chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; METOPROLOL; PANTOPRAZOLE. Past drug history included: Sulfur, reaction(s): "Known allergies: Sulfur". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (from 06Aug2022 to 11Aug2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt c/o fever, chills, aching 102 degrees temp. starting Saturday 11/1/03. Received immunizations 10/31/03.
Shortness of breath/ Difficulty breathing; This is a spontaneous report from a contactable consumer(patient). A 19-years-old female patient received bnt162b2 (PFIZER -BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: FA7484), via an unspecified route of administration, administered in Arm Left on 26Jul2021 as DOSE 1, SINGLE for covid-19 immunization (age at vaccination 19-years-old). The patient's medical history included asthma. The patient's concomitant medications was not reported. On an unspecified date patient stated that she had been experiencing like shortness of breath and difficulty breathing. The outcome of the event was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Case PHEH2011US00773 is an initial spontaneous report received from a consumer on 02 Aug 2011. This report refers to a patient of unknown age group and gender. This patient was given only the MenA powder conjugate component of MENVEO (batch number: 090701) reconstituted with a sterile diluent instead of MenCWY liquid conjugate component, intramuscularly on an unknown date. No other adverse reaction was reported.
pt recvd vax; pt exp jt aches, pruritic blotchy rash on face,chest & hand, feeling of puffiness, abdominal type swelling; pt exp bloating & some discomfort in right back; abdominal film revealed large amt of right colonic stool;
Patient was feeling light headed/dizzy, had sweaty palms, and difficulty breathing.  She also had body aches and felt warm.  I advised her to go to the emergency room if she was having difficulty breathing, so she did and was given a prescription for prednisone.
Patient is pregnant and received both doses.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Patient is pregnant and received both doses.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 021C21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), LAMOTRIGINE (LAMICTAL) and LORAZEPAM for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 18-Jun-2021. On 13-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Patient is pregnant and received both doses.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 13-Apr-2021, EXPOSURE DURING PREGNANCY (Patient is pregnant and received both doses.) had resolved.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 02-JUN-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Headaches with Chills and Nausea.   Fatigue Tylenol Helpful for a short duration.
soreness on arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "soreness on arm". Additional information: Caller wanted to know if it was okay to get eye surgery after getting first and second dose of covid-19 vaccine. Caller also stated she had soreness on arm after getting first dose 15Mar. Caller second dose was appointment on 05Apr, and eye surgery was on 07Apr. Relayed ISI. Caller disconnected during transfer. (Privacy) was not responding on call, so she disconnected due to lack of response. Will fax AE: side effect. There were not any unaddressed medical questions referred or forwarded to Medical Information. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6 days after vaccine developed bloody diarrhea. Thought to have ischemic colitis but negative evaluation. became hypotensive bradycardic   placed on ventilator. Subsequently was poorly responsive and eventually coded once more and succumbed
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 65 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Lot number: 1805031) and on 02Sep2021 as dose 2, single (Lot number: 206A21A) for Covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (13Jun2022) Negative; (17Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Other medication in 2weeks: No. No follow-up attempts are possible. No further information is expected.
fever,swollen lymp node's in neck, arm and arm pit area hurt real bad, body aches
Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced INJECTION SITE PAIN (Soreness at the injection site). On 03-Feb-2021, INJECTION SITE PAIN (Soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
PT is a 66 y.o. male with past medical history of asthma, hypertension, who presents to the PCP clinic with chief complaint of as mentioned above.  The patient is being directly admitted to the medical floor for COVID-19 and pneumonia   The patient had Moderna Covid vaccination 1st shot on April 8.  His family was sick recently.  The patient himself has been sick for the last for 5 days with fever, chest congestion, body ache, loss of appetite.  The patient denies sick contact.  He has no vomiting, diarrhea, chest pain, leg edema or calf tenderness.  Onset of his condition was gradual with moderate symptoms.  There is no aggravating factors or alleviating factors.   The patient went to see his PCP today with all the symptoms.  He was hypoxic with oxygen saturation of 88% on room air.  Chest x-ray showed bilateral lung infiltrate.  Reportedly he was tested positive for COVID-19.  The patient at this point is directly admitted to the medical floor for reason as mentioned above.   On the medical floor his O2 sat was 83% on room air.  He was tachycardic heart rate about 110.
Acute onset bilateral neuropathy Burning sensation in skin of my both legs from the ankle up Ongoing problem MRI showed no disc problems; EMG/NCT showed no connection to lumbar area Doctor believes it is small fiber neuropathy, likely autoimmune induced (I am not a diabetic)
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with MMR II (lot #, expiration date, dose, route and indication not reported). The pharmacist was reporting that the patient had negative titer for rubella and positive titer for measles and mumps possibly from either the past MMR II vaccination or natural disease; the reporter was not sure. The outcome of the events was unknown. Additional information has been requested.
After my second dose of Moderna COVID-19 Vaccination on February 16 2021, I started to experienced brown sperm discharge with bloody stain on February 21 2021. Every 7 to 14 days I have brown sperm discharge with bloody stains.  Before February 21 2021, I have abstained from any sex activities for a year because my wife was pregnant, I lived a healthy lifestyle. The brown sperm with bloody serum has continued none stop. Prior to taking the vaccination, I never had unexpected discharge of my sperm. My normal sperm color is milky white. Recently, I engaged with sexual activity with my wife after about 17 months abstinence. Myself and wife have being very concern.
Pt had a flat, edematous rash in both of her legs and on her trunk within 24 hours of receiving the vaccine.
Immunization given at 1425. By 1430 pt. c/o lt. headed, hot, sl. nausea, & taking deep breaths, and c/o anxious. No other symptoms developed but pt. continued to "not feel right" for over an hour. Given a 25 mg BENADRYL, & Rx for 3 XANAX. Pt. reports he had no other reaction after leaving clinic. No hives, rash, diaphoresis, numbness, weakness, seizure, SOB, or wheezing.
Patient said her arm at the injection site got bruised, and got darker the next day, it now the fifth day, the bruise seems to be disappearing. She does not have any other symptoms other than bruising.
Red bumps all over for 1 week 43-50 pox. No fever. Information received on follow-up states patient received the above vaccines at another location. We have no further information.
Pt. went into ER next day after Flu, pneumonia, Tdap, TWINRIX A/S shots with painful swelling of right arm. She stated it was weeping. She was given Prednisone and VICODIN counseled to continue Hep B series by ER MD.
This spontaneous report has been received from a Medical assistant referring to two patients of unknown age and unknown gender. Information about the concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, two doses of improperly stored VARIVAX (lot # L008272, expired date 03-NOV-2016) (dose, frequency and route was not provided) were administered to two unknown patients. The vaccines were store between min 13.0 F to max 18.1 F for 4 hours. There were no previous temperature excursions. No digital data logger was involved. No adverse effect was reported. Additional information has been requested.
Morning of April 16th, had a massive nosebleed (first one I?ve experienced in my life, no previous nosebleeds). It lasted about an hour. Petechiae covered my body. Went in to see my doctor for a previously scheduled  routine checkup. While there, mentioned the nosebleed and ?spots?. He took some blood work and found out that my platelet count was only 1,, when it?s supposed to be 400. He admitted me into the hospital  where I stayed until 04/19/2021 after receiving platelets, immunoglobulins, and prednisone.
Started feeling bad like nausea, I was hungry and ate a hamburger 12:15 PM the immediately got worse started vomiting, vomiting from about 12:30 PM , still vomiting at 4:00 pm.  Back body aches, chills, Still feel the very sick and vomiting at this time.
HYPOXIA 3/29/2023 DM 2 W NEUROLOGICAL MANIFESTATION
Sore arm; Tiredness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Dec2021 13:00 (Lot number: FJ8762) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies: penicillins" (unspecified if ongoing), notes: known allergies: yes - penicillins, cephalosporins, sulfa, mastisol; "allergies: cephalosporins" (unspecified if ongoing), notes: known allergies: yes - penicillins, cephalosporins, sulfa, mastisol; "allergies: sulfa" (unspecified if ongoing), notes: known allergies: yes - penicillins, cephalosporins, sulfa, mastisol. The patient's concomitant medications were not reported. Past drug history included: Mastisol, reaction(s): "Allergy: mastisol", notes: known allergies: yes - penicillins, cephalosporins, sulfa, mastisol. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 15:45), administration date: 25Mar2021, when the patient was 43 years old, for Covid-19 Immunization, reaction(s): "Soreness at injection site", "Headache"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left, Vaccine Administration Time: 15:45), administration date: 04Mar2021, when the patient was 43 years old, for Covid-19 Immunization, reaction(s): "Sore left arm at the injection site". The following information was reported: IMMUNISATION (non-serious) with onset 09Dec2021 13:00, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 09Dec2021 17:00, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset 09Dec2021 17:00, outcome "recovering", described as "Tiredness". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional Information: The patient had not received any other vaccinations within 4 weeks. The patient had not received other medication in two weeks. The patient was not diagnosed with COVID prior vaccination and not tested COVID post vaccination.  Follow-up attempts are completed. No further information is expected.
1715 lightheaded & dizzy. 1725 hands itching. 1730 50 mg im BENADRYL. 1735 itching progressed to upper lip & neck; tongue tingling; no resp probs no rash; ambulance called for transport to ED. Was given prednisone & ranitidine in ED. D/C'ed. Never developed rash of resp. distress.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age. Starting from 06-AUG-2015, the patients were inadvertently vaccinated with an improperly stored dose of GARDASIL, lot # K011325, 08-APR-2017, K011562, 08-APR-2017. No advers reactions were reported. The outcome of the events were unknown. This is one of the 4 linked cases received from the same reporter. Additonal information has been requested.
Information has been received from a nurse concerning a 23 year old female patient with no pertinent medical history or drug reactions who on 22-JUL-2009 was vaccinated with the first dose of GARDASIL (lot# not reported). On 28-SEP-2009 the patient received the second dose of GARDASIL (IM, 0.5ml, lot# 663453/0249Y) in her right deltoid. There was no concomitant medication. On 29-SEP-2009 the patient called the doctor office and complained of generalized body itching. The patient did take Antihistamine CLARITIN but it did not alleviate the itching. There was no laboratory diagnostics studies performed. The doctor recommended over the counter BENADRYL. At the reporting time the outcome was unknown. Follow up information has been received from the nurse concerning the 23 year old female student who on 28-SEP-2009, at 14:45, was vaccinated with the second dose of GARDASIL. On 30-SEP-2009, at 10:00, the patient called and stated that she was itching all over the body. She took a CLARITIN that morning and she was told to try BENADRYL. She was told that she would not receive the third dose of GARDASIL. At the time of this report, the patient's outcome was unknown. Follow up information has been received from the nurse concerning the patient who on an unspecified date in October 2009 recovered from symptoms. It was reported that the patient would not receive any more injections. Additional information is not expected.
NAUSEA, VOMITING ONCE, ITCHING, URTICARIA APPROX. ONE HOUR AFTER VACCINATION.  GIVEN DIPHENHYDRAMINE 50 MG. AT 10:05 AM AND APPLIED HYDROCORTISONE CREAM TO AFFECTED AREAS.  OBSERVED UNTIL 11:20 AM.
she got a sweet taste that turned salty and then metallic; tingling sensation; This is a spontaneous report from a contactable consumer (patient's parent) reporting for her daughter (patient). A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that her daughter received the first dose of the Pfizer COVID vaccine the previous day. The reporter stated that after 5 minutes, the patient experienced, she got a sweet taste that turned salty and then metallic within 10 minutes and a tingling sensation on an unspecified date. The reporter stated that they went back into the vaccination facility and was told to contact their primary care provider for assistance. The reporter would like to know if these side effects have been reported? She would like to know if her daughter should receive the second dose? She would like to know if she receives the second dose will her symptoms be more severe? The outcome of events was unknown.  Information about the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient reports fever, aches, swelling at injection site, pain around lymph nodes on right armpit area, explained to patient these can be included side effects, especially upon 2nd dose in series, and to follow up if symptoms persist beyond 48 hours.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE (Batch number: UI831AB, expiration date: 30-Jun-2018, site of administration: left deltoid and route was unknown) on 05-Nov-2018. The patient medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used (expired dose of FLUZONE QUADRIVALENT given to female patient). No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 55 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Jun2022 as dose 4 (booster), single (Lot number: FP4554), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: "Known allergies: Buckwheat" (unspecified if ongoing), notes: Known allergies: Buckwheat; "HBP" (unspecified if ongoing), notes: Other medical history: HBP; "pre-diabetes" (unspecified if ongoing), notes: Other medical history: pre-diabetes; "High cholesterol" (unspecified if ongoing), notes: Other medical history: High cholesterol. The patient's concomitant medications were not reported. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 from 30Dec2022 to 03Jan2023.  No follow-up attempts are possible. No further information is expected.
Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # K020182 with expiration date of 25-JUN-2016, dose and strength unknown). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
PT PRESENTS TO PHARMACY FOR 2ND MODERNA VACCINE ON 28TH DAY. PATIENT RECEIVED VACCINATION THEN IS MOVED TO MONITORING SECTION ON PHARMACY WHERE HE SAT FOR APPROXIMATELY 1 MINUTE. PATIENT AT THAT POINT VERBALIZED THAT HE WAS FEELING DIZZY. PT THEN PROCEEDED TO FAINT. PHARMACY STAFF SAW THAT HE WAS GOING IN AND OUT OF RESPONSIVENESS, AND 9-11 WAS CALLED..
About 2 min after vaccine was administered, patient stood up & then fainted. She regained consciousness about less than 1 min. She complained of feeling dizzy, hot, then cold. She stated her arm felt strange. Her BP dropped to 70-90/40.
Information has been received from a physician and a medical assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine.  Subsequently the patient developed erythema, swelling, and pain of the upper forearm.  Unspecified medical attention was sought.  Subsequently the patient recovered.  No product quality was involved.  Additional information has been requested.
Left eye pain started around mid february 2021. Sought medical help 2/26/21, diagnosed to have iritis. still have pain in left eye