chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; PNEUMOVAX 23 WAS ADMINISTERED IN ERROR INSTEAD OF PCV 13; PNEUMOVAX 23 WAS ADMINISTERED IN ERROR INSTEAD OF PCV 13; PNEUMOVAX 23 WAS ADMINISTERED TO 7 MONTH OLD; This spontaneous report as received from a medical assistant refers to a 7-month old child of an unknown gender. No information regarding patient's concurrent conditions, pertinent medical history, drug allergies and concomitant therapies was provided.  On 22-SEP-2020, the patient was vaccinated with dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, site of administration not reported) (lot # S029916 confirmed to be valid; expiration date:12-JUN-2021) for prophylaxis instead of pneumococcal 13v conj vaccine (crm197) (reported as PCV 13). The first and second doses of PCV 13 was administered as prescribed per callers report. The third dose that was administered was pneumococcal vaccine, polyvalent (23-valent) (PNEUMOV AX 23) (also reported as It was 1 time dose in 3rd dose in series). The reporter stated, that this was alike medication error , which was discovered on 06-OCT-2020. The patient was well without any residual effects or side effects. No additional adverse event (AE) was reported.    combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
I FELL IN DEC 2021 AND BROKE MY WRIST AND HAD TO HAVE SURGERY AND NOW I HAVE NO BALANCE AT ALL. MY PC IS SURE I HAVE MS AND GETTING READY TO SEE A NEUROLOGIST
pt recv vax 28AUG & devel erythematous rash, urticaria, arthralgias of hands on 31AUG
1st shot, redness, itching starting  on R arm within 3 days, spreading to rest of the body for 4 days,  Took Benadryl, and 1 tylenol at night. 2nd shot, systemic itching and redness/ flushing, hives, eyes bloodshot and blurry ( like when I had covid 11/3/20), profuse sweating within 3-4 hrs after the shot lasted for 24 hrs.  Other symptoms incl loss of taste for 12 hours, chills,  bone and muscle aches, temp 100.7, headache, fatigue x 2-3 days.  Took 1 tylenol at night.
I have barely hit my hands on something and they start bleeding on my knuckles; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 03May2021 (at the age of 39-year-old) (Lot Number: EW0176) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation and experienced heavy menstrual bleeding for 3 weeks following the first dose; very large clots. On 03May2021 at 15:00, after the second dose, the patient had barely hit her hands on something and they started bleeding on her knuckles. The patient had not recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498328 same patient/drug, different vaccine dose/AE
Left deltoid injection on 8/20 at 4PM. Mother noticed swelling on left deltoid about 24 hours later. 3cmx3cm area of induration/swelling/redness.
67 y/o F received influenza vaccine on 10/29/2010 in her right arm. Pt. also received TDAP vaccine at the same time in her left arm. Directly after the TDAP vaccine pt c/o pain in her left shoulder joint, no injection site problems with influenza vaccine. Left shoulder pain persisted for 2 weeks. 4d s/p vaccine pt. c/o rash on her forehead and both arms, rash like hives, raised, red, irregular patches that were itchy and tender to the touch. This rash resolved without any treatment in about 5 days. Pt. did not seek medical care. Pt. has received influenza vaccine 5+ prior times, with no h/o adverse reactions.
Rt handed, c/o numbness & tingling to (R) arm, rcdd fax 10/23/11, day 5 shoulder was numb, feels like to move I have it the worse it becomes. (-) obtained exam 11/2/11. No tx. B/P 100/58. Smoker - 2 packs/week.
itching; hives in the same area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching) and VACCINATION SITE URTICARIA (hives in the same area of the injection) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching) and VACCINATION SITE URTICARIA (hives in the same area of the injection). At the time of the report, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE URTICARIA (hives in the same area of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
I had a temp of 101.7 degrees. For 2 days I had body aches and I was vomiting off and on.  Off and on I still get shaky, and it's hard for me to write sometimes because of it. I was also having pain behind my ear that was caused by inflammation. My doctor said I have temporomandibular joint muscle. The doctor told me to put heat on it and take Advil 3x/day for a week.
I tested positive for covid while being vaccinated; I tested positive for covid while being vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single and administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Shell fish" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Feb2022, outcome "recovering" and all described as "I tested positive for covid while being vaccinated". The event "i tested positive for covid while being vaccinated" and "i tested positive for covid while being vaccinated" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) positive, notes: I tested positive for covid while being vaccinated. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: No other vaccine in four weeks and not available details about other medications in two weeks. No Covid prior vaccination and no Covid tested post vaccination.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Verdigo & continued over 2-3 weeks, triggered flare up of disk disease,
Vaccinated on Day 1. Day 2-6, severe headache (worse/longer than usual migraines), not alleviated by OTC painkillers. Took imitrex, so may have been rebound headache and/or related to barometric pressure (Hx of migraines). Day 7, injection site itchy and swollen (minor reactions). Day 8: injection site has visible rash (size of a quarter), no pain.
Pt c/o feeling dizzy, muffled hearing & sweating. Pt escorted to observation and placed on cot in supine position. Pt's VS obtained by clinical staff and (EMS) called. EMS assessed and monitored pt. VS WNL. Medical incident duration from onset to medically cleared by EMS was 7 minutes. Pt reports "I am feeling much better." Pt cleared by EMS that it was safe to go home and driven by her mother.
WHEN ADMINISTRATING THE SECOND DOSE OF THE COVID VACCINE, IT APPEARED THAT THE NEEDLE WAS LOOSE AND SOME OF THE DOSE WAS LOST. THE PATIENT SAW THE LIQUID OUT IN HER ARM. THE PATIENT THIT NOT RECIEVED THE 0.3 ML DOSE. WE CONTACTED THE PFIZER TEAM FOR INSTRUCTIONS AND RECIVED LITERATURE. PATIENT DECIDE THE RE DOSE 0.3 ML ON 01/07/2021
J96.00 ACUTE RESPIRATORY FAILURE 3/26/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 3/26/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 3/26/2023 CHF EXACERBATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2023 CHF EXACERBATION, UNSPECIFIED R09.02 HYPOXIA 3/26/2023 CHF EXACERBATION, UNSPECIFIED
Patient experienced very low blood pressure and fainted. He came to quickly, but was transported to hospital by ambulance as a precaution
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 12 years. It was also confirmed that on 17-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1708USA001768.
FLUSHING AND REDNESS STARTED NEAR ADMINISTRATION SITE FIRST. IN 2 DAYS SHE DEVELOPED SWELLING AND REDNESS OF RIGHT EYE, WITH RASH FROM WRISTS TO ELBOW TOO. UPPER STERNUM ALSO SHOWING RASH. BENADRYL 50 MG GIVEN BUT TOO SLEEPY. FACE STILL BROKEN OUT ON 3RD DAY (TODAY), AND NOW LEFT EYE ALSO PUFFY. RASH NOW DOWN ARM TOO AND ECZEMA OF HANDS IS WORSENING. CONTINUES TO BE ITCHY.
This case was reported by a lawyer via call center representative and described the occurrence of myelitis in a 41-year-old female patient who received FLUARIX QUADRIVALENT (batch number 497KX, expiry date 2016). On 12th October 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 28th October 2015, 16 days after receiving FLUARIX QUADRIVALENT, the patient experienced myelitis (serious criteria hospitalization and GSK medically significant) and tingling of extremity (serious criteria hospitalization). On an unknown date, the outcome of the myelitis and tingling of extremity were not recovered/not resolved. The reporter considered the myelitis and tingling of extremity to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was previously reported to a doctor. This report was the part of legal filing and the reporter was a lawyer representing the patient. The patient received the vaccine in her left deltoid. The reporter was unable to provide complete expiration date as label cut off (year was 2016). The patient experienced hospitalization with tingling in right (arm, hand, fingers, foot and leg) after receiving vaccination. The patient was diagnosed with acute myelitis during hospitalization.
injection site soreness; strong headache; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 13Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. Later on 13Apr2021, the patient experienced injection site soreness and had a strong headache. The patient did not experience any other adverse effects. Both issues resolved the following day (today). Outcome of the events was recovered on 14Apr2021.   Information on the lot/batch number has been requested.
Patient reported severe muscle pain and weakness in his legs making it difficult to walk. He reported to a local ER with his spouse who said he wouldn't get out of the car due to his inability to move his legs.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Apr2023 as dose 6 (booster), single (Lot number: GJ3270), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (30Jun2023) Negative, notes: Rebound-initially tested negative over 2 days following Paxlovid course end on 28Jun2023; (30Jun2023) Negative, notes: Rebound-initially tested negative over 2 days following Paxlovid course end on 28Jun2023; (03Jul2023) Positive, notes: Symptoms recurred on 02Jul2023 and tested (strongly) positive with rapid antigen test on 03Jul2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Rash on back began around the time of vaccines, was diagnosed as shingles on 9/26/2022
This case was reported by a consumer via interactive digital media and described the occurrence of paralysis of arms in a male patient who received Herpes zoster (Shingle's vaccine).    On an unknown date, the patient received Shingle's vaccine. On an unknown date, unknown after receiving Shingle's vaccine, the patient experienced paralysis of arms (serious criteria disability and GSK medically significant), anxiety and activities of daily living impaired. On an unknown date, the outcome of the paralysis of arms was recovered/resolved and the outcome of the anxiety and activities of daily living impaired were unknown.   It was unknown if the reporter considered the paralysis of arms, anxiety and activities of daily living impaired to be related to Shingle's vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, after shingles shot, her husband's arm paralyzed for over a week, and it was frightening. The reporter had to help the patient for everything from showering to dressing to bathroom. The reporter stated that, did some research and lysine kept you from getting shingles. The reporter stated that never again would they get vaccines, or flu shots or all these crazy shots.
ER c/o CP, non-productive cough, fatigue, and fever of 99 for the past three days. Patient was found to be COVID negative two days ago. Patient is currently on anti-rejection medication for scleroderma. Patient reports having received her COVID vaccinations in February 2021. She recently had COVID exposure. Patient discharged home in stable condition no steroids initiated as patient was not hypoxemic
2/19/22 EMS called to pt's house; pt in severe respiratory distress, found on the floor with gurgling respirations; pt became unresponsive; intubated and bagged; pt never lost pulse; bradycardic; had outpatient CT yesterday with pneumonia dx; started on ABX; found to be positive for COVID; experienced pneumothorax in hospital, chest tube placed; ICU; no improvement; family decided upon palliative extubation; pt passed away in the hospital
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Lot number: GJ3277), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
injection site looked black and blue; injection site looks pink spot as big as quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (injection site looked black and blue) and VACCINATION SITE ERYTHEMA (injection site looks pink spot as big as quarter) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for an unknown indication.     No medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site looks pink spot as big as quarter). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (injection site looked black and blue). On 07-Feb-2021, VACCINATION SITE DISCOLOURATION (injection site looked black and blue) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (injection site looks pink spot as big as quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
Morning after vaccine very dizzy, almost past out. Blood pressure high. Dizzy all day nausea, dizzy, light headed continued Tues, Wed, Thurs, Fri, Still not completely gone.
This is a spontaneous report from a contactable consumer (reported for herself). A 71-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 71-years-old) as single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Feb2021 (at the age of 71-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tested positive for covid virus, after both-covid vaccines. The case assessed as serious (medically significant). The clinical course was as follows: Patient received an antibody infusion on 10Aug2021, and she contacted Medical Information to ask how long she would have to wait for a booster shot. The outcome of the events was unknown.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chickenpox.  Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated patients was a 8 year old patient who on 17APR1996 was vaccinated with a dose of varicella virus vaccine live. On 08APR2003, the patient developed chickenpox. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified.  Additional information is not expected.
Redness, swelling at site of Flu shot, painful to impact, low grade, 99 degree temperature, site is warm to touch approximately 3" diameter. Coworker slapped site of shot the next morning.
Redness, swelling, itching, warmth on arm at site of injection beginning within hours after injection. Applied diphenhydramine cream and symptoms have decreased.
Ever since my vaccination, I seem to be more sensitive to hot weather.  Temperatures and humidity that didn't bother me last summer are now making me feel dizzy, nauseated and light headed.
A nurse reported the occurrence of right upper quadrant pain in a 24 year old female who received hep B vaccine recombinant (Engerix B) for prophylaxis. The pt had no relevant medical history, concurrent conditions or concurrent medications. On 8/13/03, the subject received her first injection of Engerix B. Approximately two weeks post-immunization, in Aug 2003, the pt developed abdominal pain. The event resolved approximately two weeks later. The second dose of Engerix B was administered on 9/15/03. Approximately eight days following the second dose, on 9/23/03, the pt developed right upper quadrant pain, abdominal pain, nausea, headache, chills, weakness and a fever of 100.4 deg F. At unspecified ultrasound and urinalysis were negative; complete blood count and liver function tests were normal. The events were resolved approximately two weeks later on 10/6/03. The series of Engerix B was discontinued. The nurse reported the events as "serious because the pt was incapacitated for two weeks." The nurse considered the events to be possibly related to Engerix B administration.