chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have been suffering from Tinnitus, HOWEVER I HAVE NO IDEA IF THIS IS RELATED TO THE VACCINE OR THE VIRUS ITSELF AT ALL. I am a musician and started this Tinnitus after practicing with headphones AT VERY LOW LEVELS, since I am mindful about my hearing. In fact, in previous audiology tests years ago not only was my hearing above average for the general population, it was above average for musicians that play amplified music. A few weeks ago I was also doing audio training at home and the Tinnitus seemed to increase. Again, it didn't make sense to me since I do this at average listening levels. I have NOT gotten treatment for it yet, as I though it was a temporary thing.
Warm, edematous and red area around injection site 4.5 inches by 3.5 inches.  No fever, pain in arm.  Seen 2 days after injection.
This event is reported because patient received the wrong 2nd dose COVID-19 vaccine. Patient received 1st Moderna dose at another facility on 3/24/21. On 4/21/21, patient came to our facility intending to receive 2nd Moderna dose, but was inadvertently given Pfizer instead. There was no adverse event, this is reported since an error was made.
Woke up around midnight with chills, fever, upset stomach, headache and vertigo.  Vertigo lasted about 12 hours, chills about 12 hours, stomach ache about 12 hours, headache lasted 24 hours.  I did not treat with any over the counter drugs.  Just rested.  Was surprised at vertigo and dizzyness.  Did not read that in reactions to shot.
20 minutes of severe diarrhea, bad headache, fatigue, and fever.; 20 minutes of severe diarrhea, bad headache, fatigue, and fever.; 20 minutes of severe diarrhea, bad headache, fatigue, and fever.; 20 minutes of severe diarrhea, bad headache, fatigue, and fever.; This is a spontaneous report received from a contactable reporter consumer(patient) reported for herself that. A 25-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 12:15 (Batch/Lot Number: Unknown) as DOSE 1 SINGLE for covid-19 immunization( Age at vaccination: 25).The patient past Medical history included asthma from an unknown date and unknown if ongoing , endometriosis from an unknown date and unknown if ongoing , gastroesophageal reflux disease from an unknown date and unknown if ongoing , pain from an unknown date and unknown if ongoing , depression from an unknown date and unknown if ongoing , anxiety from an unknown date and unknown if ongoing , dermatitis contact from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing  known allergies: prednisone and doxycycline. Concomitant medication(s) included citalopram (CITALOPRAM) taken for an unspecified indication, mirtazapine (MIRTAZAPINE) taken for an unspecified indication and montelukast sodium (SINGULAIR) taken for an unspecified indication. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Administration facility. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 07Apr2021 19:00, 20 minutes after the administration of vaccine the patient experienced severe diarrhea, bad headache, fatigue and fever. No treatment was received. The event outcome was recovered on unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Shringles started 11/19/2019; small bumps itchy at first, then painful. Extremely tired. Prescribed Valacyclovir HCL 1  gm 3 x day; 7 days
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 83-year-old female patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on an unknown date, without any adverse event). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was unknown. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional information received as follows: The patient had no issue with the first dose of SHINGRIX. In 2018, the patient received the dose of SHINGRIX and experienced a severe headache. The reporter gave consent to follow up.
Started with skin above eyebrows itching and redness on face behind mask, then chills, then at about 30 minutes post injection increased heart rate and trouble swallowing/ chest tightness Gave dose of Epi and called 911/ As waited for EMS rash showed on arms and she said hard to breath after a few minutes she started breathing easier and rash started going away and she could swallow ok  EMS arrived and transported her to hospital for observation
Painful lymph node under arm; This case was reported by a consumer via interactive digital media and described the occurrence of lymph node pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th April 2022, the patient received Shingrix. In April 2022, less than a week after receiving Shingrix, the patient experienced lymph node pain. On an unknown date, the outcome of the lymph node pain was unknown.   It was unknown if the reporter considered the lymph node pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-APR-2022 Reporter's Comments:  The patient stated that he /she had Shingrix vaccination on 13th April 2022 and had a very painful spot, it was lymph node under his/her arm. The reporter consented to follow up.
After first shot had pain in joints right hand for 5 days, then left hand, the right toes and then left. The left hand two middle fingers and ankle. 3/22/2021 Pain was 10 of 10 with movement. Unable to walk or stand. All symptoms went away by Saturday (5 days). I was given  a shot of detramedrol and  medication,colchine 0.6mg. Suspect was gout. See below about tests.
I got Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: EW0177 and Expiration date: unknown), via an unknown route of administration, in left arm on 17May2021 at 15:45 (at the age of 16-years-old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included I used to have Bell's Palsy and shellfish allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. About 2 weeks later (may be on 02Jun2021 or 03Jun2021), the patient got bell's palsy. On 03Jun2021, the patient underwent nasal swab sars-cov-2 test and tested negative. Therapeutic measures were taken as a result of bell's palsy and patient received 21 Prednisone 20 mg and 10 Valacyclovir HCL 500 mg. The clinical outcome of event was recovering.  Information on Lot/Batch number was available. Additional information has been requested.
This spontaneous report was received from a nurse, referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date in 2015, an unspecified number of patients were vaccinated (Oka/Merck) VARIVAX Lot # K016129 and expiration date 23-SEP-2016, Lot # K006139 and expiration date 29-APR-2016, Lot # L005298 and expiration date 03-SEP-2017, Lot # L004653 and expiration date 11-FEB-2017, (dose number, strength, and route of administration were not reported), that were improperly stored and exposed to temperatures of 1.6 C for 2 hours and 40 minutes. At the time of this report, it was not reported any adverse event. This is one of two reports received from the same source. Additional information has been requested.
tested positive for COVID; tested positive for COVID; Flu; This is a spontaneous report from a contactable consumer. The consumer reported for self and husband. This is the second of two reports and concerns the reporter's husband. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EH9899/expiration date: not provided), via an unspecified route of administration, on 18Dec2020, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unspecified date in Dec2020, the patient experienced the flu after receiving the vaccine. On an unspecified date in Dec2020, the flu symptoms went away and the patient tested positive for COVID. The outcome of the event flu was recovered in Dec2020 and the outcome of tested positive for COVID was unknown.
Delayed raised, red inflamed hive at injection site about 2 inches in diameter. Developed 8 days following injection.
redness; swelling; soreness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Tylenol before the injection and Benadryl (2 nights before sleeping) after injection.  No concomitant medication was provided.    This case was linked to MOD21-10243 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: Drug start date, patient details, treatment, event updated; Sender's Comments:  MOD21-10243:
was administered his third dose of GARDASIL9 (unknown lot/expiration), which was 2 weeks after his second dose of GARDASIL 9; No additional adverse effects reported; This spontaneous report as received from a nurse and refers to a 21-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 30-MAR-2016, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. The dose was administered 2 weeks after his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), therefore the patient experienced inappropriate schedule of product administration. No additional adverse effects reported.
This is a spontaneous report from a contactable physician. A 70-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) at a single dose and influenza vaccine (FLU) at an unspecified dose; both via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: flu vaccine, pneumococcal 13-valent conjugate vaccine, penicillins and sulfa drugs on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
pt. reports having SOB & chest pain.  pt. denies any difficulty swallowing / breathing &/or other S/S.   Medics present.  pt. agreeable to EMS - transferred to EMS.
febrile sz 11 days p/vax given possibly assoc w/vax secondary to fact no other source found;
Within 24 hr of vax, pt devel severe pain behind right ear. Then devel right facial paralysis (Bell's palsy). Then pt devel herpes zoster with vesicles in the ear & throat. Dx as "herpes zoster in the 7th nerve-Ramsey Hunt".
Lethargy/altered level of consciousness lead to hospital admission.  Multiple interventions during hospitalization.  Final hospital diagnoses:  Acute respiratory failure with hypercapnia, acute pansinusitis.
fevers x 3 days started 8/3 up to 101.5, nausea x 3 days, sore throat/congestion x 3 days
Circular red rash around injection site. Approximately 4" in diameter. Itching like mosquito bite  Appeared 7 days after vaccination. Lasted about 3 days.  Also had slight fever of 99.8 and felt a little off and anxious throughout the day.
Administered Dtap/IPV (quadracel) IM instead of Dtap/IPV/Hepb-ped/Hib (Vaxelis).  No adverse reaction noted. Mother states that child has no signs/symptoms as of 7/19/2021.
Husband and wife received their second Covid vaccination and developed immediately blood in their hands and fingers underneath the skin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A male patient (husband) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 1, Manufacturer unknown), for covid 19 immunization. The following information was reported: HAEMORRHAGE SUBCUTANEOUS (non-serious), outcome "unknown", described as "Husband and wife received their second Covid vaccination and developed immediately blood in their hands and fingers underneath the skin".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200039429 Same reporter/drug/event, different patient;
Rash all over body with itching started on 06/05/2018 on legs. Mother instructed to give BENADRYL for rash.
Patient developed sudden chest pain on the eve of 11-8-21, found to have a left sided pulmonary embolism that night by CT scan.  He was placed on Eliquis as a blood thinner, has had numerous labs, and a pulmonary medicine consultation.   He has no risk factors for clots, ie, no personal or family history of clots, no recent surgeries or periods of immobility.
Client received a  1st dose of  Moderna vaccine on 03/04/2021 and 2nd dose on 04/01/2021.  Client tested tested positive for covid-19 on 05/12/2021. Client was an in patient at a hospital when covid-19 sample was taken
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to cases 2018SA281637, 2018SA279973, 2018SA279979, 2018SA281635 and 2018SA281634. This case involves a 12 years old male patient who received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number not reported via unknown route. It was a case of actual medication error due to product storage error. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
He was meant to receive step 1 of VARlVAX but instead got PROQUAD; This spontaneous report was received from a physician assistant and refers to a male adult patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 01-FEB-2021, the patient was meant to be vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (formulation, strength, dose, route of administration, frequency, lot # and expiration date were not reported) for prophylaxis but instead he received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (formulation, strength, dose, route of administration, frequency, lot # and expiration date were not reported) for prophylaxis (wrong vaccine administered).
Patient noticed increased redness at the injection site around noon, about 24 hours after the injection. She reported increased itchiness and pain at the injection site.
Left arm became red, swollen and tender to the touch and warm 50-54 hours after administration. Tylenol administered, no fever.  Went away after 8-10 hours.
received an adult dose of ENGERIX-B; received an adult dose of ENGERIX-B; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a neonate patient who received HBV (Engerix B adult) for prophylaxis.   In April 2022, the patient received Engerix B adult. In April 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 21-Apr-2022 Reporter's comments: The 2 days old patient received an adult dose of Engerix-B over the last 2-3 days of the reporting date. The consent to follow up was given. No additional information was available regarding patient or product at the time of reporting. Additional Supportive Information: The neonate patient received adult dose of Engerix B, which led to overdose and adult product administered to child. Note: The age at event onset 2 days was not captured due to validation error.
Severe Arthritic pains in hands and fingers.  Just came on after the second shot.
Pt. started feeling nauseated about 2 minutes after the vaccine, asked the post observation nurse for water, drank some and then vomited a very small amount of yellow liquid. After vomiting she stated she felt better. She reported being very nervous about getting the vaccine. No s/s after vomiting. Observed for 30 minutes post event. Escorted home by mother.
Received the shot at 5:30pm on 4/16. Slept fine. Woke up at 6:00 feeling bad.  Started with dizziness, nausea, and vomiting. Pain in head and body. Body aches. Bed ridden all day. More dizziness and vomiting in the late morning. Fever of 103. Body aches, dizziness , nausea. Body aches continued until about 9 pm.
1249 Dizziness &headache 5/10VSS BP 185/110, HR 79, Resp. 17, Oxygen sat 98%. Reports of HTN she took meds today. Monitored for 20 mins. Dizziness improved, H/A 4/10. VSS 163/92, HR 79, Resp 18, 99% oxygen Sat. Stated she feels ok to leave Left accompanied by her mother who will be driving home
A few days after receiving the Second Moderna booster on 4/1/22 I have experienced nonstop ringing in my ears.  24/7 high pitched ringing, continuous.
fever highest of 100.5 F; body aches; headache; This is a spontaneous report from a contactable nurse.  An adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 04Jan2021 14:45 at single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient medical history was not reported.  The patient's concomitant medications were not reported. The patient experienced fever highest of 100.5 f, body aches, headache all on 05Jan2021 with outcome of recovered in Jan2021.  The patient underwent lab tests and procedures which included body temperature: 100.5 fahrenheit highest on 05Jan2021, COVID test: PCR: negative on 19Jan2021. Therapeutic measures naproxen was taken as a result of events. Information on the lot/batch number has been requested.
Participant had skin reaction. Fingers are numb and arm feels like jello per participant. No respiratory issues. She took Tylenol and Benadryl at facility.
Mother calling to report received HPV #3 8/22/11, awoke 8/23/11 with nausea, body aches, extreme fatigue & sweats. Mother requests symptoms be reported.
Patient was given the Adacel first. She was then given the Gardasil and within seconds, passed out. She landed on the exam room floor, prone position. Patient became conscious again in less than a minute. She rested on the floor for several minutes and was then helped onto the exam table. Soon after she began vomiting and a lump began forming on her forehead. She was given some apple juice and crackers. She stated she was feeling somewhat better however, began to vomit again and complained of a headache. Was then examined by the provider and agreed to have a CT scan of her head which was within normal limits. She was called again before the end of the shift and stated that she was feeling much better with only a small amount of pain at the site of the hematoma.
FEVER (101.8), INCREASED HEART RATE (124), HEADACHE, BODY ACHE, SORE THROAT
Friday 1/8/21 I got a bit of what i think was nerve pain or just shooting pain on the wrist of the right-arm that was not the injection arm. Then today (Sat 1/9/21) that nerve pain is gone, but I developed a worse pain (pain of 6-7 out of 10) and additionally some weakness in the left-forearm closer to my elbow than my wrist, possibly where a tendon is (the injection arm). The pain shoots down from the elbow area towards my wrist on the posterior side. I haven?t done any extraneous work or lifted anything heavy since 1-2 days before the vaccine. It?s also my non-dominant arm so I don?t use it as much as my other arm.  So far I have iced it twice and taken Tylenol which has helped the pain. The arm is currently in a sling and I haven?t tried to use it since icing it the first time.
Syncope. Patient woke up drank some Orange Juice. Blood pressure and  vitals taken. Normal
Information has been received from a Licensed Visiting Nurse referring to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On unknown date the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K003405, expiration date: 06-MAR-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
lt upper extremities warm, erythema, edema of SC tissue-MD visit 3 days post vax;
rash at the site of injection; that area is red; that area is hard; A spontaneous report was received from a consumer concerning a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash at the site of injection, that area is red, that area is hard.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event(s) rash at the site of injection, that area is red, that area is hard.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash at the site of injection, that area is red, that area is hard was unknown.
Fever, headache, fatigue, vomiting since day after shot--on fourth day and still in bed, exhausted. Has lost five pounds.