chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: YF
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: reconstituted with 0.7mL sterile diluent provided by Merck and meant for Merck live virus reconstitution, rather than 0.6mL Sodium Chloride solution with no reported adverse event; Initial information received on 02-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 45 years old male patient who received yellow fever vaccine - [YF-VAX] reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 24-Feb-2023, the patient received an unknown dose of suspect yellow fever vaccine - , solution for injection (lot: UJ782AA; expiry date: 17-Feb-2024) via subcutaneous route in the left arm for prophylactic vaccination (immunization) reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event reconstituted with 0.7ml sterile diluent provided by merck and meant for merck live virus reconstitution, rather than 0.6ml sodium chloride solution with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ACTHIB vaccine was given, with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 1 years old and unknown gender patient where expired acthib vaccine was given, with no reported adverse event while receiving vaccine hib (prp/t) vaccine [act-HIB].  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On 07-Apr-2023, the patient received a dose of suspect hib (prp/t) vaccine (batch number- UJ679AAA) via unknown route in unknown administration site (dose, frequency, route, formulation, strength and expiration date: not provided) for Immunization.  On 07-Apr-2023 expired acthib vaccine was given, with no reported adverse event (expired product administered) (latency- same day) following the administration of hib (prp/t) vaccine.  It was reported asking guidance on giving an expired ACTHIB to a patient on Friday, 07Apr2023. Product used : Used  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: temperature excursion where the temperature reached negative -40F degrees for 8 hours and 25 minutes with no reported adverse event; received the vaccine post-temperature excursion where the vaccine were not suitable for use with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA137832, 2023SA137908, 2023SA137832, 2023SA136956 and 2023SA137832.  This case involves a 1 years old female patient who received HIB (PRP/T) vaccine [ACT-HIB] post temperature excursion where the temperature reached negative -40f degrees for 8 hours and 25 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination.  On 04-Apr-2023, the patient received 0.5 ml dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot: U026802; expiry date: 03-Nov-2023) via intramuscular route in the left arm for Immunization post temperature excursion where the temperature reached negative -40f degrees for 8 hours and 25 minutes with no reported adverse event (product storage error) (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received the vaccine post-temperature excursion where the vaccine were not suitable for use with no reported adverse event and was Unknown for the event temperature excursion where the temperature reached negative -40f degrees for 8 hours and 25 minutes with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: DT
Symptoms: Unevaluable event
Clinical narrative: no adverse event; Based on information previously received, the following information has been amended: added classification of Non-Case, as there is no adverse event reported in the case
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of the vaccine with no reported AE; Initial information received on 03-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old female patient who had administered an expired dose of the vaccine with no reported ae after receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-May-2023, the patient received a dose 2 0.5 ml of suspect meningococcal a-c-y-w135 (d conj) vaccine Solution for injection lot U7211AA, 14-MAR-2023 via intramuscular route in the left deltoid for immunisation.  On 03-May-2023 the patient developed a non-serious event administered an expired dose of the vaccine with no reported ae (expired product administered) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event administered an expired dose of the vaccine with no reported ae.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Discomfort, Peripheral swelling, Pruritus, Sensitive skin, Skin irritation
Clinical narrative: full body hives, swelling and warmth in hands and feet, irritated scalp, pressure sensitive skin resulting in more hives, diffuse itchiness
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Urticaria
Clinical narrative: full body hives, swelling and warmth in hands and feet, irritated scalp, pressure sensitive skin resulting in more hives, diffuse itchiness
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast mass, Dyspnoea, Gait inability, Muscular weakness
Clinical narrative: pt reported to me today 5/5/2023 that she hasn't been able to walk since a couple days after dec bivalent shot; leg weakness (gives out). Also, she had a small lump in right breast, which is now large. experiences sob. I informed md and asked them both to arrange an appointment asap.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt has presented today with a red, hot, swollen, painful arm. 2 inch circumference. 2nd Shingrix shot
Age: 84.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient after the fact told me he faints after blood work all the time. Also stated he didn't eat anything yet today. We got him OJ, and a gronala bar and he sat and then felt much better.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Syringe issue
Clinical narrative: Error: Leaking from Syringe-
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Cough, Endoscopy abnormal, Gastrooesophageal reflux disease
Clinical narrative: I tested positive on 12/11/22.  On 12/28/22, By 12/30/22 was confined to bed with what seemed like a bad cold.  It never went away and, in fact, waxes and wanes til this day.  I've been coughing for over 4 months now with recurring laryngitis, swollen glands in throat, inflamed throat lining, etc.  Saw an ENT doc on 4/21 - was diagnosed as having severe acid reflux and bronchitis.  I've never had a single acid reflux event before Covid.  My ENT doc says she is seeing 'a lot of this'.  (She scoped my throat and saw evidence)
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis, Lymphadenopathy, Mobility decreased, Nasopharyngitis, Pharyngeal inflammation
Clinical narrative: I tested positive on 12/11/22.  On 12/28/22, By 12/30/22 was confined to bed with what seemed like a bad cold.  It never went away and, in fact, waxes and wanes til this day.  I've been coughing for over 4 months now with recurring laryngitis, swollen glands in throat, inflamed throat lining, etc.  Saw an ENT doc on 4/21 - was diagnosed as having severe acid reflux and bronchitis.  I've never had a single acid reflux event before Covid.  My ENT doc says she is seeing 'a lot of this'.  (She scoped my throat and saw evidence)
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: patient received Moderna Bivalent per new guideline but not the right bivalent of modern. PRIVACY call patient to book a new appointment to revaccinate appropriately.
Age: 69.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Urticaria
Clinical narrative: Urticaria developed  EVERYWHERE except face and bottom of feet beginning by 12 hours post-innoculation .   Went to local hospital's Urgent Care Unit to seek care to reduce/eliminate adverse reaction.  Received methyPREDNISolone sod suc (PF) (SOLU-Medrol (PF) shot in RT Glute 29 hrs 38 min. after Bivalent Booster injection.  Was prescribed and have begun taking Prednisone tablet series.  By 18 hours post SSOLU-Medrol (PF) injection and first day's tablets of Prednisone prescription series, Urticaria has begun to subside. No additional adverse events have occurred yet.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia oral
Clinical narrative: On her way home, the patient said her lips and a small area surrounding the lips went numb.  This continued for a couple hours. The patient called the pharmacy and was instructed to drink water, rinse the area with cool water and send her husband  to get benedryl.  The patient was given a call at 2:20pm to check on her condition. She was completely better.  She did not take benedryl yet.  Will follow up with the patient.  No MD was contacted.  She was instructed to go to the hospital if anything  progressed.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza, Rash, Rash pruritic
Clinical narrative: I got a rash all over my body, concentrated on my torso the night of the shot. I informed them when I got my 2nd dose and they said it's safe if it isn't within minutes of getting the shot. I got the rash on the second shot that night as well. Ever since I received the vaccine, I get a rash exactly the same as previously described, any time I get sick. I have had a cold or the flu 8 times since receiving the vaccine and have had a rash occur all over every time. The rash is itchy but no pus and not significantly raised. I have never had a rash occur any time while I was sick prior to the vaccine and it is the same rash I got from the vaccine. I KNOW it isthe vaccine that has changed something in my body to react differently when I get sick now and it is extremely worrisome.
Age: 53.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Pharyngeal swelling
Clinical narrative: Patient felt her throat swelling. Self injected her own Epipen. Started 5 minutes after receiving immunizations. Patient states she uses Epipen frequently as is allergic to many things. EMS arrived to check patient. Patient did not go to hospital and was released from store by EMS.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Glossodynia, Lip swelling, Mouth ulceration, Stomatitis
Clinical narrative: swelling of lower lip, no swelling of face. sores present on and around mouth, some sores on the inside as well as on her tongue
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain lower, Full blood count normal, Haemoglobin decreased, Human chorionic gonadotropin negative, Metabolic function test normal
Clinical narrative: PT complaining of cramping LLQ abdominal pain and nausea appx 8hr after receiving injection lasting until appcx 36hr after injection
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Muscle spasms, Nausea, Urine analysis normal
Clinical narrative: PT complaining of cramping LLQ abdominal pain and nausea appx 8hr after receiving injection lasting until appcx 36hr after injection
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Within 2 hours of receiving the injection, ears felt clogged and significant whooshing noise and popping. The whooshing noise eventually deceased and ringing in the ears began later that day and has not ceased.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Fever, body aches Nausea Severe dizziness   lightheadness    as of 5/6/2023 still occuring Went acute clinic 5/6/2023 and was told they would treat him since they did not give vaccine.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Gave second bi-valent booster to patient who is not immunocompromised.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: red area on skin surrounding vaccine, began day after administration and now (two days after administration) is still present. patient states arm is sore but that redness and soreness is improving compared to yesterday.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Computerised tomogram thorax abnormal, Pulmonary mass
Clinical narrative: no symptoms, lesions on lungs found during CT Calcium Scoring wellness scan.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pyrexia, Swelling
Clinical narrative: patient started having swelling and fever up in the night . The next day her lymph nodes were swollen and her fever was 104  and on Wednesday  she had no fever. On Thursday she went to the doctor for the nodes being swollen and had a script for keflex  sent in on 5/4/23 which she picked up today and notified us of the reaction. Patient gave me her phone number so if I needed more information  to fill out this form but she never answered so I do not have any doctor  or other information which I left blank.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dehydration, Headache, Impaired work ability, Injection site erythema
Clinical narrative: Fever, headache, swollen cervical lymph nodes bilaterally, swollen and erythema at injection site, muscle pain, joint pain, sore throat, nausea and vomiting. (Negative home Covid test.). Nausea and vomiting that required an ER visit for antiemetics and intravenous fluid rehydration.   Unable to work as RN for 4 days
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Laboratory test, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: Fever, headache, swollen cervical lymph nodes bilaterally, swollen and erythema at injection site, muscle pain, joint pain, sore throat, nausea and vomiting. (Negative home Covid test.). Nausea and vomiting that required an ER visit for antiemetics and intravenous fluid rehydration.   Unable to work as RN for 4 days
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Fever, headache, swollen cervical lymph nodes bilaterally, swollen and erythema at injection site, muscle pain, joint pain, sore throat, nausea and vomiting. (Negative home Covid test.). Nausea and vomiting that required an ER visit for antiemetics and intravenous fluid rehydration.   Unable to work as RN for 4 days
Age: 38.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Intern, administered to patient the final dose of Varivax and second dose of Twinrix under supervision of pharmacist. Shortly after administration, patient exhibited symptoms of lightheadedness and loss of consciousness. Husband was present. Pharmacist intervened to keep patient alert and directed intern to call EMS as a precaution. Patient was in and out of consciousness but later became alert and instructed intern to dismiss the EMS call because she was feeling much better and did not want to go to the hospital. Pharmacist asked patient if she was diabetic or if she felt that her blood sugar or pressure was low. After sitting for some time, blood pressure was taken by pharmacist with patient consent and it was assessed to be 88/59. Pharmacist recommended that patient take a Gatorade with electrolytes and sit for some time. Patient drank Gatorade and felt better. Pharmacist instructed patient to sit for 10 more minutes under pharmacist observation. Patient agreed and waited with husband. After the suggested time, patient said she was feeling much better (interpreted) and both patient and husband thanked the pharmacy for their assistance as they left.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Antinuclear antibody positive, Asthenia, Blindness unilateral, Cerebral disorder
Clinical narrative: 40 minutes after second dose of Pfizer started with severe head pressure, tunnel vision, dizziness. Saw pcp office multiple times. 7 days later started with bilateral lower extremity weakness. 10 days after the vaccine right leg started to drag. Seen pcp for weakness and decreased reflexes and was admitted to local General Hospital 11/8/21-11/12/21. Improved with IV steroids was discharged with home PT and OT which failed. Symptoms returned morning I was discharged and progressively worsened. Have severe sound sensitivity, severe head pressure continues even 18 months later. Intermittent tinnitus, nausea, vomiting. Started with memory and concentration problems within first month of injection. Started having seizures May 2022 and continue to have 3-4 per week. Have been admitted to hospitals 4 times since the n. January 2022- left leg started to drag as well and have been completely wheelchair bound since then. Have been diagnosed with severe immune response to Covid vaccine, incomplete paraplegia. Continue with memory loss, concentration issues, intermittent blurry vision and intermittent loss of vision in right eye. Swallowing difficulty, severe muscle cramps, intermittent tingling and numbness in lower extremities, weakness goes up to core, worsening constipation,
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Disturbance in attention, Dizziness, Dysphagia, Gait disturbance
Clinical narrative: 40 minutes after second dose of Pfizer started with severe head pressure, tunnel vision, dizziness. Saw pcp office multiple times. 7 days later started with bilateral lower extremity weakness. 10 days after the vaccine right leg started to drag. Seen pcp for weakness and decreased reflexes and was admitted to local General Hospital 11/8/21-11/12/21. Improved with IV steroids was discharged with home PT and OT which failed. Symptoms returned morning I was discharged and progressively worsened. Have severe sound sensitivity, severe head pressure continues even 18 months later. Intermittent tinnitus, nausea, vomiting. Started with memory and concentration problems within first month of injection. Started having seizures May 2022 and continue to have 3-4 per week. Have been admitted to hospitals 4 times since the n. January 2022- left leg started to drag as well and have been completely wheelchair bound since then. Have been diagnosed with severe immune response to Covid vaccine, incomplete paraplegia. Continue with memory loss, concentration issues, intermittent blurry vision and intermittent loss of vision in right eye. Swallowing difficulty, severe muscle cramps, intermittent tingling and numbness in lower extremities, weakness goes up to core, worsening constipation,
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hyperacusis, Hypoaesthesia, Hyporeflexia, Lumbar puncture
Clinical narrative: 40 minutes after second dose of Pfizer started with severe head pressure, tunnel vision, dizziness. Saw pcp office multiple times. 7 days later started with bilateral lower extremity weakness. 10 days after the vaccine right leg started to drag. Seen pcp for weakness and decreased reflexes and was admitted to local General Hospital 11/8/21-11/12/21. Improved with IV steroids was discharged with home PT and OT which failed. Symptoms returned morning I was discharged and progressively worsened. Have severe sound sensitivity, severe head pressure continues even 18 months later. Intermittent tinnitus, nausea, vomiting. Started with memory and concentration problems within first month of injection. Started having seizures May 2022 and continue to have 3-4 per week. Have been admitted to hospitals 4 times since the n. January 2022- left leg started to drag as well and have been completely wheelchair bound since then. Have been diagnosed with severe immune response to Covid vaccine, incomplete paraplegia. Continue with memory loss, concentration issues, intermittent blurry vision and intermittent loss of vision in right eye. Swallowing difficulty, severe muscle cramps, intermittent tingling and numbness in lower extremities, weakness goes up to core, worsening constipation,
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head abnormal, Muscle spasms, Muscular weakness, Nausea, Paraesthesia
Clinical narrative: 40 minutes after second dose of Pfizer started with severe head pressure, tunnel vision, dizziness. Saw pcp office multiple times. 7 days later started with bilateral lower extremity weakness. 10 days after the vaccine right leg started to drag. Seen pcp for weakness and decreased reflexes and was admitted to local General Hospital 11/8/21-11/12/21. Improved with IV steroids was discharged with home PT and OT which failed. Symptoms returned morning I was discharged and progressively worsened. Have severe sound sensitivity, severe head pressure continues even 18 months later. Intermittent tinnitus, nausea, vomiting. Started with memory and concentration problems within first month of injection. Started having seizures May 2022 and continue to have 3-4 per week. Have been admitted to hospitals 4 times since the n. January 2022- left leg started to drag as well and have been completely wheelchair bound since then. Have been diagnosed with severe immune response to Covid vaccine, incomplete paraplegia. Continue with memory loss, concentration issues, intermittent blurry vision and intermittent loss of vision in right eye. Swallowing difficulty, severe muscle cramps, intermittent tingling and numbness in lower extremities, weakness goes up to core, worsening constipation,
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraplegia, Red blood cell sedimentation rate increased, Scan with contrast abnormal, Seizure, Tinnitus
Clinical narrative: 40 minutes after second dose of Pfizer started with severe head pressure, tunnel vision, dizziness. Saw pcp office multiple times. 7 days later started with bilateral lower extremity weakness. 10 days after the vaccine right leg started to drag. Seen pcp for weakness and decreased reflexes and was admitted to local General Hospital 11/8/21-11/12/21. Improved with IV steroids was discharged with home PT and OT which failed. Symptoms returned morning I was discharged and progressively worsened. Have severe sound sensitivity, severe head pressure continues even 18 months later. Intermittent tinnitus, nausea, vomiting. Started with memory and concentration problems within first month of injection. Started having seizures May 2022 and continue to have 3-4 per week. Have been admitted to hospitals 4 times since the n. January 2022- left leg started to drag as well and have been completely wheelchair bound since then. Have been diagnosed with severe immune response to Covid vaccine, incomplete paraplegia. Continue with memory loss, concentration issues, intermittent blurry vision and intermittent loss of vision in right eye. Swallowing difficulty, severe muscle cramps, intermittent tingling and numbness in lower extremities, weakness goes up to core, worsening constipation,
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision, Vision blurred, Vomiting, Wheelchair user
Clinical narrative: 40 minutes after second dose of Pfizer started with severe head pressure, tunnel vision, dizziness. Saw pcp office multiple times. 7 days later started with bilateral lower extremity weakness. 10 days after the vaccine right leg started to drag. Seen pcp for weakness and decreased reflexes and was admitted to local General Hospital 11/8/21-11/12/21. Improved with IV steroids was discharged with home PT and OT which failed. Symptoms returned morning I was discharged and progressively worsened. Have severe sound sensitivity, severe head pressure continues even 18 months later. Intermittent tinnitus, nausea, vomiting. Started with memory and concentration problems within first month of injection. Started having seizures May 2022 and continue to have 3-4 per week. Have been admitted to hospitals 4 times since the n. January 2022- left leg started to drag as well and have been completely wheelchair bound since then. Have been diagnosed with severe immune response to Covid vaccine, incomplete paraplegia. Continue with memory loss, concentration issues, intermittent blurry vision and intermittent loss of vision in right eye. Swallowing difficulty, severe muscle cramps, intermittent tingling and numbness in lower extremities, weakness goes up to core, worsening constipation,
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient came in for varicella vaccine and stated on his consent form that he had not had a vaccine in 4 weeks.  After the vaccine was given, he asked for his vaccination record and when looking at it, he had received a MMR vaccine 2 weeks ago.
Age: 8.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Crying, Gait inability, Immobile, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: 3 hours after the vaccine, pt was resting on the couch watching tv. Pt stood up to go to the bathroom and almost collapsed. Realized she was unable to move her right leg. Ibuprofen was given and pt was put to bed alternating ice and heat packs to the affected area. Even after Motrin, pt still continues to cry out in pain and will not move right leg or let anyone touch it. By evening time, there was visible swelling to the leg all the way down to the toes. She was medicated with Tylenol, leg elevated on pillow and put to bed for the night. At midnight pt was screaming from pain. She is unable to bear weight, get up, or walk. She needs assistance to get dressed, go to the bathroom, and all other daily activities. This is day 2 and pt is still immobile and 10/10 pain. PCP was contacted first thing in am and he say ?this can happen, it?s not dangerous, just increase pain medicine?.
Age: 8.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Pain, Peripheral swelling, Presyncope, Screaming, Tenderness
Clinical narrative: 3 hours after the vaccine, pt was resting on the couch watching tv. Pt stood up to go to the bathroom and almost collapsed. Realized she was unable to move her right leg. Ibuprofen was given and pt was put to bed alternating ice and heat packs to the affected area. Even after Motrin, pt still continues to cry out in pain and will not move right leg or let anyone touch it. By evening time, there was visible swelling to the leg all the way down to the toes. She was medicated with Tylenol, leg elevated on pillow and put to bed for the night. At midnight pt was screaming from pain. She is unable to bear weight, get up, or walk. She needs assistance to get dressed, go to the bathroom, and all other daily activities. This is day 2 and pt is still immobile and 10/10 pain. PCP was contacted first thing in am and he say ?this can happen, it?s not dangerous, just increase pain medicine?.
Age: 8.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Weight bearing difficulty
Clinical narrative: 3 hours after the vaccine, pt was resting on the couch watching tv. Pt stood up to go to the bathroom and almost collapsed. Realized she was unable to move her right leg. Ibuprofen was given and pt was put to bed alternating ice and heat packs to the affected area. Even after Motrin, pt still continues to cry out in pain and will not move right leg or let anyone touch it. By evening time, there was visible swelling to the leg all the way down to the toes. She was medicated with Tylenol, leg elevated on pillow and put to bed for the night. At midnight pt was screaming from pain. She is unable to bear weight, get up, or walk. She needs assistance to get dressed, go to the bathroom, and all other daily activities. This is day 2 and pt is still immobile and 10/10 pain. PCP was contacted first thing in am and he say ?this can happen, it?s not dangerous, just increase pain medicine?.
Age: 18.0
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, Paraesthesia
Clinical narrative: YF VAX ADMINISTERED INTRAMUSCULARLY ON 5-1-2023 INSTEAD OF SUBCUTANEOUSLY  PT CAME BACK TO PHARMACY FOR TYPHIM VACCINE ON 5-4-2023 AND PHARMACIST DISCOVERED THE ERROR.   PT INQUIRE IF TINGLING IN HANDS IS ASSOCIATED WITH YELLOW FEVER. PHARMACIST INFORMED HIM "NO" BUT I CAN REPORT THESE SYMPTOMS TO HIS DOCTOR WHO ISSUED THE PRESCRIPTION FOR YELLOW FEVER  DR OFFICE INFORMED ON 5-4-2023 TO FOLLOW UP WITH PT  SANOFI WAS CONTACTED ON 5-5-2023 AND THEY INFORMED US THAT YF VAX IS STILL VALID DOSE AND DOESNT NEED TO BE REPEATED. PTS MOTHER WAS INFORMED
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Rash papular
Clinical narrative: Generalized flesh-colored papular rash within 24 hours of administration.  No respiratory distress, no angioedema, no fevers. No neurologic changes. Presented to clinic on 5/5/23 for additional catch up vaccinations. These vaccines were held off for now secondary to patient presentation. Prescribed cetirizine and topical hydrocortisone for rash and will follow closely
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Injection site discolouration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: No treatment for area on my arm, I don?t remember if I had any treatment for my chronic coughing
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Respiration abnormal
Clinical narrative: No treatment for area on my arm, I don?t remember if I had any treatment for my chronic coughing
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: PAIN FROM INJECTION SITE TO FINGERTIPS-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PATIENT HAD PAIN FROM INJECTION SITE TO FINGERTIPS THAT HAS LASTED FOR UP TO 3 DAYS
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Erythema, Fatigue, Joint stiffness
Clinical narrative: Joint stiffness and swelling, redness of the skin, muscle aches, cramps pains and stiffness, shivering, unusual tiredness and weakness, chills, fever 102.0
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Muscle spasms, Musculoskeletal stiffness, Myalgia, Pain
Clinical narrative: Joint stiffness and swelling, redness of the skin, muscle aches, cramps pains and stiffness, shivering, unusual tiredness and weakness, chills, fever 102.0
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Joint stiffness and swelling, redness of the skin, muscle aches, cramps pains and stiffness, shivering, unusual tiredness and weakness, chills, fever 102.0
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Blood creatine phosphokinase, COVID-19, Chest pain, Computerised tomogram thorax abnormal
Clinical narrative: I developed difficulty swallowing, hoarseness, loss of voice, increased heart rate in june 2021 from unknown cause. This persisted for more than 3 months without improvement. I also had feeling of fluid in chest. I had chest  CT showed multiple inflammatory nodules in my lungs. I contracted covid and had no symptoms of covid. 3 weeks later i developed chest pain and sob. these sypmtpms improved short term with dexamethasone. the symptoms has persisted and i am seeing a cardiologust who is treated me presently with colchicine and nsaids. i have also required prednisone on and off.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dysphonia, Dyspnoea, Electrocardiogram abnormal, Heart rate increased
Clinical narrative: I developed difficulty swallowing, hoarseness, loss of voice, increased heart rate in june 2021 from unknown cause. This persisted for more than 3 months without improvement. I also had feeling of fluid in chest. I had chest  CT showed multiple inflammatory nodules in my lungs. I contracted covid and had no symptoms of covid. 3 weeks later i developed chest pain and sob. these sypmtpms improved short term with dexamethasone. the symptoms has persisted and i am seeing a cardiologust who is treated me presently with colchicine and nsaids. i have also required prednisone on and off.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary mass, Supraventricular tachycardia
Clinical narrative: I developed difficulty swallowing, hoarseness, loss of voice, increased heart rate in june 2021 from unknown cause. This persisted for more than 3 months without improvement. I also had feeling of fluid in chest. I had chest  CT showed multiple inflammatory nodules in my lungs. I contracted covid and had no symptoms of covid. 3 weeks later i developed chest pain and sob. these sypmtpms improved short term with dexamethasone. the symptoms has persisted and i am seeing a cardiologust who is treated me presently with colchicine and nsaids. i have also required prednisone on and off.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Dysarthria, Muscular weakness
Clinical narrative: Two weeks after the 2nd shot  one morning patient woke up with a slurred speech
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amyotrophic lateral sclerosis, Dysarthria, Muscular weakness, SARS-CoV-2 test
Clinical narrative: Two weeks after the 2nd shot  one morning patient woke up with a slurred speech
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient says has hives for past few days after receiving vaccine.
Age: 53.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: had redness and swelling in both right and left arm, was more pronounced in the left arm which received two vaccine, she also had intense itching at the site of administration and significant erythema, was told to take benadryl for itching and allergic reaction and to seek medical care if she has facial swelling or trouble breathing or any worsening symptoms
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Passed out and seized when got up from bed
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: I  got the common cold,  runny nose, congestion..I NEVER had a cold in over 5 years before I got this stinking booster. I NEVER got sick.. I have had the COLD  5 times since the booster..1/14,1/31,2/30/3/27/and 4/27.. I didnt go to the dr  it is the common cold ..they can't do anything for the common cold.. I had runny nose, congestion in head and chest..They all lasted about 10 days.. I wish now I had NOT got the booster.   I took  like claritinD and cough drops  and it ran its course,..
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pruritus, Rash
Clinical narrative: Patient stated the day after vaccination that he had severe fatigue and a rash with itching that extended over his whole body.  He stated the rash and itching subsided after 2 days but was still present.  Patient is continuing to have itching and rash present.  Patient is using hydrocortisone cream to calm the itching.  We suggested to take diphenhydramine tablets and follow up with doctor if itching continues.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Blood pressure decreased, Dizziness, Flushing, Hypotension, Seizure like phenomena
Clinical narrative: Patient looked light headed and face got flushed and was not sure if he was breathing.  His partner put some candy in his mouth and he quickly jerked up and initially looked like he was having a seizure, but started breathing calmly right away.  Patient was feeling light headed but was conscious and breathing. Paramedics arrived, and upon evaluation, paramedics reported patient had very low blood pressure, and it was continuing to drop.  The paramedics provided IV fluids.  Per paramedics, patient has no lymph or facial swelling, and no obstruction of to airway.   Per paramedics, it seems like patient had fluid problems. Patient was being transported to ER for further stabilization.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neuropathy peripheral
Clinical narrative: Large axillary lymphadenopathy, the size of a softball, and peripheral neuropathy in distribution of the ulnar nerve
Age: 16.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Syncope
Clinical narrative: PT. FELT LIGHT HEADED AND FAINTED
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Amnesia, Brain fog, Burning sensation, Head discomfort, Mental impairment
Clinical narrative: Develop bilateral nerve burning sensations from shoulders to fingers. Sensations was continuous and lasted for 3 days. Brain fog also developed and is still experiencing now. Memory loss, head feels heavy, difficulty thinking and recalling events, names or objects.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: This claim is being reported as medication error.  Pfizer Bivalent Under 5 yrs given too soon. The guidelines changed from Pfizer Mono of 3 weeks interval to Pfizer Bivalent under 5 yrs. to 8 week interval.  Patient had first Pfizer Mono on 4/15/23. Patient was given Pfizer Bivalent under 5 yrs, 0.2ml IM, right deltoid too early. Pt. was observed for 15 minutes, without adverse effects. Discharged stable. Father was informed by RN that per CDC guidelines that this vaccine given today was invalid and to return in 8 weeks from todays date: 05/06/2023. Father understood and will return in 8 weeks for Pfizer Bivalent under 5 years.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Pulmonary embolism
Clinical narrative: Several months after vaccination I suffered pulmonary embolism.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have developed tinnitus, which I did not have prior to vaccination.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Fatigue, Head discomfort
Clinical narrative: Started feeling fatigue after the first few days post injection. Over the last week he started feeling dizziness, head pressure, and nausea that might be caused by visual impairment. He is seeing "floaters". He was seen by a doctor who also contacted an infectious disease doctor. They did CT scan, bloodwork, and routine eye exam and all were normal.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Laboratory test normal, Nausea, Visual impairment, Vitreous floaters
Clinical narrative: Started feeling fatigue after the first few days post injection. Over the last week he started feeling dizziness, head pressure, and nausea that might be caused by visual impairment. He is seeing "floaters". He was seen by a doctor who also contacted an infectious disease doctor. They did CT scan, bloodwork, and routine eye exam and all were normal.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Ear disorder, Magnetic resonance imaging head normal
Clinical narrative: Finning in both ears
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Pruritus, Pruritus genital
Clinical narrative: Began with headache and fatigue 20 hours after injection. Itching began on left side of neck and genitals. Has continued to spread across face/head, arms, chest. Conditions have not improved as of 5/7/2023
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Began with headache and fatigue 20 hours after injection. Itching began on left side of neck and genitals. Has continued to spread across face/head, arms, chest. Conditions have not improved as of 5/7/2023
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain in extremity, Product administered at inappropriate site, X-ray limb normal
Clinical narrative: vaccine was injected close to the shoulder area. it was injected about 1inch above the suggested site. Pt got sore arm and got a bruise.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Developed tinnitus 5 days after first dose of the COVID vaccine and its has not gone away
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary pain, Blood pressure increased, Injection site pain, Pyrexia
Clinical narrative: Elevated blood pressure readings (158-165/90-95) noted at routine annual physical exam approximately 48 hours after receiving COVID booster. My BP usually runs approximately 105-110/70-76. BP was monitored for 2 hours in physician office. When it did not come down, FNP prescribed valsartan. I monitored BP while awaiting availability of valsartan. BP gradually began to come down and normalized within 8-10 days. I never had to take the valsartan.  Only other symptoms with this booster were (1) fever of 103 F that started about 14 hours after booster and lasted approximately 12 hours and (2) sore arm at injection site and under arm
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Electrocardiogram
Clinical narrative: Developed a 7 hour run of A-Fib today, May 7.  Booster was April 24th . Treated with 50mg Toprol XL PO. Resolved after 7 hours. I had never had this before
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Nausea
Clinical narrative: Fever 100.2 for approx 18 hours, nausea, headache
Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Auditory disorder, Blood pressure increased, Computerised tomogram, Fatigue
Clinical narrative: I'm unsure about the exact connection to the vaccination event, since shortly after I experienced only mild and symptoms. Following weeks and month however I felt more fatigued than usual, more sluggishness until at the end of December and January. Stiffness,  nausea , some issue with hearing, nothing appeared overly significant. In January my blood pressure increased  and never went down - not even beta blocker medication helped it.  As of April however severe bleeding started through the urinary tract and I'm told that I'm having advanced renal carcinoma. A few month prior, 06/18/22 there was no sign of anything on sonogram, no lab test show any indication of such disease. Now, one of my kidney and more is essentially gone as it is engulfed by supposedly cancerous growth and infiltrations. . Nothing other than vaccination took place during those few month, the bivalent Pfizer  and flu shot about a month later. I have never had a positive covid test and I live mindfully about the risk. Exams, imaging and high risk surgery is suggested. Is there knowledge of such unwanted effect however rare it might be?