chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a consumer (patient) on 11-Dec-2017. This case involves a 54-year-old female patient who was vaccinated once with 0.5 ml dose of FLUZONE QUADRIVALENT (batch number, expiration date, dose in series and site of administration were not reported) intramuscularly on 12-Aug-2017. Medical history included hypothyroid, depression, Multiple sclerosis (MS). Patient is allergic to SEPTRA, environmental allergies. Concomitant medications was not reported. On unknown date, one day following the vaccination, the patient had developed tenderness at the injection site and in the axillary area, patient stated the pain was increased when lifting her arm up. She states that today (date not reported) there was some improvement and it does not hurt as much as before. Laboratory investigations and corrective treatment were not reported. Outcome of the events were reported as recovering. List of documents held by sender: none.
Left facial palsy; Left facial palsy; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (Lot Number: Ew0173), via an unspecified route of administration, administered in left arm on 03May2021 10:15 (at the age of 25-year-old) as single dose for COVID-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included left facial palsy in 2017. The patient had no known allergies. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: Ew0158), administered in left arm on 12Apr2021 09:00 (at the age of 25-year-old) as single dose for COVID-19 immunization. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced left facial palsy on 07May2021 11:30. The event resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab, SARS CoV2 test (qRT pcr assay) on 07May2021 with negative result.  Therapeutic measures were taken as a result of the event which included Prednisone 60mg taper for 12 days. The outcome of the event was not recovered.    No follow-up attempts are needed. No further information is expected.
Chills, fever, ache, sore eyes, cough, runny nose, productive cough.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. There was no information about patients' concomitant medications and pertinent medical history reported. On an unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX lot # L017142, expiry date 13-MAY-2017 (routes and sites of administration, dose were not reported). No adverse effects were reported. Follow-up information was received on 07-DEC-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow-up information has been received on 08-DEC-2015 from the reporting nurse. She reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. Follow up information has been received from nurse on 14-DEC-2015. This case concerns a 16 year old patient. On 11-SEP-2015, the patient was vaccinated with VARIVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Chills; Fever; Diarrhea; This is a spontaneous report from a contactable nurse (patient). A 34-year-old male patient received the second dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient experienced fever, chills, and diarrhea on 12Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
At 1:25pm patient reported that she felt slight itching (on-and-off) mostly occurring on upper extremities. V/S monitored - BP 117/91, P-85, RR-17, 02 Sat 98% RA Patient given oral Bendryl 25mg. No shortness of breath noted, no coughing or throat itching. No redness on skin (hives) noted. Patient reported less itching after taking Benadryl. Advised patient to see help from physician is symptoms worsen. Vital signs BP 118/89, RR-17, P-85, 02 Sat 98% RA
PT called to hospital today 01/26/21 reporting 2 hours after vaccine developed HA, Throat  and jaw discomfort, denied SOB, called 919 . Pain subsided at that time and she did not seek ER care, but called reporting "severe side effects"
he was given a Moderna bivalent booster instead of the primary second dose.; accidentally gave booster the first time around; Extra dose administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (he was given a Moderna bivalent booster instead of the primary second dose.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally gave booster the first time around), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Jan-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (he was given a Moderna bivalent booster instead of the primary second dose.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally gave booster the first time around), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (he was given a Moderna bivalent booster instead of the primary second dose.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally gave booster the first time around), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (he was given a Moderna bivalent booster instead of the primary second dose.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (accidentally gave booster the first time around) and EXTRA DOSE ADMINISTERED (Extra dose administered).    Patient was accidentally given booster the first time around. Patient wanted to know what was the time frame to receive primary series. Patient got booster on December 28th. Patient first primary series was given on 03 Jan. Patient received booster before primary series doses. The medical assistant stated patient was given the bivalent booster instead of the primary series. On 31-Jan-2023, patient was given a moderna bivalent booster instead of the primary second dose. He states that the patient has not reported any side effects. No concomitant medication were reported. No treatment medication were reported.
My COVID-19 infection started on 12/01/2022 in the morning. I had headaches, cough, and runny nose. I tested with a COVID-19 home test in the afternoon which was positive. I did a telehealth with my doctor's assistant who then prescribed me with PAXLOVID for 5 days. I had a mild COVID-19 case. After 1 week of finishing the medication, I did a COVID-19 home test again which negative.
Starting 11/27/2022, I got really sick after eating yogurt. I was nauseous and broke out in a sweat with chills, lightheadedness and felt ill. I was sick the next day and my nose started running, and I had developed a cough. This kept getting worse. By Tuesday, I could still only stomach some food. I was nauseous and slept all day that day. I developed a temp of 100 on Tuesday. I went to the doctor on Wednesday but didn't have a temp and the fever came back that evening. I started the PAXLOVID on 12/01/2022 and the fever reduced pretty quickly. I started feeling better pretty quickly as well. I had a bad taste in my mouth the entire time. The headache went away the first day I started it. The virus had gotten into my chest prior to seeing the doctor. I got MUCINEX for my cough and, to this day, I still have a mild cough. I was told to take baby aspirin every day for 2 weeks to prevent blood clots in the lungs (which had been prevalent in the strain of the virus that was in my area). To this day, the nausea and faintness is still intermittent.
A report has been received from a Health Professional concerning a 32 year old, Female subject, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters unknown for influenza prevention. FLUMIST Quadrivalent (Intranasal) started on an unknown date for Influenza Prevention. It was reported that the patient FLUMIST inadvertently administered to pregnant patient in her first trimester. FLUMIST Quadrivalent (Intranasal) was continued. The outcome of the event of administered FLUMIST to pregnant patient was unknown. The report was considered to be non-serious.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia and pruritus. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia and pruritus were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and pruritus to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient got vaccinated with shingles vaccine and got the shingles probably 3 to 4 years ago and still had the nerve pain and itch at the time of reporting. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were not provided.
Initial Fever, headache, body aches.  Then rash, blisters, shingles, chicken pox mixture on my face,  chin, chest breast, legs, arms and continues to spread as of today.  I went to urgent care, and the emergency room.  I was given vistaril, Valcyclovir, an anitbiotic, and steriods
Tired; Body was in pain; Felt shaky; A hard time breathing; She felt weak; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer-sponsored company. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24May2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, she got the 1st dose of the vaccine last 24May2021 and she had symptoms like heart rate, she felt weak and tired and her body was in pain and felt shaky and was having a hard time breathing on an unknown date. She would be getting the 2nd dose on the 17June. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Information has been received from a physician concerning his wife who on 27 Nov 2006 was vaccinated with a dose of Zostavax. Concomitant vaccination on the same day included a dose of influenza virus vaccine (unspecified) and a dose of Pneumovax (MSD). On 29 Nov 2006, 48 hours later, the patient developed a low grade fever (100.5) and pain at the Zostavax injection site with the appearance of local vesicles at injection site which have persisted for 24 hours. She was taking nonsteroidal anti-inflammatory drugs for the pain and fever without complete relief. As of 04 Dec 2006, she was doing better. The vesicular lesions were healing and the injection site pain in "both arms" was less severe. No further information is available.
Pt vaccinated with Engerix-B developed joint pain, which lasted 6 weeks.  On 1/3/90, developed Bell's palsy. Missed 4 months of work. Contines to have mild drooping of the rt side.
This spontaneous report was received from a pharmacist referring to unspecified number of patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. The reporter stated that her coworkers often give PNEUMOVAX23 on the same day as ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA005475: US-009507513-1612USA005476: US-009507513-1612USA004758: US-009507513-1612USA005474:
Within 5 minutes of administering the flulaval vaccine, patient developed a red, itchy rash around injection site. She denies ever feeling her throat swell up and any difficulty breathing. Patient waited in pharmacy for 15 minutes for monitoring. Her blood pressure was measured and recorded at 101/81 mm Hg and HR of 77 bpm.  After 15 minutes, rash started to subside. Patient walk around grocery store attached to pharmacy for a bit and told staff she was fine. No medications were administered, but patient was offered an ice pack which she denied. Patient was instructed to take an oral antihistamine (Zyrtec) when she got home.
About 10 hours after shot, my whole upper arm was swollen and VERY tender.  I could not lay on it when I slept.  If I tried to in my sleep the pain would awaken me. The next day after my shot at about 10 AM I began to feel wonky (dizzy) and tired.  For the entire rest of the day I had to literally lay around which is unusual for me as I'm very active. I was too tired to do anything--extreme fatigue. The night was the worst.  I had a fever and sweats and  horrible  dry mouth.  I woke up about 3 times an hour throughout the night because of the dry mouth and had to drink water.  I drank three 16 fl oz bottles of water.  I had to urinated 5 times in the night. [normal for me is I never wake to urinate.   I go to bed about 11 pm and wake up at 7.  Today I feel normal except my arm is still tender from the shot.
sore throat; nonproductive cough; fever; chills; body aches, diarreha starting on 9/15/21
Approximately 10 sec after administering immuns L arm developed erythema and wheel, then 1cc size at injection site (ProQuad). Injection site on Rt leg (Prevnar) and L leg (Hep A) developed sm area erythema. Benadryl 1 1/2 tsp given, cool compressed applied. FU PC with mother, reported all symptoms resolved in 25 minutes.
notice a rash on her left hand; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via unspecified route of administration on left arm on 05Jan2021 at single dose for Covid. The relevant medical history and concomitant medications were reported as none. The patient stated that she just got the first shot of COVID vaccine and noticed a rash on her left hand. She stated that it was the same arm that she got the shot. She wanted to know if there was anything that she needed to do. She stated that she got it through the state as a healthcare worker. She stated that she noticed the rash 20 minutes prior to the report. The patient had no treatment for the event. The patient was tested for COVID the week prior the report in Dec2020 and it was negative. She was going in at the time of the report to get another COVID test. The outcome of the event was not recovered.
Information has been received from a physician concerning a 16 year old female patient with no pertinent medical history who in June 2008, was vaccinated with her first dose of GARDASIL. In July 2009, the patient received her second dose of GARDASIL. Concomitant vaccination in July 2009 included HAVRIX. The reporter stated that two days post vaccination the patient "passed out" while she was at a friend's house. The physician also reported that the patient recovered that day and was doing fine at the time of the report, but the physician did not know if the patient was going to receive the third dose of GARDASIL. The physician stated the patient was not pregnant. The patient sought unspecified medical attention. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was septic shock,
PATIENT EXPERIENCED EXTREME PAIN IN SHOULDER JOINT AREA, LARGE AMOUNT OF FLUID IN JOINT. SHE WAS SEEN BY NUMEROUS PHYSICIANS WHICH RESULTED IN X-RAY, MRI, REMOVAL OF FLUID IN THE JOINT. THE PAIN STARTED JUST AFTER THE INJECTION AND CONTINUED TO GET WORSE THROUGH THE NIGHT.
Within 6 hrs of admin- onset of fever and headache.    Both symptoms continued for 18 days.  Resulting in need for hospitalization for Tylenol overdose, sepsis work up.   Resulting DX viral meningitis although not totally confirmed by testing.  Symptoms of headaches and neck pain still continue for 22 days currently.   Fever has stayed resolved state.
IT WAS A MANAGEMENT ERROR. A MODERN DOSE WAS ADMINISTERED AND THE PATIENT WAS UNDER 18 YEARS OLD.  THE PATIENT DID NOT PRESENT ANY ADVERSE EFFECT
pt recvd vax; 3 hrs p/ vax, suffered apnea episode, became pale & listless; to er; adm to hosp; discharged 29dec on apnea monitor;
itching/itches; swelling; rashes; Covid arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administration date 25Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Cancer treatment, start date: 2015, stop date: 2015, for Cancer treatment, reaction(s): "Immunotherapy Colitis". Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itching/itches"; SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling"; RASH (non-serious) with onset 2021, outcome "unknown", described as "rashes"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Covid arm".  Additional information: He sent a note to his PCP (Primary Care Physician) and is going to see him tomorrow. He was also looking at the CDC (Centers for Disease Control and Prevention) website and they mentioned dealing with problems he experienced, like Covid arm. He thought he would talk to Pfizer because he does not know what he can do and is looking for suggestions. He suspects they might not know all of the side effects, since this is a learning curve. He is looking to see what his options are and what he can do. Caller was advised to consult with his primary care physician for any medical advice and was advised to consult with the Medical Information department for any questions about the vaccine. He states that he does not have questions about the Pfizer vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tonic clonic sz activity last 1hr;no fever or other problems;no cyanosis, cardiovascular compromise 8NOV98 4-5PM;
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  RX Number.
This spontaneous report as received from a registered nurse refers to a 13 year old patient (unspecified gender). On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and rout were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
7/25/05 Right eye red, watery - vision blurred - no trauma - referred to Ophthalmology. Admitted to hospital. Diagnosed with Optic neuritis on 7/28/05. Treated with IV steroids and antibiotics.
48 hours post vaccination chills with fever 102 degrees (fever lasted 24 hours/and red rash covering entire neck (rash lasted 24 hours).  Child recovered after 24 hours.  Mom did not bring child for Dr to see rash.
Tiny pinpoint pimple looking raised bumps above elbows, shoulder, chest, and back of neck. Once discovered Benadryl  25mg was taken at 8:30 PM, and then a 2nd dose taken at 10:30 pm. Client then went to bed and did not wake up with bumps. Woke up feeling flu like symptoms Friday morning, nausea, muscle aches, headache, increased heart rate. Client does have history of migraines and anxiety which cause her heart to race. Sunday morning started with fever, cough, diarrhea, and runny nose.
Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the radio announcer was talking about the pain he had with his Shingrix shot. This case linked with US2019AMR078115, reported by same reporter.
Approx. on 7/6/12 Itching & burning to left mid abdomen radiating to back. On 7/8/12 redness to same area and on 7/9/12 vesicles to left mid abdomen and left mid back. No treatment.
Full body aches, nausea, vomiting, diarrhea, maculopapular rash of face
7/27/2021: patient presents with weakness x 4 days. Tested positive for COVID 2 weeks prior. was asymptomatic until 4 days ago. Diagnosed with: COVID-19 pneumonia, acute hypoxic respiratory failure Note: patient previously received the Pfizer COVID-19 vaccine; 2nd dose in March 2021.  7/31/2021: patient discharged.