chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV, PNC15
Symptoms: Product storage error
Clinical narrative: HCP called to report Administered supported TE for PEDVAX HIB and VAXNEUVANCE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 31-OCT-2023, the patient was vaccinated with a improperly stored dose (of product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot  number X002099 with expiration date 14-JUN-2025; with a dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot number X005583 with expiration date 10-DEC-2024 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature of 33.9 degrees Fahrenheit for 42 hours and 5 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; HCP reported that an expired dose of the GARDASIL 9 vaccine was administered to a patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 01-NOV-2023, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number reported as 4029623 with expiration date 26-OCT-2023 (expired product administered), (dose, route and anatomical location were not reported) for prophylaxis. No additional adverse events were reported.  Lot number 4029623 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: An adult male patient already started Paxlovid; An adult male patient already started Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "An adult male patient already started Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  An adult male patient already started Paxlovid and was advised by hist doctor not take it with statins. But there was another prescription that was issued by his doctor prescribed him as well of the Azithromycin 250 m.  Caller wanted to know what is the effect of the dosage on that medication and caller wanted to know if after taking Paxlovid for 5 days would he feel better. He'd like to know what's the effect of that dosage on Paxlovid. He also said he is getting a lot of phlegm from his throat from coughing. He is asking if he can take Mucinex. Patient also said he already had 3 shots from Pfizer COVID vaccines and there is a booster out currently/latest version. He's asking, can he get that shot after taking all these 5-day dosage. He stated that he was tested positive for COVID. Of note, he had side question like how was the virus transmitted. Told him from medical perspective, that it's transmitted via contact and airborne transmission, hence the mask and isolation precautions. He also asked where to buy test strips. Told him that it should be available from any retail pharmacy. He okayed.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300355409 same patient, different drug/event.;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "migraine" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Phenergan, reaction(s): "known allergies: Phenergan". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, lot number unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, lot number unknown), for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19. Paxlovid used as treatment of COVID-19 from 03Oct2023 to 07Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300355997 Same reporter/patient, different drug, different AE.;
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: 4/34 (12%) aSOTRs reported infection 6-12 months post-D3; 4/34 (12%) aSOTRs reported infection 6-12 months post-D3; This is a literature report.  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent solid organ transplant recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "4/34 (12%) aSOTRs reported infection 6-12 months post-D3". The patient underwent the following laboratory tests and procedures: Antibody test: Positive; Antibody test: 1275 IU/ml, notes: At 3 months, those infected 6-12 months post-D3; 927 IU/ml, notes: Mean 6 month antibody titers among those infected 6-12 months post-D3; SARS-CoV-2 antibody test (1927-2500): Unknown results, notes: (maximum: >2500 U/ml).at 1-, 3-, and 6-months post-D3.; Sender's Comments: A causal relationship to the suspect drug bnt162b2 (BNT162B2) cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Antibody test, COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: 4/34 (12%) aSOTRs reported infection 6-12 months post-D3; 4/34 (12%) aSOTRs reported infection 6-12 months post-D3; This is a literature report.  An adolescent patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Adolescent solid organ transplant recipients" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "4/34 (12%) aSOTRs reported infection 6-12 months post-D3". The patient underwent the following laboratory tests and procedures: Antibody test: Positive; Antibody test: 1275 IU/ml, notes: At 3 months, those infected 6-12 months post-D3; 927 IU/ml, notes: Mean 6 month antibody titers among those infected 6-12 months post-D3; SARS-CoV-2 antibody test (1927-2500): Unknown results, notes: (maximum: >2500 U/ml). at 1-, 3-, and 6-months post-D3.  The reporter considered "4/34 (12%) asotrs reported infection 6-12 months post-d3" related to bnt162b2.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile ,Linked Report(s) : US-PFIZER INC-PV202300180965 Same article/ drug/event and different patient;
Age: 38.0
Sex: F
Vaccine: FLUA4
Symptoms: Dysphonia, Erythema, Pruritus, Rash, Skin lesion
Clinical narrative: Redness in the side of the arm, Itchy, generalized rash, lesions in all body. amygdalitis , dysfonia.
Age: 38.0
Sex: F
Vaccine: FLUA4
Symptoms: Tonsillitis
Clinical narrative: Redness in the side of the arm, Itchy, generalized rash, lesions in all body. amygdalitis , dysfonia.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea. Feeling like throwing up and needing to poop. Started around 230 in the morning.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Ear pain, Headache, Myalgia, Pain in extremity
Clinical narrative: profound widespread body/muscle aches, headache, earache, very sore arm for approx. 12 hours. NO fever.
Age: 35.0
Sex: F
Vaccine: FLUA4
Symptoms: Ear pruritus, Ear swelling
Clinical narrative: Extreme itching and swelling of inner ear canal.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Pruritus
Clinical narrative: Extreme itching and swellin in both inner ears/canal.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dehydration, Electrocardiogram, Fatigue, Palpitations
Clinical narrative: 10/20/23 extreme fatigue 10/21/23 woke with pounding heartbeat that subsided after an hour, then fatigue. When resting in bed at 3pm, Fitness Watch vibrated with alarm about heart rate over 120 Taken by ambulance to Hospital emergency, and hospitalized until next night Treated for dehydration and tachycardia
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Ultrasound scan
Clinical narrative: 10/20/23 extreme fatigue 10/21/23 woke with pounding heartbeat that subsided after an hour, then fatigue. When resting in bed at 3pm, Fitness Watch vibrated with alarm about heart rate over 120 Taken by ambulance to Hospital emergency, and hospitalized until next night Treated for dehydration and tachycardia
Age: 63.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 94.0
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was given Flucelvax vaccine instead of high-dose Fluad for 65+. No adverse effects were noted and error was discussed with pt. Provider contacted manufacturer and Flucelvax is approved for patients ages 6months and older and should not cause harm to the patient.
Age: 31.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Exposure during pregnancy, Injection site pain, Pyrexia, Vomiting
Clinical narrative: 36 weeks pregnant. Vomiting started at 10am the day after receiving both vaccinations. Managed symptoms at home. Mild muscle soreness at injection site and low grade fever (controlled with tylenol).   Cannot remember if this is 5th or 6th dose of covid shot. It is the booster after receiving the bivalent booster last spring.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Extreme Vertigo
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Soreness Sunday and small red spot noticed to right of injection site. Monday- spot grew and became warm, size of a dime. By Tuesday, 11/7- red patch turned purple and was very hot to the touch. It was the size of the palm of my hand.  I went the ER as my  Primary Care nor the Urgent Care could see me. I was prescribed Bactrim for 7 days. As of today, 11/11/23 there is still some redness, not hot to the touch. Red are the size of a half dollar.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Axillary pain, Headache, Injection site pain
Clinical narrative: Headache and armpit pain/soreness on L side injection site. MILD, not severe.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Patient came into the pharmacy on or around 10/30/23 and stated that her arm still hurt and had a raised welt on it. She also stated that the she had been to her doctor's office for a routine appointment and mentioned it and office stated to check with the pharmacy. No raised welt was observed and no signs of infection noted.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient was seen on 10/18/23 for flu and covid vaccination. This visit was performed by APRN. On 11/10/23 a billing error was discovered. This patient was 12 years old at the time of covid vaccination, however per the documentation in the chart she received the product intended for 5-11 yo age group. The paper vaccine consent is not present in the chart.\  Pfizer was contacted and recommended we revaccinate with appropriate product. Mother was notified by provider.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome
Age: 73.0
Sex: F
Vaccine: COVID19-2, VARZOS, COVID19, VARZOS
Symptoms: Chills, Hallucination, Headache, Pyrexia, Vomiting
Clinical narrative: Chills, fever, headache, hallucination, vomiting
Age: 73.0
Sex: F
Vaccine: COVID19-2, VARZOS, COVID19, VARZOS
Symptoms: Chills, Hallucination, Headache, Pyrexia
Clinical narrative: Chills, fever, headache, hallucination, vomiting
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Pain
Clinical narrative: One day after getting the shot, I developed left hip pain. Walking upstairs is now painful in the left hip. To avoid pain, I lead with the right foot and then place the left foot on the same stair before continuing up.  Today is Day 2. Same symptom. Walking downstairs is easier, ie, not as painful.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Inflammation, Mobility decreased
Clinical narrative: PATIENT IS COMPLAINING OF RANGE OF MOTION ISSUES, INFLAMMATION, AND PAIN IN LEFT ARM FROM VACCINE ADMINISTRATION
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Body aches, headache, chills, nausea. Started 11 hrs after injection
Age: 71.0
Sex: M
Vaccine: COVID19-2, RSV
Symptoms: Muscle spasms
Clinical narrative: PT EXPERIANCING SEVERE MUSCLE CRAMPING DAY AFTER VACCINATION
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Disorientation, Fall, Loss of consciousness
Clinical narrative: Patient was given vaccine while seated. Approximately 20 minutes after vaccination she was standing in the store with her mom when she passed out and fell. Patient sat up within a couple minutes and was somewhat disoriented. She was able to talk and was given cold water. Patient reported not having eaten anything prior to vaccine. She was able walk out of the store with no issues.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleed 11-10-23 in the evening, not long, nose bleed 11-11-23 in the morning that lasted for about 30 minutes
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Asthenia, Colitis, Condition aggravated
Clinical narrative: Next 2 days too weak to get out of bed.  Severe pain in all joints - arms legs, feet. Shortness of breath. Increase in colitis symptoms. Extreme increase in arthritis symptoms. 3 severe dizzy spells. Cardiologist doubled my cardiac medicine due to shortness of breath.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Metabolic function test normal, Mobility decreased
Clinical narrative: Next 2 days too weak to get out of bed.  Severe pain in all joints - arms legs, feet. Shortness of breath. Increase in colitis symptoms. Extreme increase in arthritis symptoms. 3 severe dizzy spells. Cardiologist doubled my cardiac medicine due to shortness of breath.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Inflammation, Laboratory test, Pain in extremity
Clinical narrative: Cellulitis per MD. Redness, inflammation/swelling, and pain of the right arm. Patient went to emergency room/urgent care and was given Keflex antibiotic
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Cellulitis per MD. Redness, inflammation/swelling, and pain of the right arm. Patient went to emergency room/urgent care and was given Keflex antibiotic
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy artery abnormal, Blindness unilateral, Giant cell arteritis, Red blood cell sedimentation rate
Clinical narrative: Giant Cell Arteritis--treatment steroid---biopsy proven--loss of sight in one eye
Age: 83.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Dizziness, Fatigue
Clinical narrative: Weakness, Tiredness, Dizziness , lack of appetite.  Symptoms began two days after shot and continued with increasing severity on the following days.  Very weak by fourth day after the symptoms began.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Ecchymosis, Injected limb mobility decreased, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Quarter size scabbing wound with erythema and ecchymosis, constant throbbing pain in left arm, decreased ROM of left shoulder, and swelling of left axillary lymph nodes
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Scab, Wound complication
Clinical narrative: Quarter size scabbing wound with erythema and ecchymosis, constant throbbing pain in left arm, decreased ROM of left shoulder, and swelling of left axillary lymph nodes
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic spontaneous urticaria, Erythema, Pruritus, Rash, Sleep disorder
Clinical narrative: Spontaneous and chronic Urticaria suspected. Full body itching and associated rash/hives. Have been treating with daily 10mg Cetirizine. Itching/rash returns within 24-28 hours of previous dose. Condition has persisted since 2 weeks after Moderna Covid vaccine, for 1 month so far. Untreated, leads to sleep disruption and strong urge to scratch. Upon scratching, skin responds with raised red marks. Can write letters on skin with nails. This is despite having had 3-4 previous Moderna Shots/boosters in previous years.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Spontaneous and chronic Urticaria suspected. Full body itching and associated rash/hives. Have been treating with daily 10mg Cetirizine. Itching/rash returns within 24-28 hours of previous dose. Condition has persisted since 2 weeks after Moderna Covid vaccine, for 1 month so far. Untreated, leads to sleep disruption and strong urge to scratch. Upon scratching, skin responds with raised red marks. Can write letters on skin with nails. This is despite having had 3-4 previous Moderna Shots/boosters in previous years.
Age: 86.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Atrial fibrillation, Brain natriuretic peptide increased, Cardiac failure congestive, Chest X-ray abnormal, Electrocardiogram abnormal
Clinical narrative: Sudden onset acute respiratory distress, low oxygen, rapid atrial fib; CHF, Pulmonary edema ? Results of medical tests and laboratory tests: Elevated white count; high BNP; abnormal Chest x-ray and EKG
Age: 86.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Oxygen saturation decreased, Pulmonary oedema, Respiratory distress, White blood cell count increased
Clinical narrative: Sudden onset acute respiratory distress, low oxygen, rapid atrial fib; CHF, Pulmonary edema ? Results of medical tests and laboratory tests: Elevated white count; high BNP; abnormal Chest x-ray and EKG
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Pt is 35 weeks pregnant and accidentally received the Arexvy rsv vaccine instead of Abrysvo.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt accidentally received the 5-11 covid-19 vaccination dose instead of the 12 and up dose.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Sleep disorder, Tremor
Clinical narrative: Internal Tremors had been happening for 2-3 months but got severely worse starting the night after the 3rd immunization. Internal Tremors were impacting ability to sleep and also affecting normal work and life during the day. Went to Primary Care Physician to see whether a diagnosis of Multiple Sclerosis would be a fit. Had two meetings with PCP and was referred to a Neurologist. Neurologist did not diagnose MS.  With next two vaccinations (12/2/2022, 10/25/2023), internal tremors got slightly worse for a small period of time, but over time I return to mostly "baseline".
Age: 1.58
Sex: M
Vaccine: MMRV
Symptoms: Crying, Injection site discolouration, Injection site discomfort, Injection site erythema, Injection site irritation
Clinical narrative: Mother of PT described that at approximately 19:00 hr, on 11/09/23, PT began to become irritable, actively avoided rolling or crawling on the right side of his body and felt warm to the touch. Mother evaluated PT's temperature and right leg, noting his temperature measured 103°F, as well as, observed a small red irritation on PT's upper right thigh. She also stated that when she touched the irritated area the PT would begin to cry more aggressively. Throughout that night, mother and father of PT switched between pediatric ibuprofen and Tylenol to help reduce PT fever. The following day, 11/10/2023, PT mother states that his fever had reduced to 100°F and the previously small red irritation had grown. PT's mother described a darker red-colored bump where the small red irritation previously was. Surrounding the bump, approximately 3mm, redness and irritation of the skin was observed in a rectangular shape, measuring, approximately, 4mm laterally and 1mm vertically.  PT continued to demonstrate discomfort at the location of irritation as well as fever persisted throughout the day.   PT's mother contacted the office, at approximately 15:45hr on 11/10/23, concerned because PT's fever had not changed throughout the day and  described that the skin irritation surrounding the darkened bump seemed to continue to spread in PT's upper right thigh. PT's mother spoke with Dr where she described her observations as well as provided a photograph of PT's upper right thigh to ensure the physician could understand her description of the irritated area. Dr evaluated the image and the information that was provided to him. Dr stated to PT's mother that he would send a prescription for amoxicillin to PT's pharmacy to help lower the skin irritation and fever, stating that the PT may be experiencing possible cellulitis, as well as PT is potentially allergic to the MMRV (ProQuad) vaccination. The prescription of Amoxicillin Suspension Reconstituted, 400mg/5mL, Orally, 42mL, 3mL, Twice a day for 7 days, was sent to the pharmacy later that day.   Today, at 9:00 hr, PT?s mother contacted the office stating that there had been an issue with the telephone system of the pharmacy the day prior and asked if we could resubmit the prescription to make certain the prescription is received. She also stated that PT?s symptoms had not changed much since the day prior. PT?s temperature had stayed at around 100°F, the darker colored bump was still observed and the skin irritation had neither grown or shrunk since the last time she contacted the office. Dr resubmitted the prescription and PT?s mother stated she would pick the medication up later in the morning. She ensured that she would continue to keep the physician informed with any major changes in PT?s health.
Age: 1.58
Sex: M
Vaccine: MMRV
Symptoms: Injection site pain, Injection site swelling, Irritability, Mobility decreased, Pyrexia
Clinical narrative: Mother of PT described that at approximately 19:00 hr, on 11/09/23, PT began to become irritable, actively avoided rolling or crawling on the right side of his body and felt warm to the touch. Mother evaluated PT's temperature and right leg, noting his temperature measured 103°F, as well as, observed a small red irritation on PT's upper right thigh. She also stated that when she touched the irritated area the PT would begin to cry more aggressively. Throughout that night, mother and father of PT switched between pediatric ibuprofen and Tylenol to help reduce PT fever. The following day, 11/10/2023, PT mother states that his fever had reduced to 100°F and the previously small red irritation had grown. PT's mother described a darker red-colored bump where the small red irritation previously was. Surrounding the bump, approximately 3mm, redness and irritation of the skin was observed in a rectangular shape, measuring, approximately, 4mm laterally and 1mm vertically.  PT continued to demonstrate discomfort at the location of irritation as well as fever persisted throughout the day.   PT's mother contacted the office, at approximately 15:45hr on 11/10/23, concerned because PT's fever had not changed throughout the day and  described that the skin irritation surrounding the darkened bump seemed to continue to spread in PT's upper right thigh. PT's mother spoke with Dr where she described her observations as well as provided a photograph of PT's upper right thigh to ensure the physician could understand her description of the irritated area. Dr evaluated the image and the information that was provided to him. Dr stated to PT's mother that he would send a prescription for amoxicillin to PT's pharmacy to help lower the skin irritation and fever, stating that the PT may be experiencing possible cellulitis, as well as PT is potentially allergic to the MMRV (ProQuad) vaccination. The prescription of Amoxicillin Suspension Reconstituted, 400mg/5mL, Orally, 42mL, 3mL, Twice a day for 7 days, was sent to the pharmacy later that day.   Today, at 9:00 hr, PT?s mother contacted the office stating that there had been an issue with the telephone system of the pharmacy the day prior and asked if we could resubmit the prescription to make certain the prescription is received. She also stated that PT?s symptoms had not changed much since the day prior. PT?s temperature had stayed at around 100°F, the darker colored bump was still observed and the skin irritation had neither grown or shrunk since the last time she contacted the office. Dr resubmitted the prescription and PT?s mother stated she would pick the medication up later in the morning. She ensured that she would continue to keep the physician informed with any major changes in PT?s health.
Age: 1.58
Sex: M
Vaccine: MMRV
Symptoms: Skin irritation, Skin warm
Clinical narrative: Mother of PT described that at approximately 19:00 hr, on 11/09/23, PT began to become irritable, actively avoided rolling or crawling on the right side of his body and felt warm to the touch. Mother evaluated PT's temperature and right leg, noting his temperature measured 103°F, as well as, observed a small red irritation on PT's upper right thigh. She also stated that when she touched the irritated area the PT would begin to cry more aggressively. Throughout that night, mother and father of PT switched between pediatric ibuprofen and Tylenol to help reduce PT fever. The following day, 11/10/2023, PT mother states that his fever had reduced to 100°F and the previously small red irritation had grown. PT's mother described a darker red-colored bump where the small red irritation previously was. Surrounding the bump, approximately 3mm, redness and irritation of the skin was observed in a rectangular shape, measuring, approximately, 4mm laterally and 1mm vertically.  PT continued to demonstrate discomfort at the location of irritation as well as fever persisted throughout the day.   PT's mother contacted the office, at approximately 15:45hr on 11/10/23, concerned because PT's fever had not changed throughout the day and  described that the skin irritation surrounding the darkened bump seemed to continue to spread in PT's upper right thigh. PT's mother spoke with Dr where she described her observations as well as provided a photograph of PT's upper right thigh to ensure the physician could understand her description of the irritated area. Dr evaluated the image and the information that was provided to him. Dr stated to PT's mother that he would send a prescription for amoxicillin to PT's pharmacy to help lower the skin irritation and fever, stating that the PT may be experiencing possible cellulitis, as well as PT is potentially allergic to the MMRV (ProQuad) vaccination. The prescription of Amoxicillin Suspension Reconstituted, 400mg/5mL, Orally, 42mL, 3mL, Twice a day for 7 days, was sent to the pharmacy later that day.   Today, at 9:00 hr, PT?s mother contacted the office stating that there had been an issue with the telephone system of the pharmacy the day prior and asked if we could resubmit the prescription to make certain the prescription is received. She also stated that PT?s symptoms had not changed much since the day prior. PT?s temperature had stayed at around 100°F, the darker colored bump was still observed and the skin irritation had neither grown or shrunk since the last time she contacted the office. Dr resubmitted the prescription and PT?s mother stated she would pick the medication up later in the morning. She ensured that she would continue to keep the physician informed with any major changes in PT?s health.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Magnetic resonance imaging abnormal, Malaise, Pericarditis
Clinical narrative: I was sick 4 months later, after covid 19 vaccine, with acute pericarditis.  I had pressure on chest and was in hospital for 5 days.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthma late onset, Bronchitis, Chest X-ray, Chills, Dyspnoea
Clinical narrative: I had severe fatigue, fever, and chills x 48 hours after shot. I did get slightly better a few days after shot, but am now 3 weeks out and am still not back to normal. I have gotten worse again for last 2 weeks. I have seen multiple doctors and am still undergoing testing. I have extreme fatigue and shortness of breath. So far I have been told bronchitis, pneumonitis, and possible reactive airway disease. I am now being treated for new adult onset asthma and have been tested for multiple autoimmune disorders that are still pending. I was also told possible myocarditis if all of this checks out and may need further testing and pulmonary specialist. It may all be unrelated and coincidental, however, I have not been well since this shot and one of my doctors told me to report this in case it is linked. I just want to get back to my normal.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Laboratory test, Pneumonitis, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I had severe fatigue, fever, and chills x 48 hours after shot. I did get slightly better a few days after shot, but am now 3 weeks out and am still not back to normal. I have gotten worse again for last 2 weeks. I have seen multiple doctors and am still undergoing testing. I have extreme fatigue and shortness of breath. So far I have been told bronchitis, pneumonitis, and possible reactive airway disease. I am now being treated for new adult onset asthma and have been tested for multiple autoimmune disorders that are still pending. I was also told possible myocarditis if all of this checks out and may need further testing and pulmonary specialist. It may all be unrelated and coincidental, however, I have not been well since this shot and one of my doctors told me to report this in case it is linked. I just want to get back to my normal.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hemiplegia
Clinical narrative: right side paralyzed for 4 days.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Headache, Immunoglobulin therapy, International normalised ratio normal, Lymphocyte count decreased
Clinical narrative: 10/22 woke up with blood blisters in mouth, googled and did not seem serious, 10/23 still blood blisters plus bruising all over body and a headache. Went to ER, platelet count 3000....given platelets, IVIG and Dexamethazone, improved to 4000 that day. Hospitalized at Hospital given IVIG and Dexamethazone thru 10/25 and discharged from hospital, 10/26 last dose of dexamethasone. Follow up platelet count over 300,000.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Neutrophil count increased, Oral blood blister, Platelet count decreased, Platelet transfusion, Prothrombin time normal
Clinical narrative: 10/22 woke up with blood blisters in mouth, googled and did not seem serious, 10/23 still blood blisters plus bruising all over body and a headache. Went to ER, platelet count 3000....given platelets, IVIG and Dexamethazone, improved to 4000 that day. Hospitalized at Hospital given IVIG and Dexamethazone thru 10/25 and discharged from hospital, 10/26 last dose of dexamethasone. Follow up platelet count over 300,000.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate increased, Tremor
Clinical narrative: Patient states he experienced shaking, chills and elevated pulse rate for 30 minutes after 8 hours he received vaccine.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: patient states has local site reaction that is red, hard and hot and is 2 inches in diameter
Age: 11.0
Sex: F
Vaccine: COVID19-2, FLUA4, HPV9
Symptoms: C-reactive protein, Full blood count normal, Peripheral swelling, Rash, Red blood cell sedimentation rate
Clinical narrative: Patient developed leg swelling and rash 10 days after vaccine administration. She was diagnosed with urticarial vasculitis.
Age: 11.0
Sex: F
Vaccine: COVID19-2, FLUA4, HPV9
Symptoms: Urticarial vasculitis, X-ray limb normal
Clinical narrative: Patient developed leg swelling and rash 10 days after vaccine administration. She was diagnosed with urticarial vasculitis.
Age: 70.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Arthralgia, Asthenia, Injected limb mobility decreased, Limb discomfort, Neuralgia
Clinical narrative: Patient received the vaccines on 10/17/23. Later that day her left arm and shoulder started hurting with extreme pain. Se rated the pain 10/10. On Saturday 10/21/23 she went to the emergency room, and they recommended she take Gabapentin for nerve pain. When she went to the emergency room, she had no strength in her arm and could not lift it up.  The Gabapentin eased her pain but there was still discomfort and no strength in the arm. She had to go out of town and when she came back, she saw her primary doctor. This doctor prescribed her Gabapentin 300mg twice daily, a referral to an Orthopedic doctor and an ultrasound of the arm. She then came into the pharmacy to report the event.
Age: 70.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Pain in extremity
Clinical narrative: Patient received the vaccines on 10/17/23. Later that day her left arm and shoulder started hurting with extreme pain. Se rated the pain 10/10. On Saturday 10/21/23 she went to the emergency room, and they recommended she take Gabapentin for nerve pain. When she went to the emergency room, she had no strength in her arm and could not lift it up.  The Gabapentin eased her pain but there was still discomfort and no strength in the arm. She had to go out of town and when she came back, she saw her primary doctor. This doctor prescribed her Gabapentin 300mg twice daily, a referral to an Orthopedic doctor and an ultrasound of the arm. She then came into the pharmacy to report the event.
Age: 42.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was there for a Covid vaccine, when vaccine called out it was misheard, and a flu vaccine was given inadvertently. Patient had received a flu shot on 10/27/23 at the pharmacy.   Patient still received the Covid vaccine.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syncope, Vomiting
Clinical narrative: Patient went to sit on the bench after receiving 3 vaccinations (Spikevax, Fluzon HD, Abrysvo.) After a few minutes, she threw up and fainted. A nurse that was in the store shopping came over to help. I ran over to check on the patient and called 911. While I was on the phone with 911, my tech-in-training saw EMS in the store shopping and flagged them down. EMS then took over. EMS stabilized the patient and checked her vitals in the booth for privacy.
Age: 77.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Syncope, Vomiting
Clinical narrative: Patient went to sit on the bench after receiving 3 vaccinations (Spikevax, Fluzon HD, Abrysvo.) After a few minutes, she threw up and fainted. A nurse that was in the store shopping came over to help. I ran over to check on the patient and called 911. While I was on the phone with 911, my tech-in-training saw EMS in the store shopping and flagged them down. EMS then took over. EMS stabilized the patient and checked her vitals in the IMZ booth for privacy.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia areata
Clinical narrative: Alopecia Barbae on face; several large bald spots
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Poor quality sleep, Pyrexia
Clinical narrative: Approximately 8 hours after vaccination, I developed a headache.  When I went to bed, I developed a fever, had chills, and shivered throughout the night.  I did not sleep well because of these symptoms.  By around noon of the following day, the symptoms began to go away.  I had similar symptoms after the second vaccination, but not as severe.
Age: 14.0
Sex: F
Vaccine: FLUC4
Symptoms: Headache, Vomiting
Clinical narrative: Father called today at 11:45am and reported that patient woke up at approximately 8:00AM and vomited two separate times.  Reported that patient had a headache and temperature was 99 F.   Patient had not vomited since 8am and headache subsided.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Arthritis, C-reactive protein increased, Red blood cell sedimentation rate increased
Clinical narrative: Joint pain and inflammation in all 4 extremities
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: redness/rash inches below injection site on lower portion of arm occurring about 5-6 days after vaccination. no treatment given yet. patient has no other signs/symptoms. she has been told to contact her doctor if redness doesn't go away soon.
Age: 13.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms at time of vaccination
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Injection site pruritus, Nausea, Vomiting
Clinical narrative: Injection site itches. Dizziness and nausea followed by vomiting within a half hour of injection.
Age: 75.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: Rash the covers her neck and back.
Age: 6.0
Sex: M
Vaccine: FLU4, HEP, HPV9, MMRV, TDAP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: PATIENT RECIEVED WRONG DOSIS DUE TO ERROR VACCINE ADMINISTRATION. HE WAS ONLY DUE FOR MMR, VARICELLA AND FLU. PATIENT WAS PLACED ON OBSERVATION FOR 15 MINUTES, ADVISED PARENT TO OBSERVE PATIENT  AND IF ANY REACTION PLEASE TAKE PATIENT TO EMERGENCY ROOM.  PATIENT TOLERATED VACCINE WELL NO REACTIONS ON THE TIME OF OBSERVATION.
Age: 16.0
Sex: M
Vaccine: MENB, UNK, UNK
Symptoms: Dizziness
Clinical narrative: Patient felt light headed and was assisted to the floor by the staff with elevated legs. EMS was called and patient taken to Hospital.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Dizziness
Clinical narrative: patient stated she was lighted headed after vaccines. Patient was placed in supine position with legs elevated. patient waited 30mins for post vaccination.
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Injection site swelling
Clinical narrative: Patient received Fluzone PF HD on 11/07/2023 and came in to the pharmacy 11/11/2023. Patient reported a tingling sensation from the injection site down her muscle which stopped at her elbow, and the next day the area around her elbow was swollen, and did not go away for a few days.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Patient felt light headed after vaccinated. Pateint laid supine and ambulance called. She left with the ambulance
Age: 38.0
Sex: M
Vaccine: FLUC4, FLUC3
Symptoms: Muscle spasms, Musculoskeletal stiffness, Syncope
Clinical narrative: Patient warned pharmacist before hand that he usually have vagal syncope when getting vaccinations and would need to stay back for several minutes. After administration, patient sat on the floor for about 5 minutes, then he got up and sat in the chair. About 7 to 10 minutes later, he sat on the floor and laid back flat. Within a few seconds, he turned his neck to side like a spasm and locked up his legs. I raised his legs up in the chair and called his name twice and patient responded. He then laid on floor for about 20 minutes or so and we provided him a bottle of water when he asked. We recorded liability form and patient walked out the door.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Atrial fibrillation, Heart rate irregular
Clinical narrative: Non sustained AFIB followed by varying heart rates
Age: 9.0
Sex: M
Vaccine: HEP, HEPA, MMRV, TDAP
Symptoms: Dizziness
Clinical narrative: Patient experience dizzy, light headed. patient was oriented3x. Patient was placed in supine position with elevated legs. Nurse took Vital signs were within normal range. EMS was called, pt left with ambulance.
Age: 9.0
Sex: M
Vaccine: HEP, HEPA, MMRV, TDAP
Symptoms: Dizziness
Clinical narrative: PATIENT FELT LIGHTHEADED. PLACED ON SUPINE POSITION ON THE FLOOR  WITH ELEVATED LEGS. BLOOD PRESSURE WAS TAKEN WITH A NORMAL OUTCOME OF 110/70. PATIENT WAS OBSERVED FOR 30 MINUTES. SNACKS AND WATER WAS PROVIDED. ADVISED PARENT TO OBSERVE PATIENT THROUGHOUT THE DAY, CALL 911 OR VISIT THE NEAREST EMERGENCY ROOM IF ANT ADVERSE EFFECTS ARE PRESENTED.
Age: 10.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Tremor
Clinical narrative: PATIENT STARTED SHAKING 5 MINUTES AFTER BOTH VACCINES WERE GIVEN. PATIENT WAS GIVEN WATER AND RESTED IN VACCINE CHAIR AND WAS FINE
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: pink and firm at site
Age: 9.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Emotional disorder, Injection site pain, Loss of consciousness
Clinical narrative: Patient received Covid pediatric vaccination (Moderna) in left arm without reaction. Then received Flu vaccine in right arm and lost consciousness for approximately 2-5 seconds at approximately 4:45 pm. She was in seated position and was maintained  in position  by administering pharmacy technician. When patient regained consciousness, she reported more pain during flu vaccination which caused an emotional response. 911 was immediately called and EMS arrived at approximately 4:55 pm. Patient's blood pressure and heart rate was stated as "normal" by EMS and blood glucose 106 mg/dL. Patient's mother (who is an OB-GYN) declined further care.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Musculoskeletal disorder, Sensory disturbance
Clinical narrative: Patient reported right arm throbbing from under armpit down to the wrist about 20 minutes after administration.  She said her right arm was basically not useable.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Patient's arm is swollen and red and itchy. Patient already took Tylenol for her fever. I advised patient to take Bendryl.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The night after being vaccinated patient reports the injection site became red, swollen, and sore.  She took Tylenol for the pain with marginal benefit.  Patient reported to pharmacy the afternoon of 11/11 saying it seems to have been slowly improving, but the area was still slightly raised and about the diameter of a golf ball.  counseled patient to continue to monitor for improvement and consider using an ice pack on the site.
Age: 54.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient complained that he  still has  sharp  pain at sight of injection of  Spikevax  vaccine which he had few weeks ago  . He mentioned it is not shoulder just at sight of injection( specially at night). He  wanted to see his Dr which I suggested too.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Swollen/hot to touch/red/pain at sure if injection.  Next day redness moved down arm to elbow . Pain increased /swollen lump /hot to touch.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: Swollen/hot to touch/red/pain at sure if injection.  Next day redness moved down arm to elbow . Pain increased /swollen lump /hot to touch.
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Sharp, excruciating pain radiating from shoulder down through arm to end of fingers. Pain began the night of the injection, when I could not sleep, and continues even now both night and day, but intermittently during the day, regularly at night. I cannot sleep on the left side because of the extensive pain of doing so.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Rash
Clinical narrative: I started to get joint pain in the knees, ankles, elbows, and wrists. I got a rash on both of my forearms and chest. The rash went away, but I am still having joint pain ten days after the vaccination.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Pain, Pain in extremity
Clinical narrative: -itchy on site of injection -Big red circle on site of injection -Pain on left arm 3-4 wks -Left arm hurts when lifted
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Blood test normal, Borrelia test negative, Chest X-ray normal, Computerised tomogram head normal, Dizziness
Clinical narrative: Patient called 2 days after vaccination and stated she had foaming of the mouth and passed out- was taken to ER for a battery of tests and then followed up with more.  Still waiting on some results of tests.  The prevailing thought is possibly a reaction to the adjuvant in the Fluad vaccine since patient has done well with Fluzone HD in past.
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Electrocardiogram, Electroencephalogram normal, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Patient called 2 days after vaccination and stated she had foaming of the mouth and passed out- was taken to ER for a battery of tests and then followed up with more.  Still waiting on some results of tests.  The prevailing thought is possibly a reaction to the adjuvant in the Fluad vaccine since patient has done well with Fluzone HD in past.
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Thyroid function test normal, Ultrasound Doppler normal, Unresponsive to stimuli, Urinary incontinence, Visual impairment
Clinical narrative: Patient called 2 days after vaccination and stated she had foaming of the mouth and passed out- was taken to ER for a battery of tests and then followed up with more.  Still waiting on some results of tests.  The prevailing thought is possibly a reaction to the adjuvant in the Fluad vaccine since patient has done well with Fluzone HD in past.
Age: 68.0
Sex: F
Vaccine: FLUA4, FLUA4
Symptoms: Vomiting
Clinical narrative: Patient called 2 days after vaccination and stated she had foaming of the mouth and passed out- was taken to ER for a battery of tests and then followed up with more.  Still waiting on some results of tests.  The prevailing thought is possibly a reaction to the adjuvant in the Fluad vaccine since patient has done well with Fluzone HD in past.