chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 6-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), at the age of 5 years on 09Nov2021 as dose 1, single (Lot number: FK5127) and on 02Dec2021 as dose 2, single (Lot number: FK5127) at the age of 6 years, all intramuscular for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included multivitamin with iron. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "patient tested positive for COVID-19 on 01Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) positive. Sender's Comments: Linked Report(s): US-PFIZER INC-202201053004 same patient, different vaccine dose/AE.
Terrible headache, horrible body aches, felt exhausted, slept for 18 hours
Physician reported that pt experienced a case of breakthrough chickenpox with an unspecified number of lesions. Pt sought medical attention.
Started feeling achy with ?fever on Fri evening; by Saturday AM had fever 101 degrees, arm swollen, sore, red and hot to touch-feeling better by Sunday evening. By Monday AM, arm still warm and slightly pink borders barely visible.
2 hrs post vaccine arm discomfort 12 hrs post vaccine - fever up to 101.6, chills, left axilla lymphadenopathy, left arm pain, headache, muscle aches, joint pain
Patient got dizzy after vaccine administration and needed to lie down. Paramedic on-site checked her blood pressure and it had dropped a bit but patient never lost consciousness.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # L024993 with expiration date 17-OCT-2017; lot # M018810 with expiration date 28-MAY-2018; dose and route were not reported). The vaccine was improperly stored at 32 Fahrenheit for 41 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician refers to a 69 year old male patient. The patient was enrolled in a post marketing active surveillance. The patient's medical history and current conditions were not provided. On an unknown date in approximately 2015, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported). Secondary suspects and concomitant therapies were not reported. On an unknown day in October 2015 (six weeks after injection), the patient experienced new herpetic lesions in buttock area - developed shingles event after vaccination with ZOSTAVAX. The physician felt that ZOSTAVAX was not effective. The outcome of new herpetic lesions in buttock area- shingles after vaccination was reported as recovered on an unknown date approximately in 2015. The outcome of vaccination failure was unknown. The relatedness between adverse events and ZOSTAVAX was unknown (also reported as "not sure"). Additional information is not expected due to no consent to contact Health Care Professional was given.
About 5 minutes after the administration of the vaccines both sites had quarter size redness. After another 5 minutes the redness did not increase in size. Benadryl was given.
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No Adverse Event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed or tested positive for COVID-19.     On 18-Sep-2022 at 12:46 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Sep-2022 at 12:46 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    Patient received vaccine in deltoid. The patient received first three doses of MODERNA COVID-19 VACCINE,  Intramuscular and deltoid. No concomitant product reported by the reporter. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. No treatment medication reported by the reporter.
Headache for 1-2 hours after injection. Also itching at injection site. Ate a meal and headache went away, scratched site and itching stopped.
Discharge Provider: DO Primary Care Provider : MD (Inactive) None Admission Date: 9/23/2022 Discharge Date: 09/29/2022 Admitting Diagnoses: Principal Problem:   Generalized weakness Active Problems:   Hypertension, unspecified type   Persistent atrial fibrillation   Anticoagulated   Uses walker   At risk for falls   Acute low back pain   Chronic pain of left knee   Lab test positive for detection of COVID-19 virus  PRESENTING PROBLEM: Generalized weakness   HOSPITAL COURSE: The patient is a 90-year-old female with a history of atrial fibrillation on atenolol and Eliquis, as well as essential hypertension, who presented on 09/23 with increasing fatigue and COVID infection.  The patient's husband had recently been admitted for COVID infection.  He had been discharged to home, the patient reported that she had been doing well, but had been performing daily COVID tests in preparation for a scheduled echocardiogram and cardioversion.  The patient was noted to become positive on 09/21, and started on Paxil bid on 09/22.  Patient noted a slight cough, as well as overwhelming fatigue and weakness prompting her to come to the emergency department on 09/23.  At the time of admission, chest x-ray was negative for infiltrates.  Patient was noted to have stable vital signs, and good saturation on room air.  She was admitted for further observation for her COVID infection with severe weakness.  The patient did note a ground level fall several weeks prior to admission, with back pain.  Plain films showed anterolisthesis, but no acute fracture.  The patient was seen by PT/OT who initially recommended SAR. Patient was treated with supportive care for her COVID infection with significant improvement of weakness.  Patient re-evaluated by PT on 9/28 and changed recommendation to home with HHC PT/OT.  Patient discharge on 9/29 with HHC nurse/PT/OT.
Post vax, the pt had prolonged fevers, muscle aches, headaches, and flu-like symptoms.
Pt was seen on 3JUN93 for check up which time rt thigh skin area approx 10mm there is a depression/indentation; mom denied any erythemia, swelling or fever assoc w/vax;
I had shingles 3 to 4 weeks prior to receiving my vaccine.  Within 2 to 3 hours after the vaccine, I felt a burning sensation on the left side of my forhead going up into my scalp and then the shingles rash appeared. I was put on antiviral medication. I also had to see an eye doctor because the shingles rash started to both my vision.
Pt. stated, "My arm feels heavy.  It happened as soon as I got vaccinated."  At 10:32am pt. stated, "It's getting better."  At 10'6 pt. stated, "I feel ok, I can go home now. The heaviness is gone." Pt went home at 10:49am.
Severe migraine-type headaches for 2 weeks, starting within 5 hours of receiving the vaccine
Information has been received from a physician concerning a 32 year old male patient with Wilson's disease and decreased immunoglobulin levels who was vaccinated with 2 doses of PNEUMOVAX 23. Concomitant therapy included "penicillamine" (manufacturer unspecified). The patient underwent lab tests. The results indicated a decrease in immunoglobulin and negative pneumococcal titers. On an unspecified date, the patient developed pneumonia and was hospitalized. The patient had visited office for medical attention. The outcome of the patient's adverse effect was not reported. Additional information has been requested.
Provider was sick requiring her to call out.  Weakness resulting in inability to move/tremendous headache/body and bone aches/internal aches/diaphoretic periodically  Pain and today swelling at injection sight
it starded hurting a lot; Had such strong pain that it even made her cry; cannot breathe; lots of fever; a very strong headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (lots of fever), HEADACHE (a very strong headache), DYSPNOEA (cannot breathe), PAIN (it starded hurting a lot) and CRYING (Had such strong pain that it even made her cry) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B12LA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported.).    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (lots of fever) and HEADACHE (a very strong headache). On 08-Apr-2021, the patient experienced DYSPNOEA (cannot breathe). On an unknown date, the patient experienced PAIN (it starded hurting a lot) and CRYING (Had such strong pain that it even made her cry). At the time of the report, PYREXIA (lots of fever), HEADACHE (a very strong headache), DYSPNOEA (cannot breathe), PAIN (it starded hurting a lot) and CRYING (Had such strong pain that it even made her cry) outcome was unknown.            Treatment details included Tylenol.
Headache (severe), muscle, skin, joint pain (body), fever, swollen lymph node in armpit (left arm), fatigue.      Two days since booster.
Within 1 week of injection, patient reported pain in deltoid tendon region--required PT, multiple doctor visits including ortho, steroid injection and she is now WORSE with increased pain/decreased ROM more like adhesive capsulitis.  I will check no disability/permanent damage box, but it is really too soon to say as she has not recovered after months. Has  limited use of arm--difficulty especially with grooming.
Parent informed us that patient did not feel well via phone and will be taken to urgent care, but did not specify symptoms
Moderna COVID 19 vaccine #1 given 2/4/21 at 130pm. Patient had malaise, confusion on 2/5. She then had 3 generalized seizures- status epilepticus- on 2/5 around 4-5pm. MRI brain and labs unremarkable. She recovered 36 hr later - on Keppra.
Patient recived a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
This is a Spontaneous report from a contactable consumer (the patient), from a Pfizer sponsored program. A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration on 12Oct2017 at single dose for immunization (pneumonia shot), and INFLUENZA QUADRIVALENT VACCINE, via an unspecified route of administration on 12Oct2017 at unknown dose for immunisation. The patient medical history and concomitant medications were not reported. The patient got pneumococcal 13-val conjugate vaccine (dipht crm197 protein) along with the influenza quad vaccine. The patient told the doctor that she had already had the shot but he gave it to her anyway. In addition, after four days she started developing pain in her left leg. The outcome of the events was unknown.
pt states felt sick, limp about 1hr p/vax;went to work that noc feeling bad & nausea, fever, malaise & seen in hosp ER 3AUG97;2AM 4x for allergic rxn;painful, red raised, itchy blotches all over body;pt broke out again & felt bad;told rxn;
Information has been received from a practice manager concerning a female patient who on an unspecified date was vaccinated with Gardisal (yeast). Subsequently, following vaccination, the patient experienced syncope. Unspecified medical attention was sought. No further details were provided. At the time of this report, the outcome of the event was unknown. Additional information has been requested.
32 year old / received Infanrix; Intended vaccine was Boostrix; 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 32-year-old male patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th August 2021, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 details were provided as follows: The health care professional reported that the 32 years old patient inadvertently received Infanrix  in the right deltoid, which led to inappropriate age at vaccine administration. The Intended vaccine was Boostrix , which led to wrong vaccine administered. The reporter consented to follow up. This is 1 of the 2  linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021173224:Same reporter
RED SWOLLEN ARM WITH HARD PAINFUL LUMP UNDER SKIN; GENERALLY NOT FEELING WELL; FATIGUED.
A few minutes after vaccination,  sitting in chair started to feel dizzy, tachycardic, almost an anxious feeling- lasted about a minute or so, then subsided. I did not report it that day because I thought it may have been anxiety
Pt received vaccine on 1/10/00, felt weak and fatigued.  Pt received additional vaccines on 1/12/00, felt malaise, fatigue, fever.  On 1/14/00, pt had palpitations, syncope, fast heart rate. 1/17/00 saw MD pos atrial fib.
was scheduled to receive their second dose of GARDASIL 9, however just before the vaccine was going to be administered, the patients guardians refused the vaccine, resulting in a missed dose; No additional adverse events reported.; This spontaneous report was received from a nurse and refers to an unknown patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 13-APR-2021, the patient was scheduled to receive their second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. However, just before the vaccine was going to be administered, the patients guardians refused the vaccine, resulting in a missed dose. No adverse effects were reported.
sore throat, body aches, nasal congestion, headache, chills, diarrhea. starting 1/9/2022
I was diagnosed with shingles on 10/24/2018. Symptom of pain only in midsection began on evening of 10/21/2018. Rash was not noticed but was present at time of diagnosis. Never got blisters. Did receive anti-viral. My concern is whether steroid shot made me more vulnerable to getting shingles with the shot.
The infection got worst, different physicians have diagnosed the patient with herpes; Felt sick; This is a spontaneous report from a contactable consumer (patient's mother). A 22-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via unspecified route of administration on 10Mar2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medication was not reported. It was reported that the patient had received the first dose of the Pfizer COVID-19 vaccine on 17Feb2021 and shortly after was diagnosed with a severe yeast infection and received treatment for this. On 10Mar2021 the patient received her second dose and the infection got worst, different physicians have diagnosed the patient with herpes. Due to this reaction the patient had to be transferred to the emergency room a couple of times. The patient felt sick and went to emergency room stated she had herpes. The outcome of the events was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Pulmonary embolism; Is pregnant: yes; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 14:00 (Batch/Lot Number: EL3249) and dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 (Batch/Lot Number: EN6200); both as single dose for covid-19 immunisation. Medical history included pregnancy, allergies to penicillin and Covid prior to vaccination. The patient's concomitant medications were not reported. The patient has no other vaccine in four weeks. The patient experienced pulmonary embolism on 18Apr2021 16:00 which resulted in doctor or other healthcare professional office/clinic visit. CT scan and ultrasound were done, and patient was given lovenox injections. The patient is pregnant with last menstrual cycle on 20Jan2021; delivery date will be on 05Nov2021. The patient was not tested for Covid post vaccination. The outcome of the event pulmonary embolism was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported event Pulmonary embolism cannot be excluded based on a compatible temporal relation. The contribution of pregnancy to thromboembolic events should also be considered. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Five minutes after injection patient reported itching feeling around arms near both injection sites.  Area was red at the time, about 6 minutes after the injection visible raised rash began with continued itching to both arms.  No rashes appeared over any other location other than the arm directly above and below the injection site.
p/vax pt exp a 2cm swelling w/redness @ the inj site & a 1cm swelling of a lymph node in groin;also noted sleeping well, fussiness & an on & off appetite;
That an acute onset of accelerated heart rate and high blood pressure - 205/160 - 166 beats per minute for heart rate and I was just sitting watching the news. It persisted. I kept waiting for it to resolve but in 30 minutes I was still up there. . I called 9-1-1 and they told me I could drive myself to ER.  I went to ER - and they told me I was in sinus rhythm but everything was fast. My magnesium level was extremely low - 1.1, I think. I have not been able to get my magnesium levels to get up to normal.  The doctor has been trying to help me get  my magnesium level  into the normal range after getting out of hospital; I have had  out-patient infusions (2, four hour infusions in the hospital - and four or five since I've been out; I have another one tomorrow)  and oral supplements - it's still sub normal.  Had another episode a week ago Friday - Heart rate went up to 120 out of the blue - within 15 minutes it was back down to normal . Blood pressure was okay at that time - not near what it was when I had the episode in June. It was in the 120s over high 70's.