chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Facial paralysis, Magnetic resonance imaging head abnormal, Speech disorder, Ultrasound head abnormal
Clinical narrative: Stroke, had a blood clot developed in the back of my head; Stroke, had a blood clot developed in the back of my head; It was intravenous, a shot in the shoulder; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years intravenous for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE taken for diabetes mellitus; METFORMIN; CLAVIX [CLARITHROMYCIN]; ASPIRIN [ACETYLSALICYLIC ACID]; JARDIANCE; METOPROLOL; VIT D [VITAMIN D NOS]. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Nov2024, outcome "unknown", described as "It was intravenous, a shot in the shoulder"; CEREBROVASCULAR ACCIDENT (hospitalization), THROMBOSIS (hospitalization) all with onset Nov2024, outcome "unknown" and all described as "Stroke, had a blood clot developed in the back of my head".  The clinical course was reported as follows: The patient started feeling bad after she got the shot, it was intravenous, a shot in the shoulder (as reported) but she took Moderna, she never took Pfizer before, since the stroke she had been on blood thinner. The patient was hospitalized for cerebrovascular accident, thrombosis (start date: 22Nov2024, discharge date: 23Nov2024, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood test: (Nov2024) Unknown results; Computerised tomogram: (Nov2024) Unknown results; Magnetic resonance imaging: (Nov2024) Unknown results; Ultrasound scan: (Nov2024) Unknown results. Therapeutic measures were taken as a result of thrombosis.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Incorrect route of product administration, Magnetic resonance imaging
Clinical narrative: Stroke, had a blood clot developed in the back of my head; Stroke, had a blood clot developed in the back of my head; It was intravenous, a shot in the shoulder; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years intravenous for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE taken for diabetes mellitus; METFORMIN; CLAVIX [CLARITHROMYCIN]; ASPIRIN [ACETYLSALICYLIC ACID]; JARDIANCE; METOPROLOL; VIT D [VITAMIN D NOS]. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Nov2024, outcome "unknown", described as "It was intravenous, a shot in the shoulder"; CEREBROVASCULAR ACCIDENT (hospitalization), THROMBOSIS (hospitalization) all with onset Nov2024, outcome "unknown" and all described as "Stroke, had a blood clot developed in the back of my head".  The clinical course was reported as follows: The patient started feeling bad after she got the shot, it was intravenous, a shot in the shoulder (as reported) but she took Moderna, she never took Pfizer before, since the stroke she had been on blood thinner. The patient was hospitalized for cerebrovascular accident, thrombosis (start date: 22Nov2024, discharge date: 23Nov2024, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood test: (Nov2024) Unknown results; Computerised tomogram: (Nov2024) Unknown results; Magnetic resonance imaging: (Nov2024) Unknown results; Ultrasound scan: (Nov2024) Unknown results. Therapeutic measures were taken as a result of thrombosis.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, FLU3, COVID19
Symptoms: Thrombosis, Ultrasound scan
Clinical narrative: Stroke, had a blood clot developed in the back of my head; Stroke, had a blood clot developed in the back of my head; It was intravenous, a shot in the shoulder; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years intravenous for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes; "blood pressure" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE taken for diabetes mellitus; METFORMIN; CLAVIX [CLARITHROMYCIN]; ASPIRIN [ACETYLSALICYLIC ACID]; JARDIANCE; METOPROLOL; VIT D [VITAMIN D NOS]. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN), for COVID-19 immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 06Nov2024, outcome "unknown", described as "It was intravenous, a shot in the shoulder"; CEREBROVASCULAR ACCIDENT (hospitalization), THROMBOSIS (hospitalization) all with onset Nov2024, outcome "unknown" and all described as "Stroke, had a blood clot developed in the back of my head".  The clinical course was reported as follows: The patient started feeling bad after she got the shot, it was intravenous, a shot in the shoulder (as reported) but she took Moderna, she never took Pfizer before, since the stroke she had been on blood thinner. The patient was hospitalized for cerebrovascular accident, thrombosis (start date: 22Nov2024, discharge date: 23Nov2024, hospitalization duration: 2 day(s)). The patient underwent the following laboratory tests and procedures: Blood test: (Nov2024) Unknown results; Computerised tomogram: (Nov2024) Unknown results; Magnetic resonance imaging: (Nov2024) Unknown results; Ultrasound scan: (Nov2024) Unknown results. Therapeutic measures were taken as a result of thrombosis.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Received TDaP vaccine on Nov. 30, 2024 at local pharmacy.  I had lifted my shirt to my shoulder.  The pharmacist proceeded to lift the shirt even higher on my shoulder.  He then proceeded with the injection very high on my arm as I was thinking it felt too high.  As the vaccine entered my arm, it felt very different from other vaccines I've had.  There was a lot of pressure and an unusual pain.  My arm was sore soon afterward, but I attributed it to the soreness normally attributed to a tetanus vaccine.  The pain did not subside, however and became much worse over the following days, interfering with my daily activities, dressing, reaching, etc.  On Friday, I consulted with my PCP and she diagnosed SIRVA and recommended PT to begin with, Tylenol and heat.  Will begin PT on December 12.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site discomfort, Injection site pain, Loss of personal independence in daily activities, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: Received TDaP vaccine on Nov. 30, 2024 at local pharmacy.  I had lifted my shirt to my shoulder.  The pharmacist proceeded to lift the shirt even higher on my shoulder.  He then proceeded with the injection very high on my arm as I was thinking it felt too high.  As the vaccine entered my arm, it felt very different from other vaccines I've had.  There was a lot of pressure and an unusual pain.  My arm was sore soon afterward, but I attributed it to the soreness normally attributed to a tetanus vaccine.  The pain did not subside, however and became much worse over the following days, interfering with my daily activities, dressing, reaching, etc.  On Friday, I consulted with my PCP and she diagnosed SIRVA and recommended PT to begin with, Tylenol and heat.  Will begin PT on December 12.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Physician called and reported that a female patient 33 weeks pregnant inadvertently received the GARDASIL-9 vaccine.; No adverse events or symptoms have been reported at this time.; This spontaneous prospective pregnancy report was received from a physician and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The patient became pregnant with LMP of 17-APR-2024 and EDD of 22-JAN-2025.  On 04-DEC-2024, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #Y007197, expiration date: 18-AUG-2026, administered for prophylaxis (strength, dose and route of administration were not provided). No adverse events or symptoms have been reported. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 33 week(s). The pregnancy outcome was outcome pending.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: 3 inch diameter swollen area around Shingrix injection site with first dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: 3 inch diameter swollen area around Shingrix injection site with first dose). The outcome of the injection site swelling was not reported.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-DEC-2024 The patient reported 3 inch diameter swollen area around Shingrix injection site with first dose of shingrix.  She did decide to do the second dose. At the time of this report, 2 dose series of Shingrix was completed.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Dermatographism/Persistent hives are observed after any contact or scratching of the skin; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographism/Persistent hives are observed after any contact or scratching of the skin) in a 29-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MECHANICAL URTICARIA (Dermatographism/Persistent hives are observed after any contact or scratching of the skin). At the time of the report, MECHANICAL URTICARIA (Dermatographism/Persistent hives are observed after any contact or scratching of the skin) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. 2 weeks after dosing, dermatographism was diagnosed by Urgent Care.  The patient did not experience any additional symptoms/events.  Patient had been prescribed anti-histamines to control the reaction. The patient had no concomitant disease or risk factor.  Treatment medications were not provided.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diabetes mellitus, Erectile dysfunction, Multiple sclerosis
Clinical narrative: diabetes; erectile dysfunction; multiple sclerosis; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single) 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, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes"; ERECTILE DYSFUNCTION (medically significant), outcome "unknown"; MULTIPLE SCLEROSIS (medically significant), outcome "unknown". Clinical courses is as follows: patient got 15 or 20 Pfizer shots and also took the Moderna booster shot, and he got diagnosed with multiple sclerosis, and he also mentioned that he got diabetes. Patient badly needed the Caverject medication for 30 up to 90 day supply because he had to take it every single day. He added that he had 30 booster shots every couple of months as he has been diagnosed with multiple sclerosis, diabetes, and erectile dysfunction.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Dizziness for 3 days, thigh was warm, hard, painful, swollen for 7 days . Ice pack and ibuprofen
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: extra dose same season; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 35-year-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number A7T99, expiry date 30-JUN-2025) for prophylaxis.   Concomitant products included Influenza vaccine inact split 3v (Flulaval).   On 08-NOV-2024, the patient received the 2nd dose of FluLaval 2024-2025 season. On 08-NOV-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: extra dose same season). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-NOV-2024 Medical Assistance reported that the patient received Flulaval first and second dose with same season which led extra dose administered.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received his first dose of SHINGRIX 2 years ago. He has not gotten his second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received his first dose of SHINGRIX 2 years ago. He has not gotten his second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-NOV-2024 The patient who received his first dose of Shingrix and not received his second dose till the time of reporting which led incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: high-dose FLUZONE vaccine was given to a patient that was only 45 years old, with no reported adverse event; Initial information received on 05-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 45 years old female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] was given to a patient that was only 45 years old, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Tdap); and COVID-19 vaccine for all Immunisation.  On 05-Dec-2024, the patient received a  dose of 0.5 ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine (Suspension for injection in pre-filled syringe)lot U8499D8, Expiry date: 30-Jun-2025, strength was unknown via unknown route in unknown administration site for Immunization and high-dose fluzone vaccine was given to a patient that was only 45 years old, with no reported adverse event (product administered to patient of inappropriate age) (latency : same day).  Reportedly "Nurse mentioned that the patient has anemia and hypertension."   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: pfizer covid vaccine for ages 5-11 yrs was out of date , date on the sticker on the box says use by 11/14/24
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Electrocardiogram abnormal, Full blood count, Pyrexia
Clinical narrative: Investigator's description: Possible cause of SAE other than study treatment: Concomitant medicaiton: Moderna Covid-19 vaccine Patient attended outpatients on 02/12/2022 at 17:00 - physical exam and observations normal. Had covid-19 vaccine at 15:00 that afternoon. Patient went home, felt shivery and attended hospital 02/12/2022 with temperature of 40.2 C (self-reported). Found to be pyrexial and tachycardic on admission, commenced on IV antibiotics and IV paracetamol, stat IV fluids given.  The patient received the following relevant concomitant medications: Moderna COVID-19 vaccine (Start: 02/11/2022, Stop: 02/11/2022, 0.25 ml, 1x/1 Total, Intramuscular).  Following examinations were performed: On 02/12/2022: Body temperature (pyrexial). ECG (Sinus tachycardia). Physical examination (chest clear)  The patient was treated for the adverse event with: Paracetamol (Start: 02/12/2022, Stop: 02/14/2022, 1 g, 1x/1 As necessary, Intravenous), Piperacillin+tazobactam (Start: 02/12/2022, Stop: 02/14/2022, 4.5 g, 3x/1 Days, Intravenous), Saline (500 ml, Intravenous), Comments: stat).  Follow-up information received on 11 Nov 2024: The patient was admitted to hospital on 12 Feb 2022 and discharged on 13 Feb 2022. The SAE was updated from fever to fever ? unknown cause. The outcome of the SAE was resolved on 13 Feb 2022. Site reported that patient did not have paclitaxel - was on high dose carboplatin + etopside arm. Additional information concerning laboratory tests was provided: FBC at SAE onset (and also the worst value) was 114 g/L (on 12 Feb 2022), normal range 135-180 g/L, baseline value was 139 g/L. Value at resolution was 121 g/L on 13 Feb 2022.  Additional information was provided concernign the SAE treatment saline stat (500mL IV): started on 12 Feb 2022, stopped on 12 Feb 2022. The institution number was confirmed.  Follow-up information was received on 21 Nov 2024. Additional study treatment information was provided:  Site reports: Error made in the last follow up regarding the study treatment: Apologies, patient had carbo/etop for later cycles but paclitaxel+ifosf. Prior (C1 and C2). Carbo/Etop were not taken until after the SAE.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus tachycardia
Clinical narrative: Investigator's description: Possible cause of SAE other than study treatment: Concomitant medicaiton: Moderna Covid-19 vaccine Patient attended outpatients on 02/12/2022 at 17:00 - physical exam and observations normal. Had covid-19 vaccine at 15:00 that afternoon. Patient went home, felt shivery and attended hospital 02/12/2022 with temperature of 40.2 C (self-reported). Found to be pyrexial and tachycardic on admission, commenced on IV antibiotics and IV paracetamol, stat IV fluids given.  The patient received the following relevant concomitant medications: Moderna COVID-19 vaccine (Start: 02/11/2022, Stop: 02/11/2022, 0.25 ml, 1x/1 Total, Intramuscular).  Following examinations were performed: On 02/12/2022: Body temperature (pyrexial). ECG (Sinus tachycardia). Physical examination (chest clear)  The patient was treated for the adverse event with: Paracetamol (Start: 02/12/2022, Stop: 02/14/2022, 1 g, 1x/1 As necessary, Intravenous), Piperacillin+tazobactam (Start: 02/12/2022, Stop: 02/14/2022, 4.5 g, 3x/1 Days, Intravenous), Saline (500 ml, Intravenous), Comments: stat).  Follow-up information received on 11 Nov 2024: The patient was admitted to hospital on 12 Feb 2022 and discharged on 13 Feb 2022. The SAE was updated from fever to fever ? unknown cause. The outcome of the SAE was resolved on 13 Feb 2022. Site reported that patient did not have paclitaxel - was on high dose carboplatin + etopside arm. Additional information concerning laboratory tests was provided: FBC at SAE onset (and also the worst value) was 114 g/L (on 12 Feb 2022), normal range 135-180 g/L, baseline value was 139 g/L. Value at resolution was 121 g/L on 13 Feb 2022.  Additional information was provided concernign the SAE treatment saline stat (500mL IV): started on 12 Feb 2022, stopped on 12 Feb 2022. The institution number was confirmed.  Follow-up information was received on 21 Nov 2024. Additional study treatment information was provided:  Site reports: Error made in the last follow up regarding the study treatment: Apologies, patient had carbo/etop for later cycles but paclitaxel+ifosf. Prior (C1 and C2). Carbo/Etop were not taken until after the SAE.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Back injury, Body temperature increased, Computerised tomogram, Dizziness
Clinical narrative: On 11/8/24 received Flucelvax injection at doctors' office Starting 11/9 had flu like symptoms (headache, sore throat, low grade temp, achy) Then on 11/12 was weak and dizzy causing me to fall, injuring head, arm, foot. Fell again two times on 11/14, could not get up called ambulance, went to ER injured head, arm, back. Fell again 11/16. Started using walker 11/14. Went to primary care doctor 11/15 and nuerologist 11/19. Still running tests but feeling better. Still needs MRI of head
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Head injury, Headache, Influenza like illness, Limb injury
Clinical narrative: On 11/8/24 received Flucelvax injection at doctors' office Starting 11/9 had flu like symptoms (headache, sore throat, low grade temp, achy) Then on 11/12 was weak and dizzy causing me to fall, injuring head, arm, foot. Fell again two times on 11/14, could not get up called ambulance, went to ER injured head, arm, back. Fell again 11/16. Started using walker 11/14. Went to primary care doctor 11/15 and nuerologist 11/19. Still running tests but feeling better. Still needs MRI of head
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Walking aid user, X-ray
Clinical narrative: On 11/8/24 received Flucelvax injection at doctors' office Starting 11/9 had flu like symptoms (headache, sore throat, low grade temp, achy) Then on 11/12 was weak and dizzy causing me to fall, injuring head, arm, foot. Fell again two times on 11/14, could not get up called ambulance, went to ER injured head, arm, back. Fell again 11/16. Started using walker 11/14. Went to primary care doctor 11/15 and nuerologist 11/19. Still running tests but feeling better. Still needs MRI of head
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, COVID-19, Cerebrovascular accident, Condition aggravated
Clinical narrative: Patient reported: osteoporosis using prolia every 6 months; had parathyroid removal surgery last month to correct parathyroid hormone which is now normal; back pain which she has had for many years but lately seems to get worse, patient will get a steroid injection on 12/17 for back pain; patient sleeps well for the most part with the help of trazodone but tend to wake up 1-2 times a night to go to the bathroom, she can just go back to sleep right after; patient has had shingle twice even after getting shingle vaccines; her right knee used to hurt a ot but patient has total right knee replacement in april which removed the pain, still has some pain left knee; a little fatigue which is normal for patient and patient think its due to age; had covid last year, was in hospital and develop a stroke but recovered well. Patient also reported that she's been taking venclexta tablets out and store on pill box for years.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Enuresis, Fatigue, Herpes zoster, Knee arthroplasty, Osteoporosis
Clinical narrative: Patient reported: osteoporosis using prolia every 6 months; had parathyroid removal surgery last month to correct parathyroid hormone which is now normal; back pain which she has had for many years but lately seems to get worse, patient will get a steroid injection on 12/17 for back pain; patient sleeps well for the most part with the help of trazodone but tend to wake up 1-2 times a night to go to the bathroom, she can just go back to sleep right after; patient has had shingle twice even after getting shingle vaccines; her right knee used to hurt a ot but patient has total right knee replacement in april which removed the pain, still has some pain left knee; a little fatigue which is normal for patient and patient think its due to age; had covid last year, was in hospital and develop a stroke but recovered well. Patient also reported that she's been taking venclexta tablets out and store on pill box for years.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Parathyroidectomy
Clinical narrative: Patient reported: osteoporosis using prolia every 6 months; had parathyroid removal surgery last month to correct parathyroid hormone which is now normal; back pain which she has had for many years but lately seems to get worse, patient will get a steroid injection on 12/17 for back pain; patient sleeps well for the most part with the help of trazodone but tend to wake up 1-2 times a night to go to the bathroom, she can just go back to sleep right after; patient has had shingle twice even after getting shingle vaccines; her right knee used to hurt a ot but patient has total right knee replacement in april which removed the pain, still has some pain left knee; a little fatigue which is normal for patient and patient think its due to age; had covid last year, was in hospital and develop a stroke but recovered well. Patient also reported that she's been taking venclexta tablets out and store on pill box for years.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Feeling hot, Flushing, Headache, Heart rate increased
Clinical narrative: Recently got second dose of DMPA injection NDC 67457-0887-00 this afternoon. She tolerated first dose without any allergic reactions. When she got to her car she started feeling flushing, hot, rapid heart beat and tingling in hands and around the mouth. She returned to clinic for evaluation She had similar reaction to Hep B vaccine on a much smaller scale. She was observed for a period of time, provided diphenhydramine IM injection and given ER precautions, does not appears she went to the ER. week later she continues with nausea, anxiety and a mild headache- that is intermittent. Records show that the HBV vaccine she mentions above was Engerix B but upon reviewing the ingredients, it does not appear to be directly related from that standpoint. She will undergo possible consult with allergist and will no longer receive DMPA.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: Recently got second dose of DMPA injection NDC 67457-0887-00 this afternoon. She tolerated first dose without any allergic reactions. When she got to her car she started feeling flushing, hot, rapid heart beat and tingling in hands and around the mouth. She returned to clinic for evaluation She had similar reaction to Hep B vaccine on a much smaller scale. She was observed for a period of time, provided diphenhydramine IM injection and given ER precautions, does not appears she went to the ER. week later she continues with nausea, anxiety and a mild headache- that is intermittent. Records show that the HBV vaccine she mentions above was Engerix B but upon reviewing the ingredients, it does not appear to be directly related from that standpoint. She will undergo possible consult with allergist and will no longer receive DMPA.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Apathy, Chills, Depressed mood, Dizziness
Clinical narrative: Moderna Covid Vaccine. Uncontrollable anxiety, tears, inundated with horrible smells, food does not taste right, sweating and chilling at same time. Hot flashes, nausea, dizziness, headaches, desire to not be alive. No joy in life which is opposite of my normal state. Unstable emotions especially sadness. No motivation to accomplish anything.
Sex: F
Vaccine: COVID19
Symptoms: Emotional disorder, Headache, Hot flush, Hyperhidrosis, Nausea
Clinical narrative: Moderna Covid Vaccine. Uncontrollable anxiety, tears, inundated with horrible smells, food does not taste right, sweating and chilling at same time. Hot flashes, nausea, dizziness, headaches, desire to not be alive. No joy in life which is opposite of my normal state. Unstable emotions especially sadness. No motivation to accomplish anything.
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder, Tearfulness
Clinical narrative: Moderna Covid Vaccine. Uncontrollable anxiety, tears, inundated with horrible smells, food does not taste right, sweating and chilling at same time. Hot flashes, nausea, dizziness, headaches, desire to not be alive. No joy in life which is opposite of my normal state. Unstable emotions especially sadness. No motivation to accomplish anything.
Age: 72.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Swelling, Swelling face
Clinical narrative: Left arm became red after injection of pneumonia vaccine (not unexpected). Day two entire arm was red and swelling. Day three went to Emergency Department because of redness from elbow to shoulder with increased swelling. Including swelling this time to upper left chest and rib area along with swelling to left side of neck and face. The Emergency Department gave me a steroid shot which did help. Day four swelling decreased, arm less red slightly decreased from previous day but now left arm burning. Day five shows no further improvement however, burning is now in the upper and lower left arm. Will return to E.D. tomorrow if needed. No test done by E.D.
Sex: F
Vaccine: COVID19
Symptoms: Auricular swelling, Cutaneous vasculitis, Lip swelling, Palatal swelling, Pruritus
Clinical narrative: I received the Spikevax 12 vaccine on 09/09/2024 at pharmacy. On 09/10/24 my right external ear began to swell. Over the next few weeks I experienced bilateral external ear swelling, hives with itching on my chest, face and hands. The symptoms would come and go in different areas. On 9/27/2024 my upper lip swelled with mild internal upper palate swelling. I saw my physician on 9/30/2024 and was diagnosed with vaccine side effects. I started on Prednisone 30 mg tapering dose. That evening, after my visit on 9/30/2024, I experienced full facial swelling. I began prednisone as prescribed. On 10/01/2024 I experienced scal psoriasis (had not expereinced it since I was a teenager).Over the next few weeks the thin top later of my entire scalp came off in pieces. No new symptoms while on Prednisone. I finished the Predinsone on Friday 10/11/2024. Facial swelling and lesions on right hand started on 10/12/2024. I was seen at hospital on 10/13/2024 and diagnosed with small vessel vasculitis to the right hand related to vaccine. I was put on Prednisone 20 mg tapering dose over 6 to 8 weeks. No new symptoms while on Prednisone. I stopped Prednisone on 12/4/2024. On 12/5/2024 I had 2 small vasculitis spots develop on my right wrist. They started to diminish on their own. No new symptoms since that time. I have many pictures of my symptoms if you would like to see them. I had no other changes in diet , products or medication near the time of symptoms.
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis, Skin exfoliation, Skin lesion, Swelling face, Urticaria
Clinical narrative: I received the Spikevax 12 vaccine on 09/09/2024 at pharmacy. On 09/10/24 my right external ear began to swell. Over the next few weeks I experienced bilateral external ear swelling, hives with itching on my chest, face and hands. The symptoms would come and go in different areas. On 9/27/2024 my upper lip swelled with mild internal upper palate swelling. I saw my physician on 9/30/2024 and was diagnosed with vaccine side effects. I started on Prednisone 30 mg tapering dose. That evening, after my visit on 9/30/2024, I experienced full facial swelling. I began prednisone as prescribed. On 10/01/2024 I experienced scal psoriasis (had not expereinced it since I was a teenager).Over the next few weeks the thin top later of my entire scalp came off in pieces. No new symptoms while on Prednisone. I finished the Predinsone on Friday 10/11/2024. Facial swelling and lesions on right hand started on 10/12/2024. I was seen at hospital on 10/13/2024 and diagnosed with small vessel vasculitis to the right hand related to vaccine. I was put on Prednisone 20 mg tapering dose over 6 to 8 weeks. No new symptoms while on Prednisone. I stopped Prednisone on 12/4/2024. On 12/5/2024 I had 2 small vasculitis spots develop on my right wrist. They started to diminish on their own. No new symptoms since that time. I have many pictures of my symptoms if you would like to see them. I had no other changes in diet , products or medication near the time of symptoms.
Age: 92.0
Sex: M
Vaccine: RSV
Symptoms: Syncope
Clinical narrative: Reported Symptoms: 1042772:SYNCOPE; Narrative: Other Relevant HX:
Age: 11.0
Sex: M
Vaccine: FLU3, MNQ, TDAP
Symptoms: Injection site induration, Injection site pain
Clinical narrative: received Flu & MCV4 in (L) arm on 12/6/24. Hard area noted on 12/8/24 in area where vaccines given. 2x2 mass noted on 12/11/24 in area where vaccines given. No macular erythema. (+) tenderness to mass.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: Reported Symptoms: 10016256:FATIGUE; 10019211:HEADACHE; 10047700:VOMITING; Narrative: Other Relevant HX: Other: fatigue
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Back pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: Reported Symptoms: 1005886:BLURRED VISION; 10016256:FATIGUE; 10019211:HEADACHE; 10042043:STIFF NECK; 10043876:TINGLING; 10047700:VOMITING; Narrative: Other Relevant HX: Chronic neck and back pain Intermittent numbness and tingling for years in upper extremity Other: stiff neck, tingling in legs, stinging in arm, bloating, fatigue
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Paraesthesia, Vision blurred
Clinical narrative: Reported Symptoms: 1005886:BLURRED VISION; 10016256:FATIGUE; 10019211:HEADACHE; 10042043:STIFF NECK; 10043876:TINGLING; 10047700:VOMITING; Narrative: Other Relevant HX: Chronic neck and back pain Intermittent numbness and tingling for years in upper extremity Other: stiff neck, tingling in legs, stinging in arm, bloating, fatigue
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Reported Symptoms: 1005886:BLURRED VISION; 10016256:FATIGUE; 10019211:HEADACHE; 10042043:STIFF NECK; 10043876:TINGLING; 10047700:VOMITING; Narrative: Other Relevant HX: Chronic neck and back pain Intermittent numbness and tingling for years in upper extremity Other: stiff neck, tingling in legs, stinging in arm, bloating, fatigue
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Reported Symptoms: 10064366:EXTRA DOSE ADMINISTERED; Narrative: Patient received RSV vaccine Abrysvo both on 12/18/2023 and 3/18/2024. Only one vaccine dose of any RSV vaccine is indicated per lifetime. Other Relevant HX: Other: DUPLICATE RSV VACCINE RECEIVED
Age: 69.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Reported Symptoms: 10008531:CHILLS; 10016558:FEVER; 10028411:MYALGIA; Narrative: Other Relevant HX: Other: Chills
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypotension, Sepsis
Clinical narrative: Reported Symptoms: 10021097:HYPOTENSION; 10047862:WEAKNESS; 10047865:WEAKNESS GENERALIZED; Narrative: Other Relevant HX: 56 yro with baseline poor health with multiple chronic issues, ESRD on IHD, chronic hypotension - on outpt midordrine, chronic adrenal insufficiency - on oral outpt hydrocortisone. Other: weakness
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Reported Symptoms: 10022086:INJECTION SITE PAIN; 10037844:RASH; 10071292:INJECTION SITE LUMP; Narrative: Pt reported to her PCP 1 day after receiving Prevnar-20 vaccine she noticed itching at the injection site followed by noticing that the site is with erythema, warmth, and a firmness underneath about 7 days later. She denied any fever or chills, shortness of breath, dysphagia. She had not taken any medications or used any topicals at the injection site. She stated that overall she felt unwell but this reaction concerned her. Provider advised benadryl cream at swollen red rash injection site. Provider also called in a Rx to local pharmacy for Keflex to use if Benadryl is not helpful as this might be a cellulitis infection. Other Relevant HX: Other: painful lump at injection site
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: Reported Symptoms: 10022086:INJECTION SITE PAIN; 10037844:RASH; 10071292:INJECTION SITE LUMP; Narrative: Pt reported to her PCP 1 day after receiving Prevnar-20 vaccine she noticed itching at the injection site followed by noticing that the site is with erythema, warmth, and a firmness underneath about 7 days later. She denied any fever or chills, shortness of breath, dysphagia. She had not taken any medications or used any topicals at the injection site. She stated that overall she felt unwell but this reaction concerned her. Provider advised benadryl cream at swollen red rash injection site. Provider also called in a Rx to local pharmacy for Keflex to use if Benadryl is not helpful as this might be a cellulitis infection. Other Relevant HX: Other: painful lump at injection site
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Angina pectoris, Chest pain, Hallucination, Nausea
Clinical narrative: Reported Symptoms: 10000081: ABDOMINAL PAIN; 10002391: ANGINAL PAIN; 10008479: CHEST PAIN; 10016558: FEVER; 10019877: HALLUCINATIONS; 10028813: NAUSEA; 10047700: VOMITING; Narrative: Other Relevant HX: Other: HALLUCINATIONS; FEVER; NAUSEA; CHEST PAIN; ABDOMINAL PAIN
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Reported Symptoms: 10000081: ABDOMINAL PAIN; 10002391: ANGINAL PAIN; 10008479: CHEST PAIN; 10016558: FEVER; 10019877: HALLUCINATIONS; 10028813: NAUSEA; 10047700: VOMITING; Narrative: Other Relevant HX: Other: HALLUCINATIONS; FEVER; NAUSEA; CHEST PAIN; ABDOMINAL PAIN
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms: 10063972:VACCINATION ERROR; Narrative: Patient received a second injection of Prevnar-20 on 11/18/2024 in error at Primary Care Clinic. Patient had previously received this on 12/6/2022. Only one dose of Prevnar-20 is recommeded for adults. Patient was observed for 30 minutes post injection. Patient tolerated injection well and reported no adverse reactions. Nurse realized her error and reported it to the attending physician. Also, a report was entered and submitting to VAERS. Other Relevant HX: Other: pt got a second dose of Prevnar-20 in error.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood folate normal, Blood thyroid stimulating hormone normal, Cerebral atrophy, Computerised tomogram head abnormal
Clinical narrative: Reported Symptoms: 10016178:FALLING DOWN; 10047862:WEAKNESS; Narrative: 85 YOM with past medical history of documented unsteadiness, permanent pacmaker, hypertension, PTSD, atrial fibrillation, on chronic anticoagulation, prostate cancer, and recent COVID hospitalization 4/2020 presented to the ED for falls and weakness on 2/21/2021 after receiving the first dose of the Moderna COVID-19 vaccine on 2/20/2021. Paitent reported that he was negative for COVID-19, influenza, and RSV. A CT head showed no acute intracranial hemorrhage but diffuse cerebral atrophy and the patient was admitted. During hospitalization, neurology workup was unremarkable for dementia and peripheral neuropathy as labs such as vitamin B12, folate, and thyroid stimulating hormone which were all within normal limits. Patient was monitored closely during hospitalization and was discharged on 2/23/2021 after returning to baseline. Patient returned to the ED with weakness and a fever of 101 degrees Fahrenheit overnight on 3/21/2021 after receiving the second dose of the Moderna COVID vaccine on 3/20/2021. Patient was again negative for COVID-19, influenza, and RSV. Patient was admitted for possible pacemaker malfunction seen on EKG and his pacemaker was interrogated without events. Patient was given IV fluids and per his report experienced symptom improvement 3/22/2021. Patient was evaluated by physicial therapy and cleared to return home on 3/23/2021 without home
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Fall, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative
Clinical narrative: Reported Symptoms: 10016178:FALLING DOWN; 10047862:WEAKNESS; Narrative: 85 YOM with past medical history of documented unsteadiness, permanent pacmaker, hypertension, PTSD, atrial fibrillation, on chronic anticoagulation, prostate cancer, and recent COVID hospitalization 4/2020 presented to the ED for falls and weakness on 2/21/2021 after receiving the first dose of the Moderna COVID-19 vaccine on 2/20/2021. Paitent reported that he was negative for COVID-19, influenza, and RSV. A CT head showed no acute intracranial hemorrhage but diffuse cerebral atrophy and the patient was admitted. During hospitalization, neurology workup was unremarkable for dementia and peripheral neuropathy as labs such as vitamin B12, folate, and thyroid stimulating hormone which were all within normal limits. Patient was monitored closely during hospitalization and was discharged on 2/23/2021 after returning to baseline. Patient returned to the ED with weakness and a fever of 101 degrees Fahrenheit overnight on 3/21/2021 after receiving the second dose of the Moderna COVID vaccine on 3/20/2021. Patient was again negative for COVID-19, influenza, and RSV. Patient was admitted for possible pacemaker malfunction seen on EKG and his pacemaker was interrogated without events. Patient was given IV fluids and per his report experienced symptom improvement 3/22/2021. Patient was evaluated by physicial therapy and cleared to return home on 3/23/2021 without home
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Vitamin B12 normal
Clinical narrative: Reported Symptoms: 10016178:FALLING DOWN; 10047862:WEAKNESS; Narrative: 85 YOM with past medical history of documented unsteadiness, permanent pacmaker, hypertension, PTSD, atrial fibrillation, on chronic anticoagulation, prostate cancer, and recent COVID hospitalization 4/2020 presented to the ED for falls and weakness on 2/21/2021 after receiving the first dose of the Moderna COVID-19 vaccine on 2/20/2021. Paitent reported that he was negative for COVID-19, influenza, and RSV. A CT head showed no acute intracranial hemorrhage but diffuse cerebral atrophy and the patient was admitted. During hospitalization, neurology workup was unremarkable for dementia and peripheral neuropathy as labs such as vitamin B12, folate, and thyroid stimulating hormone which were all within normal limits. Patient was monitored closely during hospitalization and was discharged on 2/23/2021 after returning to baseline. Patient returned to the ED with weakness and a fever of 101 degrees Fahrenheit overnight on 3/21/2021 after receiving the second dose of the Moderna COVID vaccine on 3/20/2021. Patient was again negative for COVID-19, influenza, and RSV. Patient was admitted for possible pacemaker malfunction seen on EKG and his pacemaker was interrogated without events. Patient was given IV fluids and per his report experienced symptom improvement 3/22/2021. Patient was evaluated by physicial therapy and cleared to return home on 3/23/2021 without home
Age: 69.0
Sex: M
Vaccine: PNC20
Symptoms: Hemiparesis, Hyperhidrosis, Muscular weakness
Clinical narrative: Reported Symptoms: 10065794:MUSCLE WEAKNESS RIGHT-SIDED; Narrative: 69 YOM hx of multiple sclerosis, asthma, hypertension, hyperlipidemia, melanoma, and neurogenic bladder received PCV20 vaccine on 9/4/2024. Patient reported that 24 hours after receiving the vaccine he experienced right arm/upper quadrant sweating and R arm weakness. Patient reported that the sweating resolved within 48-72 hours and right arm weakness persisted and resolved gradually over 1 month without any extra measures or interventions. Other Relevant HX: Other: Right arm/right upper quadrant sweating and right arm weakness
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Echocardiogram, Electrocardiogram, Generalised anxiety disorder, Imaging procedure
Clinical narrative: MODERNA #1 5/29/2021 MODERNA #2 6/26/2021 MODERNA #3 12/29/2021 MODERNA #4 12/28/2022 MODERNA #5 9/28/2023 MODERNA #6 4/9/2024   PATIENT HAD GENERALIZED SEIZURE AND PAROXYSMAL ATRIAL FIBRILLATION REQURING HOSPITALIZATION.  DIAGNOSED WITH VACCINE INDUCED SEIZURES AND SUBCLINICAL MYOPERICARDITIS.  TREATED WITH COLCHICINE, FLECAINIDE, IVERMECTIN AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Myopericarditis, Seizure
Clinical narrative: MODERNA #1 5/29/2021 MODERNA #2 6/26/2021 MODERNA #3 12/29/2021 MODERNA #4 12/28/2022 MODERNA #5 9/28/2023 MODERNA #6 4/9/2024   PATIENT HAD GENERALIZED SEIZURE AND PAROXYSMAL ATRIAL FIBRILLATION REQURING HOSPITALIZATION.  DIAGNOSED WITH VACCINE INDUCED SEIZURES AND SUBCLINICAL MYOPERICARDITIS.  TREATED WITH COLCHICINE, FLECAINIDE, IVERMECTIN AND PROTOCOL BASE SPIKE DETOXIFICATION.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was past the 10 week refrigerator expiry date, but NOT past the boxes expiration date. No adverse reactions have occurred in patient up to this point