chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Menard spotting for two days outside of normal period; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Em9809) via an unspecified route of administration in the left arm on 23Feb2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy and allergy to sulfa drugs (sulfonamide allergy). Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En5318) via an unspecified route of administration in the left arm on 02Feb2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021, the patient experienced menard spotting (spotting menstrual) for two days outside of normal period. The event did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menard spotting (spotting menstrual) was recovered on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Patient' parents filled out the vaccine consent form online and was dishonest about the kid's birthday. They put 8/8/2016 to trick the system. Tech asked them about insurance but they said they didn't have insurance or any ID to provide. We found out the kid had insurance by running eligibility check in enterprise after giving the shot. We called insurance company to verify the birthday which was 8/8/2017. We called patient's parents to comfirm the DOB and left a message. The next morning patient's mom called back and admitted that they were dishonest about patient's birthday so they can get their kid a Covid vaccine.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524), in right 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 and 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound for 8 days one day after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 30-DEC-2015, the patient was vaccinated with improperly stored dose of MMR II (lot # L012479, expiry date 10-APR-2017, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Circular area of induration, erythema, and pruritus at injection site. Onset 1/15/21 and resolution 1/17/21.
Big red lump and redness at site of injection, itching on site and all over body-- took Benadryl on 6/5 and rubbed with Benadryl creme.
shingles; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female (also age at vaccination) patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL3248), via an unspecified route of administration at the left arm on 19Jan2021 at SINGLE DOSE for covid-19 immunization. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) on 29Dec2020 10:00 AM at the left arm for covid-19 immunization. The patient is not pregnant at time of vaccination and was vaccinated at a hospital. Medical history included breast cancer, lichen planus, hypothyroid, allergies to Sulfa drugs and environmental. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also received other medications within 2 weeks of vaccination (unspecified). The patient experienced shingles on 28Jan2021 08:00 AM (diagnosed on 02Feb2021). The event resulted in Doctor or other healthcare professional office/clinic visit. It was reported that treatment received for the adverse event includes: clinic visit and medication. The outcome of the event was recovering. Case was considered as non-serious.
Case previously recorded as MA2009-4396.  Initial case report received from a nurse via agency on 16 NOV 2009.  A 3 year-old female patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 102045P1) i.m. on 14 NOV 2009.  No adverse events were reported.  Wrong age is unexpected after vaccination with S-OIV FLUVIRIN 2009/2010.  No change in benefit-risk-ratio.  No measures are necessary.  Agency reference no.: NA09-008317.
Fever 103 and maculopapulo vesicular rash 15 to 20 spots lower abdomen, chest and spreading to face. Seen in office for this problem 1/13/05.
No adverse event; Past lot that had also been expired that was administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient).    The patient age was reported as 45 Years 2 Months.  No concomitant medication was provided.    No treatment medication was reported.
PFAPA syndrome (excessive tiredness,  swollen lymphnodes,  headache,  stomach aches,  vomiting,  rashes, joint pain, mouth sores, body sores, etc)
Patient hospitalized with closed displaced fracture of the seventh cervical vertebrae with nonunion as well as myelopathy of the cervical spinal cord and cervical radiculopathy.  Now s/p C5-T2 posterior spinal fusion with bilateral cervical 8 laminotomy and foraminotomy. This visit is within 6 weeks of receiving covid vaccination.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 44-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the information, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.
History of hypertension, gout, hypothyroidism, and allergic rhinitis who started to experience nasal congestion and stuffy nose after the shot.  No signs of airway issues and denies any other symptoms.  Vital signs stable.
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age with no medical history, drug reactions or allergies. The patient's concurrent conditions were not reported. On 14-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously, lot number L006380, expiration date 25-MAY-2016, (dose and anatomical location were not reported) for zoster vaccination. There was no concomitant medication reported. On 15-SEP-2015, the patient experienced a reddened area of 1.5 to 2 inches in diameter at the injection site. The reddened area was swollen, warm and hard to the touch. The patient sought medical attention by calling the pharmacist. No treatment was given and none laboratories were performed. At the time of the report, the outcome of the reddened area of 1.5 to 2 inches in diameter at the injection site, the reddened area was swollen and hard to the touch were reported as no recovered. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
pt recv vax & pt exp grand mal sz;approx 3wk later pt is being followed by neurologist for r/o seizure disorder;
Dizziness, Headache, Myalgia,  body aches, soreness in left arm, injection site itching, swelling, redness Narrative:
Developed scattered hives within 24 hours; then developed tachycardia and involuntary movements of head and neck, upper extremities.
From initial information received on June 23 2005 from a health care professional regarding an adverse event, it was reported that a 15 year old female received a dose of Menactra, lot number not reported, on June 17 2005. The route and site of administration were not reported. Three days later, on June 20 2005, the patient developed a headache. On June 23 2005, she developed a fever, vomiting and sore throat, At the time of this report, the patient had not recovered from these events.
10/27/2006 at 4 year well check administered Dtap, Polio, ProQuad, Flu-mom advised Sunday following injection sites red and hot and developed a rash- seen at urgent care.
Pt received vaccine at 8:27 AM.   Reaction began about 8:45am.  Began with throat itiching, and coughing.  Pt took her own albuterol.  Symptoms did not resolve. PO Benadryl given 25 mg.  Pt taken to Urgent Care on site.  Prednisone 60 mg and additional dose of benadryl 25 mg given.  Pt discharged to home at 10:16 am.
Pt started screaming approximately three hours after vax, the infant was inconsolable and after screaming for three hours, she was taken to ER with normal PE.
I started with having irregular cycles which I have never had before. They started around 2 weeks after the vaccine and then throughout the next few months, they repeated as irregular, much longer than usual and irregular mid-cycle bleeding. There is no explanation as to why it was happening. Doctor said she had seen other women with irregular symptoms after the COVID vaccine. They symptoms have persisted. It's a little better, I do not experience any bleeding outside of the normal cycle bleeding but the dates are still irregular. I have change in health plans and there is a new doctor that is going to do a pelvic ultrasound (September 21st) to see if there is anything wrong there. My new doctor said that because of the irregular bleeding, I was a little low on iron. I was told to take a multi-vitamin with iron. I was almost anemic but not quite.
Patient fainted following vaccine administration due to emotional response of needles and shots. Patient admitted after recovering fully that she has a history of fainting with exposure to needles or shots. Patient recovered immediately after fainting  with no medical treatment needed.
Patient had cardiac:rhythm disturbance tachy, brady, ectopy, other . Onsite EMS was called vitals HR 60 BP 156/84  BG 110 100% O2. Patient treated, released, against medical advise
Got vaccine the morning of 8/4/20 and had very sore arm for remainder of day.  At midnight awoke feeling cold so got a blanket.  Slept fitfully until 4 a.m. when I got up, took temperature which was 101.9 F.  Stomach upset, heaved up bile.  Forced something to eat so I could take ibuprofen.  Temp gradually started going down, but it took most of the entire day on 8/5 to get to normal.  During the day could not eat and heaved up bile several times.  Regular activities were not possible.  At 6 p.m. forced a slice of bread down, and by 8 p.m.  finally felt some relief from the misery.  Today, 8/6, temp is normal, some stomach upset remains and feel wiped out.  I worked in spite of my sickness yesterday and am forcing it today.  I will NEVER get this vaccine EVER again.  I have foregone Flu vaccines now for several years after getting high fevers both times I did get them.  Related?
Woke up the morning after fatigued and achy with the same feeling I would have when I would be sick. By mid afternoon (24 hours after injection) I was running a low grade fever, had a headache and nausea.0
A non-serious, spontaneous report of muscle strain, dizziness, paleness, flu like symptoms, chills, sore throat and pain in the abdomen, runny nose, cough, fatigue and cold extremities was received from a consumer concerning a seven-year-old female subsequent to FLUMIST. The patient's past medical history included H1N1 influenza in Aug-2009 and lymphadenopathy in left side of the neck following influenza since 2006. The patient was not taking any concomitant medications. The patient received FLUMIST on 23-Oct-2009 for flu vaccination. On 23-Oct-2009 following the vaccination the patient experienced flu-like-symptoms including dizziness, paleness, chills, sore throat, pain in the abdomen, runny nose, cough, fatigue and cold extremities. On 30-Oct-2009 the patient experienced left hip pain and was seen by physician on 04-Nov-2009 and diagnosed with a muscle strain. The patient participates in gymnastics. The patient recovered from the events of dizziness, paleness, flu like symptoms, chills, sore throat and pain in the abdomen, runny nose, cough, fatigue and cold extremities on 28-Oct-2009. The event of muscle strain improved although was ongoing.
Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022; received dose after its beyond use date/gave expired doses of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine) and PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine) and PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 20-Jun-2022. It was reported that the vial did not undergo any temperature excursions.
rash (vertical) on each side and across my back; had a red wide band of red skin on; felt unwell for days but nothing severe; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th September 2019, the patient received the 1st dose of Shingrix. On 17th September 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell. On 18th September 2019, the patient experienced rash and erythema. On an unknown date, the outcome of the rash, feeling unwell and erythema were unknown.   It was unknown if the reporter considered the rash, feeling unwell and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix, and she felt unwell for days but nothing severe. 24 hours later in the evening, she undressed and noticed a rash (vertical) on each side and across my back also. She had a red wide band of red skin on the top of her abdomen under her bra area. She had consulted with pharmacist and physician but they were unaware about how to advise her. The reporter consented to follow up.
Pt was given the 11th dose out of Polio vial, according to manufacture instructions, only 10 doses are to be given.
48 hours after the shot, I was extremely fatigued and ended up sleeping for 1 and 1/2 days. 48 hours after that, I got a large rash that severely itched at the shot site. I needed Benadryl and Calamine lotion to stop the itching. That lasted for 2 days.
STOMACH ACHE; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced stomach ache, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, stomach ache and fatigue was not reported. This report was non-serious.
I got my booster and the next day at 4pm. I started having chest pain on my left side and shortness of breath.  I called my PCP and they recommended the ER on 10-29-2021. I went to the urgent care instead, but they sent me to the ER. I stayed waiting until 1 am 10-30-2021 at the ER. They ran test but kept in waiting for 7 hours. I left the ER and went home.  I continued to have the chest pain; it has decreased. I am currently still having the same chest pain now. It comes and goes, but it is continuing. I called my PCP in November, he preformed a echo. It was fine. He referred me to a cardiologist, and he performed a cardiac MRI and he said it may have to do with inflammation in my lungs. I got COVID in early January, but I have been asymptomatic. My heart rate is running high. I have a reduction in my quality of life because the pain is still occurring.
Right Arm DVT and superficial venous thrombosis on ultrasound done on 3/30/2021-Pt noticed right arm soreness and discomfort then he started to have firmness which continued to get worse.
Case number PHEH2016US023400 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 30 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 30 Jan 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experienced any adverse events following vaccination.
pretty much like the worst flu I've ever had; really worried/really frightening/really unhappy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (pretty much like the worst flu I've ever had) and FEELING ABNORMAL (really worried/really frightening/really unhappy) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (pretty much like the worst flu I've ever had) and FEELING ABNORMAL (really worried/really frightening/really unhappy). At the time of the report, INFLUENZA LIKE ILLNESS (pretty much like the worst flu I've ever had) and FEELING ABNORMAL (really worried/really frightening/really unhappy) outcome was unknown.            NO Concomitant drug reported. NO Treatment drug reported.
12/16 began having cough and fatigue. 12/17 symptoms slightly worse and tested positive on at home COVID-19 test. Self isolated at home. 12/18 ran fever of 100.6. 12/19 symptoms improving. 12/20 had telehealth visit with PCP and symptoms had been improving. 12/31 tested negative on at home test and symptoms were completely resolved.