chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SOMNOLENCE; SENSITIVE SKIN; SORE LEFT ARM; LOSS OF ENERGY; FEVER 97 - 99.1 F; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-APR-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced somnolence. On 09-APR-2021, the subject experienced sensitive skin. On 09-APR-2021, the subject experienced sore left arm. On 09-APR-2021, the subject experienced loss of energy. On 09-APR-2021, the subject experienced fever 97 - 99.1 F. Laboratory data included: Body temperature (NR: not provided) 99.1 F, 97 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensitive skin, and loss of energy on 10-APR-2021, had not recovered from sore left arm, and the outcome of somnolence and fever 97 - 99.1 F was not reported. This report was non-serious.
p/vax pt entire thigh was swollen & red (3x4 inch area) w/in 24hr p/vax & lasted 48 to 72hr;
Approximately 5 minutes after immunization with flucelvax, patient briefly fainted.  Pharmacist immediately assisted and provided an ice pack to wrist and back of neck of patient.  Patient recovered quickly and quickly recovered awareness.  Pharmacist asked if patient has ever had a problem with a vaccine in the past and patient's mother reported that she does not normally have any issues.  Patient's mother also reported that the patient did not have very much to eat at lunch.  Pharmacist provided supervision to patient for approximately 15 minutes and patient seemed back to normal as family left the pharmacy.
She had the vaccine, felt shortness of breath and fever and chills on 4/16/21.  On 4/18/21 she felt pain and discomfort on the left leg, and she had left leg DVT and bilateral pulmonary embolisms.   Left leg was found on US, and pulmonary embolism was found on 4/22/21 on CT.  She has been given Heparin drip and he does not know when she will be released.  She is having difficulty breathing, shortness of breath mainly with activity.
Patient had multiple vomiting episodes overnight following vaccination. The following day and night, the patient had fevers ranging from 99 degrees F to 104.5 degrees F with some listlessness and ragged breathing. Patient was seen in urgent care where a strep test was performed (test was negative). Patient was given alternating doses of ibuprofen and Tylenol in an attempt to control the fever. The patient was taken to the emergency room on Saturday (6/20/2015) for a fever of 104.5 and was given Tylenol with observation. The next day, on Sunday (6/62/2015) the patient's fever had broken but he began experiencing multiple diarrhea episodes which gave rise to concerns for dehydration. Patient was taken back to emergency room at around 5 or 6 pm due to no wet diapers produced during the day along with no tears when crying. Patient had fluids administered orally under the observation of the ER physician and was discharged in the same evening.
Child's temp at 103, child went into a seizure that lasted 2 and a half minutes.  Child taken to ER Motrin was given temp decreased and child had a 2nd seizure lasting just a couple of mins.
at site of injection there is   a bruise as if just administered but it has been almost 3 months since vaccination.  patient reports that it heals and then reoccurs, not fully healing. she hasn't seen a MD yet to consult what could be underlying condition.
The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  In 2012, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Later in 2012, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Hard to breathe; Itching on feet; Itching on bumps; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard to breathe), PRURITUS (Itching on feet) and PRURITUS (Itching on bumps) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS. Concomitant products included ROPINIROLE HYDROCHLORIDE (REQUIP) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (Hard to breathe), PRURITUS (Itching on feet) and PRURITUS (Itching on bumps). At the time of the report, DYSPNOEA (Hard to breathe), PRURITUS (Itching on feet) and PRURITUS (Itching on bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: followup received on 30-apr-2021:reporter contact information was added
Reaction started with severe pain in lower back, hip and upper leg on left side of the body.  Two days later blisters appeared on lower leg, ankle foot and sole of foot
Myalgia, Fever, sore throat, fatigue, injection site reaction Narrative:  Employee reports "flu-like symptoms" including sore throat, fever, body aches, and fatigue. Employee also notes left arm pain (same arm that received injection). Reports is taking Tylenol for symptoms relief and has not yet recovered as of date of this report.
Patient experienced swelling of the left side of face and mouth after vaccination.  Patient taken to ED by EMS.
his arm was swollen up to twice it's normal size; his arm was black and purple for a week; This spontaneous report was received from a 53-year-old male patient, referring to himself. The patient's pertinent medical history included mild asthma. Drug reactions/ allergies included ASA triad. Concomitant therapies included ibuprofen (ADVIL [IBUPROFEN]). His physician wanted him to have pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) every 10 years.   On a unknown date in 2005 (also reported as 16 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis and had no reaction. On an unknown date in February 2016 (also reported as 5 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, strength, route, lot# and expiration date were not provided) for prophylaxis.   On the same day, the patient had a severe reaction, his arm was swollen up to twice it's normal size and black and purple for a week. Treatment was given for the events. The patient sought medical attention. Therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was discontinued. The outcome of the events was reported as recovered/resolved.        The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
8.11.2021 c/o fever, cough, headache, sneezing and nasal  congestion x 1 day.   Cairimab/Imdev Infusion done today
Information was received from a nurse who reported that on unknown dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (lot numbers, expiration dates, dosages, and routes of administration unknown). No adverse effects reported. Excursion information: Temperature: 32 degrees Fahrenheit to 35 degrees Fahrenheit Time frame: 1 hour 40 minutes Previous temperature excursion: No Involved "data logger"? Yes No further information provided. This a one of several reports received from the same source. Telephone call attempt on 22-MAY-2017 to obtain follow-up information was unsuccessful. Follow up information has been received from the reporting nurse (also reported as a certified medical assistant (CMA)) on 12-JUN-2017. It was reported that the temperature on the refrigerator was too cold for 5 days. The minimum temperature was ranging from 34 degrees Fahrenheit to 35 degrees Fahrenheit between these days. The maximum temperature was 42 degrees Fahrenheit. And the temperature when discovered on 25-APR-2017 at 12:45 pm was 40 degrees Fahrenheit. The dating was never notified by an alarm going off as the reporter was assuming the average time the temperature was cold was no longer the 20 min for each occasion (due to delay limit on "Tempguard" system (20 min delay), it was received from the system, all excursions were 20 minutes). Refrigerator was taped that no one was allowed to use any vaccines until each manufacturer was called to make sure. The reporter called the manufacturers seeking information about use the vaccines in the refrigerator. All companies stated vaccines were okay to still be used, with exception of opened vials, which were discarded.; Sender's Comments: US-009507513-1707USA000473: US-009507513-1707USA000474: US-009507513-1704USA013562:
Patient had trouble breathing - 911 was called - epipen administered, blood pressure taken 159/109 pulse 106
This spontaneous report was received from a registered nurse referring to a 22 year old female patient with no pertinent medical history, concurrent conditions and drug reactions. On an unspecified date in November 2016, the patient was vaccinated with the first dose of GARDASIL 9 which had a lot # M041990 and expiration date on 08-JUN-2019 (dose and route of administration were not provided) for vaccination (prophylaxis). On 16-MAY-2017, the patient was vaccinated with the third dose of GARDASIL 9 in the right arm. Concomitant therapies included DEPO-PROVERA. On approximately 23-MAY-2017, (reported as one week after she received the third dose of the vaccine), the patient experienced a lump in her right arm, near the site where GARDASIL 9 was injected. The patient was seen in the office on 05-JUN-2017, for this lump which the physician assessed as a 2 cm x 1cm localized soft mass, non tender, no induration, no ecchymosis with no difficulty in mobility and with no sensory changes. The patient had not treated the area, and declined any diagnostic treatment; therefore, no lab diagnostics studies were performed. The physician diagnosed the mass, as a delayed injection site reaction to the GARDASIL 9 and she did not receive any treatment. At the reporting time, the outcome of the patient for delayed injection site reaction to the vaccine was reported as not recovered. The reporter considered delayed injection site reaction to be related to GARDASIL 9.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FT1620) at the age of 36 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 02Apr2021 as dose 2, single (Lot number: 003B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate to severe persistent asthma (viral induced)" (unspecified if ongoing), notes: Moderate to severe persistent asthma, (viral induced); "post-viral gastroparesis" (unspecified if ongoing), notes: post-viral gastroparesis; "psoriasis" (unspecified if ongoing); "eczema" (unspecified if ongoing); "longhaul COVID from 2020 with neurological dysfunction", start date: 2020 (unspecified if ongoing), notes: longhaul COVID from 2020 with neurological dysfunction; "longhaul COVID from 2020 with neurological dysfunction", start date: 2020 (unspecified if ongoing), notes: longhaul COVID from 2020 with, neurological dysfunction; "concussion with double vision" (unspecified if ongoing), notes: concussion with double vision and neck/back injury; "concussion with double vision" (unspecified if ongoing), notes: concussion with double vision and neck/back injury; "neck/back injury" (unspecified if ongoing), notes: neck/back injury; "neck/back injury" (unspecified if ongoing), notes: neck/back injury; "Sulfa drugs" (unspecified if ongoing), notes: known allergies Sulfa drugs, latex; "latex" (unspecified if ongoing), notes: known allergies Sulfa drugs, latex. Concomitant medication(s) included: DULERA, start date: Nov2020; SPIRIVA RESPIMAT, start date: Mar2021; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; AZELASTINE; DUONEB, start date: 05Apr2022; ALBUTEROL [SALBUTAMOL]; ALEVE, start date: 05Apr2022; MELOXICAM, start date: 08Feb2022; BENADRYL, start date: 06Apr2022; SUPER B COMPLEX WITH VITAMIN C, start date: 05Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Liver function test: in normal range, notes: before Paxlovid; Renal function test: in normal range, notes: before Paxlovid; Weight: 6 lbs, notes: loss (5%). Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Had pain in her arm at first; Now has severe bloating and pain; Now has severe bloating and pain; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) and another consumer (patient's husband) reported that a 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) at the age of 73-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first covid vaccine shot. Had pain in her arm at first. Now had severe bloating and pain. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Significant very difficult to control bleeding with a very minor procedure. 3 hours of pressure required to control his bleeding.  Pt has received a testosterone pellet insert every 4 months since 2014. This involves a very small incision in the upper lateral buttocks. He has never had any complications or bleeding from prior insertions. He occasionally takes a Motrin and had taken one the night before; however nothing that could explain this uncontrollable  bleeding other than the fact that he had a Moderna vaccine series completed 1-2 months prior.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age and race received PREVNAR 13 at single dose on unknown date for immunization. Relevant medical history and concomitant medication  were not reported. On unknown date the patient experienced significant swelling and pain. The outcome of the events was unknown.
arm pain in her left are from her shoulder down to her wrist; arm pain in her left are from her shoulder down to her wrist; arm pain in her left are from her shoulder down to her wrist/it's getting worse; She did not get any sleep last night because of this pain; This is a spontaneous report from a contactable consumer (patient).  A 89-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unknown route, administered in the right arm on 30Mar2021 as dose 1, single (at the age of 89 years old) for COVID-19 immunization. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unknown route, administered in the Arm right on 20Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Apr2021, the patient experienced that she was having arm pain in her left area from her shoulder down to her wrist, since she received the 1st dose, and it's getting worse, and did not get any sleep last night because of this pain. The outcome of the event arm pain in her left are from her shoulder down to her wrist was not recovered; outcome of the event arm pain in her left are from her shoulder down to her wrist/it's getting worse, and insomnia was unknown. Treatment was received for the events arm pain in her left are from her shoulder down to her wrist and arm pain in her left are from her shoulder down to her wrist/it's getting worse.    This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected  Follow-up (21Apr2021): New information received from a contactable consumer: Event (insomnia), vaccination date (30Mar2021), anatomical location (right arm), onset event date (18Apr2021),   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pain; flu-like symptoms; palpitation; arm muscle was really sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (flu-like symptoms), PALPITATIONS (palpitation) and MYALGIA (arm muscle was really sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021321A and 040821A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VALSARTAN, VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (flu-like symptoms), PALPITATIONS (palpitation) and MYALGIA (arm muscle was really sore). At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (flu-like symptoms), PALPITATIONS (palpitation) and MYALGIA (arm muscle was really sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications include Tylenol and Advil.   This case was linked to (E2B Linked Report).; Sender's Comments:
This spontaneous report was received from a pharmacist concerning an approximately 73 year old female patient who on 19-SEP-2014, was vaccinated with a dose of ZOSTAVAX (batch and lot No. K003595, exp. 07-FEB-2015), 0.65 ml, subcutaneous in the left arm for vaccination. Concomitant therapies included MICARDIS, PEPCID, ATIVAN, LASIX, vitamin D and METAMINE. In September 2014 the patient called the pharmacist to report that she had 2 red, itchy spots at the injection site of her left arm. No treatment was received. The outcome of she has 2 red, itchy spots at the injection site of her left arm was reported as not recovered. Relationship between 2 red spots at injection site and therapy with ZOSTAVAX was not reported. Additional information is not expected since pharmacist did not give consent for follow up.
Chills! Fever, headache, lots of muscle pain,  nausea, dizziness. Most gone by 10 pm the next night. Headache lasted two days. I still have pain and inflammation at the injection site.
Patient experienced tightening of the throat area, was concerned and was close to a fire department, where he entered and was given help. They called ambulance that transferred him to the emergency room. He was given a steroid to help control the reaction. Patient came into store with wife who had gotten a SHINGRIX to buy BENADRYL as precautionary.
Headache, Myalgia, Fever, Nauseavomiting, chills, sorenees right arm at injection site, sore throat Narrative:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "former throat cancer" (unspecified if ongoing); "Squamous cell carcinoma (SCC)", start date: 2013 (unspecified if ongoing), notes: 10 years ago. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had received the treatment of COVID-19 as Paxlovid on 16Sep2023 to 20Sep2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300310711 same patient, different drug/AE;
Information has been received from a nurse practitioner via a company representative concerning a 15 year old male patient. The patient had no medical history and no drug reactions/allergies. On 09-JUN-2015 the patient was vaccinated with his first dose of GARDASIL (dose and lot # were not reported, intramuscular). On 09-JUN-2015, a few minutes after receiving the injection, the patient experienced an itching in his throat, anxiety, and difficulty breathing. The nurse practitioner administered oxygen to the patient and took his vital signs which were normal, except his heart was racing, but his oxygen level was fine. The patient, accompanied by his mother, went to the emergency room where he was not admitted, but treated with oral BENADRYL and his symptoms were improved. The patient would be following up with an allergist. The reporter considered the events to be medical significant. Additional information has been requested.