chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Immediate post-injection reaction, Inappropriate schedule of product administration, Injection site pain, Laboratory test, Myalgia
Clinical narrative: Headaches; Numbness on one side of the head; Ears were whistling; Ear was irritated specially left one; Mouth was burning; Feeling very tired / Lot of fatigue; Irritated eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13, administration date: Aug2022, for immunization. The following information was reported: EAR PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "Ear was irritated specially left one"; TINNITUS (non-serious) with onset Sep2023, outcome "not recovered", described as "Ears were whistling"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "Feeling very tired / Lot of fatigue"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "Headaches"; EYE IRRITATION (non-serious) with onset Sep2023, outcome "not recovered", described as "Irritated eyes"; ORAL DISCOMFORT (non-serious) with onset Sep2023, outcome "recovering", described as "Mouth was burning"; HYPOAESTHESIA (non-serious) with onset Sep2023, outcome "unknown", described as "Numbness on one side of the head". The events "headaches", "numbness on one side of the head", "ears were whistling", "ear was irritated specially left one", "mouth was burning" and "feeling very tired / lot of fatigue" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had Prevnar 20 on Friday, 01Sep2023 and the reactions were very awful. When the patient got the Prevnar 20, he experienced headaches, numbness on one side of the head, ears were whistling, ear was irritated specially left one, his mouth was burning, he was feeling very tired with a lot of fatigue. So, he went back to see the doctor but he was sent to the Nurse and the Nurse sent him to the emergency room (ER). At the emergency room, they did some lab work about five or six blood samples. The patient still has the symptoms, it has been over a week, but he still has the whistling sound in his ear. He still has irritated eyes. The burning in mouth went away but not completely. So, nobody was helping him because they do not seem to think this is an emergency, it does not help out. He wanted someone to take care of the symptoms that he got because it has been over a week.   The information on the batch/lot number pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Nervousness, Pain, Tinnitus, Tongue discomfort, Vision blurred
Clinical narrative: Headaches; Numbness on one side of the head; Ears were whistling; Ear was irritated specially left one; Mouth was burning; Feeling very tired / Lot of fatigue; Irritated eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13, administration date: Aug2022, for immunization. The following information was reported: EAR PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "Ear was irritated specially left one"; TINNITUS (non-serious) with onset Sep2023, outcome "not recovered", described as "Ears were whistling"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "Feeling very tired / Lot of fatigue"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "Headaches"; EYE IRRITATION (non-serious) with onset Sep2023, outcome "not recovered", described as "Irritated eyes"; ORAL DISCOMFORT (non-serious) with onset Sep2023, outcome "recovering", described as "Mouth was burning"; HYPOAESTHESIA (non-serious) with onset Sep2023, outcome "unknown", described as "Numbness on one side of the head". The events "headaches", "numbness on one side of the head", "ears were whistling", "ear was irritated specially left one", "mouth was burning" and "feeling very tired / lot of fatigue" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had Prevnar 20 on Friday, 01Sep2023 and the reactions were very awful. When the patient got the Prevnar 20, he experienced headaches, numbness on one side of the head, ears were whistling, ear was irritated specially left one, his mouth was burning, he was feeling very tired with a lot of fatigue. So, he went back to see the doctor but he was sent to the Nurse and the Nurse sent him to the emergency room (ER). At the emergency room, they did some lab work about five or six blood samples. The patient still has the symptoms, it has been over a week, but he still has the whistling sound in his ear. He still has irritated eyes. The burning in mouth went away but not completely. So, nobody was helping him because they do not seem to think this is an emergency, it does not help out. He wanted someone to take care of the symptoms that he got because it has been over a week.   The information on the batch/lot number pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Blood test, Ear pain, Eye irritation, Fatigue, Headache
Clinical narrative: Headaches; Numbness on one side of the head; Ears were whistling; Ear was irritated specially left one; Mouth was burning; Feeling very tired / Lot of fatigue; Irritated eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13, administration date: Aug2022, for immunization. The following information was reported: EAR PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "Ear was irritated specially left one"; TINNITUS (non-serious) with onset Sep2023, outcome "not recovered", described as "Ears were whistling"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "Feeling very tired / Lot of fatigue"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "Headaches"; EYE IRRITATION (non-serious) with onset Sep2023, outcome "not recovered", described as "Irritated eyes"; ORAL DISCOMFORT (non-serious) with onset Sep2023, outcome "recovering", described as "Mouth was burning"; HYPOAESTHESIA (non-serious) with onset Sep2023, outcome "unknown", described as "Numbness on one side of the head". The events "headaches", "numbness on one side of the head", "ears were whistling", "ear was irritated specially left one", "mouth was burning" and "feeling very tired / lot of fatigue" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had Prevnar 20 on Friday, 01Sep2023 and the reactions were very awful. When the patient got the Prevnar 20, he experienced headaches, numbness on one side of the head, ears were whistling, ear was irritated specially left one, his mouth was burning, he was feeling very tired with a lot of fatigue. So, he went back to see the doctor but he was sent to the Nurse and the Nurse sent him to the emergency room (ER). At the emergency room, they did some lab work about five or six blood samples. The patient still has the symptoms, it has been over a week, but he still has the whistling sound in his ear. He still has irritated eyes. The burning in mouth went away but not completely. So, nobody was helping him because they do not seem to think this is an emergency, it does not help out. He wanted someone to take care of the symptoms that he got because it has been over a week.   The information on the batch/lot number pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Age: 69.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Hypoaesthesia, Oral discomfort, Tinnitus
Clinical narrative: Headaches; Numbness on one side of the head; Ears were whistling; Ear was irritated specially left one; Mouth was burning; Feeling very tired / Lot of fatigue; Irritated eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 01Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13, administration date: Aug2022, for immunization. The following information was reported: EAR PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "Ear was irritated specially left one"; TINNITUS (non-serious) with onset Sep2023, outcome "not recovered", described as "Ears were whistling"; FATIGUE (non-serious) with onset Sep2023, outcome "unknown", described as "Feeling very tired / Lot of fatigue"; HEADACHE (non-serious) with onset Sep2023, outcome "unknown", described as "Headaches"; EYE IRRITATION (non-serious) with onset Sep2023, outcome "not recovered", described as "Irritated eyes"; ORAL DISCOMFORT (non-serious) with onset Sep2023, outcome "recovering", described as "Mouth was burning"; HYPOAESTHESIA (non-serious) with onset Sep2023, outcome "unknown", described as "Numbness on one side of the head". The events "headaches", "numbness on one side of the head", "ears were whistling", "ear was irritated specially left one", "mouth was burning" and "feeling very tired / lot of fatigue" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient had Prevnar 20 on Friday, 01Sep2023 and the reactions were very awful. When the patient got the Prevnar 20, he experienced headaches, numbness on one side of the head, ears were whistling, ear was irritated specially left one, his mouth was burning, he was feeling very tired with a lot of fatigue. So, he went back to see the doctor but he was sent to the Nurse and the Nurse sent him to the emergency room (ER). At the emergency room, they did some lab work about five or six blood samples. The patient still has the symptoms, it has been over a week, but he still has the whistling sound in his ear. He still has irritated eyes. The burning in mouth went away but not completely. So, nobody was helping him because they do not seem to think this is an emergency, it does not help out. He wanted someone to take care of the symptoms that he got because it has been over a week.   The information on the batch/lot number pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Age: 0.42
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Crying, Irritability, Restlessness, Somnolence
Clinical narrative: Extreme changes in mood and behavior.   Previously happy and laughing baby become very lethargic, withdrawn, avoiding eye contact,  with a "glassy" vacant look. Pt stopped giggling, laughing and stopped interacting with us as she was prior to vaccination. She showed some tremor-like twitches in her face that were transient and hard to pin point. There were no other factors contributing to this extreme behavior change.  She was not herself and people who did not know about her vaccination were commenting that she was different. This behavior change lasted for 2.5 weeks and even now, over a month after, she is still not back 100% to herself pre-vaccination.
Age: 0.42
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Abnormal behaviour, Decreased eye contact, Glassy eyes, Lethargy, Mood altered
Clinical narrative: Extreme changes in mood and behavior.   Previously happy and laughing baby become very lethargic, withdrawn, avoiding eye contact,  with a "glassy" vacant look. Pt stopped giggling, laughing and stopped interacting with us as she was prior to vaccination. She showed some tremor-like twitches in her face that were transient and hard to pin point. There were no other factors contributing to this extreme behavior change.  She was not herself and people who did not know about her vaccination were commenting that she was different. This behavior change lasted for 2.5 weeks and even now, over a month after, she is still not back 100% to herself pre-vaccination.
Age: 0.42
Sex: F
Vaccine: DTAP, DTAP
Symptoms: Muscle twitching, Social avoidant behaviour, Tremor
Clinical narrative: Extreme changes in mood and behavior.   Previously happy and laughing baby become very lethargic, withdrawn, avoiding eye contact,  with a "glassy" vacant look. Pt stopped giggling, laughing and stopped interacting with us as she was prior to vaccination. She showed some tremor-like twitches in her face that were transient and hard to pin point. There were no other factors contributing to this extreme behavior change.  She was not herself and people who did not know about her vaccination were commenting that she was different. This behavior change lasted for 2.5 weeks and even now, over a month after, she is still not back 100% to herself pre-vaccination.
Age: 67.0
Sex: U
Vaccine: RSV, FLU4, RSV
Symptoms: Diplopia, Laboratory test
Clinical narrative: The patient developed new-onset horizontal diplopia 8 hours after administration of the Fluzone HD and Arexvy vaccines. The diplopia was constant and resulted in her presenting for examination 7 days later. Having previously examined her eyes a month ago, I confirmed that she had developed a new-onset constant esotropia measuring 10 prism diopters.  Of note, she had also received botulinum toxin injections a few days prior to developing the diplopia, though she did not have peri-ocular injection of botulinum toxin.
Age: 67.0
Sex: U
Vaccine: RSV, FLU4, RSV
Symptoms: Diplopia, Strabismus
Clinical narrative: The patient developed new-onset horizontal diplopia 8 hours after administration of the Fluzone HD and Arexvy vaccines. The diplopia was constant and resulted in her presenting for examination 7 days later. Having previously examined her eyes a month ago, I confirmed that she had developed a new-onset constant esotropia measuring 10 prism diopters.  Of note, she had also received botulinum toxin injections a few days prior to developing the diplopia, though she did not have peri-ocular injection of botulinum toxin.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Product delivery mechanism issue, Product storage error
Clinical narrative: No additional AE; possible temp excursion due to the late shipping; Received transfer Carrier, who informed HCP stated she received late shipment on 8/7/2023 and should have been received on 8/6/2023 of VARIVAX and MMR II. Spoke with HCP who informed VARIVAX was given to 5patients. Additional AE on case 024518; This spontaneous report was received from a nurse, referring to a 31-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 07-AUG-2023, the nurse received late shipment of varicella virus vaccine live (oka/merck) (VARIVAX) as it should had been received on 06-AUG-2023 (product distribution issue). On the same date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml), administered subcutaneously (strength, vaccination scheme and anatomical site of vaccination were not reported; lot number X010525, expiration date reported and validated as 11-APR-2025) as prophylaxis. There was a possible temperature excursion due to late delivery, the manufacturer was notified on arrival, vaccine was cold and placed in freezer per nurse (product storage error). No additional adverse event.  This is one of several reports received from the same reporter.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC.; nbound call from a medical assistant with a physician on the back line reporting AE for VARIVAX.  TE case filed under 02458467. AE details were provided by medical assistant. No symptoms reported. No additional AE/PQC.  ?    Names of vaccines invol; This spontaneous report was received from a medical assistant and refers to a 7-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 mL, subcutaneously, second dose, in the right arm, lot number X006983 with expiration date 07-MAR-2025, and with hepatitis a vaccine, inactivated(VAQTA) lot number X003792 with expiration date 21-JUN-2024, second dose (dose, route and anatomical location were not reported) all vaccines for prophylaxis. The vaccines were exposed to -12.48 degrees Celsius for 1 hour and 30 minutes, there was previous temperature excursion. No additional adverse events were reported.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Biopsy skin, Blood immunoglobulin A, Blood immunoglobulin G normal, Blood immunoglobulin M, Eczema
Clinical narrative: Wells syndrome; This literature marketed report was received from the authors in a published article titled as stated below, concerning a 13-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The patient was referred to the dermatology clinic for a blistering rash that appeared 2 weeks after receiving a varicella vaccine (manufacturer unknown). Findings of the clinical examination revealed multiple pink papules and plaques involving the torso and extremities with a prominent edematous erythematous plaque involving the right elbow. Results of laboratory studies demonstrated normal complete blood count, tryptase, BP180, IgG, IgM, and IgA. A 4-mm punch biopsy was performed on the right elbow. Histopathology revealed crusted epidermal spongiosis and an eosinophil-rich, dermal infiltrate with degranulation of eosinophils surrounding collagen bundles (flame figures). Tryptase and CD117 stains demonstrated rare, scattered mast cells. Direct immunofluorescence was negative for a specific dermatosis. These findings, in combination with her clinical presentation, confirmed a diagnosis of Wells syndrome, likely attributed to recent vaccination. She was treated with oral cetirizine and topical steroids, with excellent clinical improvement.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Erythema, Full blood count normal, Histology, Laboratory test, Oedema
Clinical narrative: Wells syndrome; This literature marketed report was received from the authors in a published article titled as stated below, concerning a 13-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The patient was referred to the dermatology clinic for a blistering rash that appeared 2 weeks after receiving a varicella vaccine (manufacturer unknown). Findings of the clinical examination revealed multiple pink papules and plaques involving the torso and extremities with a prominent edematous erythematous plaque involving the right elbow. Results of laboratory studies demonstrated normal complete blood count, tryptase, BP180, IgG, IgM, and IgA. A 4-mm punch biopsy was performed on the right elbow. Histopathology revealed crusted epidermal spongiosis and an eosinophil-rich, dermal infiltrate with degranulation of eosinophils surrounding collagen bundles (flame figures). Tryptase and CD117 stains demonstrated rare, scattered mast cells. Direct immunofluorescence was negative for a specific dermatosis. These findings, in combination with her clinical presentation, confirmed a diagnosis of Wells syndrome, likely attributed to recent vaccination. She was treated with oral cetirizine and topical steroids, with excellent clinical improvement.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Papule, Rash vesicular, Skin plaque, Tryptase
Clinical narrative: Wells syndrome; This literature marketed report was received from the authors in a published article titled as stated below, concerning a 13-month-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The patient was referred to the dermatology clinic for a blistering rash that appeared 2 weeks after receiving a varicella vaccine (manufacturer unknown). Findings of the clinical examination revealed multiple pink papules and plaques involving the torso and extremities with a prominent edematous erythematous plaque involving the right elbow. Results of laboratory studies demonstrated normal complete blood count, tryptase, BP180, IgG, IgM, and IgA. A 4-mm punch biopsy was performed on the right elbow. Histopathology revealed crusted epidermal spongiosis and an eosinophil-rich, dermal infiltrate with degranulation of eosinophils surrounding collagen bundles (flame figures). Tryptase and CD117 stains demonstrated rare, scattered mast cells. Direct immunofluorescence was negative for a specific dermatosis. These findings, in combination with her clinical presentation, confirmed a diagnosis of Wells syndrome, likely attributed to recent vaccination. She was treated with oral cetirizine and topical steroids, with excellent clinical improvement.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Coombs test positive, Dermatitis diaper, Diarrhoea, No reaction on previous exposure to drug
Clinical narrative: The patient developed diarrhea 3-4 days after receiving the second dose of ROTATEQ; The patient then developed diaper rash; This spontaneous report was received from a nurse referring to a 4-month-old female patient.  The patient was born premature at 36 weeks gestation. Patient did not have concomitant medications and no known drug allergies (NKDA) were reported. On an unknown date in 2023, Coombs test was positive.   On an unspecified date in 2023, the patient received the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral (strength, dose, vaccination scheme frequency, lot number and expiration date were not provided) as prophylaxis. The patient tolerated this first dose with no difficulty and did not have any side effects. Then, on 15-AUG-2023, she was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 mL, lot number X004919, expiration date: 04-JUN-2024, administered orally as routine vaccination (strength was not provided).  On an unknown date in August 2023 (reported as 3-4 days after receiving the second dose of the suspect vaccine), the patient developed diarrhea. The patient had diarrhea about 10 times a day for eleven days. Consequently, she then developed diaper rash due the diarrhea on an unspecified date in August 2023. No treatment was given for the event. On an unknown date in August 2023, the patient recovered from diarrhoea. The outcome of dermatitis diaper was not reported.   The causal relationship between rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and diarrhea was not provided, while with diaper rash was not related.  Upon internal review, diarrhea was determined to be a medically significant event.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: No additional adverse event; the patient was vaccinated with an extra dose of VARIVAX; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-AUG-2023, the patient was vaccinated with an extra dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # X007372 and expiration date was reported as 12-MAR-2025 (dosage regimen, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event (no adverse event).
Sex: F
Vaccine: UNK
Symptoms: Lung carcinoma cell type unspecified stage IV
Clinical narrative: she has stage 4 lung cancer.; This spontaneous case was reported by a patient and describes the occurrence of LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (she has stage 4 lung cancer. ) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (she has stage 4 lung cancer. ) (seriousness criterion medically significant). At the time of the report, LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV (she has stage 4 lung cancer. ) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medication was reported.  It was reported that patient received all Moderna Vaccines. No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of Lung carcinoma cell type unspecified stage IV, which occurred related to the mRNA-1273 vaccine, received as part of COVID-19 vaccination schedule, dose number not provided. The outcome was not reported. The company considered the event as not related to the vaccine due to the nature of the event, lack of biological plausibility, short latency and known safety profile of the vaccine. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
Age: 1.75
Sex: F
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered
Clinical narrative: vaccines being in transit too long as vaccines were sent on 26Aug2023, and it should have been at the office, yesterday (28Aug2023), vaccines already being administered with no reported adverse event; Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional (nurse).  This case involves a 21-month-old female patient who experienced vaccines being in transit too long as vaccines were sent on 26aug2023, and it should have been at the office, yesterday (28aug2023), vaccines already being administered with no reported adverse event while receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Aug-2023, the vaccines being in transit too long as vaccines were sent, and it should have been at the office, yesterday (28aug2023).  On 29-Aug-2023, the patient received a dose of 0.5 ml suspect Influenza Quadrival A-B Vaccine Suspension for injection in pre-filled syringe (lot: UT8040KA, expiration date: 30-Jun-2024) via intramuscular route in unknown administration site for flu prevention (Antiviral prophylaxis) & Immunization with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  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.   Additional information was received on 08-Sep-2023 from Other health professional. Case has become non valid to valid. Patient information added, clinical course updated and text amended accordingly.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered
Clinical narrative: No further AE details.; a small portion of the product actually reaching the patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions were not reported.  On 01-SEP-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milligram, once, lot #W034364, expiration date: 20-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). A non-company needle and syringe were used to pull out product from the vial and that the needle was not completely attached resulting in a small portion of the product actually reaching the patient (also reported as a full dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was not administered to a patient) (incorrect dose administered). No further AE details.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Arthralgia, Autoimmune disorder, Back pain, Blood glucose normal
Clinical narrative: The local and immediate symptoms were routine.  The long-lasting, and ongoing, symptoms are the concern.  Symptoms developed gradually and on 9/21/21 were reported to Dr.  Symptoms included bilateral hip and shoulder stiffness and aching, and sometimes lower back, with whole body malaise.    Heart palpitations became prominent for a few weeks in September.  The second Shingrix dose was on 10/21/21 and the overall condition became precipitously worse.  Although diagnostics for the pain and malaise led to nothing specific, prednisone was started on 1/1/22, with immediate and complete symptomatic resolution by 1/5/22.   A working diagnosis of polymyalgia rheumatica was made by exclusion.  Typical approaches to tapering the prednisone have had limited success and currently no prednisone is being taken but the symptoms are mostly returned.  The diagnosis of polymyalgia rheumatica fits mostly but more accurately, this is a post-vaccination autoimmune rheumatic syndrome.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Blood testosterone normal, Bone scan abnormal, Borrelia test negative, C-reactive protein normal
Clinical narrative: The local and immediate symptoms were routine.  The long-lasting, and ongoing, symptoms are the concern.  Symptoms developed gradually and on 9/21/21 were reported to Dr.  Symptoms included bilateral hip and shoulder stiffness and aching, and sometimes lower back, with whole body malaise.    Heart palpitations became prominent for a few weeks in September.  The second Shingrix dose was on 10/21/21 and the overall condition became precipitously worse.  Although diagnostics for the pain and malaise led to nothing specific, prednisone was started on 1/1/22, with immediate and complete symptomatic resolution by 1/5/22.   A working diagnosis of polymyalgia rheumatica was made by exclusion.  Typical approaches to tapering the prednisone have had limited success and currently no prednisone is being taken but the symptoms are mostly returned.  The diagnosis of polymyalgia rheumatica fits mostly but more accurately, this is a post-vaccination autoimmune rheumatic syndrome.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac monitoring abnormal, Hepatic enzyme, Immediate post-injection reaction, Joint stiffness, Liver function test normal
Clinical narrative: The local and immediate symptoms were routine.  The long-lasting, and ongoing, symptoms are the concern.  Symptoms developed gradually and on 9/21/21 were reported to Dr.  Symptoms included bilateral hip and shoulder stiffness and aching, and sometimes lower back, with whole body malaise.    Heart palpitations became prominent for a few weeks in September.  The second Shingrix dose was on 10/21/21 and the overall condition became precipitously worse.  Although diagnostics for the pain and malaise led to nothing specific, prednisone was started on 1/1/22, with immediate and complete symptomatic resolution by 1/5/22.   A working diagnosis of polymyalgia rheumatica was made by exclusion.  Typical approaches to tapering the prednisone have had limited success and currently no prednisone is being taken but the symptoms are mostly returned.  The diagnosis of polymyalgia rheumatica fits mostly but more accurately, this is a post-vaccination autoimmune rheumatic syndrome.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal stiffness, Pain, Palpitations, Polymyalgia rheumatica
Clinical narrative: The local and immediate symptoms were routine.  The long-lasting, and ongoing, symptoms are the concern.  Symptoms developed gradually and on 9/21/21 were reported to Dr.  Symptoms included bilateral hip and shoulder stiffness and aching, and sometimes lower back, with whole body malaise.    Heart palpitations became prominent for a few weeks in September.  The second Shingrix dose was on 10/21/21 and the overall condition became precipitously worse.  Although diagnostics for the pain and malaise led to nothing specific, prednisone was started on 1/1/22, with immediate and complete symptomatic resolution by 1/5/22.   A working diagnosis of polymyalgia rheumatica was made by exclusion.  Typical approaches to tapering the prednisone have had limited success and currently no prednisone is being taken but the symptoms are mostly returned.  The diagnosis of polymyalgia rheumatica fits mostly but more accurately, this is a post-vaccination autoimmune rheumatic syndrome.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Post vaccination syndrome, Renal function test normal, Rheumatoid factor negative, Ventricular extrasystoles
Clinical narrative: The local and immediate symptoms were routine.  The long-lasting, and ongoing, symptoms are the concern.  Symptoms developed gradually and on 9/21/21 were reported to Dr.  Symptoms included bilateral hip and shoulder stiffness and aching, and sometimes lower back, with whole body malaise.    Heart palpitations became prominent for a few weeks in September.  The second Shingrix dose was on 10/21/21 and the overall condition became precipitously worse.  Although diagnostics for the pain and malaise led to nothing specific, prednisone was started on 1/1/22, with immediate and complete symptomatic resolution by 1/5/22.   A working diagnosis of polymyalgia rheumatica was made by exclusion.  Typical approaches to tapering the prednisone have had limited success and currently no prednisone is being taken but the symptoms are mostly returned.  The diagnosis of polymyalgia rheumatica fits mostly but more accurately, this is a post-vaccination autoimmune rheumatic syndrome.
Age: 4.0
Sex: F
Vaccine: FLUC4, IPV
Symptoms: Adverse event, Contusion, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Red, swollen, warm, itchy area on arm at vaccine injection site. Per provider note, likely local reaction vs. side effect. Most consistent with bruising
Age: 4.0
Sex: F
Vaccine: FLUC4, IPV
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Red, swollen, warm, itchy area on arm at vaccine injection site. Per provider note, likely local reaction vs. side effect. Most consistent with bruising
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No symptoms.
Age: 70.0
Sex: F
Vaccine: FLUC4
Symptoms: Product label issue, Wrong product administered
Clinical narrative: Bag error at pharmacy window led to patient receiving Flucelvax instead of Fluad.
Age: 82.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: pt states her left deltoid is still red and hard 6 days following injection with the RSV vaccine. pt confirmed that the area is warm to the touch but not painful. referred pt to pcp.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: REC'D IMZ IN LEFT ARM SAT 9/9 WITHOUT ISSUE. PT CALLED SUN (9/10) MORNING STATING HER RIGHT HAND HURT. NO REDNESS, SWELLING OR VISIBLE RASH. NO ISSUES AT INJECTION SITE. SPOKE WITH HER LATER IN THE AFTERNOON - HAND FELT BETTER - NO LONGER HURT.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Drug hypersensitivity, Erythema, Peripheral swelling, Tenderness
Clinical narrative: Pain to the touch and redness to deltoid area of left arm. Patient concerned it is infected. He was not angry, just concerned. I urged him to see a doctor immediately. I let him know I was reporting it. Patient made appointment with Dr. and the Dr. said that it was not infected, it was just a reaction to the vax (Fluad 2023). Prescribed Triamcinolone 0.1% cream twice daily. Pt saw Dr., who stated that it was a reaction to the flu shot, Fluad. A note was added to his profile that there was an allergic reaction to Fluad. Patient called me on 9/14/23 @ 10:20AM and stated his arm is improved and not as red or swollen.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site reaction
Clinical narrative: injection site reaction/right arm after meningococcal B vaccine
Age: 29.0
Sex: F
Vaccine: COVID19-2, FLU4, TDAP
Symptoms: Discontinued product administered
Clinical narrative: Covid Bivalent vaccine was given to patient after notification was sent that FDA is no longer authorizing the use of bivalent changing to monovalent.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Migraine, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: Employee received the vaccine on 9/7/2023, reports feeling symptoms on 9/9/23. Describes symptoms of bilateral arm & leg weakness, tingling bilateral wrists, severe migraine & nausea that started on 9/12/23. Nausea is persistent, has a loss of appetite. Employee presented to Employee Health office 9/14/23 after appointment with occupational medicine made 9/14/23.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received recent dose 13 days after already getting a flu vaccine. Mother claims she didn't know child had one for this flu season. Other dose given 8/30/2023.
Age: 67.0
Sex: F
Vaccine: FLUA4
Symptoms: Dyspnoea
Clinical narrative: Patient stated having trouble breathing 3-5 minutes post vaccination. Pt was sat in a chair and was given a 0.3mg dose of epi-pen. EMS was called and the patient was taken to the hospital for observation. She called the store at approx 6:30pm on 09/12/23 to inform us she was home and doing well.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Cold sweat, Feeling abnormal
Clinical narrative: Patient here for immunization for school.  Grandmother here with patient. During the immunization risk assessment, patient reports "I have history of seizures that started in April and has seizures very 2-3 weeks. I am taking seizure medication that the doctor double up on and it has helped a lot." Denies any other problems in agreement with grandmother.  Needs meningococcal ACWY.  Meningococcal vaccine information statement given to grandmother with risks discussed.  Meningococcal vaccine given in right deltoid.  Patient tolerated well. Awake, alert and tolerated well.  Patient escorted to discharge desk at which point she became weak and was transferred to chair.  Patient talking but reporting "feeling weird". Patient warm and clammy. 1600:  BP  95/55 pulse 69 Resp 18.  Patient sitting in chair with head resting on back of chair Patient sipping sprite. RN at chair side.  1615: 101/62 pulse 60 Resp 18 Patient awake and alert with color returning to lips and face. 1625 Patient sitting up in chair BP 110/65 pulse 56 resp 18. Patient states she feels able to ambulate to car with minimal assistance escorted by nurse and placed in vehicle sitting up in seat.  Awake and alert.  Grandmother at side.  RN Supervisor notified. Grandmother and patient comfortable leaving clinic.   Will follow up with patient. -------RN  Notified that grandmother and patient are back in parking lot. Grandmother states patient is not feeling good again. BP 105/55 Pulse 65 O2Sat 100% Resp 18. Patient looked weak, slumped, oriented x 3, diaphoretic, and talking. 1641: EMS called. BP 1645: 98/59 pulse 68, pulse ox 100% continuous monitor per Nurse. P: EMS arrival 1645.  EMS to assess and determine further need.  Accompanied by RNs.  EMS monitored and spoke with legal guardian by phone.  Mother declined transport by EMS. Mother Chooses to meet patient by private vehicle.  Patient transferred to vehicle by EMS ambulating, alert and oriented x 3. Care released to grandmother.  Will follow up with patient. ----RN
Age: 76.0
Sex: M
Vaccine: RSV
Symptoms: Peripheral swelling, Rash, Rash papular, Skin warm
Clinical narrative: day after vaccine raised bumps on arm and swollen and hot to touch
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Computerised tomogram, Dehydration, Headache
Clinical narrative: Flu-like symptoms, back pain mimicking kidney stone pain, severe dehydration, headache.  Severe day one, lessened day two,  resolved day three.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Urine analysis
Clinical narrative: Flu-like symptoms, back pain mimicking kidney stone pain, severe dehydration, headache.  Severe day one, lessened day two,  resolved day three.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: The patient called me at 9:09AM on 9/14/2023 and told me about a rash that showed up on 9/13/2023 on her left arm below the injection site.  The rash is not raised; it is not hives, according to patient.  The rash is warm to the touch.  Also, her arm still hurts at the injection site.
Age: 90.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered.
Age: 13.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Electroencephalogram, Mental status changes, Seizure like phenomena, Unresponsive to stimuli
Clinical narrative: Patient with episode of altered mental status.  Had been unresponsive and showing seizure-like activity.  Mother brought her to the emergency room where evaluated and hospitalized overnight for observation.  Discharged next day and doing well
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Frequent bowel movements, Vomiting
Clinical narrative: Mother reported two episodes of vomiting the day after receiving the two-month-old vaccinations in our office. One of the vaccines was the first dose in the series of Rotateq. Mom also reported more frequent stools, but no blood or mucous noted in the stools and vomitus appeared to be recently ingested milk.  NO fever, no apparent pain or discomfort.  Better today and seen as a follow-up in our office today. (September 14, 2023)
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Bilateral arm rash noted. " I notice that it was itchy, but I did not pay attention to it, but now I noticed I have welts reactions on my arm."
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Chest pain, Musculoskeletal disorder, Pain
Clinical narrative: He got his vaccine, broke out with a rash on his right side like he had the shingles.  Then his arm felt good, then he cut the grass and was not able to move his arm.  Called Telehealth and was told that if there was no pus on it and said that he was going to have sorness of his muscle as it went into the muscle.  Now he has swelling on his left side that flutters some times, and has a lot of pain in his arm trying to stretch it, move it over his head and when he does yard work he is in constant pain.  He has seen his doctor for this, and went yesterday and they ordered an X-ray to see if the needle went into his bone.  He is having pain in his shoulder, down his back, and going down his chest towards his heart.  He has a lot of pain in the left arm trying to do anything.  He did not have any problems with pain in that arm prior to the vaccine.  He has not been taking anything for the pain and just using alcohol on it.  Due to his constant pain he is in fear of getting the 2nd vaccine.  He got PTSD after seeing the commercial and gets highly upset and almost broke his TV over it.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Swelling
Clinical narrative: He got his vaccine, broke out with a rash on his right side like he had the shingles.  Then his arm felt good, then he cut the grass and was not able to move his arm.  Called Telehealth and was told that if there was no pus on it and said that he was going to have sorness of his muscle as it went into the muscle.  Now he has swelling on his left side that flutters some times, and has a lot of pain in his arm trying to stretch it, move it over his head and when he does yard work he is in constant pain.  He has seen his doctor for this, and went yesterday and they ordered an X-ray to see if the needle went into his bone.  He is having pain in his shoulder, down his back, and going down his chest towards his heart.  He has a lot of pain in the left arm trying to do anything.  He did not have any problems with pain in that arm prior to the vaccine.  He has not been taking anything for the pain and just using alcohol on it.  Due to his constant pain he is in fear of getting the 2nd vaccine.  He got PTSD after seeing the commercial and gets highly upset and almost broke his TV over it.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Mobility decreased, Pain
Clinical narrative: Decreased Range of motion with pain.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was given the Tdap in error at the age of 11.  Pt received the Tdap at his appropriate age last year at age 10.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red from the top of the deltoid to the bottom of the bicep. Area was red, warm to the touch, swollen, taught, and itchy. The provider suggested Hydrocortisone cream, Benadryl, and Tylenol as needed.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMRV, PNC13
Symptoms: Skin tightness
Clinical narrative: Left arm red from the top of the deltoid to the bottom of the bicep. Area was red, warm to the touch, swollen, taught, and itchy. The provider suggested Hydrocortisone cream, Benadryl, and Tylenol as needed.