chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 on 25Aug2022; Tested positive for COVID-19 on 25Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: EP6955), on 20Apr2021 as dose 2, single (Lot number: EP6955) and on 08Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Aug2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on 25Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: Patient received no other vaccine in four weeks and no covid prior vaccination. Patient tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 on 25Aug2022; Tested positive for COVID-19 on 25Aug2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). An 8-year-old male patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 1, single (Lot number: FK5618) and on 03Dec2021 as dose 2, single (Lot number: FK5618) at the age of 7 years for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25Aug2022, outcome "not recovered" and all described as "Tested positive for COVID-19 on 25Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Aug2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Information: No covid prior vaccination, No other vaccine in four weeks.  No follow up attempts are possible, Information about lot/batch number cannot be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Sleep disorder
Clinical narrative: been tired he had lack of energy problems; been tired he had lack of energy problems; problem sleeping; 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 male patient received BNT162b2 (BNT162B2), 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: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "not recovered", ASTHENIA (non-serious), outcome "unknown" and all described as "been tired he had lack of energy problems"; SLEEP DISORDER (non-serious), outcome "unknown", described as "problem sleeping".  Additional information: Patient asked if problems to sleep have been reported as a side effect of the Pfizer-BioNTech COVID-19 vaccine booster and how long this side effect may last. Patient stated that, he got his first booster of the Pfizer-BioNTech COVID-19 vaccine. He been tired he had lack of energy problems. Ever since he got the booster, he had a problem sleeping. After this, he ain't getting the second booster dose. Patient was asking how long his fatigue will last.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "cardiovascular disesase" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Feb2019, stop date: 15Aug2022; LEVOTHYROXINE, start date: Feb2002. The following information was reported: VACCINATION FAILURE (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: (unspecified date) Positive; (24Aug2022) Negative, notes: tested negative 2 days ago; (26Aug2022) Negative, notes: tested positive today. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: never had AFib until recieve the 2 shots and booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (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, UNKNOWN LOT), for Covid-19 immunization; Bnt162b2 (DOSE 2, UNKNOWN LOT), for Covid-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "never had AFib until recieve the 2 shots and booster". Therapeutic measures were taken as a result of atrial fibrillation included abalition surgery. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Never had AFib until recieve the 2 shots and booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (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, unknown lot), for Covid-19 immunization; Bnt162b2 (Dose: 2, unknown lot), for Covid-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Never had AFib until recieve the 2 shots and booster". Therapeutic measures were taken as a result of atrial fibrillation included abalition surgery. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: never had AFib until receive the 2 shots and booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (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), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "never had AFib until receive the 2 shots and booster". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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 and 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 received Paxlovid on 25Aug2022 for COVID-19 Treatment. There were no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased, Crohn's disease, Vaccination site pain
Clinical narrative: sore arm; low iron; pediatric crohns diasease flares with Humira; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4512191-00.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 21May2021 as dose 1, single (Batch/Lot number: unknown), on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 27Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 15 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CROHN'S DISEASE (medically significant) with onset Aug2022, outcome "unknown", described as "pediatric crohns diasease flares with Humira"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm"; BLIROOD ON DECREASED (non-serious), outcome "unknown", described as "low iron". The patient underwent the following laboratory tests and procedures: Blood iron: Low. The action taken for adalimumab was unknown.  The reporter considered "pediatric crohns diasease flares with humira" and "low iron" not related to BNT162b2. The reporter considered "sore arm" related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event VACCINATION SITE PAIN cannot be completely ruled out given the known suspect drug profile and/or implied temporal association.  The other events  are considered most likely associated with intercurrent or underlying medical conditions, appear unrelated to the suspect drug.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 22K-163-4510288-00.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 04May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for ankylosing spondylitis. The patient had no relevant medical history. The patient's concomitant medications were not reported. No known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 23Jun2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jun2022) Positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: On 23Jun2022, the patient experienced Covid. In 2022, the COVID resolved. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The patient was treated with Paxlovid and Cortisone. The reporter's causality for the event of Covid with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event of Covid with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Possible.  The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Sex: U
Vaccine: PNC20
Symptoms: Device issue
Clinical narrative: the Prevnar 20 they had an infiltrated inside the vial. Was not administered to any patients.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group,.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: FJ2605, Expiration Date: 31Jul2023) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "the Prevnar 20 they had an infiltrated inside the vial. Was not administered to any patients.".  Additional information: sample of the product was available to be returned, if requested. Informed caller to please retain their product and its packaging as it may be required if an investigation is required. It normally takes 3-10 business days to send out a mailer to return a sample.  Follow-up attempts are not needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Productive cough, Pruritus, Sneezing, Urticaria
Clinical narrative: Coughing, itching on lower torso, upper thighs,  This reaction also occurred with the previous shot (Moderna booster, shot #3 in November 2021).  Nighttime coughing, daily.  Daily hives covering inner thighs, parts of legs, buttocks, stomach, for 3-4 months, tapering to only cough  7 months after shot.  Coughing prevents sleep at night.  Non-productive to moderately productive cough, sometimes with sneezing. No asthma, COPD or other respiratory illness present.  Non-smoker.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: patient called pharmacy and stated that he had limited mobility in his arm that he received flu shot in. said hes gone to ER and will follow up with us if any further issues or improvement
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough  case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Systemic: Redness, swelling and heat below injection site above elbow-Mild.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Dysphagia, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Abdominal Pain-Medium
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Injection site pruritus, Injection site rash, Rash, Rash papular
Clinical narrative: Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: IM given in right thigh, after 10 minutes pt developed small papular rash on right leg and to lesser extent on left leg.-Mild, Additional Details: Pt was reassessed and given 2.5 ml of Benadryl, rash only appeared on lower ext. Pt continued to be active with no other symptoms.  Pt was watched for additional 20 minutes after initial 15minutes.  no other symptoms arose. Discussed with parent signs and symptoms to watch for over the next 24 hours and seek medical help if necessary.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting/Unresponsive-Mild, Systemic: Flushed/Sweating-Mild, Systemic: Weakness-Mild, Additional details: Patient fainted shortly after receiving the vaccine. She lost color to her face and said she felt weak. The patient sat and was given water. She quickly regained color to her face. After sitting about 15 minutes, she stated she felt much better. They left shortly after. The patient's mother called shortly after the incident and was very upset the child was not initially instructed to wait 15 minutes in the store. I apologized and told her this should have been communicated to them.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Arthropathy, Joint noise, Myalgia, X-ray abnormal
Clinical narrative: My joints began clicking, snapping and popping in body. Right shoulder more so, and at times felt out of joint and muscles painful.  The problem continues three months later. No treatment.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthropathy, Muscle strain, Myalgia, SARS-CoV-2 test
Clinical narrative: My joints began clicking, snapping and popping in body. Right shoulder more so, and at times felt out of joint and muscles painful.  The problem continues three months later. No treatment.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccine breakthrough infection
Clinical narrative: COVID 19 breakthrough
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: We had a temperature excursion the previous day that wasn't caught before giving the vaccine. The patient was given HPV and MCV4, as well, but those vaccines were okayed by our coordinator for use. The patient tolerated the vaccines and hadn't reported any reaction. The patient will have to repeat the polio dose.
Age: 83.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Immunisation reaction, Injection site reaction, Rash erythematous
Clinical narrative: Patient presented to the pharmacy two days after vaccination with a red rash on her upper left arm. She followed up with her primary care provider who explained she had symptoms of "COVID arm". The provider recommended OTC Tylenol.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization with COVID-19 despite full vaccination with 2 boosters.
Age: 24.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Pruritus, Swelling
Clinical narrative: Raised bump, mild itching noticed within 24 hours of administration lasting up to a week
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Developed SX of cough, congestion 8/30/22- tested positive for Covid on Abbott ID Now molecular test- has had known community exposure.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient came into pharmacy at 8:30pm Monday, 8/29/22 for 2nd COVID Pfizer vaccine. Technician input vaccine into local registry. No COVID vaccines had been administered, Vaccine was drawn up by technician. Pharmacist was shown the syringe but not the vial drawn from, as has been standard practice. Patient was administered vaccine. The handheld was completed after administration of vaccine, which is when it was found that a pediatric Pfizer (PEDS) vaccine was administered instead of adult Pfizer vaccine. The dose administered was 0.13mcg higher then what should have been given. Patient was spoken to regarding what to expect for possible reactions, both localized and systemic. None have been experienced by the patient as of Tuesday, 8/30/22 at 9am. Pharmacist counseled patient on what to do if events occur and reassured patient that this would be looked into to be sure it doesn't happen again. Patient was understanding and appeared unconcerned.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Injection site swelling
Clinical narrative: Swelling and redness at injection site and swelling of left arm to wrist along with low grade headache and fatigue for 2-3 days
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsey
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization with covid; fully vaccinated
Age: 1.67
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: incorrectly diluted the ped pfizer (meroon top) 6mo-4 years Vancian mixed with o.2ml of diluent in place of 2.2Ml. Patient received 0.2mls from vial.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization with COVID-19 despite full vaccination.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Hospitalized with COVID-19 despite full vaccination with 2 boosters.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received duplicate 2nd booster. Patient reported he needed the second booster but after administration, his son called the vaccine clinic and told them the patient received the second booster at another site.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was given 0.2cc of adult Pfizer purple top Covid vaccine instead of pediatric Pfizer (PEDS) orange top Covid vaccine. Patient is 11 years old, will be 12 on 09/14/2022.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Incorrect dose given.  Moderna 18 years and older booster dose (dark blue vial cap color and purple vial label border color) 0.25mL given IM.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, Blood glucose increased, Cerebrovascular accident, Decreased activity
Clinical narrative: Shot received 5/14/21- Severe reaction, Weakness, Dizziness, Tiredness, Flu-like symptoms, Not feeling well to the point of not being able to think clearly. Overtime I observed an increased incidence of forgetfulness, irritation, combined with a lack of desire to be active. On 2/9/22, Stroke occurred, started slurring speech, and blood sugar levels 300.  From this point forward, hospitalization was continuous. On approximately 8/22/22 low hemoglobin occurred dropping to 6.5. She was then given blood transfusion. On approximately, 8/24/22-8/25/22, she was sent to ER at local Hospital to treat bleeding hand, blood thinners made it difficult to stop bleeding, however there was an unexplained sudden drop in platelet count from normal to approximately 20,000 and then to 6,000
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysarthria, Fatigue, Haemoglobin decreased, Haemorrhage
Clinical narrative: Shot received 5/14/21- Severe reaction, Weakness, Dizziness, Tiredness, Flu-like symptoms, Not feeling well to the point of not being able to think clearly. Overtime I observed an increased incidence of forgetfulness, irritation, combined with a lack of desire to be active. On 2/9/22, Stroke occurred, started slurring speech, and blood sugar levels 300.  From this point forward, hospitalization was continuous. On approximately 8/22/22 low hemoglobin occurred dropping to 6.5. She was then given blood transfusion. On approximately, 8/24/22-8/25/22, she was sent to ER at local Hospital to treat bleeding hand, blood thinners made it difficult to stop bleeding, however there was an unexplained sudden drop in platelet count from normal to approximately 20,000 and then to 6,000
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Irritability, Limb injury, Malaise, Memory impairment
Clinical narrative: Shot received 5/14/21- Severe reaction, Weakness, Dizziness, Tiredness, Flu-like symptoms, Not feeling well to the point of not being able to think clearly. Overtime I observed an increased incidence of forgetfulness, irritation, combined with a lack of desire to be active. On 2/9/22, Stroke occurred, started slurring speech, and blood sugar levels 300.  From this point forward, hospitalization was continuous. On approximately 8/22/22 low hemoglobin occurred dropping to 6.5. She was then given blood transfusion. On approximately, 8/24/22-8/25/22, she was sent to ER at local Hospital to treat bleeding hand, blood thinners made it difficult to stop bleeding, however there was an unexplained sudden drop in platelet count from normal to approximately 20,000 and then to 6,000
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Thinking abnormal, Transfusion
Clinical narrative: Shot received 5/14/21- Severe reaction, Weakness, Dizziness, Tiredness, Flu-like symptoms, Not feeling well to the point of not being able to think clearly. Overtime I observed an increased incidence of forgetfulness, irritation, combined with a lack of desire to be active. On 2/9/22, Stroke occurred, started slurring speech, and blood sugar levels 300.  From this point forward, hospitalization was continuous. On approximately 8/22/22 low hemoglobin occurred dropping to 6.5. She was then given blood transfusion. On approximately, 8/24/22-8/25/22, she was sent to ER at local Hospital to treat bleeding hand, blood thinners made it difficult to stop bleeding, however there was an unexplained sudden drop in platelet count from normal to approximately 20,000 and then to 6,000
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt tested positive for COVID on 08/15/2022
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID infection
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt tested positive for COVID on 08/15/2022
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient tested positive for COVID-19 on 08/14/2022.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Cough, SARS-CoV-2 test positive
Clinical narrative: The adverse affect was coughing tested positive for COVID19 after consultation with doctor no antiviral need lost taste only as a symptom.
Age: 13.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 5-11 yr dose of Pfizer Covid vaccine instead of dose for 12 yr and older. No adverse symptoms to date.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Disease complication, SARS-CoV-2 test positive
Clinical narrative: Admitted to hospital for COVID positive complications
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression, Insomnia, Restlessness
Clinical narrative: Patient states that around 2am (approximately 12 hours after vaccination) he woke up feeling very anxious and restless. He states he was unable to go back to sleep and he just walked all night. He has followed up with his family physician who has prescribed him Xanax and another medication he cannot remember to treat new onset anxiety and depression. He states his doctor advised him to let the health department know about his reaction so that it could be reported.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Respiratory tract congestion
Clinical narrative: CONGESTION AND COUGH.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt tested positive for COVID on 08/15/2022
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Loss of personal independence in daily activities, Muscle spasms, Pain in extremity, Sleep disorder
Clinical narrative: Patient is having severe leg pain & cramps mainly in the thigh area.  she states it has affected her everyday life even painful at sleep
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Patient is having severe leg pain & cramps mainly in the thigh area.  she states it has affected her everyday life even painful at sleep
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 103.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization with covid; fully vaccinated with booster
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Admitted to Allegan Hospital for COVID-19
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Arthralgia, Chills, Iridocyclitis, Malaise, Mobility decreased
Clinical narrative: "MD      8/23/22 11:35 AM Good morning. I am reaching out to you regarding adverse reactions that I experienced following the Prevnar 20 vaccination that I received Tues., 8/16. Within hours of receiving the vaccination I began feeling malaise and on Thurs., 8/25 I experienced a severe anterior uveitis flare. I am undergoing treatment at facility. In addition, today I am experiencing chills, joint pain and difficulty getting out of bed. I am concerned about the safety and efficacy of this medication. "
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Death, Dyspnoea
Clinical narrative: 2/7/22 patient had a positive COVID test in the nursing home where she stays, she was having weakness, generalized edema, cough, SOB; DNR; given Lasix IV; patient passed away in the nursing home on 2/10/22.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised oedema, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: 2/7/22 patient had a positive COVID test in the nursing home where she stays, she was having weakness, generalized edema, cough, SOB; DNR; given Lasix IV; patient passed away in the nursing home on 2/10/22.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Myalgia, Pneumonia
Clinical narrative: Two days prior to admission pt started with cough, congestion, fatigue and myalgias. Pt was admitted with pneumonia and COVID-19.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Two days prior to admission pt started with cough, congestion, fatigue and myalgias. Pt was admitted with pneumonia and COVID-19.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization with covid; fully vaccinated
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling, Nausea
Clinical narrative: pt had large red, swollen area to injection site approximately 8 inches in diameter and nausea for 2 days
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Acute respiratory failure, Body temperature increased, COVID-19, Chest pain
Clinical narrative: Patient arrives with EMS with a chief complaint of shortness of breath.  Patient uses a home air concentrator and her sat at home was 92%.  Patient arrives tachypneic.  Patient is speaking in full sentences patient says that she has had shortness of breath for 2 days today she has had nausea vomiting and cannot keep water down. She had chest pain, which was worse earlier and now she only rates it as a 6 out of 10.  Patient denies diarrhea.  Patient has had low-grade temps, she has 99.1 here.  Patient has an obviously enlarged abdomen and she attributes this to her hernia.  Patient lives with her daughter in a second floor apartment.  Patient tested positive for COVID earlier today.  Patient has past medical history of COPD, hernia, Panic disorder coronary artery disease peripheral vascular disease CHF dyslipidemia hypertension diabetes seizures. Patient has past surgical history of 5 cardiac stents and a pacemaker, hernia repair Pt is a smoker of tobacco and denies alcohol  Associated Symptoms: chest pain, cough, nausea, shortness of breath, sputum, vomiting
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Electrocardiogram, Fluid intake reduced, Nausea
Clinical narrative: Patient arrives with EMS with a chief complaint of shortness of breath.  Patient uses a home air concentrator and her sat at home was 92%.  Patient arrives tachypneic.  Patient is speaking in full sentences patient says that she has had shortness of breath for 2 days today she has had nausea vomiting and cannot keep water down. She had chest pain, which was worse earlier and now she only rates it as a 6 out of 10.  Patient denies diarrhea.  Patient has had low-grade temps, she has 99.1 here.  Patient has an obviously enlarged abdomen and she attributes this to her hernia.  Patient lives with her daughter in a second floor apartment.  Patient tested positive for COVID earlier today.  Patient has past medical history of COPD, hernia, Panic disorder coronary artery disease peripheral vascular disease CHF dyslipidemia hypertension diabetes seizures. Patient has past surgical history of 5 cardiac stents and a pacemaker, hernia repair Pt is a smoker of tobacco and denies alcohol  Associated Symptoms: chest pain, cough, nausea, shortness of breath, sputum, vomiting
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Productive cough, SARS-CoV-2 test positive, Tachypnoea, Vomiting
Clinical narrative: Patient arrives with EMS with a chief complaint of shortness of breath.  Patient uses a home air concentrator and her sat at home was 92%.  Patient arrives tachypneic.  Patient is speaking in full sentences patient says that she has had shortness of breath for 2 days today she has had nausea vomiting and cannot keep water down. She had chest pain, which was worse earlier and now she only rates it as a 6 out of 10.  Patient denies diarrhea.  Patient has had low-grade temps, she has 99.1 here.  Patient has an obviously enlarged abdomen and she attributes this to her hernia.  Patient lives with her daughter in a second floor apartment.  Patient tested positive for COVID earlier today.  Patient has past medical history of COPD, hernia, Panic disorder coronary artery disease peripheral vascular disease CHF dyslipidemia hypertension diabetes seizures. Patient has past surgical history of 5 cardiac stents and a pacemaker, hernia repair Pt is a smoker of tobacco and denies alcohol  Associated Symptoms: chest pain, cough, nausea, shortness of breath, sputum, vomiting
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization with covid; fully vaccinated with booster
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization with covid; fully vaccinated
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Biopsy artery normal, Blood test abnormal, C-reactive protein increased, Coccidioidomycosis
Clinical narrative: About a week after receiving my second dose of Moderna, I had increased muscle and joint pain and also a rash that was mostly over the front and back of my trunk. Around 10 days after the vaccine, I saw my primary care doctor who prescribed a topical medication for the rash which didn't really help. The rash eventually went away on its own, but the muscle and joint pain persisted. He put me on a tapering dose of prednisone which completely helped the joint and muscle pain, but as soon as I got to 5 milligrams the pain came back. My doctor then referred me to a rheumatologist who I saw in September of 2021 who diagnosed me with polymyalgia rheumatica. I am now on 7.5 milligrams of prednisone daily which is helping but the joint pain is getting worse, and I expect to have to go up in my dosage. I was on a higher dosage over the summer and tapered down. I was also diagnosed with Valley fever which I contracted while hiking in February of 2022.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Computerised tomogram thorax, Hepatic enzyme increased, Inflammation, Magnetic resonance imaging normal
Clinical narrative: About a week after receiving my second dose of Moderna, I had increased muscle and joint pain and also a rash that was mostly over the front and back of my trunk. Around 10 days after the vaccine, I saw my primary care doctor who prescribed a topical medication for the rash which didn't really help. The rash eventually went away on its own, but the muscle and joint pain persisted. He put me on a tapering dose of prednisone which completely helped the joint and muscle pain, but as soon as I got to 5 milligrams the pain came back. My doctor then referred me to a rheumatologist who I saw in September of 2021 who diagnosed me with polymyalgia rheumatica. I am now on 7.5 milligrams of prednisone daily which is helping but the joint pain is getting worse, and I expect to have to go up in my dosage. I was on a higher dosage over the summer and tapered down. I was also diagnosed with Valley fever which I contracted while hiking in February of 2022.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Polymyalgia rheumatica, Rash, Red blood cell sedimentation rate increased
Clinical narrative: About a week after receiving my second dose of Moderna, I had increased muscle and joint pain and also a rash that was mostly over the front and back of my trunk. Around 10 days after the vaccine, I saw my primary care doctor who prescribed a topical medication for the rash which didn't really help. The rash eventually went away on its own, but the muscle and joint pain persisted. He put me on a tapering dose of prednisone which completely helped the joint and muscle pain, but as soon as I got to 5 milligrams the pain came back. My doctor then referred me to a rheumatologist who I saw in September of 2021 who diagnosed me with polymyalgia rheumatica. I am now on 7.5 milligrams of prednisone daily which is helping but the joint pain is getting worse, and I expect to have to go up in my dosage. I was on a higher dosage over the summer and tapered down. I was also diagnosed with Valley fever which I contracted while hiking in February of 2022.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ascites, COVID-19, Death, Dyspnoea, General physical health deterioration
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 9/28/21, LOT #FF2587; 1/27/22 pt had a hospital admission Hospital in from a facility with AMS, hepatic encephalopathy, thrombocytopenia, ascites; functional decline; 2/10/22 tested positive for COVID while in the hospital; required IV morphine for worsening dyspnea; dc'd to Hospice, where she passed away
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatic encephalopathy, Inappropriate schedule of product administration, Mental status changes, SARS-CoV-2 test positive, Thrombocytopenia
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 9/28/21, LOT #FF2587; 1/27/22 pt had a hospital admission Hospital in from a facility with AMS, hepatic encephalopathy, thrombocytopenia, ascites; functional decline; 2/10/22 tested positive for COVID while in the hospital; required IV morphine for worsening dyspnea; dc'd to Hospice, where she passed away
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Cardiac hypertrophy, Cardiac stress test, Cardiomyopathy, Electrocardiogram
Clinical narrative: Rise in blood pressure, extra heart beat, thickening of heart muscle. Cardiomyopathy.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Extrasystoles, Ultrasound scan
Clinical narrative: Rise in blood pressure, extra heart beat, thickening of heart muscle. Cardiomyopathy.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 1 x 2 cm reddened area on her left lateral thigh.  There is palpable induration.  Parents use Benadryl and hydrocortisone to site.  Areas still has redness and palpable induration.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram normal, Condition aggravated, Fatigue, Pain
Clinical narrative: Had a severe attack of Ulcerative Proctitis within 2 weeks of vaccine.  This was not new, happened for each shot.  Ulcerative proctitis flares continued in subsequent weeks, but each flare was less intense over time.  Flare that started on Jun 26 was worse, and involved low grade fever and fatique/body aches on July 3&4.  I went to urgent care on July 4, who sent me to a local hospital for a CT scan.  Nothing was found and issue cleared up on its own over the next several days.   No additional significant flares have happened since.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Proctitis ulcerative, Pyrexia
Clinical narrative: Had a severe attack of Ulcerative Proctitis within 2 weeks of vaccine.  This was not new, happened for each shot.  Ulcerative proctitis flares continued in subsequent weeks, but each flare was less intense over time.  Flare that started on Jun 26 was worse, and involved low grade fever and fatique/body aches on July 3&4.  I went to urgent care on July 4, who sent me to a local hospital for a CT scan.  Nothing was found and issue cleared up on its own over the next several days.   No additional significant flares have happened since.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine was expired, no temperature excursions occurred and moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: I had no adverse reaction to the vaccine. We had been on vacation on a cruise and I tested positive for COVID-19 on 07/18/2022. I had sore throat and a runny nose. I was prescribed PAXLOVID and I felt much better.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both of your ears.
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Electrocardiogram, Loss of consciousness
Clinical narrative: Patient passed out and lost consciousness approximately 5-10 minutes following vaccine administration
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration". Patient reported no adverse reactions.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered expired dose. No other events, treatments, outcomes noted.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Death, Hypoxia, Intensive care
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 9/23/21,  LOT #FC3182; 3/2/22 pt had a positive COVID test from a health care facility; 3/7/22 pt started requiring O2 supplementation at home, ordered by PCP (name unknown); 3/10/22 pt seen in cardiac clinic, told to return to hospital d/t worsening hypoxia; started on steroids and dc'd to home on Decadron 3/15/22; 3/17/22 pt to hospital again with O2 desaturation during the night; requiring 35L @70%; admitted ICU with AHRF; DNR/DNI; transitioned to BiPAP; O2 saturation continued to fall; pt made comfort care and passed away in the hospital
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: PFIZER COVID VACCINE #3 GIVEN 9/23/21,  LOT #FC3182; 3/2/22 pt had a positive COVID test from a health care facility; 3/7/22 pt started requiring O2 supplementation at home, ordered by PCP (name unknown); 3/10/22 pt seen in cardiac clinic, told to return to hospital d/t worsening hypoxia; started on steroids and dc'd to home on Decadron 3/15/22; 3/17/22 pt to hospital again with O2 desaturation during the night; requiring 35L @70%; admitted ICU with AHRF; DNR/DNI; transitioned to BiPAP; O2 saturation continued to fall; pt made comfort care and passed away in the hospital
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration". Patient reported no adverse reactions.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, C-reactive protein increased, Condition aggravated, Discomfort, Exercise tolerance decreased
Clinical narrative: After my second shot of Shingrix  I experienced severe Rheumatoid arthritis:  Swelling  and in hands, wrists and elbows, making it hard to dress, put on shoes or brush teeth . Swelling and pain in my feet making walking on a wood flor painful Swelling  and pain in my knees making walking, stair, biking and all functions difficult. Even SITTING for prolonged periods of time creates more pain
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Gait disturbance, Joint swelling, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: After my second shot of Shingrix  I experienced severe Rheumatoid arthritis:  Swelling  and in hands, wrists and elbows, making it hard to dress, put on shoes or brush teeth . Swelling and pain in my feet making walking on a wood flor painful Swelling  and pain in my knees making walking, stair, biking and all functions difficult. Even SITTING for prolonged periods of time creates more pain