythema of the left shoulder and arm following injection of DTAP on the shoulder.
Was diagnosed with the COVID-19 virus after receiving the COVID-19 Vaccine on 18Dec2020; Was diagnosed with the COVID-19 virus after receiving the COVID-19 Vaccine on 18Dec2020; This is a spontaneous report from a contactable Other Health Professional (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 38 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose in Deltoid Right for COVID-19 immunization. Medical history and concomitant medications were none. After receiving the COVID-19 Vaccine, the patient was diagnosed with the COVID-19 virus on 28Dec2020. she saw Dr. at the clinic where she works to seek treatment. She stated she is supposed to receive the 2nd dose of the COVID-19 Vaccine on 08Jan2021. She asked now that she is COVID-19 positive, should she get the 2nd COVID-19 Vaccine dose. Reported she had a rapid nasal swab COVID-19 test performed. Reported she is taking Hydroxychloroquine and a bunch of vitamins for treating COVID-19. Caller stated she did not have the COVID-19 Vaccine card with her to provide the Lot Number. The patient underwent lab tests and procedures, which included COVID-19 rapid POC test with positive result. Outcome of event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
13 year old patient had recieved MENACTRA vaccine 5 years early with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 20-May-2021 from other health care professional via Medical Information (Reference number- 00610012) and transmitted to Sanofi on 20-May-2021.  This case involves a 13 year-old female patient who was vaccinated with 0.5 mL MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 5 years too early (batch number and expiry date not reported) via an intramuscular route at left deltoid on 20-May-2021 for prophylactic vaccination (inappropriate schedule of product administration)  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE for prophylactic vaccination.  It was also a case of an actual medication error due to inappropriate age at vaccine administration (latency was on same day).  It was reported that, would the patient be harmed, what should they do, would the patient need a booster?  Result of assessment was not reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.