chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received 14 June 2013 from an employee at a physician's office. This case is not medically confirmed. A 60-year-old female patient had received a left deltoid injection of ADACEL, lot number C4432AB (route of administration not reported) on 07 June 2013 and six days later, she presented to the physician's office due to redness, raised area, warm to touch, approximately 2.5 inches at the injection site; then a second one distal to that one, not touching. Corrective treatment consisted of cefalexin (cephalexin) 500mg TID for one week and warm compresses. The patient had no concurrent illness and no relevant medical history at the time of vaccination. The patient had previously received a first dose of ADACEL on an unspecified date. Outcome was not recovered. Documents held by sender: None.
Information has been received from a physician concerning a 15 year old female with a history of asthma and no drug reactions or allergies who on 15-OCT-2007 was vaccinated with VARIVAX (Oka/Merck) (Lot #658061/1092U). Concomitant therapy included ADVAIR and albuterol. The patient reported that on the "next day", 16-OCT-2007, she had shortness of breath and a small bump at the injection site. The "next day" 17 OCT 2007 that patient had a large, red, hot bump at the injection site. Later that same day the patient reported having trouble breathing, and her arms and legs "felt funny". She was subsequently rushed to the emergency room (ER), where she was administered IV BENADRYL and an aerosol treatment. There was no product quality complaint. Follow up information was received from a registered nurse who reported that the patient received the IV BENADRYL in the ambulance. The patient was not admitted to the hospital, but received unspecified treatment in the emergency room. The nurse reported that the hospital discharge summary stated "allergic reaction". The event of "allergic reaction", requiring intervention enroute to the hospital, was considered as an other medically important event (OME). No further information is expected. Additional information has been requested.
Patient given 2nd dose of Pfizer vaccine at 1222.  She complained of generalized itching at 1233.  Her voice became raspy and complained of itching in the throat.  No complain of SOB or chest spin.  Epi-Pen was administered in left thigh.  Patient transported to ED via wheelchair  methylPREDNISolone Sod Succ (PF) Inj 125 mg (SOLU-Medrol PF)  ? diphenhydrAMINE Inj 25 mg (BENADRYL) ? Sodium Chloride 0.9 % IV Bolus ? Famotidine (PF) Inj 20 mg (PEPCID) ? predniSONE (ORASONE) 20 mg Oral Tab ? diphenhydrAMINE (BENADRYL) 25 mg Oral Cap
got booster in Dec2021 and now still can't taste 9 months later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown booster, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization complete-unknown number of doses; Lot number: Unknown; Route of administration: Unspecified), for COVID-19 immunisation. The following information was reported: AGEUSIA (non-serious) with onset 2021, outcome "not recovered", described as "got booster in Dec2021 and now still can't taste 9 months later". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient would like to know why the patient got the COVID vaccination in May2021 and could not taste for 4 months, got booster in Dec2021 and now still cannot taste 9 months later. The patient had never had COVID and test if the patient had symptoms and all negative, when will the patient get taste back.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This report describes inject site cellulitis following the inadvertent admin. of Hep A vaccine inactivated into the hip of a 61 y.o. female. Medical history, concurrent conditions, and concurrent medications were not specified. On an unknown date, the PT received an injection of Havrix in the hip rather than the deltoid. On 12/5/00, the vaccinee experienced a "superficial and small" area of cellulitis on the left hip. The vaccinee was examined on 12/28/00 by the MD, who noted a 1-cm broken blister w/a 0.5-cm area of erythema surrounding the blister. She was treated twice daily w/silver sulfadiazine cream from 12/28/00 to 1/5/01. The most recent info, received on 2/15/02, indicated that the cellulitis had resolved. The reporter considered the event to be mild in severity and related to Havrix admin. On 12/29/00, the vaccinee was administered another injection of Havrix in the left deltoid. No adverse events were reported.
This is my 3rd time take Fluconazole 150 mg tablet and had a severe allergic reaction. Within 1 hour of ingestion my face began to burn. Then the edema lesions that were on my face and body began hugely enlarged with a red outer circle. My lip became chuffed and underneath the lips skin swelled then ripped. The lesions are very itchy and painful to touch. This is my 3rd time taking this tablet and I finally realized my body has rejected it. My first pill This year was February 2 weeks after my 2nd Moderna vaccination. Since being vaccinated I've become allergic to shell fish as well and randomly I break out and small hives coving my entire body. I've visited the Dermatologist around June 2021 who performed a punch biopsy and determined it was a Fixed Deug Eruption. I've visited the allergist who results were the same yet he found no additional allergies to be noted. And finally I visited a Hematologist who took over 15 blood samples and all he found was low Iron counts. Ultimately, I've been warned to consider not taking the booster shot fearing what reaction it may cause to my blood. I turned 40 March 2021 and I've never had a pimple or a blemish EVER. And I've taken Fluconazole 150 mg in the past years with no side effects. My fixed Drig Eruption markings have not left my body. It's been nearly 11 months I've suffered with these markings. Please advise.
Patient feeling Exhausted, tired, Blood pressure 132/90 Pulse 96 Resp 20  SPO2 97%.  Patient stayed in observation an extra 15 min.  At 30min patient states "I feel fine" .
Fatigue; Fever 101F; Soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration on 19Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cyanocobalamin (VITAMIN B 12) and colecalciferol (VITAMIN D3); both for an unknown indication from an unknown date and unknown if ongoing. On 20Apr2021, approximately 12 hours after vaccination, the patient experienced fatigue, fever 101F, soreness at injection site lasting until 36 hours after vaccination. On the same day, the patient underwent a body temperature test and the result was 101 degrees Fahrenheit. The events did not result in doctor or other health care professional office/clinic visits, and the emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, fever 101F and soreness at injection site was recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
About a week after my first dose of Moderna, I began to have noticeable pain in my left shoulder. The only way I could get relief was to hold my arm above my head, and I had to do the same while I slept. At the time of this writing, I continue to have this issue, though it has gotten worse since I received my booster shot.
Patient received 6mo immunizations on 10/18/2011. That evening, experienced fever to 104-105 degrees F and simple febrile seizure lasting about 10 minutes.
Less than a week later I broke out in hives. I have since been diagnosed with Dermatographism by my primary Dr.
8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; 8 days after the vaccine I have swelling at the injection site on my right arm. Its hot and painful. Also, pain in my right fingers and lymph pain in my axillary region.; This is a spontaneous report from a contactable nurse (patient). A 32-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 0140), intramuscular in the right arm on 21Dec2020 15:00 at a single dose for COVID-19 immunization at the age of 31 years old at the workplace clinic. Medical history included asthma and seasonal allergies. Concomitant medications included fluticasone nasal spray, fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler, montelukast sodium (SINGULAIR), colecalciferol (VITAMIN D), salbutamol sulfate (ALBUTEROL), zinc and unspecified multivitamin. On 29Dec2020 16:00, 8 days after the vaccine, the patient had swelling at the injection site on her right arm, it is hot and painful. Also, the patient had pain in right fingers and lymph pain in axillary region. Outcome of the events was unknown. No treatment was given for the events. The events were assessed as non-serious.
Health aide was planning to give DTaP, polio, and Hep B. Give polio and Hep B and give the combo PEDIARIX for INFANRIX (DTaP) so child received extra doses of polio and Hep B.
it was rpt from preg RN who administered vax to a pt 7/17/98 on 7/31/98 she developed lesions which continued to develop as of 8/7/98 over entire body. described typical chickenpox
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 22-MAY-2013, the patient was vaccinated with a dose of GARDASIL, (lot # H021608, expiry date 13-AUG-2015), which was exposed to 31 Fahrenheit for 1 hour. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter.
sick; Initial information received on 17-Dec-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a unknown gender patient who experienced sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In December 2019, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer(dose, strength, formulation, route: unknown) (lot number not reported) in unknown administration site .  In JAN-2020 the patient developed a non-serious of  event "sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Since this is a public post on the Sanofi flu shot campaign Flu Shot Fridays we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: My last flu shot was December of 1999 resulting in my having the flu for the entire month of January of 2000. I would never been so sick in my entire life. I never got another flu shot nor have I gotten the flu since."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (sick).  At time of reporting, the outcome was Recovered / Resolved in January 2020 for the event sick.
Patient received Gardasil imm. (L) deltoid immediately developed (L) shoulder pain/tendonitis now with neuropathy=tingling (L) scapula- for 3 months.
Intermittent muscle pain; This is a spontaneous report from a contactable pharmacist. This physician reported similar events for two patients, this is the second of two reports. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration in 2019 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced intermittent muscle pain a year ago (2019) that resolved after a few months.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020483510 same reporter/drug, similar events, different patient.
First 3 days - headache, nausea, body pain, chills, sweats,fatigue.  About 3 weeks to present. Memory loss, brain ?fog?  Using the wrong word when speaking. ( not the word I was thinking ? , doing stupid things that I wouldn?t normally do , not thinking clearly.  Forgetting where I?m going and what I?m doing with a long effort to recall where I am / what I?m doing.
Client complained of "feeling odd" during the nite and slightly disoriented in the morning. Had somewhat strange behavior in the morning of confusion and chills.
This spontaneous report as received from a Licensed Practice Nurse refers to two male patients of unknown age. On 22-FEB-2013 the patients were vaccinated with a dose of CERVARIX instead of GARDASIL (dose, route, lot number not provided). No product confusion discovered, just medication error. No adverse event was reported. This is one of several reports from the same source. Additional information has been requested.
Broke out in Hives, 4 days after injection from the Johnson & Johnson Vaccine, Took Antihistamine, gone 6 days outbreak.
Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. 1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml The dose given out of this vial was 0.3 ml. The children (age 5-11) received 0.3 ml x 41.9 mcg/ml = 12.6 mcg. Pfizer Case #:ID
Rash all over body - red bumps mostly on chest, less on arms, legs. Low grade fever, baby not sick. No vesicular lesions.
Information has been received from a Certified Medical Assistant concerning a 65 year old female patient with gastroesophageal reflux disease, hyperlipidaemia, hypothyroidism, atrial fibrillation, drug hypersensitivity to "CODEINE" and drug hypersensitivity to DEMEROL who on 24-JUL-2007 was vaccinated IM into the right arm with a dose of pneumococcal 23v polysaccharide vaccine, lot # 654977/0888F. Concomitant therapy included SYNTHROID, PREVACID, CORGARD, hydrochlorothiazide, LIPITOR, aspirin, ATIVAN, NEXIUM and ACTONEL. The patient called the office "2 weeks ago" to say that she had arm pain since she received the injection. She also had redness and warmth at the injection site after the injection. No other information available at this time. The outcome was unknown. Additional information has been requested.
Arm sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M204 and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 02-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Arm sore). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm sore) outcome was unknown.            No concomitant medications were reported   This case was linked to MOD-2021-031572, US-MODERNATX, INC.-MOD-2021-032594 (E2B Linked Report). This case was linked to MOD-2021-032479, MOD-2021-032479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Follow up received on 02-MAR-2021 contains no new information; Sender's Comments:  MOD-2021-031572:Crosslinked Case: Same reporter/different patient (husband) US-MODERNATX, INC.-MOD-2021-032594:Crosslinked case: Same reporter (Wife case 1st dose)
My daughter received the Prevnar shot on August 12th at approx. 4pm. At 10:30am on the 13th of August she had a seizure.  Her temp was not taken at the hospital until an hour later which it was 99.8 degrees. She was hospitalized the 13th and 14th and was released after numerous tests did not reveal a cause. The hospital record received on 4/5/04 states macrocephaly.
Dizziness for about 4 hrs after shot. Severe headache, saw primary care Dr and was prescribed Amitirx. Headache lasted about 2 weeks after shot. I was so dizzy I could not stand and the light affected my head and made headache worser.
she has been very sleepy more than normal; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (she has been very sleepy more than normal) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SOMNOLENCE (she has been very sleepy more than normal). At the time of the report, SOMNOLENCE (she has been very sleepy more than normal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Blood glucose increased: high (High) increase. On 25-Feb-2021, Blood pressure measurement: high (High) increase.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided. The Treatment information includes Blood pressure medications and Diabetes type-2 medications.
This spontaneous report was received from a Medical Assistant refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose, route, lot number and indication were not reported). No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 12Apr2021 (Lot number: ER2613) 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: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue".  Additional Context: Consumer stated, "I am just curious about, I got the COVID-19 the Pfizer shot on Monday and you know, I am pretty athletic but I still feel like I am doing athletic stuff, I feel fatigue. Is that normal?" Date of vaccination: Consumer stated, "Where I got it? It says here on this I got it on 12Apr2021." Consumer was provided with the number of Pfizer Information Department. Consumer hung up the call abruptly, hence, product details reporter type and other details were unknown. Limited information was available over the call. Communication: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are possible. No further information is expected.
3/14/11: sweating/chills 3/15/11: body aches 3/17/11: abdominal ache
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 27-APR-2018, the patient was vaccinated one dose of with M-M-R II, intramuscularly to an unspecified arm, lot# N027781 and expiration date: 08-AUG-2019. There were no adverse effects reported.
pt recvd vax; devel weakness feb95;studies compatible w/ polio-virus infect;
I woke the next morning with flu like symptoms my arm was hurting, I was feelin tired and really couldn't get out of bed. As the day progressed I got chills, started running a fever, It went up to 104 and my heart rate went up and down from 120-165 so I went to the ER. They gave me  fluids and ran a whole bunch of test, tested me for Covid and Sepsis and everything came back normal and negative for Covid. They monitored my heart rate and once it started getting back to normal, they ended up letting me go home, I was there from 8pm to about 3am.  After that I felt tired and felt like when   I had Covid back in November.  I started feeling better about Sunday, still a little tired but felt more back to normal.  My heart rate is still getting back to normal so my Dr is following me on that.
I just noticed that I have redness around the area of the shot.  I have no pain in the arm.
Pt. Received J&J vaccine for COVID. After SOB to sit down after vaccination, Pt. felt dizziness & fainted. 911 was called immediately, before they got here pt. was fully alert and Responsive. Paramedics had him stay in store for few mins and monitored then released him as he was fine.