chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the booster of the Pfizer covid 19 vaccine yesterday; had the booster of the Pfizer covid 19 vaccine yesterday; soreness at the injection site; overall aching; it feels like flu like symptoms; muscle and joint pain/pain is like a muscular and joint pain; muscle aches/pain is like a muscular and joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 09Sep2021 (at the age of 65-year-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered on 05Feb2021 and 26Feb2021 (at the age of 64-year-old) as dose 1, single and dose 2, single for covid-19 immunisation and did not experienced any adverse effects. On 09Sep2021, the patient experienced had the booster of the pfizer covid 19 vaccine yesterday. On an unspecified date in Sep2021, patient experienced muscle aches/pain is like a muscular and joint pain, soreness at the injection site, overall aching, it feels like flu like symptoms. The outcome of the events muscle aches/pain is like a muscular and joint pain, it feels like flu like symptoms was unknown and outcome of the events soreness at the injection site, overall aching was not recovered.  Follow-up attempts are completed. No further information is expected.
Suspected vaccination failure; Got the shot and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included uterine cancer (stage 3 uterine cancer) and hysterectomy (complete).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got the shot and still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was not reported if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was not reported if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 28-Feb-2023. This case was reported by a consumer via interactive digital media. The reporter was patient's relative. Reporter sister-in-law got the shot and still got shingles. The reporter stated that Chemo,Chemo pain lasts only a couple days after each dosage, but the shingles pain last steadily and relentlessly for three-four months. The reporter didn't know my cancer was stage 3 uterine cancer until after the complete hysterectomy which was easy-peezy. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
I received the flu vaccine on the same day as the COVID-19 vaccine. The symptoms started two days later.  I was coughing and wheezing and had shortness of breath.  I went to the doctor the day after they symptoms started. The doctor stated there was inflammation in all parts of my lungs. She started me on a steroid taper yesterday. I also have an albuterol inhaler. I've been on the medication for a day, but the symptoms are the same.
medicine squirted everywhere down the patient's arm /no AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 54 years old female patient who was being vaccinated with 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1959 Expiry date: 30-JUN-2020 via intramuscular route in the left arm and a part of the vaccine touched the skin of the arm on 16-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was actual medication error case due to exposure via skin contact as the medicine squirted everywhere down the patient's arm while injecting into the arm.  At the time of reporting, the patient had no adverse event.  It was reported that the patient received a dose of the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1959 Expiry date 30-JUN-2020 via intramuscular route in the right arm as a corrective treatment.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fatigue, chest pain, shortness of breathe, unable to lay on right side (too painful); Officially diagnosed with pericarditis.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown demographics. No concurrent condition, medical history or allergy/drug reactions were reported. The nurse reported that on an unspecified date, an unspecified number of patients were administered improperly stored, Oral, ROTATEQ injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) and POOR QUALITY PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) and PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) and POOR QUALITY PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided. The vials were frozen, shipped in refrigerated temperature and then refroze for storage once arrived at facility.
Fever, swollen glands, stiff neck, stiff upper back, lethargy, anorexia, constipation, foot/leg "numbness".
3rd pregnancy, 2/10/22 due date.   Muscle aches, nausea and stomach pain for 4 days.
Within an hour of getting the shot my tongue and throat started to swell up, I took some Benadryl and within a couple of hours the swelling went down. 8pm noticed a headache and I had a low grade fever of 99. I had a headache and low grade fever Thursday and Friday. Saturday my fever was gone but my headache was worse and now lots of pressure in my head and dizziness. Wednesday 4/21 everything got worse and had some slight neurological issues, I went to the urgent care. Doctor gave me a shot of Toradol and gave me a prescription for 800mg Ibuprofen & prednisone. It helped to calm it down some. 4/26 went back to the urgent care because I still had  the bad headache, pressure and dizziness. The doctor again gave me another shot of Toradol and a prescription for prednisone, loratadine & guaifenesin. It helped to calm everything done some but nothing has taken away my bad headache. 5/3 went to  see family doctor And she put me on the migraine medicine imitrex. Nothing so far has taken away my bad headache. So now I have had this bad headache since 4/14/21.
Narrative: COVID infection following COVID vaccine series 03/022, Pfizer, dose #1 04/12, Pfizer, dose #2 10/27, Pfizer, dose #3 12/27 COVID swab, result: detected 12/25 pt cc: diarrhea, sore throat, fatigue, fever, exposure: unknown 12/27/ pt admit ED cc: myalgia, fatigue, sore throat, chills, headache, dx: covid 19  LOS: 1 day 1/1 clinically resolved
Patient was previously vaccinated 11/19/21, received current vaccine today too soon. Father of patient, was notified. I indicated that is recommended by the CDC that patient get revaccinated 21 days from this dose 12/24/21 on or after 12/26/21, father of patient was receptive and stated will follow recommended CDC revaccination.
Greater than 12 cm area of redness 2 days after injection. Reports burning type pain. S/S start to decrease after 4 days.
Hot to touch site of injection; Site of injection swollen; Chills; Arm started hurting; Dizzy; Flu Symptoms; Aches; Very cold; Was not able to lift it up her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), VACCINATION SITE WARMTH (Hot to touch site of injection) and PAIN IN EXTREMITY (Aches) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), PAIN IN EXTREMITY (Aches), FEELING COLD (Very cold), LIMB DISCOMFORT (Was not able to lift it up her arm) and CHILLS (Chills). On 09-May-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch site of injection) and VACCINATION SITE SWELLING (Site of injection swollen). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), DIZZINESS (Dizzy), INFLUENZA (Flu Symptoms), VACCINATION SITE WARMTH (Hot to touch site of injection), PAIN IN EXTREMITY (Aches), FEELING COLD (Very cold), LIMB DISCOMFORT (Was not able to lift it up her arm), VACCINATION SITE SWELLING (Site of injection swollen) and CHILLS (Chills) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Rash on right arm, right foot, and left foot; This is a spontaneous report from a contactable consumer (patient) via regulatory authority support.  A female patient of unspecified age (age: 49, units: unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8734) via intramuscular route, administered in Right arm on 19Apr2021 (age at vaccination 49-year-old) as Dose 2, Single for Covid-19 immunization. The patient was related to a study or programme The patient's had no medical history and concomitant medications. The patient received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: Not reported) via an unspecified route of administered in Left arm on 29Mar2021 (age at vaccination 49-year-old) as Dose 1, Single for Covid-19 immunization and no events reported. On an unknown date in May2021 (months after second dose), the patient experienced rash on right arm, right foot, and left foot. Rash comes and goes. These AE(s) were worsened. She confirmed that rash was not on her face, fingers, or on her legs. She doesn't know if it's from the shot. No investigation assessment was reported. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
2 days after my second dose of the vaccine, I started having headaches.  This was odd because i never get headaches.  The headaches continue, and I began hearing a 'hissing sound'  especially towards sundown.  The headaches gradually became worse. I went to my DR approx. 3 weeks ago, he started me on Fioricet, which did help, until yesterday, my headaches were constant.  I will be contacting my DR on monday 6/14 and request either a MRI or cat scan of my brain. Just to rule out any other causes of my headaches.
Dose number: 5, Brand: Pfizer /  Dose number: 4, Product: Moderma; Unusual weakness, sleeping longer hours, all over feeling strange.; Unusual weakness, sleeping longer hours, all over feeling strange.; Unusual weakness, sleeping longer hours, all over feeling strange.; Extra Dose Administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GJ3275) at the age of 79 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Nov2022 as dose 4 (booster), single (Lot number: 054A22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: CRESTOR; HYDRALAZINE; XARELTO. Past drug history included: Codine, reaction(s): "Known allergies: Codine", notes: Known allergies: Codine. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, life threatening) with onset 17Nov2022 at 14:30, outcome "unknown", described as "Dose number: 5, Brand: Pfizer /  Dose number: 4, Product: Moderma"; EXTRA DOSE ADMINISTERED (non-serious) with onset 17Nov2022 at 14:30, outcome "unknown"; ASTHENIA (caused and prolonged hospitalization, life threatening), SLEEP DISORDER (caused and prolonged hospitalization, life threatening), FEELING ABNORMAL (caused and prolonged hospitalization, life threatening) all with onset 20Nov2022 at 12:00, outcome "recovered with sequelae" and all described as "Unusual weakness, sleeping longer hours, all over feeling strange.". The patient was hospitalized and prolonged hospitalization for asthenia, sleep disorder, feeling abnormal (hospitalization duration: 25 day(s)). The event "unusual weakness, sleeping longer hours, all over feeling strange." required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Dec2022) Negative, notes: COVID test name post vaccination: In hospital. Therapeutic measures were taken as a result of asthenia, sleep disorder, feeling abnormal.  Clinical information: Patient had not received other vaccines in four weeks. Other medication in two weeks: Crestor, Hydralazine, Xarelto. AE treatment: new meds and therapy. No COVID prior vaccination, COVID tested post vaccination: yes
pt recv vax 445PM 18APR96 & on same day 815PM pt woke up w/painful screaming, no color, 2 apnea episodes, given APAP;pt became unresponsive, eyes were fixed, no response to heel thumps, t102;taken to hosp seen by ER MD & adm x 24 hr
Stomachache; Doesn't care to eat anything and that's influenced her diet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Apr2021 (Lot number: EWO158, Expiration Date: 31Jul2021) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Abscess" (unspecified if ongoing), notes: Verbatim: Abscess on her rear end. Concomitant medication(s) included: FENOFIBRATE. Vaccination history included: Bnt162b2 (Dose 1, Lot Number: ER8732, Expiration date - 30Jun2021, Anatomical site of administration: Right upper arm.), administration date: 25Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Stomachache"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "Doesn't care to eat anything and that's influenced her diet". Therapeutic measures were taken as a result of abdominal pain upper, decreased appetite.  Additional information: Reporter stated, had a shot a Pfizer shot yesterday at, that would be 15Apr2021 and she has special aids and special needs but she usually was never sick and she has a stomachache and doesn't care to eat anything and that's influenced her diet and she was wondering if it's from Pfizer or from something else. Reporter stated, Pfizer Covid-19, It dose was her second. Reporter stated, she don't know if this but she had an abscess on her rear end, and she had operated on they lanced it so that the pus could come out and then she has been taking medicine for pain, but she only got 3 of those, as if the whole bunch and it was an opioid. So she was very careful that she didn't get too much and she has not had it since the second day after she had it and then she's taking another medicine. It's a antibiotic, it has, Sulfamethoxazole and Trimethoprim (Product name not clarified. Hence, not captured in tab) and that she gets 2 pills in the morning and 2 pills at night and that was from Sunday and she is still taking those 2 pills. Reporter further stated, No, because her, let's see one for pain but she only take them 3 of those on Sunday, so it was only but the name Hydrocodone, it said as Myosin (Further clarification unknown. Hence, not captured in tab.) and she was just taking for regular kind a stuff she was taking Fenofibrate. and she loves to eat and she has very little to eat and that's all we care to have stuff so she had nothing to eat today. Treatment for AE-Reporter stated, she did gave her Pepto-Bismol last night just small amount. AE Ongoing- Reporter stated, No, she said that her stomach hurts and she has sort of she maybe she eats soup that come with fine noodles and its sort of like more like of she said she didn't wanna miss that.  No follow-up attempts are possible. No further information is expected.
Very fussy-rash on bottom since vax; rash on hip area-inject given in thigh; mom instructed to give pt DPH & APAP together then give only tetanus booster & watch for rxn;
hepatitis B nonresponder; Literature Report:   This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 56 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 57 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
Shortly after receiving the vaccine I returned to training in computer lab, I was unable to continue with training. I became extremely fatigued, dizzy and weak I was unable to focus on the task at hand. All of my fellow workers were unable to complete the day as well. We were all dismissed for the day. Over the next 24 hrs  I continued to experience fatigue, weakness, shakiness and nausea. To this date I  have nerve pain in the left arm that comes and goes. I have left side nerve pain in my Thigh that is continuous (unsure if this is linked). Also in 2019 I was diagnosed with auto immune arthritis.
Immediately after the patient was given her flu shot, the patient fell forward from her chair.  The pharmacist administering the vaccine called out to another pharmacist to call an ambulance, but the mother of the patient said she was a doctor and that calling an ambulance was not necessary.  The mother said it was most likely a vasovagal reaction.  Within a minute or two of lying on the floor, the patient got back up and sat in her chair.  The patient was offered water.  After a few minutes, the patient left the pharmacy with her mother.  Patient did not seem to get hurt after falling to the floor as the pharmacist and the patient's mother were there to help her slowly to the floor.
mother discovered pt w/stiffening & extension of arms & legs lasting 3 to 4 min;no fever, limpness or cyanosis;transported by amb to hosp;pt responsive & alert in ER:transferred to another hosp;
Patient states headache started at 3am the following morning. It was a constant headache and after contacting the pharmacy on 04/29/21, we advised to contact a MD. He did not have a PCP and visited Urgent Care the evening on 04/29/2021.  I contacted him again and spoke to his spouse, (his spouse had called on 04/29).  She stated that Urgent care prescribed medication, headache was better but not gone completely.  He also had a temperature today.  She said she would book an online appoint for a Covid test..