chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2012US013369 is an initial spontaneous report received from a medical assistant on 02 Jul 2012. This report refers to a female patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that she was vaccinated only with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X11075) intramuscularly on to unspecified site and did not receive MenA lyophilized conjugate on 29 Jun 2012. No adverse event was reported following the maladministration.
Shoulder stiffness on arm of injection. Patient presented to pharmacy on 10/10/2014 and reported pain and stifness that resulted in patient not being able to lift her arm.
cold symptoms; I started feeling bad on Monday; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported as "I am due to my get second dose today and I currently am experiencing cold symptoms. I started feeling bad on Monday and got a rapid and a PCR test and both were negative. I feel much better than I did." The events started on 2021 with outcome of recovering. The patient underwent lab tests and procedures which included investigation: a rapid and a PCR test and both were negative in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt felt dizzy, shaky,  hot (sweating), and had ringing in the ears. Pt reported she felt like she would pass out. Pt checked her blood glucose and it was 93. Pt had some water and orange juice and felt better after about 30 minutes.
I received a flu vaccination on 11.15.07. About 72 hours post vaccination, I noticed that the muscle pain in my deltoid did not resolve. It is now 11.29.07 and I am still having pain. It is difficult for me to put my shirt on and take it off, as well as pulling my left arm across my body. Last night, I had so much pain in my left arm (deltoid region) that I could not sleep. I took pain medicine, IB profen, and applied therogesic cream which helped the pain subside somewhat.
Swelling of arm, could not move arm, could not control hand, difficulty speaking, dizziness.
Rise in blood pressure, diaphoresis, redness/flushing, shaking hands, nausea, near syncope followed approx 1 hour later by weakness, and chills. The next day: fatigue, joint pain, and weakness. Symptoms resolved on day 3.
The patient's arm was hot to touch a few hours after the injection at the injection site and extended down almost to her elbow the next day. She discussed the situation with us and then decided to make an appointment with her primary care doctor. The doctor said that she had never seen a reaction to this extent from a PNEUMOVAX 23 injection. The doctor gave her a Prednisone 10 mg 6 day dosepack. The symptoms started and to resolve after she starting taking the dosepack and completely resolved in a day or two on the Prednisone.
Runny Nose; Coughing; Cold Sweats; Pounding Headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in deltoid left on 07Apr2021 13:30 (Batch/Lot Number: EW0158) as single dose for COVID-19 immunization. The patient medical history included COVID 19 in December and had serious side effects. Patient denied any medications, medical conditions, labs, testing, or treatments. Stated he was the healthiest person. The patient's concomitant medications were none. No prior vaccinations (within 4 weeks). Patient took COVID 19 Shot because he wanted to stop wearing a mask and wanted to travel. The patient experienced pounding headache (reported as worsened) from 09Apr2021 with outcome of not recovered, cold sweats from 11Apr2021 with outcome of recovered on 11Apr2021, runny nose from 12Apr2021 with outcome of not recovered, coughing from 12Apr2021 with outcome of not recovered. AEs did not require a visit to Emergency Room and Physician Office. No family medical history relevant to AEs. No relevant tests. The patient underwent lab tests and procedures which included covid-19: positive on an unspecified date. Clinical course reported as follow: Patient stated the Friday after his vaccine he had a pounding headache. He had take off from work today due to his headache. Said it had eased off, but it came back today worse. Patient said he woke up with cold sweats on Sunday. Has not experienced this symptom since then. Runny nose and coughing started on Monday and was ongoing about the same as when it started.  No follow-up attempts are needed. No further information is expected.
Metallic taste with all 3 shots.; Taste like I have a dirty penny in my mouth. Comes in through the cheeks and sits on tongue. Hit 15 minutes after injection. Lasts almost 48 hours after 1st dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 12:00 (Lot number: EW0153) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: ADHD/Depression/Anxiety combo; "Depression" (unspecified if ongoing), notes: ADHD/Depression/Anxiety combo; "ADHD" (unspecified if ongoing), notes: ADHD/Depression/Anxiety combo; "Obesity" (unspecified if ongoing); "Chronic Inflammation" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: VYVANSE; TRINTELLIX; MAGNESIUM; PROPRANOLOL; SLEEP [DIPHENHYDRAMINE HYDROCHLORIDE]. Past drug history included: Bactrim, reaction(s): "allergic to Bactrim", notes: patient drug name: Sulfa / Bactrim; Wellbutrin, reaction(s): "known allergies: Wellbutrin", notes: known allergies: Wellbutrin. The following information was reported: TASTE DISORDER (non-serious) with onset 11Apr2021 12:30, outcome "recovered" (Apr2021), described as "Taste like I have a dirty penny in my mouth. Comes in through the cheeks and sits on tongue. Hit 15 minutes after injection. Lasts almost 48 hours after 1st dose."; DYSGEUSIA (non-serious) with onset 13Nov2021 10:45, outcome "not recovered", described as "Metallic taste with all 3 shots.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, dysgeusia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Few hours post injections, pt developed rash and hives all over body, (more on lower extremities).  No respiratory distress.  Seen at Immediate Care Clinic two days later.  Given Allegra to take. Some redness on legs. No hives 1 week later.
Swelling of the left deltoid, also redness.  Dr advised patient to take Benadryl over the counter.
After vaccination, the patient fell onto his buttocks, then hit his head. He did have a small abrasion on the back of his head and small abrasion on his elbow. There was no LOC observed.  The patient did seem slightly confused. He vomited once.  Was alert and fully oriented.
Pt recv vax on 4/5/99; on 4/6/99 pt exp myalgia of right upper arm
stood up and became so light headed that I passed out.  came to on the floor, drenched in sweat
On 04/17/2001 the patient experienced 4 hours of constant unusual crying beginning 2 hours after vaccines were given.
I played gold two (2) hours after getting my flu vaccine injection.  Injection given at 10AM, 10/07/2008.  About eight (8) hours after the vaccination I started to get a headace, felt very cold (like I was coming down with a cold), even to the point I was shivering and my teeth were chatering.  I took two Aleve and went to bed with an extra blanket on at about 9:00PM.  At about 3:30AM my fever broke (woke up sweating profusely).  At 6:00AM day after injection I felt fine.  I have felt OK since.    I know this vaccine is a dead virus and will not give you the flu.  But when talking with the Nurse Practionner, she felt we should report this, as it may be a side effect not listed.
Localized rash/irritation. Urgent Care prescribed Cefdinir. Patient came into clinic to see Dr. and Dr.  discontinued Cefdinir. No further adverse reaction.
Extreme chills, head and aches, 101.3 fever, nausea. vomiting. Lasted about 15 hours. Gave tylenol for fever which helped.  Visited the ER because of the vomiting and was advised to hydrate and take tylenol.
Fatigue, Nausea, Dizziness/Vertigo, Floaters in eyes, Muscle pain from arm that was injected goes to upper neck and middle back by right shoulder blade feels like burning sensation, ringing in the ears.
The patient did suffer 2 mini strokes; Bad pain in her head; This spontaneous case was reported by a patient and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (The patient did suffer 2 mini strokes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 046A21A and 013A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TRANSIENT ISCHAEMIC ATTACK (The patient did suffer 2 mini strokes) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Bad pain in her head). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (The patient did suffer 2 mini strokes) outcome was unknown and HEADACHE (Bad pain in her head) had resolved.            No concomitant medication provided. No treatment information provided.  Patient reported she had 2 mini strokes in Jan 2022. She got her first and second dose of vaccine with no adverse reactions or any side effects. She got the third on 08 Dec 2021, and there were no side effects then too, but patient said they suffered 2 mini strokes in Jan 2022. Had a bad pain in her head which lasted for 4 to 5 minutes as well.  Company comment- This spontaneous case concerns a 74-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) AESI Transient ischaemic attack the following month after vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The age of the patient maybe a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) AESI Transient ischaemic attack the following month after vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The age of the patient maybe a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
VACCINE WAS DRAWN UP AND ADMINSITERED FROM VIAL 25 HOURS AFTER FIRST PUNCTURE. VIAL WAS REFRIGERATED FOR DURATION OF PREVIOUS 25 HOURS. PATIENT DOES NOT REPORT ANY ADVERSE EVENTS AS OF 05/13/21.
I started to have loss on weight, over the summer I started to become very thirsty and urinated frequently. I went to see a doctor and my glucose level was high and had dip tones in ears. this prompted more testing weather or not I have antibodies for insulin. Doctor referred me to endocrinologist and at that time doctor started me on type 2 diabetes medication. I had additional testing to determine whether or not I have type 1 diabetes and doctor also increased my medication. Two weeks later I had my results that shows that I had no antibodies, and I was positive for GAD, that confirms that I have diabetes type 1 and making small amount of insulin. One week later, they put me on cholesterol, maintain metformin.
Client exhibited low grade fever the evening of the immunizations. Exhibited fever of 104.5 the morning following the immunizations & maintained 104.5 off & on for 3 days. The fever broke on the 3rd day & on the 4th day the client exhibited a rash over entire body & a clear runny nose. Rash lasted for 1 week.
lightheadedness, dizziness; began to experience feeling flushed; Nausea; Difficulty breathing; Rash; Swallowing difficult; Wheezing; Throat tightness; Hoarseness; Stridor; Itching; Facial swelling; Lip swelling; Tongue swelling; This is a spontaneous report from a non-contactable other hcp.   A 66-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6203) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant drugs was not reported. The patient experienced lightheadedness, dizziness, began to experience feeling flushed, nausea, difficulty breathing, rash, swallowing difficult, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling on Unspecified date. Reported as during her 15-minute waiting period after the injection, the patient began to experience feeling flushed/nausea,rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash).Greatly improved after water/snack/reclining. Therapeutic measures were taken as a result of lightheadedness, dizziness, began to experience feeling flushed, nausea, difficulty breathing, rash, swallowing difficult, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The outcome of the events was resolved on unspecified date.  No follow-up attempts are possible. No further information is expected.
Pt with 4cm erythema on left upper arm and shoulder, streaking of entire shoulder and left neck. She has a fever to 104.5F, onset 10/29/99 and peaked 10/30/99, duration 5 days. Also, has a headache and vomiting.
Information has been received from a 22 year old female patient with no known allergies/drug reactions, who in the fall of 2007, was vaccinated with the first and second dose of GARDASIL (Lot # not provided) and early 2008, the patient was vaccinated with the third dose of GARDASIL (Lot # not provided). It was reported that the patient received her papsmear test results on 27-MAY-2010 and she tested positive for HPV serotypes 16 and 18. At the time of this report, the patient's status was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Heart rate at 150 for the whole day and next day following first vaccination injection; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 16Mar2021 at 08:00 (age at vaccination 21-years-old) as DOSE 1, SINGLE for covid-19 immunization. Facility type of vaccine was at a hospital. Medical history included covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: yes). The patient's concomitant medications were not reported. If other vaccine in four weeks reported as no. Covid tested post vaccination was reported as no. On 16Mar2021, the patient experienced heart rate at 150 for the whole day and next day following first vaccination injection. The event did not result in emergency room/ physician office visit. The patient underwent lab tests and procedures which included heart rate which showed 150 on 16Mar2021. The patient was not treated for the event. The outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
7 days following vaccine, large area of bumpy red skin around vaccine site, lasted approximately 5 days. For 6 months following vaccine, menses became much heavier and irregular. This returned to normal after approximately 6 months. B/L Tinnitus developed sometime after vaccination, unsure of the exact date related to vaccine but was within a month.  Never had tinnitus in the past.
3/17/16: Fever at 102.8, Tylenol given, lowered temp somewhat ED visit 3/18/16 0213: temp 104.3 at midnight, Tylenol given.
Felt tired; Soreness; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness, pain and fever. On an unknown date, the outcome of the tiredness, pain and fever were unknown.   It was unknown if the reporter considered the tiredness, pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received Shingrix and experienced fever, soreness, felt tired.  No specific patient The reporter did not consent to follow up.
It has been one week since I receive the Moderna vaccine, and my left fingers are still tingling.
My tinnitus and dizzy spell start all the time after 2nd dosage of vaccine I start having sensitivity to noise some noise make me dizzy and Change into the vertigo, now it start if I am talking for little long and it make me dizzy. this condition keep for couple of hours even if I take anti vert med.
PT FAINT IMMEDIATELY FOLLOWING ADMINISTRATION OF JANSSEN VACCINE. PT REPORTS FAINTING AFTER BLOOD DRAWS BUT NEVER WITH VACCINATIONS.  CALLED 911, PT DID NOT WANT TO GO TO HOSPITAL FOR OBSERVATION. ONCE RESPONSIVE, HAD SIPS OF ORANGE JUICE AND WATER. STATED SHE WAS FEELING BETTER.
No Adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date).    Concomitant product use was not provided by the reporter.  Staff gave patients vaccines past the use date of 18-Jun-2023.  On 27-Jun-2023, 3 doses were administered at administration site 2.   Treatment information was not provided.  This case contains information for the 36th patient out of 47 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received suspect vaccine details added, iNarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master Case (Patient 1)
A non-serious spontaneous report of a pregnant 16 year old got a dose of H1N1 LAIV was received from a registered nurse/health professional concerning a 15-year-old female. No relevant medical history have been reported for this patient. The obstetrical history of the patient included gravida one and para zero. On 08-Dec-2009, the patient received H1N1, Intranasal for an unknown indication. The patient was approximately six months pregnant during vaccination. The patient's expected delivery date was sometime in Mar-2010. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable. The outcome of vaccine exposure during pregnancy was resolved. Additional information was received on 04-Jan-2010 and incorporated into the narrative is obstetrical history. Other information received on 04-Jan-2010 are title of the reporter, address of the reporter and the physician and relation to patient.
white blood cells and plackets were low; white blood cells and plackets were low; Pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (white blood cells and plackets were low), PLATELET COUNT DECREASED (white blood cells and plackets were low) and PAIN IN EXTREMITY (Pain in her arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm). On 14-Jan-2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (white blood cells and plackets were low) and PLATELET COUNT DECREASED (white blood cells and plackets were low). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, WHITE BLOOD CELL COUNT DECREASED (white blood cells and plackets were low), PLATELET COUNT DECREASED (white blood cells and plackets were low) and PAIN IN EXTREMITY (Pain in her arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Platelet count: (Low) Low. On 14-Jan-2021, White blood cell count: (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
pt. got rash on lips next day in the morning and it started increasing every day and now he has all over body and its itching and now even eye is hard to open and rash not going away.  patient using hydrocortisone and zyrtec for itching and rash.