chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 40-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 10Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "low back pain" (unspecified if ongoing). No known allergies reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 15May2022, outcome "not recovered", described as "Treatment of COVID-19"; VACCINATION FAILURE (medically significant) with onset 15May2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.   The patient was treated with paxlovid since 17May2022 evening, oral as covid-19 treatment. Patient completed 5 days therapy. On 25May2022 had recurrence of symptoms (congestion, rhinorrhea, fatigue, mild fever).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments:  The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Unusual high pitched crying for 10 minutes w/in the 1st 24 hrs p/receiving DTP;
Arm became very painful about 4 hours later. After going to bed later that night, at about 12:30am, i developed major intense pain in all muscles of my body. Sudden muscular pain when I had to urinate. Then chills even though it was not cold. My body shook with chills. My dead father came to get me, so I was hallucinating. I had fever, I was unable to check my temperature. I moaned all night long. It was terrible awful pain. I also experienced dizziness and weakness and still have it today along with mild muscular cramps, especially in my legs. Shot site still hurts extremely if I move my arm. I will never be getting another of these shots again.
Patient recieved booster and complained of not feeling well. Her blood pressure was low and she was placed in Trendelburg position and hydrated. Patient stated this is common post vaccines and blood work.
small bruise on the top of the left foot after first shot/A small bruise on the top of the right foot after the second shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "small bruise on the top of the left foot after first shot/A small bruise on the top of the right foot after the second shot". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She started her menstrual 10 days late with heavy clots and cramps which is abnormal. When she went to her 16 yr old well visit on 7/17 we informed her PCP of the concerns.
sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) 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 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported.  It was reported that the patient did not remember the Lot number of vaccine and the expiration date.   This case was linked to MOD-2021-367730 (Patient Link).
discomfort at injection site; tired; headache; muscle aches; redness and swelling on the injection site; redness and swelling on the injection site; vomiting; nausea; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE DISCOMFORT (discomfort at injection site), NAUSEA (nausea), VACCINATION SITE SWELLING (redness and swelling on the injection site), VOMITING (vomiting) and VACCINATION SITE ERYTHEMA (redness and swelling on the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, High cholesterol, Latex allergy and Adhesive tape allergy. Concomitant products included ATORVASTATIN for High cholesterol, OMEPRAZOLE for Reflux gastritis.   On 12-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021 at 3:45 PM, 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 NAUSEA (nausea) and VOMITING (vomiting). On 12-Apr-2021, the patient experienced VACCINATION SITE SWELLING (redness and swelling on the injection site) and VACCINATION SITE ERYTHEMA (redness and swelling on the injection site). On an unknown date, the patient experienced INJECTION SITE DISCOMFORT (discomfort at injection site), FATIGUE (tired), HEADACHE (headache) and MYALGIA (muscle aches). On 10-Apr-2021, NAUSEA (nausea) and VOMITING (vomiting) had resolved. At the time of the report, INJECTION SITE DISCOMFORT (discomfort at injection site), VACCINATION SITE SWELLING (redness and swelling on the injection site), VACCINATION SITE ERYTHEMA (redness and swelling on the injection site), FATIGUE (tired), HEADACHE (headache) and MYALGIA (muscle aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: iincreased High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included Advil  Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-074989 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Events ( discomfort at injection site, fatigue, headache, myalgia) added.
On 2-11-2022, pt came to receive immunization services. Patient was not a resident and needed prior immunizations entered into the Database. During entering those records, the clerk missed a DTAP that was given 1-14-2016. Which because this immunization was left off, system shown that patient was missing the vaccine. Due to this error, the nurse administered the TDAP vaccine to the patient.
Fever 103.4 Nausea  Vomiting Headache  Chills Large welt at injection site
2-3 hours after Fluzone injection administered student become diaphoretic, and pale with severe nausea. Family member picked student up from school.  While traveling home she start have SOB with wheezing and feeling her throat was closing up. Family member stopped at fire station. Epipen administered, O2 started.  Student was then transferred by ambulance to the nearest Emergency dept. where she receive another Epipen injection and steroids. She was discharged from the Emergency dept and instructed not to receive the influenza vaccine again.
I had mild symptoms after three days experienced racing heart beats, diarrhea, body pain, brain fog lasted for three weeks. The Gastro issues have lingered ever since COVID. In February 2022 contacted my doctor spoke with the nurse have an upcoming appointment at the end of April 2022 for Gastro and Neurological issues. I'm still having trouble concentrating this is effecting my work.
Near syncopal episode. BP 60/40 and nauseous. LifeLine evaluated. Patient refused ambulance transport. Patient transported by their associate to Hospital.
17-Year-old patient was vaccinated; Sore arm; A spontaneous report was received from a nurse concerning a 17-year-old female patient who received Moderna's COVID-19 Vaccine and experienced sore arm and 17-year-old patient was vaccinated.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 30 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The vaccine was administered at a University's campus.  On 30 Dec 2020, the patient, a medical assistant, received the vaccine and did not inform the vaccinator of her age until after the vaccine was given. The patient experienced a sore arm after receiving the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, 17-year-old patient was vaccinated, was resolved on 30 Dec 2020. The outcome of the event, sore arm, was unknown.; Reporter's Comments: This case concerns a 17 year old, female, patient.  The patient's medical history is not provided. The event occurred on 30 Dec 2020 during administration of the first dose of the mRNA-1273, lot # 026L20A. This report refers to an unexpected event of administration of mRNA-1273 to patient of inappropriate age (17 year old). The patient had an expected event of pain in arm during the injection.   The sponsor considered the event of vaccine administration to patient of inappropriate age as not related to mRNA-1273. The event of pain in arm is related to mRNA-1273 as 'pain at the site of injection' is the listed event on the company's fact sheet for the healthcare providers.
redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness around the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
12/23/2020 VACCINATION 12/24/2020 COULD NOT RAISE ARM PAST NIPPLE LINE.  COULD NOT TOUCH IT; SWOLLEN, BIG KNOT, HOT TO THE TOUCH.   12/25/2020 STILL COULD NOT RAISE ARM, HOT TO THE TOUCH. CALLED URGENT CARE AND TELEMED CALL. 'SOUNDS LIKE A HEMATOMA UNDER INJECTION SITE THAT IS INFECTED. WILL START YOU ON ANTIBIOTICS'.  WITHIN 2 DAYS, PRETTY MUCH PAIN FREE. STILL SORE BUT ABLE TO MOVE ARM. KNOT DISAPPEARED. NO LONGER HOT TO THE TOUCH. STILL SOME RED AROUND INJECTION SITE.
On March 4th I started having symptoms and didn't feel good and I was fatigued and wanted to lay down and started sneezing a lot and I had some kind of cough, I knew they were irregular symptoms because I am a very allergic person and the antihistamine I take will make the symptoms go away and on the next few days I ran a fever and it wouldn't go away. I didn't feel good for about 5 to 6 days. I had a lot of congestion.
Dizziness, Vertigo, Tachycardia, nausea, numbness and tingling of both arms
Information has been received from a consumer concerning a 12 day old male with drug allergy (decongestants) who on 25NOV1996 was vaccinated with Hepatitis B vaccine recombinant (yeast) and "completed schedule" On 25NOV1996, the patient developed persistent  thrush of mouth and yeast diarrhea. The patient was treated with fluconazole (Diflucan) and the symptoms subsided. Unspecified medical attention was sought. The patient subsequently experienced chronic mucosol candidiasis and stopped talking for months following vaccination with measles virus vaccine live (+) and mumps virus vaccine (+) rubella virus vaccine live (second generation) (MSD) WAES#01011263 and product misuse following vaccination with Varicella virus vaccine (MSD) WAES#01011264.  The consumer reported another child who had an experience following vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) WAES01011080
Patient's right leg became red and sore to the touch.  Area about size of silver dollar on 06/17/2003.  Area began to swell more and (^) redness.  2x size of baseball.  Patient advised to apply ice and Motrin for pain.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On unspecified date in the week of September 22, 2014 the patient was vaccinated with a single dose of ZOSTAVAX, 0.65 ml, subcutaneous, (lot number and expiration date not reported) On unspecified date in the week of September 22, 2014 the patient experienced a raised round red area at the injection site while using ZOSTAVAX. The patient did not seek medical attention. At the time of the report the outcome of a raised round red area at the injection site was unknown. Additional information has been requested.
Symptoms began 1/2/2022 and included congestion, sore throat, cough, and tested positive for covid on 1/6/2022.
Coughing and tightness in chest. Felt similar to mild asthma symptoms. No treatment sought.
Severe Stomach cramps and diarrhea for two days.  Followed by 1 day of black stool; Severe Stomach cramps and diarrhea for two days.  Followed by 1 day of black stool; Severe Stomach cramps and diarrhea for two days.  Followed by 1 day of black stool; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 09:45 as dose number unknown [booster], single (Lot number: GJ5342) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sulfa drugs" (unspecified if ongoing); "shell fish" (unspecified if ongoing); "polysporum" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown.), for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), DIARRHOEA (non-serious), FAECES DISCOLOURED (non-serious) all with onset 29Sep2022 at 20:00, outcome "recovering" and all described as "Severe Stomach cramps and diarrhea for two days.  Followed by 1 day of black stool". Therapeutic measures were not taken as a result of abdominal pain upper, diarrhoea, faeces discoloured.  Additional information: It was reported that Severe Stomach cramps and diarrhea for two days. Followed by 1 day of black stool. Other medical history reported that patient had excellent health. No Other medication in 2weeks
Exascerbated local reaction with swelling, mild pain, erythema 10cm in diameter. Visits x2 for follow up. 2 hours after DTaP.
second vaccine mild pain on injection site almost gone; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (second vaccine mild pain on injection site almost gone) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 39A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for an unknown indication.   On 07-Apr-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (second vaccine mild pain on injection site almost gone). At the time of the report, VACCINATION SITE PAIN (second vaccine mild pain on injection site almost gone) had resolved. Unknown          No treatment medications were reported Action taken with mRNA-1273 in response to the events were Not Applicable    This case was linked to MOD-2021-114245 (Patient Link).
E87.1 - Hypo-osmolality and hyponatremia J18.9 - Pneumonia of both lungs due to infectious organism, unspecified part of lung WEAKNESS - GENERALIZED HEADACHE multiple hospital admissions
Patient reported nausea, back pain, body aches shortly after receiving vaccine (within 2 hours). Later developed fever (102 F, oral) increased back pain and body aches. Persistent nausea, generalized weakness and lack of appetite.
By 7:00 the night of injection ( 10/1)I had lost my appetite.  By 10:00 PM I started getting the chills. Chills off and on throughout the night.  The next morning (10/02)I had flu-like symptoms??.achy body, bad headache, chills, no appetite and nausea.  Started vomiting.  couldn?t even keep water down.  All symptoms continued the next day ( 10/03). Knew I was dehydrated so husband took me to the ER.  At ER I was diagnosed with extreme dehydration and renal failure.  Admitted to the hospital 10/03.  In hospital until late 10/05 when discharged.
45min p/receiving immun DTP/OPV/HIB pt became pale & sleepy was seen @ clinic lasted 1.5hr then was all right;
This is a spontaneous report from a non-contactable consumer. A 46-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 15:00 PM as DOSE 1, SINGLE for covid-19 immunisation. No medical history and there were no concomitant medications. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. On 04Mar2021 10:00 AM patient experienced fatigue, chills, fever, aches and pain under armpit from swollen lymph nodes. The patient did not received treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a female patient who in 2003 was vaccinated with a dose of PNEUMOVAX 23 (lot number not provided). The physician reported that in 2003 the patient experienced a "severe" reaction. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is an amended report. "Unknown" was added into "vaccinated at" and "vaccine purchased with" field. No further information is available.
This case involves an adult patient with an unknown gender who got sick as a dog 45 mins (illness) after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.   On an unknown date the patient developed a non-serious got sick as a dog 45 mins after (illness) following the administration of INFLUENZA VACCINE.  It was reported "I got flu shot years ago. Almost die. Got my (coronavirus disease) COVID shots not even a sore arm. No flu shots for me thank you very much."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was reported as unknown.  There will be no information on lot number for this case.
pt recv vax 25JUL97 & 30JUL97 pt exp pruritic lumps on legs & one on face described as a blister w/a red base;
Describes adverse event(s) (symptoms, signs, time course) and treatment, if any.
Body aches (most specifically in the neck, mid and lower back) Fever (99.4 -> 2 degrees above the pre-shot measurement/normal)  Expected shoulder soreness Headache  All started very slightly about 10hrs after the shot but were fairly significant the following morning around 19-20hrs after the shot.  Adverse effects are mostly abated now 58hours after.
bleeding event/lost a couple of units of blood; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding event/lost a couple of units of blood) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bleeding event/lost a couple of units of blood) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (bleeding event/lost a couple of units of blood) outcome was unknown.            No concomitant medications reported by reporter.  No treatment medications provided by the reporter.  Patient took booster dose.  Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the serious  unexpected event haemorrhage. The event occurred on an unknown day  after dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Nov-2021: Follow up received and contains no new information.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the serious  unexpected event haemorrhage. The event occurred on an unknown day  after dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown gender and age. On an unknown date, the patients were vaccinated with a dose of LIQUID PEDVAXHIB (dose and lot # not reported) that was improperly stored. The nurse stated that LIQUID PEDVAXHIB had multiple excursions (48 F for 2 days, 34 F for 16 hours, 34 F for 2 days, 49 F for 1 day, 34 F for 8 hours, 47 F for 4 days, 34 F for 2 days). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
My arm was very swollen at the injection site (approx 4 inch area of erythema, heat, swelling), I had a headache and was very tired.  Over 24 hrs the arm became very warm and itchy.  The headache continued for 24 - 48 hrs.  The arm became very tender after 24 hrs/ bruised feeling and the swelling remained.  It slowly regressed but at 7 days out it is still red, well demarcated 2 in diameter mark on my arm.  It is somewhat itchy, warmer than surrounding skin and slighly raised/firmer than surrounding tissue.