chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was admitted for further medical management post multiple falls.  COVID-19 testing came back positive patient was placed in isolation precautions. Chest Xray showing no active cardiopulmonary process.
flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th January 2021, the patient received the 1st dose of Shingrix. On 11th January 2021, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved.   The reporter considered the influenza-like symptoms to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient started developing flu-like symptoms after the shot and thought it prudent to get tested for coronavirus, flu and anything else they were offering that day no matter how trivial. The patient tested for the flu and COVID-19, and both results came back negative. The reporter consented to follow up.
felt like I had a bad case of the flu; Chills; High temperature; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer link case US2021AMR064339)).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza-like symptoms, chills and high temperature. On an unknown date, the outcome of the influenza-like symptoms, chills and high temperature were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills and high temperature to be related to Shingles vaccine.  Additional details were provided as follows:  This case was reported by patient himself/herself. The age at vaccination was not reported.  The age group was not reported but was selected as an adult as per vaccine indication. The patient received 2nd dose of Shingles vaccine and felt like he/she had a bad case of the flu with chills and high temperature for 2 days. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064339:same reporter
Pt felt dizzy prior to leaving after vaccination. Denies LOC. Pt ambulatory at time of transfer to med obs #1. Pt offered and accepted goldfish crackers and water. Pt requested to leave quickly after arrival to med obs, stating she felt better. VS at 1803: BP 145/86, HR 91, RR 17, O2 sat 99% on RA. VS at 1808: BP 152/98, HR 90, RR 17, O2 sat 99% on RA. No s/s of distress noted at time of d/c to home. Pt refused wheelchair escort to exit, but agreed to staff ambulating with patient to exit.
Started with extreme pain in feet at night, then the pain was also in my calf muscles, and the sensation felt like crawling, burning. By August it had spread to my thigh muscles.  At that point the pain was so bad that I was unable to sleep. My leg muscles had become extremely weak, and I was unable to take my morning walks, do regular housecleaning or gardening, and I walked with a limp. No OTC pain medication could take the edge off the pain. My doctor treated the pain with Meloxicam and tylenol on August 5, which took the edge off the pain, but it's not always effective. Blood tests revealed a Rheumatoid factor of 43 Units/mL (Normal range is below 14.) and referred me to a Rheumatologist. The earliest appointment I could get with any rheumatologist in my network is September 17, 2021, so I haven't seen the rheumatologist yet and do not have a diagnosis. Since it took so long to get an appointment with the rheumatologist, I decided to try to ease the symptoms in the meantime by changing my diet. Three weeks ago I cut out dairy, gluten, and legumes and added the vegetables and meat. This has given me enough relief from the pain that that I'm able to get some sleep most nights.
taken COVID 19 Treatment; taken COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: CVS01477) at the age of 28 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Food - sweet potatoes" (unspecified if ongoing), notes: Known allergies: Food - sweet potatoes. No medication allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "recovering" and all described as "taken COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Now, 13 days after testing positive; (11May2022) faint positive, notes: a rapid at home test went from a faint positive line 2 days after ending Paxlovid to a bold; (13May2022) positive, notes: positive line 4 days after ending Paxlovid. Therapeutic measures were taken as a result of covid-19.  Adverse event: Consumer experienced a rebound of COVID symptoms in the week after he finished the Paxlovid course. Congestion and cough came back and were worse than while he was taking the Paxlovid. Additionally, a rapid at home test went from a faint positive line 2 days after ending Paxlovid to a bold, positive line 4 days after ending Paxlovid. Now, 13 days after testing positive and 8 days after finishing Paxlovid, his symptoms are the worst they've been so far. Antiviral details: Paxlovid started on 05May2022 for treatment of COVID-19 and stopped on 09May2022.
2 INCH BY 4 INCH ITCHY, RED RASH THAT DEVELOPED ONE WEEK POST VACCINATION
One week after injection I started to experience muscle soreness and pain.  As the day went on there was heat, redness and rash around the injection site that developed and hasnt gone away.
Patient received second dose of Pfizer vaccine. Both patient and her daughter went to the car to wait. Was approached by security as daughter returned to the center stating her mother was having a reaction. I went to the car & assessed patient. Patient c/o numbness/tingling along the left side of her face and head. Significant tremors and shortness of breath noted at the time. Daughter went and secured wheelchair & we brought the patient back into the vaccine clinic. VS at 1340: BP: 164/65, PO2: 88% on 3L, HR: 60 Patient reported anxiety prior to coming in for vaccine. VS at 1347:  BP: 184/82, PO2: 94% on 3L, HR: 60. Patient states numbness/tingling increasing; reporting circumoral tingling/numbness. 25mg Benadryl given. VS at 1355: BP: 233/102, PO2: 92% on 3L, HR: 60 Discussed with Pharmacist. EMTs called for transport to ED per patient's request. Observed in ED and d/c home with no further treatment in stable condition.
A pharmacist reported that a 29 year old female inadvertently, received a DT on 10/22/99. Pt developed an injection site reaction characterized by nodules, swelling, erythema, warmth and pain. Pt was seen in the ER and treated with Keflex and Medrol. Fourteen hours later, she was reportedly "improving".
Colo:Pinkish Purplish; Warmth; Arm soreness; Rash; nausea; Feeling anxious; Hot flushes; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes), VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth) and PAIN IN EXTREMITY (Arm soreness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B2 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes) and NAUSEA (nausea). On 08-Apr-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth), PAIN IN EXTREMITY (Arm soreness) and RASH (Rash). At the time of the report, ANXIETY (Feeling anxious), HOT FLUSH (Hot flushes), VACCINATION SITE DISCOLOURATION (Colo:Pinkish Purplish), VACCINATION SITE WARMTH (Warmth), PAIN IN EXTREMITY (Arm soreness), RASH (Rash) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
14-year-old female patient received the Flublok Quadrivalent prefilled syringe rather than the Fluzone Quadrivalent prefilled syringe, No AE; 14-year-old female patient received the Flublok Quadrivalent prefilled syringe rather than the Fluzone Quadrivalent prefilled syringe, No AE; Initial information received on 20-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 14 years old female patient who was vaccinated with 0.5 ml of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] QFAA1929 and expiry date 30-Jun-2020 via intramuscular route in unknown administration site instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6686KA and expiry date 30-Jun-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of the 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
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 168 doses were given from LOT 048C21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow up. No new clinically significant information received.
Intense headache  for 2 days,  flu- like symptoms with chills, aches, fatigue for 1 day.
received 2nd dose too early; 1st dose 4/23/2021, 2nd dose 5/14/2021
This medically confirmed spontaneous report (initial receipt 18-Sep-2015) concerns a 63 year old female patient. On 15-Sep-2015, the patient received intramuscular AFLURIA (batch number U54906) at 0.5 ml. On 16-Sep-2015 (the following day), the patient experienced swelling near the injection site. The symptoms that developed at the injection site: a 3 inch diameter area that became red, swollen, itchy, warm and hard. The affected area got bigger on 17-Sep-2015. The outcome was reported as not yet recovered. Reporter's comments: The reporter assessed the events as non-serious.
Approx. 2 months after second vaccine I was diagnosed with B12 deficiency after experiencing fatigue, tingling in hands, anxiety.  Long term sinus congestion approx 4 months after second vaccine.
Pt had 2 previous Covid vaccinations. The first one, Covid PFR vaccine was administered on 12/22/2020. Lot number: EJ1685 at Hospital. Second Covid PFR  vaccine was administered by hospital on 07/20/2021. Lot number: ER8736 Third dose of Covid PFR vaccine was administered by hospital on 8/10/2021 Lot number: EW0181  Patient has received 3 doses of Covid vaccination within a year
Patient had welt on arm immediately after vaccination, pt received 50mg of BENADRYL and reported feeling a dryness in her throat with inability to swallow afterward. Pt referred to ER, pt refused EPIPEN at that time and was taken to ER by her husband for observation.
High fever, 101F for 12 hours. Headache and flu-like symptoms, very achy body for 24 hours.
My blood pressure continued to go up. It will be at 120 and will sky rocket up to 185. The bottom number of my blood pressure remained the same.
This spontaneous report was received from a healthcare worker refers to a 8 years and 10 months old female patient. On 02-OCT-2015, the patient was inadvertently vaccinated with GARDASIL 9 (Lot# L023230, 28-JUL-2017). No adverse effects were reported. Additional information has been requested.
1 day after injection sxs of weakness, nausea, fever 101 F and erythema, warmth, tenderness over injection site of Pneumovax. Subsequently hospitalized for fever, possible lung infiltrate. 11/29/07-records received for DOS 10/20-10/23/07-DC DX: Pneumonia. Anemia. Received 2 units packed red blood cells. Presented with acute on chronic weakness and decreased exercise tolerance over a week prior to admission. Fever. Leukocytosis.  Seen in follow-up on 10/25/07-C/O fatigue, cough. Left arm swelling since vaccination.
Mom called at 440pm - stated son had imm 7/5/07 and now would not walk -, no swelling, no redness, no bruising
sore arm; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache) and FATIGUE (fatigue). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Pain relief, at a dose of 1 dosage form. On 24-Mar-2021, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 26-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient became dizzy and passed out within a minute of receiving last (4th) vaccine. He passed out for 5 secs. His blood pressure dropped to 85/52 HR 43. He had sustain HR around 40 and had to be sent to ER via ambulance.
This is a spontaneous report obtained from a contactable nurse. This nurse reported on behalf of physician. A 17-year-old female patient received, on 27Nov2017 at 14:54, TRUMENBA (Lot. S56023, Expiration date: 28Feb2019) intramuscularly, in the right deltoid, at 0.5 ml, single dose, for immunization. Relevant medical history included attention deficit/hyperactivity disorder (ADHD), ongoing food allergy (allergy to tree nuts), allergy, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient previously received, on 09Oct2017, influenza vaccine (FLU) for immunization and amoxicillin from 23Jan2005 (ongoing) for an unspecified indication. The patient experienced allergy due to amoxicillin. Family history included asthma and thyroid disease for father. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 25 mg, for ADHD and epinephrine injection 0.3 mg, as needed, for hypersensitivity (allergy to amoxicillin and tree nuts). On 27Nov2017, the patient developed generalized weakness, discomfort pain over the sternum (started at night), irritation, and she felt sick and didn't go to school. On 28Nov2017, the patient experienced also shortness of breath, palpitations, chest tightness, headache with allergic reaction and she felt a tinge down her right arm. Sinus tachycardia was detected with electrocardiogram (EKG). No evidence of local site infection or significant reaction. The patient's parent called the office and reported the patient was seen in the emergency room, the day after the vaccination, on 28Nov2017. Hospitalization was not required. Relevant laboratory tests, performed on 28Nov2017, were the following: Chest X-ray unremarkable, EKG showed sinus tachycardia, full blood count (CBC) with platelets unremarkable, basic metabolic panel unremarkable and troponin normal. Clinical outcome of the events was unknown at time of this report. The events, palpitations, generalized weakness, shortness of breath, chest tightness, paraesthesia, discomfort pain over the sternum, were assessed as serious (Medically Significant); while the other events were considered non-serious.; Sender's Comments: 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.
Chronic Migraine/tension headaches for 9 consecutive day, 3 times daily, hypertension, bp was 173/125, and constipated. Taking large amounts of ibuprofen
Information has been received from a nurse referring to a current 66 year old patient of unknown gender. No pertinent or historical conditions were reported. In 2013, the patient was vaccinated with immunization series of RECOMBIVAX HB (strength, dose, route, lot# and expiration date unknown). There was no concomitant medication reported. On an unknown date the patient had antibody testing completed and the results showed negative titers. The patient was visiting office to received additional dose of RECOMBIVAX HB as treatment and dose had not yet been administered at the time of reporting. The outcome of the event and causality were not reported. Additional information has been requested.
Numbness to feet, hands, and tongue, abnormal sensation in trunk with twisting movements, left eye droop, dysphagia, and fatigue.
Couldn't function after second dose but was within the normal limits; Second dose made me ill; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED ACTIVITY (Couldn't function after second dose but was within the normal limits) and ILLNESS (Second dose made me ill) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0BL20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included ALENDRONATE SODIUM for Osteoporosis.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, 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 DECREASED ACTIVITY (Couldn't function after second dose but was within the normal limits) and ILLNESS (Second dose made me ill). At the time of the report, DECREASED ACTIVITY (Couldn't function after second dose but was within the normal limits) and ILLNESS (Second dose made me ill) outcome was unknown.            No treatment medicines were reported.  Patient stated she hesitant to take the booster.   This case was linked to MOD-2021-354399 (Patient Link).
Local injection site swelling (3in x 1.5in). Red, inflamed, painful. Worsened overnight. Fatigued, but no other systemic symptoms.
After receiving 3rd HPV vaccine, patient fell from examining table, lost consciousness, become tense for one minute, regained consciousness. Patient has known seizure disorder.
pt recv vax & was dx w/ SLE;pt was placed on disability;tx unspecified non-steroidal anti-inflammatory drug, ASA & multivitamin +Fe;2DEC94 cont joint pain, weakness, fatigue; PE revealed conjunctiva a little pale & swelling of proximal IPJ
Neuropathy of both arms lasting one week after vaccination; Dizziness; severe headache; fatigue; This is a spontaneous report from a contactable other HCP (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Right, on 16Oct2021 12:00, at the age of 25-year-old, as DOSE 1, SINGLE, for covid-19 immunisation. Medical history included covid-19. The patient had no allergies. The patient is not pregnant at the time of vaccination. There were no concomitant medications.  The patient had no other vaccines in four weeks and had no other medication in two weeks. On 17Oct2021 at 04:00, the patient experienced neuropathy of both arms lasting one week after vaccination; dizziness, severe headache, and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not tested for COVID post vaccination. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered.  The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the available information in the case, the causal association between the event neuropathy peripheral and the suspect drug BNT162B2 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.