chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: M
Vaccine: PNC20
Symptoms: Decreased appetite, Fatigue, Feeding disorder
Clinical narrative: fatigue/was very tired; little appetite/could not eat anything, had no appetite; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 86-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 06Jan2025 as dose number unknown, 0.5ml single (Lot number: LG5577, Expiration Date: Apr2026) at the age of 86 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE NUMBER UNKNOWN, SINGLE), administration date: 2019, for Immunization. The following information was reported: FATIGUE (non-serious) with onset 07Jan2025, outcome "recovering", described as "fatigue/was very tired"; DECREASED APPETITE (non-serious) with onset 07Jan2025, outcome "recovering", described as "little appetite/could not eat anything, had no appetite". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient wants to know if prevnar20 had a generic and he also wants to know if the label says Privacy, are they are also allowed to make under PREVNAR20 name. Patient could not get out of bed, was unstable, with fatigue and with little appetite. But today patient feeling much better , are this common side effects patient was worried there was a generic product or someone was using the prevnar 20 name other than pfizer. Call regarding Prevnar 20. First of all, wanted to make sure Pfizer was the only company that manufactures this. The reason he wanted to know was, he received the Prevnar 20 vaccine Monday (06Jan2025). The whole day yesterday, could not eat anything, had no appetite, was very tired, had to maker sure he did not fall. Wants to make sure it was not another company, manufacturing under Pfizer name because, he did have Prevnar 13, he believes, 6 years ago. Never experienced anything like he did yesterday (07Jan2025). Wanted to make sure, sometimes at doctor's office, they might put name Prevnar on it. Could also be another company manufacturing on their behalf. Suspect product: Prevnar 20. Ask them to print label that came off small vial with half a cc. Do have some information. Had to get magnifying glass, it was very small, hard to read. Will read from the top. Conjugate vaccine, Prevnar 20 1 dose (0.5ml) for intramuscular use only refrigerate, do not freeze, shake well. Clarified, these details printed from pharmacy from label, was not the actual label. Asked for label because he had to send it, to get money. Description of complaint: caller questioning if given generic vaccine, if other manufacturer allowed to manufacturer under Pfizer name. Product strength and count size dispensed: 0.5ml dose. Additional lot numbers: PAA201729
Sex: U
Vaccine: RSV
Symptoms: Diarrhoea, Dizziness, Vomiting
Clinical narrative: Diarrhea; Vomiting; Lightheadedness; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 07Jan2025 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset Jan2025, outcome "unknown", described as "Diarrhea"; DIZZINESS (non-serious) with onset Jan2025, outcome "unknown", described as "Lightheadedness"; VOMITING (non-serious) with onset Jan2025, outcome "unknown". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: RSV
Symptoms: Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Vaccination failure
Clinical narrative: diagnosed with RSV by PCR despite receiving ABRYSVO; diagnosed with RSV by PCR despite receiving ABRYSVO; This is a spontaneous report received from a Physician from a sales representative.  A 71-year-old female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 10Nov2023 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 10Nov2023. The following information was reported: VACCINATION FAILURE (medically significant), RESPIRATORY SYNCYTIAL VIRUS INFECTION (medically significant) all with onset Jan2025, outcome "recovering" and all described as "diagnosed with RSV by PCR despite receiving ABRYSVO". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (Jan2025) diagnosed with RSV. It was unknown if therapeutic measures were taken as a result of vaccination failure, respiratory syncytial virus infection. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event respiratory syncytial virus infection based on the known safety profile and temporal association.
Age: 49.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Large red induration to left deltoid 4 days after injection was received; Site is red, warm to the touch, and itchy; Site is red, warm to the touch, and itchy; Site is red, warm to the touch, and itchy; This is a spontaneous report received from a Nurse.  A 50-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 03Jan2025 as dose number unknown, single (Lot number: LJ5280) at the age of 49 years, in left deltoid for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE INDURATION (non-serious) with onset 07Jan2025, outcome "recovering", described as "Large red induration to left deltoid 4 days after injection was received"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 07Jan2025, outcome "recovering" and all described as "Site is red, warm to the touch, and itchy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site induration, vaccination site erythema, vaccination site warmth, vaccination site pruritus.  Additional Information: The patient did not receive any other vaccines on the same date or within 4 weeks prior as the suspect vaccine. The patient was taking other medications within 2 weeks of the event starting. The patient saw provider on 09Jan2025 for exam and was instructed to take diphenhydramine (BENADRYL).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Nausea, Non-cardiac chest pain
Clinical narrative: pain on right side of the chest and  heartburn; chest to stomach pain; pain on right side of the chest and  heartburn; nausea; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Oct2024, outcome "not recovered", described as "chest to stomach pain"; NAUSEA (non-serious) with onset Oct2024, outcome "unknown"; NON-CARDIAC CHEST PAIN (non-serious) with onset Oct2024, outcome "not recovered", DYSPEPSIA (non-serious) with onset Oct2024, outcome "unknown" and all described as "pain on right side of the chest and  heartburn". The events "pain on right side of the chest and  heartburn", "chest to stomach pain" and "nausea" required physician office visit.  Additional information: Patient had nausea, pain on right side of the chest and heartburn, she did have GERD and acid reflux but not like this sharp pain and it had not disappeared not completely and some soreness, chest to stomach pain and digestive system issues. Her cardiologist checked and it was not a heart thing, and she was having an endoscopy next week but the gastroenterologist said that it could have been an immune response to the vaccine. It had been 3 months and she still had pain. The night, right after she had it, which she got it around 5, the next night after dinner she had terrible pain in her right side like heartburn and was a little nauseous. Since then, she has had constant like indigestion pains that go from her chest to her stomach like gas and like a heaviness in chest and stomach.  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: Influenza like illness, Tremor, Vomiting
Clinical narrative: Uncontrollable tremors; Severe flu-like symptoms; Vomiting; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; WELLBUTRIN; PREGABALIN; CYMBALTA; TIZANIDINE; HYDROCODONE; ESTRADIOL. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: TREMOR (non-serious), outcome "recovered", described as "Uncontrollable tremors"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Severe flu-like symptoms"; VOMITING (non-serious), outcome "recovered". Therapeutic measures were not taken as a result of tremor, influenza like illness, vomiting.  Additional information: The patient had no known allergy. Hospitalization prolonged reported as no. The patient did not receive any other vaccines on the same date. The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). The patient taking other medications within 2 weeks of the event starting.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: he had in Nov2024, after the shot that the hard lump occurred; This is a spontaneous report received from a Pharmacist.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in Nov2024 as dose number unknown, single. Vaccination history included: comirnaty (DOSE 1, SINGLE, Anatomical Site of injection: Unknown, thinks left arm., Lot number: EL9265), administration date: 03Feb2021, when the patient was 76-year-old, for Covid-19 immunization; comirnaty (DOSE 2, SINGLE, Anatomical Site of injection: Right or left arm., Lot number: EL9267), administration date: 24Feb2021, when the patient was 76-year-old, for Covid-19 immunization; comirnaty (DOSE 3 (BOOSTER), SINGLE , Lot number: FD8448), administration date: 31Aug2021, when the patient was 77-year-old, for Covid-19 immunization; comirnaty (DOSE 4 (BOOSTER), SINGLE , Lot number: FL3197), administration date: 05Apr2022, when the patient was 77-year-old, for Covid-19 immunization; comirnaty bivalente ba.4/ba.5 (DOSE 5 (BOOSTER), SINGLE , Lot number: Not quite sure, looks like GJ5342), administration date: 09Sep2022, when the patient was 78-year-old, for Covid-19 immunization; Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE, Anatomical Site of injection: Arm Right), administration date: Mar2024, when the patient was 79 years old, for Covid-19 immunization, reaction(s): "large lump in abdomen", "lipoma", "Developed something hard, like a cyst, at injection site", "lost 15 pounds". The following information was reported: MASS (non-serious) with onset Nov2024, outcome "unknown", described as "he had in Nov2024, after the shot that the hard lump occurred".  Additional information: Prior Vaccinations (within 4 weeks): No With the last one that he had in Nov2024, after the shot that the hard lump occurred after, had Flu shot and Covid shot. Had 1 in each arm. Did not have any problems with anything.  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, FLUX
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginning of Oct; we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginning of Oct; This is a spontaneous report and received from Consumer or other non HCPs, Program ID.  A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), in Oct2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "we had we were surprised we tested positive we did get the flu and Covid vaccine back at the beginning of Oct". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: 2 years ago I think, we had tested positive; (Oct2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: horrible tinnitus; 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 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: TINNITUS (non-serious), outcome "unknown", described as "horrible tinnitus". 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: Abdominal discomfort, Diarrhoea
Clinical narrative: stomach has been terrible with constant diarrhea; stomach has been terrible with constant diarrhea; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Dec2024 at 10:40 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: DIARRHOEA (non-serious), ABDOMINAL DISCOMFORT (non-serious), outcome "unknown" and all described as "stomach has been terrible with constant diarrhea".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Blood creatinine, Blood test
Clinical narrative: Sudden onset of weakness starting at toes, rapidly ascending to head, affecting all neuromuscular organs except lungs and heart.  Vague symptoms started 12/21 with toe tingling. 12/22, weakness in left arm. 12/23 could not ambulate, taken to hospital ER and has been in hospital system since then. Paralyzed from head to toe, other than breathing and heart. That includes face, swallowing, Gi tract, kidneys, pancreas, and entire body
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Blood urea, Borrelia test, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram thorax
Clinical narrative: Sudden onset of weakness starting at toes, rapidly ascending to head, affecting all neuromuscular organs except lungs and heart.  Vague symptoms started 12/21 with toe tingling. 12/22, weakness in left arm. 12/23 could not ambulate, taken to hospital ER and has been in hospital system since then. Paralyzed from head to toe, other than breathing and heart. That includes face, swallowing, Gi tract, kidneys, pancreas, and entire body
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Electrocardiogram, Full blood count, Gait inability, Laboratory test, Lumbar puncture
Clinical narrative: Sudden onset of weakness starting at toes, rapidly ascending to head, affecting all neuromuscular organs except lungs and heart.  Vague symptoms started 12/21 with toe tingling. 12/22, weakness in left arm. 12/23 could not ambulate, taken to hospital ER and has been in hospital system since then. Paralyzed from head to toe, other than breathing and heart. That includes face, swallowing, Gi tract, kidneys, pancreas, and entire body
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Magnetic resonance imaging abdominal, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Metabolic function test, Muscular weakness
Clinical narrative: Sudden onset of weakness starting at toes, rapidly ascending to head, affecting all neuromuscular organs except lungs and heart.  Vague symptoms started 12/21 with toe tingling. 12/22, weakness in left arm. 12/23 could not ambulate, taken to hospital ER and has been in hospital system since then. Paralyzed from head to toe, other than breathing and heart. That includes face, swallowing, Gi tract, kidneys, pancreas, and entire body
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Paraesthesia, Protein urine, Quadriplegia, Stool analysis, Urine analysis
Clinical narrative: Sudden onset of weakness starting at toes, rapidly ascending to head, affecting all neuromuscular organs except lungs and heart.  Vague symptoms started 12/21 with toe tingling. 12/22, weakness in left arm. 12/23 could not ambulate, taken to hospital ER and has been in hospital system since then. Paralyzed from head to toe, other than breathing and heart. That includes face, swallowing, Gi tract, kidneys, pancreas, and entire body
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Several minutes after receiving flu vaccination while waiting in the vaccination room, patient's guardian reported that the patient had fainted and had concerns that a seizure may have occurred (although pharmacy staff was not present at the time to observe or confirm). Patient visually looked ok, although shaken. Description of the event and how the patient was feeling seemed characteristic of a vasovagal reaction. EMS was contacted and although no further details were provided to the pharmacy, the patient was visibly ok when leaving the premises.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: The patient's right arm was red and warm to the touch, about an inch beneath the believed injection site, and spread towards the inner arm. The red area was about the size of the patient's palm. The patient was advised to monitor if the swelling became worse, or spread over more surface area, and to contact their primary care doctor if so.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity
Clinical narrative: As of 1/14/25, patient states that she is still experiencing right arm pain/discomfort with reduced range of motion. She has been taking over-the-counter ibuprofen to help with pain.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry throat, Injection site erythema
Clinical narrative: Patient presented to the site of vaccination (the pharmacy) on 1/14/25  with redness below injection site about the size of a human palm. The area did not look swollen to the eye. The patient said she was experiencing chills and dry throat. Patient declined any swelling in the mouth, lips or throat. She declined any trouble breathing. She said she had not had a fever.  Pharmacist looked at reddness and asked follow up questions. Pharmacist discussed over the counter options but directed the patient to go to the Urgent Care Clinic right away and patient agreed.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was inappropriately given RSV Arexvy vaccination when they had already received this vaccine in October 2023. No indication for a second dose. No side effects reported.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of Arexvy after pharmacist did not check vaccine history for the patient, first dose was received 10-17-2023 and second dose was received on 1-10-2025
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: Pt said that she got swollen glands along her jawline after vaccine
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was inappropriately given RSV Arexvy vaccination when they had already received this vaccine in October 2023. No indication for a second dose. No side effects reported.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Injection site mass, Injection site pain
Clinical narrative: Pt had a lump which turned into pain that moved from lower deltoid to upper tricep and only has 10% movement in left shoulder. Pt visited an urgent care facility, regular visits with PCP, and physical therapy. Doctors allegedly claim that the needle for the vaccine may have hit the bursa of the shoulder, exacerbating the pain.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Redness, pain, hard skin, hot to touch
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash under breast with small red bumps and rash on partial breast
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: After receiving the second vaccination in the series, symptoms and diagnosis of type 1 diabetes within two months. Perfectly healthy, no health issues, non smoker, underweight and non prescriptions use. 1st vaccination  03/03/2021  - second vaccination 03/31/2021    diagnoses 6/19/2021
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient involved has not experienced any medical concerns or symptoms as of the time of this interaction; A dose of PROQUAD had a labeled expiration date of 1/5/2025 and was inadvertently administered to a patient today, 1/10/2025; This spontaneous report was received from a medical assistance and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JAN-2025, the patient was inadvertently vaccinated with a dose of two-dose series of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter, lot #X018580, (labeled expiration date: 05-JAN-2025), administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The patient involved had not experienced any medical concerns or symptoms as of the time of this report. No additional information provided. No additional adverse event (AE) reported.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV1
Symptoms: High-pitched crying, Infant irritability, Infantile diarrhoea, Nuchal rigidity, Vomiting
Clinical narrative: Baby presented to clinic on 1/15/2025 with a history of vomiting, diarrhea and irritability since 1/10/2025. Mother reports symptom onset was after the vaccines were given on 1/10/2025.  On exam, baby was irritable with neucal rigidity and high-pitched cry. Baby was referred to the Emergency Room for further evaluation.
Age: 41.0
Sex: M
Vaccine: FLU3, PNC20
Symptoms: Fatigue, Herpes zoster, Pyrexia, Rash
Clinical narrative: Rash (shingles), fever, fatigue within 24 hours, Rx Valtrex.
Age: 72.0
Sex: M
Vaccine: MEN
Symptoms: Arthritis bacterial, Aspiration joint abnormal, C-reactive protein increased, Joint fluid drainage, Meningitis meningococcal
Clinical narrative: Patient developed invasive Meningococcal disease (septic joint) on Ultomiris therapy on 1/6/25. He was hospitalized and underwent a right ankle I&D on 1/6/25 with the orthopedic service. Patient started Ultomiris on 9/13/23. He received both MenB and MenACWY vaccinations on 8/30/23 and 10/23/24.
Age: 72.0
Sex: M
Vaccine: MEN
Symptoms: Red blood cell sedimentation rate increased, Synovial fluid analysis abnormal
Clinical narrative: Patient developed invasive Meningococcal disease (septic joint) on Ultomiris therapy on 1/6/25. He was hospitalized and underwent a right ankle I&D on 1/6/25 with the orthopedic service. Patient started Ultomiris on 9/13/23. He received both MenB and MenACWY vaccinations on 8/30/23 and 10/23/24.
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Angiogram, Aphasia, Cardiac imaging procedure, Computerised tomogram head
Clinical narrative: Family Dr. prescribed an Ozempic Compound for weight loss and also gave a flu shot on Thursday, Jan. 3, 2024. Within 24 hours My husband was so ill. He had severe stomach pain, and diarrhea. He was given Zofran for nausea with no relief. Within 30 hours of having the flu vaccine and weight loss shot he had an Acute L PCA stroke due to ischemia. He had at least 2 MRI scans of the brain, CT Scan of the brain, Scan of the arteries, scan of the heart and the doctors at the hospital could not find the cause of the stroke. We believe that the stroke was caused by the medication. The medication came from a compounding pharmacy. My husband had Asphasia due to the stroke and will required months of therapy. He is 64 years old this has greatly impacted his quality of life and may have lifelong effects.
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Magnetic resonance imaging head, Malaise, Nausea, Quality of life decreased
Clinical narrative: Family Dr. prescribed an Ozempic Compound for weight loss and also gave a flu shot on Thursday, Jan. 3, 2024. Within 24 hours My husband was so ill. He had severe stomach pain, and diarrhea. He was given Zofran for nausea with no relief. Within 30 hours of having the flu vaccine and weight loss shot he had an Acute L PCA stroke due to ischemia. He had at least 2 MRI scans of the brain, CT Scan of the brain, Scan of the arteries, scan of the heart and the doctors at the hospital could not find the cause of the stroke. We believe that the stroke was caused by the medication. The medication came from a compounding pharmacy. My husband had Asphasia due to the stroke and will required months of therapy. He is 64 years old this has greatly impacted his quality of life and may have lifelong effects.
Sex: M
Vaccine: FLUX
Symptoms: Vertebrobasilar stroke
Clinical narrative: Family Dr. prescribed an Ozempic Compound for weight loss and also gave a flu shot on Thursday, Jan. 3, 2024. Within 24 hours My husband was so ill. He had severe stomach pain, and diarrhea. He was given Zofran for nausea with no relief. Within 30 hours of having the flu vaccine and weight loss shot he had an Acute L PCA stroke due to ischemia. He had at least 2 MRI scans of the brain, CT Scan of the brain, Scan of the arteries, scan of the heart and the doctors at the hospital could not find the cause of the stroke. We believe that the stroke was caused by the medication. The medication came from a compounding pharmacy. My husband had Asphasia due to the stroke and will required months of therapy. He is 64 years old this has greatly impacted his quality of life and may have lifelong effects.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Anxiety, Aphasia, Asthenia, Hypotension
Clinical narrative: I am a healthy women, who has had flue shots for year and several Covid shots with no effects or minor (a little tired or sore at the injection site). I had my first Shingles Shot (Shingrex) at my local pharmacy at 3:20 pm on Sunday, September 29. I felt fine the rest of the day and went to bed as normal. I woke up at about 1:00 am (Sept. 30) and told my husband I was very ill. He could see that I was very pale and out of it. He laid me down on the floor and I was unresponsive with eyes open. I could not talk and could not move. He called EMS. I was unconscious but vaguely remember hearing the medics arrive, they carried me to the ambulance and took me to the ER. I have vague memory of the ambulance ride, I was very nauseous and weak. My blood pressure was extremely low. They hooked my to an IV and gave me fluids and anti nausea medicine. I was discharged about 3 hours later and went home. I was weak and sick the entire next day and for several days after. My side effects after that incident have been anxiety and panic attacks. I am 5'3", 112 lbs. The doctor at the ER told me it was a "viral overload". I will not get the 2nd Shingles shot. Also, I spoke to the pharmacist after all of this, a young woman, and she told me she had a very similar experience when she had the shot. She said she was so sick she went out to her car and almost passed out and was sick for several days after. This was definitely a reaction to the Shingrex Shingles shot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Malaise, Mental status changes, Mobility decreased, Nausea
Clinical narrative: I am a healthy women, who has had flue shots for year and several Covid shots with no effects or minor (a little tired or sore at the injection site). I had my first Shingles Shot (Shingrex) at my local pharmacy at 3:20 pm on Sunday, September 29. I felt fine the rest of the day and went to bed as normal. I woke up at about 1:00 am (Sept. 30) and told my husband I was very ill. He could see that I was very pale and out of it. He laid me down on the floor and I was unresponsive with eyes open. I could not talk and could not move. He called EMS. I was unconscious but vaguely remember hearing the medics arrive, they carried me to the ambulance and took me to the ER. I have vague memory of the ambulance ride, I was very nauseous and weak. My blood pressure was extremely low. They hooked my to an IV and gave me fluids and anti nausea medicine. I was discharged about 3 hours later and went home. I was weak and sick the entire next day and for several days after. My side effects after that incident have been anxiety and panic attacks. I am 5'3", 112 lbs. The doctor at the ER told me it was a "viral overload". I will not get the 2nd Shingles shot. Also, I spoke to the pharmacist after all of this, a young woman, and she told me she had a very similar experience when she had the shot. She said she was so sick she went out to her car and almost passed out and was sick for several days after. This was definitely a reaction to the Shingrex Shingles shot.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pallor, Panic attack, Unresponsive to stimuli
Clinical narrative: I am a healthy women, who has had flue shots for year and several Covid shots with no effects or minor (a little tired or sore at the injection site). I had my first Shingles Shot (Shingrex) at my local pharmacy at 3:20 pm on Sunday, September 29. I felt fine the rest of the day and went to bed as normal. I woke up at about 1:00 am (Sept. 30) and told my husband I was very ill. He could see that I was very pale and out of it. He laid me down on the floor and I was unresponsive with eyes open. I could not talk and could not move. He called EMS. I was unconscious but vaguely remember hearing the medics arrive, they carried me to the ambulance and took me to the ER. I have vague memory of the ambulance ride, I was very nauseous and weak. My blood pressure was extremely low. They hooked my to an IV and gave me fluids and anti nausea medicine. I was discharged about 3 hours later and went home. I was weak and sick the entire next day and for several days after. My side effects after that incident have been anxiety and panic attacks. I am 5'3", 112 lbs. The doctor at the ER told me it was a "viral overload". I will not get the 2nd Shingles shot. Also, I spoke to the pharmacist after all of this, a young woman, and she told me she had a very similar experience when she had the shot. She said she was so sick she went out to her car and almost passed out and was sick for several days after. This was definitely a reaction to the Shingrex Shingles shot.
Sex: M
Vaccine: DTAPIPVHIB, FLUX, PNC20, RVX
Symptoms: Rash papular
Clinical narrative: ON 12/12/2024, infant received beyfortis, Pentacel, prevnar 20, rotavirus and influenza vaccine. About 2-3 days later, he developed fine red papular rash and no other symptoms. he is otherwise fine.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Injection site pain, Injection site swelling, Lymphadenopathy, Pain in jaw
Clinical narrative: Major swelling at injection site and severe tenderness. Intense, debilitating mandibular pain, probably due to lymph glands, at back of jaw.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Joint swelling, Peripheral swelling, Pharyngeal swelling, Rash
Clinical narrative: 10002424---ANGIOEDEMA^ 10037844--RASH Pt has a long history of receiving an annual flu shot (since at least 2007) with no prior severe reaction documented. Pt received high dose flu shots since 2020. Pt was administered his annual shot on 10/8/24. The next day (10/9/24) the pt presented to urgent care reporting that he thought he was having a reaction to the flu shot. Per pt, he had hives to his beltline and posterior neck that started the evening he received the shot. It was also noted the left side of his face was swollen with slight redness, hands/wrist slightly swollen, no redness noted on hands, and redness and rash noted on belt waist line. Pt was then sent to the emergeny room in an ambulance due to severe swelling in his throat. He was treated at the ER with solu medrol, benadryl, and NS. He was sent home with prednisone and an epi pen. ER provider recommended to hold lisinopril should it be the causative agent until f/u with primary care. Pt stated he woke up with left face swelling and hives on his left leg. Pt reported using his epi pen at home, but that it did not help his facial swelling. Pt noted he went to a new restaurant the night before, started magnesium 2 weeks prior, and started glipizide 2 months ago. Pt was given benadryl, solu medrol and famotidine. Facial swelling improved and pt was discharged with prednisone x 5 days. Lisinopril was discontinued by PCP.
Sex: M
Vaccine: FLU3
Symptoms: Swelling face, Urticaria
Clinical narrative: 10002424---ANGIOEDEMA^ 10037844--RASH Pt has a long history of receiving an annual flu shot (since at least 2007) with no prior severe reaction documented. Pt received high dose flu shots since 2020. Pt was administered his annual shot on 10/8/24. The next day (10/9/24) the pt presented to urgent care reporting that he thought he was having a reaction to the flu shot. Per pt, he had hives to his beltline and posterior neck that started the evening he received the shot. It was also noted the left side of his face was swollen with slight redness, hands/wrist slightly swollen, no redness noted on hands, and redness and rash noted on belt waist line. Pt was then sent to the emergeny room in an ambulance due to severe swelling in his throat. He was treated at the ER with solu medrol, benadryl, and NS. He was sent home with prednisone and an epi pen. ER provider recommended to hold lisinopril should it be the causative agent until f/u with primary care. Pt stated he woke up with left face swelling and hives on his left leg. Pt reported using his epi pen at home, but that it did not help his facial swelling. Pt noted he went to a new restaurant the night before, started magnesium 2 weeks prior, and started glipizide 2 months ago. Pt was given benadryl, solu medrol and famotidine. Facial swelling improved and pt was discharged with prednisone x 5 days. Lisinopril was discontinued by PCP.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: 1-15-25 Pt called this morning stated rolled over in bed onto Lt arm noticed a knot where shot was given, sore to touch. Pt stated the knot is "larger than an egg", I told her to put ice on the knot and to take some Benadryl and she said she had topical Benadryl she will apply as well. Then soreness started this am about 02:00 in the morning. Instructed Pt to draw a line with a marker around the knot (remaining is not legible).
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Headache, Influenza
Clinical narrative: I started to not feel well within a few hours, as if I had the flu. Within a day, I had an upset stomach and diarrhea, and then I developed a severe headache last night. This morning I woke up with dizziness.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: I started to not feel well within a few hours, as if I had the flu. Within a day, I had an upset stomach and diarrhea, and then I developed a severe headache last night. This morning I woke up with dizziness.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Delusion, Psychotic disorder
Clinical narrative: My brother is a very smart civil engineer. After he received the Covid vaccine he has become very paranoid with delusion thoughts.
Age: 43.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events to report. Reporting administration error.  Dtap + IPV (Kinrix) administered instead of Tdap.
Age: 71.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event, however this patient received RSV vaccine (Arexvy) at different pharmacy Jan 9,2024.  ACIP only recommends one RSV vaccine.  This was discovered Jan 14, 2025.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, General physical health deterioration, Loss of personal independence in daily activities, Pain, Walking aid user
Clinical narrative: Patient reports that since getting vaccine has had weakness and physical decline where now needing help with all cares. Patient and spouse reports prior to this, patient not needing any assistance. Has to use walker due to weakness, help getting dressed, help in and out of bed,  assistance with bathing and other cares. Pain has increased as well.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Condition aggravated, Magnetic resonance imaging spinal abnormal, Muscular weakness, Myelomalacia, Pain
Clinical narrative: Following the administration of the vaccines was predominated by body aches and a weakness which progressed rather quickly until she presented to Urgent Care on 11/13/24 (Five days after the vaccinations). She was sent home after the Urgent Care visit.  The next day (11/14/24) she called for an ambulance and was taken and she was admitted to hospital with the diagnoses of LE weakness, RA, RLS. Neurology was consulted. ---  MRI of her Cervical spine was notable for demonstrating 'prominent hyperintense T2/STIR Signal at the central C3-C4 cord likely myelomalacia. Additional Foci of hyperintesne T2/STIR Signal at C4-5, C5, C6, C7 cord. but no abnormal enhancement. ----  Followed by Neurology and with improvement in her symptoms the patient was discharged to clinic on Saturday 11/23/24 with the diagnoses of Myelomalacia, LE weakness, RA, RLS, and discussion in the D/C summary included the possibility of an AIDP. Neurology follow up was advised and the patient was advised for rehab.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Restless legs syndrome, Rheumatoid arthritis
Clinical narrative: Following the administration of the vaccines was predominated by body aches and a weakness which progressed rather quickly until she presented to Urgent Care on 11/13/24 (Five days after the vaccinations). She was sent home after the Urgent Care visit.  The next day (11/14/24) she called for an ambulance and was taken and she was admitted to hospital with the diagnoses of LE weakness, RA, RLS. Neurology was consulted. ---  MRI of her Cervical spine was notable for demonstrating 'prominent hyperintense T2/STIR Signal at the central C3-C4 cord likely myelomalacia. Additional Foci of hyperintesne T2/STIR Signal at C4-5, C5, C6, C7 cord. but no abnormal enhancement. ----  Followed by Neurology and with improvement in her symptoms the patient was discharged to clinic on Saturday 11/23/24 with the diagnoses of Myelomalacia, LE weakness, RA, RLS, and discussion in the D/C summary included the possibility of an AIDP. Neurology follow up was advised and the patient was advised for rehab.
Age: 6.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: The patient had received 2 previous MenQuadfi in another country, which were entered in the registry system. Because of receiving 2 of a 6 series immunizations, a  "check box"  in the registry system indicated that it was due (despite her age and ACIP guidelines) along with several others based on the vaccines entered into the system previously.  A newer nurse working in immunizations gave the MenQuadfi ( 3 rd dose) to the patient, which is outside of the guidelines for ACIP, which we follow here in our clinic.
Age: 45.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Dysstasia, Hyperhidrosis, Pallor, Syncope
Clinical narrative: patient was at register after receiving both vaccines and patient was sweating and color didnt look good I asked him to sit down and he said he couldnt and started to look like he was going to pass out I grabbed him and put him in a chair he said he was feeling better and asked if he could just have some soda I yelled to the pharmacist on duty to wait with patient while I went to get soda while I was gone patient tried to stand up and droped to the floor when I got back patient was on floor I proceeded to call amublance they came and took vitals and sat patient in chair again and said he was fine. I made patient wait another 15 min in chair before he left.
Age: 33.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Mobility decreased, Muscular weakness, Neuralgia, Pain
Clinical narrative: Within several hours of receiving this injection, my arm was sore and I experienced weakness. The pain lingered for a few weeks and then became more severe, leading to weakness in the arm, pain to the touch, nerve pain shooting down to the fingers, and "pins and needles" in hand. My arm is currently very weak. I'm having trouble lifting my arm and I cannot put pressure on it (ex: cannot lean on arm) or it will give out. I saw my doctor about this issue on 1/10/2025 and received a cortisone injection. I was diagnosed with rotator cuff tendinitis. I've never had any issues with my shoulder prior to this, nor have I ever had any adverse events associated with an injection.
Age: 33.0
Sex: F
Vaccine: PNC20
Symptoms: Paraesthesia, Rotator cuff syndrome, Tenderness
Clinical narrative: Within several hours of receiving this injection, my arm was sore and I experienced weakness. The pain lingered for a few weeks and then became more severe, leading to weakness in the arm, pain to the touch, nerve pain shooting down to the fingers, and "pins and needles" in hand. My arm is currently very weak. I'm having trouble lifting my arm and I cannot put pressure on it (ex: cannot lean on arm) or it will give out. I saw my doctor about this issue on 1/10/2025 and received a cortisone injection. I was diagnosed with rotator cuff tendinitis. I've never had any issues with my shoulder prior to this, nor have I ever had any adverse events associated with an injection.
Age: 75.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: pt received a second flu shot, was notified by the RN of the mistake, no adverse events/symptoms reported
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity, Sleep disorder
Clinical narrative: Patient reports very sore arm, unable to sleep through the night, nauseous, and just "not feeling well.
Age: 1.75
Sex: F
Vaccine: HEPA, HIBV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt came in for her WCC and it was administered Tdap instead Dtap
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Client states within 24 hours of receiving the vaccine he began to experience dizziness, nausea/vomiting, headache and weakness.  He stated his arm was sore around the injection site which has gone away, but he now has red blotchy areas on his arm below the vaccination site.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Rash macular, Vaccination site reaction, Vomiting
Clinical narrative: Client states within 24 hours of receiving the vaccine he began to experience dizziness, nausea/vomiting, headache and weakness.  He stated his arm was sore around the injection site which has gone away, but he now has red blotchy areas on his arm below the vaccination site.
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive COVID-19 booster but received RSV in error. He had already received the RSV vaccine in Jan 2024. He reports no ADR and will schedule to receive COVID-19 booster
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dry skin, Dyshidrotic eczema, Furuncle, Hidradenitis
Clinical narrative: About a month after receiving the vaccine I developed psoriasis on the sides of my feet, dyshidrotic eczema covers my hands, and hidradenitis suppurativa in several spots on my body.  I developed this skin conditions and had not had them previously. I have had blisters on my hands for 4 years, develop boils in my armpits, stomach, groin, and thighs, and have dry itchy patches of skin on the side of both of my feet. I have tried creams and steroids to no avail.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Psoriasis, Skin disorder
Clinical narrative: About a month after receiving the vaccine I developed psoriasis on the sides of my feet, dyshidrotic eczema covers my hands, and hidradenitis suppurativa in several spots on my body.  I developed this skin conditions and had not had them previously. I have had blisters on my hands for 4 years, develop boils in my armpits, stomach, groin, and thighs, and have dry itchy patches of skin on the side of both of my feet. I have tried creams and steroids to no avail.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Needle issue, Syringe issue
Clinical narrative: Patient received a Dtap vaccine and the needle used was cracked resulting in the vaccine leaking out of the syringe. Patient had to receive a second dose of the vaccine.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: I accidentally gave the patient the vaccine on 08/28/2024 shortly after the DOH discontinued it.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric vaccine given to adult
Age: 29.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Chest discomfort, Chills, Dizziness, Electrocardiogram normal, Nausea
Clinical narrative: Pt visited PCP office on 09/27/2024 for vaccines only. After vaccines given by RN, nursing was notified by facility staff that pt feels dizzy and nausea. Brought pt back to exam room, checked BP, HR, SpO2 and EKG all normal. MD assessed patient at about 4:25pm. pt reported that no reaction with HPV#1, never had flu vaccine before.  c/o dizziness, nausea and mid-chest discomfort when seen; felt "shivers", denies dyspnea. Pt was alert, in mild discomfort when seen and examined. No abnormal finding in cardiac or lungs, no swelling or hives noted. Diphenhydramine 25mg PO given per MD's order. MD reassessed pt at about 5:05pm, pt appeared much better and reported feeling improved with resolving chest discomfort. patient