chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (was given a 0.5 ml dose as booster dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 024M20A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 30-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (was given a 0.5 ml dose as booster dose). On 30-Nov-2021, ACCIDENTAL OVERDOSE (was given a 0.5 ml dose as booster dose) had resolved. Concomitant medication included Diet medicine for an unknown indication.No treatment information was provided by the reporter.Patient was given a 0.5 ml dose as booster dose. Patient was not immunocompromised.Nurse who gave patient booster dose said that it was optional to get full or half dose and let patient choose. Patient was suspicious about this but asked for full dose. Patient stated repeatedly that was no  immunocompromised.
About 5 hrs post vaccine, significant muscle soreness began-has persisted for 23 days, pain worse at night, taking OTC TYLENOL to help with pain.
hyperglycemic event occurring 2 days post vaccination, pt with DM but no previous admit for hyperglycemia, admits to high carb meal, eval by EC and discharged home
Headache, nausea, fever, fatigue, neck stiffness, eye soreness, racing heart, dry mouth, sore arm Tylenol
Kidney Stone; Pain; Terrible Headaches; A spontaneous report was received from consumer concerning 66 year old, female  patient who developed kidney stone/nephrolithiasis, terrible headaches/headache, pain.   The patient's medical history included a procedure for colonoscopy. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 9 Mar 2021 intramuscularly at right arm for prophylaxis of COVID-19 infection.   On 9 Mar 2021 the patient experienced terrible headaches and pain; therefore visited emergency department. Upon arrival to ED, the patient was diagnosed with kidney stone and discharged the same day with Ondansetron and Ibuprofen. The headaches and pain did not subside, so the patient visited ED again on 10 Mar 2021 and was once again discharged after few hours. The patient visited the ED 3rd time on 12 Mar 2021 and was given IV fluids and Ibuprofen. She was discharged on 13 Mar 2021. The medically significant event is kidney stone. Treatment for the event included IV fluids, Ondansetron, and Ibuprofen.  Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events kidney stone, terrible headaches, and pain were considered Resolved.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and the administration of mRNA-1273 vaccine and based on the known safety profile, a causal association cannot be excluded for the event of fever.  Kidney stone and pain are assessed as unlikely based on the known etiology of the disease.
Patient received vaccine in RD.  Patient states swelling above right shoulder area extending to neck and under jaw.  Experienced pain under right ear and facial numbness.  States general malaise. States muscle and joint pain around right side of neck and shoulder.
2 breast cysts on the right breast.; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200009733 (Pfizer), US-PFIZER INC-202200004220 (Pfizer).  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single and administered in arm right, administration date 21Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST CYST (non-serious) with onset 07Jul2021, outcome "not recovered", described as "2 breast cysts on the right breast.". The event "2 breast cysts on the right breast." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of breast cyst.  Additional Information: Additional information: After receiving my two vaccine doses, I developed a breast cyst which was very concerning for me in the beginning given that it was on the same side that I received both doses of vaccines. Patient stated that he did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Patient reported that he did not receive any other medications received within 2 weeks prior to the vaccination and Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Four months after I got the second dose of the vaccine, I started to experience extreme shortness of breath. I had severe left leg pain and dizziness. I was very weak and I could barely walk 20 feet. I went to the ER and they tested for Blood Clots. The tests were negative. They suspected pneumonia and I was so short of breath and weak that I collapsed. I was taken to the ER and no clots were found again. I was prescribed some antibiotics. All COVID-19 test were negative during that time. I never recovered. I still have Tachycardia and it is 150-160 with very little activity. I still have the left leg pain in my calf that comes and goes. Some days are better that others. I get pins and needles in my feet. It has been seven months and I have not recovered so far. I am currently on disability and I am unable to work. I have been diagnosed with Paroxysmal Tachycardia. The tilt table showed that my blood pressure dropped and my heart rate increased when I was vertical.
The second shot made me very sick as well-Down for 6 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 2, single (Lot number: EP7534) at the age of 66 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto" (ongoing). Concomitant medication(s) included: NP THYROID taken for autoimmune thyroiditis (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Administration time: 10:00 AM, Route of administration: Intramuscular, Anatomical location: Right arm, Lot number: EN6198), administration date: 03Mar2021, when the patient was 66-year-old, for COVID-19 immunization. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "The second shot made me very sick as well-Down for 6 days". The event "the second shot made me very sick as well-down for 6 days" required emergency room visit.  Additional information: The patient did not received any other vaccine within the 4 weeks prior to vaccination. The reporter notified that there are too many tests to list for lab data. The patient is a very healthy Individual very active and did not get COVID. Still work, had business 38 years, care for 3 workers, eat organic. Have many witnesses who can testify to the fact that was basically paralysed within days of the booster. The second shot made the patient very sick as well-Down for 6 days. The patient had 2 emergency room visits and no one could figure out why the patient was in such state. The patient was under the care of 2 osteopaths, 2 Neurologists, 1 Rheumatologist and now 1 Cardiologist.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346544 same patient/drug/event, different dose;US-PFIZER INC-PV202200116558 same reporter/drug, different events/patient;
Lymph nodes under left arm swelled 36 hours after inj-"pain and lumped"-fever low grade. Trouble concentration-supraclavicle nodes swollen.
3RD DOSE PFIZER COVID VACCINE GIVEN 11/26/21, LOT #FJ1620 8/9/22 Pt to hospital and had a positive COVID test; hyponatremia; CHF; underwent paracentesis; pneumonia; given ABX; developed Atrial Fibrillation with RVR; tx with medication; pt's condition deteriorated; DNR; 8/19/22 pt transfered to another Hospital; condition continued to worsen; hepatorenal syndrome; transitioned to comfort measures and pt passed away in the hospital
Covid arm; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and VACCINATION SITE REACTION (Covid arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (Itchiness). On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm). On 25-Jan-2021, PRURITUS (Itchiness) had resolved. At the time of the report, VACCINATION SITE REACTION (Covid arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Employee calling to report a reaction after receiving a COVID-19 vaccine.    Vaccine Name -  Pfizer  Vaccine Lot # - EJ 1685  Vaccine Date and time  - ?   12/18/2020 @ 9:40am  Is this your first or second dose?  First  Date and time of symptom onset - ? 12/19/2020 @ 12am  Symptoms - ?  Headache, nausea, fatigue, runny nose, no fever, cough, rash on left eye, itching  Last day of work and shift - ?  Friday 12/18/2020  Home remedies? -    Claritin 5 mg 12/20/2020 @ 8:30pm, Warm steamy shower this morning 12/21/2020  Any improvement? -    Patient noted symptoms are better and gone except for on & off headache.  Recommendation?  To continue to monitor symptoms & take ibuprofen or Tylenol when headache comes back. Call back if experienced any other symptoms. She's not back to work til 12/23/2020. advice to call work if she's unable to work and notify employee health for missed work. If 4 or more days, to send doctor's note for back to work clearance.  Employee voiced understanding Employee of information ? yes  Employee voiced any concerns ? no  Employee?s questions answered to employee?s satisfaction - yes
Fever up to 104, chills, body aches. Up and down with ibuprofen. Started 10 hours after dose went up and down controlled or uncontrolled for 36 hours after it started. Lymph node under arm of injection is still the time of a tennis ball now 72 hour after and still very painful. Today a rash similar to hives began on the arm of injection. Under the arm and near the wrist.
I had three total vaccinations series shots for Hep C. The vaccinations were Hep A & B series shots that were given to me in May 18 of 2010, August 9 of 2010 and November 18 of 2010. I was also given a flu shot between Sept/Oct of 2010 there is no record of this in my medical records. Also I began Hep C chemo treatment (Interferon injections weekly) beginning on July 3, 2010 - May 27, 2011. I became very ill with so many symptoms beginning in October of 2010, major was breathing and very weak. I also came down with the Guillain Barre Syndrome beginning as early in late April of 2011. I was dismissed of my symptoms at my ER Hospital. As they could see that I was in severe pain and could not walk. This was on May 26, 2011 and June 1, 2011. On June 6, 2011 my husband made a complete vocal fit advising ER staff that if they refuse admitting me they might as well have him arrested. They admitted me. I was completely paralyzed/quadriplegic on June 6, 2011.  I was is my local hospital from June 6 - June 17, 2011. Then I was transferred to a higher level of medical needs and medicine beginning on June 17, 2011 - June 27, 2011. I was then transferred to a Rehab Hospital for 3 long gruesome months of therapy. I was there from June 27, 2011 - September 27, 2011. I still have not recovered as I am still dependent on my wheelchair and walker and still in pain. I look forward to hearing for you.
Myalgia, UrticariaPruritus, NauseaVomiting,  Palpitations, Site pain, redness, swelling, Fatigue, chills Narrative:
2-3 days after receiving the vaccine, patient had a 3x3 in red swollen area which appeared around the shot. It was sore, hurt, pain score 7 (scale 1-10). On 10/23, the area was still visibly red and still could see the 3x3 in circle.
Moderna COVID-19 Vaccine EUA Fever for ~12 hours Chills Fatigue Muscle pain Diarrhea
Interchanged JNJ & Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchanged JNJ & Moderna Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchanged JNJ & Moderna Vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchanged JNJ & Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Pt recvd Engerix-B 15JUL91, 19AUG91 & 25JAN92 & 31MAR92 titer levels revealed pt had not seroconverted;
Progressive lightheadedness, weakness, and activity intolerance over the past 2 months following COVID-19 vaccination (10/25/22) and subsequent COVID infection.  The patient describes episodes of fatigability during normal activities of daily living.  Beginning on 1/21/23, the patient presented to the ED with chills, generalized weakness, diaphoresis and chest tightness.  New accelerated junctional rhythm/intermittent Mobitz II cardiac rhythm noted, including 2:1 AV conduction with exertion.
Electrical shots on right leg, right arm, upper back, then on my right side with head, nausea, headaches went to left side of the head and still with headache on 02/03/2021
Expired dose administered to patient/multiple patients received expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/multiple patients received expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/multiple patients received expired vaccine). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient/multiple patients received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient experienced no symptoms.  Reporter declined to share concomitant medication.   No treatment information was provided  It was reported that patient's first 2 doses were Pfizer.   HCP said multiple other patients from the clinic also received this expired vaccine.    Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up information received on 16 Nov 2021 includes patient gender
Strange feeling of weakness all of the sudden; A bit nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ASTHENIA (Strange feeling of weakness all of the sudden) and NAUSEA (A bit nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant Medical history Reported.  Concomitant products included INSULIN and VITAMINS NOS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 01-Mar-2021, the patient experienced ASTHENIA (Strange feeling of weakness all of the sudden) and NAUSEA (A bit nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 27-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), ASTHENIA (Strange feeling of weakness all of the sudden) and NAUSEA (A bit nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Nurse gave a 6 month old the Kinrix Vaccination; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 25ZH4) for prophylaxis.   On 18-JUL-2023, the patient received the 1st dose of Kinrix (intramuscular, left thigh) .5 ml. On 18-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Nurse gave a 6 month old the Kinrix Vaccination). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-Jul-2023 The health care professional (HCP) called to report that a nurse gave a Kinrix vaccination. The HCP had not heard of any effects from receiving the vaccination from the child parents.  HCP to followed up today with the parents of the child. The Vaccine Administration Facility was the same as primary reporter. The 6 month old child received Kinrix by a nurse, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Patient began having severe headaches within 24 hours of second dose of Moderna vaccine. The following day patient became light headed and dizzy, unable to stand up straight with blinding headaches. Called the clinic where she received the vaccine and told to relax as these were temporary side effects and that is how she knows it's working. Headaches did not subside, patient died 2 and a half months after second dose of Moderna vaccine that was administered at the Hospital/clinic
ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. On an unknown date, after receiving the vaccine, the patient experienced ringing in ears that would not go away. The adverse event result in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported event. The clinical outcome of the event ringing in ears was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional.   A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 30-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
12 hours from injection fatigue started. 14 hours past and chills and sweats started (highest measured temp 99.4F orally). Body aches occurred at 16 hours. Body aches and sweats and chills continued until hour 36. At hour 33 awoke from sleep with nausea but did not have emesis. At 48 hours all symptoms basically resolved.
Information has been received from a nurse practitioner referring to 4 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 7lb 5oz. Concomitant therapies included KINRIX and VARIVAX. On 02-MAY-2016 at 10:36, the patient was vaccinated with M-M-R II lot # L026553 dose 2, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd flu vax 9NOV93 & had pain in lt arm when lifted the arm; pt's husband reported arm pain still persists; pt's arm was x-rayed;
Information has been received from a dentist (D.M.D.) concerning a 3 year old male patient, a twin, who was autistic and whose mother was vaccinated with Rhogham during pregnancy. On an unspecified date, the patient was vaccinated with a dose of MMR (lot number unknown). The doctor reported that the patient was diagnosed autistic at birth. However, following MMR vaccination things became worse. Unspecified medical attention was sought. Diagnostic studies were performed and results were high level mercury count. It was also reported that the patient was involved in a study (not specified). The doctor reported Rhogam use to have mercury in it. Upon internal review, autistic was determined to be an other important medical event (OMIC). Additional information has been requested. The dentist reported the patient's twin brother had a similar experience following vaccination with MMR.
On February 26,(eleven days after the second shot),  I felt tingling and numbing in both hands. On February 27, I had pain and swelling in both hands and arms from the elbows to the fingertips. On February 28th, I had severe pain, stiffness, and swelling in both hands and arms from the elbows to the fingertips. I called my primary care physician who told me to go the the ER at the hospital. I was treated in the hospital by doctor and given prescriptions for prednisone, pain medication, and nausea. Doctor said that the second shot could have triggered my symptoms. I was referred to rheumatology provider. I saw a doctor on March 10th. The pain was gone at the time of my appointment, but it returned on March 13th.