chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 at 04:00 as dose 1, single (Lot number: EL9265), in left arm, on 04Mar2021 at 11:00 as dose 2, single (Lot number: EN6198), in left arm, on 27Oct2021 at 17:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 29Mar2022 at 17:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Liver hyper metabolism" (unspecified if ongoing), notes: Liver hyper metabolism; "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs; "Prothrombin mutation G20210A" (unspecified if ongoing), notes: prothrombin 20210a heterogeneous, C677T. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood homocysteine: Unknown results, notes: Result: Unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Arm very sore, could not lift by 5:00 PM of same day/Also headachy and very achy same day also through the evening and the next day....very much like flu symptoms............first shot symptoms lasted almost 2 weeks....so far the second shot symptoms are the same to the second day.  I am reporting it today...
Patient states after receiving vaccine on 5/16/22 was experiencing discomfort in shoulder, radiating to neck. RPH stated to patient call 5/20/22 symptoms seem consistent with bursitis, but not qualified to diagnose.  Follow up call with pt 5/21/22, pt went to urgent care and diagnosis was improper location of injection "into joint".
5 year old received Moderna COVID-19 Vaccine Bivalent Booster, dark pink cap, 6m-5y
Headache, Body Aches (6 on a scale of 10), Pain at injection site, lethargy, soft stool.  36 hours after onset of symptoms.
pt returned to clinic accompanied by both parents & c/o gen weakness & nausea;pt recuperate 10 min p/resting lt clinic in stable condition;14JUN96 mom states pt doing fine;
A few weeks after the vaccination, I experienced a high level of burning/red skin, swollen feet, legs and face, an accelerated heart rate & general irritable mood/feelings, all occurring at different times of day and for intense stretches of time, still at present time. Also numbness at times.
Nurse documented that a Hepatitis A adult dose was administered when a pediatric/adolescent dose should have been given.
I received my shot on Friday afternoon and by Saturday night when I went to sleep I had a wooshing sound in my ears. It calmed down the next day and now intermittently comes and goes and is a high pitched ringing sound now.
Administered a pediatric dose of 0.5 ml split from a adult Engerix formulation syringe; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received HBV (Engerix B adult) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th May 2021, the patient received Engerix B adult .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pediatric  patient was administered a pediatric dose of 0.5 ml split from an adult Engerix formulation syringe which led to inappropriate preparation of medication. Patient other details were unknown. The reporter consented to follow up. This case has been linked with the case US2021AMR123238 by same reporter.; Sender's Comments:  IT-GLAXOSMITHKLINE-IT2021112533:Deleted US-GLAXOSMITHKLINE-US2021AMR123238:Same reporter
Extreme chest pain only helped by ibuprofen- sharp stabbing breath taking pain on both sides of heart, extreme fatigue, ringing in ears 4 days after injection, blurred vision for 3 days starting at night day of injection until 3 days after (no blurred vision prior to Covid vaccinations). Headache- at times stabbing pain others pulsing dull pain, body-aches, chills, sweating. Hive like rash down both arms and covering torso. Covid arm which occurred on this second dose but not first dose one month prior- large red painful patch around injection site, feels inflamed. Treating symptoms with ibuprofen and diphenhydramine HCL.  Rash and extreme chest pain still come and go.
Hot, flushed & nausea.  Symptoms started 23 minutes post vaccination & lasted 20 minutes. Treatment was a snack & vital monitoring.
09/03/13 pt came to pharmacy because there was a red circular area about 1 1/2" diameter around site of injection. It was warm to touch per patient. She also said she had a headache since vaccination on 9/1/13.
Hospitalization for acute appendicitis, diagnosed with COVID-19 (8/2/2023) on dates 8/10/2023-8/11-2023. Treated with no COVID-related medications.
pt recv vax 15AUG96 & 5 to 6 days later pt exp flu-like sx including fever, n/v & gen malaise;4 pt were reported (WAES 96081699 through 96081702);
joint pain; pain on her nails.; weak; without coordination; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache; body ache; pain at the site of injection on the R arm; pain above the ribs; legs and feet chained; dizziness, she felt she was going to faint; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (legs and feet chained), DIZZINESS (dizziness, she felt she was going to faint), PAIN (body ache), ONYCHALGIA (pain on her nails.) and MUSCULOSKELETAL CHEST PAIN (pain above the ribs) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL and TORSEMIDE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2002, the patient experienced DIZZINESS (dizziness, she felt she was going to faint). On 01-Apr-2021, the patient experienced FEELING ABNORMAL (legs and feet chained), MUSCULOSKELETAL CHEST PAIN (pain above the ribs) and VACCINATION SITE PAIN (pain at the site of injection on the R arm). On 02-Apr-2021, the patient experienced PAIN (body ache), ASTHENIA (weak), COORDINATION ABNORMAL (without coordination), CHILLS (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache), NAUSEA (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) and HEADACHE (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache). On 03-Apr-2021, the patient experienced ONYCHALGIA (pain on her nails.). On an unknown date, the patient experienced ARTHRALGIA (joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (legs and feet chained), DIZZINESS (dizziness, she felt she was going to faint), PAIN (body ache), ONYCHALGIA (pain on her nails.), MUSCULOSKELETAL CHEST PAIN (pain above the ribs), ASTHENIA (weak), COORDINATION ABNORMAL (without coordination), ARTHRALGIA (joint pain), VACCINATION SITE PAIN (pain at the site of injection on the R arm), CHILLS (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache), NAUSEA (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) and HEADACHE (she stayed the rest of the day on bed with chills, dizziness, nausea, headache, body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient second shot was on 29-APR-2021, and was hesitating to receive or not. The patient took Onglaze 2,5 mg drug.
After I got the vaccine the next morning I woke up with a severe headache and bloody nose. I had a headache every day since I received the vaccine. The headaches don't last all day maybe an hour or half an hour. I never have had headaches before the vaccine. I had severe headaches and fever in August and went and had a COVID-19 test but it was negative. I had rash all over the right side of my face and still fever and headaches. I went into a local urgent care and was diagnosed with shingles. I have a lesion on my rectum between my tailbone and my anus and it bled for a month.
A non-serious, spontaneous report of joint pain, muscle aches, left ear burning and fever has been received from a patient's father concerning his four year old son subsequent to Flumist. This case is submitted in accordance with manufacturer post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patients medical history was not reported. The patient received Flumist on 02-Sep-2009 as well as his four year old shots such as DTP, tetanus, MMR, polio, and chicken pox vaccines. On the night of 02-Sep-2009, the patient complained of joint and muscle pain.  Around 3 am on 03-Sep-2009, the patient ran a fever of 102.9 degrees. and in the morning of the same day his left ear was burning. The outcome of the events was not reported. All follow-up attempts have been made per company SOPs. No further information available. Per MI convetions, non - MI mfr not captured - queries 1-6.
Headache, fatigue, sore throat, swollen left axillary lymph nodes and swollen lymph nodes on the left side of the neck.
Local swelling in arm at injection site and up and down arm within 24 hours. Treated with Cephalexin and Vioxx.
PATIENT HAS A HISTORY OF SEIZURES AND WAS GETTING VACCINE AT THE RECOMMENDATION OF HER PROVIDER.  SHE STARTED SEIZING AT 12:25PM, AND HAD RECEIVED VACCINE AT 12:03PM.  SHE LEFT THE STORE WITH THE PARAMEDICS
Patient received injection at 3:35PM. Called clinic ast 4:15pm from home reporting facial swelling, numbness and difficulty breathing. Sent to ER. Called patient next morning. Reports she received anthistamines and steroids in ER and told to stay home following day. She reports no further symptoms
Generalized flesh-colored papular rash within 24 hours of administration.  No respiratory distress, no angioedema, no fevers. No neurologic changes. Presented to clinic on 5/5/23 for additional catch up vaccinations. These vaccines were held off for now secondary to patient presentation. Prescribed cetirizine and topical hydrocortisone for rash and will follow closely
On day 7 injection site began to turn red, swell and itch. Days 8-9 it worsened (grew in side and swelling) but began to resolve on day 10. There is a circular scar where the affected area was on day 12 and slight redness.
FELT LIKE COVID-19 SYMPTOMS; SLEEPINESS; EXTREMELY LETHARGIC; EXTREMELY FATIGUED; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced sleepiness. On 18-MAY-2021, the subject experienced extremely lethargic. On 18-MAY-2021, the subject experienced extremely fatigued. On 19-MAY-2021, the subject experienced felt like covid-19 symptoms. Laboratory data included: Body temperature (NR: not provided) 103.1 F. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from sleepiness, and extremely lethargic, and the outcome of felt like covid-19 symptoms and extremely fatigued was not reported. This report was non-serious.
About 8 weeks after my second Moderna dose I started to have some eyelid issues. My eyelids started to feel heavy and by the end of the day my eyes were stinging. About 2 1/2 weeks after symptoms started I had an appointment with an Optometrist (8/4/21) who diagnosed dry eye syndrome and gave me artificial tears to lubricate my eyes. Three days later (8/7/21) my eyelids dropped onto my eyes and I was unable to open my eyes except for a small slit. I went to the emergency room following day (8/8/21) but they didn't know what was going on. On 7/2/21 I'd had Dysport injections in my forehead, and around my eyes and they thought maybe this was causing my eyelids to drop. The gave me some ointment to put in my eyes and referred me to another eye clinic. I called my Optometrist and told him what had happened and he referred me to an Ophthalmology doctor (8/11/21) who diagnosed a condition called Benign Essential Blephorospasm. When I try to open my eyes my eyelids spasm and won't open. Treatment involves Botox injections in the eyelids to stop the spasms and I have had three treatments on the following dates: 8/11/21, 8/17/21, 8/24/21. I can open my eyes a little now and see down but when I try to open my eyes all the way the eyelids spasm and I'm unable to open my eyes all the way. I have been referred to a neurologist and my appointment is scheduled for 10/7/21.
diagnosed with covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid-19) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (diagnosed with covid-19). At the time of the report, COVID-19 (diagnosed with covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took unknown high blood pressure medications.  No treatment medications were reported.
Localized erythema and pain at injection site - Mild to Moderate, lasting mainly 3 days, up to 5 days. General fever, Max <102.0 °F (38.9 °C), - Mild to Moderate, lasting mainly 2 days.
Patient's parent called the clinic and stated that 5 hours after the patient received the Heb B Vaccine the patient started to develop a fever and vomiting.  Advised parent to take the patient to the ER. Followed up with parent, and parent stated that the patient was given medication in the ER and was told to monitor situation. Parent stated that patient started to stabilize after ER Visit.  Parent stated that adverse reaction lasted for about 30 hours in total.
Patient has not received second dose of vaccine till day 48; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not received second dose of vaccine till day 48) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not received second dose of vaccine till day 48). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient has not received second dose of vaccine till day 48) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
A rash appeared on entire back. hot cold flashes, headaches that come and go, foggy brain, fatigued but cant sleep. Nine days into the first injection, my right arm (around injection sight ) approx 4 inch x 4 inch rash and major swelling of my upper arm.  Seems to be getting worse. Very itchy, warm to the touch , and hurts. Rash on the back has not gone away either.
Pt was inadvertently administered undiluted Pfizer orange cap 5-11 years old.  Pt remained afterwards, did not show any adverse reaction. Guardian was notified of incident and was told to keep an eye out for pt. Was placed on provider schedule tomorrow 10/7 for a follow up and check in.
CELLULITIS LT UPPER THIGH 18 CM X 3 CM  PRESCRIBED KEFLEX 250/5 1 1/2 TSP BID X 10 DAY ON 3-10-06, IN EVENING OF 3-10 CELLULITIS INCREASED SEEN ER AND REC'D ROCEPHIN   RECK ON 3-13-06 AREA NOW RESOLVING. PT REC'D DTAP LT ANT THIGH ON 3-8-06
ALL STANDARD SIDE EFFECTS +++++ HIGH FEVER ++++  The fever of 102 is there after 36 hours of getting the vaccine
Patient has Pericardial Effusion and pericarditis and required a pericardial drain. This even happened 3 weeks after the vaccine and the symptoms the patient had following the vaccine were persistent fevers.
pt recvd vax;28sep94 to er following a fall;weakness in lower extremities & distal upper extremities;to hosp for 7 days;MRI neg;lumbar puncture revealed inc protein;dx as GBS;in ICU&tx w/ IV gamma globulin;disch to rehab;f/u pt better
Information has been received from a physician concerning a 75 year old male who on 17-JAN-2007 (also reported as 28-JAN-2007) was vaccinated subcutaneously with one 0.65 mL dose of Zostavax. Concomitant therapy included amlodipine besylate (NORVASC) and ezetimibe (MSD). There was no illness at the time of vaccination. On 01-FEB-2007, the patient presented to the office with "severe imbalance with tendency to fall backwards" and couldn't keep his balance. Due to the persistence of symptoms, a MRI of the brain was done on 19-FEB-2007 to rule out stroke. The MRI showed no acute stroke, results were negative. At the time of the report, the patient has improved but not to 100% yet. There was no product quality complaint. Additional information has been requested.
she developed rashes in both  arms; This is a spontaneous report received from a contactable consumer (patient) and from a Pfizer-sponsored program . A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: WAH363) via an unspecified route of administration in left arm on 21Jun2021 at 20:30 (age at vaccination 25-year-old) as dose 1, single for Covid-19 immunization at  Pharmacy/Drug Store. Patients medical history was none. Patients concomitant medications were not reported. Additional vaccines administered on same date of the pfizer suspect, prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and Adverse events following prior vaccinations was none. Caller had the 1st dose of the Pfizer COVID 19 vaccine last 21Jun2021 and afterwards on 26Jun2021 patient experienced rash on both arms, but mostly the right arm. She went to  on 13Jul2021 to have the 2nd dose and she was advised not to get it and should call us first due to the reaction she had from the 1st shot. She wanted to know if she can still get the 2nd dose. When asked about allergic reaction, she stated she had a rash in her arm after the first dose. Not sure if it is an adverse event or if she ate something she is allergic to. Adverse event did not result into emergency room visit and physicians office visit. The outcome of event was recovered on an unspecified date in Jun2021.  No follow-up attempts are possible. No further information is expected.
Pt called MD office after receiving Hepatitis B vax at school and reported rash at injection site. School secretary called MD later saying rash had spread to leg. She was advised to call parents for authorization for medical attention. Public health nurse called parent the following day. Pt's rash had become generalized, and she received treatment with Claritin which cleared up the rash.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with their first dose of PNEUMOVAX 23 injection (exact dose, route of administration, lot # and expiry date were not reported). Then, on unknown dates and at unspecified intervals between doses, the patient received their second and third dose of PNEUMOVAX 23 injection (exact dose, route of administration, lot # and expiry date were not reported). The reporting pharmacist did not administer any doses to the patient. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
arm pain (shoulder to elbow), worse when moving arm; pain in her shoulder; Constant nerve pain (PT); Injection site pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included knee injury.   On 27-JAN-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 27-JAN-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain). On an unknown date, the patient experienced pain in arm (Verbatim: arm pain (shoulder to elbow), worse when moving arm), shoulder pain (Verbatim: pain in her shoulder) and nerve pain (Verbatim: Constant nerve pain (PT)). The patient was treated with non-drug therapy (Physical Therapy). The outcome of the injection site pain was not recovered/not resolved and the outcome of the pain in arm, shoulder pain and nerve pain were not reported.   It was unknown if the reporter considered the injection site pain, pain in arm, shoulder pain and nerve pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, pain in arm, shoulder pain and nerve pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2023 The reporter was the patient.  The patient received first dose of Shingrix vaccine. The patient experienced injection site pain. The pain had not lessened and worsened when she tried to move her arm. Sometimes it hurts from her shoulder to her elbow.  She described it as a constant nerve pain.  She saw her orthopedic doctor for a pre existing knee problem and mentioned the pain in her shoulder and arm.  The doctor took an x-ray that was normal.  The orthopedic doctor recommended physical therapy which was began on day of reporting.  No other information was reported.  The reporter did not consent to follow up.
I had a demyelinating event of my left brachial plexus It is known as Parsonage-Turner syndrome.  I have lost the use of my left shoulder muscles at this time.
diaphoretic, sudden fatigue, dystonic reaction only in hands that was reversible and able to be controlled by patient. All symptoms resolved within about 5-10 min
Vaccine administration error.  The patient is 10 years old.  The patient was given the Pfizer COVID 19 vaccine for 12 and above.
Shoulder joint pain, Swelling at various places near injection site, upper arm, and shoulder Neck pain and tightness