chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Bad migraine; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient received her first dose of the Pfizer vaccine earlier, last week on 26Feb2021 and she started experiencing headache, and it's a bad migraine. The patient wanted to know if it was okay to receive her second vaccine. She also mentioned that she had to drive 5 hours to get that vaccine and she do not think she want to drive the next time with a headache. So, that is why she asked if they could be moved. The patient mentioned treatment as Just Excedrin, Tylenol. Outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch cannot be obtained.
Patient has had numbness, tingling, and pain in his arm, shooting down to his hand since his shot.  He is going to see a neurologist soon but his doctor thinks we hit a nerve.
headache,vomiting.  25y/o male Had Covid vaccine today @0800, now PT has all the symptoms plus Lumbar pain. PT looks to be in a lot of discomfort, talks in breaks, lower back TTP.
Information has been received from a physician concerning a 6 month old female pt with no past medical history who on 4/11/02, was vaccinated with the right thigh with a second dose of Haemophilus B conjugate vaccine (+) hep B vaccine recombinant. There was no concomitant medication. On 4/25/02, the pt developed a 5x6 red induration and abscess on the right thigh (injection site). The physician performed an incision and drainage. The abscess was cultured and E. fecalis was noted. On 1/6/03, the pt was vaccinated in the left thigh with a third dose of Comvax. On 1/13/03, the pt presented with an injection site abscess on the left thigh. The abscess Acinetobacter baumannii, Staph A. Pseudomonas and Strep B. Upon internal review, injection site abscesses were considered to be other important medical events (OMIC). Additional info has been requested. Follow up received on 3/19/03 states the pt was treated with IM Rocephin and Augmentin. At the time of the report, the abscess was resolving. The reporter noted that infectious disease colleagues recommended an immunological deficiency work up if this ocurred again in this pt. Additional info has been requested.
On 2/26/2021-after the vaccine, I started getting really bad headaches, after the vaccination my body was feeling kind of drained. I went home and slept. I did not go back to work that day. 2 days after the vaccine, my whole body started feeling funny. 03/05/2021 I was working, and my legs started feeling kind of funny. For some reason my legs started feeling weak. I went home. While was falling asleep, I had tingling in my legs, like a nerve, like lightening in my legs and in my shoulders, I had pain. My legs started feeling really weak. I felt like I was having reaction to the vaccine. I was trying to figure out what was going on. I was not able to go to work. On 05/21/2022 - my legs were giving out. And one day them completely gave out. I fell to the floor and went to the Hospital on 05/23/2021 - I went to the ER. They scheduled me for surgery on 05/26/2021 and the admitted me on that day and I had Immediate surgery on my neck and my spine. I was in the hospital for 3 months. I have not recovered from the adverse event. My nerve system has changed ever since the vaccine. I have screws and rods on my C1 through T3. I was diagnosed with cervical myelopathy and clonus palsy. I am not able to go back to work. I am fully disabled. I cannot lift my arms; I cannot turn my head.
Left upper arm (presumably) vaccine site is itchy and slightly raised and red; 8 days after receipt of vaccine.
Vomiting, hives started on left leg then moved upward towards the neck and face. Face completely swollen.
after administering vaccine, noticed the time I had punctured the vial was 7 hours and 15 minutes prior to the patient's vaccine. I informed the patient after the 15 minutes were up and told the patient I would call the manufacturer and get back to her. she said no problem. manufacturer said off label data showed stability in vial at 24 hours after dilution. this is off label and not per FDA, but i called the patient and informed her this. she said this made her feel better and I apologized once again.
2nd shot only developed "Covid Arm" on L arm only within 24 hrs of 2nd dose extreme redness warmth and swelling and arm become very hard. are started size of gold ball next day approx 6 in by 4in area was raised and welted very itchy.
I had my first Moderna shot in my right arm on March 4th. I got a bad headache the next day. After that a very low ringing in my ears started. I barely noticed it. On April 1st, I had my second shot in my left arm. By that night I was very sick with splitting headache, fever, chills, fatigue. After three days I got better. The ringing in my ears increased from then on getting louder every day. It is now a high pitched ring tone that does not subside that is loud enough to be heard all day and night no matter what I am doing. Nothing I do changes the loudness or tone. I have never had tinnitus before or any hearing loss or hearing issues. I am in good health with no underlying medical conditions.
Next afternoon - swollen lympth nodes, very sore. Later knee swollen, twice normal size, cannot bend, extremely painful. Lasted 12 days. Diclofenac gel (no help) from Nov. 7 to Nov. 18. Dec. 3 to Jan. 5 Toe - (same leg) - joint and foot swollen - colchicine (no help). Toe joint back to normal in a few days after taking Prednisone. Over a month - swollen, extreme pain and joint won't bend. Knee injured 4 years ago. Toe joint broken twice. Never had bursitis or gout before and no history.
only adjuvant was administered; only adjuvant was administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received Shingrix. On 10th November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows: Age at vaccination was not reported. Pharmacist called on behalf of a doctor's office to report that a patient received the Shingrix vaccine prior to the vaccine being reconstituted, only adjuvant was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist would like to know if the patient need to receive the dose again. The pharmacist reported that this occurred on the reporting day and was unaware of any adverse events experienced by the patient. The pharmacist was unaware of the dose number and doctor's office did not provide any patient demographics. The pharmacist did not have patient demographic information or health care professional contact information apart from phone number. The reporter denied to follow-up.
Client was discharged from hospital on 09/20/2021 and was found deceased on 09/21/2021
Varicella vaccine given 11-13-2018 due to non-immune status. Patient had titers drawn for employment. Patient began with localized maculopapular rash on evening of 11-25-2018 at injection site. Patient developed lesions on stomach and face throughout the day 11-26-2018. On 11-27-2018 patient reportedly had "about 20" lesions throughout torso, arms, face, and head. No other signs or symptoms. Patient was advised by MD reaction is due to vaccine and not disease. No lab testing done and no treatment.
Vomiting, weakness, vertigo, double vision entered Hospital. MRI plus more testing done by Dr. Dr. knew of vaccine, however, dismissed it. I believe my father contracted GBS from this H1N1 vaccine and he could be dying.  Please help him.
Information has been received from a RN concerning a 37 y/o female pt with no medical history who four years ago (approx 1999) was vaccinated with 2 doses of varicella virus vaccine live. There was no concomitant medication. The RN reported that "recently" the pt had a blood test conducted and was found to "have negatives titers". The reporter indicated the pt had immunizations done at her primary care physician, and her records have been requested. No additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. Follow-up information was received from a RN who reported that the pt is a prospective employee, and any additional information about the pt cannot be provided.
The patient presents with 44 year old female with a medical Hx of DM, HTN and CAD presents with a covid positive test on 8/7/21. Patient reports of worsening cough, shortness of breath and fever. Pt does note of receiving both of her covid Pfizer vaccinations. Patient was seen here x5 days ago in the ED after being exposed to son who is covid positive but has worsened since. Pt denies any chest pain, abdominal pain, urinary complications, diarrhea or vomiting.  The onset was 5  days ago.
Had significant Vertigo with room spinning and then did Epley's maneuver and vomited profusely due to temporary worsening of Vertigo. Now had slight Vertigo last night again but slight lightheaded was and nausea for past two days.
This spontaneous report as received from a other health professional refers to unspecified number of patients of unknown age. It was reported that the PEDVAXHIB of unknown dose, have undergone a second temperature excursion dated 2-JUL-2014 and have been administered post initial excursion reported as 16-JAN-2014. Excursion supported. It was reported that no adverse events and no concerns are reported by any patients. PEDVAXHIB, have been administered since date of last excursion of 27-JAN-2014 is with Lot number J009134 and expiry date 15-APR-2016. This is one of the several reports from the same source: different patients same reporter. Additional information has been requested.
dizziness; pressure around ears and eyes; pain in back of neck; hyperventilating; stress; raised bp 187/105; confusion; thinking has been off; walking difficulty; eras are buzzing; sleep talking; aches/ pain all over; fever 104; heahache; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty) and TINNITUS (eras are buzzing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Multiple sclerosis and Pacemaker insertion (cardiac) (follow up).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced SLEEP TALKING (sleep talking), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating) and STRESS (stress).  At the time of the report, BLOOD PRESSURE INCREASED (raised bp 187/105), CONFUSIONAL STATE (confusion), THINKING ABNORMAL (thinking has been off), GAIT DISTURBANCE (walking difficulty), TINNITUS (eras are buzzing), SLEEP TALKING (sleep talking), DIZZINESS (dizziness), HEAD DISCOMFORT (pressure around ears and eyes), NECK PAIN (pain in back of neck), HYPERVENTILATION (hyperventilating), STRESS (stress), PAIN (aches/ pain all over), PYREXIA (fever 104) and HEADACHE (heahache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement (140-90 mmHg): 94/62 mmHg (Low) Losartan 50mg  titrated to 20mg  still BP low, Losartan completely stopped by HCP. On 11-Mar-2021, Body temperature:. On 05-Apr-2021, Blood pressure measurement (140-90 mmHg): 187/105 mmHg High. On 05-Apr-2021, Body temperature: 104 High. On 28-Apr-2021, Chest X-ray: normal. On 28-Apr-2021, Electrocardiogram: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-0100891 (Patient Link).
Hive at injection site a few days after injection. Red. Not sore or itchy. About 2" x 4 "
Initial unsolicited report received from a pharmacist and healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2017366848) on 25-Oct-2017. This case involves a patient of unknown age and gender, who was vaccinated with a dose of TETANUS TOXOID and with a dose of PERTUSSIS VACCINE (batch number, expiration date, dose, dose in series, route and site of administration were not reported for both); both on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified day, following the vaccination, the patient had developed allergy to components of the Pertussis and Tetanus vaccine. Laboratory investigations and corrective treatment were unknown. Outcome of the event was not reported. List of documents held by sender: none.
The patient received a dose from a vial more than 30 days on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose from a vial more than 30 days on the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   HCP mentioned that there were 14 patients instead of 18 because of some duplicates.  No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-369249 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Addition information received included new reporter information, race information, pregnancy information, ethnic group, route of administration and site of administration. On 02-Nov-2021: Addition information received  included the information that the HCP confirm number of patients.
Swollen/painful axillary lymph nodes on right side, started approximately 4 days after injection and has proceeded to worsen for the past week.
Information has been received from a registered nurse concerning a female with no known allergies or past medical history who was 22 years old at the time of the report, and was vaccinated with a first and second dose of Varivax in July 1998 and August 1998 respectively. Subsequently, a titer from an unspecified date showed no immunity to varicella. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a physician concerning a 15 year old immunocompromised female pt who is 3 months post-cardiac transplant (5/01). On 8/4/01, the pt was vaccinated with varicella virus vaccine live and hepatitis b vaccine recombinant. Approx. 2 weeks, post vax, the pt developed 150-200 pruritic vesicular and maculopapular lesions and a sore throat. The pt also complained of an abdominal pain that radiated to her back. The pain became excruciating and was localized to the lumbar sacral and lower thoracic region. Initially, the pain was intermittent then it became persistent. It progressed to flank pain. The pt required morphine for back pain relief. She experienced a single episode of vomiting. It was reported that she was negative for cough, diarrhea, headache, joint pain and swelling. Additionally, the physician noted that the pt did not have elevated LFT's to her knowledge, however, at the time of admission her WBC was 10,170 with 82 polys and 12 lymphs. The physician stated that the pt did not have any known exposures to wild type virus. Acyclovir 500mg/day was started on 8/22/01. The pt was admitted to the hospital on 8/22/01 and was discharged on 8/28/01. All symptoms except for a mild sore throat had resolved. The physician felt that her symptoms might be indicative of the viremia she was experiencing. The lesions had scabbed. A lesion sample was obtained for PCR analysis. The pt's discharge dx was disseminated varicella. Additional information has been requested. F/U states that the lesion sample obtained was an inadequate specimen; no strain was identified. Additional info has been requested. F/U states the sample was B-globin neg. Additional follow-up from the physician, received on 10/2/01, indicated that the pt recovered. It was also noted that the pt did not develop herpes zoster, encephalitis, ataxia, meningitis or pneumonia. Additional info is not expected.
Systemic: BLEEDING IN ARM-Medium, Additional Details: PATIENT REPORTED BLEEDING IN INJECTION SITE THAT FULLY SOAKED THROUGH A COTTON BALL AND THAT CONTINUED FOR A FEW HOURS AFTER THE VACCINATION. PATIENT REPORTS NOT BEING INFORMED BY IMMUNIZER OF THE BLEEDING, OR WHAT TO DO ABOUT THE BLEEDING. IMMUNIZER WILL BE CONSULTED AND RETRAINED ON PROPER IMMUNIZATION PROCESS
Parent of pt. reports 1 inch x 2 inch raised, red, swollen, tender area at site of vaccine.
injection site pain, chills, fever, nausea, feeling unwell, body aches. Tried sleeping it off from 930am to about 1pm--did not work. Took a shower and that seemed to help the most--chills, nausea, and feeling unwell went away at that time.
7 y/o male, received Pfizer booster on 06/18/2022 around 10:20am. 0.2ml of Pfizer vaccine (orange cap) was administered without dilution. RN informed mother the error via phone on same day at 5pm, explained the potential local and symtemic adverse events, do not repeat dose as per CDC gideline. Mother reported patient was doing well at that time, denied any local and systemic adverse reactions, denied chest discomforts and respiratory distress.  2nd f/u with mother  via phone on 06/20/2022,  mother reported patient experienced positional dizziness that "last about 1 min"on 06/18/2022 afternoon after vaccination, and able to resume normal activities afterwards. Also experienced soreness around injection site for 2 days, denied redness, swelling. Full ROM, used cold compress with positive relife. Overall pt  was doing well,  no any discomforts or concerns at that time. Advised mom to continue monitoring sx, maintain adequate fluids and rest, call back with questions, mom voiced understanding. 3rd f/u with mother on 06/28. Spoke with mother. patient reportedly experienced dizziness x1 episode on 6/25. she was not with the patient at the time of sx onset, but reports no other notable symptoms. dizziness resolved after nap. asymptomatic since then. appetite WNL, normal activity level. no active complaints at this time. mother concerned if dizziness will recur as "long term side effect". no prior hx before vaccine on 6/18/22. advised to continue monitor, maintain PO hydration. will relay her concern with PCP.  4th f/u by PCP on 06/30. As per mother, pt's symptoms of dizziness on 6/25 fully resolved after napping; no further symptoms since then, no headache, no fatigue or malaise, no fever or chillds, no body aches, etc. Advised mother to monitor for recurrence of symptoms, call PCP office if occurs.
I had my first 2 Moderna shots at  hospital.   During the month of November, I had my Moderna booster on 11/17/2021 at my local drug store Pharmacy. Later that month, on 11/23/2021 some labs I had taken showed that I was anemic.  In January, I had an EGD/colonoscopy and a capsule endoscopy.  No loss of blood could be found.  I was given 2 doses of IV iron 2 weeks apart.  My levels are slowly almost back up to the normal range.  During this time, my hypothyroidism suddenly swung to hyper, despite being on the same 88mcg of levothyroxine for the past 5 years.  I am currently taking 3 pills a week instead of daily while I wait to see the endocrinologist?s nurse practitioner.  I am currently wearing a 30 day heart monitor because of major heart palpitations, perhaps from the hyperthyroidism, and I am have other tests run as well.
Chills, fever, headache, malaise, fatigue. Stayed in bed most of day after shot. Awoken at night by chills. *NOTE: This is nearly everyone's experience I've spoken with but they are never going to take the time to fill out this form. There needs to be active interviewing post-vaccine going on. I know of someone who had a ministroke after their vaccine and others who became very ill. None of them are reporting, because they don't know how, and it's a difficult reporting system. *
This spontaneous report was received from a physician, via a company representative, referring to an unspecified number of patients of unknown age. The patients medical histories and concurrent conditions were not reported. The patients were each administered a total of three doses of PNEUMOVAX 23 on separate unspecified dates, (lot number, expiration date, dose and route of administration were not reported). Each unspecified patient received two doses of PNEUMOVAX 23 before age 65 years, then a third dose of PNEUMOVAX 23 at age 65 years or older. No adverse effect reported. There was no product quality complaint involved. Additional information has been requested.
Pt recvd 3 doses of Engerix-B vax 5APR91, 6MAY91, & 3OCT91 & 19NOV91 it was determined that pt did not respond to the vax series; no tx was given; booster dose was given 22NOV91 & booster was given 20DEC91;
Information has been received from a physician concerning a female (age not reported) who on an unspecified date, was vaccinated intramuscularly with the first dose of 0.5 ml of HPV rLi 6 11 16 18 VLP vaccine (yeast).  The day after receiving HPV rLi 6 11 16 18 VLP vaccine (yeast), the patient developed "flu-like symptoms" (date unknown).  The patient sought unspecified medical attention.  At the time of this report, the patient had recovered from the event (date unknown).  Additional information has been requested.
redness in arm; rashes is still there almost after a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 15Jul2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "redness in arm"; RASH (non-serious), outcome "not recovered", described as "rashes is still there almost after a week". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.