chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash all over her body; This spontaneous case was received on 23-Oct-2020 from other health professional via Med Communications (reference number: SEQW20-04173) and concerned a female patient of unreported age.   The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad (TIV), the patient developed rash all over her body.  The outcome of rash was not reported.  The reporter did not provide a causality assessment.  Company comment: The event of 'rash all over' is assessed as related to Fluad (TIV).; Sender's Comments: The event of 'rash all over' is assessed as related to Fluad (TIV).
Documentation shows patient to have received the Pfizer two dose series - 2/25/21 & 3/18/21.  Patient has not received a booster.  Unable to provide the lot numbers for received vaccines.  Unable to obtain information for requested information not included in this report.   Patient presents to ED following a fall from bed to floor.  Patient has been feeling very weak w/ a mild cough.  Attempt to raise out of bed produced dizziness = fall.  New onset a-fib w/ RVR admitting diagnosis.  No other S/S r/t Covid-19 infection.
Muscles spasms causing stiff painful joints, more severe on left side of body.  Predominantly neck, shoulders and hips . Massage helps slightly to be able to start moving. Standing, walking or lifting 5 lbs or more increases pain and triggers spasms. Can only walk 10-15 steps at a time.
slight heart palpitations; stress; This is a spontaneous report from a contactable consumer (Patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection,), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date in 2021, after her first dose patient experience slight heart palpitations that only lasted briefly and then she stated, but that could have been stress. The outcome of the event palpitations was recovered, and outcome of the event stress was unknown.
Patient presented to the ER for nausea and vomiting, found to have Covid-19, hypoxic and requiring oxygen initially.  Patient started on steroids, abx, IV fluids and anti-nausea medications. At discharge, patient was on room air with no oxygen needs.
The evening after receiving the high dose influenza vaccine the patient report suffering the following symptoms: fever, chills, sweating, itching, swollen/sore throat, swollen ears, headache, pain in joints, pain in hands. patient says she phone her physician and has an appointment for next week.
Foot heaviness, pain infrequently in right and left pain. rotating pain in the body ( abdominal, leg, arm). Dizziness for 5-6 hours on 04/12/2021. It subsided afterwards. Breathlessness for 3-4 days.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 82-year-old female patient who received SHINGRIX. The patient's past medical history included back surgery (has rods and screws in her back). Concomitant products included simvastatin, lisinopril and PROCARDIA. On 10th April 2018, the patient received the 1st dose of SHINGRIX. On 12th April 2018, 2 days after receiving SHINGRIX, the patient experienced fever and chills. On 14th April 2018, the patient experienced vomiting. In April 2018, the patient experienced dizziness and headache. In May 2018, the patient experienced back pain. On an unknown date, the patient experienced activities of daily living impaired. The patient was treated with Meclizine and NOS Steroids. On an unknown date, the outcome of the fever, chills and vomiting were recovered/resolved and the outcome of the back pain, dizziness and headache were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown. It was unknown if the reporter considered the fever, back pain, dizziness, headache, chills, vomiting and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: In the morning, the patient received SHINGRIX on left arm. Four days after receiving SHINGRIX, the patient started to vomit at 11:00 at night, which lasted until 3:00 am the next morning. The dizziness and headache started at end of April (less than a month after vaccination). The dizziness had improved but it was still slightly present. The headache was on the top of the patient's head. On 5th May 2018, the patient had a steroid shot to help relieve symptoms and was prescribed meclizine and that did not work. The patient also had Magnetic resonance imaging (MRI) in the week before reporting and other tests were done a day before reporting and the test results were clean. There was no presence of crystals in her ears. The patient was not hospitalized due to the symptoms. The patient said she was immobilized by them because she could not got out and could not get her regular physical therapy treatments and exercise her back hurts.
pt recvd vax & w/in 5 mins of inj pt devel dizziness, weakness, sweats & fatigue;this is one of four patients who exp above reaction at this site
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot #, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting within 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA003021, 1209USA003022, 1209USA003023, 1209USA003024). Additional information has been requested.
PT DISCOVERED  INATTENTIVE AN  SQUINTING HIS EYES. ONCE ALERT, PT C/O OF LIGHT HEADEDNESS, SWEATING, BLURRED VISION, PARESTHESIAS IN BOTH ARMS AND LEGS.  VS @ 3:08 BP 78/62 HR 86 REPEAT VS @ 3:20 PT GIVEN GATORADE FOR REHYDRATION AND INSTRUCTED TO BREATH SLOW LY AND DEEPLY. AFTER 10 MINUTES, PT SYMPTOMS STARTED TO RESOLVE. SYMPTOMS COMPLETELY RESOLVED WITH TIME. PT BECAME STABLE TO LEAVE OBSERVATION SITE. INSTRUCTED TO F/U WITH PCP.
rash developed predominately on torso, but also affected arms legs and neck.; The measles like rash created a burning sensation that lasted 2 days and resulted in some lesions t; rash created a burning sensation; some lesions; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 10:30 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies and the patient had no chronic health conditions. Concomitant medications included red beet powder and only beet powder as reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 10:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 11:00, 4 days after 2nd dose a rash developed predominately on torso, but also affected the arms legs and neck. The measles like rash created a burning sensation that lasted 2 days and resulted in some lesions that persisted and required additional days of healing. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events rash, measles like rash, rash created a burning sensation and some lesions were recovering at the time of the report.  No follow-up attempts are needed. No further information is expected.
PT NOTED ITCHING AT RIGHT ARM SITE, SCRATCHED AND NOTICED REDNESS TO SKIN IN A CIRCLE AROUND INJECTION SITE. EXAM REVEALS 3 CM ROUND SURFACE ERYTHEMA, NO INDURATION, NO HIVES
Left thigh, red swollen warm to touch around injection site. Keflex ZSO/5. 5ml PO BID; possible cellulitis.
Issues with vision, went to eye doctor, referred to retina specialist. Hemorrhaging in the back of left eye. Appointment with pediatrician and pediatric Cardiologist. blood work and EKG done.  Follow up with retina doctor on 5/14/21
I WAS VERY ILL LIGHT HEADED AND LETHARGIC.  STARTED HAVING VERY PAINFUL MONTHLY MENSTRUATIONS  AFTER THE INOCULATION.
pt recv vax & exp low grade fever-given Motrin; woke @ 6PM vomiting & then went back to sleep; 8PM T105.5 went limp called MD;vomited then t104;
Reduced the blood pressure; Blood pressure gradually reduced/Reduced the blood pressure; Blood pressure were fluctuated; Edema in the leg which got worst; Arm sored; Tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (Edema in the leg which got worst), BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated), BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure), HYPOTENSION (Reduced the blood pressure) and MYALGIA (Arm sored) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation, Rheumatoid arthritis and Tingling (Pain in the leg). Concomitant products included HYDRALAZINE, LOSARTAN, FUROSEMIDE, METOPROLOL SUCCINATE and POTASSIUM CHLORIDE (K-TAB) for Blood pressure management, METHOTREXATE for Rheumatoid arthritis, GABAPENTIN for Tingling, FOLIC ACID for an unknown indication.   On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced OEDEMA PERIPHERAL (Edema in the leg which got worst). 10-Mar-2021, the patient experienced MYALGIA (Arm sored) and FATIGUE (Tired). On 01-Apr-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated). On 01-May-2021, the patient experienced BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure). On 01-Jun-2021, the patient experienced HYPOTENSION (Reduced the blood pressure). At the time of the report, OEDEMA PERIPHERAL (Edema in the leg which got worst), HYPOTENSION (Reduced the blood pressure), MYALGIA (Arm sored) and FATIGUE (Tired) outcome was unknown and BLOOD PRESSURE FLUCTUATION (Blood pressure were fluctuated) and BLOOD PRESSURE DECREASED (Blood pressure gradually reduced/Reduced the blood pressure) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported in the month of June physician give medication which help her to reduce blood pressure to140/66 and 123/58.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-221114 (Patient Link).
Roughly 1 hour after receiving SHINGRIX patient was dizzy, shaking, and unable to lift arm. He went to ER and tests/scans were performed. He was discharged home with muscle relaxants and anti-inflammatory meds.
1/29/09--Pt. stated did not feel shot "going in" when administered; felt a little faint approx 15min after shot, but recovered. 2/2/09--severe aching pain in bicep (L), especially when arm moved or repositioned; so severe it woke pt. up during the night.  2/20/09--continued aching pain in bicep;making appt for doctor;stes heat/cold/ibuprofen has been ineffective.
Had shingles 2 times and 2 shots/suspected vaccination failure; Eye shingles; Had shingles on my face, right side, scalp my hair; Hair hurt to touch; Brutal headache on right side; Confused; Brain fog; Bump in my ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 2 times previously).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles 2 times and 2 shots/suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Eye shingles) (serious criteria GSK medically significant), shingles (Verbatim: Had shingles on my face, right side, scalp my hair), pain (Verbatim: Hair hurt to touch), headache (Verbatim: Brutal headache on right side), confusion (Verbatim: Confused), foggy feeling in head (Verbatim: Brain fog) and local swelling (Verbatim: Bump in my ear). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, shingles, pain, headache, confusion and foggy feeling in head were not reported and the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, pain, headache, confusion, foggy feeling in head and local swelling to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, shingles, pain, headache, confusion, foggy feeling in head and local swelling to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 11-Mar-2023 The case was received from the patient via interactive digital media. The patient had 2 shots and on his/her face, right side, eye, scalp his/her hair hurt to touch them, 8 weeks, brutal headache on right side, confused, meds, brain fog, had one bump in his/her ear still.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per narrative information, it seems that patient had all reported events after vaccination, therefore conservatively captured as event. It was not clear whether this 8 weeks was event duration or it was like since 8 weeks events were ongoing therefore this information was captured in narrative.
exhaustion; feel like I had a cold coming; I was running a fever of 101.2/My fevers ranged from 100.1 to 103.2/fevers/have a low grade fever; had body aches; headache; no energy; my arm was extremely sore; This is a spontaneous report from a contactable nurse (patient).  A 35-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm right on 20Jan2021 at 09:15 at single dose for COVID-19 immunization. The patient medical history included chronic constipation, depression and known allergies to latex, apples and adhesive, all from an unknown date and unknown if ongoing. The patient's concomitant medication included sertraline hydrochloride (ZOLOFT), trazodone, cetirizine hydrochloride (ZYRTEC), cholecalciferol (VITAMIN D). The patient previously received fist dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at arm left on 30Dec2020.  The patient reported that: "on 21Jan2021 I started to feel like I had a cold coming when I woke in the morning.  As the day went on, I began to feel worse. I was running a fever of 101.2, had body aches, headache, no energy, and my arm was extremely sore. This continued 22Jan2021. My fevers ranged from 100.1 to 103.2. On the 23Jan2021 I continued to have a headache, fevers and no energy. On 24Jan2021 I continued to have a low-grade fever, no energy, and headache. I was only able to work 5 hours due to exhaustion". Therapeutic measures were taken as results of events and included treatment with TYLENOL 1000 mg and ibuprofen 600 mg every 6 hours. The patient underwent lab test and procedures which included SARS-COV-2 tests (nasal swab and rapid test) both negative on 22Jan2021. The patient outcome of the events was not recovered.  No follow-up attempts are possible, information about batch number cannot be obtained.
Information has been received from a registered nursing concerning a 36 year old female who in December 2000 was vaccinated with her first dose of hep b vaccine recombinant. Three weeks alter, the pt experienced jaw and eye pain and her tongue felt as if it was swollen. She was seen by a few doctors including a neurologist. By that time, her symptoms had resolved. She was diagnosed with polyneuritis which was "related to virus." On 04/04/2001, she received her second dose of hep b vaccine recombinant. Three weeks later, on approximately 04/25/2001, the symptoms resumed. The pt was scheduled to see a neurologist on 05/04/2001. Additional information has been requested.
hard rigors-chills p/3rd dose in post exposure series that resolved in approx 2hr w/o tx;
Patient requested Pfizer COVID vaccine on 1/19/22 at clinic.  He reported that he initially got his first dose about a year prior.  He was advised to contact the clinic where he got his first dose for their records.  He then came back to the clinic and stated that they did not have record of him receiving his COVID vaccine and isn't sure if he maybe received a flu vaccine instead. He then reported he needed 2 doses of the COVID vaccine to start work. His first dose was given on 1/19/22. His 2nd dose was given on 2/5/22. Patient received 2nd dose 4 days early. Patient was immediately notified he received his dose too early and was advised to closely monitor for symptoms. Dose is considered valid since within 4 days of first dose. Patient did not experience any adverse effects. Error was noted when RN went to hand the patient his vaccine card and thought the dates seemed off.
Rash occurred on legs within 1 hour of administration of vaccine.  Fever: 103F Fussiness, swelling (lump) at site of injections
Redness at area on injection, body aches, joint pain, injected arm was sore for 48 hours. I'm a breastfeeding mother and 4 days later my 8 month old son was running a fever, had diarrhea, a runny nose and was restless (prior no issues).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: Fr8727), in left arm, on 04Oct2021 as dose 2, single (Lot number: Ff8841), in left arm and on 22Apr2022 as dose 3 (booster), single (Lot number: Ft9943) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Known allergies : tetracycline, reaction(s): "Known allergies : Tetracycline", notes: Known allergies : Tetracycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment started from 14Sep2022 to 19Sep2022.
Vertigo; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) 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 VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
2 days after vaccination the injection site was mildly swollen and hot. Treated with cold compress and ibuprofen. The event lasted one day.
Vaccine given Monday in AM. By PM (10-12 hours) later that day site was red, swelling, and warm to the touch. Low grade fever of 100.4.  Parent gave benadryl which did help some. Was seen in office 3 days later at which time area had significantly improved.
Fever, chills, severe headache, nausea, aches, mouth blistered (inside and outside)
Systemic: Patient came back after 30 minutes of receiving the vaccine and complaint of itchy of throat and body. No apparent rash observed. gave 50 mg of Benadryl PO. 10-15 minutes, patient complaint of diffucu
Patient's mother called nurse to vehicle to report daughter was having a seizure.  Patient had 2 seizures in the car immediately after receiving Janssen Covid-19 vaccine.  Patient then placed on the ground beside the vehicle and patient continued to have 3 more grand mal seizures.  Nurses kept patient safe from any injuries.  EMS called and responded.  Patient transported to medical facility.
Got Covid 12/29/2022 fatigue body aches lasted for 3 weeks. Experienced a lot of phlegm and deep coughing.
Patient presented to emergency department on 11/3/2021 with hypoxia. He was found to be COVID-19 positive and admitted for further management. He required 1-2L of oxygen during admission. He was discharged home on 11/7/2021.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported. On 27-JAN-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ "2ml, 10 unit dose tube" and lot number K009752 with expiration date of 15-APR-2016, orally, which was stored at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 168 hours and at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 384 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Approximately 15 hours after second dose of vaccine, severe chills for 3 hours. Later ran a fever for over 24 hours from 100.8 - 101.3. Two days after injection (on 4/28/2021), arm became very hot to the touch and a red rash appeared.   The rash was about the size of the palm of my hand.  The fever was a steady 99.9 at this time too.  Called the Pharmacist and she informed this side effect was COVID arm.  The pharmacist advised to put a cool cloth on the site and do not scratch. Today, 5/2/2021, the fever and rash are gone.