chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for herself. A 79-year-old female patient received the 1st dose of PREVNAR 13 via an unspecified route of administration at single dose into the left arm in Nov2016 for immunisation, she thought that the product was prescribed for flu prevention, received at the local pharmacy. A nurse administered the shot. She had other medical conditions years before, but did not provide them. No illness at the time of vaccination. She mentioned that she had other medical conditions years before, but did not provide them when asked. Concomitant medication included alprazolam oral 1 mg, 1x/day (each night) started probably about 10 years before and ongoing for sleep, and supplements. The patient previously took flu and experienced pain in extremity. She mentioned that her arm was sore after she received any type of flu shot. No history of previous immunization with the PREVENAR 13. No additional vaccines administered on same date of the suspect. The patient Shingles vaccine (uncertain) at left arm at least 4 weeks prior to the PREVNAR 13 shot. In Nov2016 she experienced sore arm after she received the product and she recovered completely the next day. In Dec2016 she experienced a rash all over her body 2 to 3 weeks after receiving the product and she still had it. Again, 2 to 3 weeks later she experienced a rash all over her body, referring to this time period as around the first or second week of Dec2016. She has been to dermatologists for rash and they seem to be treating the symptoms of rash and have not determined the cause. She was prescribed a product or products to help with the crazy itchiness from the rash. The product helped the itchiness, but the rash was still there. It worsened, but then it improved after she started receiving a pill that she did not recall the name of and it helped or made it better regarding the itchiness of the rash. The product she received had some type of chemo in it that took away the itching. Now the rash was right back. The rash used to be spotty originally, and now it was sores. She also referred to receiving some type of shot. She was prescribed many products for the rash. She routinely had received other flu shots in the past, but never experienced this event. Her arm was sore after she received any type of flu shot. Her doctor wanted her to receive the product again this year, but she was not going to receive another one. No tests performed. She was going to have an allergy test starting on 01May. No event required a visit to Emergency room, but the events rash all over her body and crazy itchiness from the rash required a visit to Physician office. A product complaint was filed.
Patient is a 25 y.o. female at G4P1021 at 31w6d with PMH significant for substance abuse, patent foramen ovale and pregnancy complicated by above who was admitted on 9/17/2022 for COVID in pregnancy. During her stay, the patient was stable on RA and in good condition. EKG demonstrated sinus tachycardia and CTPA was negative. She received 48 hours of dexamethasone for fetal benefit. It was recommenced she go home with a 5 day methylprednisolone taper. However, after consulting ID, this was not recommended. ID recommended remdesavir inpatient and paxlovid outpatient. She received remdesavir one time dose 9/18. However, due interaction between paxlovid and home seroquel, patient receive monoclonal antibodies prior to discharge on 9/19.  Patient in good and stable condition. Appropriate for discharge.     Discharge Diagnoses: * COVID Assessment & Plan Patient is a 25 y.o. G4P1021 at 31w6d with PMH significant for substance abuse, patent foramen ovale and pregnancy complicated by above who was admitted on 9/17/2022 for COVID in pregnancy.    COVID Tachycardia - COVID pos 9/17 - Imaging:             - EKG: sinus tach             - CTPA: no PE - Tylenol q6hr for symptoms - dexamethasone course followed by methylprednisolone taper - Remdesivir infusion 9/18 - Clarify outpatient paxlovid vs monoclonal antibodies with ID    Fetal Status: - Monitoring: TID EFM/Toco unless requiring supplemental O2 - BSUS (9/18): breech, EFW 1616gm (13%), AFI subjectively normal - TVUS (9/17): CVL 4.6cm at the shortest - Dexamethasone Q12hr (9/17-9/19) - GBS pending (9/17)   - IVF: mIVF, s/p 3L bolus - Diet: Preg diet - Ppx: SCDs - Delivery method anticipated: vaginal, PCS consent on chart - PPBC:Micronor   PMH: Substance abuse history Bipolar depression and Anxiety: continue Seroquel and fluoxetine   Dispo: Inpatient monitoring for symptomatic COVID. Patient receiving supportive treatment. Will receive four doses of dexamethasone then transition to methylprednisolone taper. Receiving remdesivir inpatient and will be transitioned to outpatient therapy. Discharge likely 9/19
Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Nitrous oxide allergy), Grass allergy, Seasonal allergy (trees allergy), Asthma (since childhood.) and Anxiety disorder since 09-Jan-2019. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, FLUOXETINE HYDROCHLORIDE (PROZAC) for Generalized anxiety disorder, DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for Nausea, ACETYLSALICYLIC ACID (ASPIRIN 81) for Pregnancy, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), FOLIC ACID, VITAMIN B12 NOS and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 10-Jun-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test: positive (Positive) Positive. On 25-Nov-2020, Ultrasound foetal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Genetic testing done on 25 Nov 2020, Normal. Anatomy scan was done on 19 Jan 2021 (results not reported). Treatment medications were not reported.
Abdominal pain/Belly Ache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain/Belly Ache) and DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Gallbladder removal (Gall-bladder was taken 15-20 years ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain/Belly Ache) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN (Abdominal pain/Belly Ache) and DIARRHOEA (Diarrhea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient mentioned that the bellyache was there for approximately 6 months as of now. Patient was scheduled to take the second dose on the next day of the time of report. No concomitant medications were reported.  Treatment information was not provided.
Pt recvd flu vax 24OCT91 & 5NOV91 c/o rash over shoulder & down neck; also c/o poss herpes zoster lesion in rt eye; Given Zovirax & DPH; pt also sues Neodecadron Ophthal Ointment; Rash resolving; almost disappeared by 21NOV;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 at 14:00 as dose 1, single (Lot number: EN6207), in left arm, on 31Mar2021 as dose 2, single (Lot number: EN5712), in left arm, on 09Oct2021 as dose 3 (booster), single (Lot number: 320308D), in left arm and on 07May2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE, start date: 10Jun2020. Past drug history included: Sulfamethoxazole, reaction(s): "Known Allergy sulfamethoxazole"; Trimethoprim, reaction(s): "Known Allergy Trimethoprim". The following information was reported: COVID-19 (medically significant) with onset 22May2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive, notes: I tested covid positive; (16May2022) Negative, notes: Tested negative; (22May2022) Positive, notes: positive test result. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient tested COVID positive on 11May2022 and started Paxlovid evening dose 11May2022 and completed Paxlovid morning dose on 16May2022. Tested negative for COVID on 16May2022. COVID symptoms started again on 21May2022 and positive test result on 22May2022.
2 mo old who 12 hrs after getting PEDIARIX, PCV13, ROTA and HIB developed a 102 fever and had a 1 min seizure. Neg sepsis w/u. Now doing well.
Patient reports worsening joint pain- back, knees, hips, elbows, shoulders that limits activity since he had the vaccine; of note he has a history of chronic joint pain, but symptoms has been mild and seem to be activated post vaccine.
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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 at 05:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 31Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATENOLOL; MONTELUKAST; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; METFORMIN; HYDROCHLOROTHIAZIDE. Past drug history included: Ace inhibitors, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were not taken as a result of covid-19, vaccination failure.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Diffuse muscle aches and fatigue with mild SOB.  Treated with Motrin 600mg BID.  Symptoms have been persistent now for over one month.
Information and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 28-AUG-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 23 year old female patient with penicillin allergy who on 02-SEP-2009, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL (lot number not provided).  There was no concomitant medication.  On 07-APR-2010, the patient received intramuscularly on the left upper arm a second 0.5 mL dose of GARDASIL.  On 08-APR-2010, one day after receiving her second dose of GARDASIL, the patient developed redness and swelling at the injection site of the left upper arm.  On 14-APR-2010, the patient was evaluated in the office and had a fever of 101.2F.  At the time of reporting, the symptoms were increasing in severity (not recovered).  No labs or diagnostic studies were performed.  The patient sought medical attention via office visit.  Additional information is not expected.
Patient got home and started feeling short of breath.  She tried using her albuterol inhaler, but had no relief.  She developed thick mucous, and she continued to cough up the mucous throughout the night.  She had chills to the point where the bed was shaking.  She was so cold she placed an electric blanket on top of her plus four more blankets.  She woke up the next morning feeling completely awful and unable to leave her bed.  She called me on Saturday, 10/10/09 still feeling achy and under the weather, but much better than the previous day.
Patient came into the pharmacy 10 days after the vaccine was administered complaining of arm pain and the inability to life her arm. Due to allergies, she was unable to take NSAIDS. She has taken Tylenol and applied ice to the area with no relief.
-About 20-25 minutes after received vaccine, had already left the facility felt a surge tightness wrap around my diaphragm up to my collar bone, as if my breath was being taken away. I yelped out but the three people in the car with me did not here me. I remained calm took a deep breath- feeling went away.  - Had vaccine on Saturday. Woke up in the night on Sunday night, feeling like my tongue was swelling and my throat was closing up. I took 1/2 Benadryl and used Albuterol enhaler. Temp was 99.8 (my average at home is 96.5)Fell back asleep. Woke up the next day and was fine. - other symptoms were tiredness, headaches, achy joints, which went away fairly as quickly. -since the vaccine I have had a bad outbreak of do
test positive 25May2022; test positive 25May2022; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 75-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL;IPRATROPIUM other, start date: 14Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "not recovered" and all described as "test positive 25May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: home antigen test; (25May2022) Positive; (03Jun2022) Negative, notes: test at home. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies were reported. Other medication received in 2 weeks was Albuterol/Ipratropium via inhalation route. COVID symptom start date: 25May2022 test positive 25May2022 Paxlovid 25May2022 completed 5 days negative test at home 03Jun2022 recurrent symptoms 05Jun2022 with a positive home antigen test 05Jun2022. Treatment included Paxlovid via oral route from 25May2022 to 31May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.
Hives started on December 26 and have been ongoing since. He has been taking Claritin and Benadryl to help.
Information has been received from a physician concerning a 16 year old female who in January 2008, was vaccinated intramuscularly with her second dose of Gardasil. In January 2008, the patient experienced vertigo. The patient had gone to a neurologist, but it was not known if the patient went to the neurologist for this reason or another reason. The patient's outcome was not reported. Additional information has been requested.
Upper arm muscle sore & achy; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non-pregnant female patient received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206) via an unspecified route of administration, administered in Left Arm on 08Mar2021 02:00 as single dose for covid-19 immunization; tozinameran (PFIZER BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: #EN6206), via an unspecified route of administration on 08Mar2021 as single dose for covid-19 immunization. Medical history included diabetes mellitus, chronic kidney disease, thyroid, rheumatoid arthritis from an unknown date and unknown if ongoing , osteoarthritis and high blood pressure. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. No known allergies were reported for the patient. On 09Mar2021 the patient experienced upper arm muscle sore & achy. No treatment was received for the event. The outcome of event was not recovered. Location of injection information is available for all vaccines received on the same date.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (12May2021): This follow-up is being submitted to notify that the lot/batch number was not available despite the follow-up attempts made.
Information has been received from a health care facility concerning a 13 year old female with no known medical history or allergies who was vaccinated with her second dose of hep b vaccine recombinant. There was no concomitant medication. Subsequently, the pt experienced a red, sore, hard knot at injection site. The pt had no reaction with the first dose of hep b vaccine recombinant. Unspecified medical attention was sought and the pt's outcome was unknown. Additional info has been requested.
extreme fatigue  mild headache muscle pains nausea and vomiting chills taste confusion loss of appetite   eye focus issues  dizziness  brain fog low grade fever sores on tongue lip blisters (Important to note: still experiencing severe blisters on my lips) low energy and fatigue continues day to day
Havrix expired first dose administered; Maladministration of Havrix adult dose to a child; Maladministration of Havrix adult dose to a child; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix adult) (batch number 7595K, expiry date 30-DEC-2021) for prophylaxis.   On 08-OCT-2020, the patient received the 1st dose of Havrix adult. On 08-OCT-2020, an unknown time after receiving Havrix adult, the patient experienced expired vaccine used (Verbatim: Havrix expired first dose administered), overdose (Verbatim: Maladministration of Havrix adult dose to a child) and adult product administered to child (Verbatim: Maladministration of Havrix adult dose to a child). The outcome of the expired vaccine used, overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 26-MAY-2023 Medical Assistant has a 6 year-old patient who was previously vaccinated, with a Havrix adult dose and she has never received Havrix second dose. The reporter declined to follow up. The patient received an expired dose of Havrix, which led to expired vaccine used. The pediatric patient received an adult dose of Havrix (first dose), which led to overdose and adult product administered to child.
Pain and redness at inject site, aches and flu-like symp. gradual onset of extreme pain in upper back, neck, and arms/hands. Arm and hand weakness from approx. 10-13 thru 1-14. "heavy arms and intense pain for approx. 4 mos. Unable to sleep due to pain.
pt recv vax 1JUN98 & 7JUN98 rash began on hands, feet, elbows & knees taken to immed care 8JUN98 & dx w/erythema mult d/t hep b vax by MD;
COVID-19 vaccine given after BUD date of 5/3/22.  Expiration date: 5/31/22.   Letter being sent to parents to re-vaccinate patient.
Within 2 hours of administration client was having chills, fever, and a sore (L) arm. Patient called nurse line and 3/30/10 advised to see his Dr. Patient did not see Dr that day but came into our clinic on 4-1-10 complaining of same symptoms along w/vomiting. Patient advised to see Dr. and app was set up for 4-1-10 AM.
CHILLS; HEADACHE; INJECTION SITE PAIN ON HIS ARM; FEVER; SORE ARM; This spontaneous report received from a patient concerned a 37 year old male. The patient's weight was 180 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fever. On APR-2021, the subject experienced injection site pain on his arm. Laboratory data included: Body temperature (NR: not provided) 101.5 F. On 06-APR-2021 19:00:00, the subject experienced chills. On 06-APR-2021 19:00:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, had not recovered from headache, and injection site pain on his arm, and the outcome of chills and sore arm was not reported. This report was non-serious.
Worried that her fingers on left hand are swollen because could not get her ring on to 4th finger especially is painful. Her concern is that she had a flu shot in left arm 9/8 in addition to starting lisinopril 20 mg on that day. The finger pain began that . No injury. However it is noted that she has arthritis elsewhere in body. No fever. No redness. Says her BP had been controlled on bisprololHCTZ until recently. Denies chest pain or SOB. No new GI symptoms. Also was feeling in her hair and thinks she felt some blisters in post scalp so wants checked.