chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: FLUA4
Symptoms: Hypoaesthesia, Impaired work ability, Pain, Paraesthesia
Clinical narrative: Reports flu vaccine administered to left deltoid on 10/9/20, during night shift. Felt more pain than usual with previous injections. Later that shift, noticed numbness and tingling extending to left fingers. Noted pain increasing, over one month, such as lifting above her shoulder. Reported increasing pain to her supervisor on 10/18/20. And now reporting pain to Occupational Health Services on 11/09/20.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Injection site erythema, Injection site reaction, Injection site swelling, Paraesthesia
Clinical narrative: Welt at the site, redness and swelling, tingling down the Left arm and fine rash with burning sensation on legs. Started within hours of injection.  Continues to have symptoms
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Welt at the site, redness and swelling, tingling down the Left arm and fine rash with burning sensation on legs. Started within hours of injection.  Continues to have symptoms
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient experienced inflammation and redness at site of injection 2 days following vaccination
Age: 71.0
Sex: M
Vaccine: FLU4, VARZOS, FLUA3, VARZOS
Symptoms: Dyspnoea, Endotracheal intubation, Fall, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: About 2 weeks after receiving the Shingrix and flu shots, the patient began to have weakness in his legs and fell several times over the next few days before going to the hospital.  He was transferred to Clinic and an MRI was taken.  He had some degenerative changes, but no other nerve involvement.  He had trouble breathing and was intubated.  He was diagnosed with Guillain-Barre Syndrome and received treatment with immune globulin gamma.
Age: 71.0
Sex: M
Vaccine: FLU4, VARZOS, FLUA3, VARZOS
Symptoms: Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: About 2 weeks after receiving the Shingrix and flu shots, the patient began to have weakness in his legs and fell several times over the next few days before going to the hospital.  He was transferred to Clinic and an MRI was taken.  He had some degenerative changes, but no other nerve involvement.  He had trouble breathing and was intubated.  He was diagnosed with Guillain-Barre Syndrome and received treatment with immune globulin gamma.
Age: 71.0
Sex: M
Vaccine: FLU4, VARZOS, FLUA3, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: About 2 weeks after receiving the Shingrix and flu shots, the patient began to have weakness in his legs and fell several times over the next few days before going to the hospital.  He was transferred to Clinic and an MRI was taken.  He had some degenerative changes, but no other nerve involvement.  He had trouble breathing and was intubated.  He was diagnosed with Guillain-Barre Syndrome and received treatment with immune globulin gamma.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Paraesthesia
Clinical narrative: Pain at site within 1/2 hour and then tingling down arm started an hour -2 later, extremely sore.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Dizziness, Heart rate decreased, Hypotension, Pallor
Clinical narrative: Patient had flu vaccine and watched her for 15 minutes since she had history of syncope with her 11 years vaccines. Patient was trying get up in the bed and felt dizzy, looked very pale, back to bed and never loss the consciousness. Checked HR and BP, HR dropped to 40s for few second with weak pulse. BP at 80/60s, called 911 and but the HR back to 50s and skin color back and BP stayed 80/60s, so cancelled the 911 call. Watched the patient for next 30 minutes . HR back to 60-70s and BP stayed 80/60s. Denies any nausea but did complaint about stomach pain.  Patient left the clinic with Mother.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Pulse abnormal
Clinical narrative: Patient had flu vaccine and watched her for 15 minutes since she had history of syncope with her 11 years vaccines. Patient was trying get up in the bed and felt dizzy, looked very pale, back to bed and never loss the consciousness. Checked HR and BP, HR dropped to 40s for few second with weak pulse. BP at 80/60s, called 911 and but the HR back to 50s and skin color back and BP stayed 80/60s, so cancelled the 911 call. Watched the patient for next 30 minutes . HR back to 60-70s and BP stayed 80/60s. Denies any nausea but did complaint about stomach pain.  Patient left the clinic with Mother.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Neck pain, Pain, Paraesthesia
Clinical narrative: Within 2 hours site was extremely sore and tender to touch, started experiencing numbness and tingling from shoulder to finger tips, today experiencing pain lower neck, shoulder and back of neck,  warm and painful, numbness and tingling continues.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm, Tenderness
Clinical narrative: Within 2 hours site was extremely sore and tender to touch, started experiencing numbness and tingling from shoulder to finger tips, today experiencing pain lower neck, shoulder and back of neck,  warm and painful, numbness and tingling continues.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Pain immediately at injection site. Worsened over the day, evening of 11/2/2020. Woke up 11/3/2020 in the morning with redness at injection site and bruise where needle entered skin. Remained painful. Redness and pain worsened 11/3/2020 and began to streak to her axillae. She notified the office on 11/4/2020 and was brought in for an exam.  Bruising noted at injection site.  Erythema noted lower than injection site with streaking towards axillae. Hot to touch and painful
Age: 70.0
Sex: F
Vaccine: FLUA4
Symptoms: Dysstasia, Tension
Clinical narrative: after the shot was given, patient's back tensed up and she was unable to stand. I had her sit, took her blood pressure 139/84 with pulse of 85.  i gave her water as she sat for 10 min. when i checked back she felt better. she claims she had the flu shot before without any problems.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reports history of persistent left arm pain 3 weeks after vaccination
Age: 83.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Erythema, Feeling abnormal
Clinical narrative: left arm was real red and hot, started feeling bad about 30 min after, pain went up the shoulder, neck and to other shoulder and arm. Stomach pain, headache. Felt all over with back and body muscle ache.
Age: 83.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Headache, Myalgia, Neck pain, Skin warm
Clinical narrative: left arm was real red and hot, started feeling bad about 30 min after, pain went up the shoulder, neck and to other shoulder and arm. Stomach pain, headache. Felt all over with back and body muscle ache.
Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Sore upper arm, muscle soreness developed within 2 hours and persists still mildly 4 weeks later
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Injected limb mobility decreased
Clinical narrative: Severe pain in right shoulder with decreased range of motion that has lasted for 10 days.  He has been treated with sling, prednisone, and gentle range of motion exercises.  It is minimally improved.  He has been referred to  orthopedist for consideration of MRI and/or intra-articular steroid injection
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Nausea
Clinical narrative: Joint pain, nausea, headache, shivers
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Patient reports bruising post flu shot. When patient appeared at the pharmacy counter, the bruising was yellow/brown which likely indicates healing. The bruise appeared to be to the left and much lower than the injection site. Not sure if the bruise was due to the vaccination. Patient will follow up with his doctor soon.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain
Clinical narrative: Other than the expected sore arm at the injection site, I experienced fatigue, chills, achy joints overnight on the day of the injection and more so the following day.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Vertigo
Clinical narrative: Awaken from sleep with severe Vertigo. I never experienced Vertigo before or any flu shot reactions. (I've consistently received a flu shot over the past 20+ years.) I could manage the vertigo by not laying on my right side and by making very slow head movements. Gradually it disappeared over the course of 3 - 4 days.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Received FluLaval IIV4 .5mg lot NY927   NDC 19515-816-52  On Oct 17, 2020. On or about Nov 01,2020 Shingles developed lower Left back and side. Pain, Blisters.  I wonder: Vaccinate about two weeks before Shingles developed. Related?
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient reported a fever of 101.5F after receiveing vaccine
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Laboratory test abnormal, Polymyalgia rheumatica
Clinical narrative: Patient called pharmacy today stating they developed PMR ( polymyalgia rheumatic) after shingrix shot they got in 7/2019 and 9/2019.  Symptoms developed in October 2019.  Patients PMR is managed by Dr,  Patient stated hips and shoulders  are affected.  They also got a prevnar 13 in 8/2019.  Patient believe PMR was trigged by the shingles vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient is having swelling, redness, and warmth of the right deltoid that began within 24hrs after injections.  treatment after being evaluated in office: Benadryl 25 mg q 6hrs until the swelling is gone. Cold compress 20 minutes 3x a day. Call for an update tomorrow
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient's wife stated he was experiencing arm pain for months after the injection.  States that it has improved at this time.  She could not give a better time frame
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Pallor, Skin warm
Clinical narrative: Pt complained of dizziness and warmth. Pt was visibly sweating and pale in color. Pt complained of difficulty breathing.
Age: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Asthenia, Fatigue, Pain, Peripheral swelling
Clinical narrative: pain, feeling tired and weak, arm twice as big
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Myalgia
Clinical narrative: Muscle/joint pain and chills lasting for about 10 hours beginning about 9 hours after injection.  Redness at injection site - about 6 inch circle.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: Patient was unintentionally administered Shingrix instead of flu vaccine. Symptoms and outcomes are unknown.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: After receiving the vaccine, patient began to feel faint and dizzy
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Patient stated that she has an itchy, irritated rash on the arm where she got the injection.
Age: 52.0
Sex: M
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Infection, Pain, Pyrexia, Renal failure
Clinical narrative: Pt stated that he had achiness and low grade fever 11/09 that went away after taking tylenol. He reported 11/11 that he had an infection and renal failure and is in treatment at an ER. He attributes this to Pneumovax 23.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Fall, Feeling abnormal, Headache
Clinical narrative: Patient received vaccination and was sitting on dad's lap. Dad told her to stand up. She rose but fell to the floor face down. Dad turned her over and picked her up. She said she felt like "she was dreaming.." She said she had a headache.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: After each dose: low grade fever  99.5-100.5 for 36 hours, heavy fatigue  Second dose chills, fever  100.5
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Crying, Feeling cold, Head injury, Headache, Loss of consciousness
Clinical narrative: shortly after patient received afluria vaccine at pharmacy, patient fainted in pharmacy area and hit head on concrete floor of building. immediately went to patient and she came to within 5-7 seconds. she began to cry and said her head/neck hurt. she was alert and oriented x 3. technician called 911. checked blood pressure. it was 98/77. EMS arrived about 10-15 mins later.  patient remained on floor. We propped up her head on her sisters sweatshirt and got a blanket from the store to cover her  due to her being cold. EMS didn't think she had a concussion but wanted to take her to the hospital. her mother didn't want her to go via the ambulance. mother stated she would take her to the hospital. the EMS personnel helped her up into a chair. A scooter that is used for shoppers was brought to the pharmacy. patient was helped into the scooter and was followed out by the EMS personnel and her mother and twin sister.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Syncope
Clinical narrative: shortly after patient received afluria vaccine at pharmacy, patient fainted in pharmacy area and hit head on concrete floor of building. immediately went to patient and she came to within 5-7 seconds. she began to cry and said her head/neck hurt. she was alert and oriented x 3. technician called 911. checked blood pressure. it was 98/77. EMS arrived about 10-15 mins later.  patient remained on floor. We propped up her head on her sisters sweatshirt and got a blanket from the store to cover her  due to her being cold. EMS didn't think she had a concussion but wanted to take her to the hospital. her mother didn't want her to go via the ambulance. mother stated she would take her to the hospital. the EMS personnel helped her up into a chair. A scooter that is used for shoppers was brought to the pharmacy. patient was helped into the scooter and was followed out by the EMS personnel and her mother and twin sister.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Pain
Clinical narrative: The patient still has pain at the injection site when touched or raised arm
Age: 50.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Pruritus, Urticaria
Clinical narrative: a few hours later, thought I had a few bug bites on my Right leg. Ignored it, went through my day and went to bed. Woke up with hives on legs, hips, lower torso and stomach (not on arms or back though). PCP said to take Zyrtec, which I took at 12:30pm on 11/11/20 and started to itch less within an hour. New ones popping in slowed down and I am about to go to bed now, feeling fine.
Age: 50.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Rash, Urticaria
Clinical narrative: a few hours later, thought I had a few bug bites on my Right leg. Ignored it, went through my day and went to bed. Woke up with hives on legs, hips, lower torso and stomach (not on arms or back though). PCP said to take Zyrtec, which I took at 12:30pm on 11/11/20 and started to itch less within an hour. New ones popping in slowed down and I am about to go to bed now, feeling fine.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: woke up - left arm upper injection site erythematous - swelling - tight  painful. temp 99 3 has gotten tylenol.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Abdominal pain, Constipation, Death, Faecal volume increased
Clinical narrative: Pt was seen in ED with abdominal pain, distention, and vomiting. Was flown to another Hospital. Unknown until notification of death. No other information known.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Gastric dilatation, Intra-abdominal fluid collection, Ultrasound abdomen abnormal, Urinary system X-ray, Vomiting
Clinical narrative: Pt was seen in ED with abdominal pain, distention, and vomiting. Was flown to another Hospital. Unknown until notification of death. No other information known.
Age: 6.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was due for 5 tetanus and was given TDAP as Patient didn't need other components of DTAP vaccine was told by RN to give Adacel
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Computerised tomogram, Ovarian cyst, Ovarian cyst torsion, Ovarian operation, Ultrasound scan
Clinical narrative: Ovarian cyst; Ovarian cyst torsion; "This report was obtained on request by the Company from the FDA under the Freedom of Information Act."  This spontaneous report was received from a regulatory authority referring to a 13-year-old female patient. Patient's concurrent conditions, illnesses at the vaccination time, allergies, or reactions were reported as none. Concomitant therapies included drospirenone, ethinyl estradiol (YAZ).    On an unknown date, the patient had the first and second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R023608, expiration date 30-APR-2021, and on 15-JAN-2019 at 10:00; she received the third dose, lot number R027577 and expiration date 23-JUN-2021, all of them 1 dosage form in the left arm as prophylaxis (administration route was not provided).       On 22-NOV-2019, in the 3-shot series, the patient developed an ovarian cyst larger than an orange and ovarian cyst torsion that required emergency surgery and hospitalization for 2 days. Also, it was reported that a computerized tomography and an ultrasound were performed.  The outcome of ovarian cyst and ovarian cyst torsion was reported as unknown. The reporter did not assess the causal relationship between the events and  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9 ).   The agency considered the events as serious due to a disability or permanent damage and hospitalization.  As of 09-NOV-2020, all telephone attempts to obtain follow-up information have been unsuccessful.  combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. West Point; manufactureraddress: devicelotnumber: R023608; expirationdate: 30-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy skin abnormal, Drug interaction, Erythema, Food interaction, Hypersensitivity
Clinical narrative: After the first dose of Shingrix on 7/27/20, I developed two types of rash on August 14, 2020 - a large spread of hives on the backs of my legs, and also small red bumps erupting in various locations.  The dermatologist biopsied the two.  The hives was a typical allergic reaction but the small red bumps were diagnosed as PLEVA, a rare immonological response disorder of the skin.  I received my second dose on 10/6/20 and immediately the next day I had another set of breakouts of the red bumps.  Physician confirmed they were the same type by visual inpsection.  I had never had PLEVA or any skin eruptions in my life prior to August.  Also, I have been receiving care for a strange heart occurance by a Cardiologist starting 8/21/20.  I wore a heart monitor and had an EKG and stress test.  The diagnosis was that I have been having an "extra beat" which makes me gasp for breath sometimes.  It is not know if this is also related to the vaccine; however, again, I have never had any heart-related issues or "extra beats" prior to the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Parapsoriasis, Rash, Rash erythematous, Swelling, Urticaria
Clinical narrative: After the first dose of Shingrix on 7/27/20, I developed two types of rash on August 14, 2020 - a large spread of hives on the backs of my legs, and also small red bumps erupting in various locations.  The dermatologist biopsied the two.  The hives was a typical allergic reaction but the small red bumps were diagnosed as PLEVA, a rare immonological response disorder of the skin.  I received my second dose on 10/6/20 and immediately the next day I had another set of breakouts of the red bumps.  Physician confirmed they were the same type by visual inpsection.  I had never had PLEVA or any skin eruptions in my life prior to August.  Also, I have been receiving care for a strange heart occurance by a Cardiologist starting 8/21/20.  I wore a heart monitor and had an EKG and stress test.  The diagnosis was that I have been having an "extra beat" which makes me gasp for breath sometimes.  It is not know if this is also related to the vaccine; however, again, I have never had any heart-related issues or "extra beats" prior to the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arrhythmia, Biopsy skin abnormal, Blood test, Cardiac monitoring abnormal, Cardiac stress test abnormal
Clinical narrative: After the first dose of Shingrix on 7/27/20, I developed two types of rash on August 14, 2020 - a large spread of hives on the backs of my legs, and also small red bumps erupting in various locations.  The dermatologist biopsied the two.  The hives was a typical allergic reaction but the small red bumps were diagnosed as PLEVA, a rare immonological response disorder of the skin.  I received my second dose on 10/6/20 and immediately the next day I had another set of breakouts of the red bumps.  Physician confirmed they were the same type by visual inpsection.  I had never had PLEVA or any skin eruptions in my life prior to August.  Also, I have been receiving care for a strange heart occurance by a Cardiologist starting 8/21/20.  I wore a heart monitor and had an EKG and stress test.  The diagnosis was that I have been having an "extra beat" which makes me gasp for breath sometimes.  It is not know if this is also related to the vaccine; however, again, I have never had any heart-related issues or "extra beats" prior to the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Electrocardiogram abnormal, Hypersensitivity, Pityriasis lichenoides et varioliformis acuta, Rash papular
Clinical narrative: After the first dose of Shingrix on 7/27/20, I developed two types of rash on August 14, 2020 - a large spread of hives on the backs of my legs, and also small red bumps erupting in various locations.  The dermatologist biopsied the two.  The hives was a typical allergic reaction but the small red bumps were diagnosed as PLEVA, a rare immonological response disorder of the skin.  I received my second dose on 10/6/20 and immediately the next day I had another set of breakouts of the red bumps.  Physician confirmed they were the same type by visual inpsection.  I had never had PLEVA or any skin eruptions in my life prior to August.  Also, I have been receiving care for a strange heart occurance by a Cardiologist starting 8/21/20.  I wore a heart monitor and had an EKG and stress test.  The diagnosis was that I have been having an "extra beat" which makes me gasp for breath sometimes.  It is not know if this is also related to the vaccine; however, again, I have never had any heart-related issues or "extra beats" prior to the vaccine.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria, Vaccine positive rechallenge
Clinical narrative: After the first dose of Shingrix on 7/27/20, I developed two types of rash on August 14, 2020 - a large spread of hives on the backs of my legs, and also small red bumps erupting in various locations.  The dermatologist biopsied the two.  The hives was a typical allergic reaction but the small red bumps were diagnosed as PLEVA, a rare immonological response disorder of the skin.  I received my second dose on 10/6/20 and immediately the next day I had another set of breakouts of the red bumps.  Physician confirmed they were the same type by visual inpsection.  I had never had PLEVA or any skin eruptions in my life prior to August.  Also, I have been receiving care for a strange heart occurance by a Cardiologist starting 8/21/20.  I wore a heart monitor and had an EKG and stress test.  The diagnosis was that I have been having an "extra beat" which makes me gasp for breath sometimes.  It is not know if this is also related to the vaccine; however, again, I have never had any heart-related issues or "extra beats" prior to the vaccine.
Age: 71.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Imaging procedure, Seizure
Clinical narrative: Grand Mal seizure about 5 hours after the vaccine was given.  I came home, ate supper, watched tv and went to bed at 9pm.  I had a seizure during sleep, my wife woke up, realized what was happening, and called 911.  I woke up dazed and confused in the street, noticed all of the flashing lights from the police car, firetruck and emergency unit as they loaded me into the emergency vehicle.  I was transported to the Hospital. We were directed to the ER and attended there by the ER doctor. While there I was given an EKG and CT scan.  I was extremely uncomfortable post seizure as the contractions resulted in very sore muscles throughout my body.  My mind was fuzzy that evening and for the next several days. My chest and upper back muscles are still sore after almost 2 months.
Age: 71.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Computerised tomogram, Confusional state, Electrocardiogram, Electroencephalogram, Feeling abnormal
Clinical narrative: Grand Mal seizure about 5 hours after the vaccine was given.  I came home, ate supper, watched tv and went to bed at 9pm.  I had a seizure during sleep, my wife woke up, realized what was happening, and called 911.  I woke up dazed and confused in the street, noticed all of the flashing lights from the police car, firetruck and emergency unit as they loaded me into the emergency vehicle.  I was transported to the Hospital. We were directed to the ER and attended there by the ER doctor. While there I was given an EKG and CT scan.  I was extremely uncomfortable post seizure as the contractions resulted in very sore muscles throughout my body.  My mind was fuzzy that evening and for the next several days. My chest and upper back muscles are still sore after almost 2 months.
Age: 71.0
Sex: M
Vaccine: FLUA4, FLUA4
Symptoms: Generalised tonic-clonic seizure, Laboratory test, Magnetic resonance imaging, Myalgia
Clinical narrative: Grand Mal seizure about 5 hours after the vaccine was given.  I came home, ate supper, watched tv and went to bed at 9pm.  I had a seizure during sleep, my wife woke up, realized what was happening, and called 911.  I woke up dazed and confused in the street, noticed all of the flashing lights from the police car, firetruck and emergency unit as they loaded me into the emergency vehicle.  I was transported to the Hospital. We were directed to the ER and attended there by the ER doctor. While there I was given an EKG and CT scan.  I was extremely uncomfortable post seizure as the contractions resulted in very sore muscles throughout my body.  My mind was fuzzy that evening and for the next several days. My chest and upper back muscles are still sore after almost 2 months.
Age: 50.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient called and reported several hours after the vaccine she developed hives on her legs, abdomen. No other symptoms except rash.
Age: 50.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Rash, Urticaria
Clinical narrative: Patient called and reported several hours after the vaccine she developed hives on her legs, abdomen. No other symptoms except rash.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood test, Burning sensation, Feeling abnormal, Heart rate increased, Hypoaesthesia
Clinical narrative: Numbness and tingling of mid-back, abdomen, groin, bilateral legs and bilateral feet. Burning, pins and needles sensation of both feet. Inflammation of bilateral legs. Brain fogginess, elevated heart rate, assistance with activities of daily living. Weakness and lack of mobility in bilateral extremities.  I was given a five day course of high dose of steroids from 10/03/2020-10/08/2020 and sent to in-patient rehab 10/13/2020.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Inflammation, Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging brain, Magnetic resonance imaging neck
Clinical narrative: Numbness and tingling of mid-back, abdomen, groin, bilateral legs and bilateral feet. Burning, pins and needles sensation of both feet. Inflammation of bilateral legs. Brain fogginess, elevated heart rate, assistance with activities of daily living. Weakness and lack of mobility in bilateral extremities.  I was given a five day course of high dose of steroids from 10/03/2020-10/08/2020 and sent to in-patient rehab 10/13/2020.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Muscular weakness, Paraesthesia
Clinical narrative: Numbness and tingling of mid-back, abdomen, groin, bilateral legs and bilateral feet. Burning, pins and needles sensation of both feet. Inflammation of bilateral legs. Brain fogginess, elevated heart rate, assistance with activities of daily living. Weakness and lack of mobility in bilateral extremities.  I was given a five day course of high dose of steroids from 10/03/2020-10/08/2020 and sent to in-patient rehab 10/13/2020.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Feeling hot, Foreign body in gastrointestinal tract, Hypersomnia, Oesophageal oedema
Clinical narrative: I'm the patient so the 2 vaccines do NOT represent the exact type of shots. All I can say is that I got the yearly Flu shot in my left arm and the new Pneumonia shot in my right are (This is the one I think that caused the problems. My arm swelled for days and was red, hot and very raw pain).  Friday night (after the shots I received on the previous day), I started feeling sleepier than usual but I made myself stay up until after midnight when my kids arrived). During the night I got hot and achy like I had the flu (but not as bad as I normally get). I slept until 2:00pm the following day. I could not get up. Then I had something to eat and by 7:30pm I went upstairs to pet the cat on my bed and it was "lights out" again until Sunday morning about 8:30am when I awoke. When I had dinner with my kids later in the afternoon I got food stuck in my esophagus and had to throw it up. I'm pretty sure that my esophagus was smaller (closed up slightly??). This has NEVER happened to me before. My Pneumonia shot arm was bad so I iced it and iced it again, and again, etc.. The Flu shot arm was like always, neutral. I was absolutely miserable for 2 1/2 days.  Monday morning (4 days later) I was back to normal:  staying up late, getting up early, energy Xs 10, not an achy bone in my body, symptoms gone (except the pneumonia arm).
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain, Peripheral swelling, Skin warm, Somnolence, Vomiting
Clinical narrative: I'm the patient so the 2 vaccines do NOT represent the exact type of shots. All I can say is that I got the yearly Flu shot in my left arm and the new Pneumonia shot in my right are (This is the one I think that caused the problems. My arm swelled for days and was red, hot and very raw pain).  Friday night (after the shots I received on the previous day), I started feeling sleepier than usual but I made myself stay up until after midnight when my kids arrived). During the night I got hot and achy like I had the flu (but not as bad as I normally get). I slept until 2:00pm the following day. I could not get up. Then I had something to eat and by 7:30pm I went upstairs to pet the cat on my bed and it was "lights out" again until Sunday morning about 8:30am when I awoke. When I had dinner with my kids later in the afternoon I got food stuck in my esophagus and had to throw it up. I'm pretty sure that my esophagus was smaller (closed up slightly??). This has NEVER happened to me before. My Pneumonia shot arm was bad so I iced it and iced it again, and again, etc.. The Flu shot arm was like always, neutral. I was absolutely miserable for 2 1/2 days.  Monday morning (4 days later) I was back to normal:  staying up late, getting up early, energy Xs 10, not an achy bone in my body, symptoms gone (except the pneumonia arm).
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: 6-7 / 10 pain in her left arm
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Tremor
Clinical narrative: Began with chills that progressed to violent chills with my whole body trembling and my teeth chattering. I also have a dull headache and my arm is very sore. This is subsequent to my second vaccine. After the first vaccine in July, I had a very bad headache as well as a very sore arm.
Age: 1.92
Sex: F
Vaccine: FLU4
Symptoms: Hypersomnia, Injection site bruising, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Emesis noted morning after administration. Patient irritable all day according to parents.  About 24 hours after administration, patient overslept nap. Patient woken up by parents, and noted to have significant erythema and edema on left thigh. Patient given 2.5 ml of benadryl at 1630. Erythema became more intense, patient brought to ER on 11/11/2020 @1800, erythema noted to be 8.5 cm x 6cm located on left thigh. Patient discharged without further intervention, instructed to follow up in clinic. Benadryl 2.5 ml given again at 0800 11/12/2020. Patient seen for f/u appointment on 11/12/2020 at 0900. Slight bruising at point of injection on left thigh. Maximum dimension of erythema is 12cm x 9cm. Warm and firm to touch. No fever. Patient alert, walking around,  good spirits. Patient would sometimes grab at injection site and say "boo boo." No other symptoms or difficulty breathing.
Age: 1.92
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Irritability, Vomiting
Clinical narrative: Emesis noted morning after administration. Patient irritable all day according to parents.  About 24 hours after administration, patient overslept nap. Patient woken up by parents, and noted to have significant erythema and edema on left thigh. Patient given 2.5 ml of benadryl at 1630. Erythema became more intense, patient brought to ER on 11/11/2020 @1800, erythema noted to be 8.5 cm x 6cm located on left thigh. Patient discharged without further intervention, instructed to follow up in clinic. Benadryl 2.5 ml given again at 0800 11/12/2020. Patient seen for f/u appointment on 11/12/2020 at 0900. Slight bruising at point of injection on left thigh. Maximum dimension of erythema is 12cm x 9cm. Warm and firm to touch. No fever. Patient alert, walking around,  good spirits. Patient would sometimes grab at injection site and say "boo boo." No other symptoms or difficulty breathing.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Sinus headache, Sleep disorder
Clinical narrative: Throbbing sinus headache that kept me awake.  It has backed off a little at 7:30 am but is still hurting a fair amount.  It could be unrelated to the vaccine because there is a tropical depression (Eta) blowing through and a cold front coming through.  The combination sometimes gives me a sinus headache but rarely this painful.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; administration of PROQUAD was outside the PI recommendation; This spontaneous report was received from the supervisor from pediatric clinic referring to a 15 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (unspecified rHA or HSA) (strength, dose, route, frequency, were not reported) for prophylaxis. The valid lot number T018278 was reported, with expiration date reported as 23-NOV-2021. The reporter believed this was his first and only dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). She wanted to know if he needed to receive his Measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MMR) and varicella vaccines separately at a later date, since his age at administration of PROQUAD was outside the PI recommendation as this information was discovered on 26-OCT-2020. No additional adverse event (AE) reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Seizure
Clinical narrative: The patient passed out within 15 minutes once moved from table to chair.; The patient's father felt that the patient had a seizure and was insisting that the patient see a neurologist.; This spontaneous report was received from a Nurse Practitioner via company representative, referring to an 11 year old female patient. The patient's medical history, concurrent conditions, and historical drugs were not reported.  On an unknown date in October 2020, the patient was vaccinated with her first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, frequency, anatomical location, lot # and expiration date were unknown) via intramuscular route for prophylaxis. Additionally, the patient was vaccinated concomitantly with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(TDAP) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) on the same date.  The Nurse Practitioner reported that the patient passed out (loss of consciousness) within 15 minutes once she moved from the table to the chair. Further, the nurse stated that the patient's father felt that the patient had a seizure and was insisting that the patient seek for a neurologist.  At the time of the report, the outcome of loss of consciousness and seizure was reported as resolved on an unknown date. The reporter did not mention the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccination.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported.; patient received expired ROTATEQ; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 06-NOV-2020, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered as prophylaxis (lot number 1660943 which has been verified to be valid, expiration date reported as 05-NOV-2020, but upon internal validation established as 05-NOV-2021) (conflicting information) (dosage, frequency, and vaccination scheme were not reported). No additional adverse effects were reported in the patient.
Sex: F
Vaccine: PPV
Symptoms: Herpes zoster, Rash vesicular, Vaccination failure
Clinical narrative: yearly vaccinations of pneumonia vaccine; adverse reactions or side effects experienced: none; This spontaneous report as received from a consumer referring to herself, a female patient of unknown age. The patient's concurrent conditions included hypothyroidism. The patient's historical conditions included chicken pox. The patient was a non-tobacco user.   Since an unspecified date 2010, the patient has been vaccinated with pneumococcal vaccine (manufacturer unknown) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis on a yearly basis (inappropriate schedule of product administration) without experiencing any adverse reactions or side effects.  On 11-OCT-2016, the pt experienced vaccination failure, herpes zoster and rash vesicular and on 30-NOV-2016, the pt experienced another episode of herpes zoster (captured in MARRS# 1811USA012180).; Sender's Comments:  US-009507513-1811USA012180:
Sex: U
Vaccine: MEN
Symptoms: Seizure
Clinical narrative: Seizures; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Meningococcal B vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient had seizures after vaccine then after every single one.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site rash, Injection site urticaria
Clinical narrative: rash at the injection site; red welts; The are was sore; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site rash, erythema urticarial and pain in arm. On an unknown date, the outcome of the injection site rash and erythema urticarial were recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injection site rash, erythema urticarial and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had rash at the injection site presented.   It was described as red welts and arm was sore for a few days also.  The reporter did not consent to follow up. This case linked with US2020219727, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219727:same reporter (reporter´s case)
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: her arm was very sore (at the injection site).; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   The reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix shot and had pain at the injection site. The patient warned him that if planned on getting the shot that was not going to want to go to work the next day.  No further information was known. The reporter provided limited information. This case linked with US2020219735, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219735:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: some left arm soreness; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine in her left arm and she did have some left arm soreness which resolved. The reporter did not consent to follow up. For tolerance of 2nd dose of Shingrix, refer case US2020AMR221220.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221220:same patient
Age: 0.5
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Extra dose administered, Injection site erythema, Injection site warmth
Clinical narrative: Injection site was a little warm to the touch; A little bit of redness at the injection site on her son's left thigh; This is a spontaneous report from a contactable nurse. A 7-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot. DJ7719, Expiration date: 20Aug2022, NDC number: 0005-1971-01) at 0.5 ml, single dose, in the left thigh (left vastus lateralis) and hib vaccine conj (tet tox) (HIBERIX, Lot. KP24R, Expiration date: 24Oct2021) in the left thigh (left vastus lateralis); both on 15Oct2020, for immunization. Relevant medical history and concomitant medications were none. On an unspecified date, in Oct2020, the patient's mother stated there was a little bit of redness at the injection site on her son's left thigh, and the injection site was a little warm to the touch, but nothing else. Clinical outcome of the events was unknown at time of this report.  It was reported that on 29Oct2020, patient was inadvertently re-administered the pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) and hib vaccine conj (tet tox) (HIBERIX) again. Patient was also administered diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) on 29Oct2020.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Influenza like illness
Clinical narrative: symptoms of flu; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case is linked to cases 2020SA317477 and 2020SA317467 (same reporter).  This case involves a female patient (age unspecified) who had symptoms of flu (Influenza like illness), when she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had non-serious symptoms of flu (influenza like illness) unknown latency following the administration of INFLUENZA VACCINE.  The reporter stated that a person can have a reaction to the flu shot. She did her son did and she spoke to several of her friends that have had the same thing happened to them. They had all the symptoms of the flu.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.