chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling that went down his arm; no strength in hand; Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it; prevented him from sleeping; After the second dose it got worse; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Tendonitis and Diabetic.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse). The patient was treated with PREDNISONE for Pain, at a dose of 1 dosage form. At the time of the report, PARAESTHESIA (tingling that went down his arm), ASTHENIA (no strength in hand), VACCINATION COMPLICATION (Arthritis and Tendonitis in the arms and legs thinks the vaccine had activated it), INSOMNIA (prevented him from sleeping) and CONDITION AGGRAVATED (After the second dose it got worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) showed arthritis and tendonitis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient confirmed that the tingling stared after the first dose and after the second dose it got worse and also took advil as treatment  No concomitant medications were provided by reporter.  Patient had MRI showed arthritis and tendonitis in him.   This case was linked to MOD-2021-305218 (Patient Link).
Left arm became sore; Left arm became red; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included influenza virus vaccine inactivated (Fluzone Quadrivalent (Influenza Virus Vaccine)) for prophylaxis.   Concurrent medical conditions included arthritis and fibromyalgia.   On 8th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Fluzone Quadrivalent (Influenza Virus Vaccine) at an unknown dose and frequency. On 8th October 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were recovered/resolved.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix vaccine and at the same time she also received Fluzone vaccine just below the Shingrix injection site. On same day, the patient's left arm became sore and red which lasted for at least 3 weeks. The patient stated that there were no symptoms from the Fluzone vaccine.   On November 27, 2019, the patient received her regular injection of the Depo Medrol which she gets once in month and informed that she got very little relief from the back pain and muscle pai. The back pain and muscle pain are conditions that were she had regularly prior to vaccinations due to arthritis and fibromyalgia.   The patient normally gets full relief from the pain when she receives the injection.   The patient also reported that she recently had a Nuclear Stress test that came back as abnormal.  The patient would be receiving heart catheterization to determine if there was something else wrong. The reporter was unable to provide any additional details. The reporter did not consent to follow up.
Pain on their arms; A spontaneous report was received from a consumer concerning patient of unknown age and sex who developed pain on their arms/pain in extremity.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   The patient received their unknown of two planned doses of mRNA-1273 (Batch number: unknown) on unknown date at unknown injection site for prophylaxis of COVID-19 infection.    The patient developed pain on their arms. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event pain on their arms was not reported.
FULLY VACCINATED COVID-19 CASE. Admitted with general weakness, acute respiratory failure and hypoxia secondary to Covid-19 Pneumonia
I called pt parent today 9/20/12. Reports no problem. Spoke to provider. Dr. pt's height/weight 5 feet 1 & 205 lbs. pt should be ok w/ no adverse events.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route of administration on an unknown date at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date, the patient was tested positive for Covid. She received a BAM fusion after testing positive and was not sure if she can get 2nd dose after receiving BAM fusion. The outcome of the events was unknown. The patient underwent lab tests and procedures which included SARS-CoV-1 test which was positive on an unknown date.  Information on the lot/batch number has been requested.
Information has been received from a physician concerning a 21 year old female with sulfonamide allergy who on 18-JAN-2008 was vaccinated intramuscularly, 0.5 ml, a first dose of GARDASIL (Lot # 655327/1287U).  Concomitant therapy included APRI.  On 19-JAN-2008 the patient experienced shortness of breath and pruritus.  She also experienced redness and irritation at the site of injection.  The patient was examined at Emergency Room but was not admitted.  The patient recovered and all symptoms had resolved.  It was reported on 06-APR-2009 that the patient was seen by the physician and the patient reported the event to the physician.  Additional information has been requested.
right knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (right knee pain) 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) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (right knee pain). At the time of the report, ARTHRALGIA (right knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
24 hours after presentation patient had developed high fevers 104.  He presented to the emergency department with symptoms of severe sepsis and respiratory distress.  He was intubated, suffered cardiac arrest with return of spontaneous circulation, requiring vasopressors.
Syncope vs convulsions. Pt appeared to have syncopal episode s/p administration of HPV vaccine. I was not present, *see RN note. Spoke with mother following incident and she states observed convulsions (?) and gurgling sound in throat/gasping for air, pt was laid back onto exam table, no falls. Sister experienced a similar episode following administration of the same vaccine prior to this appt. Pt still with nausea, dizziness, pale clammy skin, pt resting in exam room until recovered. Much improved following vomiting episode. Sent home with mother and sister stable.
C/O BURNING AND REDNESS LEFT THIGH, GOT IMMUNIZATIONS THURS 9-10-09.FRIDAY CHILD LIMPING AND LEG LOOKED PURPLE AND VERY WARM. IMPROVED BY TIME SEEN SAT, ERYTHEMATOUS COVERING ANTERIOR PORTION OF THIGH. PT EXAMINED IN ER 9-12-09.
Right eye doesn't close all the way when blinking or closing symptoms started 2/6/21 also couldn't keep mouth closed shut tight to swish after brushing teeth same night.  Headache above right eye, right ear pain and right side neck pain all starting 2/6/21 morning.  Had televisit on 2/8/21 who advised me to be further checked out.  At the er they did an head ct without contrast which was normal did a neuro exam and determined I had bell's palsey.  Prescribed prednisone 20 mg tid x 7 days and valacyclovir 1 gm tid x 7 days.  They also advised to tape my eye shut when sleeping.  My eye hurts when I drive or focus on pc or tv so I had to miss 2 days of work thus far.
the area right by his arm pit, right by the front of his body is swollen and hurts like crazy; the area right by his arm pit, right by the front of his body is swollen and hurts like crazy; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0170, (Reporter stated that they could be 0's or O's, she did not know) Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 12May2021 at 14:00 (at the age of 17 years old) as first dose, single for COVID-19 immunisation. The patient has no medical history and no family medical history relevant to adverse effect. No prior vaccinations was received within 4 weeks. The patient's concomitant medications were not reported. On 13May2021 at 23:00, the patient experienced that on the side where the patient received the injection, which was his left side, the area right by his arm pit, right by the front of his body was swollen and hurt like crazy. The events did not require visit to Emergency Room or Physician Office. Outcome of all events was unknown. The reporter was asking if this is normal and if she should be concerned.   No follow-up attempts are needed. No further information is expected.
Complained of headache, nausea, and vomiting. Denied eating breakfast. Refused orange juice and doughnut
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 11:30 as dose 4 (booster), single (Lot number: GJ5342) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Mar2021 at 14:00 as dose 1, single (Lot number: ER8734), in left arm, on 20Apr2021 at 14:00 as dose 2, single (Lot number: ER8736), in left arm and on 26Nov2021 at 14:00 as dose 3 (booster), single (Lot number: 330268D), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "thyroiditis (positive antibodies)" (unspecified if ongoing); "asthma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cipro abx, reaction(s): "known allergies: Cipro Abx". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 28Aug2023 to 01Sep2023. Clinical course: This is patient's first time having Covid since getting 4 Vaccines. Severe nausea, abdominal pain, sinus congestion, and mucus. Fatigue. Patient contracted Covid from a family member who returned from (name) antigen positive for Covid.
Patient recieved HAV#2 on 2/3/09, went home and had a 3hr nap, mom woke patient and noticed coughing and wheezing, which continued through the night. The next morning patient had increased work to breath and occasional cough. In office Dr noted labored respirations w/few retractions and heard wheezing on right, albuterol administered via nebulizer and was clear to auscultate except for occasional crackle. Dr. then sent patient to obtain chest Xray to rule out foreign body ingestion. Patient returned from Xray w/grunting respirations and wheezes throughout, after 2nd treatment given patient was clear to auscultate. Dr then admitted patient to pediatrics to administer fluids, solumedrol, frequent neb treatments and possible O2 therapy. Patient was discharged the following day.  2/18/09 Received hospital medical records which consisted only of CXR & lab.  Medical records states only records available. CXR 0f 2/4/09 abnormal w/marked gastric distention.  HIV test of 8/4/08 neg.
First pregnancy (around 5 weeks pregnant),two day long migraine and fever that was resistant to Tylenol. Was eventually prescribed a nausea medicine to sleep it off.
MODERNA COVID #3 VACCINE GIVEN 11/5/21, LOT #047C21A; pt lives in a residential facility; pt had a positive COVID test on 1/17/22 at the facility; pt's condition worsened; DNR; pt passed away in the residential facility
pt recvd vax; about few  seconds after vax, pt fainted;placed on supine position; pallor;bradycardic; adrenaline given;O2 by mask;recovered soon after;observed for 1/2 hr; no ther problems; vagal response;
no adverse event; patient received Pneumonia Booster in 2017 and 2018; This spontaneous report has been received from a lawyer via a Plaintiff Fact Sheet and refers to an approximately 75-year-old male patient. In 2017 and 2018 the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacture unknown) (reported as Pneumonia Booster vaccine) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The lawyer reported that there was no adverse reaction or side effect experienced.  This is one split report from a case in litigation (case# US-009507513-1902USA008606)
This case was reported by a physician via call center representative and described the occurrence of serum sickness in a 7-year-old male patient who received HAVRIX. The patient's past medical history included leg pain (the day before getting the vaccine). Concurrent medical conditions included seasonal allergy (the child is generally healthy). On 27th February 2018, the patient received the 1st dose of HAVRIX .5 ml. On 5th March 2018, 6 days after receiving HARVIX, the patient experienced rash. On 7th March 2018, the patient experienced face edema, edema hands, pruritus and urticaria. In March 2018, the patient experienced serum sickness. The patient experienced serum sickness. The patient was treated with ZYRTEC and BENADRYL. On an unknown date, the outcome of the serum sickness, face edema, edema hands, pruritus, rash and urticaria were not recovered/not resolved. The reporter considered the serum sickness, face edema, edema hands, pruritus, rash and urticaria to be possibly related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. At 16:22, the patient received full dose of HAVRIX in left deltoid. Six days after receiving HAVRIX, the patient experienced serum sickness. On 7th March 2018, 8 days after receiving HAVRIX, the patient developed a rash on his thigh that was spreading and had some edema in his face and hands. Also had pruritus and urticaria. He was playful at the time of reporting. The patient was not taking treatment.
Fatigue; Flu-like symptoms; This is a spontaneous report from a contactable physician, the patient. A 46-year-old-male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 31Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID -19 immunisation. Medical history included hypocholesteremia. The patient was unknown about the allergies to medications, food, or other products. Concomitant medication included atorvastatin calcium (LIPITOR) of 10mg and clomiphene (MANUFACTURER UNKNOWN) of 50mg; both for unknown indications from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 00:00, the patient experienced fatigue and flu-like symptoms. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measure was taken as a result of fatigue and flu-like symptoms and included treatment with ADVIL of 400mg. The clinical outcomes of the events fatigue and flu-like symptoms were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
It is my strong belief that the covid-19 vaccine has interfered with my menstrual cycle. My period is very regular and comes at the same time every single month with very little cramping, light bleeding, and barely any other side effects. However, since receiving my vaccine in August 2021, my menstrual cycle has been completely off. In September 2021, my period was non existent with just light spotting very randomly throughout the month (and there was no chance of pregnancy). Now as of October 24, 2021, I am experiencing the heaviest and most painful period that I have ever experienced. On the first day of my period, I went through 3 very thick feminine pads within 2-3 hours and have experienced cramping that has actually taken my breath away.  The cramping has persisted throughout the week of 10/24-present (10/31) while only today I am beginning to feel the side effects lessen. I have never had such a painful and heavy period as I have experienced this month and I know my body well enough to know that this is not typical at all. There has been absolutely nothing else that has changed in my daily life that would have caused this change in my menstrual cycle and the changes began back when I received my 2nd dose of the Pfizer vaccine in August 2021.
Everywhere where I've ever had pain, wrist, ankle swelling, back, neck aches and feels very arthritic.  I have never had every area do that.  My ankle which has given me problems when I twisted it months ago hasn't been a problem at all and when I woke up on the 11th it was swollen and tender.  I did no strenuous work to cause it.  My right hand and wrist is very weak.  My back aches along with my neck.  If symptoms persist I will see my primary care doctor this coming week.
Pt with vasovagal response after vaccination. Started feeling ?hot? and like was going to pass out. Pt was seated and became extremely diaphoretic and had brief (<3 seconds) episode of syncope. Applied ice pack to neck and coached Pt on slow breathing. Vital signs remained stable throughout. Extended observation time from 15 to 30 mins and Pt was responding appropriately and ambulated to vehicle unassisted but accompanied by two colleagues.
arm is swelled; pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6205) as unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm is swelled"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in the arm".  Additional information: Patient's arm was swelled and really quite a bit in pain. Patient cannot lift it, and cannot really move it and just wanted to know if that is normal and how long it will last.  No follow-up attempts are possible. No further information is expected.
At first, immediately after the vaccination I felt super sore in my right arm and fatigued. Then after a few days, it went away. Now on 01/16/2021, I started getting a cough, a sore throat, a  fever, and extremely tired. Then the next day the symptoms got worse and now I had a stuffy nose, inner ear pain, nausea, muscle aches all over my body, dizzyness, and chills. This continued into Sunday and now Monday.
12 year-old boy received a daptacel vaccine, rather than the adacel that was indicated with no reported adverse event; 12 year-old boy received a daptacel vaccine, rather than the adacel that was indicated with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel], rather than the adacel that was indicated with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine for Immunisation.  On 11-Jul-2023, the patient received a dose of 0.5 ml (dose 6) once of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: C5969AD; strength: standard) via unknown route in intramuscularadministration site for Immunization.  On 11-Jul-2023, 12 year-old boy received daptacel vaccine, rather than the adacel that was indicated with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency: same day).  It was reported, "Caller is reaching out regarding a DAPTACEL vaccine that was given to a patient over the age of 7. She is asking for recommendation on how to proceed with the situation or what should be done."   Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vertigo, eye drooping, tenderness to head, pressure in head, inflammation of the head, neck and shoulders.  Has been to PCP x 3.  Scheduled for MRI 01/23/2021
patient got fever, red swollen arm at area of shot for at least 3 days, the area was extremly hot and had a big lump.
Muscle pain, fever, chills, headache, fatigue, lymph node swelling in armpit near injection site