chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: first got Covid, was about 6 months after the first shot; first got Covid, was about 6 months after the first shot; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, 0.3 ml single (Batch/Lot number: unknown) intramuscular, in left arm and on 24Feb2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Jan2021 (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing), notes: Has been taking Januvia, going to say, was 50 years old, has been like, forever.; "Blood pressure" (unspecified if ongoing); "something in neck not functioning" (unspecified if ongoing), notes: Has been taking Synthroid since 30 years old, is 70 something now. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); JANUVIA [SITAGLIPTIN PHOSPHATE] taken for type 2 diabetes mellitus (ongoing); SYNTHROID taken for musculoskeletal discomfort (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2021, latency 6 months after the suspect product(s) administration, outcome "unknown" and all described as "first got Covid, was about 6 months after the first shot". The event "first got covid, was about 6 months after the first shot" required physician office visit. The patient underwent the following laboratory tests and procedures: COVID-19: (Aug2021) Positive. Clinical course: Patient received first dose 0.3ml in muscle; Arm, probably asked for left arm because she is right handed. Patient got Covid 3 times and got really sick last time with Covid. Got first shot in Feb2021, was 04FEB2021 and second shot, 24Feb2021. When she first got Covid, was about 6 months (Aug2021) after the first shot, from 04Feb2021. First time having Covid was Jan2021 and most recent time was Jan2024. She was taking those medications within 2 weeks prior to getting Covid, and after that. Patient refused to go to hospital. Went to doctor's office, went through side door to get test, tested positive for Covid. When she asked if her husband should come, they told her no, unless he gets sick. Husband got all 3 shots, only got sick with Covid 1 time. The doctor thought it was because of his blood type.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400254253 same patient and drug, different dose and event;US-PFIZER INC-202400254252 same patient and drug, different dose and similar event;US-PFIZER INC-202400254254 same patient and drug, different dose and event;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Nausea
Clinical narrative: first got Covid, was about 6 months after the first shot; first got Covid, was about 6 months after the first shot; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, 0.3 ml single (Batch/Lot number: unknown) intramuscular, in left arm and on 24Feb2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Jan2021 (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing), notes: Has been taking Januvia, going to say, was 50 years old, has been like, forever.; "Blood pressure" (unspecified if ongoing); "something in neck not functioning" (unspecified if ongoing), notes: Has been taking Synthroid since 30 years old, is 70 something now. Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); JANUVIA [SITAGLIPTIN PHOSPHATE] taken for type 2 diabetes mellitus (ongoing); SYNTHROID taken for musculoskeletal discomfort (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2021, latency 6 months after the suspect product(s) administration, outcome "unknown" and all described as "first got Covid, was about 6 months after the first shot". The event "first got covid, was about 6 months after the first shot" required physician office visit. The patient underwent the following laboratory tests and procedures: COVID-19: (Aug2021) Positive. Clinical course: Patient received first dose 0.3ml in muscle; Arm, probably asked for left arm because she is right handed. Patient got Covid 3 times and got really sick last time with Covid. Got first shot in Feb2021, was 04FEB2021 and second shot, 24Feb2021. When she first got Covid, was about 6 months (Aug2021) after the first shot, from 04Feb2021. First time having Covid was Jan2021 and most recent time was Jan2024. She was taking those medications within 2 weeks prior to getting Covid, and after that. Patient refused to go to hospital. Went to doctor's office, went through side door to get test, tested positive for Covid. When she asked if her husband should come, they told her no, unless he gets sick. Husband got all 3 shots, only got sick with Covid 1 time. The doctor thought it was because of his blood type.   Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400254253 same patient and drug, different dose and event;US-PFIZER INC-202400254252 same patient and drug, different dose and similar event;US-PFIZER INC-202400254254 same patient and drug, different dose and event;
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Sore arm; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Pfizer Employee stated, "I am a Pfizer employee and I am calling to report an adverse, report of an adverse event for a Pfizer product.". Pfizer employee stated that, "They were not a provider, she was a school administrator. Pfizer employee did not had her mailing address, name, email. He reported that, she was women (Clarified female). Ethnicity redacted. Employee had never saw her. That was online meeting. Employee stated that, patient did not have name initials, age at the time of event, height and weight. Employee did not have information LOT#, Expiration date, NDC# and UPC# , (Facility type, Name, telephone#, mailing address), Route, anatomical location, date and time. It was unknown if patient was suffering from any other medical condition or taking any other medication. Employee did not have information regarding lab work (Within 2 weeks), prior vaccination within 4 weeks, treatment. Employee was provided with the reference.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had significant symptoms of the disease for 7 days. I have had Covid 19 several times and I know the symptoms; I had significant symptoms of the disease for 7 days. I have had Covid 19 several times and I know the symptoms; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had significant symptoms of the disease for 7 days. I have had Covid 19 several times and I know the symptoms". Clinical course: Patient reported "I had a significant reaction to the most reason covid 19 immunization. Not an allergic reaction. I was ill for 7 days. Please respond. I want you to know in case others respond this way. I had significant symptoms of the disease for 7 days. I have had Covid 19 several times and I know the symptoms. I would rather get the disease than have another immunization that reacts that strongly and only provides 6 month of immunity."  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Hypoacusis
Clinical narrative: completely lost his hearing in the right ear; could lose hearing on his left ear that already has some lost; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A male patient received BNT162b2 (BNT162B2), in 2020 as dose number unknown, 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: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "completely lost his hearing in the right ear"; HYPOACUSIS (non-serious), outcome "unknown", described as "could lose hearing on his left ear that already has some lost". Clinical Course: Caller mentioned that she heard some disturbing news that Pfizer was putting MRNA in the flu shot that they started last year. Caller said she was sent a screenshot from a friend regarding increased of seizures in young kids after getting the MRNA covid vaccine. It also showed that Pfizer CEO confirms that the MRNA is in the seasonal flu. Caller said her husband was forced into the covid vaccine in 2020 because he was working in the hospital. Her husband completely lost his hearing in the right ear, which was documented through CDC, Pfizer, and the hospital. Her husband was not qualified for boosters because he could lose hearing on his left ear that already has some lost. Caller was worried about the flu shots containing part of the MRNA. Caller asked if there is MRNA in the flu vaccine and will it be disclosed. Caller said she needs to know before she gets the flu shot and wanted a response from somebody who knows about the flu shot.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: extreme swelling of her arm after the Injection; This is a spontaneous report received from a Pharmacist, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "extreme swelling of her arm after the Injection". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my right upper arm  is throbbing; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), 24 hrs after the suspect product(s) administration, outcome "unknown", described as "my right upper arm  is throbbing". Additional information: Patient had a covid shot, 24 hours later the right upper arm was throbbing.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUZONE HD give to the wrong age group, with no reported adverse event; Initial information received on 04-Sep-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 48 years old female patient (117 kg) who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in a wrong age group, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Sep-2024, the patient received 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe(lot, expiry, strength and route: unknown) (product administered to patient of inappropriate age) (latency same day) in unknown administration site for prophylactic vaccination.  Intentional Use: No  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Condition aggravated, Generalised tonic-clonic seizure
Clinical narrative: grand mal seizure for 10-15 minutes; Initial information received on 03-Sep-2024 regarding an unsolicited valid serious case received from a nurse.  This case involves a 12 years and 6 months old male patient who experienced grand mal seizure for 10-15 minutes after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing chronic seizure with the most recent seizure occurring in 2019.  On 28-Aug-2024, the patient received a dose 1 of 0.5 ml of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine (Solution for injection) (lot: U8351CA; strength: standard; frequency: once; expiry date: 31-Mar-2028) via intramuscular route in the left deltoid for Immunization.  On 29-Aug-2024 the patient developed grand mal seizure for 10-15 minutes (generalised tonic-clonic seizure) (latency: within less than 24 hours).   Action taken was not applicable.  An unknown corrective treatment was received for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2024 for the event.  This event was assessed as medically significant and the patient was hospitalized on the same day this event occurred. The patient was discharged on 30-Aug-2024 at 12:26am (hospitalization during 1 days).; Sender's Comments: Sanofi company comment for information received on 11-Sep-2024: This case involves a 12 years old male patient who experienced grand mal seizure for 10-15 minutes after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. Additionally, the patient's concurrent condition of chronic seizure could be a confounding factor in occurrence of event. Further information regarding previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine(s) cannot be assessed.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Chills, Dizziness, Dyskinesia, Loss of consciousness, Nausea
Clinical narrative: Syncope with jerking movements for a few seconds; Syncope with jerking movements for a few seconds; chills; reported dizziness; nausea; Initial information received on 05-Sep-2024 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 11-year-old male patient who experienced syncope with jerking movements for a few seconds, chills, reported dizziness and nausea after receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for prophylactic vaccination (Immunisation).  On 29-Aug-2024, the patient received a standard 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of lot U8194AA and expiry date: 30-Sep-2027 via intramuscular route in the left deltoid (strength unknown) as immunization.  On an unknown date the patient developed syncope with jerking movements for a few seconds (syncope), (dyskinesia) and after the patient regained consciousness he reported chills, dizziness, nausea (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.   Seriousness criteria: The event syncope was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.; Sender's Comments: Sanofi company comment dated 12-Sep-2024: This case involves a 11-year-old male patient who experienced syncope with jerking movements for a few seconds, chills, reported dizziness and nausea after receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2024SA261460:
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Syncope
Clinical narrative: Syncope with jerking movements for a few seconds; Syncope with jerking movements for a few seconds; chills; reported dizziness; nausea; Initial information received on 05-Sep-2024 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 11-year-old male patient who experienced syncope with jerking movements for a few seconds, chills, reported dizziness and nausea after receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for prophylactic vaccination (Immunisation).  On 29-Aug-2024, the patient received a standard 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of lot U8194AA and expiry date: 30-Sep-2027 via intramuscular route in the left deltoid (strength unknown) as immunization.  On an unknown date the patient developed syncope with jerking movements for a few seconds (syncope), (dyskinesia) and after the patient regained consciousness he reported chills, dizziness, nausea (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.   Seriousness criteria: The event syncope was assessed as medically significant.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.; Sender's Comments: Sanofi company comment dated 12-Sep-2024: This case involves a 11-year-old male patient who experienced syncope with jerking movements for a few seconds, chills, reported dizziness and nausea after receiving vaccine meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. US-SA-2024SA261460:
Sex: F
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: menquadfi administered to a patient earlier than scheduled to a patient with no reported adverse event; Initial information received on 05-Sep-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old female patient who experienced menquadfi administered to a patient earlier than scheduled to a patient with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP rL1 4v (yeast) (Gardasil) for Immunisation; and Diphtheria vaccine toxoid, Pertussis vaccine acellular 5-component, Tetanus vaccine toxoid (Adacel) for Immunisation.  On 05-Sep-2024, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE lot U8370AA via intramuscular route in the right deltoid. On 12-Jun-2024 she also received a  dose of vaccine U8370AA via intramuscular route in the right deltoid.  On 05-SEP-2024 the patient developed a non-serious menquadfi administered to a patient earlier than scheduled to a patient with no reported adverse event (inappropriate schedule of product administration) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  It was not reported if the patient received a corrective treatment for the event (menquadfi administered to a patient earlier than scheduled to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event menquadfi administered to a patient earlier than scheduled to a patient with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia
Clinical narrative: muscle aches all over, especially my legs during and after my daily bicycle ride.; Felt weak; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 10Sep2024 at 12:15 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tramadol, reaction(s): "Hypersensitivity". The following information was reported: ASTHENIA (non-serious) with onset 10Sep2024 at 12:40, outcome "recovered", described as "Felt weak"; MYALGIA (non-serious) with onset 11Sep2024 at 06:45, outcome "recovering", described as "muscle aches all over, especially my legs during and after my daily bicycle ride.". Therapeutic measures were not taken as a result of asthenia, myalgia. Additional information: The patient didn't receive any other vaccines on the same date as the vaccine for which reporting. The patient didn't receive any other vaccines within 4 weeks PRIOR to the vaccine for which reporting. The patient was not taking any other medications within 2 weeks of the event starting. Patient felt weak about 25 minutes after receiving the shot.  Then felt fine again. The next morning, I had muscle aches all over, especially my legs during and after my daily bicycle ride. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Gastrointestinal inflammation, Investigation
Clinical narrative: debilitating GI inflammation; This is a spontaneous report received from an Other HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Oct2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, unknown manufacturer; Covid 19 vaccine trial), administration date: 2020, for COVID-19 immunisation; Covid-19 vaccine (dose 2, unknown manufacturer; Covid 19 vaccine trial), administration date: 2021, for COVID-19 immunisation. The following information was reported: GASTROINTESTINAL INFLAMMATION (medically significant), outcome "not recovered", described as "debilitating GI inflammation". The event "debilitating gi inflammation" required physician office visit. The patient underwent the following laboratory tests and procedures: tests: Unknown results, notes: run out of tests. Therapeutic measures were taken as a result of gastrointestinal inflammation. The patient informed that the doctors has run out of tests and treatments so they told patient to notify Pfizer so maybe the patient can be on a long Covid study or see if Pfizer has treatments for the patient. The patient was seeking any help Pfizer has to offer.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based in limited available information, in the absence of any other risk factors and no clear temporal association details available, it is impossible to exclude the causal association between the event gastrointestinal inflammation and suspect drug BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Significant local erythema, swelling, induration, warmth, pruritis, tenderness measuring 20 cm x 20 cm.   Seen in ER on 9/12/24, given benadryl.  Prescription sent for benadryl and cetirizine.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Tenderness
Clinical narrative: Significant local erythema, swelling, induration, warmth, pruritis, tenderness measuring 20 cm x 20 cm.   Seen in ER on 9/12/24, given benadryl.  Prescription sent for benadryl and cetirizine.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Single component of a two-component product administered
Clinical narrative: Hib was not mixed and only the diluent/saline in prefilled syringe was given.   Mother was notified.  No adverse symptoms reported.
Age: 81.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received  Fluad vaccination on 7/24/2024 and another one on 9/11 /2024
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder, Headache, Hyperhidrosis, Hypopnoea
Clinical narrative: I felt moderately ill during the night. After being out of bed about 20 minutes the episode started with increasing lightheadedness then my partner who was with me at the time said my face went white, my breathing was very shallow, my eyes rolled back in my head and for about 10 seconds I was unresponsive to him shaking and yelling at me.  When I came back to consciousness , I started sweating profusely, completely drenching my nightshirt. We then got me to the floor and elevated my legs. I was left with nausea and headache that lasted into the next day.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Malaise, Nausea, Pallor, Unresponsive to stimuli
Clinical narrative: I felt moderately ill during the night. After being out of bed about 20 minutes the episode started with increasing lightheadedness then my partner who was with me at the time said my face went white, my breathing was very shallow, my eyes rolled back in my head and for about 10 seconds I was unresponsive to him shaking and yelling at me.  When I came back to consciousness , I started sweating profusely, completely drenching my nightshirt. We then got me to the floor and elevated my legs. I was left with nausea and headache that lasted into the next day.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blister, Burning sensation, Contusion, Fatigue
Clinical narrative: Pt received the shingles vaccine 8/22/24 here. She experienced some pain in the following days, then 1 wk later the area began to bruise. The bruise continued to grow for a few days and then blistered over. She now complains of so much burning and sensitivity that she cannot wear long sleeves over the site. Also endorses fatigue, arthralgias, myalgias. Denies fevers/chills, changes in vision, sob or cp, n/v, diarrhea, changes in appetite. She has been using topical diclofenac without relief and lidocaine patches with some relief.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Sensitive skin
Clinical narrative: Pt received the shingles vaccine 8/22/24 here. She experienced some pain in the following days, then 1 wk later the area began to bruise. The bruise continued to grow for a few days and then blistered over. She now complains of so much burning and sensitivity that she cannot wear long sleeves over the site. Also endorses fatigue, arthralgias, myalgias. Denies fevers/chills, changes in vision, sob or cp, n/v, diarrhea, changes in appetite. She has been using topical diclofenac without relief and lidocaine patches with some relief.
Age: 25.0
Sex: M
Vaccine: MMR, TDAP, UNK
Symptoms: Dizziness, Loss of consciousness, Pallor, Syncope
Clinical narrative: Adacel (Tdap), Fluzone (Influenza) and MMR-II (MMR) vaccines administered at 3:33pm, patient sitting on exam table for post injection monitoring. Noted patient becoming pale and stating "I feel woozy." Patient fainted for approximately two seconds and when he regained consciousness he stated "Where am I?" before becoming aware of surroundings. Patient was assisted to lay down (side lying left side) on the exam table. This nurse placed wet cold towels on patient's face and a cold pack to the back of his neck. Patient conscious, eyes open, talkative and sitting up. Vital signs checked at 3:36PM: Blood Pressure left arm sitting 125/72 mmHg; Pulse 95 bpm; Respirations 18, SpO2: 97%. Patient was alert and oriented to name, time and place, no respiratory distress was noted, denied any dizziness, headache or nausea. Patient was provided with apple juice. Doctor on site was notified immediately for further assessment. MD further evaluated the patient, per MD no visual or palpable injuries observed to any parts of his body at this time. Patient reported that his last full meal was on Tuesday evening  9/10/2024. Reported just having rice and french fries at approximately 1:15 pm on 9/11/24. Patient was alert and oriented to name, time, and place, denied any headache, nausea, or  dizziness.  This nurse re-assessed the patient, no visual or palpable injuries noted at this time. On-site physician advised patient and nurse to continue to observe the for any dizziness, headache, nausea, altered mental status, or sleepiness. If any of these occur to call 911 or go to the nearest Emergency Room as soon as possible. Patient discharged home at 4:25PM, left  clinic ambulatory to his vehicle.
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient given high dose flu vaccine, which is the incorrect dosage (Patient is 64 y/o). Patient and PCP aware.
Age: 0.75
Sex: M
Vaccine: FLUR4
Symptoms: Feeling abnormal, Incorrect dose administered, Product administered to patient of inappropriate age, Rhinorrhoea
Clinical narrative: On date of incident, patient and mother presented to clinic for patient's 9 month well check up . At this visit patient was due for influenza shot and was incorrectly administered adult influenza vaccine (18+) from our private supply instead of state supplied child vaccine (6 months +).  Administer confused private supply for state supply due to placement in fridge, recency of private supply's addition to fridge and administers error. Administer mistakenly consulted vaccine information sheet instead of box to determine age appropriateness of vaccine instead of box. Vaccine given with no immediate complications. When error was discovered, administer reported to clinic superior for further action. Provider and clinic manager and supervisor notified along with patient's mother who reports that patient has has runny nose and has been feeling under the weather but reports patient is generally doing fine and encouraged to reach out to clinic for further questions, concerns, or patient updates. 5 rights were reviewed, vaccine fridge has been assessed and reorganized by vaccine coordinator and administration and further organizing and education has been initiated.
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Swelling
Clinical narrative: Localized swelling "the size of a golf ball"
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Malaise, Tinnitus
Clinical narrative: Patient with h/o  egg  allergy, per CDC and  Pharmacist Fluad is ok to be administered, vaccine was administered and instantly patient c/o headache 8/10, bilateral tinnitus, slight dizziness, feeling of passing out, not feeling  well,   per patient she never experienced similar symptoms with previous flu vaccine, bp 120/61, patient continued with symptoms after 5 minutes of observation in clinic,patient was taken to Urgent Care Clinic for further evaluation.
Age: 39.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was mistakenly given a Fluad vaccine instead of the Fluarix vaccine that he was signed up for/allowed to have.  Patient has been advised on what side effects to expect and to call us back/seek medication attention with any developing concerns.  Additionally, patient did not receive the quadrivalent vaccine, but instead the trivalent.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Pruritus, Rash, Rash erythematous, Skin ulcer
Clinical narrative: I had the shot on 9-10-24 around noon...morning of 9-11-24 I had a large swollen itching spot on left forehead and then about 5 more appearing down the left side of the face.  They itch something awful.  then on both inside of thighs, I developed a red rash...not itching, but sores are smaller and close together unlike on the face.  I went to urgent care...urgent care at 8am on 9-12-24 and think they prescribed a steroid but I have yet to go to pharmacy to get it.  I just don't feel well at all.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Swelling face
Clinical narrative: I had the shot on 9-10-24 around noon...morning of 9-11-24 I had a large swollen itching spot on left forehead and then about 5 more appearing down the left side of the face.  They itch something awful.  then on both inside of thighs, I developed a red rash...not itching, but sores are smaller and close together unlike on the face.  I went to urgent care...urgent care at 8am on 9-12-24 and think they prescribed a steroid but I have yet to go to pharmacy to get it.  I just don't feel well at all.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Asthenia, Brain fog, Disability, Erythema, Feeding disorder
Clinical narrative: Severe disabling lethargy/weakness. Couldn't lift head from chest. Had to seek help from friend across the street. Red streak on arm, brain fog, couldn't eat.
Age: 80.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Lethargy, Mobility decreased
Clinical narrative: Severe disabling lethargy/weakness. Couldn't lift head from chest. Had to seek help from friend across the street. Red streak on arm, brain fog, couldn't eat.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Petit mal epilepsy
Clinical narrative: Patient had what appeared to be an absent seizure. Patient then reported not able to breath despite trying to calm patient. Administered an epipen. Patient was taken with emergency personal.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Pain
Clinical narrative: Chills, fever, body aches, runny nose, sneezing, cough, headache. Symptoms started within 12 hours of vaccine. Symptoms still ongoing after 3 days
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Chills, fever, body aches, runny nose, sneezing, cough, headache. Symptoms started within 12 hours of vaccine. Symptoms still ongoing after 3 days
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: Right after patient received Havrix IM, Engerix-B IM, IPOL Subq, Menquadfi IM, and Adacel IM patient began to experience dizziness, sweatiness, and appeared pale. Vital signs were obtained at 2:30pm BP 72/41, HR 67, O2 100%. No respiratory distress was observed and patient remained alert and oriented throughout the reaction. Instructed patient to continue taking deep slow breaths and patient's feet were elevated using a chair. Vital signs obtained at 2:40pm were as follows BP 91/68, HR 62, O2 100%. Patient's mother stated that patient had breakfast and lunch and no prior history of vaccine reactions. Vital signs obtained at 2:44pm BP 101/77, HR 78, O2 100%, patient stated feeling better and dizziness had resolved. Vital signs at 2:53pm BP 88/68, HR 70, O2 100%. Provider was notified. Continued to monitor patient for an additional 30 minutes. Final vital signs at 3:28pm BP 113/74, HR 70, O2 100%. Patient mentioned feeling better and was no longer feeling dizzy. Educated mother to seek emergency medical care if patient's symptoms return. Patient's mother verbalized understanding. Patient was released in stable conditions at 3:30pm with parents and siblings.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Injection site nodule, Pain in extremity
Clinical narrative: Patient had a lot of pain in his leg starting at about 5 hours after his vaccine. He had the pain for over 24 hours before it went away. He developed a large knot where it was given. The knot is still there.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to the pharmacy with redness and swelling around the injection site. Site was hot to the touch per patient. Patient has been using ice packs with redness and swelling. Advised patient to keep doing so and will follow up in 24-48 hours.
Age: 83.0
Sex: F
Vaccine: COVID19-2, FLU4, RSV
Symptoms: Pruritus
Clinical narrative: The patient contacted the pharmacy on 9/12/2024 to report the adverse reaction. She reported non-localized itching starting the evening of 9/11/2024. She reported taking a dose of Benadryl (diphenhydramine) that successfully reduced the itching to the point she was able to sleep. No other adverse effects were reported, including anaphylaxis, any trouble breathing, or swelling. She reported that the itching returned the following day (9/12/2024) and requested guidance from the pharmacist on duty, myself. I advised the patient to utilize OTC Zyrtec to manage the itching during the day while avoiding the sedating effects of Benadryl. I advised her to closely monitor for any additional adverse effects such as anaphylaxis, any trouble breathing, or swelling and to reach out to her PCP if the itching has not improved by the following day.  The patient agreed to this care plan, and I instructed her to contact the pharmacy again with any other questions or concerns.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema, Neck pain
Clinical narrative: patient felt pain from shoulder and neck and had picture of red spot on arm below injection site
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash
Clinical narrative: developed persistant rash around injection site
Age: 68.0
Sex: F
Vaccine: FLUR4
Symptoms: Incorrect dose administered, Wrong patient
Clinical narrative: PATIENT ADMINISTERED THE WRONG VACCINE SHOULD HAVE GOTTEN HD AND RECIEVED FLUBLOK
Age: 11.0
Sex: U
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: comirnaty covid vaccine 2024-2025 for patients 12 years and older to  a patient 11 years and 11 months old. patient's guardian says patient is doing fine. no adverse effects
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Hypoaesthesia, Lethargy, Paraesthesia, Swelling face
Clinical narrative: Face became puffy from ear to ear across the eyes and nasal; Face became puffy from ear to ear across the eyes and nasal; Tingling started in left hand moving up to chest down into right hand; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1,SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: SWELLING FACE (hospitalization, disability), PERIORBITAL SWELLING (hospitalization, disability) all with onset 07Jul2023 at 12:00, outcome "recovered with sequelae" and all described as "Face became puffy from ear to ear across the eyes and nasal"; PARAESTHESIA (hospitalization, disability) with onset 07Jul2023 at 12:00, outcome "recovered with sequelae", described as "Tingling started in left hand moving up to chest down into right hand". Therapeutic measures were taken as a result of swelling face, periorbital swelling, paraesthesia. Clinical course: Vaccination Facility Type was Pharmacy or Drug Store. There were no other vaccine on the same date, no other vaccine in four weeks and no other medications in two weeks. The patient's face became puffy from ear to ear across the eyes and nasal. Tingling started in left hand moving up to chest down into right hand. Paramedics were called to attend. The patient was rushed to (Withheld). The adverse event resulted in Hospitalization, Disability or permanent damage. The patient recovered with lasting effects. Treatment included Toeredal (as reported). The patient has no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Periorbital swelling, Swelling face
Clinical narrative: Face became puffy from ear to ear across the eyes and nasal; Face became puffy from ear to ear across the eyes and nasal; Tingling started in left hand moving up to chest down into right hand; This is a spontaneous report received from a Consumer or other non HCP.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 22Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1,SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: SWELLING FACE (hospitalization, disability), PERIORBITAL SWELLING (hospitalization, disability) all with onset 07Jul2023 at 12:00, outcome "recovered with sequelae" and all described as "Face became puffy from ear to ear across the eyes and nasal"; PARAESTHESIA (hospitalization, disability) with onset 07Jul2023 at 12:00, outcome "recovered with sequelae", described as "Tingling started in left hand moving up to chest down into right hand". Therapeutic measures were taken as a result of swelling face, periorbital swelling, paraesthesia. Clinical course: Vaccination Facility Type was Pharmacy or Drug Store. There were no other vaccine on the same date, no other vaccine in four weeks and no other medications in two weeks. The patient's face became puffy from ear to ear across the eyes and nasal. Tingling started in left hand moving up to chest down into right hand. Paramedics were called to attend. The patient was rushed to (Withheld). The adverse event resulted in Hospitalization, Disability or permanent damage. The patient recovered with lasting effects. Treatment included Toeredal (as reported). The patient has no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.