chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a hospital, for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. Additional information has been requested.
swelling around injection site; redness around injection site; This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The nurse reported that within hours after the injection, the patient experienced very large reaction of redness and swelling (5 inches diameter) around the injection site, which lasted for 5 days. The reporter consented to follow up.
inj site sl raised; red area 30 x 50mm @ inj site;pt seen in MD office;pt also exp rt arm numbness; dizziness & vomiting; hosp;
No adverse reaction; patient received the incorrect vaccination, as she should have received Fluzone Quad not High Dose
Patient came in and asked if she was having a normal reaction to flu shot she received. Arm was red, swollen, and bruised looking. Arm was also warm to the touch. Patient stated the swelling had gone down some since it occurred. Instructed patient to take an OTC NSAID, BENADRYL, and hydrocortisone cream.
This spontaneous report as received from a pharmacist refers to a 85 year old patient with no drug allergies/reactions. The patient's pertinent medical history was none. On 28-APR-2014 the patient was vaccinated with ZOSTAVAX (lot # J008436, expiry date: 11-OCT-2014, Dose: 0.65 milliliter (ml), subcutaneously. Concomitant therapies were reported as nothing really significant. On the first day patient was fine, (injection) site just a little warm. "Pharmacist stated that "in the last 2 days, the injection site was red, swollen and has blisters around it. The pharmacist reported that he was not aware of lab diagnostic studies performed. The outcome of injection site just a little warm and the injection site was red, swollen and has blisters around it was unknown. The causality was not reported. The patient sought medical attention (reported as contacted pharmacy). Additional information has been requested.
Zero discomfort at injection site or for 4 hours after, but at almost exactly 4 hours +one minute, upper portion of left arm became unusable. Could not lift arm, or support even as much weight as a tissue.  Could not pull pants up. Needed help changing clothes. Unable to sleep that night. Symptoms persisted through next day, but began to resolve very gradually 24 hours after onset. By day 4, arm was back to normal. However, 7 days after injection,  woke up with arm unusable again. Same time progression -- arm non-functional and extremely uncomfortable (not excruciating, but very intense)  for about 24 hours. Another night of no sleep. Gradual improvement over 3 days. Pain was largely confined to muscles in upper arm, but radiated partially up left side of neck, and occasionally down into lower arm.  A small price to pay for not getting the virus though! No other aches, pains, fever or nausea.
A few days following the 3rd dose (booster) of the Moderna vaccine, I experienced intense headache, nausea, light sensitivity, and lightheadedness.  This lasted for approximately 3 days.  I do not get headaches of this sort at any time.  Following 3 days, the headache and other symptoms dissipated and have not returned.  No other adverse events.
Starting the following day after receiving the vaccine, I had all of the symptoms listed for the vaccine and I had to be hooked up to oxygen at my doctors office due to having trouble breathing. These symptoms lasted for about 3-5 days and then resolved.
Severe headache, bowel movement change, dizzy, vomiting; pt denies any local reaction;
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
About 3 inches below the injection site, developed a 3-4 inch wrap around bruise. Area was itchy. Recommended BENADRYL and ice.
first evening I felt woozy, vertigo. Morning after had mild headache, general aches and difficulty controlling body temperature. Hot to cold. Lasted 3 days then eased. However, the vertigo is not going away and I am 9 days passed vaccination.
Initial information received on 15-Nov-2018 regarding an unsolicited non-valid non-serious case received from a nurse via phone. This case involves a 66 years old female patient who received a 0.5ml first and second dose of FLUZONE QUADRIVALENT, lot UT6290KA via intramuscular route in the left deltoid on 04-Oct-2018 and 02-Nov-2018 respectively. Concomitant medications included was Pneumococcal Vaccine for Immunisation. The patient's medical history were not reported. It was an actual medication case error due to extra dose administered. The patient received two FLUZONE QUADRIVALENT 0.5ml, intramuscular injections in her left deltoid one month apart. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This spontaneous report was received from a consumer regarding her 25 year old daughter. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown in 2009, the patient was vaccinated with GARDASIL. The reporter stated that her daughter did not complete immunization series of GARDASIL. She inquired if she can finish or restart series since she is not yet 26 years. Additional information is not expected as the reporter contact details were not provided.
Add'l info was received on 2/6/03 from a healthcare prof'l provided event outcome. A healthcare prof'l reported that on 1/2/03, a 22 y.o. female nurse inadvertently injected herself subcutaneously w/Prevnar. She was administering the Prevnar to a child when the child kicked her and she accidentally injected the Prevnar in her left hand. Subsequently, her hand became swollen and painful. She was treated with fexofenadine. She recovered.
This is a spontaneous report from a contactable pharmacist, reporting for his daughter, via a Pfizer sales representative. This female patient of an unspecified age, race and ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on an unspecified date for immunization. The patient medical history was not reported, there were no concomitant medications. On an unspecified date the patient experienced nausea, vomiting, headache and pain at injection site. Events outcome was unknown.
Bulus lesion then ulcerated the whole size L deltoid and and now pt has to have surgery.
memory loss of all events that happened that day.  For a 3 hour period patient could not remember what had happened that day at work, his appointments after work, that he had gotten hearing aids 2 weeks prior and that he had ever seen or worn hearing aids.  He was very confused for about 3 hours.  I called our doctor and he advised me to take him to the ER, it took me 45 minutes to get him there and by that time his memory was back.  He has never had a problem like this before and I thought he might be having a stroke or something.  there was definitely something severely wrong.
Moderate to severe joint pain lasting 6 hours, moderate muscle aches lasting ~4 hours. Acetaminophen did not help.
Caller wanted information about the Pfizer COVID-19 Vaccine Bivalent being able to cause vaginal bleeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary immunization series completed with unknown manufacturer.), for COVID-19 immunization. The following information was reported: VAGINAL HAEMORRHAGE (non-serious), outcome "unknown", described as "Caller wanted information about the Pfizer COVID-19 Vaccine Bivalent being able to cause vaginal bleeding". Therapeutic measures were taken as a result of vaginal haemorrhage.  Additional information: Caller wanted information about the Pfizer COVID-19 Vaccine Bivalent being able to cause vaginal bleeding. She received the booster yesterday. Caller stated she takes warfarin and that she's over the period of being able to have babies. Caller also felt concerned that she was asked if she takes any blood medication before receiving the vaccine.  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.
I developed endometriosis due to this vaccine as well as several heart conditions including SVT (Superventricular tachycardia) also, about a year later I went into emergency surgery with my gallbladder rupturing. I am constantly tired, I have no energy at all. I developed headaches shortly after the vaccine and i have never been the same. I have also developed several ovarian cysts. Had to have surgery on my uterus.
4 wks post inject-wkly visit pt exp diarrhea, vomiting, CXR-diffuse COPD, limited infiltrate;
8:50 AM Flu shot given (R) arm. 12:15 P rash noted to neck and chest - sl. red maculopapular fine rash to neck and torso - arms and legs without rash. 12:45 P seen at health clinic.
Patient received the Moderna COVID-19 second dose vaccine on 4/7/21 -> she did fine + had no symptoms + had a good night sleep that night. On 4/8/2021 at 10:30AM she fainted and ambulance was called in around 11:15AM -> patient was taken to the hospital & released 4/18/21 @ 2:00PM  MD informed & will see the patient on 4/16/21
pt with history of "anaphylactic" type reax to allergy shots in past and aspaaragas 3 years ago for which she was given epi. today after vax she reports "peppery" feeling in the back of her throat and R side of tongue.  Dr administered 25 mg of benadryl po and 45 min later a second dose of 25 mg po.  Oral cavity examination was repeatedly negative.  Lungs were clear to auscultation.    She was monitored closely on site for over an hour before stating she felt well and wanted to go home.
Whole body (and teeth) started to shiver severely beyond my control; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 38-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0175), via an unspecified route of administration in arm right on 17May2021 at 16:45 (at the age of 38-years-old) as dose 1, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 17May2021, the patient experienced i was able to walk away after 30 minutes but it was a traumatic experience and on 17May2021 at 16:45, the patient experienced whole body and teeth started to shiver severely beyond my control. The patient reported right after receiving his Pfizer first dose, his whole body and teeth started to shiver severely beyond his control. He wasn't feeling cold or anything bad apart from that. That lasted for about 15 minutes or so and then it got milder by time. The pharmacist called an ambulance and paramedics checked his vital signs. He was able to walk away after 30 minutes but it was a traumatic experience. The events resulted in emergency room visit. It was unknown if the patient received treatment for the events. The patient recovered from the event on an unspecified date in May2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Formulation was made with .3 of diluent instead of 1.3 of diluent. Patient received a 20mcg dose of the vaccine instead of the recommended 10mcg of the vaccine.
was  diagnosed with multiple bilateral pulmonary blood clots; This is a spontaneous report from a contactable Nurse (patient's wife). A 73-year-old male patient (Husband) received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 06Feb2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient received his first COVID vaccine dose on 06Feb2021. On 10Mar2021 he was admitted to the hospital for trouble breathing and was diagnosed with multiple bilateral pulmonary blood clots. He was hospitalized from 10Mar2021 to 13Mar2021. Seriousness of the events was reported as hospitalization. Outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of multiple bilateral pulmonary blood clots cannot be excluded. 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.
On 3/30/2023, I contacted my doctor to see if I should simply see him or go to an urgent care or ER to investigate the causes of a slight sensation that I had in my upper chest. The sensation was similar to the slight sensation that I had in 1996. The sensation is hard to describe, partly because it is so slight. It feels as if you put your forefinger on your breastbone or if you're holding your breath really hard; there's no pain or pressure. In 1996, the only sensation I felt was as if you put your finger at the base of the throat. A 1996 investigation led to four bypasses. The surgery then went extremely well. The doctors told me then that when veins are used in bypasses (two were used in my case), the veins can wear out in an average of 15-20 years, but in my case, several doctors assured me that this would not apply. They emphasized that this was just an average. Since 27 years had passed since the bypass, I thought I should look into it. When I did this, I underwent an echocardiogram, an angiogram, a stress test, and an ultrasound. The results indicated that I'm doing very well and that the veins used in the bypass were "completely clean."  When I asked if I could resume my regular activities, my doctor said, "Absolutely!" When I asked the doctor why I felt this way, he said that he didn't know. I'm very active and exercise regularly. I don't have hypertension or high cholesterol. I'm also not overweight.
Wheezing; Shortness of Breath; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2022 at 12:15 as dose 1, single (Lot number: FK9895) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "If covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DYSPNOEA (non-serious) with onset 21Feb2022 at 15:30, outcome "unknown", described as "Shortness of Breath"; WHEEZING (non-serious) with onset 21Feb2022 at 15:30, outcome "unknown". Therapeutic measures were taken as a result of wheezing, dyspnoea.  Additional information: The patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No other medications in two weeks. Received treatment with Rescue Inhaler. The patient had covid prior vaccination. The patient was not tested for covid post vaccination. Known allergies: NKDA. Other medical history included: Asthma  No follow-up attempts are possible. No further information is expected.
Bells Palsy; This is a spontaneous report from Pfizer - General Company Information received from contactable consumer reporting for himself (patient). A male patient (Age: 49; Unit: Unknown) received bnt162b2 (Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included DVT (deep vein thrombosis). Concomitant medication included ongoing rivaroxaban (XARELTO) taken for DVT. The patient developed Bell's Palsy after receiving vaccination shot on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Patient vaccinated with Covid vaccinations and was admitted to hospital with Covid symptoms.  She came to the ED with shortness of breath and dyspnea and was admitted with pneumonia due to covid and hypoxia.
Tested positive for Covid while traveling. Got care at home with Ivermectin. Ibuprophen, loratadine, ambroxol and azotromicin. symptoms lasted for 15 days. Still have cough and light headache.
get COVID despite being vaccinated; get COVID despite being vaccinated; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), (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: "COVID" (unspecified if ongoing), notes: had COVID the first of the year.t was, it was in Dec. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "get COVID despite being vaccinated".  Clinical information: Age of patient was between 80-84. Patient infected with COVID, despite being vaccinated. Physician asked the patient what was the last time that he had took the COVID vaccine. Patient answered that he had took first, second and booster dose and didn't get second booster. Doctor asked whether it was more than four or five months of his last dose. Patient replied yes and said that he has not taken second booster because of COVID infection in December. Causality: Not reported.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective and covid 19 with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
Case number PHEH2016US004977, is an initial spontaneous report received from a nurse on 25 Feb 2016. This report refers to 44 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157904) at a dose of 1 ml, intramuscularly on 23 Feb 2016. The reported stated that, FLUVIRIN was administered after a temperature excursion of 1.4 degrees C (Celsius) for 1.5 hours. The nurse assessed the case as non-serious. No adverse event was reported following this medication error (incorrect storage of drug).
Gardasil #1 12/12/06, Gardasil #2 2/12/07 New onset seizures on 3/8/07 and 3/9/07 (non-hypoglycemic0
From initial info received on 10/22/03, from a health care professional, regarding a death occurring, it was reported that a 79 year old female pt died of a "heart attack" on 10/19/03, two days after receiving a dose of Fluzone SV '2003-'2004, lot number U1260AA, given IM in the left deltoid on 10/17/03. The reporter stated that the case of death indicated on the death certificate was cardiac arrest. A 15-day follow up report received 11/04/2003 adds: From additional info obtained on 10/27/2003, from a telephone conversation with the reporter, it was stated that the responsible physician is waiting for follow-up documents. The reporter also stated that she was not sure if there will be an autopsy report and that they had not yet received any hospital records or test results. The correct spelling of the responsible physician's last name was also provided. A 15-day follow up report received 11/13/2003 adds: From additional info received on 11/06/2003 from faxed correspondence from the reporter, it was reported that the pt had pre-existing conditions of hypertension, hyperlipidemia, osteoarthritis, spinal stenosis, acromegaly and Parkinson's disease. The pt received the influenza vaccine on 10/17/2003 and expired on 10/19/2003 at 9:31 AM. Per the reporter, the pt's death was not caused by the vaccine. The death certificate was also provided and the "immediate cause" of death was listed as cardiac arrest . Both hypertension and hyperlipidemia were listed as "underlying cause". No other info was reported. Case is closed.
A few hours after receiving my second shot my arm got very red and developed a hot, painful rash. I also have a fever of 102 along with chills and fatigue.