chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, was initially received on 23-Oct-2017, from other-health professional (nurse), concerning a 61-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 23-Oct-2017, the patient was administered with FLUCELVAX Quadrivalent (dose: less than 0.5 ml (as reported), batch number: 195229, expiry date: May-2018, route of administration, anatomical location: not reported). It was reported that, the patient was administered with the vaccine (25 gauge needle) and it leaked (explicitly considered as product leakage) down the patient's arm (explicitly considered as exposure via skin contact), hence the patient received only a partial dose (explicitly considered as incomplete dose administered). It was reported that leak was coming from the base of the needle and there were no signs of damage and before vaccination needle appeared tightly attached. The patient had no averse event and no treatment measures were given to the patient. This case was associated with PTC reference number: 1025634. Based on he investigation performed, it was concluded that FLUCELVAX (Batch number: 195229) was manufacturer in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process or related to the syringes or stopper components, and no trends were identified for the batch for leaking syringes. There was no internal root cause that could be confirmed and no external/user root cause could be determined. The reporter considered the events as non-serious. Follow-up received on 13-Nov-2017: Added new events exposure via skin contact and no adverse event. It was reported that the patient had no adverse event. The HCP (health care professional) was unaware of the precise spot of vaccine leakage and the product ran down the patient's arm during administration. Narrative amended accordingly. Follow-up report  request report) received on 17-Nov-2017: reference number (1025634) was added. As per the report 25 gauge needle was used and before vaccination needle appeared tightly attached. It was reported that leak was coming from the base of the needle and there were no signs of damage. Narrative amended accordingly. Follow-up report was received on 13-Dec-2017: Based on the investigation performed, it was concluded that FLUCELVAX (Batch number: 195229) was manufactured in compliance with the approved internal procedures an in accordance with the quality requirements. No internal root cause was identified in the manufacturing process or related to the syringes or stopper components, and no trends were identified for the batch for leaking syringes. There was no internal root cause that could be confirmed and no external/user root cause could be determined. The narrative was amended accordingly.
Her arm was red and a little sore after given the vaccines. Each day afterwards redness has spread upwards and after 2 days became itchy and hot. The redness was just below the shoulder and she wanted to report this. I told her to use some ice and also some BENADRYL cream. If it continued to spread to go seek medical attention. I also gave her another copy of the VIS sheets for each vaccination because she did not know where hers went.
This was my second dose. I was sleepy I laid down it felt as though I heard noise but I thought that it was a fever. I can't remember how long afterwards I began to hear noises sound like in my whole head. Went to my dr. She said it was tinnitus.  Went to ear Dr He said my hearing was good. Its a constant noise, sometimes I can tune it out then sometimes I can't.  But I never had tinnitus before. Its going on 9 months. I ran across this article. So I am reporting this. I do not know if related. Would like to know. Thanks
I have had high blood pressure ever since getting the vaccine. It has been 160 over high 90s that lasted for 2 or 3 months. Now it is finally down to normal. I have always had low blood pressure. My doctor told me to watch my blood pressure, and if it stays high then he will have to treat it. He never got to treat it because it has came down now. It started coming down at the end of December 2021 and beginning of January 2022.
Patient presented on 7/29/15 concerned about redness and itching at injection site. Stated it was improving. Area was approximately the size of the palm of the hand. Counseled patient that redness at the reaction site was common with Zostavax and to monitor and report if it worsened.
16:30: Pt was standing up to leave when she advised observer in room that she didn't feel right.  I had just walked in after she sat back down and pt said she felt difficulty swallowing.  We talked a little bit as I asked her about any other symptoms.   Pt was given a drink of water and this helped.  Pt told me she was 18 months pregnant.  She did not have difficulty swallowing water.   After a couple of minutes she felt improved.  We walked to a separate room.  Pt did not develop any other symptoms and was not light-headed.  She did not report feeling light-headed or dizzy, had no chest tightness or shortness of breath, no rash/itching, no chest pain, palpitations or tachycardia, nausea or vomiting.   Pulse 64, color pink, skin warm and dry. Alert and talkative throughout.   Pt rated her swallowing difficulty at 2-3/10.  Initially it was 6-7/10.   Pt was advised to f/u with her physicians as to whether to have the second Moderna dose.  Pt lives across from ambulance service.  Driven home by her husband.  Continued to feel no worse and was comfortable going home with her husband.  At 17:40 pt called in to report she was continuing to improve.   Now throat feeling is 1/10.  Will call 911 if any worsening.  Will sign in to mobile reporting program.
Small rash pn L thigh more proximal and lateral to the injection site. 5 days later no Tx.
has not received 2nd dose; got into car accident; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose) and ROAD TRAFFIC ACCIDENT (got into car accident) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included LIDOCAINE HYDROCHLORIDE (LIDOCAINE [LIDOCAINE HYDROCHLORIDE]) for Anaesthesia, ENOXAPARIN SODIUM (LOVENOX HP) for Anticoagulant therapy, LISINOPRIL for Blood pressure management, METFORMIN for Diabetes mellitus, TRAMADOL for Pain, VITAMIN D NOS for Supplementation therapy, PARACETAMOL (TYLENOL) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ROAD TRAFFIC ACCIDENT (got into car accident). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received 2nd dose) had resolved and ROAD TRAFFIC ACCIDENT (got into car accident) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2020, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Patient got into a car accident same day second dose was due on 19-Apr-2021 and skipped the second dose.
Strong flu-like symptoms (chills, 100°F fever, muscle aches, swollen and achy glands including testicles, and headache) that lasted for ~24 hrs beginning 13 hrs after injection and ending about 37 hrs after injection.
ADMINISTERED MCV4 TO 69 YEAR OLD CLIENT INSTEAD OF PPSV23.
Shortly after my second dose, I experienced significant pain in my opposite shoulder.  Couldn't raise the bed covers the next morning.  Then experiences tingling and tightness in my lower left leg.  Muscle tightness followed through my back and into the traps.  I experienced tingling in my left arm for several days.  Occasionally tingling in my right arm.  Then then tingling made its way to my trapezius region and along the back of my head/occipital region.  I started to experience pressure in my right temple.  Then, finally the tingling went to the lower right side of my face.  These occurrences happened on and off for about 6 weeks.  During that time I also experienced multiple cold sores, multiple tonsil stones, and a sore inside my nose.  I have chest pressure that has persisted for several weeks.  I have a rash on my backside at the moment.    I did not seek any medical attention at the time of any of the symptoms.  They were quick to come and go, and only lasted a few minutes at a time.    I was told by an Aunt of mine that Gullian barre runs in my family and to avoid the flu shot.  My concern with the vaccine was that it could possibly trigger the GB.  I am worried that some of the tingling is the reaction to the vaccine.
Patient report bilateral aching that has been since his last anthrax shot, which has progressively gotten worse.
swelling at injection site that is red and warm to touch; swelling at injection site that is red and warm to touch; swelling at injection site that is red and warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (swelling at injection site that is red and warm to touch), VACCINATION SITE SWELLING (swelling at injection site that is red and warm to touch) and VACCINATION SITE ERYTHEMA (swelling at injection site that is red and warm to touch) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (swelling at injection site that is red and warm to touch), VACCINATION SITE SWELLING (swelling at injection site that is red and warm to touch) and VACCINATION SITE ERYTHEMA (swelling at injection site that is red and warm to touch). At the time of the report, VACCINATION SITE WARMTH (swelling at injection site that is red and warm to touch), VACCINATION SITE SWELLING (swelling at injection site that is red and warm to touch) and VACCINATION SITE ERYTHEMA (swelling at injection site that is red and warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No information provided about ay concomitant and treatment medications.   Reporter did not allow further contact
lip is swollen; Discomfort; Body aches; High temperature; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lip is swollen), MYALGIA (Body aches), PYREXIA (High temperature) and DISCOMFORT (Discomfort) in a female 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 LIP SWELLING (lip is swollen), MYALGIA (Body aches), PYREXIA (High temperature) and DISCOMFORT (Discomfort). At the time of the report, LIP SWELLING (lip is swollen), MYALGIA (Body aches), PYREXIA (High temperature) and DISCOMFORT (Discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. Patient stated that she missed work one of those days. No treatment information were provided.
red stripes around the chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red stripes around the chest) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red stripes around the chest). At the time of the report, ERYTHEMA (red stripes around the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was taken. No treatment drug was taken.   Reporter did not allow further contact
Severe headache ( mild beginning Nov 4-5; severe by Nov 7). Add symptoms of fever of 102 degrees and 1 episode of vomiting.
Information has been received from a physician concerning a 8 year old male patient who on 13-MAR-2004 and 25-AUG-2005 was vaccinated with the first and the second doses of MMR II respectively.  On 21-DEC-2009 the patient experienced mumps.  The patient had no fever.  The parotitis was on the right side.  The parotitis count was 13.  The date of mumps diagnosis was 08-DEC-2009.  The patient was exposed to a classmate with mumps.  On 08-DEC-2009 lab diagnostics revealed the patient's IgM was 0.64, IgG was 5.62 and serum amylase was 347.  At the time of report the patient's status was unknown.  Follow-up information has been received from a physician concerning an 8 year old male patient who on 15-MAR-2004 and 25-AUG-2005 was vaccinated with the first and the second doses of MMR II respectively.  On 11-JAN-2010 the patient experienced mumps.  The date of mumps diagnosis was 12-JAN-2010.  The patient was had right parotitis and was afebrile.  On 12-JAN-2010 lab diagnostics revealed the patient's IgM < 1:10, IgG was 7.55 and serum amylase was 54.  Additional information has been requested.
Starting April 7th, then again April 11th and continuing until the present day, an uncomfortable and itching rash had covered the majority of my body.  This led to 2 UrgentCare visits and a course of steroid pills (that helped for a few hours before the rash would start to reappear each day) After completing my second dose of the vaccine on April 25th (Lot# EW0169) around 7pm I woke up April 27th with the rash the completely covered my legs/groin/hip area and started spreading up my spinal and trunk as well as swelling fingers, face and lips, resulting in a hospital visit, more steroids and on the morning of April 28th a new rash began on my trunk, arm, neck and face in addition to the hive-like rash on my legs.
Swollen lymph nodes on right side in neck, near collarbone, and armpit.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the arm right on 30Apr2021 at 12:00(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included episcleritis, granuloma annulare, acid reflux, and latex allergy (slight skin irritation from latex product). Concomitant medications esomeprazole (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and prednisolone (MANUFACTURER UNKNOWN); all from unknown date for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced swollen lymph nodes on right side in neck, near collarbone, and armpit. The clinical outcome of the event swollen lymph nodes on right side in neck, near collarbone, and armpit. was not recovered.  No follow-up attempts are needed. No further information is expected.
patient asymptomatic.  Breakthrough Covid 19. positive  Covid-19 Cepheid screening test positive.
Vaccinated with the 2nd dose and after 15 days; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 6-May-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The patient received 2nd dose but after 15 days only. Additional Supportive Information: The 2nd dose was given earlier than the recommended timeframe, which led to shortening of vaccination schedule.
This case was reported by a nurse via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On 4th June 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and painful rash. On an unknown date, the outcome of the shingles and painful rash were unknown. It was unknown if the reporter considered the shingles and painful rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The health care professional asked if there had been any reported cases of patients who are just 2-3 days post SHINGRIX vaccination (1st dose), getting diagnosed with shingles. The health care professional had the patient who might had experienced shingles 2 to 3 days post vaccination and was trying to determine the likelihood of this occurring. The healthcare professional was not 100 percent convinced it was shingles but it was a theory. The patient had what looked similar to shingles rash on his soft palate and the reporter was just trying to figure out new onset, painful rash with only new variables being the vaccinations on Monday. The patient received SHINGRIX vaccine. The health care professional did not have vaccine information.
Redness, swelling to R thigh began 8/29/03 (1 1/2cm x 4cm) fever (101-102 deg F) began 8/29/03; relieved by Tylenol.
extreme thirst; runny nose; sore throat; head ache; This spontaneous case was reported by a consumer and describes the occurrence of THIRST (extreme thirst), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (head ache) 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 THIRST (extreme thirst), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (head ache). At the time of the report, THIRST (extreme thirst), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
This is a spontaneous report from a contactable physician. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) (Age at Vaccination 30 years) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included transgender operation from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing , haematuria from an unknown date and unknown if ongoing. Concomitant medication(s) included estradiol (ESTRACE) 2 mg TID; spironolactone (SPIROLACTONE) 50 mg TID; ibuprofen (IBUPROFEN) 200mg PRN and vitamin d3 (VITAMIN D3) 200u one daily. The patient historical vaccine included (BNT162B2), dose 1 via an unspecified route of administration on unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation and had no adverse event. The patient referred to nephrology for evaluation of proteinuria and microscopic hematuria in the setting of the second dose of the COVID 19 vaccine. It was wondered if there wasn't an autoimmune reaction like HSP or IgAN type syndrome. Kidney biopsy preformed, confirmed IgA Nephropathy, primary and secondary forms as well as infection on unknown date in Mar2021. If primary IgA nephropathy the findings are consistent with Oxford Classification of MI E0 S1 T0 C0. The outcome of the events was not resolved.  Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: Based on the information in the case report and a plausible temporal relationship,  a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded.  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.
States rash started at site of DTaP. Child developed a generalized rash in the pm of 6/16/03 approx 6pm became very anxious and had diff with speech. Taken to ER via ambulance. 6/17/03 developed rash again at 6pm taken to ER no additional tx on 6/17/03.  6/16/03 child was given steroid injections as well as anaphylaxis. 6/23/03 child has recovered completely.
This spontaneous report as received from two pharmacists (one via field representative) refers to a patient of unknown age. On 03-SEP-2013 the patient was vaccinated with ZOSTAVAX vials of lot number J001700 and expiry date 08-MAY-2014. Dose and route were unspecified. The reporter informed that one shipment of improperly stored ZOSTAVAX vials (lot number J001700 and expiry date 08-MAY-2014) received on 27-JUN-2013 were exposed to 5 degrees centigrade for possibly 105 days. The patient had been administered with the improperly stored vaccine. No adverse event was reported. This is 5 of several reports from same reporter. Additional information has been requested.
Experienced Primary Diagnosis of Stroke to left rear side of head (Also Mixed Hyperlipidemia, Coronary Artery Disease involving Native Coronary Artery of Native Heart without Angina Pectoris, Type 2 Diabetes)
kind of felt loopy; lightheaded; arm was generally sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was generally sore), FEELING ABNORMAL (kind of felt loopy) and DIZZINESS (lightheaded) in a 38-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm was generally sore), FEELING ABNORMAL (kind of felt loopy) and DIZZINESS (lightheaded). At the time of the report, VACCINATION SITE PAIN (arm was generally sore), FEELING ABNORMAL (kind of felt loopy) and DIZZINESS (lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. Patient states she got her flu shot and felt kind of tired, have bump which is hot to touch, looks like insect bite and she states this is unusual after flu shot.   This case was linked to MOD-2021-385924 (Patient Link).