chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 14Dec2021 as dose 3 (booster) (Lot number: FE3594) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 22May2022, outcome "unknown", COVID-19 (medically significant) with onset 22May2022, outcome "recovering" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound of Covid symptoms and positive test after three days of negative Covid tests and no symptoms except coughing. Symptoms suddenly restarted on day 12 after starting Paxlovid treatment; positive, notes: Rebound of Covid symptoms and positive test after three days of negative Covid tests and no symptoms except coughing. Symptoms suddenly restarted on day 12 after starting Paxlovid treatment. Therapeutic measures were not taken as a result of covid-19.  Clinical course: It was reported that rebound of Covid symptoms and positive test after three days of negative Covid tests and no symptoms except coughing. Symptoms suddenly restarted on day 12 after starting Paxlovid treatment.
10 cm diameter erythema/pruritis/indurated area at site of injection.  Site was notably warmer than surrounding skin.
Headache, Extreme Fatigue; Headache, Extreme Fatigue; This is a spontaneous report from a contactable Other-HCP. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number Unknown), intramuscular at Left arm on 23Dec2020 10:00 at single dose for covid-19 immunisation.  Medical history included Diabetes mellitus, Known allergies: penicillin.  Concomitant medication included metformin. The patient experienced headache, extreme fatigue on 23Dec2020 23:00. Both events were non serious. No treatment was received. The patient was not Pregnant at the time of vaccination.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The outcome of the events was resolved in Dec2020.  Information about lot/batch number has been requested.
Reported dizziness, cold extremities, redness in left ear and rash on left shoulder noted.  Mild anxiety.  25 mg Benadryl po administered.  Returned to work at 10:25 am. No reaction to first dose reported.
Pt entered observation @ 1315.  Patient c/o itching BL hands/wrist @ 1340. Benadryl 25mg was given @ 1340.  V/S Obtained.  BP-166/103, P-82, R-24, O2-97%.  Still continued to voice s/s of itching @ 1407.  Remains in observation @ present time.  V/S also retaken @ 1407.  BP-140/93, P-84, R-18, O2-97%.  States Benadryl 25mg had alleviated some of the s/s as well.  Pt voices no s/s of itching @ 1423, left observation @ 1424.
My arm was way bigger, more swollen, itchier and red. It started off as a really bad headache. I had a bad reaction the first time also, so I thought this was what it was. After the headache my head hurt so bad, and I had issues with my sinuses. I also have lots of fatigue and muscle pain, I have very watery eyes. I had chills and it felt like I had a fever. I tested myself on Saturday morning and it was positive. I took a picture and sent it to my doctor, and I am still waiting for a response. I have been taking ibuprofen and acetaminophen to treat my symptoms. My head is still pounding. Im not stuck in bed anymore but I am still sick.
2 weeks after first injection started with severe itching of feet and hands.  Occurred mainly at nighttime everyday for months. Hands and feet would welt and itch for hours. Started using Chetaphill Body Cream  and Benadryl to help with the itch. Then it moved to not everyday just a few times a week but now I welt up and get rash like on my arms, legs, stomach.
Patient advised he sometimes gets dizzy or loses consciousness  with vaccines. After receicing injection, patient said he was feeling dizzy and was supported in chair by pharmacist as patient lost consciousness. Patient regained consciousness after 20-30 seconds and asked to put his feet up on a chair. Patient was given a bottle of water and waited 20-30 minutes until he felt well and was able to walk and stand. Patient waitied an additional 15 minutes in store before departing.  No injury occurred.
13 yo received 2nd Gardasil 8/27, had sz on 9/4/13. Pt previously healthy though also had 1st sz on 7/28/13 after receiving Gardasil on 6/27/13.
This spontaneous report was received from a certified medical assistant and refers to a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose od M-M-R II (lot # K009192 with an expiration date on 27-JUN-2016; dose and route of administration were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent for further contact.
Pt COVID + on 10/13/2021. Admitted with dyspnea, SOB and found to have acute respiratory failture due to   pneumonia due to COVID virus.  Treated with IV decadron, Breo and albuterol inhaler. Supplemental oxygen. Discharged to home.
Client rec'd (R) arm - PNEUMOVAX and Hep A #2 (L) arm - MMR #2. C/O of (R) arm, warm, swollen, bruised, slight fever on 2/24/16.
Problems with voice; Problem with throat; Has lost her voice; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Problems with voice), OROPHARYNGEAL DISCOMFORT (Problem with throat) and APHONIA (Has lost her voice) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  .  Concomitant products included TRAZODONE, LEVOTHYROXINE, SIMVASTATIN, METHOCARBAMOL, METFORMIN, LISINOPRIL, LAMOTRIGINE, GLIMEPIRIDE, FLUOXETINE, DILTIAZEM and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.   On 01-Feb-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) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced DYSPHONIA (Problems with voice), OROPHARYNGEAL DISCOMFORT (Problem with throat) and APHONIA (Has lost her voice). At the time of the report, DYSPHONIA (Problems with voice), OROPHARYNGEAL DISCOMFORT (Problem with throat) and APHONIA (Has lost her voice) outcome was unknown.            Other concomitant medications included Novolin.  No treatment information was provided.
Pericardial effusion; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDIAL EFFUSION (medically significant), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Adverse event; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had adverse reaction. The reporter wanted to know long do the symptoms from getting the shot lasts.
Generalized tonic clonic seizure.  Final DX; Generalized seizure, resolved, lymnphocytosis, Recent URI Tonic clonic sz <1 min. Short post ictal. All diags neg. Increased lymphocytes, viral illness. Phenergan for recent URI, cough.  Neuro PE neg. D/C to home stable.  Refer to neuro. Abnormal EEG. Complex partial seizure. MRI ordered. ICD9 Codes: 780.39  12/17/09  ED  Medical records received for DOS 10/27/09
1500 FELT "PALPIATATIONS"  AND FACIAL FLUSHING EPISODE IN IN HE LAST 10 MINUTES, RESOLVED SPONTANEOUSLY  1504  BLOOD PRESSURE 75/86, HR 105 O2 100%; HEART RATE REGULAR AND RAPID, FEELS FLUSHED  HEART RACING. PATIENT REPORTS SEIZURE EPISODE LAST NIGHT  1511 BP 54/87 HR 99 O2 99%, PATIENT STATES SHES FEELING BETTER  1530  PATIENT FEELING MUCH BETTER. INSTRUSTED TO SEEK EMERGENCY MEDICAL ASSISTANCE IF SYMPTOMS RETURN
This spontaneous report as received from a nurse refers to a 14 months old male patient with no Pertinent Medical History and no Drug Reactions/Allergies. On an unknown date the patient was vaccinated with three respective dose of PROQUAD (merck) (lot #, expiration date and dose unspecified), PEDVAXHIB (lot #, expiration date and dose unspecified) and PREVNAR 13 (lot #, expiration date and dose unspecified), they were all administered intramuscularly, and they were all administered right next to each other on the patient's right thigh. No concomitant medication included. The patient's parents brought him to see the physician as the area with the three injection sites swelled up "to the size of a golf ball". The swollen area was lanced by the physician and was filled with serous fluid. The fluid was sent for a culture, but was determined to be negative with no bacterial growth. The event outcome was reported as recovering. Additional information has been requested.
My right arm was very sore for 2-3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My right arm was very sore for 2-3 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.  No Medical History information was reported.  On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (My right arm was very sore for 2-3 days). At the time of the report, PAIN IN EXTREMITY (My right arm was very sore for 2-3 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received on 06-Jul-2021 contains non significant information of contact details added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient passed out after administration of vaccine (5 seconds later). Patient came to, then reported severe back spasms (lower back); she felt sweaty, flushed, warm. Pt given water to drink & ice for her back. Pt remained at site for 20 minutes she was feeling better & back no longer hurting. Pharmacy intern accompanied pt on errand & back to work.
red rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (red rash at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INJECTION SITE RASH (red rash at injection site). On 14-Mar-2021, INJECTION SITE RASH (red rash at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment medication was not reported.
Generalized hives - started 12 hrs after injections was taken to the ER. Given IV and oral steroids in ER.
Still where the injection site was I have a bump and its still red; Still where the injection site was I have a bump and its still red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Still where the injection site was I have a bump and its still red) and INJECTION SITE ERYTHEMA (Still where the injection site was I have a bump and its still red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INJECTION SITE MASS (Still where the injection site was I have a bump and its still red) and INJECTION SITE ERYTHEMA (Still where the injection site was I have a bump and its still red). At the time of the report, INJECTION SITE MASS (Still where the injection site was I have a bump and its still red) and INJECTION SITE ERYTHEMA (Still where the injection site was I have a bump and its still red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications reported.  No treatment information provided.
Muscle soreness in shoulders, upper back, and neck. Intermittent hot flashes in face and upper body. Earaches and pressure. No rash. Member presented on 6 Dec 2017 which is 10 days after the Anthrax vaccination on 27 Nov 2017 with above symptoms resolved, except for continued intermittent hot flashes in face and upper body. Physical exam normal. No treatment given.
Chest tightness and higher blood pressure (ranging from 125 -135 systolic blood pressure) than normal  day after receiving the vaccine.
Mild aches and fatigue.  Severe headache at 3:30 am.  Some relief with Advil went to work, had to come home at 1:00 pm.  the next day.  Subsided by 10:00 pm.
After the first shot i was severely ill for 3 days with severe headaches and high fever (102.4F at the highest); After the second shot i was sick for 2 days with headaches and fever up to 101F; After both shots, severe arm pain. Both illnesses symptoms were controlled with advil 2x200mg every 6-8 hours.
Sores on head, numbness on right side of face/neck, with sensation of burning when touched.
PT EXP RASH, SWOLLEN FACE AND HIVES ON DAY OF VACCINATION.  NO TREATMENT GIVEN.  RASH RESOLVED.
Body Aches, Fatigue, Headache symptoms lasted approximately 48 hours within  24 hours of receiving 2nd vaccine
At approximately 11:00 AM on Friday, November 11th I received an injection for pneumonia vaccination at the Clinic. Everything was routine until around 2:00 PM that day when I began to experience stiffness in my shoulder and growing pain in the shoulder, upper and lower left arm. By 3:00 PM I was unable to use my left arm to assist in driving my vehicle home. In approximately one hour the pain had grown so intense that I could only lie down and hold my arm across my body. I telephoned the clinic and was told to take two Ibuprofin, apply a heating pad and rest. Nothing more could be done for me. This situation persisted for 48 hrs before the pain began to ease. It was 96 hrs. after the shot before I began to regain some of the use of my left arm. As of this writing, the pain is still present to the extent that it interfers with sleep and activity and I still have not recovered full use of my left arm.
felt like his arm was about to kill him; was weak but fine afterwards; soreness was across his shoulder to his neck; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt like his arm was about to kill him), ASTHENIA (was weak but fine afterwards) and MYALGIA (soreness was across his shoulder to his neck) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (felt like his arm was about to kill him), ASTHENIA (was weak but fine afterwards) and MYALGIA (soreness was across his shoulder to his neck). At the time of the report, LIMB DISCOMFORT (felt like his arm was about to kill him) and MYALGIA (soreness was across his shoulder to his neck) outcome was unknown and ASTHENIA (was weak but fine afterwards) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were reported.
Received dose in left arm on 10/17. Stuffy nose, headache starting Saturday morning, aching lymph nodes between arm pit on Sunday. Left side ache and right side ache and about 30 red dots all over body (neck, arms, legs, stomach).
Client states in pm 3/12/14 (L) deltoid became red with some swelling then on 3/13/14 (L) deltoid became very swollen, red and warm. Client states she applied alcohol to area. 3/14/14  (L) deltoid lg amt swelling, redness and warmth. Referred to medical doctor.
Large area of erythema and pruritus noted to arm where MMRV was administered 2 days after vaccine was administered.
3 yo intentionally underimmunized boy seen 3/9 for dysuria, noted to have small abrasions at foreskin/glans, c/o dysuria but unable to give urine specimen in clinic, advised to apply vaseline/aquaphor, has been doing and pt symptoms improving. At 3/9 visit pt received DTaP and PCV13 catchup immunization, both in left leg. A few hours after visit mom noted swelling and slight redness at site, with c/o pain when touched. No fever , no respiratory symptoms. Area of swelling grew until approximately 10 cm X 10 cm but did not become more red.  Area visualized on video visit 3/12, pinkish and possibly slightly raised, no red streaking or drainage, Ice, acetaminophen/ibuprofen recommended, return precautions reviewed.
Diarrhea starting 2 hours after injection Then headache a few hours later That night fevers to 101.4, chills, aches, fatigue, weakness
AFTER ADMINISTRATION DURING OBSERVATION PERIOD, PATIENT INFORMED PHARMCIST OF TINGLING/FUZZY FEELING IN THROAT, DIZZINESS, RACING HEART AND CHEST TIGHTNESS.  PHARMACIST HAD PATIENT ELEVATE LEGS, GAVE WATER AND LIQUID BENADRYL. PATIENT OBSERVED FOR 10-15 MINUTES WHILE WAITING FOR IMPROVEMENT. PATIENT NEVER LOST CONSCIOUSNESS OR REPORTED TROUBLE BREATHING.  PATIENT WAS ABLE TO CALL OWN DOCTOR AND HAVE PRESCRIPTION FOR PREDNISONE CALLED IN WHILE PHARMACIST CONTINUED TO MONITOR PATIENT. SHE WAS ABLE TO LEAVE PHARMACY ON HER OWN ABOUT 30 MINUTES LATER, HUSBAND WAS WITH HER AT THIS TIME. SHE WAS GIVEN BENADRYL AND PREDNISONE FOR AT HOME USE
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  A 36-year-old female patient received BNT162b2 (BNT162B2), 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 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim", notes: Known allergies: penicillin, Bactrim. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 and drug ineffective.
Headache, Myalgia, Arthralgia, Rash, Deltoid painful couple of days, fatique
took 2 days to see straight again; This case was reported by a consumer via media and described the occurrence of visual impairment in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced visual impairment. On an unknown date, the outcome of the visual impairment was recovered/resolved.   It was unknown if the reporter considered the visual impairment to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient had no adverse event for the 1st dose, it was considered as 1st shot piece of cake. The patient received dose of Shingles vaccine and it took 2 days to see straight again. No further information reported.