chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown date, an unspecified amount of doses of PROQUAD (Merck) 0.5 ml, subcutaneous (lot # and expiration date were not reported) that underwent a temperature excursion was administered to an unspecified amount of patients. No adverse effect was reported. Follow up information was obtain during a telephone call to the licensed practical nurse, on 23-JAN-2015. The licensed practical nurse did not have lot numbers and expiration dates readily available for PROQUAD (Merck), and reported that no adverse event had been reported following administration of vaccinations. Follow up information has been received from the licensed practical nurse on 18-MAR-2015, concerning a currently 6 years old patient of unknown gender, who was vaccinated with a dose of PROQUAD (Merck) lot number K011313, expiration date not reported. This is one of several reports from the same reporter. Additional information is not expected, since all the information needed to complete the case has been already received.
Extremely extremely low platelets count numbers; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's wife). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6205) via an unspecified route of administration on 11Apr2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (lot number: EL9267) administered on 18Feb2021 for COVID-19 immunization. On an unspecified date, the patient experienced extremely extremely low platelets count numbers. Reporter stated that my husband got a bad side effect from the COVID 19 Vaccine. I was wondering if you have heard of anymore side effects like my husband had. Reporter wanted to know if Pfizer knows about this and what you recommend doing. Asked if reporter also experiencing side effects: Reporter stated, I do not think that I am but I never had a blood test. He was having weekly blood test that so alright. The patient lab tests and procedures which included extremely extremely low platelets count numbers and weekly blood test that so alright on an unspecified date. The clinical outcome of the events was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Blood pressure increase  (unto 180/80 for three weeks after the second shot. Went to Dr. And had Amoldolpine (blood pressure medics, 10 mg, which had its own side effects. Have now discontinued the BP medication and am fine but for three weeks I suffered a lot.
Patient in COVID vaccine clinic today for dose 2 of Pfizer Vaccine.  A few minutes post vaccine, while patient was standing upright but hunched over the exam table, I observed the patient to look slightly pale.  When asked the patient how he was feeling he stated that he had a headache.  When asked if he felt light headed or dizzy he said that he did.  Upon assisting him to sit in a chair, he buckled his knees and went limp into my arms to which I lowered him safely to the ground.  Once on the ground the patient opened his eyes spontaneously and was able to answer questions appropriately.  When asked he stated that he remembered feeling like he was going to pass out but then woke up on the ground.  He still appeared slightly pale and diaphoretic.  A pillow was placed under his head as well as an icepack to his forehead.  I observed him in this position for a few minutes until his color improved and his symptoms had improved.  At this time he was able to sit upright on the floor and take sips of water.  After a few minutes he stated that he felt able to stand up.  He proceeded to stand and was able to walk out of the clinic with his parents without incident.  A=remained open B=remained spontaneous, regular, adequate C=brief vasovagal syncope, pale, diaphoretic improved to pink, warm, dry with cap refill less than 2 seconds D=brief vasovagal syncope improved to GCS 15 without deficits  Subjective = + for headache, lightheadedness/dizziness; resolved
Undiluted vaccine administered to the patient. As of now, he has not experienced any adverse reactions. I left the parent a voicemail asking them to contact us, so we can inform of the error.  Also, we need to obtain doctor information to notify child's doctor.
Given client expired rotavirus; had client to wait 15 min after meds. given; no problem noted. Inform Dr. & supervisor. Will call or send letter to revaccinate.
pt recv vax 29JUN98 & nl exam x/sl inc BS-active - had snack a/bed;awakened w/heavy breathing 1AM, not consciously responsive, combative;EMT summoned, BS 60 given glucagon no effect to ER;c/o h/a & somnolence;glucose 95;heart murmur;
Patient was fine in clinic - Had Epipen with her. at noon she was in urgent care with chest pains, nausea vomiting - at 6:34 ED - Epi drip Patient has prior Influenza alergic reactions PPD alergic reaction Patient came with Epi pen, was observed for 20 mins after with no problems Returned to work.  Reaction happened after returning to work
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th October 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 1st November 2018, the patient experienced muscle pain and pain. In November 2018, the patient experienced leg pain. On an unknown date, the outcome of the injection site pain and muscle pain were not recovered/not resolved and the outcome of the pain and leg pain were unknown. It was unknown if the reporter considered the injection site pain, muscle pain, pain and leg pain to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX in the right arm. The patient immediately experienced soreness at the injection site. He claimed that he started to feed his cattle and that was when he first started to experience muscle pain. The pain occurred with any activity he did and the pain would start within hours of physical activity. He also reported that the pain occurred in his leg but he said it would occur all over. On 28th November 2018, he had a physician visit at his physician's office and the physician provided no insight. The patient claimed that he would not be getting his second dose of the SHINGRIX because of the side effects which he was experiencing. The reporter consented to follow up.
measles rash ( 4 days), fever 102.2 (1 days);poor appetite, loose stools;
Seventeen days later, on Nov 12, 2021, I had a syncope episode, taken to the ER to get stitches and EKG, CXR, CT scan Brain and neck; MRI brain and carotid doppler were done, all negative. On the EKG I appeared with a CRBBB, 1st degree AV block and left anterior fascicular block. My last EKG dated 2009 was negative for any of the previous findings. On Jan 28, 2022, I was place on a loop recorder to monitor my activity and see if a pacemaker might be needed in the future. I have never had a stroke, ischemic heart disease or MI. Given that Moderna has history of causing pericarditis and myocarditis in some patients induced me to report this in case other patients have experienced a similar event.
COVID-19 VIRUS TEST POSITIVE.; This spontaneous report received from a physician concerned a male patient in his 40s (exact age unknown), of an other race and unknown ethnic origin. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  Four days after vaccination, the patient tested positive for covid-19 (covid-19 virus test positive).The doctor wanted to know if the vaccine could cause a positive test.  The action taken with covid-19 was not applicable. The outcome of covid-19 virus test positive. was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
sudden and severe double vision andmild dizziness; sudden and severe double vision andmild dizziness; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 05Feb2021 at 15:00(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was allergic to ciprofloxacin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 10:00 the patient experienced sudden and severe double vision and mild dizziness. Closing either eye he had normal vision. Vision and dizziness self corrected within approximately 20 minutes. He never had these symptoms before or after this single event. Therapeutic measures were not taken as a result of the event(s). On 07Apr2021, the patient underwent lab test included nasal Swab and the result was Negative. The clinical outcome of the event sudden and severe double vision and mild dizziness were recovered on 15Feb2021 within 20 minutes.    No follow-up attempts are needed. No further information is expected.
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box), UNDERDOSE (patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and UNDERDOSE (patient that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication details not reported by the reporter. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter. This case contains information about patient 15th out of 18 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Pt came in for a routine visit including Tdap vaccine for Physical Therapy School requirements. A PPD was administered and a Tdap at 11:45am.  After vaccination pt was questioned if she was feeling well and stated, "I'm ok."  While making f/u appointment for pt, she stood in front of this nurse and suddenly fell to the floor.  Never lost consciousness.  Pt responsive saying she felt cold to her extremities and had the feeling she was going to faint.  Pt wearing a book bag, therefore head never hit the floor.  Lips appeared slightly dusky but returning to pink almost immediately.  O2 Sats 98%.  Pt monitored and placed on 02 @ 2L.  Remained in office for 30 minutes.  Episode resolved.
A little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of sore arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of sore arm). At the time of the report, PAIN IN EXTREMITY (A little bit of sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
fatigue; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE) and VITAMINS NOS for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes annihilator.   This case was linked to MOD-2021-016404, MOD-2021-016404 (Patient Link).
synovitis in his first metatarsal of his left hand; inappropriate schedule of vaccine; This case was reported by a physician via sales rep and described the occurrence of synovitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of synovitis (received 1st dose on 19th April 2018, refer case US2018GSK169735).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced synovitis and drug dose administration interval too long. On an unknown date, the outcome of the synovitis and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the synovitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional has self report of synovitis in his first metatarsal of his left hand after receiving his 2nd dose of Shingrix. He had it evaluated by a rheumatologist and it did not appear to the rheumatoid arthritis. He had a similar adverse event after 1st dose however it happened on his right hand. That was previously reported. His 2nd dose occurred 1 year and 2 months after his 1st dose.
06/25/2021 I had pain in my left arm. I thought I had pulled muscle. I ignored it for a while thinking it would get better. I started seeing a chiropractor in August until November. She stated I was not progressing and referred me to an Orthopedist in November. They did x-rays and it was normal. Then they did an MRI and found the bone lesion in the left scapula.
Fever and body aches starting at 9pm (9 hours after injection) and lasting 24hrs headache starting at 9pm (9 hrs after injection) and lasting 48hrs
Patient came into pharmacy complaining of swollen. Patient given oral BENADRYL 25 mg to take every 4-6 hours per protocol. Rx dept called patient next day she said she was better. She was told to call md and or pharmacy if not improved completely.
he tested positive with Covid-19; This is a spontaneous report from a Pfizer sponsored program  via contactable consumer or other non hcp. A 36-year-old male patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 09Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced he tested positive with covid-19. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  No follow-up information needed. Information on the lot/batch number has been requested.
This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 71-year-old male patient with end-stage renal disease on peritoneal dialysis. His concomitant therapies were not reported. He had history of blood transfusion in 1988, but no history of tattoos, intravenous drug use (IVDU), or other risk factors for acquiring hepatitis B virus (HBV) infection. The patient had no previous history of liver disease, and his hepatitis B surface antigen (HBsAg) was negative one year prior to his presentation. On an unknown date, the patient was vaccinated with hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, lot #, expiry date, and route of administration were not provided) for prophylaxis. On an unknown date, 5 days post-vaccination, during a routine evaluation for kidney transplant, the patient's blood tests showed positive HBsAg and he was referred for further investigations. His hepatitis B core antibody (HBcAb) and hepatitis B surface antibody (HBsAb) were negative. International normalised ratio (INR), total bilirubin, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were within normal limits. Albumin was low: 2.9 (unit not provided) due to the patient's chronic kidney disease. He was asymptomatic and denied abdominal pain, jaundice, fever, change in urine or stool color, or nausea/vomiting. On examination, vital signs were stable with no other findings except the presence of left-sided abdominal wall peritoneal dialysis catheter in place. Repeat testing for HBsAg, HBsAb, hepatitis B E antigen (HBeAg) and hepatitis B DNA (28 days post vaccination), all returned negative. The outcome of hepatitis B surface antigenemia was recovered. The authors considered positive HBsAg test to be related to recent hepatitis B vaccine (recombinant) (manufacturer unknown) vaccination, and they stated that hepatitis B virus vaccination can produce a transiently detectable level of HBsAg, which may be misdiagnosed as prior exposure to HBV, and be the cause of false positive HBsAg test. A copy of the published article is attached as further documentation of the patient's experience. On 23-NOV-2021, a follow-up with additional literature reference was added.
Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 8/2/2023 Discharge Date: 8/5/2023 Discharge Disposition:  Home with services - Occupational therapy and Physical therapy  DETAILS OF HOSPITAL STAY: HOSPITAL COURSE: Patient is a 94 y.o. female who presented to Hospital with generalized weakness fever, chills.  In the emergency department she had a temperature 39.4°, with leukocytosis and tachycardia.  She is found to be COVID-19 positive.  X-rays showed left opacity, suspicious for infection.  Prolactin levels were increased, blood cultures are negative since discharge.    Throughout the hospital course patient was on room air and did not complain of any SOB. She did note to have generalized weakness.  PT and OT recommended home with healthcare, patient is agreeable and understands the plan.   Patient also had elevated liver enzymes with AST in the 70-60 range.  Was noted in the past patient had a biliary stent placed and removed sometime this year.  Since then is noted that her bilirubin and liver enzymes have been elevated. Her bilirubin levels were increasing, however patient was asymptomatic and will be seeing PCP on 8/8. Will need further workup outpatient.    She was discharged on stable condition and was to complete her antibiotic course.
Received first doze today at 3:00 PM, around 4:00 PM my face became flushed/pink.  4:30 I noticed that both sides of my face twitch uncontrollably when I smile.
Around 10:28, client expressed tingling in the throat and wheezing. EMS attended. Vitals BP 134/87, O2 99%. EMS released customer at 10:33, which he wanted to remain under observation for 30 minutes more. Client stated he was fasting.
Dizziness, Headache, Myalgia, Fever, CHILLS, FATIGUE Narrative:
On 12/02/2022 it felt like common cold. I did a home test on 12/03/2022 and it was positive. A couple days later I had fatigue. It took me about a week or so to feel back to normal. I did lose my taste a little bit, but it came back right away. I went to urgent care on 12/04/2022 but they sent me home.
This spontaneous report was received from a registered nurse via company representative concerning to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 31-OCT-2008, the patient was vaccinated with PNEUMOVAX 23 to prevent pneumonia (route, dose, lot number and expiration date were not reported). On an unknown date, the patient experienced fever of 104 °F, severe pain in an unspecified area on her body, injection site swelling and the area was sensitive to touch. On an unspecified date in November 2017, the patient was vaccinated with PNEUMOVAX 23, intramuscular to prevent pneumonia (dose, lot number and expiration date were not reported). Subsequently in 2017, the patient experienced again severe pain in an unspecified area on her body, injection site swelling and the area was sensitive to touch. It was also reported that the patient was seen at the health office for a follow-up appointment. The treatment as well the outcome of the events injection site hypersensitivity, pain, pyrexia and injection site swelling was unknown. The causal relationship between the events and therapy with PNEUMOVAX 23 was not reported.
Pt developed rash following administration of Varicella and MMR vaccines. Rash lasted approx 3 weeks. Results in non raised red flat rash on bil arms. Possible MMR related ITP.
Skin change 10 minutes after getting the vaccine. Numbness on my tone. A few dates after skin change came back. I am feeling dizzy. Without energy