chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: hallucinating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 16Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing); "Lupus" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "epilepsy" (unspecified if ongoing). Concomitant medication(s) included: PREVNAR 20 taken for immunisation, on 16Oct2023 as unk, single; FLU VACCINE VII taken for immunisation, on 16Oct2023 as unk, single; VENLAFAXINE, start date: Jan2010, stop date: 17Oct2023; SUMATRIPTAN, start date: Jan2021, stop date: Oct2023; UBRELVY, start date: Jan2021, stop date: Oct2023; ALPRAZOLAM, start date: Jan2010, stop date: Oct2023; TIZANIDINE, start date: Jan2020, stop date: Oct2023; NORCO, start date: Jan2011, stop date: Oct2023; BUSPIRONE, start date: Jan2022, stop date: Oct2023; DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: Jan2010, stop date: Oct2023; ETHINYL ESTRADIOL, start date: Jan2009, stop date: Oct2023; HYDROXYZINE, start date: Sep2023, stop date: Oct2023; TREMFYA, start date: Jan2023, stop date: Oct2023; GABAPENTIN, start date: Jan2010, stop date: Oct2023; PREDNISONE, start date: Jan2011, stop date: Oct2023; TOPIRAMATE, start date: Jan2017, stop date: Oct2023; HYDROXYCHLOROQUINE, start date: Jan2011, stop date: Oct2023; EMGALITY [GALCANEZUMAB GNLM], start date: Jan2019, stop date: Oct2023; LEVETIRACETAM, start date: Jan2018, stop date: Oct2023. The following information was reported: HALLUCINATION (medically significant) with onset 16Oct2023 at 10:00, outcome "recovered", described as "hallucinating". Therapeutic measures were not taken as a result of hallucination. Clinical course was reported as follows: Several hours after receiving the vaccine patient began hallucinating. It lasted for several hours. The day she received the covid vaccine she also received flu shot and prevnar 20. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid administered from 06Oct2023 to 11Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown.), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "Sore arm", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Additional information: Patient was taking blood pressure medication. Patient always went with Pfizer for the Covid virus and never had any side effects. She just had a sore arm from the needle when being injected that goes away in 3 days, had this after all the injections. Patient stated It was right upper arm where she was given the needle.  It was the same like when she gets the flu shot where she has a sore arm for a few days, later clarified that the consumer was not administered the flu shot. Patient got the new vaccine on 16Oct2023, and it was the four-booster shot that she got from Pfizer.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300332493 same patient/event, different vaccine doses;
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old female patient received bnt162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: I take blood pressure medication. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "sore arm". The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300332493 same patient/event, different vaccine doses;
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 07Apr2022 as dose 3 (booster), single (Lot number: FK9895) at the age of 56 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 2, single (Lot number: 939904), in left arm and on 14Sep2022 as dose 4 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 10Mar2021 as dose 1, single (Lot number: 1805022), in left arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19 included Paxlovid from 07Oct2023 to 12Oct2023.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included nirmatrelvir, ritonavir (PAXLOVID) from 08Oct2023 to 12Oct2023. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 24Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfa antibiotics" (unspecified if ongoing), notes: known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LAMICTAL, start date: 01Jan2018, stop date: 17Oct2023; DULOXETINE, start date: 01Jan2021, stop date: 17Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid for Treatment of COVID-19.  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.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Disturbance in attention, Gait disturbance, Hypoaesthesia, Hypokinesia
Clinical narrative: Was diagnosed with early on set of Parkinson's disease; patient began to move slower; started to stumble; developing tremors; numbing on right side; Has difficulty with concentration; anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). No other comorbidities. Very healthy individual prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EJ1685), administration date: 30Dec2020, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset Feb2021, outcome "not recovered", described as "Has difficulty with concentration"; PARKINSON'S DISEASE (medically significant) with onset Feb2021, outcome "not recovered", described as "Was diagnosed with early on set of Parkinson's disease"; ANXIETY (non-serious) with onset Feb2021, outcome "not recovered"; TREMOR (non-serious) with onset Feb2021, outcome "not recovered", described as "developing tremors"; HYPOAESTHESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "numbing on right side"; HYPOKINESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "patient began to move slower"; GAIT DISTURBANCE (non-serious) with onset Feb2021, outcome "not recovered", described as "started to stumble". The events "was diagnosed with early on set of parkinson's disease", "patient began to move slower", "started to stumble", "developing tremors", "numbing on right side", "has difficulty with concentration" and "anxiety" required physician office visit. Facility type vaccine reported as hospital. In Feb2021 patient began to move slower, started to stumble started developing tremors and numbing on right side. Had difficulty with concentration and anxiety. Was diagnosed with early onset of Parkinson's disease. Therapeutic measures were taken as a result of parkinson's disease, hypokinesia, gait disturbance, tremor, hypoaesthesia, disturbance in attention, anxiety included prescribed Carbidopa/levodopa.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Parkinson's disease, Tremor
Clinical narrative: Was diagnosed with early on set of Parkinson's disease; patient began to move slower; started to stumble; developing tremors; numbing on right side; Has difficulty with concentration; anxiety; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), on 20Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing). No other comorbidities. Very healthy individual prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EJ1685), administration date: 30Dec2020, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: DISTURBANCE IN ATTENTION (non-serious) with onset Feb2021, outcome "not recovered", described as "Has difficulty with concentration"; PARKINSON'S DISEASE (medically significant) with onset Feb2021, outcome "not recovered", described as "Was diagnosed with early on set of Parkinson's disease"; ANXIETY (non-serious) with onset Feb2021, outcome "not recovered"; TREMOR (non-serious) with onset Feb2021, outcome "not recovered", described as "developing tremors"; HYPOAESTHESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "numbing on right side"; HYPOKINESIA (non-serious) with onset Feb2021, outcome "not recovered", described as "patient began to move slower"; GAIT DISTURBANCE (non-serious) with onset Feb2021, outcome "not recovered", described as "started to stumble". The events "was diagnosed with early on set of parkinson's disease", "patient began to move slower", "started to stumble", "developing tremors", "numbing on right side", "has difficulty with concentration" and "anxiety" required physician office visit. Facility type vaccine reported as hospital. In Feb2021 patient began to move slower, started to stumble started developing tremors and numbing on right side. Had difficulty with concentration and anxiety. Was diagnosed with early onset of Parkinson's disease. Therapeutic measures were taken as a result of parkinson's disease, hypokinesia, gait disturbance, tremor, hypoaesthesia, disturbance in attention, anxiety included prescribed Carbidopa/levodopa.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Got covid shot and my arm hurt later as common after vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 17Oct2023 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, start date: 14Oct2023, stop date: 14Oct2023; QULIPTA. Vaccination history included: Covid 19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid 19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for Covid-19 immunization; Covid 19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Oct2023 at 21:00, outcome "recovering", described as "Got covid shot and my arm hurt later as common after vaccines". Therapeutic measures were not taken as a result of pain in extremity. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 07Oct2023, outcome "unknown", described as "tested positive". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Caller calling in behalf of her mother who had the vaccine 7 days ago, she was exposed to a covid positive patient and 6 days ago she was tested positive. Caller is asking if when can her mother take the vaccine again.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Sarcoidosis
Clinical narrative: sarcoidosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation; Bnt162b2 nos (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 Immunisation. The following information was reported: SARCOIDOSIS (medically significant), outcome "unknown". Clinical course: A reporter said that they got their Pfizer vaccine at (withheld), but they only had the Moderna for this year. So her mother and she are trying to find out where they can get the Pfizer vaccine this year, and they both had several vaccines. She mentioned her mother is diabetic, and she had sarcoidosis. They had several vaccines, their cards full front and back, because they both had the extra boosters, they wanted to continue with Pfizer and did not want to get a different brand, and they wanted to stay consistent. Provided the website for vaccine appointments.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331501 Same reporter/product, different patient/event;
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no reactions, no symptoms.
Age: 19.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis
Clinical narrative: Patient describe he has sweats in his chest a couple of hours after getting the influenza vaccine. His BP was 138/82 and temperature was 98.1f degrees. We monitor symptoms and was asked to come back to use the cold compress. He elected to go home after 30 minutes.
Age: 24.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Hot flush, Hyperhidrosis, Night sweats, Pyrexia, Sleep disorder
Clinical narrative: I have had hot flashes and excessive night sweating for 4 consecutive nights since receiving the vaccine. I have had to change my clothes in the middle of the night 2x, once normally around 2 am and once around 5am. I have not had a fever since after Tuesday, which was 24 hours after I received the vaccine
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Acoustic stimulation tests, Deafness unilateral, Laboratory test, Tinnitus, Vestibular neuronitis
Clinical narrative: Five days after the vaccine shot, I suddenly lost hearing in my left hear and could only hear a very load buzzing sound. The next morning I went for an emergency visit to my ear doctor who did several tests, along with a hearing test. I had lost about 50% of my hearing in that ear. These test were done on 10/18/23.  The diagnosis was acoustic nerve inflammation, probably caused by a virus. Since I had not been sick all for many months, the only virus I was knowingly exposed to was the Covid vaccine. I was given 12 days of prednisone and omeprazole. So far after 2 days, some of hearing has returned, however, the buzzing is still prominent.
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Joint range of motion decreased, Peripheral swelling, Skin warm
Clinical narrative: ARM SWOLLEN AND HOT TO THE TOUCH ALSO NOW HAS LIMITED RANGE OF MOTION SINCE RECEIVING VACCINE NO LONGER ABLE TO LIFT ARM ABOVE SHOULDER LEVEL
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood test, Condition aggravated, Diabetic ketoacidosis, Intensive care
Clinical narrative: I received a Flu Vaccine 2 days later (10/2/2023). (Fluzone High Dose Quadrivalent). Within 1 hour, my blood sugar started to dramatically rise.  In 2 hrs, my blood sugar was over 600. I have been an insulin dependent diabetic for 48 years and my blood sugar only rose once to this level before - when I was initially diagnosed in 1975. My endocrinologist advised that I go to the Emergency Room as I was likely in the early stages of diabetic ketoacidosis. I was placed in the ICU for 3 days on an insulin drip and IV fluids.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: I received a Flu Vaccine 2 days later (10/2/2023). (Fluzone High Dose Quadrivalent). Within 1 hour, my blood sugar started to dramatically rise.  In 2 hrs, my blood sugar was over 600. I have been an insulin dependent diabetic for 48 years and my blood sugar only rose once to this level before - when I was initially diagnosed in 1975. My endocrinologist advised that I go to the Emergency Room as I was likely in the early stages of diabetic ketoacidosis. I was placed in the ICU for 3 days on an insulin drip and IV fluids.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Immobile
Clinical narrative: Moderate back pain for a few days, culminating in severe immobilizing back pain requiring treatment with hydrocodone.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 2.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, Vaccination error, Wrong product administered
Clinical narrative: Vaccine error. Provider inadvertently administered Influenza vaccine to patient. Pt received influenza vaccine in 08/2023 and not due to receive another flu shot until Fall of 2024. Pt's mother requested COVID-19 vaccination, not influenza. Appropriate COVID-19 vaccine administered per Mother's request after inadvertent influenza vaccination.
Age: 63.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling
Clinical narrative: Redness, Swelling and bruises at the injection site/ no fever
Age: 74.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Within an hour of arriving home, pt became fatigued and slept for a good portion of 3 days.
Age: 6.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Wrong vaccines administered.  Correct vaccine to be administered DTAP.
Age: 49.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extra dose administered, Product administration error, Wrong product administered
Clinical narrative: Patient received a second flu vaccine when he wanted a Covid booster vaccine. The first flu vaccine was administered 8/12/2023. The second flu vaccines was administered 10/15/2023. The patient was counseled and his primary care doctor was notified of the administration of an additional flu vaccines 2 months after the first. The patient received the Covid vaccines after discovery of the error.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Unknown
Age: 69.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Amnesia, Blood pressure increased
Clinical narrative: Patient has been suffering from temporary memory loss since the vaccines were given. She is having a hard time remembering if she's done things and can't recall names of common objects. She also experienced an increase in blood pressure. BP went up to 165/105 for about 36 hours after receiving.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: RN was called to room after pt experienced syncope post vaccination. Felt nauseous - emesis bag was provided. Pallor noted. Normal cognition.  Pt was placed supine with knees lifted.  Vitals checked and rechecked. BP noted to be low. Pt rested for a few minutes then was able to come to a sitting position without issue.  Verified vitals returned to normal. Skin color improved. Pt reported he was feeling much better.  Pt was then able to stand without issue - then ambulated normally.  Pt's mother felt comfortable with going home after pt had improved.    Of note - pt/parent would like to move forward with only doing 1 immunization at a time.  He has done well with that plan previously.
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: local site reaction, red/swollen surrounding injection site up and down half of arm. patient has followed up with prescriber for possible antibiotics and ultrasound.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth, Pain, Peripheral swelling, Swelling
Clinical narrative: The patient had heat and slight swelling around Arexvy injection site starting 5 to 6 hours after injection. The next morning there was significant swelling around the injection site and throughout the day spreading along the arm. The following day the swelling spread down that side of her body to her foot, eventually having both feet swollen. As of today, a week later, the swelling only remains in the feet and pain has stopped. Patient did not seek medical attention, and did not let us know until today. I recommended she seek care from her primary care physician.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Chest discomfort, Dyspnoea, Dyspnoea exertional, Fatigue
Clinical narrative: Palpitations (feeling of very strong heart beat ), chest pressure, worse with laying flat, shortness of breath, worse with exertion, fatigue, fever and brain fog.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Palpitations (feeling of very strong heart beat ), chest pressure, worse with laying flat, shortness of breath, worse with exertion, fatigue, fever and brain fog.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Diplopia, Neuralgia
Clinical narrative: Pt described nerve pain going in and down the right arm that went away within the hour of getting the vaccine. Four hours later, pt calls to report vision problems, seeing double ("up and down crown, double vision") that lasted for about 25 minutes and resolved. Pt then reports  lower back pain (level 2-3) around 6:45pm, neither sharp nor dull pain.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Fatigue, Fear, Pain in jaw, Pyrexia
Clinical narrative: PT HAD REACTION TO SPIKEVAX: YDAY HE HAD PAIN ON RIGHT SIDE OF FACE THAT RESEMBLED TRIGEMINAL NEURALGIA AND TODAY ITS ON LEFT SIDE BELOW TEETH TO BOTTOM OF JAW SHARP PAIN AND FATIGUE AND FEVER AND PERSON GAVE HIM SHOT BUT WAS GIVEN THREE FINGER LENGTHS BELOW AND PT CONFIRMED IN MUSCLE--FOUND ARTICLES WITH THIS ADR --has reached to doctor for consult.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Blood pressure increased, Bone pain, Dizziness, Headache
Clinical narrative: After receiving shot patient was standing waiting for husband.   She had an immediate headache, felt dizzy, had lower back pain and pain in the right clavicle area.  Patient was seated in a chair.  EMS was called.  Symptoms started to improve slightly before EMS arrived.  EMS found patient had an elevated BP.  Symptoms improved and patient declined going to hospital with EMS.  Patient left shortly after EMS left the pharmacy.
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Immediate post-injection reaction
Clinical narrative: After receiving shot patient was standing waiting for husband.   She had an immediate headache, felt dizzy, had lower back pain and pain in the right clavicle area.  Patient was seated in a chair.  EMS was called.  Symptoms started to improve slightly before EMS arrived.  EMS found patient had an elevated BP.  Symptoms improved and patient declined going to hospital with EMS.  Patient left shortly after EMS left the pharmacy.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Acute kidney injury, Blood creatinine, Blood lactic acid increased, Computerised tomogram abdomen abnormal, Diarrhoea
Clinical narrative: Patient developed acute onset of gastroenteritis type symptoms (persistent non-bilious emesis and diarrhea) necessitating evaluation by the emergency department.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Gastroenteritis, Gastrointestinal wall thickening, Leukocytosis, Vomiting, White blood cell count increased
Clinical narrative: Patient developed acute onset of gastroenteritis type symptoms (persistent non-bilious emesis and diarrhea) necessitating evaluation by the emergency department.
Age: 34.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Asthenia, Tinnitus
Clinical narrative: Strong ringing in ears, general weakness
Age: 51.0
Sex: F
Vaccine: FLUR4, PNC20
Symptoms: Pain, Pain in extremity, Peripheral swelling, Staphylococcal infection
Clinical narrative: Pt claim that she developed a  staph. infection due to the vaccines that was given to her on the right arm.  She's currently on antibiotics prescribed by her doctor.  She stated that her arm was swollen, throbbing and in pain.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Mobility decreased, Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: She felt the vaccine was given too high and developed sharp stabbing pain in her arm, difficulty moving her arm without pain and some nausea and vomiting with the pain of movement
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Pain, warmth at injection site. A quarter sized lump around injection site appeared 4 hours post injection.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Resident has significant edema to LUE. LUE red and hot to touch. Resident c/o significant pain throughout arm.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Cardiac pacemaker insertion, Hypertension, Pyrexia, Sinus node dysfunction
Clinical narrative: pt called today and said after Arexvy (RSV) vaccines , she got high fever and  her BP went very high after 3 days of vaccines , she went to Er and hospital told her to admit right way , she end up to pace maker , she disgnois with 6 sinus syndrome , she stayed in the hospital for 1 week and now home but taking many Bp medication. pt is ok now but daugher is very upset and asking for lot numer which is 5bn3t and expiation date of vaccines 11/05/24
Sex: U
Vaccine: HEPA
Symptoms: Injection site discharge, No adverse event, Syringe issue, Underdose
Clinical narrative: No AE; While administering VAQTA vaccine, the patient jerked their leg. Small amount left; While administering VAQTA vaccine, the patient jerked their leg. Small amount left; This spontaneous report has been received from a medical assistant and refers to a 12-month-old child patient of unknown gender. Information regarding the patient's current conditions, pertinent medical history, previous drug reactions or allergies and concomitant medications was not provided.  On 19-SEP-2023, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) "25/0.5" intramuscular injection as prophylaxis (dose and route of administration were not provided; lot number 1971534 has been verified to be valid, expiration date reported as 26-OCT-2024, but upon internal validation, it was established as 06-OCT-2024); while administering the vaccine, the patient jerked their leg and a small amount was dripping down the child's leg and a small amount left in syringe (exposure via skin contact and incorrect dose administered). There were no adverse events reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects; HCP calling to report AE for patient who received improperly stored VARIVAX; This spontaneous report was received from other health professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 12-OCT-2023, the patient was vaccinated with an improperly stored dose of with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, for prophylaxis subcutaneous injection, for prophylaxis (lot number: X007372, which has been verified to be valid, expiration date reported and validated as 12-MAR-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of -9.8 degrees Celsius (C), during a time frame of 12 minutes (product storage error). There was a previous temperature excursion reported of -8.8 C for 14 minutes and -12.1 for 11 minutes.   No additional adverse events were reported in the patient.; Sender's Comments:  US-009507513-2310USA007934:
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: has not reported any symptoms. No additional AE/no PQC.; a 17 year old was inadvertently administered the adult formulation of VAQTA; This spontaneous report was received from a physician referring to a 17 year old male patient. No information regarding patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 23-AUG-2023, the patient was vaccinated with the adult formulation (Incorrect dose administered) of hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route, frequency, anatomical location, lot number, and expiration date were not provided) for prophylaxis.  No adverse events reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The patient received a second dose of VARIVAX instead of VAXELIS; The patient received a second dose of VARIVAX instead of VAXELIS; The patient received a second dose of VARIVAX instead of VAXELIS; No additional AE; This spontaneous report was received from other health care professional referring to a 2-year-old female patient.   The patient's pertinent medical history and concomitant medications were not reported. Was reported that as the patient was born during the Covid pandemic and was limited to go out, she was behind schedule on all vaccinations.   On 16-MAY-2023, the patient received the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (dose, vaccination scheme frequency, route, anatomical site of administration, lot number and expiration date were not reported), and was supposed to receive the first dose of diphtheria toxoid (+) hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (VAXELIS) on 17-OCT-2023, but instead, that day, the patient was inadvertently administered a second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection 0.5 mL as prophylaxis (vaccination scheme frequency, route, anatomical site of administration, lot number and expiration date were not reported) (Product administered to patient of inappropriate age/Inappropriate schedule of product administration/Wrong product administered). No additional adverse event was reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: She continually gets covid virus and reports having covid 4 times; She continually gets covid virus and reports having covid 4 times; She continually gets covid virus and reports having covid 4 times; long term Covid/burning with fever, mental fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "fibromyalgia" (unspecified if ongoing), notes: Has migraines from fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "She continually gets covid virus and reports having covid 4 times"; POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown", described as "long term Covid/burning with fever, mental fog". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive; Positive; Positive, notes: the proteins and peptides were positive; negative. Clinical course: Provided by transferring agent that caller has taken all Covid-19 vaccines, still experienced Covid.  Caller states she took all of the Pfizer covid 19 vaccines, she had the original, the reinforcer and got the boosters. She continually gets covid virus and reports having covid 4 times. 07Sep (year unspecified) was her last test and the antigens were negative and the proteins and peptides were positive. Took original vaccine then, got booster twice, both of them. Still tested positive 4 times, not 14 weeks, for 8 weeks every time, still has it. Right now, is burning with fever, mental fog is there. Throat is all swollen, can not swallow, in pain, does not know what to do. Caller states, she still has Covid, after taking original vaccine and booster, twice. They changed name to long term Covid. When queried, caller provides date, 10May2020 (as reported), clarified as first date she had Covid. Took vaccine 05May2020 (as reported). The reporter wanted to know if Paxlovid works for long covid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333580 same patient, product, different dose number/event;
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "herpes" (unspecified if ongoing); "Carrots allergy/peas allergy" (unspecified if ongoing); "Allergic to cats" (unspecified if ongoing); "Allergy: fir trees" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 05Oct2023 to 10Oct2023.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331385 same patient, different drug/event;
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: 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 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02May2023 as dose 6 (booster), single (Lot number: GL1990) at the age of 74 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date 04Oct2023, stop date 09Oct2023).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331377 same reporter/patient, different drug/ event;
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 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 36-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperprolactemia" (unspecified if ongoing); "Thallasemia trait" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive. Therapeutic measures (Paxlovid treatment start date: 04Oct2023, stop date: 09Oct2023) were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331879 same patient, different drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Sep2023 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "History of cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Marijuana, reaction(s): "Known allergies: Marijuana". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2023 at 12:00, outcome "recovered", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 05Oct2023 to 10Oct2023 as Treatment of COVID-19.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331380 same patient, different drug/event;