chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received series, showed no immune response; Engerix-B series on 21Sep2001, 20Nov2001, and 27Jun2002; Engerix-B series on 21Sep2001, 20Nov2001, and 27Jun2002; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 20-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th June 2002, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 20th November 2001, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 21st September 2001, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 20th November 2001, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 27th June 2002, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The office manager reported that the patient received second dose of Engerix B on 20th November 2001 and third dose on 27th June 2002.  The doses were given at a different facility, so reporter did not had the lot number or expiration date information. The patient was going to be starting nursing school and recently had lab work that showed no immune response to hepatitis B. The plan was to revaccinate the patient, though this had not been initiated at the time of reporting. The reporter consented to follow up. Additional Supportive Information: The patient completed the series of Engerix B, but result showed no immune response, which led to therapy non-responder. The patient received the second dose and third dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule.
Palpations and burning sensation of the heart for about 1 hour. After that dizziness and low blood pressure (96/56) for about 24 hours. The second COVID-19 shot (Moderna 059H21A) on 12/28/21 gave me palpations only for about 10 minutes but I still had dizziness and low blood pressure for around 24 hours
Extreme fatigue, burning muscles, bruising, night sweats, borderline low platelets, high MPV, dizziness, cannot exercise
COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness at the injection site) and VACCINATION SITE SWELLING (Slight swelling at the injection site). On 19-Jan-2021, the patient experienced INSOMNIA (Difficulty sleeping), VACCINATION SITE INDURATION (Muscle being hard as rock), VACCINATION SITE PAIN (Pain at injection site/very tender) and VACCINATION SITE SWELLING (Arm more swollen than last week). On 13-Jan-2021, VACCINATION SITE PAIN (Mild soreness at the injection site) and VACCINATION SITE SWELLING (Slight swelling at the injection site) had resolved. At the time of the report, INSOMNIA (Difficulty sleeping), VACCINATION SITE INDURATION (Muscle being hard as rock), VACCINATION SITE PAIN (Pain at injection site/very tender) and VACCINATION SITE SWELLING (Arm more swollen than last week) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow-up information received on 13-Apr-2021 does not contain any new information. On 23-Apr-2021: Follow-up information received on 23-Apr-2021 does not contain an new information
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as DOSE 4 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 48 years old for COVID-19 immunization; Covid-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 1, single (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): Positive, notes: COVID-19 treatment. Therapeutic measures were taken as a result of Drug ineffective, Covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
About an hour after receiving the Moderna bivalent vaccine (right deltoid) and a Flublok flu vaccine (lotUJ893AA) (left deltoid), she began having laryngospasm (stridor and could not talk).   She called our office to report it and we referred her to the local  ED where she received racemic epinephrine and Solu-Medrol.  She was observed for approximately 6-7 hours.
Chills, headache, body aches. Lasted about 18 hours. No treatment.
nausea, vomiting, numbness (tongue and lips).  Evaluated by EMS-Cleared
Employee was vaccinated with Flucelvax (NDC: 62577-0614-01, lot# 174085, exp# 05/2016).  Approximately 1 hour later, employee experienced swollen upper palate progressing to a feeling of throat swelling.  Visual assessment shoed a markedly swollen area along the midline upper palate.  Employee's voice was affected as well, raspy and hoarse.  Benadryl 50 mg PO was given and the employee monitored 1:1 for 2 hours with an EpiPen immediately available.  Her symptoms began to resolve during the 2 hour monitoring and she went home for the day.
Pt stopped breathing mom did mouth to mouth; took to ER where was stabilized; then referred to MD; pt has irregular heart beat & appointment w/peds cardiologist; pt has heart monitor;
This case was reported by a physician via call center representative and described the occurrence of local reaction in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local reaction. The patient was treated with MOTRIN and Ice pack (NOS). On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that he had a patient who had a local reaction. The reporter did not recall any details other than he told the patient to apply ice and take MOTRIN and call him if it did not improve. This case is linked with US2018032633, as reported by same reporter.
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment included Antibiotics.
chills; muscle ache; joint pain; sweat; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received second single dose of BNT162B2 (Solution for injection, lot number: EL3247, exp date not reported), via an unspecified route of administration  (Anatomical location: Arm Right)on 20Jan2021 15:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient previously took first single dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunization. The patient experienced chills, muscle ache, joint pain, and sweat on Jan2021. The events were considered as non-serious. The outcome of events was unknown.
Discharge Provider: MD Primary Care Provider at Discharge: PA-C  Admission Date: 11/25/2022 Discharge Date: 12/06/2022 COVID positive Date 11/25/2022 Discharge Provider: MD Primary Care Provider at Discharge: PA-C  Admission Date: 11/25/2022 Discharge Date: 12/06/2022     HOSPITAL COURSE: Per HPI or hospital summary: "79 years old female with the past medical history of obesity, depression/anxiety, iron-def anemia, and UC with ileostomy, hx of DVT/PE, hx of obstructing ureteral stone, NICM, presented to ICU with septic shock from e. Coli bacteremia and e. Coli/aerococcus UTI will not have with right pyelonephritis without hydronephrosis or obstruction, as well as + COVID and entero/rhinovirus.  Course complicated by tachy-brady arrhythmias, multi-pressor shock, and AKI on CKD stage 3 requiring CRRT followed by dialysis.  Renal function continues to improve and was able to stop dialysis.  She was noted to have hold ATN diuresis with and was maintained on IV fluids a reverse oral hydration to help.  In   With patient's AFib and history of DVT she was managed on a heparin for reviewed tachy-brady syndrome with concern for needing cardioversion initially was transition to lower no with Eliquis with renal function along with amiodarone load.  And rice use a patient remained in sinus rhythm.       Follow ups  BMP 2-3 weeks may need increase in eliquis if renal function continues to improve close to higher dosing F/u WMC ziopatch at discharge     "   Interim hospital course:  Patient treated with antibiotics for pyelonephritis, receive Rocephin and plan to complete an additional 3-4 days of Omnicef at discharge to complete a course of therapy.  Patient to follow-up with Cardiology in the outpatient setting was started on amiodarone as well as low-dose Eliquis given renal function during her hospital stay.  ZIO patch placed prior to discharge will need outpatient follow-up with Cardiology to continue her care as well as dose adjust Eliquis of her renal function continues to improve.  Recommend follow-up with primary care physician the next 1-2 weeks.  Patient seen by PT OT with plans discharge to subacute rehab today with transportation set up at 17:00 per care management.  Medically stable for discharge to subacute rehab on 12/06/2022.
I talked to the patient about the incident, apologized, and told her to stayed in the pharmacy for 30 minutes, so I could monitor her. The patient was fine. She had no adverse reaction or symptoms. She went home safely without any adverse reactions.
1. Because of my issues with gadolinium, the facility had me wait 30 mins after my vaccine. I felt transient head issues but nothing notable. I felt a little dizzy as I was leaving the facility but didn't make much of it. It went, and I felt great. I had 'normal' side effects for the next two days (a little dizziness off and on, but nothing major).  2. For the last 2 days however (i.e. approx. Days 7 and 8 since the vaccine), I have acute dizziness.   3. I also have other issues which I believe are expected and which have mostly resolved, such as: very bad stomach pain (mostly resolved); very bad headache initially (resolved); pain in left shoulder and chest area above heart last night (resolved now); weird pain/fullness feeling in lung/ribcage area (resolved).
Post vax, the pt developed body aches and pains, dizziness, diarrhea, and nausea.
Moderna COVID-19 Vaccine EUA Injection site itchiness on the evening of 1/30/21 (8 days following first dose administration). Morning on 1/31/21 red/hot rash at injection site, sore lymph nodes and fatigue
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 10-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX, lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013111: US-009507513-1701USA013082.
Began with injection site, head, neck pain, nausea. Progressed to total body pain especially in head, small joints and large muscles. Pins and needles in extremities. Extreme fatigue and heaviness.  Occasional chest pain.
swelling, pain, erythema, warmth, tingling, cellulitis several rxn; treated w/ice, elevation anti-inflammatories, ATB
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pcp. it was the weekend after her vaccine she got \"hives all over body and itchy\" We reccomended she take bendryl and head to the emergency room after she reported to us.
From 5/21/2022 Admission H&P:  The patient is an 81-year-old female who presents to the ER with dizziness and sudden onset of shortness of breath that lasted for approximately 1/2-hour today.  She recently flew approximately 1 month ago.  She denies any chest pain, cough or hemoptysis.  There has been no leg swelling or pain.  She has not noticed any heart palpitations.  During the ER evaluation a D-dimer was significantly elevated at 17,680.  CT of the chest does confirm multiple numerous large acute bilateral pulmonary emboli.  There is increased RV/LV ratio concerning for right heart strain.    She will be admitted to the hospital for IV anticoagulation and EKOS.
On 09/13/2022 I received my Covid-19 vaccine. On 12/12/2022 I had a routine doctor appointment I was given a chest Xray. the finding of the test was that I was diagnosed with mild COPD and thyroid cancer.
2 x2 cm of erythema and edema developed over the following 24 hrs post injection of Prevnar into light thigh.
Approx 5-10 min after receiving the injection patient c/o not feeling well, lightheaded, visual migraine (has history of. Assisted to private location and removed some of her winter garments to cool her. She also took in water as she had not drank much that day she stated. Ice pack to the back of neck also applied. Vitals taken and wnl. Affter approx 10 min patient states headache resolved and was feeling slightly better. Observed till symptoms resolved. Denies any resp symptoms during entire process. No swelling anywhere on person.
Lump the size of a lime at injection site that is itchy and hot to the touch. Soreness in upper arm from elbow to shoulder with any movement and stiffness in shoulder.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 8, 8.3 and R; 24, 9 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Moderna COVID-19 Vaccine EUA The day after I received the 2nd dose of the vaccine I had a headache. That same night I ran a fever and woke up the next morning feeling ok. I was taking a shower and it was reported to me by my fiancé I had passed out, started to seize, my eyes rolled to the back of my head. A few minutes later I woke up on the floor and asked what had happened. I was not sure what had happened.  I felt fine when I woke up. When first responders arrived they asked me if I knew who I was, the date, the president, where I lived to all I was able to answer correctly. I went to the ER and they did a ECG, blood test, urine test, chest x-ray, CT of my head and they said everything came back normal. I was prescribed Keppra and have an MRI scheduled in the coming week.
immediate reaction; trouble breathing/shortness of breath, sweating, dizziness, hives, nausea, fast heart rate
03/04/21 - @2:55pm - Follow up with Dr. on Labs - told left eye was hemorrhaging, and right eye is stable. 03/05/21 @ 6:45-8:50 am - Went for Covid Vaccine (J&J) 03/05/21-03/08/21- Severe Headache, Nausea, and stomach pain 03/11/21 @ 5:30 pm - MRI of the Brain & Orbits 03/12/21 @ 11:30 am - Labs 03/19/21 @ 6:30 am - Lumbar Puncture 03/22/21 call from Dr. explained headaches and severe pain in the head. 03/29/21 - Appt with PCP 04/01/21 @ 2:20 pm Appt with Dr. to follow-up from Labwork 04/07/21 - Vomited 4x - strong pain in stomach 04/08/21 - Appt at Dr. office 04/09/21 @ 5 pm appt with Acupuncture for headaches 04/13/21 ? I woke up to work and could not see anything. Went to Dr. for an emergency visit & testing done. He Confirmed I am hemorrhaging in my right eye as well.  04/15/21 @ 9 am ? appt at Dr. office for Eylea Injection on the right eye. 04/19/21 @ 4 pm appt with (Neurology)
20 minutes of intestinal cramping, diarrhea, and migraine a few hours later. But I got better after an hour.
Pt in clinic for mtx reading of c/o itching to her legs. Mother noticed and had daughter had hive on her legs only. It was about 3pm 08/01/02. Pt saw MD. Dx hives. Benadryl 12.5mg tid as needed. Hives are disappearing and no itching.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021 at 12:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 12:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.71.  Concomitant products were not provided.  On 24-May-2021, Excursion time was 08 AM, temperature was 35, Excursion time was 09AM, temperature was 35, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 18-May-2021, vial was moved to clinic on 24-May-2021. 3 vials were sent to clinic. Vaccine BUD date was 17-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I was working in the urgent care and the father brought this child in 24 hours after he was given his 2mo vaccines.  Per father ~ 12 hours after receiving the vaccines child broke out in rash; beginning at head and slowly spreading over face, then back and trunk and arms.  When I saw him the rash had extended onto his legs.  He was well prior to receiving the vaccines and family felt sure rash was from vaccines.  He also had increased irritability and did not sleep all night.  when I saw him he looked well except for the rash.  He was alert and playful.  He had no respiratory of GI symptoms.