chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: In  November pt. received booster dose of 0.25ml (booster dose) instead of 0.5ml (additional dose). In December it was advised to give other half of additional dose so received another 0.25ml. According to CDC Covid-19 administration errors and deviations (2-22-2022), lower-than- authorized dose volume should be repeated so pt. was given 0.5ml dose on 4/8/22 and completing VAERS for 12/2/21 dose of 0.25ml
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna was administered after the BUD of 3/30/2022
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: PATIENT CALLED TODAY AT 3:45 PM CONCERNED THAT THE VACCINATION SITE HAD DEVOPED A PAINFUL KNOTT, APPORIMATELY A QUARTER IN SIZE AREA OF SWELLING AND SOME HEAT. I RECOMENED THAT SHE HAVE IT SEEN BY A DOCTOR
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna was administered after the Beyond Use Date of 3/30/2022
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient is 17 years and nearly 11 months. She will be fully 18 years old in few weeks by 5/11/22. She had signed up for Moderna first dose vaccine, instead of the pfizer one. So when she arrived in the pharmacy, her age was missed that she wasn't quite 18 years old yet and was given the Moderna shot instead of the pfizer as recommended. We spoke to the patient the next day and she was doing fine.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: Nausea and vomitting, and severe headache for 3 days after receiving the 2nd dose of COVID-19 vaccine Frequent episodes of chest pain, shortness of breath, lightheadedness 6 weeks after receiving the 2nd dose of COVID-19 vaccine
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea and vomitting, and severe headache for 3 days after receiving the 2nd dose of COVID-19 vaccine Frequent episodes of chest pain, shortness of breath, lightheadedness 6 weeks after receiving the 2nd dose of COVID-19 vaccine
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: PATIENT STOPPED BY THE PHARMACY AT 3:56PM TO SHOW ME THE ODD SHAPED FOUR PLUS INCH RED RAISED WARM RASH OVER THE VACCINATION SITE. I ADVISED SHE SHOW IT TO HER DOCTOR OR POSSIBLY TRY AN ANTIHISTAMINE
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Basedow's disease, Biopsy, Blood test, Computerised tomogram, Fatigue
Clinical narrative: Tachycardia,Trembing hands,fatigue,hyperthyroidism,graves disease,mediastinal mass,lymph nodes.  Xrays,ct scan,mei,pet scan ,countless bloodwork,biopsy Mediastinoscopy
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperthyroidism, Mediastinal mass, Mediastinoscopy, Positron emission tomogram, Tachycardia
Clinical narrative: Tachycardia,Trembing hands,fatigue,hyperthyroidism,graves disease,mediastinal mass,lymph nodes.  Xrays,ct scan,mei,pet scan ,countless bloodwork,biopsy Mediastinoscopy
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tremor, X-ray
Clinical narrative: Tachycardia,Trembing hands,fatigue,hyperthyroidism,graves disease,mediastinal mass,lymph nodes.  Xrays,ct scan,mei,pet scan ,countless bloodwork,biopsy Mediastinoscopy
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral infarction, Fatigue, Full blood count normal, Headache, Hyperhidrosis
Clinical narrative: Headache, fatigue, diaphoresis for 2 days after vaccine, followed by sudden visual disturbance with worsened headache and one episode of vomiting. Headache persisted for a week despite patient's typical migraine treatment, which prompted patient to present to the ED (especially considering her history of hydrocephalus).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Metabolic function test normal, Pregnancy test urine negative, Transverse sinus thrombosis, Venogram
Clinical narrative: Headache, fatigue, diaphoresis for 2 days after vaccine, followed by sudden visual disturbance with worsened headache and one episode of vomiting. Headache persisted for a week despite patient's typical migraine treatment, which prompted patient to present to the ED (especially considering her history of hydrocephalus).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment, Vomiting
Clinical narrative: Headache, fatigue, diaphoresis for 2 days after vaccine, followed by sudden visual disturbance with worsened headache and one episode of vomiting. Headache persisted for a week despite patient's typical migraine treatment, which prompted patient to present to the ED (especially considering her history of hydrocephalus).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Eructation, Flatulence, Secretion discharge
Clinical narrative: Mild to moderate stomach ache, excess burping and flatulence  Increased mucoid secretions, mild asthma symptoms: some wheezing and tight cough  Started at 10 pm day of injection and continued through the next day.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Mild to moderate stomach ache, excess burping and flatulence  Increased mucoid secretions, mild asthma symptoms: some wheezing and tight cough  Started at 10 pm day of injection and continued through the next day.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: MOC called morning after receiving 4 yo vaccine to say Right Thigh was swollen.  Did not resolve for 24 hours and presented to office for evaluation and Right thigh site 3"x2" area of erythema, mild edema and mild tenderness. Slightly warm to touch.     No fever Rx: Benadryl Zyrtec ; ibuprofen prn
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Body temperature increased, Epistaxis
Clinical narrative: brief epistaxis which occured about 6 hours after immunization. epistaxis lasted 5-10 min total. otherwise had temp up to 101.3 but was otherwise well. had same epistaxis following the 4 month vaccines as well
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Syncope
Clinical narrative: Syncope episode with body movements,], pt. awoke was checked by RN's & MD and given fluids & cookies. (patient stated when she woke up this happens w/ every vaccine)
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Headache & Myalgia headache, soreness, and fatigue
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Injection site pain
Clinical narrative: Myalgia, Arthralgia & NauseaVomitting Narrative: 4/6- Sore at injection site. Slightly nauseated. Body aches. Chills. Joint pain, mainly bilateral knees. Runny nose. Took ibuprofen. 4/7- Very fatigue. Body aches. Chills. Soreness to entire upper left arm, left shoulder and L side of chest. Joint pain
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Rhinorrhoea, Vomiting
Clinical narrative: Myalgia, Arthralgia & NauseaVomitting Narrative: 4/6- Sore at injection site. Slightly nauseated. Body aches. Chills. Joint pain, mainly bilateral knees. Runny nose. Took ibuprofen. 4/7- Very fatigue. Body aches. Chills. Soreness to entire upper left arm, left shoulder and L side of chest. Joint pain
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Mechanical urticaria, Rash, Urticarial vasculitis
Clinical narrative: Moderna COVID-19 Vaccine EUA A bad rash all over body diagnosed with urticarial vasculitis. Treated with prednisone medication and zyrtec over 3 weeks. Still have symptoms of dermatographism.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Chest pain, Electrocardiogram, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: high lung pressure; heart attack; chest pain; feeling weird little sensations in my arms & legs; This is a spontaneous report received from contactable Consumers (including patient).   A 32 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in deltoid right, administration date 03Jan2022 (Lot number: FD7218) at the age of 32 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: ongoing immune system disorder (reported as "Immunity"); ongoing loss of energy (reported as "Energy"); "depression" (ongoing). Concomitant medications included: VITAMIN D [VITAMIN D NOS] taken for immune system disorder (ongoing); ASHWAGANDHA taken for asthenia (ongoing); FISH OIL taken for depression (ongoing); VITAMIN B12 [CYANOCOBALAMIN] taken for asthenia (ongoing). Vaccination history included: BNT162b2 (Dose 1, Anatomical site of injection: rt deltoid, Route of administration: Intramuscular, Batch/lot number: 30155BA), administration date: 12Nov2021, for COVID-19 Immunization, reaction(s): "She has inflammation around her heart and has been seeing a doctor for about a month now". The patient stated she started feeling weird little sensations in her arms & legs (in Jan2022) and then a few days later chest pain (on 13Jan2022), especially after exercise, clarifying this had continued for about 2 months to varying degrees and had lessened over time but was still present. The patient considered the event chest pain was life-threatening and required physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (25Jan2022) normal; echocardiogram: (09Feb2022) almost normal, notes: showed high lung pressure; electrocardiogram: (25Jan2022) abnormal, notes: showed heart attack; (27Jan2022) abnormal, notes: showed heart attack. Therapeutic measures were taken as a result of the events which included anti inflammatory & heart meds. The outcome of the events was not recovered.  Follow-Up (08Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Myocardial infarction, Pain
Clinical narrative: high lung pressure; heart attack; chest pain; feeling weird little sensations in my arms & legs; This is a spontaneous report received from contactable Consumers (including patient).   A 32 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in deltoid right, administration date 03Jan2022 (Lot number: FD7218) at the age of 32 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: ongoing immune system disorder (reported as "Immunity"); ongoing loss of energy (reported as "Energy"); "depression" (ongoing). Concomitant medications included: VITAMIN D [VITAMIN D NOS] taken for immune system disorder (ongoing); ASHWAGANDHA taken for asthenia (ongoing); FISH OIL taken for depression (ongoing); VITAMIN B12 [CYANOCOBALAMIN] taken for asthenia (ongoing). Vaccination history included: BNT162b2 (Dose 1, Anatomical site of injection: rt deltoid, Route of administration: Intramuscular, Batch/lot number: 30155BA), administration date: 12Nov2021, for COVID-19 Immunization, reaction(s): "She has inflammation around her heart and has been seeing a doctor for about a month now". The patient stated she started feeling weird little sensations in her arms & legs (in Jan2022) and then a few days later chest pain (on 13Jan2022), especially after exercise, clarifying this had continued for about 2 months to varying degrees and had lessened over time but was still present. The patient considered the event chest pain was life-threatening and required physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (25Jan2022) normal; echocardiogram: (09Feb2022) almost normal, notes: showed high lung pressure; electrocardiogram: (25Jan2022) abnormal, notes: showed heart attack; (27Jan2022) abnormal, notes: showed heart attack. Therapeutic measures were taken as a result of the events which included anti inflammatory & heart meds. The outcome of the events was not recovered.  Follow-Up (08Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest pain, Echocardiogram, Electrocardiogram, Lung disorder
Clinical narrative: high lung pressure; heart attack; chest pain; feeling weird little sensations in my arms & legs; This is a spontaneous report received from contactable Consumers (including patient).   A 32 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in deltoid right, administration date 03Jan2022 (Lot number: FD7218) at the age of 32 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: ongoing immune system disorder (reported as "Immunity"); ongoing loss of energy (reported as "Energy"); "depression" (ongoing). Concomitant medications included: VITAMIN D [VITAMIN D NOS] taken for immune system disorder (ongoing); ASHWAGANDHA taken for asthenia (ongoing); FISH OIL taken for depression (ongoing); VITAMIN B12 [CYANOCOBALAMIN] taken for asthenia (ongoing). Vaccination history included: BNT162b2 (Dose 1, Anatomical site of injection: rt deltoid, Route of administration: Intramuscular, Batch/lot number: 30155BA), administration date: 12Nov2021, for COVID-19 Immunization, reaction(s): "She has inflammation around her heart and has been seeing a doctor for about a month now". The patient stated she started feeling weird little sensations in her arms & legs (in Jan2022) and then a few days later chest pain (on 13Jan2022), especially after exercise, clarifying this had continued for about 2 months to varying degrees and had lessened over time but was still present. The patient considered the event chest pain was life-threatening and required physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (25Jan2022) normal; echocardiogram: (09Feb2022) almost normal, notes: showed high lung pressure; electrocardiogram: (25Jan2022) abnormal, notes: showed heart attack; (27Jan2022) abnormal, notes: showed heart attack. Therapeutic measures were taken as a result of the events which included anti inflammatory & heart meds. The outcome of the events was not recovered.  Follow-Up (08Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, Sensory disturbance
Clinical narrative: high lung pressure; heart attack; chest pain; feeling weird little sensations in my arms & legs; This is a spontaneous report received from contactable Consumers (including patient).   A 32 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in deltoid right, administration date 03Jan2022 (Lot number: FD7218) at the age of 32 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: ongoing immune system disorder (reported as "Immunity"); ongoing loss of energy (reported as "Energy"); "depression" (ongoing). Concomitant medications included: VITAMIN D [VITAMIN D NOS] taken for immune system disorder (ongoing); ASHWAGANDHA taken for asthenia (ongoing); FISH OIL taken for depression (ongoing); VITAMIN B12 [CYANOCOBALAMIN] taken for asthenia (ongoing). Vaccination history included: BNT162b2 (Dose 1, Anatomical site of injection: rt deltoid, Route of administration: Intramuscular, Batch/lot number: 30155BA), administration date: 12Nov2021, for COVID-19 Immunization, reaction(s): "She has inflammation around her heart and has been seeing a doctor for about a month now". The patient stated she started feeling weird little sensations in her arms & legs (in Jan2022) and then a few days later chest pain (on 13Jan2022), especially after exercise, clarifying this had continued for about 2 months to varying degrees and had lessened over time but was still present. The patient considered the event chest pain was life-threatening and required physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (25Jan2022) normal; echocardiogram: (09Feb2022) almost normal, notes: showed high lung pressure; electrocardiogram: (25Jan2022) abnormal, notes: showed heart attack; (27Jan2022) abnormal, notes: showed heart attack. Therapeutic measures were taken as a result of the events which included anti inflammatory & heart meds. The outcome of the events was not recovered.  Follow-Up (08Apr2022): Follow-up attempts are completed. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Basedow's disease, Hypothyroidism
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: FK5618) at the age of 11 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MENINGOCOCCAL VACCINE, administration date 02Nov2021; INFLUENZA VIRUS VACCINE INACTIVATED, administration date 02Nov2021; TDAP, administration date 02Nov2021; ADDERALL. Vaccination history included: Bnt162b2 (previous dose details:, previous dose product= COVID-19, previous dose brand= Pfizer, previous  dose brand unknown= False, previous dose lot number= fk5127, previous  dose lot unknown= False, previous  dose administration date=11Dec2021, previous  dose dose number=1), administration date: 20Nov2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant) with onset 15Jan2022, outcome "not recovered", described as "Hyperthyroidism"; BASEDOW'S DISEASE (medically significant) with onset 15Jan2022, outcome "not recovered", described as "Graves' Disease". The events "hyperthyroidism" and "Graves' disease" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hyperthyroidism, Basedow's disease. Clinical Courses: There was no vaccination prior to Covid and no Covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Basedow's disease, Hyperthyroidism
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 11Dec2021 (Lot number: FK5618) at the age of 11 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MENINGOCOCCAL VACCINE, administration date 02Nov2021; INFLUENZA VIRUS VACCINE INACTIVATED, administration date 02Nov2021; TDAP, administration date 02Nov2021; ADDERALL. Vaccination history included: Bnt162b2 (previous dose details:, previous dose product= COVID-19, previous dose brand= Pfizer, previous  dose brand unknown= False, previous dose lot number= fk5127, previous  dose lot unknown= False, previous  dose administration date=11Dec2021, previous  dose dose number=1), administration date: 20Nov2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: HYPERTHYROIDISM (medically significant) with onset 15Jan2022, outcome "not recovered", described as "Hyperthyroidism"; BASEDOW'S DISEASE (medically significant) with onset 15Jan2022, outcome "not recovered", described as "Graves' Disease". The events "hyperthyroidism" and "Graves' disease" were evaluated at the physician office visit. Therapeutic measures were taken as a result of hyperthyroidism, Basedow's disease. Clinical Courses: There was no vaccination prior to Covid and no Covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: DEVELOPED A RIGHT SIDED VIITH CN PALSY (FACIAL PARALYSIS); MILD FACIAL (LEFT) ITCHING; LEFT EYE TEARING; This spontaneous report received from a patient patient (also a healthcare professional) concerned a 73 year old, male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no recent significant medical history. The patient was a physician. The patient previously received covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number, expiry were not reported) dose was not reported, 1 total administered on unspecified date in MAY-2021 for prophylactic vaccination. It was unknown if patient experienced any adverse reactions following administration of covid-19 vaccine ad26.cov2.s vaccine (Dose number in series 1). The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: Unknown) dose was not reported, 1 total administered to left arm on 18-NOV-2021 for prophylactic vaccination. The product was stored in appropriate temperature conditions and it was properly stored from receipt to administration. No concomitant medications were reported.  On 06-MAR-2022, the patient experienced left eye tearing. On 30-MAR-2022, (Reported as 28 weeks after vaccination) the patient developed a right sided VII th cranial nerve (CN) palsy (facial paralysis) and also experienced prodromal symptoms included left side mild facial itching (Dose number in series 2). On 05-APR-2022, patient started treatment with prednisone (taped dossing 30 mg/qd x 5). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from left eye tearing, and the outcome of developed a right sided vii th CN palsy (facial paralysis) and mild facial (left) itching was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220410169-COVID-19 VACCINE AD26.COV2.S- Developed a right sided VIIth CN palsy (facial paralysis), Left eye tearing, Mild facial (left) itching. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Lacrimation increased, Pruritus
Clinical narrative: DEVELOPED A RIGHT SIDED VIITH CN PALSY (FACIAL PARALYSIS); MILD FACIAL (LEFT) ITCHING; LEFT EYE TEARING; This spontaneous report received from a patient patient (also a healthcare professional) concerned a 73 year old, male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no recent significant medical history. The patient was a physician. The patient previously received covid-19 vaccine ad26. cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number, expiry were not reported) dose was not reported, 1 total administered on unspecified date in MAY-2021 for prophylactic vaccination. It was unknown if patient experienced any adverse reactions following administration of covid-19 vaccine ad26.cov2.s vaccine (Dose number in series 1). The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: Unknown) dose was not reported, 1 total administered to left arm on 18-NOV-2021 for prophylactic vaccination. The product was stored in appropriate temperature conditions and it was properly stored from receipt to administration. No concomitant medications were reported.  On 06-MAR-2022, the patient experienced left eye tearing. On 30-MAR-2022, (Reported as 28 weeks after vaccination) the patient developed a right sided VII th cranial nerve (CN) palsy (facial paralysis) and also experienced prodromal symptoms included left side mild facial itching (Dose number in series 2). On 05-APR-2022, patient started treatment with prednisone (taped dossing 30 mg/qd x 5). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from left eye tearing, and the outcome of developed a right sided vii th CN palsy (facial paralysis) and mild facial (left) itching was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220410169-COVID-19 VACCINE AD26.COV2.S- Developed a right sided VIIth CN palsy (facial paralysis), Left eye tearing, Mild facial (left) itching. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose
Clinical narrative: He was feeling a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (He was feeling a little tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tuberculosis (Tuberculosis when we had 3-4 years of age). Concurrent medical conditions included Seasonal allergy.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (He was feeling a little tired). At the time of the report, FATIGUE (He was feeling a little tired) outcome was unknown.            Patient was never tested positive for COVID-19 Concomitant medication reported as Unknown drug for Cholesterol No vaccines given within 1 month prior to Moderna COVID-19 vaccine No treatment details were reported.   This case was linked to MOD-2022-533860 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: He was feeling a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (He was feeling a little tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tuberculosis (Tuberculosis when we had 3-4 years of age). Concurrent medical conditions included Seasonal allergy.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (He was feeling a little tired). At the time of the report, FATIGUE (He was feeling a little tired) outcome was unknown.            Patient was never tested positive for COVID-19 Concomitant medication reported as Unknown drug for Cholesterol No vaccines given within 1 month prior to Moderna COVID-19 vaccine No treatment details were reported.   This case was linked to MOD-2022-533860 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Rash papular, Rash pruritic
Clinical narrative: Over a week after receiving my second COVID-19 booster, I started getting rashes on my skin on different part of my body; below waist, hand, inner side wrist, foot, over groin, under the breast. It was itching and burning. Occasionally I could see and feel very thin elongated bump strips on the rash area. I had also itched on my head under the hair.  The largest rash size was about 4"x3". The rash attack' would build up in few minutes and last close to an hour. I have been having rashes every day till the present day. In recent days the rash frequency has been coming down and the rash area is now smaller and less intensive in terms of itching and burning. I have never experienced such rashes in my life. (All my 3 previous COVID-19 vaccination were Moderna after which there were no rashes.) I would like to point out that my husband received his second booster on 3/11/2022 at the same pharmacy, Moderna lot 045L21A (same as my lot). However, my husband till the present day did not experience any rash
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Myalgia, Pyrexia
Clinical narrative: Fever, muscle pain, generalized malaise, weakness.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No other issues or concerns noted; a patient was administered a improperly stored vaccine on 07-MAR-2022; HEP A vaccine was prepared on Friday with needle attached, notified to supervisor, mother was call and notified about the incident; This spontaneous report was received from an other, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was unknown by reporter.    On 04-MAR-2022 (reported as Friday), the vaccine had the needle attached  and was put back in the refrigerator. On 07-MAR-2022, the patient was administered an improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # T031201 with expiration date: 14-JUN-2022; dose, strength and route of administration were unknown by reporter) for prophylaxis (product storage error;  product preparation issue). No other issues or concerns noted.  The case is non-valid due to lack of the patient's identifiers.  Follow-up information was received from a registered nurse on 08-MAR-2022, referring to a 1-year-old male patient.  The patient had no concurrent conditions, past medical history and drugs reactions or allergies. The patient's concomitant vaccines included haemophilus b conjugate vaccine (meningococcal protein conjugate)( LIQUID PEDVAXHIB), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck)( VARIVAX) and pneumococcal vaccine conj 13 v (crm197)( PREVNAR 13).  The patient's mother was called and notified of the incident and was informed that the manufacturer recommended a repeat vaccination. The patient's mother confirmed that he did not have any adverse effects. On 14-MAR-2022, the patient was revaccinated with hepatitis a vaccine, inactivated (VAQTA).
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Adult patient received a pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant concerning to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 22-DEC-2021, the adult patient was vaccinated with a pediatric dose (incorrect dose administered) of hepatitis b vaccine (recombinant) thimerosal-free (RECOMBIVAX HB), 5 mcg/0.5 mL strength, lot number U001837 with expiration date reported as 21-NOV-2022 but internally validated as 28-APR-2023 for prophylaxis (dose, route of administration and anatomical location were not reported).  No adverse event or product quality complaint (PQC) were reported.  At the reporting time, the patient's outcome was unknown.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA004547: US-009507513-2203USA004223:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: VARlVAX and MMRII administered with 0.9 sodium chloride instead of the supplied sterile diluent; No additional AE; This spontaneous report was received from a registered Nurse referring to a currently 1 year old patient. The patient's medical history, concurrent conditions, drug/allergy history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T016195, expiration date: 11-JUN-2022, administered for prophylaxis (strength, and route of administration were not provided); varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #T032316, expiration date: 22-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that vaccines were administered with sodium chloride 0.9 lot #27-065-DK, expiration date: 01-MAR-2023 (strength, formulation, route of administration, and indication were not provided), instead of the supplied diluent (Product preparation issue). No additional adverse event was reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administration of expired ROTATEQ; This spontaneous report was received from a licensed practical nurse regarding a 4-month-old patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 18-MAR-2022, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot number: 1741377 and expiration date: 07-MAR-2022; both confirmed as valid) as prophylaxis (expired product administered). No additional adverse events reported (no adverse event).
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product, Wrong technique in product usage process
Clinical narrative: her daughter coughed after receiving the vaccine; a 7-day-old patient received ROTATEQ; The staff member did not follow protocol/ Was the vaccine/vaccine-device used according to the instruction leaflet? No; Administered rotavirus vaccine to the newborn instead of the designated child; This spontaneous report has been received from a nurse, an office employee, and a consumer referring to a 7-day-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.   On 22-MAR-2022, according to the nurse and the office employee, the patient was administered 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose not reported; lot number 1742421 has been verified to be valid, expiration date reported as 17-DEC-2022, but upon internal verification was established as 07-DEC-2022) as prophylaxis (product administered to patient of inappropriate age).   On 22-MAR-2022, according to the patient's mother, the patient coughed after receiving the vaccine.   According to the office employee, the patient was being seen at the clinic for routine newborn follow up. A child with a similar name as the patient was ordered vaccines. The staff member did not follow the protocol (wrong technique in product usage process) and administered rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to the patient, instead of the designated child (wrong patient received product). The child was monitored and had daily follow ups for three days. The office employee stated that no significant side effects occurred.   The outcome of cough was unknown. The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No other adverse events reported; Caller reports that seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 16-MAR-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, 1 dose, lot # U008899, expiration date 12-AUG-2023 (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The temperature excursion was 33.4 Fahrenheit degrees for 2595 hours. There were no previous temperature excursions. No other adverse events were reported (no adverse event).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2203USA008097: US-009507513-2203USA007812: US-009507513-2203USA008063: US-009507513-2203USA007915: US-009507513-2203USA008053:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; a patient was administered an expired dose of ROTATEQ; This spontaneous report was received from a physician and refers to a patient of unknown age or gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.  On 24-MAR-2022 (also reported as today), the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (expired product administered) (dose and route not reported; valid lot #1741376, expiration date: 06-MAR-2022) for prophylaxis. It was confirmed that the vaccine never experienced any temperature excursion. The reporter was provided the supported disclaimer based on the post expiry memo, and was provided the case number for reference. No additional adverse event was reported (no adverse event).
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HCP reports no further AE's; inadvertent administration of PROQUAD instead of MMR II; inadvertent administration of PROQUAD instead of MMR II; This spontaneous report was received from a nurse and refers to a 17-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included varicella virus vaccine live (oka/merck) (VARIVAX) and multiple other vaccines (unspecified).  On 23-MAR-2022, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #U029325, expiration date: 19-MAR-2023, reconstituted with sterile diluent administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). Vaccines were administered. No further adverse events (AE's) were reported.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported; Caller is nurse who reported that patient received PNEUMOV AX 23 on 11/3/2020 and then agian 11/22/2021; This spontaneous report was received from a registered nurse and refers to a 51-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 03-NOV-2020, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dose (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On 22-NOV-2021, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dose (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse events were reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Accidental underdose, Exposure via skin contact, Product administration error
Clinical narrative: No further AE's were reported; when GARD ASIL 9 was administered to a patient some of the vaccine leaked down the patients arm; Exposure via skin contact; it was a user error with administering the vaccine; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug allergies were not reported.   On 23-MAR-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 ml one time, lot # U008316 was found to be valid, expiration date 15-AUG-2023 (route of administration and injection site were not reported) for prophylaxis. While vaccination, due to error with administering the vaccine (product administration error) some of the vaccine leaked down the patient's arm (accidental underdose, exposure via skin contact). No further adverse events (AE's) were reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: No additional AE.; patient was administered ROT ATEQ and PEDV AX HIB after products experienced supported temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 21-MAR-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2ml at once orally, lot # 1742464, expiration date 20-SEP-2022; and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5ml at once, lot # u014992, expiration date 29-OCT-2023 (exact route of administration was not provided) for prophylaxis (product storage error). No details about the temperature excursion was provided. It was unknown if digital data logger was involved. No additional adverse event was reporter (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other symptoms or AE reported; Caller is an office manager who reports four doses of VARIVAX were given following temperature excursion. No other symptoms or other AE reported. No other AE/no PQC.         ?    Names of vaccines involved (including lot/exp) VARIVAX, lot U022732 e; This spontaneous report was received from an office manager on 29-MAR-2022, concerning a patient of unknown age and gender.There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. In March 2022, the patient was vaccinated with an improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) lot # U022732, expiration date: 20-JUL-2023 for prophylaxis (dose and route of administration were not reported) (Product storage error).  The administered dose of the vaccine experienced a temperature excursion of 7.4 Fahrenheit for 10 minutes and 5.4 Fahrenheit for 5 minutes, on 25-MAR-2022. Previous excursion was not reported. The cumulative time frame was reported as 15 minutes. It was unspecified if the data was recorded by a data logger. There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: a patient received a dose of a vaccine that was stored outside of the recommended storage range.; No additional AE reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided   On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) valid lot # U025791, expiration date 19-AUG-2023 for prophylaxis (strength, and route of administration were not provided). The vaccine underwent a temperature excursion of -11.3 degree Celsius (C) for a period of 23 hours and 35 minutes (Product storage error). The vaccine did not undergo a previous temperature excursion. The patient did not experience any adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: nerve damage; Information has been received regarding a case in litigation from a lawyer and referred to a female patient (pt) of unknown age. No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. In or around February 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route, strength, lot number and expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of suspect vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of suspect vaccine, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The reporter considered the event was related to the suspect vaccine.  The reporter considered the events to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   In or about March 2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prophylaxis.  On an unspecified date, shortly after to the patient vaccination, the patient was caused to suffer shingles. As a direct and proximate result receipt of the zoster vaccine live (ZOSTAVAX) vaccine, patient had resulted in physical limitations not present prior to using the vaccine; Patient had also experience mental and emotional distress due to resulting physical limitations and seriousness of Plaintiffs' condition. The patient sustained severe and permanent personal injuries; Patient had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Medical assistant reported dose of PROQUAD administered after supported temperature excursion.; No additional AE; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/Allergies and concomitant medications were not provided.      On an unknown date, after supported temperature excursion, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL/once, lot # u029322, expiration date on 19-MAR-2023, for prophylaxis (strength, route of administration and anatomical location were not reported) (product storage error). No additional Adverse Event (AE) was reported.