chrisvoncsefalvay/vaers-outcomes huggingface dataset:
admitted on 01/23/2022 with severe COVID-pneumonia.  Tx: antibiotics, steroids, no remdesivir due to kidney function; zinc, singulair, 2 LPM O2; During his clinical course found to have right internal jugular vein thrombosis and was instituted on anticoagulation therapy.  Also found to have nonfunctioning arteriovenous fistula and underwent ligation of right arm AV fistula on 04/28/2022. The patient had a prolonged hospital stay awaiting placement however was refused by multiple facilities and eventually is being planned for discharge home with home health. He also was unable to be enrolled in outpatient HD facility and has been advised for return to ER MWF every week for HD ; back to baseline at d/c
Patient broke out in a rash, and his arms were shaking. Patient was given Liquid benadryl. Patients rash did start to resolve in the time he was in the pharmacy waiting area (appx 30 minutes)
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: rash on arm, extremities and torso-Medium
I  have developed hives on my hands and feet. My face looked like it had been pricked by pins. The hives have dried out and are flattened out. I have pics. I had a fever but not outrageous. I felt good on Wednesday, but then developed a fever again that night on 9/22. Felt like the flu. Body aches. Tired.
Injection Site Swelling; Injection Site Redness; Heat at the Injection Site; Feel achy; Low grade fever; Sore Throat; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On 11th September 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat were recovering/resolving.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, pain, low grade fever and sore throat to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but may be between 82 or 83 years. The reporter stated that, the patient experienced swelling, redness, and heat at the injection site. The patient also felt achy, had a low grade fever, and a sore throat. The reporter stated that, the patient at the time of reporting was having these symptoms. The reporter was unable to obtain additional details because her mother was not with her at the time of reporting. This case is 1 of the 2 linked cases, reported by the same reporter.
On 05/05/2021 at  08:43 A Moderna vaccine was given to patient by another nurse. The Vaccine was open on 05/04/2021 at 2:20 pm. After giving the vaccine the nurse told this nurse she had given a vaccine that was on the vaccine cart and stated she did not know it was not a new vial because it was on the cart. The incident was reported to the Clinical Director and Moderna  Manufacture. The client was monitored for thirty minutes and she showed no reactions. Viability of the vaccine was not decided.
This spontaneous report was received from an office manager referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates in January and February 2017, the patients received improperly stored doses of PROQUAD lot # M015695, expiration date: 26-SEP-2017 (dose and route of administration were not reported) for prophylaxis. The reporter had not been informed of an adverse experience. Administered doses of PROQUAD were exposed to temperature excursions as follows: In January 2017, between 5°F and 14°F for 4640 minutes (806 minutes highest 32°F); in February 2017, between 5°F and 14°F for 5164 minutes (560 minutes highest 36°F). Data logger was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA008835: US-009507513-1703USA009922: US-009507513-1703USA009923: US-009507513-1703USA009924: US-009507513-1703USA009925: US-009507513-1703USA009926: US-009507513-1703USA012105: US-009507513-1704USA001630: US-009507513-1704USA001631.
Pt received tetanus- diptheria vaccine on 5-7-04. Parent called 3 days later to report fever, T101-104 for two days, arm was red on first day after vaccine given. Neck was sore and pt had slight sore throat. Neck was supple. Parent spoke with doctor on the telephone.
12/13/06 patient presented in office with fever. Rales heard right lower lobe Oxygen sat 92-94%. Positive mycoplasma given Rocephin 1g admitted to hospital.  2/2/07 Received medical records from hospital which reveal patient admitted 12/13-12/16/06 for runny nose, cough, vomiting, lethargy & fever of 104. Admitted for IV antibiotics & nebs.  ID consult done & antibiotics adjusted per c/s. D/C to home on continued 2 wk course of oral antibiotics, f/u CXR in 2 wks & f/u w/PCP. FINAL DX: RLL pneumonia w/streptococcal bacteremia. 3/26/07 Received medical records from PCP which reveal patient w/fever & cough x 4 days when seen on 12/11.  Returned on 12/13 s/continued fever of 104.  O2 sat 92-94.  Tx w/antibiotics & nebs & was admitted to hospital.  ID consult obtained in hospital.  Returned to PCP on 12/23 s/p hospitalization.  Now w/fever & cough on antibiotics.  Started on nebs & continued on antibiotics.  Returned on 12/26 w/fever, cough & chills.  Had gone to ER night before due to high fever/chills & difficulty breathing.  Found to have bilater otitis media on exam.  Tx w/IV antibiotics.  Labs & CXR repeated.  Returned to PCP on 12/27 much improved.  Phone consult w/pulm & ENT.  Returned to PCP on 1/2/07 s/p 5 days of IV antibiotics at home.  Much improved & now started on oral antibiotics for 10 additional days.  Pneumococcal titers were neg & received pneumo polysac vax this date.  Continued to improve on antibiotics.
I received the 2nd dose of Moderna at 8:30am at the clinic for employees. I began to feel itching and numbness in my face starting around 8:55am. By 9:30am the itching had spread to my whole face, lips, roof of the mouth and tongue. The supervising nurse followed protocol and alerted our health team as well as 911. I was transported to Hospital ER via ambulance where I was treated with Benadryl and ZyTEC at 10:30. I was observed by the staff for any more adverse reactions, and was cleared to be released at 12:30pm.  At no point did I have trouble breathing, and all my vitals were stable throughout the event.
Arm swelled up and turned red. Rash on arm for about 3-4 days around injection site. Got really sick to stomach for about 6 hours. Almost fainted.
Started itching all over, whole body is on fire and is scratching; Annoying; This is a spontaneous report from  Pfizer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left upper arm on 08Jun2021 as dose 2, single dose for covid-19 immunization.  Medical history included hypertension. Concomitant medication included Bystolic (Nebivolol Hydrochloride, strength: 5mg), via an unspecified route of administration on an unspecified date at 5 mg, unknown frequency for hypertension. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: unknown, Expiry Date: unknown), via an unspecified route of administration on an unspecified date for COVID-19 immunization and had no reaction on previous exposure to vaccine. Consumer did not took any vaccination 4 weeks prior to COVID Vaccine. The patient experienced started itching all over, whole body is on fire and is scratching; under in my chest, my abdominal area, around my ribs, below my naval and above my pubis, whole abdominal trunk is itchy/sometimes it will be in my hairline, it's just annoying it's not breaking my skin apart on an unspecified date in Jun2021. Consumer stated, whatever the process normally would be it's fine, I just wanted to know what to do because I'm itchy, it started after the second shot and I never in my entire life had to take Benadryl for anything. But I've been to few doctors who tried to get rid of it and it's not, because they don't know what it is because it is something nobody has experienced apparently. Started itching all over, whole body is on fire and is scratching; Under in my chest, my abdominal area, around my ribs, below my naval and above my pubis, whole abdominal trunk is itchy/sometimes it will be in my hairline and annoying. Therapeutic measures were taken and the patient took hydrocortisone and that didn't work, and I took Benadryl and just nothing is helping. The clinical outcome of event started itching all over, whole body is on fire and is scratching, annoying was not recovered.
This spontaneous report was received from a 67 year old female patient, reporting on herself, with arthritis and bipolar disorder. The patient did not have any known allergy or drug reaction. Concomitant therapies included clozapine, NEURONTIN, quetiapine fumarate and PLAQUINOL. On 07-SEP-2018, the patient was vaccinated with PNEUMOVAX 23 at a dose of single dose of 0.5 ml, intramuscularly for prophylaxis (lot# and expiration date were not provided). The patient reported that she received a PNEUMOVAX 23 injection and was still experiencing "site pain, her arm was warm and sore, like she had been punched several times, it was tender and she cannot sleep on that side of her body". No treatment was administered for the adverse events. No laboratory test were performed. At the reporting time, the outcome the events was reported as not recovered. The reporter did not assess the causality between the events and PNEUMOVAX 23.
slight arm pain (3rd booster dose)/arm pain less than the first two doses; given 3rd full dose (0.5 ml)  for "booster dose"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) and ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose") in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A, 002A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) and ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose"). On 21-Oct-2021, ACCIDENTAL OVERDOSE (given 3rd full dose (0.5 ml)  for "booster dose") had resolved. At the time of the report, VACCINATION SITE PAIN (slight arm pain (3rd booster dose)/arm pain less than the first two doses) outcome was unknown.            It was reported that patient is not immunocompromised and mentioned that the half (0.25 ml) booster dose wasn't yet approved at the time of the vaccination, which is why he received a full dose(0.5 ml). Patient had no known drug or food allergies.    No Concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2021-428648, MOD-2021-428659 (Patient Link).
Information has been received from a licensed visiting nurse concerning a patient who within the last couple of days was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). "Right after getting the vaccine" the patient experienced fever and significant swelling of the arm. The patient was administered an epinephrine shot and recovered. The nurse also stated that she will hold off on administering the PNEUMOVAX 23 vaccine with that lot number to the patients. Follow up information has been received from the licensed visiting nurse who indicated that the patient was vaccinated with PNEUMOVAX 23 (Lot # 665300/1314Y) on approximately 09-FEB-2010. The licensed visiting nurse thought that the patient had been treated with SOLUMEDROL and an antibiotic (unspecified). The licensed visiting nurse did not consider the patient's fever or swelling of the arm to be life - threatening. The licensed visiting nurse stated that according to the office's policy they were not administering PNEUMOVAX 23 with the lot # 665300/1314Y. The nurse also stated that the patient had not received epinephrine as previously reported. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of two reports received from the same source. Additional information has been requested.
parosmia. I have a weird smell everything smells the same and it all smells horrible. Thought it would go away but it has not.
PATIENT CLAIMS TO HAVE BLED ON DAY 2 AT INJECTION SITE. HAD SEEN PRIMARY CARE BUT DID NOT CORRELATE THE REACTION TO THE VACCINATION. PRIMARY CARE HAD RECOMMENDED SHE CONSULT A DERMATOLOGIST. PATIENT CAME TO THE PHARMACY FOR THE FIRST TIME SINCE VACCINATION TO CONSULT ABOUT ADVERSE REACTION. CURRENT STATE OF INJECTION SITE IS SWOLLEN WITH A BUMP, BLED YESTERDAY, SCABBED. PATIENT STATES IT IS ITCHY, WITH NO PAIN.
At first his arm was " a normal sore" that he would expect from an IM injection. About 1 week after the vaccine he began to feel a burning sensation/weakness/inability to lift his arm above a certain level in his left shoulder. He first went to the Dr on Nov 19. He was given samples of a steroid - a 4 day course. The first 2 days it helped a lot.
This spontaneous report as received from a pharmacy student refers to a 50 year old female patient. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date were not reported) to prevent shingles. On an unknown date (reported as approximately one year 1 later), the patient developed shingles. On an unspecified day, the shingles resolved. On an unknown date (reported as now), the patient experienced another case of shingles. The patient sought medical attention via contacting a pharmacist. The outcome of second case of shingles was not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Patient Blood pressure Report  July 22, 2021  Urgent Care    PA-C   Yearly Physical??.All Athlete status?. All tests perfect, Blood pressure 120/60  August 16, 2021 (24 DAYS LATER)  Second Covid vaccine??Immediate atrial flutter one hour after vaccine.  My wife and myself, with increasing high blood pressure. PFIZER BATCH # 7/23/21 FA6780 AND FC3181 8/16/21  October 27th. 2021  Appt. PA-C   EKG negative report.  October 31 st. 2021  Hospital Emergency Room Blood pressure 163/106/144 Dr.   All test attached. Dr. stated that there were no findings all perfect.  10/31/21 to 1/4/2022 Blood pressure readings 3 times per day on file Dr., Hospital.  1/4/21 Referred to Dr. at Hospital   EKG, ZIO PATCH, NKG, STRESS TEST   Dr. stated all test perfect no issues.  1. PA-C, Dr., and other Dr. all stated there were no findings all is perfect. 2. If all is perfect why would my blood pressure sky rocket in 24 days from physical July 22 to August 16th.? 3. I asked you Dr. what would cause my blood pressure to rise so rapidly. Dr, stated ? Because you are now a senior citizen? What kind of a unprofessional answer is that. You could not give me one reason. By age I am 65, relative age 40. Surf everyday, ride a bike over 100 miles per week, yoga, and have my own work out room. So to blame it on being a Senior citizen is bogus. Dr. you didn?t even want to discuss the fact that the cause is the vaccine.  (common sense) THE VACCINE HAS CAUSED MY HIGH BLOOD PRESSURE, THERE IS ABSOLUTLY NO QUESTION. 4. No discussion of Dr. who developed RMDA who stated in his report that  ?THE COVID VACCINE CAUSES BLOOD PRESSURE TO RISE? WHICH IS CAUSED BY A PROTIEN SPIKE. I understand that Dr. would be vilified if he stated the side effect of the vaccine is high blood pressure.  In conclusion it is obvious that the vaccine has caused  blood pressure in my wife and myself to rise right after the second vaccine. As there are no other factors which relate to having high blood pressure.  If my wife didn?t have the same issues I would consider that the high blood pressure was another issue. However it?s not. I would say that the doctor missed something accept all three doctors stated all is well?
Admitted with a dx of chicken pox, c/o swollen of right side of face and ear pain and skin rash.
Patient states that her hands began to turn beet red about 2 hours after the vaccination. She did not report any itching or pain, just a bright red color on both hands. The redness persisted for about 6 hours before it went away.
Site: Pain at Injection Site-Mild, Systemic: Dizziness/Lightheadedness-Medium, Systemic: Exhaustion/Lethargy-Medium, Systemic: Flushed/Sweating-Mild, Additional Details: It was 100 degree temperature outside. Patient said she had been outside all day. I fanned her, gave her water to drink and observed her for 20 minutes. She was fine in 15 minutes.
delayed rxn to DT booster, bad swelling @ inj site (upper outer quad, deltoid lt arm) almost as large as small fist;indurated rash, itching;painful;site was not;large patch of reddened skin still evident on 4FEB97;
joint pain in her hands and feet; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 30th September 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on August 2020). Concomitant products included celecoxib (Celebrex).   In November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than 6 months after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The patient developed joint pain in hands and feet. The patient was taking celebrex prior to getting the shingrix vaccine and her health care practitioner increased celebrex dose due to the joint pain in her hands and feet.  The joint pain had not yet resolved. The reporter consent to follow up
Patient has canker sores on tongue, cheeks, gums. Lesions are very inflamed and painful. Has not seen a doctor yet.
I teasted positive for COVID; I'm gonna be down,goanna go lay down,Extremely tired; It was bad allergies; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I teasted positive for COVID), FATIGUE (I'm gonna be down,goanna go lay down,Extremely tired), HYPERSENSITIVITY (It was bad allergies) and HEADACHE (Headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for an unknown indication.    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 COVID-19 (I teasted positive for COVID), FATIGUE (I'm gonna be down,goanna go lay down,Extremely tired), HYPERSENSITIVITY (It was bad allergies) and HEADACHE (Headaches). At the time of the report, COVID-19 (I teasted positive for COVID), FATIGUE (I'm gonna be down,goanna go lay down,Extremely tired), HYPERSENSITIVITY (It was bad allergies) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested Positive for COVID-19.         No concomitant medication was reported. Patient had booster shot. No treatment medication was reported.  Company Comment: This spontaneous case concerns a  patient of an unknown age and gender, with a no medical history reported, who experienced the unexpected AESI of COVID-19, and the expected events of Fatigue, Hypersensitivity and Headache. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was also being treated with Pristiq. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a  patient of an unknown age and gender, with a no medical history reported, who experienced the unexpected AESI of COVID-19, and the expected events of Fatigue, Hypersensitivity and Headache. The event occurred on an unknown date after receiving a dose of mRNA-1273 Vaccine. The patient was also being treated with Pristiq. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient experienced dizziness, numbness of tongue/mouth and spreading to body, stroke-like symptoms.
Lost hearing in one ear due to labyrinthitis.; Labyrinthitis; Virus probably chickenpox/infection; This case was reported by a consumer via interactive digital media and described the occurrence of hearing loss unilateral in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hearing loss unilateral (serious criteria GSK medically significant), labyrinthitis and chickenpox. On an unknown date, the outcome of the hearing loss unilateral, labyrinthitis and chickenpox were unknown.   It was unknown if the reporter considered the hearing loss unilateral, labyrinthitis and chickenpox to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the Shingrix vaccination and 6 months later had the chickenpox infection. The patient stated that he/she did not have shingles rash, but lost hearing in one ear due to labyrinthitis caused by a virus probably chickenpox virus harbored in his/her body. The follow-up would not be possible as no contact details were available.
Patient called Employee Health department c/o diarrhea, cough + headache one day after receiving vaccine.
L thigh swollen, red, + bump Dxper Dr L leg cellulitis vaccine Rxn.
I had severe headache on Thursday. Turned into severe migraine, pain in left calf, shortness of breath, and pain and pressure in my left ear and eye. I went to the doctor and was prescribed migraine prescription.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient hospitalized (reasons unspecified) and vaccinated with PNEUMOVAX23 (lot # H014653, expiration date was 19-APR-2014, 0.5 ml, subcutaneous). On an unknown date the patient had developed redness, swelling, tenderness in arm at injection site. The outcome of event was unknown. The relationship between events and PNEUMOVAX23 was unknown. The pharmacist was requesting a lot check for PNEUMOVAX23 lot H014653 (Expired date e 19-APR-2014). This is one of several reports received from the same source. Additional information has been requested.