chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was inoculated with ZOSTAVAX at a medical office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at the same medical office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not recovered/not resolved. Causality assessment was related. Additional information has been requested.
Taken to the Hospital due to a fracture, severe UTI and sepsis. Dies at the Hospital.
About a week after the vaccine shot, I developed a large circular rash over the injection site. It is raised off the skin and itches horribly. It started about the size of a dime and has grown to be about 2 inches in diameter.
Itchy/painful rash developed on back of left arm into armpit and down to mid side.
Patient started having ongoing uncontrolled perspiration 4 days after vaccine administration. Patient reported to pharmacist on 3/5/17.
Severe chills with shivering thermogenesis for only ~10 minutes (1 episode only). I was unable to speak for a few minutes due to the uncontrolled muscle contractions and was just generally too uncomfortable to move. It was not a seizure, but it was temporarily debilitating. Once I got myself wrapped in a warm blanket, it only took about 10 minutes to pass (and never returned). The rest of the day I did feel generally ill, but the day after I felt completely back to normal.
Red spots varying in size on left and right side of face, and left and right arm. Similar in color.  Legs swollen and red from the knees down,
This is a spontaneous report from a contactable consumer via Pfizer employer. A male patient of an unspecified age and ethnicity received TRUMENBA (Lot# 43514 Expiry date: 31Jul2016), via an unspecified route of administration on 30Aug2015 at single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced itching and bradycardia. His blood pressure was 90, then his blood pressure went to 88/60 and then 88/77 at 4:30pm on Aug2015 with outcome of unknown. Pulsation was of 40 and went to 60 at 4:30 pm. All events occurred on unknown date in Aug2015 and the outcome was reported as unknown. The patient received 500cc of normal saline solution and then his pulse went to 87 and blood pressure to 110/84. The Pfizer employee mentioned the patient did not have any past medical history. Follow-up (09Sep2015): Follow-up attempts are completed. No further information is expected.
No adverse reactions. Moderna vaccine given on 04/21/2021 (1st dose), however: patient had the Jannsen vaccine on 03/24/2021, and thought that she needed a 2nd dose.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note: "Patient is a 91 YO year old female with past medical history of persistent atrial fibrillation, CAD, HTN, and subdural hematoma who presented with difficulty breathing and tachycardia.  Patient was tested COVID positive.  CT chest abdominal and pelvic show multifocal pneumonia.  Given concern for bacterial pneumonia, patient was treated with Rocephin, and her breathing status has improved.  Unfortunately, CT angiogram of the aorta and runoff shows complete occlusion of the left common femoral artery and Complete occlusion of the right profunda femoris . CTS surgical team was consulted, CTS recommends that patient may likely require left AKA and right BKA. Discussed and explained to her son, Son states he does not want any surgery for her. Son elected for hospice. He signed with hospice on 5/29."
Pt with underlying COPD and chronic respiratory failure requiring BIPAP. Pt had cardiopulmonary arrest on 2/24/21 and died as a result. Pt was overall palliative-focused plan of care.
Status epilepticus - treated with home vimpat and phenytoin load Septic shock requiring norepinephrine
Feet started feeling cold and tingling the evening of the injection. Tingling moved up to calves, then thighs. Small amounts of muscle twitching in legs. On Sept. 26, I went to the doctor who did numbness and muscle tests and he said to come back when it was worse.  Arm with injection site became more sore. Developed pain in neck, left shoulder and arm. On Oct. 2 I went to the doctor who did numbness and muscle tests. He said to come back when it is worse. Over two weeks later my arm still feels very sore and I still have tingling in my legs.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for about 1 minute, urinated during fainiting. Paramedics checked patient vitals, everything was norma-blood pressure, heart rate. Pt has history of fainting in the past. Followed up with pt at 6 pm 7/25/21, pt is doing well with some headache. Before vaccination pt did not eat and he exercised. Pt received Pfizer Covid vaccine at 12;15 pm.  Pt also said that he felt dehydrated, he only consumed caffeine in the morning.
I received my 1st COVID vaccination at about 10:30am on Monday, March 8th, 2021. I engage in rigorous aerobic exercise regularly, including swimming. On the day of my 1st vaccination I did not exercise that day. About 24 hours later, late morning March 9th, I was at the pool for a workout that lasted about 90 minutes. Usually in the pool I may experience a bit of lower leg cramping, if any. But during this swim I experienced a considerable amount of lower leg cramping. After my March 9th swim I was not in the pool again until three days later on March 12th. During that swim I experienced absolutely NO leg cramps. I can?t say if the cramping 24 hours after my 1st vaccination was caused by it, or if it was simply coincidental.
extreme thirst; feeling lightheaded; feeling strange with the thirst; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (extreme thirst), DIZZINESS (feeling lightheaded) and FEELING ABNORMAL (feeling strange with the thirst) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced THIRST (extreme thirst), DIZZINESS (feeling lightheaded) and FEELING ABNORMAL (feeling strange with the thirst). At the time of the report, THIRST (extreme thirst), DIZZINESS (feeling lightheaded) and FEELING ABNORMAL (feeling strange with the thirst) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not provided by the reporter. Concomitant product was centrum. patient had taken Shingrix Vaccine in July & Oct of 2020,   This case was linked to MOD-2021-282754 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up received and contains non significant information.
Site of injection red, hard, tender. Ibuprofen 350mg Q6hrs x3. Benadryl 25mg HS and AM only. Cold pack.
Fever, body aches, cough, diarrhea, loss of smell, congestion, shortness of breath, watery eyes, and runny nose. Prednisone 20mg 1 twice a day 9 tablets, cefuroxime 500mg 1 twice a day 10 tablets, azithromycin 500mg 1 tablet daily 3 tablets, Tylenol 500mg 2 tablets every 6 hours.
no adverse event; administered an improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 21-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S021324 a,d expiration date 05-JAN-2021, for prophylaxis (dose, strength, route of administration and frequency were not reported). Sterile Diluent used was properly stored.      The patient experienced no adverse events. It was reported that the vaccine had a temperature excursion of 6°F to 14°F (7.5 F) for 11 hours and 30 minutes. Previous excursion of 6°F to 14°F (40 F) for 18 hours was reported. No digital data logger was involved.
Gave 0.25mL of the Moderna Bivalent; gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (Gave 0.25mL of the Moderna Bivalent) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks).    No concomitant medication was reported.  Reportedly, one pharmacist had been only giving 0.25 mL of the Moderna Bivalent Booster shot to approximately 30 patients including reporter and her husband. The pharmacist who only gave 0.25mL of the Moderna Bivalent Vaccine had the assumption that it was just the same as the first Moderna Vaccine. They gave another 0.25mL of the Moderna Bivalent Vaccine to that patients with an interval of two days and two to three weeks.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654629, US-MODERNATX, INC.-MOD-2022-654591 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2022: Live non significant follow up information received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654629:Husband case US-MODERNATX, INC.-MOD-2022-654591:Remaining patients case
She is breastfeeding; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (She is breastfeeding) in a  patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during breast feeding.    No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (She is breastfeeding). At the time of the report, EXPOSURE VIA BREAST MILK (She is breastfeeding) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter. This is a case for the baby exposed to product via breast milk. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Additional information - Contact information provided; Sender's Comments: This case report concerns a  breastfeeding female patient of unspecified age who was administered mRNA-1273 vaccine Lot# unknown (vaccine exposure via breast milk). There was no associated adverse event reported for the event of vaccine exposure via breast milk.
Patient developed visual symptoms the week following administration of the COVID vaccine. Symptoms included blurry vision and double vision. Patient did not seek care. Patient received 2nd dose of Moderna vaccine on 5/12 and had escalation in symptoms after that dose. Patient finally saw her PCP on 5/18 who immediately sent her to optometry where she was noted to have papilledema. She was sent to the ED where an MRI/MRV confirmed increased intercranial pressure without space occupying lesion. LP showed elevated opening pressure of 45/ Patient started on Diamox for presumed IIH.
Report received via a healthcare student on 04-OCT-2010 (received via Merck WAES: 1010USA00210). An 82 year old female patient received 0.5ml dose of AFLURIA (batch 0644911A, expiry 24-JUN-2010) via intramuscular route on 01-OCT-2010. The patient's medical history and concomitant medications were not reported. On 01-OCT-2010, the patient received an expired dose of AFLURIA. No adverse effects were known. The event outcome was unknown. No additional information available. The reporter did no give a causality assessment. The company considered events unassessable. Information derived from this AE report does not change the current safety profile of the product.
A 20 year old female was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. The patient experienced bronchospasm and laryngospasm almost immediately after vaccination. The paramedics had to be called and the patient received Benadryl injection before symptoms resolved. Another patient had a similar reaction with MMR. It was reported that the physician  is "uncomfortable using MMR from the same lot". Upon internal review the patient's experience was considered an other important medical event. F/U states another pt (WAES01092710) had a similar reaction after receiving the same vaccine lot number and dilutent vail. The records of testing prior to the release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologic Evaluation and Research and was released.
Nausea, general malaise sl elevated temp 99 orally, 24 hrs p/1st dose Hep B vax; sx lasted approx 8 hrs;
I began heavily spotting/bleeding 2 days after on 9/18 and have spotted every day since. Currently 1 week straight of spotting and cramping. This occurred 2 weeks before my usual menstrual cycle
Hoarseness, fast/ erratic heartbeat, dizziness Blood pressure shot up. Did not go to Dr. Ill for several days
A 25 year old female patient experienced fever and hives after post exposure treatment with RabAvert following bat exposure. The bat was found dead but not sent for testing. The patient recieved Rabies Immune Globulin and the first dose of RabAvert on 09/07/04. She was observed in the health department office for one hour and sent home. An unknown period ot time later the patient presented to the university student health services with complaint of fever and hives from head to toe. She gave a history of having finished a course of sulfa one week prior and by the fifth dose her throat had swelled shut. The patient was given Zyrtec and sent home.
Patient received first dose of the Moderna COVID vaccine about 1 hour prior to arrival to the emergency department.  Patient developed an itchy rash to her face, neck, arms and back.  Patient did not have any complaints of shortness of breath, throat swelling or airway involvement.  Patient treated with solumedrol, benadryl and pepcid.
Right thigh and left thigh contusion. Rx: warm compress and TYLENOL PM.
This was the Moderna booster - received the 2-shot series of Pfizer vaccine in March 2021.  After 2nd dose of Pfizer noticed fatigue, pain and swelling at injection site that last about 5 -7 days, and swollen lymph node in the  axilla.  The booster, administered on 12/15/21  has produce much more pronounced symptoms.  By later that night I had developed tinnitus (present and noticeable but not debilitating).  Beginning the morning after, significant body ache that worsened through the day, fever off an on through the day; fever that produced drenching sweats during the night.  Continued  moderate  body ache into the next day with headache and abnormal fatigue.  Today, 12/18/21, the body ache is present but mild, headache present but not as painful.  And the tinnitus has continued; not changed since the first night.
July 13th and 14th pain at injection site and fatigue. July 15th at 6:00am to current chest pain
The patient tested positive for COVID-19. The patient arrived in the emergency room with fever, cough, malaise, fatigue, and shortness of breath. The patient was discharged on 08/21/21 in good health.
Depression and anxiety/gotten worse; Depression and anxiety/gotten worse; Brain fog/gotten worse; Brain fog/gotten worse; Fatigue /gotten worse; This is a spontaneous report from a contactable other health professional (registered nurse reporting for her son).A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.On an unspecified date, A week or two later after first dose he started getting a lot of fatigue and brain fog and became depressed and anxious over the last few months. The patient had second dose 09Mar2021. States it has just gotten worse. Caller wants to know if this has been reported or if this could be related to the vaccine. The outcome of the events was not recovered.  Information about batch/lot number has been requested.; Sender's Comments: Based on the plausible temporal relation, the association between the events of anxiety aggravated, depression worsened, brain fog, brain fog condition worsened and fatigue aggravated with the suspect product of BNT 162B2 cannot be completely ruled out. 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.
Symptoms began 12 minutes after vaccine given. Back of throat felt tight; tingling in arms; shaking; red splotchy rash on front and back of neck, behind ears, chest; red fine rash on both arms. 50mg Benadryl PO and 0.3mg EpiPen IM (L thigh) given at 4:29 pm. EMS called at 04:29 pm. States she is feeling better at 4:30 pm. Transported to ER by EMS at 4:40 pm. Medical director notified of reaction at 8:10 pm.
Woke at 6am feeling dizzy. By 7:30, I was vomiting, lose stool and cold sweats. Lasted until approximately 1:00pm. Still feeling lethargic and have slight headache
Next day, site of injection was red, warm and in pain.  By night, affected area was more swollen and expanded; not sure if put ice.   Patient went to bed.  By Wednesday, affected area worsened and it expanded more. Patient called the doctor who recommended Advil/Tylenol.   Since rash was spreading patient went to doctor on Wednesday. Doctor prescribed a 10-day use of Doxycycline and  Mupirocin ointment.  Patient went back to doctor on 10/15 since arm still hurt and ache. Doctor did not extend prescription; by then area was a greyish bruise, not inflamed, but turned red when rubbing. Doctor described problem as infection of pathway of lymph nodes but did not provide any instructions in terms of care.  Patient went back to pharmacist on 11/18 and pharmacist was not sure if patient covered for shingles.   Recovery at 50% lingering ache where rash was. Patient received Flu on same facility as vax administrator.
pt recvd vax OCT95 & the following day devel an inj site rash characterized by raised itchy bumps;this rxn resolved w/o treatment by the third day post vax;
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 67 year old white and non Hispanic or Latino female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s unspecified manufacturer (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose and therapy start date was not reported, 1 total administered on unspecified date for prophylactic vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: 11-APR-2022) with dose less than 0.5 ml ( approximately around 0.3ml), 1 total administered on 01-DEC-2021 at right arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  The HCP (health care provider) reported that they had a pod on 01-DEC-2021 and a HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL (vaccine underdose) and had off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.(Dose number in series 2) The outcome of the individual received less than 0.5ml vaccine as a booster dose and off label use was not reported.  This report was non-serious. This case, from the same reporter is linked to 20211209551, 20211210067, 20211209976, 20211210058, 20211210160, 20211210588, 20211210112, 20211210197, 20211210159, 20211210610, 20211210409, 20211210555, 20211210733, 20211210408, 20211209880, 20211209816, 20211209782, 20211212088, 20211212082, 20211210662, 20211209679, 20211209740, 20211210670 and 20211210824.