chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 28-FEB-2018, the patient was vaccinated with an expired dose of VAQTA intramuscular route (dose, frequency, and anatomical location were unknown) with lot # M012261 and expiration date 01-FEB-2018 for prophylaxis. No adverse effect were reported.
Patient's wife states that the patient was not alert, could not open eyes, and would only answer the simplest of questions for 3 days after 2nd booster dose of Moderna vaccine. The patient had 4 total doses of Moderna and only had this reaction on the last dose.
At 1408 after receiving her second dose of Pfizer COVID-19 vaccination (Pt. tolerated first dose without incident) Pt. started coughing in the observation waiting area. She appeared red in the face, was very hot and had a raspy voice. Pt. said she felt that her throat was tightening and that was causing her to cough. Writer got Pt. water and made charge RN aware of situation. VS were assessed by HVA at 1410 (HR: 78 bpm; O2 97%; RR 16; BP 134/78) and lung sounds were clear. It was decided to administer 50 mg of Benadryl IM in the R. deltoid at 1411. Pt. stated she normally takes 100 mg of Benadryl PO and 1-2 EPI pen doses when she feels these symptoms at home (Hx of anaphylaxis). Pt. reported little relief and symptoms persisted. EPI pen (0.3 mL) was administered at 1420 in the right lateral thigh. VS reassessed at 1420 (HR: 84; O2 97%; RR 18; BP 128/70) and lung sounds were clear. After EPI her redness subsided but her coughing continued. VS reassessed at 1427 (HR: 84; O2 98; RR 20; BP 138/76). Contacted emergency services and EMS arrived at 1435. Pt. has some relief but stated she thinks she would benefit from another dose of EPI. EMS VS at 1436 BP 106/62 (after 1 dose of EPI). A second dose of the EPI pen (0.3 mL) was given at 1440 in the L. lateral thigh. EMS VS at 1444 was BP 98/41 (after second dose of EPI was given). Pt. transported to ED via ambulance.
102F fever  for 24 hours and sever soreness at injection site. Cannot move that shoulder for two days.
COVID -   Positive test for COVID was after the vaccination - on the 18th January; I started having symptoms on the 16th  - no treatment  - just quarantine; Low grade fever; cough, tiredness; Loss of taste and smell and a little runny nose. Those symptoms lasted for about a week.   April - I had a Biopsy - and that showed it was a cancerous tumor in left breast. Surgery - has been completed and I have started the radiation therapy.  I get the radiation therapy at Radiation Center
PATIENT RECEIVED FIRST DOSE OF THE COVID-19 PFIZER VACCINE, AND ROUGHLY 5 MINUTES LATER TRIED TO STAND UP AND PASSED OUT.
Bloody Noses 2 to 3 times per day, starting the evening after the vaccine was administered, still ongoing.  There were two very bad ones today, the second one caused by sneezing once.
In August 1999, the pt wanted to donate blood and he was found to be hepatitis b core antigen positive. The pt has given blood prior with no problems. The reporter feels it may be due to the vaccine or lab error.
A third Shingrix dose was mistakenly given today 30-AUG-2022; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received his 1st Shingrix dose Dec 2021) and Shingrix (received his second dose on an unknown date).   On 30th August 2022, the patient received the 3rd dose of Shingrix. On 30th August 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.       Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's comments: The reporter was the HCP (pharmacist) who stated that the patient had received his 1st Shingrix dose on DEC-2021 and his 2nd on an unknown date. A 3rd Shingrix dose was mistakenly given today 30th August 2022. The Healthcare Professional(HCP) had nothing else to report. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received his 3rd dose of Shingrix, which led to Extra dose administered.
Pustules appeared on torso, buttocks & groin. Itchy. No fever. ZYRTEC, BENADRYL & CALAMINE lotion as needed.
redness, swelling, extreme pain, warmth and this reaction goes from the top of the shoulder to beyond the deltoid muscle; redness, swelling, extreme pain, warmth and this reaction goes from the top of the shoulder to beyond the deltoid muscle; induration at the injection site; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 11 years old male patient who experienced redness, swelling, extreme pain, warmth and induration at the injection site, this reaction goes from the top of the shoulder to beyond the deltoid muscle (inflammation), (vaccination site reaction) and (induration), while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) (guardasil as reported) in the right deltoid.  On 26-Nov-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6455CB and expiration date: 15-NOV-2020 via unknown route in the left deltoid.  On an unknown date, the patient developed a non-serious redness, swelling, extreme pain, warmth and induration at the injection site, this reaction goes from the top of the shoulder to beyond the deltoid muscle (inflammation), (vaccination site reaction) and (induration) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The physician thinks that it is either cellulitis or an immune response.  Other relevant test not provided.  Final diagnosis was induration at the injection site, redness, swelling, extreme pain, warmth and this reaction goes from the top of the shoulder to beyond the deltoid muscle and this reaction goes from the top of the shoulder to beyond the deltoid muscle.   No corrective treatments reported.  The outcome for all the events was unknown.
Information has been received from an office manager referring to a 12 month old patient of unknown gender. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # N011867, expiration date (autogenerated with 08-NOV-2018), route and dose not reported) for prophylaxis, when PROQUAD (lot #, expiration date and route not reported) was intended to be given. Product confusion was not the issue. No adverse effect was reported.
12 Hours After:  Developed an extremely sore arm, considerably worse than the reaction to the previous two vaccines.  Pain was an 8/10, couldn't lift the arm at all, pain radiated down to the arm pit, left breast, shoulder, and chest.  24 Hours After: Fever of 101.9, lasted six hours.  Chest pain remained as arm, shoulder, and breast pain began to subside.  1st ER Visit:  December 17- Sharp chest pain on left side of chest.  All test results were normal, administered IV fluids and discharged.  2nd ER Visit: December 19- Heavy, squeezing feeling in the center of the chest.  Difficult to breathe.  EKG was abnormal (nonspecific t-wave).  Held for 24 hours for observation in the cardiology wing on a heart monitor.  Echo, troponin levels normal. 3rd ER Visit: December 22- Brought in by ambulance.  Severe chest pain, difficulty breathing, racing heart (over 160bpm).  All test results normal, discharged with instructions to start taking Ibuprofen 3x/day. Ibuprofen 600mg 3x/day alleviated some of the symptoms.  Saw cardiologist on 12/27, cardiologist suspects pericarditis, prescribed colchicine. 4th ER Visit: December 30- Cramp in right leg that wouldn't go away for several days.  Checked for DVT, CT scan for blood clots, all tests negative.  Continuing to have chest pain, chest heaviness, difficulty breathing, racing heart when standing or walking, a feeling of fullness in the lungs, and muscle cramps.
Fever, rash, blister like lesions.  Irritable, sore throat, puffy face.
Patient came into pharmacy Sunday evening 6/12  after getting his prevnar20 on Thursday 6/9. He told me he experienced seizures and arm soreness after his prevnar vaccine.
thromboembolic events; She had the Pfizer mRNA Covid vaccine in Feb2021. In Mar2021 her platelets were at 135,000; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 2, single (Lot number: EN6201) at the age of 61 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Date and Time of Start of Drug: 04Feb2021, Batch/lot number: EZ9265, one time intramuscular injection right arm, Pharmaceutical form (Dosage form): Suspension), administration date: 04Feb2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: PLATELET COUNT DECREASED (caused and prolonged hospitalization, medically significant) with onset Mar2021, outcome "not recovered", described as "She had the Pfizer mRNA Covid vaccine in Feb2021. In Mar2021 her platelets were at 135,000"; EMBOLISM (caused and prolonged hospitalization, medically significant) with onset Mar2021, outcome "unknown", described as "thromboembolic events". The patient underwent the following laboratory tests and procedures: Full blood count: (unspecified date) decreased platelet, notes: had a CBC with differential and that is how they discovered the decreased platelet; Platelet count: (2020) 187,000, notes: In 2020 before any vaccine at her physical her platelets were 187,000; (Mar2021) 135,000, notes: decreased; (unspecified date) Unknown results.  Clinical course: Reported that in 2020 before any vaccine at her physical her platelets were 187,000. She had the Pfizer mRNA Covid vaccine in Feb2021 had two doses three weeks apart. In Mar2021 her platelets were at 135,000. In Dec2021 she had the first booster. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none reported. There was investigation assessment. For thromboembolic events with thrombocytopenia: Yes had a CBC with differential and that was how they discovered the decreased platelet. It was first noticed at her physical. Initially, they were not specifically looking for it. They also did titrated platelet level. Antibody test to platelet factor IV was none reported.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the reported event of platelet count decreased and embolism and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Began itchy, developed rash all over with a few hives that night and throat felt sick. Saw Dr. next day and was told she had an allergic reaction to the flu shot. Rx for medrol dose pack and visteril
Episode of status epilepticus within 30 days of receipt of AVA and Hep A vaccines in April 2000. Found down while stationed overseas and treated with medications (Lamictal) x 6 months. No records available from 2000, but some of history discussed in attached Neurology notes.
Within 12 hours he ran a fever of 102.5, within 24 hours was running a fever of 104.5. Went to doctor's office again on 7/31/03 and then to hospital on 8/1/03 where they took a strep culture and prescribed antibiotics. Within 24 hours of taking meds his fever was down to 101 then gone next day.
on 9/28/21, I woke up with a very tender, sore & hot to touch injection site, I also had a migraine & felt exhausted, ended up sleeping for the rest of the day & the next day.  The injection site remained sore & felt hot for approximately a week.  By 9/30, the migraine & fatigue let up & I was feeling better.  On 10/5/21, I woke up in the middle of the night (approximately 2am) with a tender, sore to touch & swollen right arm pit.
7 days later diagnosed with pneumonia; 3 days after developed hives on my stomach and arm; felt tired; confused; unwell; This is a spontaneous report from a contactable healthcare professional (patient). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5730), via an unspecified route of administration on the left arm on 28Dec2020 12:00PM at a single dose for COVID-19 immunization at hospital facility. Medical history included Hashimotos disease. The patient had no known allergies and has not had COVID prior to vaccination. The patient's concomitant medications were not reported. The patient reported that she felt tired and confused and unwell on day of injection, 28Dec2020. After three days (31Dec2020), she developed hives on her stomach and arm and seven days later (04Jan2021), she was diagnosed with pneumonia and continued to have hives all over her legs and arms to this day. The patient was treated with antibiotics for pneumonia. She underwent Covid test/ Nasal swab post vaccination on 09Jan2021, pending result. The outcome of the events was not recovered.; Sender's Comments: The reported pneumonia was more likely an intercurrent disease, and unlikely causally related to the use of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 54C23, expiry date 30th June 2022) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: Practice administrator reported that a dose of Fluarix vaccine was given to a 2 month old inadvertently, which led to inappropriate age at vaccine administration. The reporter consented to follow up by email or phone.
Soreness in shoulder and upper arm muscles of arm that was vaccinated.  No pain at site of injection.  Hurts to move arm overhead, side to side and to reach over opposite shoulder.  Hurts to use computer mouse for more than about ten minutes.  No previous pain or soreness in shoulder or upper arm.  Seen by primary care physician on 10/07/2010, who had no diagnosis and recommended taking 500 mg Tylenol.
Extreme headache, full body aches, uncontrollable chills/shaking and slight fever
Red swollen painful injection site as large as patient's right palm. Hot to touch. Patient had itchy sensation all over the body. Patient took BENADRYL with some relief.
got very sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE; unknown manufacturer), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very sick".  Additional information: The patient had Pfizer as her 2nd booster with the flu shot and got very sick. The reporter considered event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
hives breaking out/hives were quite large; miserable; 10 days later the back of my head itching; burning feeling; neck was red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (10 days later the back of my head itching), BURNING SENSATION (burning feeling), ERYTHEMA (neck was red), URTICARIA (hives breaking out/hives were quite large) and FEELING ABNORMAL (miserable) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Concomitant products included ALBUTEROL [SALBUTAMOL], HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ), VITAMIN D3, UBIDECARENONE (COQ-10), ZINC, VITAMIN B COMPLEX (SUPER B COMPLEX [VITAMIN B COMPLEX]), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], ACETYLSALICYLIC ACID (ASPIRIN 81) and MONTELUKAST for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PRURITUS (10 days later the back of my head itching), BURNING SENSATION (burning feeling) and ERYTHEMA (neck was red). On an unknown date, the patient experienced URTICARIA (hives breaking out/hives were quite large) and FEELING ABNORMAL (miserable). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) in November 2021 for Adverse event, at a dose of UNK, as necessary; PREDNISONE in November 2021 for Adverse event, at an unspecified dose and frequency and CORTISONE in November 2021 for Hives, at an unspecified dose and frequency. At the time of the report, PRURITUS (10 days later the back of my head itching) and URTICARIA (hives breaking out/hives were quite large) had not resolved and BURNING SENSATION (burning feeling), ERYTHEMA (neck was red) and FEELING ABNORMAL (miserable) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Medical history information was reported.   Other concomitant medications included Wixela 250/50, cholestoff, prostate plus.  Patient went to the provider who prescribed some steroids (prednisone) as a 5 day course and antihistamines which helped but they still stayed. Patient has it on his legs, shin, feet, armpits, down his arms, back, hairline, face. They put patient on stronger prednisone and took it for 10 days. They have dissipated a little over the next month. They show up mainly in the morning. Patient still has them but not as severe. They pop up when he has pressure on his skin. Patient stated will probably not take another booster shot. Patient would have to be convinced into it.   This case was linked to MOD-2022-470215 (Patient Link).
For the first two days, I had sever body pain, fever, and migranes. On the third day, I had severe chest pain and breathing difficulty that lasted for two additional days. The chest pain went away on the sixth day but the breathing difficulty lasted for a few more days. I never recieved treatement for any of the side effects.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received SHINGRIX. Concomitant products included Multivitamin and VYVANSE. On 6th March 2018 12:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th March 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, shivering, dizziness, headache and wrong injection technique. On an unknown date, the outcome of the pain in arm, shivering, dizziness and headache were not recovered/not resolved and the outcome of the wrong injection technique was unknown. It was unknown if the reporter considered the pain in arm, shivering, dizziness and headache to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the pharmacist initially injected her left arm, was unable to push in the vaccine, pulled out the needle, changed the needle, and injected the patient a second time into the left arm and was able to give the injection, which led to wrong injection technique. Limited information was provided by the patient. The patient disconnected while on hold to research her questions about side effects experienced.
Cried non-stop for about 4hrs began about 4hrs p/DTP given; Crying intermittently p/that;
16 Year old female inadvertently administered both doses of moderna covid 19 vaccine to a person under the age of 18.
Student received IM injection of Hepatitis B vaccine at approximately 11:50 AM in the right deltoid. At approximately 12:30 PM she complained of itchiness at the site of the injection. An area approximately 2" by 4" was warm to touch, slightly red and slightly swollen an ice pack was applies. She was kept under observation and the symptoms subsided in approximately 20 minutes. There were no other signs or symptoms of distress.
Patient received meningococcal polysaccharide diphtheria toxoid conjugate vaccine Menactra in the morning. Patient was in good health, and had no complaints until 07/13/2005 at 16:30 when he began to feel weak. Over the next 30 minutes patient became profoundly weak and unable to stand or walk with assistance. Patient was make recumbent for about 4 hours, given fluids, and at that point he stated that he was improving. Although still somewhat weak, he was able to walk with out assistance. There was no recurrence.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. The healthcare worker reported that, on unknown date, VAQTA (dose, frequency, route, lot number and exp. date were not reported) that underwent a temperature excursion has been administered to an unspecified amount of patients. No adverse effect was reported. Additional information has been requested.
Patient received PNEUMOVAX, next day reported reaction of swelling, heat and redness at injection site. Appt made for follow up.
pt recvd vax 16FEB93, woke up w/fever & chills;7FEB92 temp 99.5;when questioned pt states did not feel good 15FEB93 or the day recvd the vax over next wk devel cough, aching, & felt lousy;states it felt like flu 22FEB93;states feels better
pt was up 3-4times crying;normally sleeps during noc;next day & noc did not stop crying;seen in ER;red spots raised;advil given;
Ears clogged slight head pressure. Ringing in ears. No other symptoms. No pain No nose running No fever.