chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Angina pectoris, Axillary pain, Back pain, Blood test normal
Clinical narrative: Next day after shot I had chest pains (Heart area). Went to the ER maybe a week later and had blood drawn and an EKG. Everything checked out ok. I was still having chest pains and almost passed out about a week after that. Went to ER by way of rescue squad. Had blood taken and an EKG. Again everything seemed to be ok. I was referred to a cardiologist and had an Echo Cardiagram. I was told everything was ok.  Not long after that I started getting underarm and rib pain. I was concerned about my lymph nodes so I went to see a rheumatologist. I had an extensive blood panel done and everything seemed to check out. I then started to smell burning cigarettes every day. I researched this and I made an appointment to see an ENT. He put a scope up my nose and he said everything looked good. That smell lasted for more than a month. While still experiencing underarm and rib pain I started to have pain in my chest, stomach, and back also. I started to see blood in my stool. I made an appointment with a gastroenterologist. I scheduled a colonoscopy and an eddoscopy. I was diagnosed with ulcerative colitis. I also started experiencing tingling hands and feet. I scheduled an appointment with a neurologist. I had an EMG and was diagnosed with neuropathy. I had none of this before the shot. I still experience pain in my ribs, back, chest and stomach on a daily basis. I have tingling in my hands and feet. The bottoms of my feet hurt when I walk.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Echocardiogram normal, Electrocardiogram normal, Electromyogram abnormal, Endoscopy normal
Clinical narrative: Next day after shot I had chest pains (Heart area). Went to the ER maybe a week later and had blood drawn and an EKG. Everything checked out ok. I was still having chest pains and almost passed out about a week after that. Went to ER by way of rescue squad. Had blood taken and an EKG. Again everything seemed to be ok. I was referred to a cardiologist and had an Echo Cardiagram. I was told everything was ok.  Not long after that I started getting underarm and rib pain. I was concerned about my lymph nodes so I went to see a rheumatologist. I had an extensive blood panel done and everything seemed to check out. I then started to smell burning cigarettes every day. I researched this and I made an appointment to see an ENT. He put a scope up my nose and he said everything looked good. That smell lasted for more than a month. While still experiencing underarm and rib pain I started to have pain in my chest, stomach, and back also. I started to see blood in my stool. I made an appointment with a gastroenterologist. I scheduled a colonoscopy and an eddoscopy. I was diagnosed with ulcerative colitis. I also started experiencing tingling hands and feet. I scheduled an appointment with a neurologist. I had an EMG and was diagnosed with neuropathy. I had none of this before the shot. I still experience pain in my ribs, back, chest and stomach on a daily basis. I have tingling in my hands and feet. The bottoms of my feet hurt when I walk.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Haematochezia, Musculoskeletal chest pain, Neuropathy peripheral, Pain in extremity
Clinical narrative: Next day after shot I had chest pains (Heart area). Went to the ER maybe a week later and had blood drawn and an EKG. Everything checked out ok. I was still having chest pains and almost passed out about a week after that. Went to ER by way of rescue squad. Had blood taken and an EKG. Again everything seemed to be ok. I was referred to a cardiologist and had an Echo Cardiagram. I was told everything was ok.  Not long after that I started getting underarm and rib pain. I was concerned about my lymph nodes so I went to see a rheumatologist. I had an extensive blood panel done and everything seemed to check out. I then started to smell burning cigarettes every day. I researched this and I made an appointment to see an ENT. He put a scope up my nose and he said everything looked good. That smell lasted for more than a month. While still experiencing underarm and rib pain I started to have pain in my chest, stomach, and back also. I started to see blood in my stool. I made an appointment with a gastroenterologist. I scheduled a colonoscopy and an eddoscopy. I was diagnosed with ulcerative colitis. I also started experiencing tingling hands and feet. I scheduled an appointment with a neurologist. I had an EMG and was diagnosed with neuropathy. I had none of this before the shot. I still experience pain in my ribs, back, chest and stomach on a daily basis. I have tingling in my hands and feet. The bottoms of my feet hurt when I walk.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Parosmia, Presyncope
Clinical narrative: Next day after shot I had chest pains (Heart area). Went to the ER maybe a week later and had blood drawn and an EKG. Everything checked out ok. I was still having chest pains and almost passed out about a week after that. Went to ER by way of rescue squad. Had blood taken and an EKG. Again everything seemed to be ok. I was referred to a cardiologist and had an Echo Cardiagram. I was told everything was ok.  Not long after that I started getting underarm and rib pain. I was concerned about my lymph nodes so I went to see a rheumatologist. I had an extensive blood panel done and everything seemed to check out. I then started to smell burning cigarettes every day. I researched this and I made an appointment to see an ENT. He put a scope up my nose and he said everything looked good. That smell lasted for more than a month. While still experiencing underarm and rib pain I started to have pain in my chest, stomach, and back also. I started to see blood in my stool. I made an appointment with a gastroenterologist. I scheduled a colonoscopy and an eddoscopy. I was diagnosed with ulcerative colitis. I also started experiencing tingling hands and feet. I scheduled an appointment with a neurologist. I had an EMG and was diagnosed with neuropathy. I had none of this before the shot. I still experience pain in my ribs, back, chest and stomach on a daily basis. I have tingling in my hands and feet. The bottoms of my feet hurt when I walk.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Amaurosis fugax, Blindness unilateral, Blood test, Cardiac monitoring, Computerised tomogram head normal
Clinical narrative: This form only allows one vaccine.  My first vaccine was on 04/08/2021 and was Johnson and Johnson Janssen 043A21AZ at the Pharmacy.  It was an injection in left arm.  On 04/16/2022 At 10 pm I became blind instantaneously in my left eye.  Subsequent emergency room visit determined I had suffered Amaurosis Fugax meaning a loss of vision in one eye.  It was then determined I had suffered a Central Retinal Vein occlusion.  I have been treated five times by Retinal specialists with eyelea shots and my vision is partially restored.  I have had multiple CT scans of my brain, ultra sounds of my heart, MRIs.  It has been determined that my tests are normal and nothing associated with those tests caused this.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Immediate post-injection reaction, Magnetic resonance imaging head, Magnetic resonance imaging normal, Retinal vein occlusion
Clinical narrative: This form only allows one vaccine.  My first vaccine was on 04/08/2021 and was Johnson and Johnson Janssen 043A21AZ at the Pharmacy.  It was an injection in left arm.  On 04/16/2022 At 10 pm I became blind instantaneously in my left eye.  Subsequent emergency room visit determined I had suffered Amaurosis Fugax meaning a loss of vision in one eye.  It was then determined I had suffered a Central Retinal Vein occlusion.  I have been treated five times by Retinal specialists with eyelea shots and my vision is partially restored.  I have had multiple CT scans of my brain, ultra sounds of my heart, MRIs.  It has been determined that my tests are normal and nothing associated with those tests caused this.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler
Clinical narrative: This form only allows one vaccine.  My first vaccine was on 04/08/2021 and was Johnson and Johnson Janssen 043A21AZ at the Pharmacy.  It was an injection in left arm.  On 04/16/2022 At 10 pm I became blind instantaneously in my left eye.  Subsequent emergency room visit determined I had suffered Amaurosis Fugax meaning a loss of vision in one eye.  It was then determined I had suffered a Central Retinal Vein occlusion.  I have been treated five times by Retinal specialists with eyelea shots and my vision is partially restored.  I have had multiple CT scans of my brain, ultra sounds of my heart, MRIs.  It has been determined that my tests are normal and nothing associated with those tests caused this.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthma, Chest discomfort, Condition aggravated, Dizziness, Dyspnoea
Clinical narrative: lightheadedness and asthma exacerbation. Tightness in chest, difficult breathing, shortness of breath, fatigue. As of 11/3/2022 doctor prescribed Advair 250/50 BID, Prednisone 40mg PO daily 3 days, Singulair 10mg daily. Symptoms resolved in 4 days with occasional use of albuterol inhaler following. On 11/17/2022 worse asthma exacerbation with difficult breathing, couth, tightness in chest, lightheadedness. Had to leave work after two hours. Doctor prescribed 12-day Prednisone tapering dose. I still required albuterol inhaler 3 times per day until 11/22/22, Albuterol  inhaler 1-2x/day since 11/23/22
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Impaired work ability, Sinusitis, Spirometry abnormal
Clinical narrative: lightheadedness and asthma exacerbation. Tightness in chest, difficult breathing, shortness of breath, fatigue. As of 11/3/2022 doctor prescribed Advair 250/50 BID, Prednisone 40mg PO daily 3 days, Singulair 10mg daily. Symptoms resolved in 4 days with occasional use of albuterol inhaler following. On 11/17/2022 worse asthma exacerbation with difficult breathing, couth, tightness in chest, lightheadedness. Had to leave work after two hours. Doctor prescribed 12-day Prednisone tapering dose. I still required albuterol inhaler 3 times per day until 11/22/22, Albuterol  inhaler 1-2x/day since 11/23/22
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Irregular menstrual cycles
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Conjunctival haemorrhage
Clinical narrative: Subconjunctival hemorrhage, right eye
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ageusia, Dysgeusia, Flushing
Clinical narrative: lost my abiity to taste things;  everything tastes bitter;  Face is flushed like a light sunburn;  has continued for a week
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cough, Influenza A virus test negative, Influenza B virus test, Nasal congestion, Oropharyngeal pain
Clinical narrative: Developed sore throat on  11/15/2022. The next day, had a fever, sore throat, body aches, and nasal congestion. Sore throat, body aches, and fever were gone by 11/17/2022. Congestion is ongoing and developed a cough that is still ongoing.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative, Upper respiratory tract infection
Clinical narrative: Developed sore throat on  11/15/2022. The next day, had a fever, sore throat, body aches, and nasal congestion. Sore throat, body aches, and fever were gone by 11/17/2022. Congestion is ongoing and developed a cough that is still ongoing.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site paraesthesia
Clinical narrative: Tingling and discomfort at the injection area which is now 40 days after injection.  This is continuous all day, and it is most noticeable when I am trying to go to sleep.  I am concerned this may lead to other arm related issues in the future.   The vaccine provider should provide some remedy for this.  Please advise what I need to do.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Hypotension, Syncope
Clinical narrative: Fainting, hypotension 80/32
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cardiac operation, Death, Intracardiac thrombus
Clinical narrative: Weakened heart.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Patient received vaccine at 1249 then proceeded to develop urticaria and welts to LE. By the following morning the rash involved the trunk, legs, neck, and face.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Malaise, SARS-CoV-2 test positive
Clinical narrative: I developed COVID-19 symptoms (light cough, fatigue) on August 09, 2022.  I tested positive using a home test.  I attended Urgent Care on August 13, 2022 and was examined by PA-C.  I received a prescription for molnupiravir and took the whole course as prescribed.  The cough ended in 3 days but I remained fatigued for 18 days. It took until August 28 before I had a negative COVID-19 home test.  A second home test on August 30 corroborated the test on August 28.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alpha tumour necrosis factor increased, Arthralgia, Chemokine increased, Cytokine increased, Fatigue
Clinical narrative: DIAGNOSIS TOOK MANY MONTHS. STARTED TREAMENT 1 APRIL 2021. SYMTOMS: BRAIN FOG, BUZZING HEAD, FATIGUE, JOINT PAIN. TREATMENT INCLUDED: 300MG MARAVOROC BID, 10MG TRINTELLIX QD, 10MG PRAVASTATIN QD, 81 MG ASPIRIN QD. THE BRAIN FOG CLEARED IN THREE DAYS, ALL OTHER SYMPTOMS REMAIN.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Inflammatory marker increased, Interferon gamma level increased, Interleukin level, Interleukin level increased
Clinical narrative: DIAGNOSIS TOOK MANY MONTHS. STARTED TREAMENT 1 APRIL 2021. SYMTOMS: BRAIN FOG, BUZZING HEAD, FATIGUE, JOINT PAIN. TREATMENT INCLUDED: 300MG MARAVOROC BID, 10MG TRINTELLIX QD, 10MG PRAVASTATIN QD, 81 MG ASPIRIN QD. THE BRAIN FOG CLEARED IN THREE DAYS, ALL OTHER SYMPTOMS REMAIN.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interleukin-2 receptor increased, Laboratory test abnormal, Tinnitus, Vascular endothelial growth factor assay
Clinical narrative: DIAGNOSIS TOOK MANY MONTHS. STARTED TREAMENT 1 APRIL 2021. SYMTOMS: BRAIN FOG, BUZZING HEAD, FATIGUE, JOINT PAIN. TREATMENT INCLUDED: 300MG MARAVOROC BID, 10MG TRINTELLIX QD, 10MG PRAVASTATIN QD, 81 MG ASPIRIN QD. THE BRAIN FOG CLEARED IN THREE DAYS, ALL OTHER SYMPTOMS REMAIN.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema, Injection site haemorrhage
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Additional Details: Patient's arm bruised and turned red after IM injection, applied cotton ball to stop bleeding, then ice, redness was relieved, left voicemail message for parents to follow up following day
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong Vaccine/Product Administered-
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Coronary arterial stent insertion, Echocardiogram, Myocardial infarction
Clinical narrative: Heart attack occured October 27, 2021 at approximately 10:30 am. Surgeon at hospital put stent in my right coronary artery
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: non localized arm pain, pain all over arm ranked 7 out 10 on pain score for 12 days after and still going-Severe, Systemic: Joint Pain-Severe, Additional Details: patient's whole arm is in pain for 12 days after taking shot and still going on. already called dr and left message for MA on vm
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location)-
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test abnormal, Dyspnoea, Red blood cell count decreased, Red blood cell transfusion
Clinical narrative: Couldnt breathe : red blood cells count went down to three. had to have three units of red blood.
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oligomenorrhoea
Clinical narrative: Menstrual cycle started 11/15 (normal date), but lasted 9 days.  Normal cycle is 4-5 days.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Injection site swelling, Injection site warmth, Myalgia, Nausea
Clinical narrative: nausea, tireness, swelling and warm at injection site, muscle ache
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered, Incorrect route of product administration
Clinical narrative: The second dose of Jynneos vaccine was expired; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-003739 is a spontaneous case report initially received from a nurse via Communications (reference number: USBAV22-1597) on 03-Oct-2022 and concerns an adult male patient.  The patient's medical history and concomitant medication details were not provided.  On 02-Sep-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP0004), at dose 0.1 mL, administered intradermally, for monkeypox prophylaxis (explicitly coded as 'intradermal injection').  On 30-Sep-2022, 28 days after the first dose, the patient was vaccinated with second dose of Jynneos vaccine (batch number: FDP0004, expiration date: 27-Sep-2022), at a dose 0.1 mL, administered intradermally (explicitly coded as 'intradermal injection' and 'expired product administered').    At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 03-Oct-2022 included the local BN case ID.; Reporter's Comments: An adult male patient was vaccinated with the first dose of Jynneos, at dose 0.1 mL, administered intradermally, for monkeypox prophylaxis, which is considered as intradermal injection. Reportedly, on 30-Sep-2022, the patient was vaccinated with second dose of Jynneos vaccine (expiration date: 27-Sep-2022), at a dose 0.1 mL, administered intradermally, which is considered as intradermal injection and expired product administered. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient born in 1968 was vaccinated with the first dose of Jynneos, at dose 0.1 mL, administered intradermally, for monkeypox prophylaxis, which is considered as intradermal injection. Reportedly, on 30-Sep-2022, the patient was vaccinated with second dose of Jynneos vaccine (expiration date: 27-Sep-2022), at a dose 0.1 mL, administered intradermally, which is considered as intradermal injection and expired product administered. At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos. Expired product administered and intradermal injection are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered and intradermal injection have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Condition aggravated, Herpes simplex, Lip swelling
Clinical narrative: Swelling of upper lips as with herpes simplex outbreak. Multiple locations.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Fatigue, Nasopharyngitis, Pulmonary congestion, SARS-CoV-2 test positive
Clinical narrative: Note: My sister in-law visited on Nov 10, left Nov 13. They tested Covid positive that evening.  I tested positive for Covid on Nov 15, and again Nov 17, Nov 20,  Nov 22 (so far).  Symptoms Nov 15-18 moderately severe cold symptoms, sinus, and lung congestion, fatigue.  Started improving Nov 18.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Sinus congestion
Clinical narrative: Note: My sister in-law visited on Nov 10, left Nov 13. They tested Covid positive that evening.  I tested positive for Covid on Nov 15, and again Nov 17, Nov 20,  Nov 22 (so far).  Symptoms Nov 15-18 moderately severe cold symptoms, sinus, and lung congestion, fatigue.  Started improving Nov 18.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood pressure increased, Head discomfort, Heart rate increased, Insomnia
Clinical narrative: Sky rocketing Blood Pressure, massive head pressure, sleeplessness, racing heart beat, n
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: C-reactive protein, Erythema, Full blood count, Irritability, Metabolic function test
Clinical narrative: mother reports that patient had Varicella, Tetanus, Hepatitis B, and flu vaccines though exact types are unknown. The next day patient was irritable and developed redness and swelling of his ears, hands, feet, and papular rash on his face, trunk, and in his armpits. No difficulty breathing, vomiting, diarrhea, facial or lip swelling, difficulty swallowing, or signs of anaphylaxis.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Rash papular, Red blood cell sedimentation rate, Swelling
Clinical narrative: mother reports that patient had Varicella, Tetanus, Hepatitis B, and flu vaccines though exact types are unknown. The next day patient was irritable and developed redness and swelling of his ears, hands, feet, and papular rash on his face, trunk, and in his armpits. No difficulty breathing, vomiting, diarrhea, facial or lip swelling, difficulty swallowing, or signs of anaphylaxis.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site induration, Injection site nodule, Injection site warmth
Clinical narrative: hard knot at area of injection, warm to touch
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Immune system disorder, Pain in extremity, Weight increased
Clinical narrative: Patient stated that they experienced leaky gut syndrome and after getting their covid shot
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fluid retention, Intestinal barrier dysfunction, Nervous system disorder
Clinical narrative: Patient stated that they experienced leaky gut syndrome and after getting their covid shot
Age: 58.0
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Injected limb mobility decreased, Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: difficulty in changing clothes / in day-to-day activities including driving/difficulty when using left hand; movements (specially at joints) were painful; pain at shoulder where shot was given; massive pain in hand /Movement is painful, another day/night with pain/ pain hasincreased; could not move my hand/ not able to lift / is restricted, left hand not normal in function, restricted movement; could not sleep due to pain; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2022 15:00, the patient received the 2nd dose of Shingrix. On 13th November 2022 19:00, 4 hrs after receiving Shingrix, the patient experienced injection site pain, pain in hand, injected limb mobility decreased and insomnia. On 14th November 2022, the patient experienced activities of daily living impaired and joint pain. On an unknown date, the outcome of the injection site pain, pain in hand, injected limb mobility decreased, insomnia, activities of daily living impaired and joint pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, pain in hand, injected limb mobility decreased, insomnia, activities of daily living impaired and joint pain to be related to Shingrix.     Additional Information: GSK receipt date: 15-Nov-2022, 17-Nov-2022, 18-Nov-2022, 19-Nov-2022, 20-Nov-2022 and 21-Nov-2022 Reporter's comment:  The patient received the second shot of Shingrix on the left hand. From about 7 pm onwards on the day of vaccination, the patient had massive pain in left hand; it was so bad that patient could not move the hand. The patient could not sleep that night due to the pain. This situation remained for entire Monday, on the next day of vaccination during the day the patient had difficulty in changing clothes due to the pain. By late 14th November 2022, there was a slight reduction in the pain but movements (specially at joints) have been painful. Right now, it was 10 pm on 15th November 2022, the patient was not able to lift left hand due to the pain at/around shoulder where shot was given. Movement of my left hand remained painful and restricted causing difficulty in day-to-day activities including driving. The reporter wanted to know was this normal and what was GlaxoSmithKline recommendation and when would left hand be normal. The patient had another day/night with pain and restricted movement of the left hand. Though, there was an improvement, but left hand was far from being normal in its function. Things were improving and not worsening but still not normal. Continued to have pain and difficulty when using left hand. But now able to (minor) lift left hand and be able to do few small things with left hand, which had not been possible so far.
Age: 58.0
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Arthralgia, Impaired driving ability, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: difficulty in changing clothes / in day-to-day activities including driving/difficulty when using left hand; movements (specially at joints) were painful; pain at shoulder where shot was given; massive pain in hand /Movement is painful, another day/night with pain/ pain hasincreased; could not move my hand/ not able to lift / is restricted, left hand not normal in function, restricted movement; could not sleep due to pain; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2022 15:00, the patient received the 2nd dose of Shingrix. On 13th November 2022 19:00, 4 hrs after receiving Shingrix, the patient experienced injection site pain, pain in hand, injected limb mobility decreased and insomnia. On 14th November 2022, the patient experienced activities of daily living impaired and joint pain. On an unknown date, the outcome of the injection site pain, pain in hand, injected limb mobility decreased, insomnia, activities of daily living impaired and joint pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, pain in hand, injected limb mobility decreased, insomnia, activities of daily living impaired and joint pain to be related to Shingrix.     Additional Information: GSK receipt date: 15-Nov-2022, 17-Nov-2022, 18-Nov-2022, 19-Nov-2022, 20-Nov-2022 and 21-Nov-2022 Reporter's comment:  The patient received the second shot of Shingrix on the left hand. From about 7 pm onwards on the day of vaccination, the patient had massive pain in left hand; it was so bad that patient could not move the hand. The patient could not sleep that night due to the pain. This situation remained for entire Monday, on the next day of vaccination during the day the patient had difficulty in changing clothes due to the pain. By late 14th November 2022, there was a slight reduction in the pain but movements (specially at joints) have been painful. Right now, it was 10 pm on 15th November 2022, the patient was not able to lift left hand due to the pain at/around shoulder where shot was given. Movement of my left hand remained painful and restricted causing difficulty in day-to-day activities including driving. The reporter wanted to know was this normal and what was GlaxoSmithKline recommendation and when would left hand be normal. The patient had another day/night with pain and restricted movement of the left hand. Though, there was an improvement, but left hand was far from being normal in its function. Things were improving and not worsening but still not normal. Continued to have pain and difficulty when using left hand. But now able to (minor) lift left hand and be able to do few small things with left hand, which had not been possible so far.
Age: 58.0
Sex: U
Vaccine: UNK, VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: difficulty in changing clothes / in day-to-day activities including driving/difficulty when using left hand; movements (specially at joints) were painful; pain at shoulder where shot was given; massive pain in hand /Movement is painful, another day/night with pain/ pain hasincreased; could not move my hand/ not able to lift / is restricted, left hand not normal in function, restricted movement; could not sleep due to pain; This case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th November 2022 15:00, the patient received the 2nd dose of Shingrix. On 13th November 2022 19:00, 4 hrs after receiving Shingrix, the patient experienced injection site pain, pain in hand, injected limb mobility decreased and insomnia. On 14th November 2022, the patient experienced activities of daily living impaired and joint pain. On an unknown date, the outcome of the injection site pain, pain in hand, injected limb mobility decreased, insomnia, activities of daily living impaired and joint pain were recovering/resolving.   It was unknown if the reporter considered the injection site pain, pain in hand, injected limb mobility decreased, insomnia, activities of daily living impaired and joint pain to be related to Shingrix.     Additional Information: GSK receipt date: 15-Nov-2022, 17-Nov-2022, 18-Nov-2022, 19-Nov-2022, 20-Nov-2022 and 21-Nov-2022 Reporter's comment:  The patient received the second shot of Shingrix on the left hand. From about 7 pm onwards on the day of vaccination, the patient had massive pain in left hand; it was so bad that patient could not move the hand. The patient could not sleep that night due to the pain. This situation remained for entire Monday, on the next day of vaccination during the day the patient had difficulty in changing clothes due to the pain. By late 14th November 2022, there was a slight reduction in the pain but movements (specially at joints) have been painful. Right now, it was 10 pm on 15th November 2022, the patient was not able to lift left hand due to the pain at/around shoulder where shot was given. Movement of my left hand remained painful and restricted causing difficulty in day-to-day activities including driving. The reporter wanted to know was this normal and what was GlaxoSmithKline recommendation and when would left hand be normal. The patient had another day/night with pain and restricted movement of the left hand. Though, there was an improvement, but left hand was far from being normal in its function. Things were improving and not worsening but still not normal. Continued to have pain and difficulty when using left hand. But now able to (minor) lift left hand and be able to do few small things with left hand, which had not been possible so far.
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Itching; Arm turned red/ red spot was half as big as her hand; Swelling of arm; Arm was real hot where the swelling was; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), 0.3ml single (Lot number: GL0446, Expiration Date: Nov2022) at the age of 78 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Doesn't hear as well as she used too" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2021, for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 15Nov2022, outcome "recovering", described as "Arm turned red/ red spot was half as big as her hand"; FEELING HOT (non-serious) with onset Nov2022, outcome "unknown", described as "Arm was real hot where the swelling was"; PERIPHERAL SWELLING (non-serious) with onset 15Nov2022, outcome "recovered" (Nov2022), described as "Swelling of arm"; PRURITUS (non-serious) with onset 20Nov2022, outcome "recovered" (Nov2022), described as "Itching". Therapeutic measures were taken as a result of erythema, peripheral swelling, pruritus.  Additional information: The patient was taking unspecified high blood pressure and high cholesterol medicine, and baby aspirin every day. She was taking them for years and before ever taking a COVID-19 Vaccine. She got her first booster over a year ago. Every vaccine and booster she got was Pfizer and she never had a problem before. The patient had her second booster and that evening her arm turned red. The red spot was half as big as her hand, started swelling, put ice on it per her HCP instruction. Swelling went down the 3rd or 4th day and then it started itching.  No itching this morning on 21Nov2022, just a bit red. It was red all-day on 19Nov2022 and on 20Nov2022 started getting lighter colour, started to go down. On 21Nov2022 area was pale pink and not as big, more like a strip across; was ongoing and improved. The arm was real hot where the swelling was. She had no swelling at this time, doesn't remember what day swelling went down. She took Benadryl when it started itching. The patient does not hear as well as she used too which occurred a long time ago before receiving any COVID-19 Vaccines or Boosters. Product has nothing to do with it, just her aging. The patient did not have any investigations.
Age: 78.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus
Clinical narrative: Itching; Arm turned red/ red spot was half as big as her hand; Swelling of arm; Arm was real hot where the swelling was; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), 0.3ml single (Lot number: GL0446, Expiration Date: Nov2022) at the age of 78 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Doesn't hear as well as she used too" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 2021, for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 15Nov2022, outcome "recovering", described as "Arm turned red/ red spot was half as big as her hand"; FEELING HOT (non-serious) with onset Nov2022, outcome "unknown", described as "Arm was real hot where the swelling was"; PERIPHERAL SWELLING (non-serious) with onset 15Nov2022, outcome "recovered" (Nov2022), described as "Swelling of arm"; PRURITUS (non-serious) with onset 20Nov2022, outcome "recovered" (Nov2022), described as "Itching". Therapeutic measures were taken as a result of erythema, peripheral swelling, pruritus.  Additional information: The patient was taking unspecified high blood pressure and high cholesterol medicine, and baby aspirin every day. She was taking them for years and before ever taking a COVID-19 Vaccine. She got her first booster over a year ago. Every vaccine and booster she got was Pfizer and she never had a problem before. The patient had her second booster and that evening her arm turned red. The red spot was half as big as her hand, started swelling, put ice on it per her HCP instruction. Swelling went down the 3rd or 4th day and then it started itching.  No itching this morning on 21Nov2022, just a bit red. It was red all-day on 19Nov2022 and on 20Nov2022 started getting lighter colour, started to go down. On 21Nov2022 area was pale pink and not as big, more like a strip across; was ongoing and improved. The arm was real hot where the swelling was. She had no swelling at this time, doesn't remember what day swelling went down. She took Benadryl when it started itching. The patient does not hear as well as she used too which occurred a long time ago before receiving any COVID-19 Vaccines or Boosters. Product has nothing to do with it, just her aging. The patient did not have any investigations.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Angiogram, Balance disorder, Balance test, Electrocardiogram
Clinical narrative: All her vaccine doses would be given on left side/it makes her arm a little sore; She has had dizzy spells for over a year.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9263) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "All her vaccine doses would be given on left side/it makes her arm a little sore"; DIZZINESS (non-serious), outcome "unknown", described as "She has had dizzy spells for over a year.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has had dizzy spells for over a year. When she first had it, they would last 30 seconds then be gone. All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thinks they were all given in left arm.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, Feeling abnormal, Magnetic resonance imaging head, Magnetic resonance imaging neck, Palpitations
Clinical narrative: All her vaccine doses would be given on left side/it makes her arm a little sore; She has had dizzy spells for over a year.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9263) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "All her vaccine doses would be given on left side/it makes her arm a little sore"; DIZZINESS (non-serious), outcome "unknown", described as "She has had dizzy spells for over a year.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has had dizzy spells for over a year. When she first had it, they would last 30 seconds then be gone. All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thinks they were all given in left arm.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: All her vaccine doses would be given on left side/it makes her arm a little sore; She has had dizzy spells for over a year.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9263) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "All her vaccine doses would be given on left side/it makes her arm a little sore"; DIZZINESS (non-serious), outcome "unknown", described as "She has had dizzy spells for over a year.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has had dizzy spells for over a year. When she first had it, they would last 30 seconds then be gone. All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thinks they were all given in left arm.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Dizziness, Electroencephalogram, Electromyogram, Magnetic resonance imaging
Clinical narrative: All her vaccine doses would be given on left side/it makes her arm a little sore; She has had dizzy spells for over a year.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9263) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "All her vaccine doses would be given on left side/it makes her arm a little sore"; DIZZINESS (non-serious), outcome "unknown", described as "She has had dizzy spells for over a year.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has had dizzy spells for over a year. When she first had it, they would last 30 seconds then be gone. All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thinks they were all given in left arm.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: All her vaccine doses would be given on left side/it makes her arm a little sore; She has had dizzy spells for over a year.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EL9263) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "All her vaccine doses would be given on left side/it makes her arm a little sore"; DIZZINESS (non-serious), outcome "unknown", described as "She has had dizzy spells for over a year.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She has had dizzy spells for over a year. When she first had it, they would last 30 seconds then be gone. All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thinks they were all given in left arm.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Physician reporting an AE for VARIVAX being administered after the expiration. No additional AE. No PQC.; This spontaneous report has been received from a physician, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 22-NOV-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) Subcutaneous Injection, at a dose of 0.5 milliliters as prophylaxis (lot number: T038830, which was determined to be valid, with an expiration date on 17-NOV-2022) (strength, scheme, route and anatomical location of administration were not reported) (Expired product administered). No additional adverse event was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Headache, Immunisation reaction, Muscle spasms
Clinical narrative: leg cramps /severe leg cramps; joint pain all over /joint pain; headache; Covid arm; Discomfort; Itching at injection site; Large swelling at injection site; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (leg cramps /severe leg cramps), IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Large swelling at injection site) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE SWELLING (Large swelling at injection site). On 19-Nov-2022, the patient experienced MUSCLE SPASMS (leg cramps /severe leg cramps), ARTHRALGIA (joint pain all over /joint pain) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (leg cramps /severe leg cramps), IMMUNISATION REACTION (Covid arm), DISCOMFORT (Discomfort), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE SWELLING (Large swelling at injection site), ARTHRALGIA (joint pain all over /joint pain) and HEADACHE (headache) outcome was unknown.            No concomitant information provided. Patient took the offered four doses Covid Moderna vaccine, at the appropriate times.  Patient was in relatively good health and patient had O negative blood. Patient had no fever or life threatening issues.  It was reported that patient had previously received different vaccines, that did nothing of the sort. Patient had a general doctor appointment coming up and would report this.   This case was linked to MOD-2022-675368 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Nov-2022: Live Follow-up Significant information which includes Events added