chrisvoncsefalvay/vaers-outcomes huggingface dataset:
influenza; Initial information received on 03-Dec-2022 regarding an unsolicited valid Social Media serious case via consumer/non-hcp.  This case involves Adult and unknown gender patient who had influenza after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, form, batch lot number, expiry date: unknown) via unknown route in unknown administration site for influenza.  On an unknown date the patient had an event of influenza (unknown latency) following the administration of influenza vaccine.   Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.  Seriousness Criteria: the event caused hospitalization.; Sender's Comments: Sanofi company comment dated 07-Dec-2022: This case involves Adult and unknown gender patient who had influenza after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, hospitalization details, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
2 convuls w/temp of 103.4F; 3 prior DTP w/no problems; Recovered in 1 day;
The patient then underwent a hysterectomy and was hospitalized following the procedure; contracted Human Papillomavirus and ended up with cancer; contracted Human Papillomavirus and ended up with cancer; This spontaneous report has been received from a nurse, via a field-based representative, concerning a female patient who at the reporting time was 31 years old. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were unknown by the reporter.   On an unspecified date (reported as "when she was 14 years old"), the patient completed the vaccination scheme of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) 0.5 milliliters (ml) injection administered intramuscularly (anatomical site of vaccination was not provided; lot number, and expiration date were unknown by the reporter) as prophylaxis.   On an unspecified date, the patient contracted human papillomavirus (papilloma viral infection) and experienced cancer (neoplasm malignant). Then, as a treatment for cancer, the patient underwent a hysterectomy and was hospitalized following the procedure. The reporter stated that the patient was doing better, however the outcome of the events was reported as unknown.   It was reported that the physician who treated the patient stated the human papillomavirus type was a type contained within Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), as far what the vaccine covered.   The reporter's causality assessment between the events and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was not provided.  Upon internal review, hysterectomy and neoplasm malignant were determined to be medically significant events.
patient has a a red ring around her arm that is over 4 weeks  have advised patient to visit doctor
Chills lasting approximately 1-2 hours, headache and fatigue last approximately 12 hours
Complaint of rash on left arm and itching. BP at 4:22 was 134/76 HR 74. Benadryl elixir 50mg given 4:32 pm. BP 4:42 140/82 HR 71, itching subsiding. 4:54 complaint of left upper lip swelling, was not visible. 4:58 advised patient and mom to go to urgent care for evaluation and that Benadryl 50mg could be given every 4-6 hrs. At discharge swelling sensation was resolving. Spoke with mom on 8/12/2021 informed that patient went to urgent care but no other treatment was recommended and doctor advised not to give dose #2 of Pfizer.
Vomiting, Diarrhea, Screaming/Crying. Asphyxiating in sleep, gagging on vomit. Fever of 104F, Coughing, runny nose.
Chills,Fever,Headache,Muscle/Body Aches which lasted up to 4 days.
Shingrix was administered to a 21 year old; was accidental/was to receive the Boostrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   On 15th July 2021, the patient received Shingrix. On 15th July 2021, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.  Additional details were provided as follows: The patient received dose of Shingrix in left deltoid. The reporter stated that, the 21 years old patient received Shingrix instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. At the time of the report the patient had not reported any issues. The reporter consented to follow up.
Pt received her first dose of Pfizer vaccine. She sat in chairs for approximately 10 minutes before becoming dizzy and experiencing syncopy. Her head was bumped as she fell. She recovered within a moment and was reseated. She was given orange juice and a granola bar. She stated that she frequently experiences dizziness upon standing or rising from bed. She stated she had not had anything to eat or drink prior to the vaccine. Her parents sat with her for another 1/2 hour and exited the store.
Infected cyst on my leg; This spontaneous case was reported by a consumer and describes the occurrence of INFECTED CYST (Infected cyst on my leg) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTED CYST (Infected cyst on my leg) (seriousness criterion medically significant). At the time of the report, INFECTED CYST (Infected cyst on my leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  The patient wanted to know if patient could get second dose of vaccine, in instance of having an infected cyst on the leg. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Awoke Monday morning with very red blood shot eyes and red, splotchy rash. Tiny dots over torso and neck. Complaints of itching. Denies fever. 6/14/05 Mom states rash lessened throughout the day and child had no further complications.
Hives/red raised bumps on chest and both arms. Tried to see Dr., they informed her to take Benadryl.
Severe chills began at 8:15 PM lasting 5 hours, followed by fever of 101.6 nausea and diarrhea.  Severe symptoms  lasted for about 16  hours followed by fatigue, loss of appetite and weakness.  Symptoms are improving daily .
pt recv vax & suffered repeated episodes of hives p/2nd dose of vax;no rxn occurred p/dose 1;
Patient received a 2nd flu this season by mistake when patient was supposed to receive Tdap and Pneumovax.
Painful, throbbing, aching pains in arms and shoulders. Left arm is numb feeling in my fingers, hand is weak, with burning pain, also in shoulder, arm and on left side of neck, with stinging feeling following. Deep aching pain in my muscles and shoulders.
This is a prospective pregnancy case. This female subject was enrolled in a study. The subject received Flu Seasonal QIV (other) .5 ml on 23rd September 2014. On an unknown date, an unknown time after receiving Flu Seasonal QIV the subject developed injection site cellulitis. Serious criteria included GSK medically significant. Additional event(s) included vaccine exposure during pregnancy. The subject was treated with antibiotics nos (Unknown Antibiotic). The outcome of injection site cellulitis was unknown. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. It was unknown if the investigator considered the injection site cellulitis to be related to Flu Seasonal QIV. Additional details provided: It was unknown if the patient had concomitant medication, medical history, past drug therapy or any adverse events following previous vaccinations. It was not precisely known if patient was pregnant, but the field representative noted it may be a possibility. The patient developed cellulitis at the injection site and was seen by the nurse practitioner. The patient was placed on an unknown antibiotic and compresses were applied to the site.
Did not have an adverse event. But both guardian and kid gave false date of birth, and the shot was given to the kid who hasn't turned 12 yet.
pt recvd vax & noticed red area on left arm &  began to itch the area; area is 3 inches in diameter;
Information has been received from a physician concerning a 14  year old male who was vaccinated as a child with a dose of hepatitis B virus vaccine rHBsAg (yeast). Subsequently, the pt developed hepatitis B and metastatic liver cancer "as a result of vaccine failure". Unspecified medical attention was sought. At the time of this report the pt had not recovered. There was no product quality complaint involved. Additional information has been requested.
SICK; This spontaneous report received from a consumer via a company representative concerned a several multiple patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patients experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220126450, 20220126177, 20220126708, 20220126582 and 20220126701.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 18-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   On 18-Oct-2021, the vial was initially stored in the refrigerator.  The Vial did not go undergo any temperature excursion. The patient had no any adverse event post administration of expired vaccine.  Treatment information was not provided.
94 yo F presented w/ weakness, fever, rigors. Covid +. Vaccinated and boosted. Symptomatic since 3/3. Pt is immunocompromised. Pt felt to be septic as well from possible UTI/ PNA.  Pt was started on IV abx as well as remdesivir, steroids given initial hypoxia. Pt was able to be weaned to RA. Pt's blood cultures and urine culture have been negative, but she was on Abx prior to arrival. Pt has a h/o klebsiella UTI. Will d/c on cipro to complete 7 days. Pt's bp has remained stable while holding HCTZ, lopressor and lasix. Will continue to hold these and d/w daughter. PT/OT has seen the patient and recommended SNF, but daughter would like to try caregivers in the home. Will resume HH and add PT/OT. Of note, echo obtained reveals severe AS (Pt does have a h/o rheumatic fever) Pt is not symptomatic from this.
weak; back pain; diarrhea; feeling dizzy; sore all over; I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot; I have to stay at home for probably 36 hours; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy) and ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy), ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have to stay at home for probably 36 hours) and MYALGIA (sore all over). At the time of the report, ASTHENIA (weak), BACK PAIN (back pain), DIARRHOEA (diarrhea), DIZZINESS (feeling dizzy) and MYALGIA (sore all over) outcome was unknown and ILLNESS (I get sick every time I get a Shot/get sick for almost 3 days after receiving this shot) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I have to stay at home for probably 36 hours) had resolved.            Concomitant medication of the patient was not reported.  The patient would like to know if a 4th dose came up and if patient have it, will get sick as well. The patient would also like to know if can switch the vaccines to avoid being sick.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-427003, MOD-2021-427000.   Reporter did not allow further contact
Myocarditis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID: (Unknown). The reporter is the parent.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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 (dose 1, single; lot number: unknown), for COVID-19 immunization; BNT162b2 (dose 2, single; lot number: unknown), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown". Clinical course: The patient's father reported that the patient (his son) got harmed after getting the Pfizer COVID-19 vaccine. The patient received first two shots of Pfizer COVID-19 vaccine in the time period he was supposed to and also got the booster. He did not have a problem that time. In the last few weeks prior to the time of the report, the patient got a heart condition. The father was complaining about the vaccine and how there is no plan on what to do with patients who developed myocarditis. The father stated, "You said that this was safe and effective...it turns out it is not safe." and mentioned a passing comment "there might be a class action lawsuit." Upon callback, the patient's father noted that his son became dizzy with heart palpitations and "struggles to take the trash out". He asked what "Pfizer is doing" about this event and how Pfizer is helping people with myocarditis "reclaim their health". He wanted to know how Pfizer is advising treatment. The father was advised to discuss the situation with the patient's HCP and noted that the patient has an appointment with a cardiologist the following week.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300010911 same patient and event; different dose and event (invalid);US-PFIZER INC-202300010981 same patient and event; different dose and event (invalid);
has not yet received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not yet received the second dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not yet received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not yet received the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has not yet received the second dose because she could not attend her appointment on 04 May 2021.  No relevant concomitant medications were reported
6PM next day muscle spasms radiating out from spine (inflamed herniated disk area), pain. Used heat, ibuprofen, and prescribed meloxicam and that has helped significantly.
Pt was with another pt her to get flu shots. His friend complained of "bad taste in mouth" "metal taste" and was triaged out assessed. 30 minutes later, pt complained of numbness and tingling at the end of his tongue and mouth. Pt waited 15 minutes and symptoms resolved.
Patient experienced some dizziness shortly after receiving vaccination. Patient was attended to by paramedic staff and a health care provider and transferred to local emergency room .
pt recvd vax; same day as vax, exp rash on upper torso; pt seen by dermatologist; no tx ordered;
Left upper arm became red, warm, firm and swollen, tender to touch on 11/16/2005. Treated with ice, cold compresses, improving.
I got the vaccine on Monday 12/21.   The main symptom that I was having was tachycardia(HR-90?s to 130) for 3 days.    Only other symptoms were injection site discomfort, myalgias, fatigue.    I had lab work on Tuesday by PCP - normal.  EKG showed sinus tachycardia.  Resolved by Thursday 12/24.
BOTH VACCINES GIVEN IN LEFT ARM 11/26/13.  11/27/13 MORNING THE L ARM BECAME VERY UNCOMFORTABLE; SYSTEMIC PAIN IN JOINTS; 11/27 PM BECAME FEVERISH TEMP 101.6. 11/28/13 P.M. TEMP 103.3 X 24 HOURS; SAW PRIVATE MD 11/29/13. Rx KEFLEX 500 MGM QID; SAW MD AGAIN 11/30/13 AND STARTED ON PREDNISONE.
Fever greater than 103, dilated pupils, eyes glossy, extremely tired, fussy, rapid breathing, crying while sleeping throughout the night, coughing from previous illness was increased/worsened. These symptoms lasted until the morning of 01/13/11; however, the coughing persists. Treatment given was alternating Tylenol and Ibuprofen for the fever.
Mom states pt began uncontrollable screaming about 1 hrs p/vax; had PMD eval that afternoon, stated it was vax rxn;
Pfizer for children 5 to 11. Patient suddenly pulled back while giving vaccine. The needle scratched his arm. Parent held the child in her lap but she was unable to keep him still. I do not know how much vaccine went into the arm but I know some did. Patient should get the 2nd dose at a medical facility where he feels comfortable and the staff can handle him.
Gave 0.5mL  for booster....should have been 0.25mL....was unable to reach patient
patient was administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 2nd June 2022, the patient received the 2nd dose of Havrix. On 2nd June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments: The reporter was a medical assistant. The patient received an expired dose of Havrix vaccine. The reporter consented to follow up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Cardiac Tamponade as a Complication of Microscopic Polyangiitis; Cardiac Tamponade as a Complication of Microscopic Polyangiitis; This is a literature report for the following literature source(s): "Cardiac Tamponade as a Complication of Microscopic Polyangiitis: A Case Associated With a COVID-19 mRNA Vaccine".  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: CARDIAC TAMPONADE (medically significant), MICROSCOPIC POLYANGIITIS (non-serious), outcome "unknown" and all described as "Cardiac Tamponade as a Complication of Microscopic Polyangiitis".; Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported event cardiac tamponade and BNT162B2 is considered possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Migraine set in within 2-3 hours, sore arm immediately after for about an hour and a half
Three days after receiving vaccination I became extremely nauseous, had facial flushing and spikes in blood pressure.  This has continued for four additional days.  Visited doctors office on third day of sickness.  Was given promethazine for nausea.