chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: The patient had covid and was prescribed with Paxlovid. The patient further stated, "Everything's fine. It's just the coughing is so bad I think that's a part of its respiratory I never had it."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400334976 same reporter/patient, different dose/event;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID".  Clinical course: The patient had covid and was prescribed with Paxlovid. The patient further stated, "Everything's fine. It's just the coughing is so bad I think that's a part of its respiratory I never had it."; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400334976 same reporter/patient, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunizaion. The following information was reported: DEATH (death, medically significant), 4 days after the suspect product(s) administration, outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The reporter stated that both of his aunts died four days after the second shot.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400335024 Same reporter/event, different patient;; Reported Cause(s) of Death: Unknown Cause Of Death
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: the patient and her husband had covid/they received with Lot number LN0588; the patient and her husband had covid/they received with Lot number LN0588; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Lot number: LN0588, Expiration Date: 17Apr2025) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patient and her husband had covid/they received with Lot number LN0588".  No follow-up attempts are possible.
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: had a cold; flu; Sore throat; This is a spontaneous report and received from Consumer or other non HCPs. Other Case identifier(s): 2024US010104.  A 75-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), in Nov2024 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; abaloparatide (TYMLOS), (Lot number: F601761568) at 80 ug daily, subcutaneous. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; Manufacturer Unknown), administration date: Nov2024, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2024, outcome "unknown", described as "Sore throat"; INFLUENZA (non-serious) with onset 2024, outcome "unknown", described as "flu"; NASOPHARYNGITIS (non-serious) with onset 2024, outcome "unknown", described as "had a cold". The action taken for abaloparatide was unknown.  Additional information: On an unspecified date, the patient began treatment with Tymlos (abaloparatide) 80 mcg daily. Covid-19 vaccine and an unspecified cholesterol medication were reported as co-suspect medication. On an unspecified date, the patient reported she had a cold (nasopharyngitis), flu (influenza), and sore throat (oropharyngeal pain). She stated she was unsure if it was due to the new unspecified medication she started for her cholesterol or just the reason. Additionally, she had her COVID-19 vaccine last month. No treatment information was provided. The outcome of nasopharyngitis, influenza, and oropharyngeal pain was unknown.  Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: PNC13, PNC20
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: she has gotten PREVNAR in the past and that she still gets hospitalized almost every year with pneumonia; she has gotten PREVNAR in the past and that she still gets hospitalized almost every year with pneumonia; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization), PNEUMONIA (hospitalization), outcome "unknown" and all described as "she has gotten PREVNAR in the past and that she still gets hospitalized almost every year with pneumonia".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, Vaccination site mass
Clinical narrative: had covid back in Jul2024; had covid back in Jul2024; very sick; a lump on the arm the size of a cantaloupe; This is a spontaneous report received from an Other HCP, Program ID.  A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 62 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Jan2024, outcome "unknown", described as "a lump on the arm the size of a cantaloupe"; ILLNESS (non-serious) with onset Jan2024, outcome "recovered" (2024), described as "very sick"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "had covid back in Jul2024". The last time patient received a vaccine she got very sick. The symptoms lasted a full seven days after receiving the vaccine. Patient had a lump on the arm the size of a cantaloupe where the injection was given. Patient also had covid back in Jul2024.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMI XBB.1.5 cannot be fully excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: a lot of pain in her left arm where she received the shot; numbness in her left hand; This is a spontaneous report received from an Other HCP, Program ID.  A 76-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2024 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2024, outcome "unknown", described as "a lot of pain in her left arm where she received the shot"; HYPOAESTHESIA (non-serious) with onset 2024, outcome "unknown", described as "numbness in her left hand".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 89.0
Sex: F
Vaccine: COVID19, RVX
Symptoms: Illness
Clinical narrative: she got very sick for two weeks after; This is a spontaneous report received from an Other HCP, Program ID.  An 89-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Feb2024 as dose 1, 30 ug single (Batch/Lot number: unknown) at the age of 89 years intramuscular for covid-19 immunisation; rsv vaccine (RSV VACCINE), in Feb2024 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 2024, outcome "unknown", described as "she got very sick for two weeks after".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: FLUX
Symptoms: Coma
Clinical narrative: flu vaccination put me in a coma for a week; Initial information received on 30-Dec-2024 regarding an unsolicited valid Social Media serious case received from a Patient.  This case involves Adult and unknown gender patient who reported flu vaccination (Influenza Vaccine) put him in a coma for a week (in the hospital 3 weeks).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received once (1X) suspect Influenza Vaccine by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for prophylactic vaccination. There will be no information available on the batch number for this case..  On an unknown date the patient reported flu vaccination put me in a coma for a week (coma) (unknown latency). This event was assessed as medically significant. The patient was hospitalized for this event (in the hospital 3 weeks).  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (flu vaccination put me in a coma for a week).  At time of reporting, the outcome was Unknown for the event flu vaccination put me in a coma for a week.; Sender's Comments: Sanofi Company Comment dated 03-JAN-2025: This case involves Adult and unknown gender patient who reported flu vaccination (Influenza Vaccine) put him in a coma for a week (in the hospital 3 weeks). Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: was so sick for weeks; Initial information received on 21-Dec-2024 regarding an unsolicited valid Social Media non-serious case received from a Non-Healthcare Professional.  This case involves an unknown age and unknown gender patient who was so sick for weeks after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2001, the patient received influenza vaccine produced by unknown manufacturer via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) (strength, dose, batch and expiry date unknown). Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient was so sick for weeks (illness) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Feeding disorder, Hypoxia, Near death experience
Clinical narrative: Stroke / Massive stroke; Still dealing with the aftermath of almost dying; There was a cascade of blood, his blood cells could not hold oxygen, there were a whole of cascade of problems with his blood; Can hardly eat; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), (administration reported as three and a half years ago "the first batch that came out the very first vaccines from Pfizer" for both) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient did not have other vaccine on the same date of getting the Pfizer COVID-19 vaccine or 4 weeks prior getting the Pfizer COVID-19 vaccine. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke / Massive stroke"; NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Still dealing with the aftermath of almost dying"; HYPOXIA (medically significant), outcome "unknown", described as "There was a cascade of blood, his blood cells could not hold oxygen, there were a whole of cascade of problems with his blood"; FEEDING DISORDER (non-serious), outcome "unknown", described as "Can hardly eat". Therapeutic measures were taken as a result of cerebrovascular accident. Additional information: The reporter stated that the patient was still dealing with the aftermath of almost dying, having a stroke four days after the second vaccine and had to have two transfusions to get that stuff out of his blood system. The patient can hardly eat. He is suffering from having had a massive stroke because of that. There was a cascade of blood, his blood cells could not hold oxygen, there were a whole of cascade of problems with his blood that he had never had in his life. That was why he had to have the transfusions to save his life.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19 vaccine (Pfizer) 2021/06Jan2022 bosutinib was stopped due to newly diagnosed covid; Covid-19 vaccine (Pfizer) 2021/06Jan2022 bosutinib was stopped due to newly diagnosed covid; This is a spontaneous report and received from Physicians, Program ID.  A 68-year-old female patient received BNT162b2 (BNT162B2), in 2021 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "unknown" and all described as "Covid-19 vaccine (Pfizer) 2021/06Jan2022 bosutinib was stopped due to newly diagnosed covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jan2022) diagnosed covid.; Sender's Comments: Based on the information provided , temporal association and the administration  of the suspect drug a possible contributory role of the suspect drug in triggering the onset of the events Drug ineffective, COVID-19  cannot be excluded.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Tenderness
Clinical narrative: At visit on 12/23/24 patient described swollen but nontender area on L arm that lasted from 9/12/24 to approximately holiday of that year.  The person who administered the vaccine is extremely skilled
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site reaction, Loss of personal independence in daily activities
Clinical narrative: Date of Incident: December 18, 2024 Location: Pharmacy Incident Report: On Wednesday, December 18, 2024, I sustained an injury to my right foot that required a tetanus booster. Accordingly, I received the Td vaccination in my left shoulder at approximately 1:30 PM at the Pharmacy. While the administration of the shot was painful, the attending pharmacist assured me that this was normal and advised that I might experience soreness in the area for up to 48 hours. Initially, I was not concerned as the pharmacist indicated the discomfort would subside within the specified timeframe. However, on Sunday, December 22, 2024, the pain persisted, significantly impeding my ability to perform routine activities, such as sleeping on my left side, raising my arm, carrying items on my left side, and engaging in tasks that utilized my shoulder muscles. Subsequently, on Monday, December 23, 2024, I contacted my Primary Care Physician (PCP) but was informed that they were fully booked. The receptionist, after consulting with the Physician Assistant (PA), advised that it could take 5-7 days for the pain to resolve, prompting me to wait through the Christmas holiday. On December 26, 2024, I contacted the PCP's office again and secured an appointment for the following day. I was examined by the PA on Friday, December 27, 2024, nine days post-vaccination. The PA suggested that the injection might not have been administered in the optimal location, leading to persistent pain, bruising, and suspected nerve swelling. As a result, I was prescribed a topical pain-relieving gel and an oral steroid. Current Status: As of today, January 3, 2025, my pain has diminished slightly, but I continue to experience weakness in my left arm and pain during certain activities involving the shoulder muscles.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Nerve oedema, Pain
Clinical narrative: Date of Incident: December 18, 2024 Location: Pharmacy Incident Report: On Wednesday, December 18, 2024, I sustained an injury to my right foot that required a tetanus booster. Accordingly, I received the Td vaccination in my left shoulder at approximately 1:30 PM at the Pharmacy. While the administration of the shot was painful, the attending pharmacist assured me that this was normal and advised that I might experience soreness in the area for up to 48 hours. Initially, I was not concerned as the pharmacist indicated the discomfort would subside within the specified timeframe. However, on Sunday, December 22, 2024, the pain persisted, significantly impeding my ability to perform routine activities, such as sleeping on my left side, raising my arm, carrying items on my left side, and engaging in tasks that utilized my shoulder muscles. Subsequently, on Monday, December 23, 2024, I contacted my Primary Care Physician (PCP) but was informed that they were fully booked. The receptionist, after consulting with the Physician Assistant (PA), advised that it could take 5-7 days for the pain to resolve, prompting me to wait through the Christmas holiday. On December 26, 2024, I contacted the PCP's office again and secured an appointment for the following day. I was examined by the PA on Friday, December 27, 2024, nine days post-vaccination. The PA suggested that the injection might not have been administered in the optimal location, leading to persistent pain, bruising, and suspected nerve swelling. As a result, I was prescribed a topical pain-relieving gel and an oral steroid. Current Status: As of today, January 3, 2025, my pain has diminished slightly, but I continue to experience weakness in my left arm and pain during certain activities involving the shoulder muscles.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Deep vein thrombosis, Pain in extremity, Peripheral swelling, Skin discolouration, Ultrasound Doppler abnormal
Clinical narrative: Patient received vaccine on 12/10/24, started to have left arm swelling /pain and change in color.  Diagnosed on 12/15/24 with DVTs in the arm.  Currently on Lovenox.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chest discomfort, Cough, Ear discomfort, Herpes zoster
Clinical narrative: I started a fever on 12/24/24 that lasted until 12/29/24; shaking, muscle aches, violent dry cough, deep chest congestion, burning ears, lethargic, tight chest, minimal sleep at night like I wanted to crawl out of my skin- these symptoms lasted until 12/1/25; currently still experiencing a dry cough, chest congestion and shingles blisters under my chin (I've never had shingles before)- 1/3/25. Nobody else in my household has been sick at all since this began on 12/24/24 or prior to the vaccine. It's like my body is glitching with various symptoms like it can't decide how to recover.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Lethargy, Myalgia, Pyrexia, Respiratory tract congestion
Clinical narrative: I started a fever on 12/24/24 that lasted until 12/29/24; shaking, muscle aches, violent dry cough, deep chest congestion, burning ears, lethargic, tight chest, minimal sleep at night like I wanted to crawl out of my skin- these symptoms lasted until 12/1/25; currently still experiencing a dry cough, chest congestion and shingles blisters under my chin (I've never had shingles before)- 1/3/25. Nobody else in my household has been sick at all since this began on 12/24/24 or prior to the vaccine. It's like my body is glitching with various symptoms like it can't decide how to recover.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: I started a fever on 12/24/24 that lasted until 12/29/24; shaking, muscle aches, violent dry cough, deep chest congestion, burning ears, lethargic, tight chest, minimal sleep at night like I wanted to crawl out of my skin- these symptoms lasted until 12/1/25; currently still experiencing a dry cough, chest congestion and shingles blisters under my chin (I've never had shingles before)- 1/3/25. Nobody else in my household has been sick at all since this began on 12/24/24 or prior to the vaccine. It's like my body is glitching with various symptoms like it can't decide how to recover.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: Patient complained of arm numbness and loss of mobility with a minute of vaccination. After another minute movement and feeling was restored.
Age: 66.0
Sex: M
Vaccine: PNC21
Symptoms: Influenza like illness, Malaise
Clinical narrative: Pt. stated that he started feeling sick starting the day after the vaccine with flu-like symptoms. He stated that he felt deathly sick and had to call EMS and hasn't felt right since.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Rash/blistering/itching of both feet Bilaterally. presentation 1 week after vaccination and has not subsided after 2 months
Age: 71.0
Sex: F
Vaccine: PNC20, RSV, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was given a duplicate dose of Prevnar 20 pneumococcal vaccine. Previous dose was administered on 3/17/2023.
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: The patient received Arexvy instead of Abrysvo (which is approved for pregnancy). No issues or adverse effects reported by the patient at time of this report.
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Prevnar 20 was administered to patient inappropriately on 01/03/2025 . Patient had already received Prevnar 20 last year (01/08/2024).  Patient had made an appointment to receive this vaccination and was unaware that no further doses were required. First dose of Prevnar 20 was not registered and insurance did not reject claim as duplicate. Patient did not report any adverse events due to receiving extra Prevnar 20 dose.
Age: 29.0
Sex: F
Vaccine: UNK, UNK, FLU3, TDAP
Symptoms: Chills, Exposure during pregnancy, Headache, Pain, Pyrexia
Clinical narrative: I am currently 7 months pregnant. My estimate due date is 3-18-2025. My symptoms started about 12 hours after receiving the flu vaccine and a Tdap booster. I?m unsure of the brands. I had a low grade fever, extreme aches and extreme chills, and severe headache. I initially took 1 500 mg Tylenol but the symptoms continued for 12 more hours. I took the next dose of Tylenol (1000 mg) and the symptoms subsided until it was time for the next dose of Tylenol   I started getting a fever, chills and aches again. I took more 500 mg Tylenol and the symptoms subsided again after 1 hour.
Age: 29.0
Sex: F
Vaccine: UNK, UNK, FLU3, TDAP
Symptoms: Diarrhoea, Headache, Pyrexia, Vision blurred, Vomiting
Clinical narrative: I am currently 7 months pregnant. My estimate due date is 3-18-2025. My symptoms started about 12 hours after receiving the flu vaccine and a Tdap booster. I?m unsure of the brands. I had a low grade fever, extreme aches and extreme chills, and severe headache. I initially took 1 500 mg Tylenol but the symptoms continued for 12 more hours. I took the next dose of Tylenol (1000 mg) and the symptoms subsided until it was time for the next dose of Tylenol   I started getting a fever, chills and aches again. I took more 500 mg Tylenol and the symptoms subsided again after 1 hour.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: No adverse events noted.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, IPV, UNK
Symptoms: Behaviour disorder, Blood test, Febrile convulsion, Lethargy, Pyrexia
Clinical narrative: Extremely high fever, emergency room visit, lethargic movements on day of given vaccines. Later, extremely delayed speech, left eye crossed, febrile seizures, ADHD like behavior.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, IPV, UNK
Symptoms: Speech disorder developmental, Strabismus
Clinical narrative: Extremely high fever, emergency room visit, lethargic movements on day of given vaccines. Later, extremely delayed speech, left eye crossed, febrile seizures, ADHD like behavior.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: At time of injection, I felt a pain/burning sensation in left arm at injection site.  I did notice that injection was given midway between shoulder and elbow instead of the upper arm.  I did report this to my PCP who advised me "it should get better", which it never did.  If I move my arm a certain way I experience pain in arm under injection site.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: After a couple of weeks I noticed that food tasted different and I couldn?t smell. I had COVID in October 2022 and my only symptoms were loss of smell and taste for two months. This is my third COVID vaccine from Pfizer.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder
Clinical narrative: Loss of strenth in legs and loss of balance
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave an additional dose in error. Patient already received dose in September 2023. No adverse events yet
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arem
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dyspnoea, Hyperhidrosis, Motion sickness
Clinical narrative: tinnitus sweating feeling out of breath feeling lightheaded nauseous clammy and pale motion sickness
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pallor, Tinnitus
Clinical narrative: tinnitus sweating feeling out of breath feeling lightheaded nauseous clammy and pale motion sickness
Age: 58.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Injected limb mobility decreased, Limb injury, Ultrasound Doppler normal
Clinical narrative: PATIENT REPORTS SHOULD PAIN/INJURY UPON ADMINISTRATION AND SINCE. PATIENT HAS TROUBLE USING LEFT ARM AND HAS DECREASED RANGE OF MOTION. PATIENT HAS FOLLOWED UP WITH HER DOCTOR, SHE HAD AN ULTRASOUND THAT WAS NEGATIVE FOR A BLOOD CLOT.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site induration, Injection site mass, Injection site pain, Peripheral swelling
Clinical narrative: Left arm is swollen, red, warm to touch. Patient also noted that there is a firm lump at site of injection and that it is painful. Advised her to touch base with PCP or go urgent care facility because it may be infected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Left arm is swollen, red, warm to touch. Patient also noted that there is a firm lump at site of injection and that it is painful. Advised her to touch base with PCP or go urgent care facility because it may be infected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Limb mass, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm is swollen, red, tender, warm to touch, and has hard lump under the skin. She noticed the swelling this morning, but it was sore after injection yesterday. Since it is warm to touch and has hard lump under skin I advised her to touch base with her PCP or seek medical attention at urgent care facility if she is unable to reach PCP. From what she described it sounds like it may be infected.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Left arm is swollen, red, tender, warm to touch, and has hard lump under the skin. She noticed the swelling this morning, but it was sore after injection yesterday. Since it is warm to touch and has hard lump under skin I advised her to touch base with her PCP or seek medical attention at urgent care facility if she is unable to reach PCP. From what she described it sounds like it may be infected.
Age: 53.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Abdominal pain upper, Blister, Herpes zoster
Clinical narrative: Severe pain in upper right abdomen two days after receiving vaccination that lasted four days, then breakout of sores/blisters 5 days after vaccination. Diagnosed with Shingles by physician on 01/03/2025.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was vaccinated with expired vaccine due to improper handling. Patient has not reported any adverse effects.
Age: 86.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Duplicate vaccine given. Arexvy was previously given in October 2023. No actual adverse events reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bell's palsy, Electrocardiogram
Clinical narrative: Joint pain, Bells Palsy
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was vaccinated with expired vaccine due to improper handling. Patient has not reported any adverse effects.
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received dose of Arexvy in October 2023 and January 2025. Per patient, not experiencing any side effects at this time.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was vaccinated with expired vaccine due to improper handling. Patient has not reported any adverse effects.
Age: 5.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This patient was given an extra dose of Varicella.  The patient was due for an MMR and Varicella, so they qualified to get Proquad. The MA mistakenly gave the Proquad thinking it was just MMR and not realizing that it is MMR and Varicella mixed. The Paitent's mother was called and a follow up was done, no symptoms or concerns at this time.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Seizure
Clinical narrative: Patient received the vaccine and proceeded to get dizzy, pass out and went into a seizure
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was vaccinated with expired vaccine due to improper handling. Patient has not reported any adverse effects.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: pt had redness, itching, swelling, hot feeling about 1 inch under the immunization. There was very bad pain right after. There was also 3x3 red bumps around the site causing irritation
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: pt had redness, itching, swelling, hot feeling about 1 inch under the immunization. There was very bad pain right after. There was also 3x3 red bumps around the site causing irritation
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient said after imz next day she got rash from neck to waist and lasted for  3 days
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Unevaluable event
Clinical narrative: PATIENT CAME INTO PHARMACY WITHOUT HER OXYGEN. IT WAS UNKNOWN PATIENT REQUIRED OXYGEN. AFTER ALL 3 VACCINES WERE ADMINISTERED PATIENT SAID SHE NEEDED HER OXYGEN. WE CALLED 911 AND ADMINISTERED OXYGEN IN A CAN UNTIL EMS ARRIVED. THEY CHECKED HER AND SHE WENT HOME. SHE DID NOT GO WITH EMS
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA, patient describes chronic shoulder pain that began roughly 48 hours post-administration of vaccine and has continued constantly since then.
Age: 25.0
Sex: F
Vaccine: IPV
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Patient received the Ipol vaccine at approximately 3:47pm. At approximately 3:54, her boyfriend (name stated) told me that she was experiencing itching, pointing at her arm. Two diphenydramine 25mg and water were administered to the patient. Approximately 3-4 minutes later, the patient  began itching throughout her body. I asked if she was having any trouble breathing. She stated none but then appeared to have difficulty with breathing. At approximately 3:57, I notified our staff to call EMS. I administered one adult dose of epinephrine.  The patient continued to experience breathing problems and approximately 5-7 min later another dose of epinephrine was administered.  EMS arrived at approximately 4:23pm.
Age: 86.0
Sex: M
Vaccine: FLU3, RSV
Symptoms: Extra dose administered
Clinical narrative: PATIENT RECEIVED TWO DOSES OF RSV VACCINE. ONE IN 2023 AND ONE IN 2025. MORE THAN CURRENT CDC GUIDELINES. PATIENT REPORTED NO ADVERSE EVENTS, NO SIDE EFFECTS. NO ISSUES.
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Neuralgia, Pain, Pain in extremity
Clinical narrative: Patient received this shot back in June. After he received the vaccine he had shooting pains down his arm. When he went to see his doctor, his doctor states it could be side effects from the shot or one of his nerves could have been hit during the administration of the vaccine. The doctor then explained to the patient that these side effects could last for a few months. The patient reported to the pharmacy on 12/31/2024 to state that he is still having pains shooting down his arm and it feels like someone is taking a screw driver to his bone and scraping it down the side of his arm.  Gave patient Lidocaine over the counter to see if that will help his nerve pain until he can see his doctor to get medication for a prescription nerve medication.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: pt received 1st arexvy on 12/6/2023. Pt received the same vaccine again on 1/3/2025. The 2nd vaccine was not appropriate given guidelines
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient received flu vaccine 12/26/24 , but came into the pharmacy 01/03/25 with changed of insurance and asked for flu vaccine. Pt received another dose of Flucelvax. Went over potential side effects with patient
Age: 43.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Atrial fibrillation, Chills, Fatigue, Lethargy
Clinical narrative: Day after injection chills, 101F fever, lethargic, extreme fatigue, joint aches; within approx 3-4 days started to feel moderate to severe bilateral  anterior thigh/hip/adductor weakness/pain/soreness and approx 3+/5 MMT (my wife and I are physical therapists) This thigh/hip weakness and pain has been present on a daily basis just varying in intensity. Does not change with positions, exercise or movements
Age: 43.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Day after injection chills, 101F fever, lethargic, extreme fatigue, joint aches; within approx 3-4 days started to feel moderate to severe bilateral  anterior thigh/hip/adductor weakness/pain/soreness and approx 3+/5 MMT (my wife and I are physical therapists) This thigh/hip weakness and pain has been present on a daily basis just varying in intensity. Does not change with positions, exercise or movements
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Fall, Gait inability, Weight bearing difficulty
Clinical narrative: Patient stated that he fell approximately 5-6 hours post vaccination. He stated that he felt very weak and could not support the weight of his body with his feet so subsequently he fell down. He stated he could not put any pressure on his limbs and could not walk after. He was hospitalized for 4-5 days post vaccination and was evaluated for GBS. His providers did rule out GBS and also did not find a conclusive diagnosis for what happened. He stated that the only thing he did differently with his daily activities or diet was receiving  the vaccination and while he is unsure if it is related, wanted it to be reported as this was the first occurrence of such an event for him post-vaccination.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Patient stated that a couple days later she felt some tingling in arms and now she is feeling general numbness mainly down her wrists (both sides) and down to the toes (both sides)
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given expired vaccine due to improper storage. Patient has not reported any adverse effects.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted.
Age: 20.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Abdominal pain upper, Confusional state, Cough, Dyspnoea, Flushing
Clinical narrative: Patient was given both immunizations back-to-back. About 2 minutes later, the patient had a flushed face, swollen lips, confusion, and stated she was having difficulty breathing and couldn't see straight. She also started coughing. I administered an Epipen and called 911. The Epipen relieved her flushing, swelling, and difficulty breathing, but patient still seemed a bit confused and "out of it." She said she had never had an allergic reaction to anything before. When EMS arrived, she started complaining of stomach cramping and nausea. At that point EMS took her away on a gurney to their ambulance to take her to the hospital.
Age: 20.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Lip swelling, Nausea, Visual impairment
Clinical narrative: Patient was given both immunizations back-to-back. About 2 minutes later, the patient had a flushed face, swollen lips, confusion, and stated she was having difficulty breathing and couldn't see straight. She also started coughing. I administered an Epipen and called 911. The Epipen relieved her flushing, swelling, and difficulty breathing, but patient still seemed a bit confused and "out of it." She said she had never had an allergic reaction to anything before. When EMS arrived, she started complaining of stomach cramping and nausea. At that point EMS took her away on a gurney to their ambulance to take her to the hospital.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: A second dose of Arexvy was given upon patient request. First dose was unknown to vaccinating pharmacist and was not documented in the registry. Patient experienced no ill effects from second vaccination.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Gout, Pain in extremity
Clinical narrative: Pt claims pain in left foot later that evening - Resulted in Gout
Age: 67.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse events Administration was IM not sub Q
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Swollen tongue
Clinical narrative: Severe itching on palms, feet, shoulders, sides and thighs.  Tongue swelling and trouble breathing
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Erythema, Headache, Lethargy, Pruritus, Skin warm
Clinical narrative: Larthagic,- slept ,  large welt (lump), itchy, redness, soreness, headache - took Advil midday on Friday the 3rd. On Saturday 4th started getting redder and hotter, more itchy. Placed cold compress on in early evening and then ibuprofen at night. Jan 5th woke up still red no increase in size, still itchy, placed cold compress. Won't take further medication unless pain gets worse
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Urticaria
Clinical narrative: Larthagic,- slept ,  large welt (lump), itchy, redness, soreness, headache - took Advil midday on Friday the 3rd. On Saturday 4th started getting redder and hotter, more itchy. Placed cold compress on in early evening and then ibuprofen at night. Jan 5th woke up still red no increase in size, still itchy, placed cold compress. Won't take further medication unless pain gets worse
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Syncope
Clinical narrative: Extreme weakness resulted in fainting
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Swelling at injection site, sore. Swelling and sore in left armpit
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Asthenopia, Diplopia, Dizziness, Fall, Fatigue
Clinical narrative: Double vision. Fell asleep at 8pm and woke a little after midnight with severe double vision , dizziness. Tried closing eyes to read on phone what could be wrong. Tried to rub eyes & pop ears, tried doing head maneuvers. Got up and fell bad but didn't bread anything. Made it to kitchen, drank water, rinsed eyes. Kept pressing eyes & refocusing eyes. Put warm compresses on them. Finally got sort of adjusted to single vision. Tired fell asleep very scared. Woke up with phone call at 8:30 - 9 am and no vision issue except eyes feel tired.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Injection site pruritus, Mobility decreased, Neck pain
Clinical narrative: Extreme pain with injection. Still have pain in left arm on 1/5/52025.  On Dec 15 went to Dr with red  blotches up and down left arm and terrible pain in left shoulder and neck. Diagnosis possible shingles.  Treated shingles ( only on left arm)  still having issues  lifting arm and had itching at site the last 2 days
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Extreme pain with injection. Still have pain in left arm on 1/5/52025.  On Dec 15 went to Dr with red  blotches up and down left arm and terrible pain in left shoulder and neck. Diagnosis possible shingles.  Treated shingles ( only on left arm)  still having issues  lifting arm and had itching at site the last 2 days
Age: 55.0
Sex: U
Vaccine: UNK
Symptoms: Axillary pain, Biopsy breast, Breast mass, Chest pain, Chest wall abscess
Clinical narrative: approx. 6 days after injection experienced severe soreness and pain under both arms radiating into sides of chest, this dissipated after 7-10 days then after approx. 6-8 days while showering found large lump in right outer breast I monitored this for approx 5-7 days when it didn't go away I went to urgent care, they sent me to the ER they did CT with contrast finding possible malignant growths in both breast radiating under each arm. They referred me to a cancer breast surgeon specialist who sent me for mammogram, ultrasound, and needle biopsy findings were "no malignancy detected" so not cancer. The surgeon is calling it a chest wall abscess I am scheduled for surgery 1/9/25 to have the fist sized mass removed.
Age: 55.0
Sex: U
Vaccine: UNK
Symptoms: Computerised tomogram breast abnormal, Mammogram, Pain, Ultrasound breast
Clinical narrative: approx. 6 days after injection experienced severe soreness and pain under both arms radiating into sides of chest, this dissipated after 7-10 days then after approx. 6-8 days while showering found large lump in right outer breast I monitored this for approx 5-7 days when it didn't go away I went to urgent care, they sent me to the ER they did CT with contrast finding possible malignant growths in both breast radiating under each arm. They referred me to a cancer breast surgeon specialist who sent me for mammogram, ultrasound, and needle biopsy findings were "no malignancy detected" so not cancer. The surgeon is calling it a chest wall abscess I am scheduled for surgery 1/9/25 to have the fist sized mass removed.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chemotherapy, Chest pain, Philadelphia positive acute lymphocytic leukaemia, Radiotherapy, Stem cell transplant
Clinical narrative: Presented to emergency department with chest pains and tachycardia, several tests performed resulting in  a diagnosis of ph+ b cell acute lymphoblastic leukemia. Treatments included chemotherapy, radiation and stem cell transplant
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Presented to emergency department with chest pains and tachycardia, several tests performed resulting in  a diagnosis of ph+ b cell acute lymphoblastic leukemia. Treatments included chemotherapy, radiation and stem cell transplant
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Hypertension, Laboratory test normal, Thyroid function test normal
Clinical narrative: High blood pressure up to 175/102.  Up until 08/15/2024 never had a blood pressure above 126/82 before.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received 1st boostrix on 5/31/2024. Pt received the same vaccine again on 1/4/2025. The 2nd vaccine was not appropriate given guidelines
Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Dizziness, Fatigue, Injection site swelling, Peripheral swelling
Clinical narrative: The patient started to experience arm swelling, light headedness and fatigue within 24 hours.  The swelling at the injection site became progressively more prominent over the subsequent days. Treatment was sought at an urgent care clinic. The patient was assured that she was not developing cellulitis.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: A few hours after receiving the vaccine (1/3/25 at 10:30 am), the site began to itch, so I removed the Band-Aid, but the site was normal. The next morning (1/4/25 at 6 am) the injection site was red, hard, and tender. It is starting to heal as of today, 1/5/25 and is not as tender but still red and hard.
Age: 69.0
Sex: F
Vaccine: PNC21, TDAP
Symptoms: Peripheral swelling, Pruritus, Rash, Skin warm
Clinical narrative: Itching, rash, feverish arm, swollen arm
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Nausea, Pyrexia
Clinical narrative: Fever for at least two days, tired, naseaous.