chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From telephone contact with reporting nurse supervisor, it was stated that a 4 year male patient received a Tripedia vaccination, Lot # UO532CA administered in the gluteous on 08/24/2001. The next day, 08/25/01, parent reported that the patient had a large area, the size of a baseball, reaction with redness. Resolved within a few days.
On 2/11/21 bruising possibly related to anticoagulant use. D'C's med.  2/21/21 recieved vaccine, dose #2.  on 2/14/21 resident expereinced a temp of 100.4°F. C/O "pain all over".  MD visited resident in the facility on 2/14. Spoke with family, comfort measures only. Due to history of ESBL treating empirically with ABT.   As of 2/19 no improvement in condition. On comfort care.
Pt. reported redness, lump, swelling at inj. site 11/10. Sought treatment from Dr 11/12/14. Dx cellulitis w/ abscess. Treated with inj and oral antibiotics. Evening of 12th, eruption of zoster blisters on (R) foot. Sought treatment from Dr 11/19/14.
Injection given on right arm (1 am left-handed) way close to shoulder area. Injection site was never sore but pain and limited motion on right arm shoulder by 2nd day or so. Painful to lift arm and move pt carry things.
Bell's Palsey with first symptoms of tearing eye beginning next day after shot. Progressed to numbness and drooping on one side of face by the next day. Went to urgent care and was immediately directed to the ER
Severe Shoulder and arm pain. Very limited range of motion. Could not lift my hand to my face. Fever reaching 101. 4 days later and still facing limited range of motion and major pain in shoulder.
04/10/2021 My legs began hurting, when I got up to walk, my lower back hurt badly. This was during the night when I was sleeping, it woke me up out of my sleep.
Pt received injection, first dose.  of Pfizer vaccine at 10:27am.  Pt was taken to observation station in mall area of hospital for 15 minute observation, by another nurse..  At approx. 10:32, when observing nurse questioned pt about any headache, nausea, vomiting   or other reactions, , pt c/o headache, then dizziness, nausea and ultimately started attempting to vomit, having "dry heaves" only.  This nurse calls Code RRT to location of event..  Pt was taken to ER via stretcher.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Batch No - EP7534) on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to (Patient Link).
Swelling in supraclavicular & axillary areas, enlarged lymph nodes all on R side.
This case was reported by a nurse and described the occurrence of metallic taste in mouth a 37 year old female subject who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The subject has no known allergies. There were no concurrent medications. On 9/28/2005 the subject received 1st dose of Havrix (lot AHAVB078AB). On 09/28/2005, the subject was also vaccinated with tetanus and diphtheria toxoids absorbed (adult formulation). Approximately two weeks after the injections, on an unspecified date in 10/2005, the subject experienced metallic taste in mouth. The event was ongoing at the time of initial reporting, 11/2/2005.
Donor noticed itching underside of left arm near arm pit 2 days later 5/15/05 at home found red rash. No treatments given.
This case was reported by a other health professional via sales rep and described the occurrence of localized erythema in a 16-year-old female patient who received BEXSERO (batch number 16E901, expiry date 31st March 2019) for prophylaxis. On 17th August 2018, the patient received the 1st dose of BEXSERO (intramuscular). On an unknown date, less than a year after receiving BEXSERO, the patient experienced localized erythema. On an unknown date, the outcome of the localized erythema was not reported. It was unknown if the reporter considered the localized erythema to be related to BEXSERO. Additional details were provided as follows: The reporter was a Certified Medical Assistant (CMA) or an office manager. The reporter stated that patient developed a large circular red ring on her arm after vaccination with BEXSERO. The shape was mentioned to be circle.
Patient was walking out the immunization room and fell about a minute after receiving the vaccine. He appeared to be having a seizure but quickly gained consciousness. Mom was with him and refused for me to call 911. He then began to vomit on his side laying down. I eventually got him to sitting up he was pale and sweaty, put cold packs on him and wet wash clothes. He drank a cold water slowly and I gave him 2 Benadryl tablets. after about 15 minutes he was able to stand and I helped him out to the car with his mother.
Severe headaches, muscle aches, nausea, diarreah, extreme fatigue.
Information has been received from a physician concerning his wife who was receiving other concomitant medications which are unknown. The pt developed cellulitis of the right arm from the elbow to the shoulder, a stiff neck, nausea, anorexia and orthostasis. the pt sought unspecified medical attention. Additional information has been requested.
Narrative:  Other Relevant Hx: Symptoms:  Headache Treatment: ACETAMINOPHEN 325 MG ONCE
L hip pain- diagnosed as toxic synovitis- lasted approx  6 days- started  12/20
pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
This spontaneous report as received from a pharmacist via employee refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU. On an unknown date the patient experienced burning sensation during the administration of ZOSTAVAX. Th pharmacist mentioned the sensation lasted a little bit after vaccination. The patient sought medical attention she was in pharmacy. The outcome of burning sensation was reported as recovered/resolved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an 5 year old patient of unknown gender who, on an unspecified date of 2014, was vaccinated with a dose of PROQUAD (lot#: J014238, expiration date: 07-MAY-2015) which on 20-FEB-2014, 25-MAR-2014 and 26-MAR-2014 were exposed to unspecified temperature excursions not exceeding 11F and for no more than 2 hours at a time. The vaccines were supported by Merck's stability data. The reporter stated that she does not believe that any patients have experienced any adverse effects. This is one of several reports (MARRS# 1403USA013236, 1404USA005557, 1403USA005558, 1404USA005559, 1404USA005560, 1404USA005561 and 1404USA005562) from the same source. Additional information has been requested.
Pt recvd vax 18NOV92 booster for low titer and as of 23FEB93 vax titer p/booster was 2.2; pt refused to have another booster due to vaginal & oral candida;
At 14 weeks pregnant, woke up with worst headache. Tried treating with tylenol and water but it did not improve. OBGYN recommended going to ER. Blood pressure was fine and ultrasound showed that baby was okay. They treated me with fluids and sent me home a few hours later. Don't know if it was vaccine related - doctor thought it was dehydration and/or pregnancy hormones.
Sore arm all day. Woke up at 1am extremely nauseated, headache, and in sweats. Went to kitchen to get some nausea meds and felt my ears closing. I couldn?t breathe and apparently passed out. My husband called 911 and I came in and out for about 30 min he said. I couldn?t open my eyes and couldn?t feel my legs. Bp was normal and so was blood glucose. They gave me some fluids and nausea meds and I started coming too. Today I am extremely achy and terrible headache, scared to get out of bed.
Hot, red, puffy from injection site upper arm to elbow. Localized reaction to injection site. Keflex prescribed.
This report was received from a nurse. On 8/4/98, the pt  received an injection of Engerix-B; it was not known if she had received previous injections of Engerix-B. On 8/10/98, the pt experienced nausea, diarrhea, anorexia, acne on her face and back and "severe" abdominal pain. She was hospitalized on 8/24/98 with a dx of acute hepatitis. The pt was discharged on an unspecified date. On 9/5/98, the pt was admitted to a different hospital with a dx of acute hepatitis "etiology unclear". Treatment included hydration and vitamin K. She was discharged on 9/8/98 with a dx of "acute and subacute necrosis of the liver with a secondary dx of other coagulation defect". A biopsy was not performed. The reporter stated that the events were life-threatening and possibly related to Engerix-B. As of 2/14/02, the outcomes of the events were unknown. This information received on 6/11/02 reported the events as ongoing.
36 y.o.  female with history of insomnia, presenting with progressive weakness.  She was initially seen on 6/5 with 3 days of leg heaviness and difficulty lifting arms.  Exam at that time showed minimal weakness in left shoulder/wrist as well as mild hip flexor weakness bilaterally and right knee flexor weakness with diffuse hyperreflexia and Hoffman's.  MRI of neuroaxis was recommended but patient left AMA.  She represented the following day with significant progression of weakness, inability to walk and inability to lift arms antigravity.  At that point, she had loss of reflexes in lower extremities.  She subsequently developed respiratory failure requiring intubation.   .  She was started on IVIG for presumed GBS.
Fever of up to 102.5 for 2 days, chills, body aches, headache, weak Very swollen and red, itchy upper arm, hot to the touch. Lasted 10 days, redness still persists, as does itching.
Pts PCP called and explained that pt was behind several injections and needed total of 5 injections. Pts mother was given the VISs and I explained to pt and his mother that he would need 5 shots. Pt was brought in and he sat in a chair at the entrance because it was raining.  The first injection was given (Menactra) and he stated that he felt some tingling to his arms and hands. I inspected the injection site and then proceeded to give the next injection ( Tdap). He then stated that he could not see and that everything went black. I then called for his mother to come in. He then became very pale and stated that he could not breath. He did have a facial covering so I pulled it down and opened the door so he could get some fresh air. my co workers began fanning him with a booklet and some wet paper towels were placed on his neck and forehead.
Agency had a moderna clinic on 4/13 by another company. pt received first dose of moderna on 4/13.  Agency had a clinic on 5/13 for pfizer as a first dose sponsored by RA. the 2nd dose clinic for RA pfizer was 6/5.  pt returned to Agency clinic  on 6/5 for  her 2nd covid dose.   she did not realize that it was a pfizer clinic and not a moderna clinic.  pt received a pfizer dose on 6/5.  staff did not recognize that pt was receiving dose off cycle nor did they realize it was a different mfg.  pfizer dose was given.  it was only after pt did not match RA 2nd dose clinic that pt was out of cycle and received different MFG.  pt had no negative reaction to  pfizer dose.
TC from mom 28APR pt devel fever & a red bumpy rash on back & abd;29APR rash subsiding looks like pinpoint-t100.4;noticed a spot on shoulder;has appointment @ clinic Wednesday PM;
I have constant pain at the injection site. Comes & goes. The person might have given it to me too high on the shoulder . The pain becomes evident when I move the arm up to my shoulder.  It's now May 29.  It is the same pain as the time of the injection. The night of the injection I had terrible arm pain. I was unable to sleep the entire night. Could not lie on that shoulder. Hope this is not nerve damage.
multiple sclerosis; weak immune system; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: MULTIPLE SCLEROSIS (medically significant), outcome "unknown"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "weak immune system". Clinical course: She said that she's 63 and her husband was 65 with multiple health issues and just wanted to verify because he got an email that said that individuals aged 65 and over that have had their booster 4 months ago are eligible for a booster and moderately or severely immunocompromised which would be her. She wanted to know what the Bivalent vaccine is.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dose was not diluted before administered. Vaccinator (who is a paramedic) sat on scene with patient for about 45 minutes to watch for reactions. No adverse reaction occurred. Patient instructed to call  911 if any concerns or reactions.  Follow up by phone with patient 2 days later (3/19/21) confirmed patient had no adverse reaction associated with this dose of vaccine.   PLEASE NOTE: PATIENT DID NOT HAVE AN  ADVERSE REACTION.  WE ARE REPORTING A MEDICATION ERROR THAT DID NOT RESULT IN AN ADVERSE EVENT.
THE PATIENT WAS TO START THEIR FIRST IN THE SERIES OF THE PFIZER COVID 19VACCINE..THE MONOVALENT. PT RECEIVED THE BIVALENT AS THEIR FIRST DOSE IN THE SERIES.
Severe coughing for bout 40 seconds not being able catch my breath. Severe headache, tired nd weak.
Moderna COVID-19 Vaccine EUA  Headache, fatigue, chills, fever, body aches, hard to focus and function. Missed one day of work. Most symptoms other than a slight headache were gone in 24 hours.
Significant rash to upper body noticed within 6 hrs of receiving flu shot. Was asleep so may have had rash earlier. Took 1 week to resolve. Reported mild itching but did not seek treatment.
The patient had a headache within 5 minutes of receiving the vaccine.  The patient was monitored and her blood pressure taken three times, 5 minutes apart; the readings were 95/65 SBP/DBP, then 106/64, and finally 93/67.  The patient was counseled by a pharmacist that since her headache was not severe she was able to leave if she wanted to.  She did leave and upon follow up 6 hours later, the patient reported taking over the counter Tylenol to treat the headache that still persisted.  The patient was asked to please report back to the pharmacy if the headache persists to tomorrow.
Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; This is a spontaneous report from a contactable physician (patient). A 37-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 17:15 at single dose on her left arm for covid-19 immunization. Medical history included known allergies to penicillin. The patient had no other medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient was not received list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection on 23Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had received prednisone to treat the events. The outcome of the events was not recovered.; Sender's Comments: A possible contribution role of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of sensorineural hearing loss in left ear and headache cannot be excluded due to temporal relationship.  The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Within 24 hours developed rash size of softball in armpit of left arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: en6206), via an unspecified route of administration, administered in arm left on 11Mar2021 11:00 AM as dose 1, single for COVID-19 immunization. Patient had no known allergies. The patient relevant medical history includes have low producing thyroid and thyroid. The patient concomitant medications include levothyroxin from an unspecified start date for thyroid. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Within 24 hours that was on 12Mar2021 developed rash size of softball in armpit of left arm and still had it 4 days later. The patient did not had prior vaccination for covid. The patient did not had covid test post vaccination. The patient did not received any treatment for adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Information has been received from a licensed practical nurse concerning a 5 year old male with no medical history history or allergies who on 20-MAR-2002 was vaccinated with a 0.5mL SC dose of Varivax (lot #641267/1294L). There was no concomitant medication. On 19-SEP-2006 the patient was seen in the office with a chickenpox rash with multiple papules. He was treated with ZYRTEC and oatmeal bath. Subsequently, the patient recovered. It was reported that the patient's sister (WAES#0610USA07227) had a similar experience after vaccination with Varivax. Additional information has been requested.
I had a lot of pain and some swelling at the injection site. This lasted about 4 days. The site remained tender and slightly sore for another 5 days or so after that; 3 weeks after receiving the first dose of Gardasil 9, I had a lot of pain and some swelling at the injection site.; This spontaneous report was received from a company representative who is also the female patient of unknown age, reporting on herself. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, frequency, lot # and expiration date were not provided) for prophylaxis. Patient stated that 3 weeks after the vaccination, she had a lot of pain and some swelling at the injection site. This lasted about 4 days. The site remained tender and slightly sore for another 5 days or so after that." No additional information provided.    The reporter did not assess the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
After the first shot, I had a milder fever and bone pain. After the second shot, the bone pain became acute in the hand fingers and knees joints, especially in the morning when I woke up. After some activities and some time, the pain is relieved but never gone totally. It's almost 4 months, the symptom is still active.
I had my 2nd Moderna Vaccine on March 12th approx. 1 day later I started having a headache that continued to become worse nto realizing it was my blood pressure (BP) running high . On March 19th I took my BP at home & it was