chrisvoncsefalvay/vaers-outcomes huggingface dataset:
treatment of COVID-19; treatment of COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single at the age of 70 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (batch/lot number: unknown), as dose 2, single (batch/lot number: unknown) and as dose 3 (booster), single (batch/lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "allergies penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "treatment of COVID-19". The patient underwent the following laboratory tests and procedures: home test: (unspecified date) positive; (03Mar2023) repeat positive, notes: home test day 14 after original symptoms onset and day 10 after completing Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 17Feb2023 to 21Feb2023.
Real red on the right arm; Itchy from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Real red on the right arm) and PRURITUS (Itchy from shoulder to elbow) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Liver cirrhosis, Diabetes, Cardiac disorder and Hypertension.   On 12-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Real red on the right arm) and PRURITUS (Itchy from shoulder to elbow). At the time of the report, INJECTION SITE ERYTHEMA (Real red on the right arm) and PRURITUS (Itchy from shoulder to elbow) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Benadryl was used as treatment medication on 16th and 17th march 2021.
30 minutes after leaving the site, got a mild reaction where my face got tingly and red but then it subsided but then 4 hours after receiving the vaccine I began getting a low grade fever (100.6) by 5pm that same day, I began having flu like symptoms, body aches, headaches, fatigued, chills, sweating and fever had risen to 101.7. Took ibuprofen to help with the symptoms but fever kept rising. By 8pm., fever was at 102.9,  headache worsen, sweats throughout the night and felt dizzy. Next morning 3/18, fever was low grade by 7am (100.4) by 9AM, fever was gone, felt tired, with mild body aches and moderate headache and  felt exhausted the rest of the day. Symptoms are getting better with rest.
Expired doses of Moderna COVID 19 vaccine given to 3 patients/ The vial was punctured and used beyond the 12 hour time frame; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID 19 vaccine given to 3 patients/ The vial was punctured and used beyond the 12 hour time frame) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID 19 vaccine given to 3 patients/ The vial was punctured and used beyond the 12 hour time frame). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID 19 vaccine given to 3 patients/ The vial was punctured and used beyond the 12 hour time frame) 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 reported. The vial had been stored in the refrigerator since then. For 2 patients, it was the 2nd dose. For 1 patient, it was the 1st dose.
Teledoc - 3/24/2021 - fatigue, sorethroat and headahe for 2 days . After your vaccine your shoulder blades hurt and I had a lump on my shoulder blade and my 4/12/2021 - she ordered bloodwork and chest xray all come normal. but vitamin d was low  HPV - 1st dose  4/7/2021
Patient's son came to pharmacy in the morning of 6/29/2018 and showed pictures of slight swelling after SHINGRIX vaccination with no pain. Vaccination was accidentally administered subcutaneously rather than intramuscularly. Advised patient to take BENADRYL and use cool compress. Followed up with patient later in the day, and son stated that the swelling was mostly gone.
(L) upper arm pain increased overnight woke patient from sleep due to level of pain. Ice and Ibuprofen were given by parent. Pain continued for >48 hours, slowly resolved.
patient had difficulty raising right arm over the first week then developed paralysis in right arm and hand. patient currently getting physical therapy
A week following my mothers vaccination, she became increasing fatigued. On day 10 following her vaccination she went to bed and had to be helped to her room, this was unusual. She remained in bed for 19-20 hours a day for three days. I called all of her doctors, all of whom she had just been seen by, routine CT scans performed, blood work done, and visit with her neurologist. Her oncologist suggested we seek a hospice evaluation, even though her CT scans showed that her cancer had only slight growth, nothing to be concerned about. Her primary care office ordered the hospice evaluation and it was performed on Thursday, 3/18. They said ?she may just be having a bad week following her vaccination? and ?lets revisit this the following week?. her condition continued to deteriorate significantly over the next few days, so much that she began sleeping 21?23 hours a day. On the following Tuesday, 3/23, she was admitted into the hospice system. Now, four weeks later, we are in the final weeks of her life. She refuses food and water now, and her nurse says that it won?t be much longer. She went from a relatively healthily, senior woman, with underlying health issues, none of which presented her imminent demise, to dying at home within weeks of receiving her J&J vaccine. I have no idea if he demise is in anyway related to her vaccine, but thought it was important to report her symptoms.
This spontaneous report was received from a pharmacist concerning a 68 year old female patient. The patient had no pertinent medical history or drug reactions or allergies. On 07-AUG-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # K023622; expiration date: 20-FEB-2016) (dose and route not provided). The patient's concomitant medications included unspecified medicines. On 09-AUG-2015, the patient reported having an unspecified red, bumpy rash on an unspecified side of her neck. The patient reported that it was itchy and a little painful. The patient was then seen at an unspecified urgent care center and was diagnosed with the shingles (herpes zoster) and was prescribed an unspecified medication. There were no laboratory tests of diagnostic studies performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 7XY2P, expiry date 4th April 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed shingles 1 week later.  The reporter consented to follow up.
Pain in left shoulder; Chills; Rash associated with itching on the right side at midsection of the body about 7 to 8 inches in size from bra area to the waistband, and towards the back; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shoulder pain, chills and itchy rash. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the shoulder pain and chills were recovered/resolved and the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the shoulder pain, chills and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced pain in her left shoulder and chills that lasted for couple days and took motrin for it.  About 5 days after vaccination, she broke out in a rash associated with itching on the right side at midsection of the body about 7 to 8 inches in size from her bra area to the waistband, and towards the back.  She had reached out to her doctor via email portal. The reporter did not consent to follow up. No further details were provided.  The patient was reporting event for herself, her friend, and her friends husband. This report 1 of 3 reported by the same reporter.
Information has been received from a health professional concerning an 8 year old female with no known allergies and a history of microscopic hematuria, who on 20-FEB-2008 was vaccinated with a second 0.5 ml subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot# "L5006"). Concomitant vaccination included a dose in her right arm of hepatitis A vaccine (inactive) (manufacturer unspecified) and a dose in the right arm of influenza virus vaccine (manufacturer unspecified). The health professional reported that the erythmea, and papulule/blister began at 12:00 hours on 23-FEB-2008 (3-5 days post vaccination). It was indicated by the health professional that there were no other rashes or sytemic complaints and that the patient was afebrile. On 25-FEB-2008, the patient was seen in the office and complained of soreness at injection site of the left arm. Within 24 hours (26-FEB-2008, also reported as 23-FEB-2008), the patient developed blisters around the injection site. It was reported that the patient's mother treated the patient with oral diphenhydramine (BENADRYL) and cold compresses. On 28-FEB-2008, the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of EYE SWELLING (eye swelling) and VITREOUS FLOATERS (seeing "eye floaters"/seeing "squiggly things") in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced EYE SWELLING (eye swelling) and VITREOUS FLOATERS (seeing "eye floaters"/seeing "squiggly things"). At the time of the report, EYE SWELLING (eye swelling) and VITREOUS FLOATERS (seeing "eye floaters"/seeing "squiggly things") outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
My son became unresponsive and his facial expressions became blank. It was like he was not present. I believe he suffered a seizure. At 8:26 PM, it occurred again while I was administering children's Tylenol. He became normally warm with a temperature of 100.3. He suddenly became unresponsive, his jaw tightened, and he stopped breathing.
Muscle pains; Joint pains; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date unknown), dose number 1, via an unspecified route of administration on 05Jan2021 at a single dose on the left arm for vaccination. The patient had no relevant medical history and no concomitant medications. The patient volunteers at a local hospital. She reported muscle pains and joint pains after Pfizer COVID-19 vaccine. She had onset of muscle pains and joint pains around 1:00am on 06Jan2020. Muscle pains and joint pains worsened around 5:30am on 06Jan2021. She was taking 500 mg of Equate Acetaminophen every 4 hours for the muscle pains and joint pains, but the Equate Acetaminophen does not seem to be helping the muscle pains and joint pains. Her second dose was scheduled on 26Jan2021. The outcome of the events was not recovered.
Mild itching throughout different parts of the body; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3246), via an unspecified route of administration in left arm, on 07Jan2021 11:15 at single dose, for COVID-19 immunization, in a public health facility. Medical history included mitral valve prolapse, glaucoma, and allergy to strawberry. The patient is not pregnant. Concomitant medication included latanoprost; estradiol, norethisterone acetate (MIMVEY); multivitamins; and ergocalciferol (VIT D). The patient did not receive any vaccine within 4 weeks prior to COVID vaccine. The patient experienced mild itching throughout different parts of the body beginning on day 2, 09Jan2021 10:00, and continuing on day 5. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Very sore arm @ injection site within an hour.  Cold chills started about 8 hours later and lasted about 12 hours then lessened. Cold chills returned about 24 hours later and were sporadic.  Arm still very sore, 2 days later.
Patient called clinic the evening of receiving her vaccination complaining of localized swelling to the injection site, and the area had swelled up to the size of her hand. Patient stated she had been icing the area, but was advised to take BENADRYL and TYLENOL or ibuprofen for the swelling, and to return to clinic or ER with worsening of symptoms. The next day the patient reported low grade fever and nausea when she was called to check on her.
sense of smell changed,  It's best described as a burnt scent when around fried foods (deep and saute), toothpaste, and mouthwash.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8734) via an unspecified route of administration in the left arm on 31Mar2021 at 15:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. The medical history included ARVC (arrhythmogenic right ventricular cardiomyopathy), COVID-19 and penicillin allergy. Prior to the vaccination, the patient was diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. On 11Apr2021, about 11 days after the first dose of the vaccine, the patient experienced sense of smell changed. It was best described as a burnt scent when around fried foods (deep and saute), toothpaste and mouthwash. Therapeutic measures were not taken as a result of the reported event. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sense of smell changed, it was best described as burned scent when around fried foods (deep and saute),toothpaste and mouthwash was unknown at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0170) via an unspecified route of administration in the left arm on 28Apr2021 at 14:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
Patient felt faint,  headache, arm/throat/tongue became numb, blurry vision, felt cold, feel tired and nausea. Patient BP and HR was initially high, lied patient on ground with legs elevated and cold pack and patient eventually felt better and BP and HR eventually normalized. Patient had already eaten prior to coming in.
getting Covid after Covid shots; The patient confirmed that she did have coronavirus after getting both Covid; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021088374). The case was split from master case 2021688566 for a female patient taking BNT162B2 and experienced COVID-19 and Vaccination failure.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis current medical condition. Concomitant medication included etanercept (ENBREL) taken for rheumatoid arthritis. The patient experienced getting covid after covid shots, the patient confirmed that she did have coronavirus after getting both covid. This non-serious solicited report (USASL2021088374) was reported to Amgen on 07Jun2021 by a consumer from a commercial program (PSP00180b) and involves a female patient who experienced coronavirus antibodies and results came back positive, [PT: sars-cov-2 antibody test positive] while receiving Enbrel. No historical medical condition was reported. The patient concomitant medications included Covid-19 (corona virus disease-2019) Vaccine. No co-suspect medications were reported. The patient began Enbrel on an unknown date. On an unknown date, the patient stated that she was concerned about Coronavirus and taking Enbrel. On an unknown date, the patient stated that she just went in to give blood at rheumatologist and was checked for coronavirus antibodies and results came back positive. The patient stated that she knows Enbrel would wear down immune system. The patient would like to know, if Enbrel was result of getting Covid after Covid shots. Action taken with Enbrel was reported as unknown for the event sars-cov-2 antibody test positive. The causal relationship between the event sars-cov-2 antibody test positive and Enbrel was not provided by the consumer. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive. No treatment information was received. The outcome of events was unknown.   Follow up has been requested.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality Assessment: Event SARS-CoV-2 antibody test positive as per Company were assessed to be non-serious and unrelated to etanercept, whereas causality of event Covid after Covid shots was unknown.  No follow-up attempts possible. No further information expected
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with doses of improper stored ROTATEQ (lot # K023532, expiration date 24-JUN-2016) (dose and route were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 22-MAY-2018, the patient received a dose of VARIVAX (lot number N031001, expiration date 03-NOV-2019) for prophylaxis (strength, dose number, anatomical location and route of administration were not reported) and a dose of PROQUAD (lot number N028447, expiration date 09-APR-2019), also for prophylaxis (strength, dose number, anatomical location and route of administration were not reported). No adverse effects were reported.
approx 24 hours after vaccine given my daughter passed out and started seizing follow by episode of vomiting. Entire event lasted less than 5 minutes and no problems after that. She had been feeling a little nausea earlier that morning but no other symptoms or concerns
reporting what she terms a pocket under the skin where the shot was given.  She states it is deep and hard and feels like it is not absorbing. This happened with her B12 shot as well.
Patient states after receiving arexy it hurt when vaccine was administered despite being warned this one stings. she said it really stung. She states that it took about 3 or 4 days then she had severe arm pain from the injection site down to almost her elbow for about 3 to 4 days, then has started to improve.  She has been using OTC APAP and Ibuprofen to treat the pain.
red itchy swollen knot at vaccine site , ongoing  swollen lymph node in armpit
Patient complains of dizziness and was brought to medical tent. Offered water and rest , elevated legs. Pt then c/o of numbness and tingling to left side of face. Benadryl 25mg was given @ 11:53AM. PT was stable and symptoms continued to progressively increase. More numbness, tingling extending to entire face, lips, and neck. Able to speak in full sentences, lips appear slightly edematous. Given a second dose of Benadryl. VS stable. Pt left with EMS at 12:15
After ten minutes of monitoring after pfizer dose 1 vaccine patient developed nausea and vomiting. Then several minutes after N/V patient started to get dizzy and tunnel vision. Vitals obtained  by this RN and B/P was 158/98 and heart rate was 111. Pt alert and oriented and didn't eat breakfast this morning. Patient reports recent history of high blood pressure and anxiety. Pt continued ongoing s/s and per decision to call EMS.  Vitals obtained again before EMS arrival and B/P was 160/101 and heart rate 115. Pt remains alert and oriented during EMS arrival and departure. EMS and patient agreed to go to ER clinic for evaluation. Pt transported to EMS ambulance via wheelchair by EMS staff.