chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Mar2021 at 16:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. 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. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and dicyclomine (dicycloverine) (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication and unknown if ongoing. On 14Mar2021 at 17:00, the patient experienced sore arm at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm at injection site was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Engerix-B pediatric administred to adult; Engerix-B pediatric administred to adult; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult male patient who received HBV (Engerix B pediatric) (batch number YM444, expiry date 22nd May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 µg and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were 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: 18-Nov-2022 Reporter's comment: The reporter transferred to medical information for further assistance. The reporter gave permission for follow-up from GlaxoSmithKline. Additional supportive information: The patient accidently received pediatric dose of Engerix-B, which led to accidental underdose and adult use of a child product.
Lab visit for immunizations (QUADRACEL and MMRV) given at 3:35pm by nurses. Patient with history of possible egg allergy as an infant so patient was advised to wait 30 minutes after injections to monitor and observe for any reactions. Within 5-10 minutes, patient began coughing and not feeling well. Became agitated and anxious, c/o abdominal pain and nausea with dry heaves. Patient also began to develop hive-like rash on his forehead, c/o itchiness and scratching at the site. Seen immediately by covering MD (PCP not in office). Patient noted to be wheezing and in distress (02 94%, HR 160, BP 92/60). EPIPEN Jr. given at 3:52pm along with 13 mL of ORAPRED and 10 mL of BENADRYL at 3:56. 911 and EMS notified. By the time EMS was ready to transport patient to the ER, patient was feeling much better, happy and active and was able to walk into ambulance unassisted.
Patient says that she lost vision in her left eye about 45 minutes to an hour after receiving her vaccinations. She was aslo extremely fatigued and went to lay down. She woke up the next morning, told a friend about the incident but did not seek any medical intervention.  She also told her friend she felt a little dizzy, was swaying , and staggering when she woke up but that resolved itself as the day progressed. Her vision loss had also resolved  itself the next morning.
Chills; Tiredness; Feverish; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th April 2019, the patient received the 1st dose of Shingrix. On 29th April 2019, less than a day after receiving Shingrix, the patient experienced chills, tiredness, fever and influenza-like symptoms. On an unknown date, the outcome of the chills, tiredness, fever and influenza-like symptoms were unknown.   It was unknown if the reporter considered the chills, tiredness, fever and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced chills and tiredness as well as feverish. The patient asked how long the side effects last. It was reported that the individual responses may vary, but the majority of solicited local adverse reactions and general adverse events seen with Shingrix in the two pivotal clinical trials had a median duration of 2 to 3 days. Solicited adverse reactions were collected for 7 days after each dose. Some patients may continue to experience reactions beyond 3 days. Unsolicited adverse events were collected for 30 days after each dose.
At the vaccination clinic where 70 vaccines were administered, this patient was administered the influenza vaccine after informed that we had administered it together with the pneumococcus vaccine, without informing us that she had already received the flu vaccine during the month of September 2023. According to CDC guidelines, only one dose should be administered per season and in this patient, it was administered a second time. The patient has had no adverse effects.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP7534), in left arm, on 06Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 09Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: TRUVADA, start date: Sep2019, stop date: 05Jun2022; BENICAR HCT taken for blood pressure abnormal, start date: 01Aug2012, stop date: 05Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jun2022, outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (03Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical courses: The patient had no known allergies.
Large hot, swollen, hard red area-3 inches in diameter-red disappeared and then returned headache, fever of 2 degrees above my normal dizziness, lethargic; stayed in bed almost a week; nauseous raised blood pressure 165/95. My primary care told me NOT to get the second dose of SHINGRIX due to the difficulty I had with the initial dose.
Fine rash on upper torso. Severe itching. Pt states that she tried Cortisone Cream to relieve the itching with no relief. Pt rash has improved, as of 9/1/04.
Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated via injection with the first dose of Gardasil, (lot number not reported).  Concomitant therapy included BOOSTRIX and MENACTRA.  Subsequently the patient passed out, was pale white, shaking and having convulsions after receiving the first dose of Gardasil.  The physician reported that the patient did not have a seizure.  The physician also reported that it was unknown whether or not the patient would receive the second and third doses of Gardasil.  Subsequently, the patient recovered from passing out, being pale white, shaking and having convulsions.  Unspecified medical attention was sought.  Upon medical review it was determined that convulsions was considered an other important medical event.  Additional information has been requested.
Swelling at injection site and redness within 24 hours. Area of redness increased after 36 hours and after 48 hours has not improved. Hot to the touch, painful swelling. Looks similar to an allergic reaction to a bee sting. Cold compress, ibuprofen, fluids, and benadryl administered regularly.
Numbness on the entire face after the first shot; Pain in  left arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on the entire face after the first shot), PAIN IN EXTREMITY (Pain in  left arm) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy (Mild Neuropathy in feet,) and Vitamin deficiency (B).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness on the entire face after the first shot), PAIN IN EXTREMITY (Pain in  left arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 14-Jan-2021, HYPOAESTHESIA (Numbness on the entire face after the first shot) had resolved. On 21-Jan-2021, PAIN IN EXTREMITY (Pain in  left arm) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not reported.  Patient was not sure about Benadryl.   This case was linked to MOD-2021-289712, MOD-2021-290616 (Patient Link).
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from 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 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19; patient was given PAXLOVID.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient was admitted to the ER on 1/31/2021 with erythema all over her body.  Patient reported that it itched intensely.  Provider reported that patient took diphenhydramine at home, and then administered Methylprednisolone 80 mg/ 2 mL at the ER visit.
Fever, bodyaches, general malaise, conjunctivitis, postauricular lymphadenopathy for three days. Rash beginning on 3/24/10 or late the night before.  Macular/maculopapular rash beginning around ears and on face, then spreading to rest of body. Fever has resolved by the time this report was filled out.
This patient rec'd his first HPV on 8/9/2013 and his second on 2/11/2014.  On both injections, he developed severe neck pain on the same side of his body that he rec'd his injections.
(03/16/2021)Pain in right kidney and went to the ER. Two stints for each kidney for kidney stones.(03/19/2021) Later the stones were removed by laser. (03/20/2021)Developed sepsis after and was given intravenous antibiotics. About 9 days treatment for that and successfully recovered from it.
Patient had dizziness episodes the evening following vaccination and presented to the clinic due to dizziness. She was found to have atrial fibrillation with RVR and was subsequently evaluated in the emergency department (discharged home after ED evaluation)
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 16-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# M044718 and expiration date 07-MAY-2018) for prophylaxis (Incorrect product storage). The Merck Sterile Diluent was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709; US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001959.
9 year old male patient received the Fluzone High Dose with no AE; 9 year old male patient received the Fluzone High Dose with no AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA311567 (same reporter).  This case involves a 9 year old male patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot no: UJ288AA, Expiry date: 02-Jun-2020) via intramuscular route in the left deltoid on 06-Nov-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of reporting, the patient had no adverse event.  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 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.
Severe headache 2 days, tinnitus continuing, nausea 3 days. diarrhea 3rd day, chills 2 days, fever 2 days, Weak, fatigue 3 days.
Inability to raise arm, tingling to fingers, constant pain.  Injection was given very high in joint area. Have taken ibuprofen and iced and exercised. Continued pain and immobility almost three weeks after injection.
Patient referred having persistent cough and slight shortness of breath that started the day after the immunization which slowly faded week and a half after the immunization.
left arm numbness; bulgining painful veins on hands and feet; tingling in arms; This is a spontaneous report received from a contactable reporter(s) (Physician).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "left arm numbness"; VASCULAR PAIN (non-serious), outcome "unknown", described as "bulgining painful veins on hands and feet"; PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in arms".  No follow-up attempts are possible. No further information is expected.
Drug dermatitis NOS on 2014-04-29, clinician comment: Pt also received amoxicillin at the same visit so may be amox reaction. Rash occurred on day 9 of antibox and 9 days after getting MMR vaccine.
This spontaneous report as received from a physician via a company representative refers to a 50-59 year old male patient (exact age unspecified). "A year ago", in approximately July 2012 the patient was vaccinated with PNEUMOVAX23 (lot # not reported) (strength and total daily dose not reported). On an unknown date the patient developed redness in his arm where he received the PNEUMOVAX23 vaccine. The physician believed it might have been cellulitis. The patient sought for medical attention by seeing the physician. Unspecified treatment was given. The outcome was reported as recovered. Additional information has been requested.
Vac area hot to touch, burning. Worse at night the day of shot. Bad pain at 1 or 2 pm daily . Took Ibup 800 mg take for another condition. Manager gave SOLARCAINE gel 1%, Ibu 200 #20, water.
Site hard, hot and red hives appearing to run across  arm t armpit. Still a little red today and warm, but better. Took a bendryl and iced site.
Bright red rash at site of injection and spreading down upper arm, across shoulder, across top of neck to right shoulder and other areas of my back.  Dr. recommended that I see a Dermatologist.  Dr. prescribed a cortisone cream 2/3 times a day.  By the second day I had also developed individual "spots" on my hands and up each of my arms.  As of this date, October 18th, the rash on my back is almost gone.  However the spots on my hands and arms have not improved.  I have continued to break out up to this date.  I have been using the cream on these spots too.
I had the COVID injection in the AM of 03/27/2021, later that day I came down with a Temperature of 102.2 lasting 3 days, I had severe chills & sweats, Severe body aches, nausea and vomiting, I have never been this sick in my life!  This lasted a week.  I did not have medical insurance at the time, otherwise I would of have gone to the emergency Dept for treatment.  I will not take the second COVID injection, I do not want go this hell again.
affect blood tests / high monocyte absolute reading; This case was reported by a consumer via interactive digital media and described the occurrence of monocyte count increased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced monocyte count increased. On an unknown date, the outcome of the monocyte count increased was unknown.   It was unknown if the reporter considered the monocyte count increased to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced affect blood tests and result in high monocyte absolute reading. The patient asked could Shingrix affect blood tests and result in high monocyte absolute reading. The follow-up would not possible, as no contact details were available.
I have been having general aches and pains in my joints and bones. I do have some arthritis but this is totally different because I usually don't have pain like this. I started feeling odd a couple of days ago. Every time I get up from sitting my back would get to hurting. When I sit back down it would stop, but then I would still feel the aches. I do have bone spurs and so those would hurt too. When I had got home that day I just ended up going to bed because I was hurting so much. When I got up I took my steroid for my bone spurs. Since taking the steroid I have been feeling better. It has helped with some of the pain in my joints and bones. When I went to bed that first night I couldn't even move because it hurt. It is hard to rest or move after getting up. I am feeling better now than what I did on the original day.
Had manageable bodyaches but following day triggered his Migraine headaches which is what patient came in for primarily. Symptoms managed with fluids, tylenol, reglan with improvement and was subsequently discharged from the ED.
no adverse effect; the patient was inadvertently administered a dose ofPROQUAD, on 9/24/2019, that had been improperly stored; This spontaneous report as received from a vaccine coordinator refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 24-SEP-2019, the patient was inadvertently vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S003326, expiration date 02-AUG-2020), (lot # R030805, expiration date 22-APR-2020) (dose and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent. There was no adverse effect reported. The administered vaccines experienced the temperature excursion of 27.1 degrees Fahrenheit for 40 minutes. There was no previous excursion. The data logger was involved.
tested positive for Covid (home test) - twice; bad cold; This spontaneous case was reported by a nurse and describes the occurrence of NASOPHARYNGITIS (bad cold) and COVID-19 (tested positive for Covid (home test) - twice) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 045A21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2022, the patient experienced NASOPHARYNGITIS (bad cold). On 05-Oct-2022, the patient experienced COVID-19 (tested positive for Covid (home test) - twice). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (bad cold) and COVID-19 (tested positive for Covid (home test) - twice) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies to medications, food and other products. Patient had no medical history relating to adverse event. Patient had no acute and chronic illnesses at the time of vaccination. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was not provided. No concomitant medications were reported. Patient called HCP for consultation. It was stated that patient tested positive (twice) with a home COVID test. The patient had a bad cold yesterday (04Oct2022) and was feeling worse today (05Oct2022).
Sudden onset of chills, fever, shaking, no energy. Lasting 12 plus hours.
11/11 12m patient experienced headache, earache, fever did not feel well for the next 12 days. Sought medical care 11/23 dr suggested vaccine may have caused symptoms especially in light of history of multiple scelorsis. Having mild headaches only.