chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; she's feeling down; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 as dose number unknown , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she's feeling down". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Increased seizure activity and parasthesia in both arms. Seizure activity has lessened but parasthesia has remained constant since injection.
Decrease in hearing with loud pop on 4th day after booster resulting in total loss of hearing in left year, 40% loss in right year.
Information has been received from a pharmacist concerning a 94 year old female who on 04-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On 06-OCT-2007 the patient developed injection site itching and a 2 inch area of redness at the injection site. No further information was provided. Additional information is not expected.
Patient was administered Quadracel vaccine in error. Verbal order was given by the provider. Patient should have received DTap only per vaccine schedule.
Fever started just after midnight and was around 101.5.  She also complained of headache.  I gave Motrin and the fever and headache subsided.  She continued to have a fever for 24 hours but it resolved with Motrin each time.
patient present for well child exam- there was a vaccine administration error and he received 2 doses of Varicella and Proquad on accident in different legs at the same visit at the same time (MMR and Varicella were ordered to be given separately)   the patient has had no known adverse effects, but my question is regarding the risks/what to watch for if he received 2 doses of varicella at the same time.
Patient reports severe pain in the left arm where the vaccine was administered.  She called the pharmacy two days after the injected and said her arm was very sore and was instructed to try an OTC analgesic and ice to ease the pain.  She followed up a few days later with her primary care physician who instructed her to wait a few more days to see if the pain goes away.  The patient then proceeds to see an orthopedic doctor who sent her for physical therapy.  The customer then said she couldn't afford the therapy and went back to the orthopedic for an injection into the shoulder (sometime in February 2019).  The pain went away almost immediately after that injection but came back a few weeks later.  The patient then went back to the orthopedic doctor who ordered an ultrasound and gave yet another injection.  The orthopedic doctor said there was a bruise from an injection found upon an ultrasound.
I had a semi-circular reddish rash about  3 inches below my injection site that lasted two weeks. My arm was very swollen and fairly tender.  I also had a fever that lasted four days and ranged from 99 to 102. ( my usual afternoon temp is approximately  96 -97). I also experienced chills, body aches and a throbbing headache for the four days. I didn?t take any meds until the evening of the fourth day, when I took Aleve. Most symptoms were gone the next morning although I remained tired and a little sore for the next day or so.
Case number PHEH2014US018326, is an initial spontaneous report from a pharmacist received on 10 SEP 2014. This report refers to a 92-year-old male patient. Past medical history and concomitant medications were not reported. On 09 SEP 2014, the patient received 5 ml dose of FLUVIRIN 2014/2015 (batch number: 1411201) intramuscularly instead of 0.5 ml dose. No adverse events were reported following the maladministration. No additional information was available.
October 7,  2021 ; 39 year old male patient received his second Covid 19 vaccine, Pfizer. Pt states he started having symptoms of nausea, and dizziness,  after 10 minutes of receiving the vaccine. Pt states he felt nauseas during his 1st dose for the first two hours but it went away afterwards.. Pt's vitals were: 109/74 ; 62 Hr ; 16 RR ; 97 SPO2 at 1538 and another set of VS were taken at 1553 with results of 117/81 ; 63 HR ; 99 SP02. Pt refused ER transport. Pt did not receive EPI
This spontaneous report was received from a pharmacist and refers to a 83 year old male patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On 08-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L033311, expiration date 01-DEC-2016), dose: 0.65 ml, administered subcutaneously. Post the vaccination, the patient advised pharmacist that, on an unspecified time in the past (reported as "years ago"), he received an earlier dose of ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) (extra dose administered). Concomitant therapy was not provided. No adverse effect was reported. Additional information has been requested.
About 3-4 hrs. after 2nd Covid vaccine, sore arm. Next day:  sore arm, bones ached, injection site pain and swelling, muscle and joint pain, feeling unwell
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Since 25-JUN-2015 the patients were vaccinated with GARDASIL (dose and route of administration were not reported; lot # K008931 with exp. date: 04-JUL-2017, lot # K005881 with exp. date: 14-JAN-2017, lot # K006960 with exp. date: 19-FEB-2017, lot #K004205 with exp. date: 12-JAN-2017) which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
No additional AE or PQC reported.; ROTATEQ was administered after a temperature excursion. Temperature: 10.8C Time frame: 4 hours 12 minutes 0 seconds; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not provided.   On 13-JUL-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot number 1837116 has been verified to be a valid lot number with expiration date on 24-MAR-2023 (dose, strength, route of administration, anatomical injection site and frequency were not reported), administered for prophylaxis, that underwent a temperature excursion of 10.8 Celsius degrees for 4 hours and 12 minutes (improper storage of product in use). There was no previous temperature excursion. No additional adverse events were reported.
dose administered after excursion; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered after excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered after excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered after excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Treatment information was not reported  On 24-May-2022 Case became invalid because multiple patient case.
complete exhaustion, went to bed woke up 2 hours later with severe HA and nausea.  slept fitfully despite Tylenol and awoke hurting all over and with HA which has continued all day.  Arm was sore as expected.  28 hours after the vaccine finally starting to feel better
10 min after immun began sneezing and coughing then developed all over hives, given 0.5cc epinephrine SC, given 7.5ml oral Benadryl, still c/o hives, face red, sent via ambulance to ER for further treatment and observation.
Patient tested positive yesterday via home Covid test.  Now having worsening shortness of breath.  Has a cough.  Chest pain with cough and deep breath only
Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster) 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 assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administering 0.25 ml instead of 0.5 ml to uncompromised adults/approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster).    No concomitant medications were reported.   It was reported that, nurses had no standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster.  No treatment details were reported.
I started with a scratchy throat, headache, body aches, and then the next day I still had the headaches, sore throat, cough, loss of appetite, no taste of smell. I contacted my doctor on Monday and she put me on PAXLOVID. I started taking that on the 9th of August for five days twice a day. I tested positive at home for 11 days straight.
Developed fatigue 5 weeks after 2nd Pfizer vaccine and shingles 7 weeks after vaccine.  Was healthy, low stress, and fully immunized (Shingrix) against shingles 3 years previously.  Shingles was on left upper thigh,  buttocks and genital area.
Pain in the arm of  injection that lasted for 2 days  and 1 week later armpit pain which is still hurting as of 1/7. Can't feel any swelling of lymph nodes. This also occurred in the arm of injection
Felt bad; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical hstory is provided.    On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (Felt bad) and CHILLS (Chills). At the time of the report, FEELING ABNORMAL (Felt bad) and CHILLS (Chills) had resolved.            No treatment medication were provided.   This case was linked to MOD-2021-013381 (Patient Link).
My arm at injection site is much more sore than previous injections.; armpit is EXTREMELY sore; chest is tight on the same side (left) where the injection was given.; chest does not hurt as much; booster; a little more tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 14:15 (Lot number: FF8841) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Diabetes (unspecified if ongoing); depression (unspecified if ongoing); anxiety (unspecified if ongoing); ADHD (unspecified if ongoing). Concomitant medication(s) included CELEXA; TRULICITY; SYNJARDY; BUPROPION. Past drug history included Codine, Drug Allergy. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Reaction: arm at injection site is much more sore than previous injections), administration date: 22Mar2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s) included arm at injection site is much more sore than previous injections; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0612, Location of injection Arm Left. The Reaction included arm at injection site is much more sore than previous injections, administration date: 15Apr2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 18Nov2021 14:15, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome not recovered; AXILLARY PAIN (non-serious) with onset 19Nov2021, outcome not recovered; CHEST DISCOMFORT (non-serious) with onset 19Nov2021, outcome recovering; FATIGUE (non-serious) with onset 18Nov2021, outcome recovering; CHEST PAIN (non-serious) with onset 19Nov2021, outcome recovering. Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, chest discomfort, fatigue, and chest pain.  Patient arm at injection site is much more sore than previous injections. Her armpit is extremely sore and chest is tight on the same side (left) where the injection was given. The same day after receiving the shot, she had no pain. She was a little more tired than usual. The next day, her chest was tight, and armpit hurt real bad. Today is day 3 and still have armpit pain and pain at the injection site, chest does not hurt as much. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Fatigue onset was same day as the vaccination, while other events onset latency was 9 hours 45 minutes.  Follow-up attempts are completed. No further information is expected.
anxiety; flushing; missed dose; red cheeks; swollen cheeks; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), FLUSHING (flushing), ERYTHEMA (red cheeks), SWELLING FACE (swollen cheeks) and PRODUCT DOSE OMISSION ISSUE (missed dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Stenosis (spin,neck), Arthritis and Dermal filler injection. Concurrent medical conditions included Drug allergy (Bactrim, Ceclor,cipro,), Penicillin allergy, Tetanus immunisation, Coronary artery disease, Bee sting (Bees) and Hay fever. Concomitant products included ATORVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Coronary artery disease, LISINOPRIL, METOPROLOL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PROBIOTICS NOS (PROBIOTICS) for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced ERYTHEMA (red cheeks) and SWELLING FACE (swollen cheeks). On an unknown date, the patient experienced ANXIETY (anxiety), FLUSHING (flushing) and PRODUCT DOSE OMISSION ISSUE (missed dose). On 23-Jan-2021, ERYTHEMA (red cheeks) and SWELLING FACE (swollen cheeks) had resolved. At the time of the report, ANXIETY (anxiety), FLUSHING (flushing) and PRODUCT DOSE OMISSION ISSUE (missed dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) pulse and B. P were elevated. On an unknown date, Electrocardiogram: normal normal (normal) normal. On an unknown date, Heart rate: increased (High) pulse and B. P were elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was received by the patient   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: significant follow up includes patient other relevant history and events added flushing and anxiety and lab data was added. On 02-Aug-2021: Non-Significant follow up appended On 02-Aug-2021: Non significant follow up patients image was added
pt had a sz about 5min p/vax x1min & then seemed fine;p/about 5min pt begin to have resp distress;epi given & emergency assist summoned;pt transported to hosp for eval;8OCT pt reported had been given DIlatin for sz & discharged;was better;
Patient's lips, toes and fingers turned white in color and had tonic-clonic seizure lasting approximately 20-30 seconds.
p/vax pt devel severe vomiting & weight loss (6/15/99-15lb 6oz, 8/10/99-13lb 10oz);hosp for 3day w/neg GI work up; except devel of GERD at 6 mon (?)
Bruising, low platelets. Diagnosed with ITP (Immune Thrombocytopenic Purpura). Information from 60 day follow up letter states child continues treatment for low platelets. Has to wear a helmet due to bruising very easily.
This spontaneous reprot has been received from a registered nurse referring to a patient of unknown gender and age. No concurrent or medical history was reported. On 29-MAY-2015 the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) dose, route, frequency and anatomical location were unknown (lot number reported as J013278). No adverse event was reported. No further information was provided. No product quality complaint was reported. Lot number J013278 is an invalid lot number for VARIVAX (Merck). This is one of two cases received from the same source (#MARRS 1506USA012931). Additional information has been requested.
Sore arm; his heart rate is going up; This is a spontaneous report from Pfizer Sponsored Program COVAX US Support via a contactable consumer (parent) reported for her son. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced sore arm and his heart rate was going up. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Erythema, pain at injection site (right deltoid), and nausea on and off with chills.
This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 59-year-old female patient who received BOOSTRIX (batch number 43MP2, expiry date 15th August 2017). On 29th June 2016, the patient received BOOSTRIX .5 ml. On 30th June 2016, 1 days after receiving BOOSTRIX, the patient experienced generalized pruritus, injection site hives, hives and rash. The patient was treated with CLARITIN. On an unknown date, the outcome of the generalized pruritus, injection site hives, hives and rash were unknown. It was unknown if the reporter considered the generalized pruritus, injection site hives, hives and rash to be related to BOOSTRIX. Additional details were provided as follows: This case was previously reported to a manufacturer. No other vaccines were administered on the same day or 4 weeks prior to the suspect vaccine. On 29th June 2016, at 12 pm, the patient received a dose of BOOSTRIX in her right deltoid and the next day after receiving BOOSTRIX, she started itching everywhere on her body. She also experienced a rash of about an inch and half in diameter on her right breast and hives on the right hip and right upper arm. The itching was treated with CLARITIN. On 1st July 2016, the patient called the pharmacist to report the adverse events.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: Strawberries, kiwi. The patient's concomitant medications were not reported. Past drug history included: Cipro, reaction(s): "Allergy:Cipro". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID Treatment). No follow-up attempts are possible. No further information is expected.
Swollen lymph nodes under left armpit were severely inflamed when I woke up on Saturday 2/06/2021. 1-2 days later I had severe pain on my Left back- ended up being my brachial plexus nerve. Few days after that I developed numbness and weakness on my left side and pins and needles in my Left index finger. I saw my primary care doctor twice that week. He started me on low dose Prednisone and gabapentin for the pain while sleeping. When the nerve pain/numbness did not subside, I asked for a neurology referral. Two doctors saw me for brachial plexus neuritis. I have had 2 ultrasound guided and one fluoro guided cortisone shots along the nerve. I have also been going to PT 2-3 x/week to regain my strength on the Left side & calm nerve.
One week after vaccination, erythema, tenderness, swelling still present at site of Td injection. Sought evaluation by private MD, given prescription for Keflex, Anaprox and samples of Zyrtec. Client had not used any analgesic, antipyretics or cold medication post vaccination.
Dizziness on 8/30 / 21 a few hours after the vax  Headache on 8/31/21
8 hours after Pediarix and HIB pt was crank & crying. Tylenol was given around the clock by pt. (? Fever) crying stopped after 1 1/2 days. Child is fine today & happy.
Patient was 11 years old at the time of Vaccination. Patient is below FDA approved age for the Pfizer Vaccine. Parents
pt cried for several hrs following vax then had episode off floppiness & pallor lasting apparently breifly; seen by MD;
Metallic taste in mouth after 10 minutes of receiving injection.  Left arm axillary lymph node swelling that began the day after vaccination. The swelling persist, it is day 4 today.