chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash; She describes it as welts/clusters throughout her body; This is a spontaneous report from a contactable consumer (patient's mother). A 23-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 18Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 16Apr2021, the patient started experiencing chills and heavy feeling in her chest. On 23Apr2021, the patient started to develop a rash that started every evening around 9:30- 10:30 PM. She described it as welts/clusters throughout her body. The reporter stated that she heard that the vaccine might not protect everyone.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Face was puffy/ face has continued to be puffy; Eyes are puffed; Severe hives all over her body/hives shifting around her body; Rash is on her stomach, arms, and back.; Allergic reaction/with welts on the back of her head; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face was puffy/ face has continued to be puffy), PERIORBITAL SWELLING (Eyes are puffed), URTICARIA (Severe hives all over her body/hives shifting around her body), RASH (Rash is on her stomach, arms, and back.) and HYPERSENSITIVITY (Allergic reaction/with welts on the back of her head) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 041B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Nov-2021, the patient experienced SWELLING FACE (Face was puffy/ face has continued to be puffy), PERIORBITAL SWELLING (Eyes are puffed), URTICARIA (Severe hives all over her body/hives shifting around her body), RASH (Rash is on her stomach, arms, and back.) and HYPERSENSITIVITY (Allergic reaction/with welts on the back of her head). The patient was treated with EPINEPHRINE for Adverse event, at a dose of 1 dosage form; PREDNISONE for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Face was puffy/ face has continued to be puffy), PERIORBITAL SWELLING (Eyes are puffed), URTICARIA (Severe hives all over her body/hives shifting around her body) and RASH (Rash is on her stomach, arms, and back.) had not resolved and HYPERSENSITIVITY (Allergic reaction/with welts on the back of her head) was resolving.            No concomitant information were reported by the reporter
Headaches after the vaccine; Muscle pain after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches after the vaccine) and MYALGIA (Muscle pain after the vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches after the vaccine) and MYALGIA (Muscle pain after the vaccine). At the time of the report, HEADACHE (Headaches after the vaccine) and MYALGIA (Muscle pain after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Patient has no history of fainting post vaccination. Per immunization technician, patient had appeared nervous and was breathing heavy when receiving the vaccine. As the patient left the hallway, patient had dropped to the ground but did not lose consciousness. Patient stayed on the ground because he was feeling dizzy. Pharmacist had measured his blood pressure and heart rate while patient was laying down. Patient moved to a chair once feeling less dizzy. Paramedics had arrived and measured his blood pressure. Paramedics were not worried about patient's vital signs and did not recommend patient to go to the ER. Patient was advised to be driven home by wife and left the pharmacy after 15 minutes.
Rapid onset of macular rash within 2 hours after immunizations.  Trunk to extremity spread, spares hands, feet, mucosa.  Rectal temps 99.4 within 12 hours later increased 101.4.  Today approximately 75 hours later afebrile, rash remains.
pt recvd vax & on waking up from nap mom noticed pt was broken out in whelps all over & sounded croupy;advised to got to ER;ER told pt's mom pt having adverse rxn to one of vax recvd;given cortisone & sent home
Rectal temp 103 72 hours after immunization 7/18/06, 7/23/06 tachycardia, tachypnea.  Infant presented to PCP 3 days s/p vax. with c/o fever, tachypnea, and tachycardia which began the day of vax.  PE shows a fatigued and easily irritated infant not putting up much fight. Increased WOB and tachycardia noted.  Temp 102.3'F. Otherwise WNL.  Admitted for FUO.  Continued to have fever, pulse 100-144, and RR 30-40 on day of discharge, but vigorous and playful and taking po well. DX: FUO, viral phayngitis.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm and feeling unwell were unknown. The reporter considered the pain in arm and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 62 or 63 years old. The reporter stated that the patient was one of their nurses at her clinic. She said that the nurse had a very sore arm and did not feel well after the shot. The reporter said that the nurse did not want to get 2nd dose in series. The patient felt that her experience was related to vaccine.
Facial numbness with tingling and pain sensation and enlarged lymph nodes several hours after the 1st dose of Moderna shot  Swollen neck with pain started soon after A rash over the legs and body within a few months Diagnosed with t-cell lymphoma in March 2022  Died August 2022 He visited his doctor for all those symptoms and received treatment at the hospital for cancer. He received both doses of the Moderna vaccine (2/13/2021 & 3/13/2021)
This case was reported by a pharmacist via call center representative and described the occurrence of lymphadenopathy cervical in a patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced lymphadenopathy cervical. On an unknown date, the outcome of the lymphadenopathy cervical was unknown. It was unknown if the reporter considered the lymphadenopathy cervical to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that, the patient developed left-sided neck lymphadenopathy which was goiter size after receiving FLUARIX QUADRIVALENT. The patient was already hospitalized at the time of receiving the product (reason not specified). No other symptoms were reported. No further information was available at the time of repot regarding the incident.
hot flashes; vomited 2-3times; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), VOMITING (vomited 2-3times) and NAUSEA (nauseous) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HOT FLUSH (hot flashes), VOMITING (vomited 2-3times) and NAUSEA (nauseous). At the time of the report, HOT FLUSH (hot flashes), VOMITING (vomited 2-3times) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
LOST SEX DRIVE THE DAY VACCINE WAS ADMINISTERED ON 9 MAY 03. UNABLE TO KEEP ERECTION OR GET AN ERECTION. WHICH IS STILL PERSISTENT AT THIS TIME.
Fatigue, Chills, Fever, Nightsweats, Muscle pain, Headache, Loss of appetite, Swelling at the site of injection, Red streaking local to site. Treatment: Motrin, Tylenol, Bedrest, Cool compresses to site.
Fever 100, swollen left arm, right arm mildly swollen, treated with KEFLEX.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient with history of herpes outbreaks and penicillin allergy. On 17-APR-2013 the patient was vaccinated with ZOSTAVAX, (subcutaneous, concentration and lot number unknown). Concomitant therapies included VALTREX and SYNTHROID. In approximately May 2013 (reported as a couple of days ago) the patient experienced rash on an unspecified part of her body. The patient sought for medical attention, called the pharmacist to see if she can take VALTREX again. The pharmacist reported that the patient has "an ongoing issue with herpes and has been getting prescriptions of VALTREX for a while now". No treatment was given. The outcome of rash on an unspecified part of her body and an ongoing issue with herpes was reported as not recovered/not resolved. Additional information has been requested.
Rash, generalized on face, legs, chest, back & arms; rash 9OCT PM through 14OCT AM; 16OCT t102; fever gone 17OCT; 17OCT ear infection & rx w/Ceclor 17OCT AM; in past pt responded to Ceclor w/in 24hrs; drainage from tube cont 'til rash gone;
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not specified. On 15-OCT-2015, the patient was vaccinated with an expired dose (supported) of VARIVAX (Merck) injection, lot # J006359, expiry date 23-MAY-2015, (route of administration, dose and frequency not reported). No adverse effect reported. No product quality complaint (PQC) was involved. No further details provided. Additional information has been requested.
Awareness of urinary discomfort about 2-3 weeks after 1st shot. Not a full blown UTI, but an awareness of being on the verge of having a UTI. Some cloudiness in the urine. After the second shot, urinary discomfort came more pronounced after one weeks time. I went into an urgent care center for urinalysis where white blood cells were apparent in the urine. I was placed on the keflex antibiotic which did not work and have since been place on cipro which does not seem to be working either.  Bladder discomfort.
Patient and mom came into immunization clinic for shots. Mom reported that after last set of shots, patient was in emergency room for: swollen glands, temp 104 degrees, seizure like symptoms, and bland stare. He was treated and released. Upon further questioning it was determined he immunizations 1st MMR, 1st varicella and 4th PREVNAR on 08/31/2007 and he did well. Until suddenly mom states he had the above symptoms and was take for treatment in ER. He has recovered completely. 08/11/08 numerous attempts to get this mom to sign authorization to obtain more medical information have been ignored.
listed expiration date 9/30/22, stability data available showed good until 10/19/22
After the first day, I had a large red swollen spot about an inch and a half or two up and to the left of my injection site. It was painful as if I receieved the shot directly into my upper shoulder bone. The injection spot did not feel tender at all. Additionally, under this red spot is a large, hard lump. The pain has subsided a bit but the lump is still there. It's very hard and I just cannot find any info online suggesting this specific issue. I don't know if it is in my mind but it also feels a bit numb surrounding the general area. It has been 104 hours and i still have pain, redness, swelling and a large lump. I am also itchy in general both at the arm and all over. I don't know if this is related or not.
Narrative: COVD infection following COVID vaccine series 02/09, Pfizer, dose #1 03/02, Pfizer, dose #2 08/03 pt cc: fatigue, rhinorrhea, sore throat exposure, daughter in school 08/18 COVID swab, result: detected 08/18 SARS-COV-2 Variant Sequencing result: pending
I was breathless and extremely exhausted for several weeks prior to the most extreme symptoms presented. I started feeling excruciating chest pain so much so that I thought I was having a heart attack, could not sleep at night because the pain grew increasingly worse, radiating pain down my arms, and it was extremely difficult to even complete sentences I was so winded.   As these symptoms progressed I thought they were an injury from yard work and wrote it off as costochondritis and suffered. Eventually I was at work and could not even get a sentence out without extreme pain and breathlessness. I was taken to urgent care where they instructed me to go to the emergency room at hospital. There I was given a series of tests. I believe I had a echocardiogram where all my findings were normal. Then they did a blood test where they look for clotting as they were concerned about a blood clot. That was a slightly elevated number which then brought me to a CT scan with contrast. This is where they found that it was not a blood clot but pericarditis. They followed up with a ultrasound of my heart where they saw the sack around my heart inflamed with fluid. The first question I asked the doctor is could this be related to my vaccine which I just completed. The more I learned about pericarditis, the longer I realize how long I have been suffering with breathlessness.  I dismissed it for such a long time because I had recently had another baby and was doing a lot of heavy lifting carrying her around as well as mask wearing as a teacher. Because of the mask I dismiss my breathlessness and ignored it for a long time.
I had shortness of breath, sinus issues, and upper respiratory issues. I had a headache and my body was aching. I had complete exhaustion. For first 48 hours I was in bed sleeping and only got up to go to the restroom. I took TYLENOL. I was really out of it. About Sunday, I woke up and I was soaking wet like my fever broke and I started feeling better. The clinic prescribed me multiple anticoagulants and molnupiravir. I took medications for 5 days.
both hands started itching; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:00 (Batch/Lot Number: ER8732, NDC 59267-1000-1) as, 0.3 ML SINGLE DOSE for covid-19 immunisation. The patient had no family medical history. Medical history included breast cancer from Sep2006; she completed 6 rounds of chemo and 37 days of radiation and finished in Aug2007; she had right mastectomy on 13Oct2006; she had 3 surgeries in 3 weeks and had 27 lymph nodes removed. Concomitant medication(s) included carvedilol (COREG) taken for arrhythmia (has been taking 14 years) start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure abnormal (has been taking 14 years) start and stop date were not reported. The patient previously took herceptin on Dec2006 and experienced cardiac failure congestive (she had heart damage from chemo and radiation, she had a reaction to Herceptin. They stopped it, stated she had congestive heart failure from it, but it did reverse and she still has that tagged on her. Caller stated she didn't die from breast cancer, but that's her history. Stated she previously had echos done monthly between chemo that was every 3 weeks to check the ejection fraction. Ejection fraction at some point started showing she was in trouble and he called the oncologists and said the Herceptin was done. Confirms she was told she had congestive heart failure, heart damage, but it was reversed now); Tylenol was like a big pain med for her, but it puts her to sleep; Aleve gave her hives and this occurred when it first came out, but she was not sure when that was. Caller stated both hands started itching at some point the evening of 29Mar2021, beginning around midnight, between midnight and 5 am on 30Mar2021. The patient didinot receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Caller describes as kind of itch that is internally itching and cant scratch, it was inside of her itching. Caller stated it fully resolved by the time she woke up on 30Mar2021. The ouctome of th event was recovered on 30Mar2021. No treatment was received for the event.
pt recv vax & devel an inj site rxn;pt was dx as having cellulitis;use of an ATB for tx of the rxn has not been confirmed;this is one of three patients from this site who received same lot# & exp the above reaction;
Approximately 12 hours after vaccination, woke up with numbness and tingling on complete right side of my body. Reaction has not gone away since the vaccination, 3 weeks ago. The reaction has decreased butt still exist up and down my right arm and hand, along on the right side of stomach.
Expired Havrix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th January 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 10th January 2023, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Jan-2023 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
patients may have received vaccines after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Engerix B, Boostrix, Kinrix, Kinrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. On an unknown date, unknown after receiving FluLaval Quadrivalent, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix, Engerix B, Boostrix, Kinrix, Kinrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device and Menveo, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Sept-2022 Reporter's comment: The pharmacist with the department of health reported that from 28th May 2022 until the end of June 2022 there was no temperature recording data from a fridge were Flulaval, Infanrix, Havrix, Engerix-B, Boostrix, Kinrix, Bexsero and Menveo were stored in a vaccination site.  The reporter reported that there might had been a temperature excursion during that time and patients might had received vaccines after a temperature excursion. The reporter consented to follow-up. Additional supportive information: The patients might had received the vaccines after a temperature excursion, which led to incorrect storage of drug.
ON WAKING NOTICED RIB PAIN IN THORACIC AREA WITH DEEP INSPIRATION AND MOVEMENT.
Blood Clot; This is a spontaneous report from a contactable nurse.  A 60-year-old female patient (no pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208), intramuscular at the age 60-year-old at arm right on 11Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular at the 60-year-old at right arm on 19Feb2021 for COVID-19 immunisation and experienced pneumonia. There was no other vaccine in four weeks. Facility type vaccine was reported as public health clinic/administration facility. The patient experienced blood clot on Mar2021 after 2nd. The patient was hospitalized for event for 5 days. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The patient received the treatment for event. The outcome of event was unknown.; Sender's Comments: Based on information available, a possible contribution role of the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event clot blood cannot be completely excluded.  The case will be reassessed should additional information become available.  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.,Linked Report(s) : US-PFIZER INC-2021422806 same patient/product, different dose and event