chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 61-year-old female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting SHINGRIX, the patient would get partial cases of shingles which would go away before blisters were fully formed). On an unknown date, the patient received the 1st dose of SHINGRIX. In December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, allergic reaction, erythema, skin rough and injection site vesicles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, skin rough and injection site vesicles were unknown and the outcome of the shingles was recovering/resolving and the outcome of the allergic reaction and erythema were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and skin rough to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the allergic reaction, erythema and injection site vesicles to be related to SHINGRIX. Additional details were provided as follows: The patient had an allergic reaction to the SHINGRIX. The 2nd dose wadded up under her skin and she got a huge red circle that stayed forever, at least 2 weeks. In the last week from the date of reporting, the patient developed a full blown case of Shingles and had to be treated with Valtrex. The shingles was mostly resolved at the time of reporting, but she did still have a little roughness. The reporter consented to follow up. This case was considered as suspected vaccination failure as time to onset for the event was unknown.
This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included METFORMIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criteria hospitalization and medically significant). The patient was treated with CARVEDILOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 220/140 (High) Blood pressure was recorded as 200/140 in emergency.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Four days ago the patient received her 2nd coronavirus vaccine. She received at the hospital pot. She received her 2nd Pfizer vaccine. She tolerated her 1st vaccine dose without incident. She did not have any problems approximately 15 minutes after her 2nd dose and she was then released to drive away. About 30 minutes after her 2nd dose she developed nonspecific symptoms of shortness of breath and a sensation of something sticking in her throat. She presented to the emergency department. She did not receive epinephrine. She was monitored and received intravenous fluids and diphenhydramine. She notes ongoing itching with rash and which she describes as exacerbation of asthma. She has known asthma with frequent exacerbations. She has been hospitalized numerous times in the past for asthma exacerbation. Now that it has been several days since her vaccination and she is still having rash and difficulty with her asthma we have discussed initiation of low-dose steroids for ongoing improvement.
PATIENT VERBALIZED DIZZINESS AND WAS SWEATING PROFUSELY AFTER RECEIVING COVID VACCINE,  HE VERBALIZED THAT HE HAD A PHOBIA OF NEEDLES AND APPEARED TO BE VERY ANXIOUS. ALERT AND ORIENTED X3, VITAL SIGNS STABLE, BP 128/80 RR 24 PR 88 T 98.1 AFEBRILE. NO S.SX OF ANY ACUTYE DISTRESS, BREATHING IS EVEN AND UNLABORED. DENIES ANY PAIN, NO INDICATORS OF PAIN PRESENT. GATORADE OFFERED, PATIENT STARTEDTO FEEL BETTER A FEW MINUTES AFTER DRINKING GATORADE, ASYPTOMATIC. APPEARED TO BE LESS ANXIOUS. PATIENT RESTATED THAT HE HAS A LONG HISTORY OF NEEDLE PHOBIAS. MONITORED FOR ANOTHER 15 MINUTES, ASYMPTOMATIC. NO SSX OF ANY DISTRESS, MD PRESENT AND CLEARED PATIENT FOR DISCHARGE. NEEDS MET, PROVIDED A CALM,SAFE, AND COMFORTABLE THERAPEUTIC MILIEU.
Pt a period of 4h shaking, 7 AM, 01-12-08. 3 mild seizures with fever. 1st one afterward seen by paramedics. He felt it was febrile seizure. Seen at ER; found to have UTI infection.
Female developed symptoms and then tested positive for Covid-19 despite having 3 shots of the vaccine.; Female developed symptoms and then tested positive for Covid-19 despite having 3 shots of the vaccine.; Female developed symptoms and then tested positive for Covid-19 despite having 3 shots of the vaccine.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative and product quality group.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: On a medication for high blood pressure; "Cholesterol" (unspecified if ongoing), notes: Maybe on something for cholesterol. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Female developed symptoms and then tested positive for Covid-19 despite having 3 shots of the vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The patient was fairly healthy overall. She has had a mild case and has not needed to go to the hospital. The event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the vaccine at 10:10A. Patient reported the following symptoms at 10:19A: Heart racing, Palpitations, numbness in the hands. Staff present were RN and  RN. After coaching with her breathing, her heart rate went from 111 bpm to 87 bpm. Her SAO2 remained at 99% throughout the encounter. Patient reported eating breakfast and having coffee to drink this morning. Patient denies chest pain, itchiness, difficulty breathing. Patient given 240 ml of water and then 240 ml of apple juice. Patient reports no known allergies. Patient denies any prior history of cardiac or respiratory problems. Patient reports history of anxiety and depression and reports that she is taking medications for these diagnoses. Patient reports that she has had panic attacks previously. Patient denies any prior reaction to a past vaccine. Vital signs taken at 10:10A, 10:32A, and 10:43A were all within normal limits. Patient encouraged to wait an extra 15 minutes for observation. Patient presented to Dr. Dr. agreed with plan to monitor extra 15 minutes and allow patient to leave if no worsening of symptoms and after further teaching and precautions reviewed. Patient reported feeling better and after ER precautions reviewed with patient and patient agreed with plan. Patient left at 10:43A.
Right under arm pain and swelling 2 mornings after receiving booster Covid and flu vaccines. It is the arm that the Covid vaccine was given in.
I developed "COVID arm."  I had soreness, redness, swelling and itchiness
Pt developed chest pain and heard a "pop" in his chest.  Dyspnea worsened. Diagnosis is pneumonia.
pt states her left arm started swelling, itching, became hot to the touch.  Her left shoulder is swollen like the size of an orange.  She has pain from her shoulder down to her hand.  It is starting to spread to the chest.  She has a painful red bump between her collarbone and her left shoulder bone which she thinks maybe a lymph node. Pt has contacted her doctor and is waiting for a call back for medical advice.
her brother got cancer because of the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "her brother got cancer because of the vaccine". Clinical course: Caller was calling in about the covid-19 vaccine, caller wanted to know why it was called vaccine if it is a shot. Caller mentioned that vaccine was meant to prevent something. Reporter mentioned that she knew many people who have gotten the quote unquote vaccine. Also, she was asking why Pfizer was continuing to provide something that was proven to create situations such as cancer, heart attacks etc. to a very large percentage of the population. She further asked that why were they being allowed to do this and under what approval they were allowed to provide something that created these situations. She mentioned that her brother got cancer because of the vaccine. She said that she guarantees that she will join any class action. Caller wanted to know how many vaccines Pfizer have. She also mentioned that the vaccine has side effect that has been devastating to the entire world and she hoped that Pfizer run out of business. Also mentioned that 80% of the population was suffering because of this. She also said that Pfizer is a criminal organization and will be sued. Caller refused to provide manual AE form because caller's brother got cancer after the vaccine was administered. Caller mentioned the Pfizer COVID vaccine was shoving down the throats of people in the country and around the world.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster related conditions. In October 2014, the patient was administered ZOSTAVAX by a healthcare provider (lot# and route unknown). In November 2014, the patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
cough after second dose; fever after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough after second dose) and PYREXIA (fever after second dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (cough after second dose) and PYREXIA (fever after second dose). At the time of the report, COUGH (cough after second dose) and PYREXIA (fever after second dose) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Reporter did not allow further contact
Information has been received from a pharmacist concerning an 83 year old female with osteoarthritis, hypertension, hyperlipidaemia and allergies to xylocaine and epinephrine who in July 2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included TENORMIN, ACCUPRIL, hydrochlorothiazide and AROMASIN.  On 07-AUG-2007 the patient started to experience shingles-like symptoms that included sores on both sides of her mouth, swelling of the lips, tingling sensation in her lips and rash on each cheek, forehead and one of her hands.  As of 13-AUG-2007, the patient had not recovered from her experiences.  Medical attention was sought.  Additional information has been requested.
The facility was not aware of the patient having a booster dose on 3/17/22 so a booster dose was given on 6/7/22. The dose was not given at least 4 months from the 1st booster.
On the day of the vaccine 01/13/21 I developed a fever, chills, muscle aches, headaches, and swollen lymph nodes in my left armpit and and left neck. I still have these symptoms three days later.
Breakthrough case admission after 3 vaccines  Moderna 1/18/21 lot# 012L20A;  Moderna 2/15/21 lot# 010M20A;  Moderna 11/2/21 No LOT#
I was feeling really tired, and a bad migraine that I took Tylenol. That only lasted a day, a little bit of body aches. My migraine was to the point where I couldn't see.  My arm did swell up and was very itchy and soar. About a week later my was really red, itchy and swollen. It lasted for three weeks so I went to the Dr. The Dr. put me on antibiotics and it went away in two days. The vaccine was given more towards the back of my arm and even the Dr. said it shouldn't have been given there.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 31 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
pt brought to ED with CPR in progress; CPR had been started 30-40 minutes prior to EMS call; code called to stop after 1 hr. 15-30 mins after initially started; reported to be positive for COVID; pt had a positive COVID test from hospital where pt was staying
Death; suspected vaccination failure/ Got shingles shot. Got shingles in eyes, died in a month; Shingles in eyes, close to brain, died in a month; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), vaccination failure (serious criteria GSK medically significant) and ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the vaccination failure and ophthalmic herpes zoster were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death, vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-Sep-2022 Reporter's comment: This case was reported by a patient's friend via interactive digital media. Reporter stated patient got the Shingles vaccine. The patient got shingls in eyes, was too close to patient's brain, however died under a month. Additional supportive information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.; Reported Cause(s) of Death: Death NOS
A circular rash developed a week after the injection. It has grown steadily and is now (13 days post-injection) to approximately 4" in diameter. It itches on occasion.
received notification from pharmacy that  the vaccination was kept in the refrigerator longer than allowed. resident did not have any adverse effects from this.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2014, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a healthcare facility, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2015, the patient was treated by the healthcare facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Diffuse erthymic , pruritic rash from injjection site of left deltoid extending to upper right shoulder.
Immediately after first dose at clinic needed Epi pen shot ego recognition could leave cuz couldn't breath. Both does was sick as hell, has progressively gotten worse, currently have pneumonia, bronchitis and blood clots and  "elevated risk of more"; To an extent that the er doctor says I should be concerned. This vaccine poisoned me, there no "possibly" no "allegedly" , these vaccines are why I am sick.
Shortness of breath, cough, dizziness, severe air hunger, weakness, fatigue,
51 yo  M p/w virtually for rash to all extremities within 48 hours of receiving second COVID 19 vaccination on 24 MAR. He reports noting itching and small 'hives' and bumps that were red in color as well as itchy. When scratched they would burst and have fluid in them. He reports only other change is he starting using OTC medication for athlete's foot. He self treated with 50 mg of Benadryl q12h and has noted improvement in symptoms since Sunday. He reports no F/C/myalgia/arthralgias.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 26-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), for Covid-19 immunization; Bnt162b2 (Dose-2), for Covid-19 immunization; Moderna (Dose-3), for Covid-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "recovered", described as "muscle aches"; HEADACHE (non-serious), outcome "recovered"; CHILLS (non-serious), outcome "recovered"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "recovered" and all described as "a red, swollen, itchy, and warm injection site (commonly known as COVID arm)".  Additional information: Patient experienced negative side effects following the fourth COVID booster vaccine (bi-valent). These side effects included muscle aches, headache, and chills for one day, as well as a red, swollen, itchy, and warm injection site (commonly known as COVID arm) for approximately three days. Optional Information: Patient has previously received the initial two Pfizer shots, a Moderna booster, and now this bivalent Pfizer booster. Patient has reacted poorly to all COVID vaccines to date, with each reaction being different in symptoms. Patient has no comorbidities and was currently not taking any medication.  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.
CHEST PAINS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced chest pains. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pains was not reported. This report was non-serious. This case is a duplicate of 20221158489.
Patient reports after her third COVID shot, she experienced the following: headaches, diarrhea, vomiting, loss of taste, difficultly breathing. These symptoms last for approximately 2 weeks.
I woke up with severe itching on my left hand and arm and small welts and bumps also appeared.  Later in the day large welts appeared on my left upper arm. They were very itchy.