chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: 039A21A), in left arm, on 26Apr2021 as dose 2, single (Lot number: 045B21A), in left arm, on 17Nov2021 as dose 3 (booster), single (Lot number: 027H21B), in left arm and on 18May2022 as dose 4 (booster), single (Lot number: 049L21A) at the age of 65 years, in left arm for covid-19 immunisation. The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (Lot number: GA1189) from 03Jun2022 to 07Jun2022.
I had kidney pain. First time, it woke me up from sleep and it subsided quickly. Three days later, it started in the afternoon and it hadn't subsided the next day. I stayed home from work and she had me come in to office to see her. She had me take aspirin for inflammation for kidney and the headache and she told me to re-hydrate myself and keep pushing the water and that's what I did. She thought it was from extra sugar. It resolved by Sunday -and the pain was gone. Kidney pain was gone but on Monday, I had similar symptoms occur again, I thought maybe it was a bladder infection. I felt like it was  pain in the Urethra - she did another lab test - and she said no bladder infection. She thought it was sugars expressing from my body. I'm slowly getting my sugars back under control. That resolved that same Monday in the afternoon. I had another health event: This last Sunday, on the 1st of August. I had a really bad headache. I ran a temperature. Our work rules, if you have any symptoms that may relate to COVID that I have to stay off of work for at least 72 hours and call my doctor. I called the doctor - (she is my main doctor at that office). She asked me to come in to get a COVID test. (To the parking lot) It was the nasal swab test. I drove it to the lab Monday. I had no fever as of the middle of the night Sunday night. I have had a slight headache since then. The test was negative for COVID.
As per patient's accounts vaccination area started itching and developed a rash  and turned red, no other symptom, reported, patient iced it and apply alcohol. Pt reported some relieve felt for about an hour and the the itching returned, Pt is using  alcohol wipes and icing but continues having the recurrent itchiness.
Information has been received from a nurse and the father of an approximately 4 year old female who on 5/19/95 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. In 1998, the patient was diagnosed with leukemia. The patient was hospitalized a couple of times with a fever and neutropenia, otherwise the treatment was usually outside the hospital. In 1999, the patient's varicella antibody titer IgG was 1- 80, which should have been immunity, but the chemotherapy probably wiped out her immunity. The father reported that while receiving chemotherapy for leukemia, the patient developed a mild episode of varicella that was considered an equivocal case. In 2001, after 2.5 years, the patient finished chemotherapy. In approximately 2002 the patient developed full flown chicken pox. Unspecified medical attention was sought and no treatment was required. No chemotherapy was received at that time. In June 2002 the patient was seen in the office 10 months off therapy and was doing great. The patient was last seen at the physician's office in December 2002. She is no longer a patient in his practice. It was also noted that the patient was not vaccinated at their facility. No product quality complaint was involved.  Follow up information indicated that the patinet was treated for Acute Lymphoblastic Leukemia. Diagnosis was in 1998 and she completed treatment in 2001. It was reported that she received the vaccine prior to treatment at her pediatricians office and contracted chicken pox after therapy was completed. The patient then moved from their area. Additional information is not expected.
received second dose on the 45th day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose on the 45th day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose on the 45th day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose on the 45th day) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up received on 07 Apr 2021.Updated second dosage details (patient took  second dose on the 45th day).
Patient received her second dose 16 days from the first Pfizer dose, she was supposed to have 21 days in between.
having seizures way worse than normal for about 3 weeks; This is a spontaneous report received from a contactable other health professional. Other Case identifier was 02130346. A 27-year-old male patient received his first dose of BNT162b2 (BNT162B2), in Apr2021 as single dose (Batch/Lot number: unknown) and his second dose of BNT162b2 (BNT162B2), on an unspecified date as single dose (Batch/Lot number: unknown) for covid-19 immunisation. The patient had a previous medical history of Seizures (unspecified if ongoing). Concomitant medications included: DILANTIN [PHENYTOIN SODIUM]; KEPPRA XR; EPIDIOLEX and ONFI. The patient was given a dose of the COVID mRNA vaccine one year ago in Apr2021. Shortly after receiving the vaccine, the patient began having seizures way worse than normal for about 3 weeks. The patient then received the second dose of the mRNA vaccine and the patient began seizing again at an increased rate for about three weeks after. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relationship, the association between the event convulsion aggravated with BNT162b2 can not be fully 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Myalgias-Legs, arms, back, neck, headache, Malaise 4 days as of now--symptoms still present. Treated with rest, fluids, Ibuprofen.
Patient was given a bivalent booster dose based off the information provided to us, we tried to look up in database, however, nothing was listed  as she is listed as other in database.  On 12/20/22 we determined she should have received her second dose of her primary series with the monovalent vaccine. Patient had no negative outcome. We are awaiting clinical support for a decision on revaccination or further recommendations for vaccination.
one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection; one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 21Feb2022, this case now contains all required information to be considered valid.  This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "one participant reconverted for anti-N IgG between days 90 and 210 after the prime, indicating a breakthrough infection". The patient underwent the following laboratory tests and procedures: anti-ABD antibodies: unknown results; spike antigen on antibody specificities: unknown results; spike antigen: unknown results; anti-N lgG: unknown results; Plasma samples: unknown results; core needle biopsy: unknown results; Spike protein: unknown results; SARS-CoV-2 reverse-transcription quantitative polymerase chain reaction: unknown results.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded
This spontaneous report as received from a certified medical assistant refers to a female patient of unknown age with no drug reactions/allergies. The patient's medical history included Hepatitis C. On 21-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (route and dose not reported, lot # K010016, expiration date 05-AUG-2015). Concomitant therapies included atorvastatin and omeprazole (manufacturer unknown). On 21-OCT-2014 the patient experienced achiness through the whole body, chills, fever, swollen lymph nodes and a sore throat after receiving PNEUMOVAX 23. There were an unspecified over the counter medications given as a treatment. There was no lab diagnostic studies performed. The outcomes of the events were reported as recovering. The patient did not seek medical attention. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (The patient stated that she had issues with her blood pressure due to her condition.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
expired Pentacel vaccine that was administered to a patient with no adverse event; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00328227) was received from other health care professional and transmitted to Sanofi 22-Oct-2020.  This case involved 22 months old male patient who was administered with a 0.5 mL expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ021AA, expiry date: 21-Oct-2020) (expired product administered), via intramuscular route in the right thigh for prophylactic vaccination.  Relevant medical history, past medical treatment, vaccination details, concomitant medication and family history were not provided.  It was a case of an actual medication error as expired vaccine used (latency same day).  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
under the age of 18 years old patient administered of FLUBLOK QUADRIVALENT, no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves patient (unknown demographic) (under the age of 18 years old) who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age (on same day latency).  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  There will be no information available on the batch number for this case.
Breakthrough COVID.  admitted 5/19/2022.  73 year old female with a Past Medical History of Hypertension, Hyperlipidemia, Diabetes Mellitus, Dilated Cardiomyopathy, Anxiety, Congestive Heart Failure, Pericardial Effusion, Peripheral Vascular Disease, Osteomyelitis, Smoker, Aortic Valve Stenosis, and Muscle Weakness.  She is Admitted to Medical for Hypoxemia, Chest Pain, Respiratory Failure, Shortness of Breath, Dehydration, Leukocytosis, Congestive Heart Failure, Hyperlipidemia, and Positive Troponin. First dose 1/5/2021 EK5730 Second dose 1/26/2021 EL 8982 Booster 11/10/2021  330268D
Client was standing and talking to her mother and passed out falling backward and hitting her head on the floor - hit occipital area.
This spontaneous report was received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored PNEUMOVAX 23. 4 doses were administered. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2015, the VARIVAX (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with VARIVAX (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Wrong vaccine was given, patient wanted to get M-M-R, no adverse event reported within 24 hours.
4/1/2021 patient received JNJ Vaccine 4/12/2021 Miscarriage was confirmed on Ultrasound done by and also Right Pelvic vein thrombosis seen. 4/13/2021 Patient placed on Anticoagulation.
Information has been received from a registered nurse who reported that "most patients" (95%) who were vaccinated with Gardasil (dosage and date not reported). They experienced pain at the injection site. Their symptoms lasted for 1/2 to a couple of days, the average being 1-2 days. No further information was available.
Difficulty breathing/ shortness of breath; Face and throat swelling; Face and throat swelling; Fast heartbeat; Bad rash all over my body; Dizziness and weakness; Dizziness and weakness; Pounding heart; Injection site pain and redness; Injection site pain and redness; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; Feeling unwell; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 31Aug2021 15:30 (at the age of 46-year-old) (Lot Number: FC3183) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included none. There were no concomitant medications. 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 and since the vaccination, the patient has not been tested for COVID-19. On 01Sep2021 20:00, the patient experienced difficulty breathing, face and throat swelling, fast heartbeat, bad rash all over my body, dizziness and weakness, shortness of breath, pounding heart, injection site pain and redness, tiredness, headache, muscle pain, chills, joint pain, nausea, feeling unwell, swollen lymph nodes. The patient did not receive treatment for the events. The outcome of the events was not recovered. The reporter assessed the events as non-serious.  Follow-up attempts are completed. No further information is expected.
3" red, swollen, area left thigh. Area feels hard when pressed and warm to touch. Diagnosed with cellulitis, antibiotic given.
chills; muscle aches; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced chills and muscle pain. On an unknown date, the outcome of the chills and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the chills and muscle pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient received 1st Shingrix vaccine about 24 hours ago and experiencing chills and muscle aches. The patient asked how long does this typically last.
Bone/joint pain deep inside left hip. Unable to bear weight without severe pain. Onset 25mins after injection.
Day 1 started with tingling in the left arm and hand.     By Day 2 progressed to tingling/pins & needles in both hands and both feet.     Periodic burning sensation in the palm of both hands.     These symptoms have not subsided.   Tuesday June 22 will be 2 weeks since my vaccination.
Patient received the 2nd dose covid 19 vaccine at 12:07 and at approximately 12:10 began to feel nauseated.  Patient immediately began vomiting copious amounts and had a decreased level of consciousness.  Pt was responding to painful stimuli and then after a minute to verbal commands but remained with an altered mental status.  HR tachycardia at 118 bpm, pulse oximetry initially 96 on room air.  The rapid response team arrived, an IV was established, cardiac monitor placed, Oxygen at 15 lpm via non rebreather mask. Zofran IM given prior to IV being established. Zofran IV given next. Solumedrol given IV. Bolus of Normal Saline given.  Patient transported to the emergency department via stretcher.
Patient reports he was administered Pfizer as a 2 dose in the series, after receiving Moderna for the first dose.
Onset of fever approximately 2 hrs after administration in healthy 17 YO male. Cyclical fever over the next 11 days, spiking to as high as 103.7  at night, breaking in the am. Patient experienced night sweats and chills also. CBC on 6/19/17 was normal and monospot test negative. Another bout of unexplained fever 7/11/17  through 7/17/17, also cyclical with fever highest at night, with chills and night sweats. CBC on 7/14/17 showed slight anemia but no indication of infection.
Feels that nurse gave vaccine in fat instead of muscle; Big spot and it expanding about 4 inches; Red (spot); itchy (spot); Having very heavy arm; A spontaneous report was received from a consumer concerning about a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and after a week she got big red itchy spot and it expanding about 4 inches. she was having very heavy arm and feels that nurse gave vaccine in fat instead of muscle.  The patient's medical history was not reported. Concomitant medications were not reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via an unknown route in the arm for prophylaxis of COVID-19 infection.  On an unknown date, a week after vaccination she got big red itchy spot and it expanding about 4 inches. she was having very heavy arm and feels that nurse gave vaccine in fat instead of muscle. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events are unknown.  The outcomes of the events, she got big red itchy spot and it expanding about 4 inches, she was having very heavy arm was unknown. The outcome of the event, feels that nurse gave vaccine in fat instead of muscle was considered as recovered.; Reporter's Comments: This report refers to a case of Incorrect route of product administration for mRNA-1273, lot # unknown,  with adverse events of rash macular, erythema , pruritus and limb discomfort. 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.
The event is a 3rd Heplisav B vaccine given, without a titer.  When speaking with the patient about 1 hour later, there were no current adverse reactions to the vaccine.
Chills, spot of insertion huge red and itching, and headache.  Felt awefull.  First of two shots