chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 07-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 years old male patient who experienced weren't able to administer the fifth Dtap because of his age, while he received vaccines ADACEL and DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation; and IPOL for Immunisation. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. On an unknown date, the patient did not received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication error due to Missed dose. (Other relevant tests included No lab test). Final diagnosis was weren't able to administer the fifth Dtap because of his age. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for weren't able to administer the fifth Dtap because of his age. 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.
snatching feelings when trying to raise arm, can't raise arm over my head/ it's a funny snacking feeling while moving; can't sleep on shoulder, have to sleep face down on pillow/ can't lift arm up over head or sleep, in a certain position; something about the muscle; it hurt and it hurt; right arm sore/  it's still sore; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (snatching feelings when trying to raise arm, can't raise arm over my head/ it's a funny snacking feeling while moving), MUSCULOSKELETAL DISCOMFORT (can't sleep on shoulder, have to sleep face down on pillow/ can't lift arm up over head or sleep, in a certain position), MUSCLE DISCOMFORT (something about the muscle), PAIN (it hurt and it hurt) and MYALGIA (right arm sore/  it's still sore) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 019B21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL, PRAVASTATIN and GABAPENTIN for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced LIMB DISCOMFORT (snatching feelings when trying to raise arm, can't raise arm over my head/ it's a funny snacking feeling while moving), MUSCULOSKELETAL DISCOMFORT (can't sleep on shoulder, have to sleep face down on pillow/ can't lift arm up over head or sleep, in a certain position), MUSCLE DISCOMFORT (something about the muscle), PAIN (it hurt and it hurt) and MYALGIA (right arm sore/  it's still sore). At the time of the report, LIMB DISCOMFORT (snatching feelings when trying to raise arm, can't raise arm over my head/ it's a funny snacking feeling while moving), MUSCULOSKELETAL DISCOMFORT (can't sleep on shoulder, have to sleep face down on pillow/ can't lift arm up over head or sleep, in a certain position), MUSCLE DISCOMFORT (something about the muscle), PAIN (it hurt and it hurt) and MYALGIA (right arm sore/  it's still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 contains non- significant informations.
He started having a cough, headache, fatigue. When he started having respiratory issues, I called his PCP.  He put him on PAXLOVID immediately. He had traveled with his group the week prior to his testing positive for COVID-19. He does have migraines and I was not sure if he was experiencing the migraines from the stress of all the excitement or others coming down with COVID-19. After starting the PAXLOVID his symptoms lessened. He had to stay quarantined until 09/25/2022.
COAGULOPATHY, UNSPECIFIED TYPE TRANSIENT CEREBRAL ISCHEMIA
inadvertantly administered a dose of Proquad instead of MMRII; no adverse effect; This spontaneous report was received from a nurse regarding a 16-year-old patient gender was not reported. The patient's medical history, concurrent condition and concomitant medications were not reported. The nurse described that two siblings, both sixteen years old, were inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), therapy type rha, lot # S002496 and expiry date 23-JUL-2020, (strength, dose, route were not reported) for prophylaxis, instead of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (wrong product administered). No adverse effects reported.   This is one of several reports received from the same reporter.
administering act-hib to a patient but the diluent portion of the act-hib was expired with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who had received hib (prp/t) vaccine [Act-Hib] but the diluent portion of the Act-Hib was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, the patient had received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection total (Lot # UJ575AA Expiration Date (Product): 07-OCT-2022 Lot # UJ575AA Expiration Date (Diluent): 20-SEP-2022) (dose, strength unknown) via unknown route in unknown administration site for Immunization but the diluent portion of the act-hib was expired with no reported adverse event (expired product administered) (latency same day).  Action: not applicable.  Outcome: Unknown   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.
Itch on injection site of left arm at noon of 8th day after vaccination. On morning of 9th day, still itchy and redness appeared about 3 inches long. At 3:30pm, still itchy and redness spread about 1 foot upward toward shoulder. Called Dr. who advised I take Benadryl tablet and report to VAERS.
Patient passed out a few minutes after her vaccine.  "Patient hard to wake with verbal and mild shaking.  Provider applied ice packs to chest and face.  Patient came became more verbal and was able to speak and rink water.  Patient was observed longer by provider.   During this time the patient reported her tongue was swelling and throat felt funny.  Provider ordered we administered Diphenhydramine 25 mg IM.  EMS was called and patient was transported to area hospital.
21APR93 pt recvd vax & later became cool, clammy, stiff & was shaking & appeared like was going to faint;
This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 12:00 at single dose on right arm for COVID-19 immunisation. Medical history included mild osteoarthritis. Concomitant medication included vitamin D, meloxicam and multivitamin. The patient experienced violent vomiting 24 hours after injection lasting 5 hours with fever chills headache. Followed by weakness and headache. Events onset at 15Jan2021 15:00. No treatment was received for all events. Outcome of the events was resolving. This case was reported as non-serious.  Information on the lot/batch number has been requested.
Vaccines given on 07/30/2020, Patient states his reaction began on 08/10/2020. He saw a rash on his right arm. It was red, raised bumpy and warm. He visited his physician who diagnosed this as shingles caused by Shingrix vaccine
Fever, chills, achy, vomiting, tiredness, headache, injection site pain.
Shot was given on 5/23/08 at 4pm. On Sunday late afternoon into early evening developed temperature of 101.3.  I gave children's Tylenol fever came down later that evening. I gave Motrin before bed, slept thru the night no problems.  Next morning I changed her diaper and found some spots in her private area, thought it was a diaper rash, applied Balmex.  Next diaper change I noticed the spots had spread to her torso and outer thighs.  I called the Dr's office and explained what I saw, she told me to wait 24 hours and if things didn't improve I was to call the pediatrician in the AM.  On Tues morning the spots were out of control, she had them 1000 times worse on her legs both sides, very raw and pus looking.  The arms started to have spots come out as well.  When I took her to the Dr's.  They said they have never seen such an out break due to a vaccine.  Then she suggested we see a dermatologist.  That's where he did a scraping of where the pox came out and diagnosed her with the Herpes Chicken Pox.  Her pediatrician then prescribed Acyclovir to try to control the out break.  She was on the med's for 7 days.
Sore arm- 5inches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm- 5inches) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm- 5inches). At the time of the report, PAIN IN EXTREMITY (Sore arm- 5inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
The next day after patient's 2nd dose he experienced the following symptoms: Headache and was treated with Tylenol and hot shower and recovered right away and last week from the week of January 7th - 11th he was experiencing sore throat, and another headache, it was consistent for 1 week and was tested negative for COVID-19. His doctor advised to gargle with salt water, Take Tylenol, and cough drops for the sore throat. As of today, he still has a little bit of headache, his throat is feeling better, and stomach is a bit upset and he took Tylenol before he went to school.
Client received CanSio COVID vaccine, no reaction. Previous vaccine not approved. Janssen given as an alternative on 09/15/21.
Had some bleeding; I am on my fourth time of break through bleeding since than; Doctor thought it might be pre menopause; Have break through bleeding every two an half weeks before after a period; It might be pre menopause; I thought may be just you know cramping or whatever before my periods; This is a spontaneous report from a non-contactable consumer(patient). A 35-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) and also received second dose of BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date in Apr2021 (Batch/Lot number was not reported) as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. About two and half weeks after her first vaccination, she had some bleeding and she thought may be just a cramping or whatever before her periods. Now she was on her fourth time of break through bleeding since then and it was, her doctor thought it might be pre menopause. She had both the doses and ever since than she had the break through bleeding every two to two an half weeks before after a period. So is that now a side effect of the Pfizer vaccination. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
The morning after my vaccine I woke up with a very sore upper arm. By 4pm that evening I had fatigue, chills, and body aches. I went to bed and slept much longer than normal and woke up the next morning without chills or body aches. My arm still hurt quite a bit and I started to have elbow joint and hip pain. The following day I started to have sciatica from my hip to my foot on my injection side, the left side. My elbow joint was sore for about 3-4 days after the injection. I also had some numbness right at the injection site the night of the vaccine.
Patient called pharmacy about 3 hours after getting vaccination to report injection site pain. she denied any allergy symptoms. over the counter tylenol was recommended and 4 hours after reporting pain, patient is doing better and pain has subsided.
very large bruising and she states it swelled to feel like a "golf ball" underneath her skin. She states she also experienced significant pain in the injection site for a couple days. She states she has since recovered.
After second shot of the Covid vaccine I started feeing some anxiety. This anxiety worsened over the following days to the point where it was affecting my sleep and ability to function during the day. I have had anxiety in the past and took medication for it (Clonazepam 0.5 mg and Paroxetine 10 mg per day), but was off the Clonazepam for approximately 8 months prior to getting the vaccine. The anxiety and panic got to a point where I needed to start taking the Clonazepam again at an even higher dose (1 mg) to manage the it, and the Paroxetine has been increased to 10 mg. Even with the medication the anxiety is somewhat present and my doctor is considering increasing the Clonazepam further.
approx 3-4hr p/vax pt noticed rash on upper arm in arm pits, chest, belly & sl rash on thighs;MD suggested DPH cream & do not receive any further hep B vax;
Dizzy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) and HEADACHE (Headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizzy) and HEADACHE (Headache) 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.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 58-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 06Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 07Dec2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 25Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 58 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 16Sep2022 as dose 5 (booster), single (Lot number: 1A57144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep Apnea" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Restless Leg Syndrome" (unspecified if ongoing). Concomitant medication(s) included: ROPINIROLE, start date: Apr2019. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive, notes: Now 13 days after first positive test, and 14 days after starting Paxlovid treatment; (Dec2022) Negative, notes: Took Paxlovid for 5 days. After treatment tested negative for Covid twice, 48 hours apart; (Dec2022) Negative, notes: Took Paxlovid for 5 days. After treatment tested negative for Covid twice, 48 hours apart; (Dec2022) Positive, notes: Tested positive for Covid 14 days after started Paxlovid treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies. Took Paxlovid for 5 days. After treatment tested negative for COVID twice, 48 hours apart. Now 13 days after first positive test, and 14 days after starting Paxlovid treatment, had nasal congestion and fatigue. Tested positive for COVID 14 days after started Paxlovid treatment.
Dizziness, Flushing Denies trouble breathing. Escorted to stretcher to lie down.  BP 157/88, HR 98 RA 100%.  Snack/juice given.  BP rechecked 130/84 and HR 86.
P/removing needle baby began to cry, w/in 5 sec, baby's eyes became fixed, stopped breathing mildly cyanotic complete body stiffened lasting approx 5 sec appeared to have sz picked baby up, shook baby & began breathing;
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with improperly stored dose of GARDASIL 9, lot # M041212 with expiration date 21-JUN-2019, for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccine had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA011005: US-009507513-1808USA011006: US-009507513-1808USA011007:  US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003:
Patient fainted in office post vaccine admin. Fell hitting her head, appeared to have seizure lasting just under one minute. Pt. recovered in less than 30 min.
This spontaneous report as received from a registered pharmacist refers to a female patient with no drug reactions or allergies who on 24-JUL-2012 was vaccinated SQ with a dose of ZOSTAVAX (lot # reported as 0562AE). No other co-suspects were reported. No concomitants were reported. The patient had been experiencing itching and induration around injection site after receiving ZOSTAVAX. No treatment was given for the adverse events. The patient spoke to pharmacist. At the time of the report, the patient had not recovered. Additional information is not expected.
Soreness at Injection site for about 30 hours. Slight Headache next day. Tiredness next day.
pulse racing; increase blood pressure; Dizzy; Weakness; Nausea; Fatigue; Headache; Chills; Fever; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), PAIN IN EXTREMITY (Arm pain), DIZZINESS (Dizzy) and ASTHENIA (Weakness) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PYREXIA (Fever) and CHILLS (Chills). On 31-Jan-2021, the patient experienced HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), DIZZINESS (Dizzy), ASTHENIA (Weakness), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (pulse racing), BLOOD PRESSURE INCREASED (increase blood pressure), PAIN IN EXTREMITY (Arm pain), DIZZINESS (Dizzy), ASTHENIA (Weakness), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (Fatigue), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Blood pressure medication. Treatment details included blood pressure medicine off and on normally.
Pt. states that after receiving the 3rd dose of Moderna 01/02/2021, started experiencing symptoms 01/03/2021 of fever, Lymphnoid swelling in the Left armpit area, joint pain, and chills. Symptoms have subsided with Lymphnoid swelling. No noted Primary visit/communications.
I experienced in 24 hours to 48 hours, i got muscle pain and joint pain. It then started to become pretty significant and got nauseous.  The injection site got quite red about the second day of the reaction. the muscle pain and joint pain was getting worse. I got to take NSAID's, Toradol injection 30mg IM which worked quite well.
Site: Bruising at Injection Site-Medium, Additional Details: Patient presented to pharmacy with a large bruise (about 4 inches diameter) on the left arm at injection site. Patient reported no initial discomfort at time of vaccination, but the following day noticed the bruising in addition to mild flu-like symptoms of body ache, headache, fatigue, and fever.