chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash macular, Sleep disorder
Clinical narrative: Pink Rash on her legs; Blotches on her legs; is uncomfortable for her to sleep; pain when bending down; confirmed with a case of Shingles; pain in her left leg; nerve pain and her leg; feels like burning sensation; dots on her left side of the back.; Redness at injection site; Soreness at injection site; bad bruise under the left arm; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included crohn's and immunocompromised (on immunosupresants). Concomitant products included mercaptopurine.   On 11th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th January 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site pain. On 13th January 2020, the patient experienced contusion. In January 2020, the patient experienced shingles, leg pain, nerve pain, burning sensation and rash. On an unknown date, the patient experienced red rash, blotchy, sleep disorder and pain. The patient was treated with dermatologicals nos (Calamine Lotion). On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site erythema, injection site pain and contusion were recovered/resolved and the outcome of the leg pain and nerve pain were not recovered/not resolved and the outcome of the burning sensation, rash, red rash, blotchy, sleep disorder and pain were unknown.   It was unknown if the reporter considered the shingles, injection site erythema, injection site pain, contusion, leg pain, nerve pain, burning sensation, rash, red rash, blotchy, sleep disorder and pain to be related to Shingrix.  Additional information was provided as follows: The patient received the vaccine on her left arm. The same day of vaccination she experienced redness and soreness at injection site that lasted for 3 days. On the third day she experienced a bad bruise under the left arm which took 5 days to resolve.  About a week later from the day of vaccination she started to experience pain in her left leg. At the same time she experienced dots on her left side of the back.  She visited her physician and was confirmed with a case of Shingles. About 2 weeks after vaccination she started to experience pink rash and blotches on her legs, and from knee to groin area.  The Shingles on her back and legs got better and lighter.  The pain in her legs was ongoing and she described it as nerve pain and her leg feels like burning sensation.  It is uncomfortable for her to sleep and she had pain when bending down. The patient used calamine lotion on the affected area.  The patient experienced all the adverse events on the left side of the body. The reporter did not consented to follow up. This is 1 of the 5 cases reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Off label use, Pain, Pyrexia
Clinical narrative: experienced flu like symptoms; body aches; shivering; fever; The physician prescribed a 3rd dose; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 3rd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain, shivering, fever and off label use. On an unknown date, the outcome of the influenza-like symptoms, general body pain, shivering, fever and off label use were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain, shivering and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix about a year before the time of reporting. The patient experienced flu like symptoms consisting of body aches, shivering and fever. The patient had 2nd dose about 3 months after dose 1st dose and there were no events reported with that injection. A physician ordered a 3rd dose of Shingrix. No events were noted with that injection, other than it was outside recommended dosing intervals. The pharmacist became aware that the patient had 3 injections of Shingrix and investigated.  The physician prescribed a 3rd dose of Shingrix, which led to off label used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Mobility decreased, Pain
Clinical narrative: had flu like symptoms; achy; feverish; headache; chills; just decreased mobility; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, fever, headache, chills and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, pain, fever, headache, chills and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, fever, headache, chills and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient herself. The age at vaccination was not reported. The patient received a dose of Shingrix on the high up on the deltoid. The patient stayed in chair most of the day. About 36 to 72 hours later the issues were resolved. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: had flu like symptoms; achy; feverish; headache; chills; just decreased mobility; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, fever, headache, chills and mobility decreased. On an unknown date, the outcome of the influenza-like symptoms, pain, fever, headache, chills and mobility decreased were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, pain, fever, headache, chills and mobility decreased to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient herself. The age at vaccination was not reported. The patient received a dose of Shingrix on the high up on the deltoid. The patient stayed in chair most of the day. About 36 to 72 hours later the issues were resolved. The reporter consented to follow up. This is 1 of the 3 cases, reported by same reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Pain in extremity
Clinical narrative: sore arm; stung at injection site/ she experienced tenderness at the site; felt lousy; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced feeling bad, pain in arm and injection site pain. On an unknown date, the outcome of the feeling bad, pain in arm and injection site pain were recovered/resolved.   It was unknown if the reporter considered the feeling bad, pain in arm and injection site pain to be related to Shingrix.  Additional information received were as follows: This case was reported by patient herself. The patient received a dose of Shingrix on the left arm. The patient felt lousy, but the symptoms resolved after 3 to 4 days. The patient arm was so sore and she could not lay on her side and it stung at the injection site and she experienced tenderness at the site. For tolerance with 2nd dose refer linked case US2020AMR019492.
Age: 32.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: vaccination site reaction: It is circular and there is a raised spot where the needle went in, but a diffuse rash has formed that is 4 inches around and there are actual rash bumps around it, kind of; Fever; This is a spontaneous report from a contactable pharmacist.   A 32-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/lot # CD0412, Expiry Date Jan2022. NDC # 0005197102) intramuscular at 0.5 ml, single at left arm on 05Feb2020 for immunisation.  Medical history included ongoing Non-familial hypogammaglobulinaemia.  There were no concomitant medications.  The patient received PREVNAR 13 with the indication of non-familial hypogammaglobulinaemia on 05Feb202. On Thursday, 06Feb2020, morning the patient began running a fever of 100 or better.  She has been treating it with Tylenol and it will help a little bit. She has also had an injection site reaction in Feb2020: it is circular and there is a raised spot where the needle went in, but a diffuse rash has formed that is 4 inches around and there are actual rash bumps around it, kind of like hives. The reporter assessed the events as non serious. The patient underwent lab tests and procedures which included: body temperature: 100 or more  on 06Feb2020. The outcome of fever, injection site reaction, it is circular and there is a raised spot where the needle went in, but a diffuse rash has formed that is 4 inches around and there are actual rash bumps around it, kind of like hives was not recovered.
Sex: U
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: I was just diagnosed with pneumonia; I was just diagnosed with pneumonia; This is a spontaneous report from a contactable consumer reported for him/herself.   A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose on unspecified date in 2019 (Nov2019-Dec2019) via unspecified route of administration, for immunization. In Feb2020 the patient was diagnosed with pneumonia. The outcome of the event was unknown. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood glucose increased, Cellulitis, Ear pain, Foot fracture
Clinical narrative: 12/22/19 Broke left foot Blood Sugars very high over 200 1/06/20 received 2nd Shingrix vaccine 4 hrs later felt flu like symptoms 1/08/20 experiencing ear and sinus pain on left side. Put on antibiodics. 1/09/20 Pain worse, Blood sugars very High 200-300's 1/10/20 Pain unbearable. Put on stronger antibiodics. Put on stronger antibiodics Told that ear was no Infected. Possible sinus infection Should get sinus CAT scan 1/11/20 Woke up with shingles. Left side Put on Valatcyclovir 3X's day  All this time pain in left ear and left head is unbearable 1/13/20 Pain is also in left foot. Past 2 nights I can not walk on it. Started Swelling and discoloration of whole foot. Fever 102 at night. 1/14/20 Diagnosed with Trigeminal Neuralgia. Put on Gabapectin 300mg 2X's. 1/15/20 woke up w both feet double in size and debilitating pain. Also in hands, wrists, elbows, (joints) Fever 102. 1/16/20 Went to Hospital 1/17/20 Put on IV antiviral (Acyclovir) antibiotics (piperacillin - Tazobactam- Vancomycin) Infectious Disease suspect Cellulitis. 1/19/20 RA Drs. diagnose me with Serum Sickness because of Shingle Vaccine Put me on Steroids and I shingle vaccine Put me on steroids and I begin to Improve. 1/20/20 Blood Sugars which were high are now becoming higher because of Steroids 1/23/20 Discharged with Steroid Plan and Endo Plan
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Herpes zoster, Influenza like illness, Pain in extremity
Clinical narrative: 12/22/19 Broke left foot Blood Sugars very high over 200 1/06/20 received 2nd Shingrix vaccine 4 hrs later felt flu like symptoms 1/08/20 experiencing ear and sinus pain on left side. Put on antibiodics. 1/09/20 Pain worse, Blood sugars very High 200-300's 1/10/20 Pain unbearable. Put on stronger antibiodics. Put on stronger antibiodics Told that ear was no Infected. Possible sinus infection Should get sinus CAT scan 1/11/20 Woke up with shingles. Left side Put on Valatcyclovir 3X's day  All this time pain in left ear and left head is unbearable 1/13/20 Pain is also in left foot. Past 2 nights I can not walk on it. Started Swelling and discoloration of whole foot. Fever 102 at night. 1/14/20 Diagnosed with Trigeminal Neuralgia. Put on Gabapectin 300mg 2X's. 1/15/20 woke up w both feet double in size and debilitating pain. Also in hands, wrists, elbows, (joints) Fever 102. 1/16/20 Went to Hospital 1/17/20 Put on IV antiviral (Acyclovir) antibiotics (piperacillin - Tazobactam- Vancomycin) Infectious Disease suspect Cellulitis. 1/19/20 RA Drs. diagnose me with Serum Sickness because of Shingle Vaccine Put me on Steroids and I shingle vaccine Put me on steroids and I begin to Improve. 1/20/20 Blood Sugars which were high are now becoming higher because of Steroids 1/23/20 Discharged with Steroid Plan and Endo Plan
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Serum sickness, Sinus pain, Skin discolouration
Clinical narrative: 12/22/19 Broke left foot Blood Sugars very high over 200 1/06/20 received 2nd Shingrix vaccine 4 hrs later felt flu like symptoms 1/08/20 experiencing ear and sinus pain on left side. Put on antibiodics. 1/09/20 Pain worse, Blood sugars very High 200-300's 1/10/20 Pain unbearable. Put on stronger antibiodics. Put on stronger antibiodics Told that ear was no Infected. Possible sinus infection Should get sinus CAT scan 1/11/20 Woke up with shingles. Left side Put on Valatcyclovir 3X's day  All this time pain in left ear and left head is unbearable 1/13/20 Pain is also in left foot. Past 2 nights I can not walk on it. Started Swelling and discoloration of whole foot. Fever 102 at night. 1/14/20 Diagnosed with Trigeminal Neuralgia. Put on Gabapectin 300mg 2X's. 1/15/20 woke up w both feet double in size and debilitating pain. Also in hands, wrists, elbows, (joints) Fever 102. 1/16/20 Went to Hospital 1/17/20 Put on IV antiviral (Acyclovir) antibiotics (piperacillin - Tazobactam- Vancomycin) Infectious Disease suspect Cellulitis. 1/19/20 RA Drs. diagnose me with Serum Sickness because of Shingle Vaccine Put me on Steroids and I shingle vaccine Put me on steroids and I begin to Improve. 1/20/20 Blood Sugars which were high are now becoming higher because of Steroids 1/23/20 Discharged with Steroid Plan and Endo Plan
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: 12/22/19 Broke left foot Blood Sugars very high over 200 1/06/20 received 2nd Shingrix vaccine 4 hrs later felt flu like symptoms 1/08/20 experiencing ear and sinus pain on left side. Put on antibiodics. 1/09/20 Pain worse, Blood sugars very High 200-300's 1/10/20 Pain unbearable. Put on stronger antibiodics. Put on stronger antibiodics Told that ear was no Infected. Possible sinus infection Should get sinus CAT scan 1/11/20 Woke up with shingles. Left side Put on Valatcyclovir 3X's day  All this time pain in left ear and left head is unbearable 1/13/20 Pain is also in left foot. Past 2 nights I can not walk on it. Started Swelling and discoloration of whole foot. Fever 102 at night. 1/14/20 Diagnosed with Trigeminal Neuralgia. Put on Gabapectin 300mg 2X's. 1/15/20 woke up w both feet double in size and debilitating pain. Also in hands, wrists, elbows, (joints) Fever 102. 1/16/20 Went to Hospital 1/17/20 Put on IV antiviral (Acyclovir) antibiotics (piperacillin - Tazobactam- Vancomycin) Infectious Disease suspect Cellulitis. 1/19/20 RA Drs. diagnose me with Serum Sickness because of Shingle Vaccine Put me on Steroids and I shingle vaccine Put me on steroids and I begin to Improve. 1/20/20 Blood Sugars which were high are now becoming higher because of Steroids 1/23/20 Discharged with Steroid Plan and Endo Plan
Age: 7.0
Sex: M
Vaccine: IPV, TD
Symptoms: Condition aggravated, Depressed level of consciousness, Ear infection, Erythema, Failure to thrive
Clinical narrative: Severe headache, 104+ temperature, decreased level of consciousness, vomited 13 times, afternoon, evening at home & hospital, OTC could not reduce fever or stopped vomiting. Passed out 2x. One arm was swollen, red, painful, hot for 5 Days. At ER - Acute Febrile Illness & Viral Syndrome  Adverse Immune Reactions after Vaccinations  Continued ear infections  Difficulty w/weight gain/failure to thrive - gastro & nutritional support required  Pneumonia - 2x  Kidney Disease  Immune Compromised - In 2013 - Diagnosed w/ MTHFR Gene Mutation  Currently followed by Pulmonary, Nephrology, Allergist & Cardiological Specialists  Pediatric office did not respond to patient's request for records.
Age: 7.0
Sex: M
Vaccine: IPV, TD
Symptoms: Full blood count, Headache, Immune-mediated adverse reaction, Immunodeficiency, Loss of consciousness
Clinical narrative: Severe headache, 104+ temperature, decreased level of consciousness, vomited 13 times, afternoon, evening at home & hospital, OTC could not reduce fever or stopped vomiting. Passed out 2x. One arm was swollen, red, painful, hot for 5 Days. At ER - Acute Febrile Illness & Viral Syndrome  Adverse Immune Reactions after Vaccinations  Continued ear infections  Difficulty w/weight gain/failure to thrive - gastro & nutritional support required  Pneumonia - 2x  Kidney Disease  Immune Compromised - In 2013 - Diagnosed w/ MTHFR Gene Mutation  Currently followed by Pulmonary, Nephrology, Allergist & Cardiological Specialists  Pediatric office did not respond to patient's request for records.
Age: 7.0
Sex: M
Vaccine: IPV, TD
Symptoms: Methylenetetrahydrofolate reductase gene mutation, Pain in extremity, Peripheral swelling, Pneumonia, Pyrexia
Clinical narrative: Severe headache, 104+ temperature, decreased level of consciousness, vomited 13 times, afternoon, evening at home & hospital, OTC could not reduce fever or stopped vomiting. Passed out 2x. One arm was swollen, red, painful, hot for 5 Days. At ER - Acute Febrile Illness & Viral Syndrome  Adverse Immune Reactions after Vaccinations  Continued ear infections  Difficulty w/weight gain/failure to thrive - gastro & nutritional support required  Pneumonia - 2x  Kidney Disease  Immune Compromised - In 2013 - Diagnosed w/ MTHFR Gene Mutation  Currently followed by Pulmonary, Nephrology, Allergist & Cardiological Specialists  Pediatric office did not respond to patient's request for records.
Age: 7.0
Sex: M
Vaccine: IPV, TD
Symptoms: Renal disorder, Skin warm, Viral infection, Vomiting, Weight gain poor
Clinical narrative: Severe headache, 104+ temperature, decreased level of consciousness, vomited 13 times, afternoon, evening at home & hospital, OTC could not reduce fever or stopped vomiting. Passed out 2x. One arm was swollen, red, painful, hot for 5 Days. At ER - Acute Febrile Illness & Viral Syndrome  Adverse Immune Reactions after Vaccinations  Continued ear infections  Difficulty w/weight gain/failure to thrive - gastro & nutritional support required  Pneumonia - 2x  Kidney Disease  Immune Compromised - In 2013 - Diagnosed w/ MTHFR Gene Mutation  Currently followed by Pulmonary, Nephrology, Allergist & Cardiological Specialists  Pediatric office did not respond to patient's request for records.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Audiogram abnormal, Chills, Deafness neurosensory, Deafness unilateral, Discomfort
Clinical narrative: By that evening, I experienced severe body aches, chills and fever that lasted approximately 3 days.  Shortly afterward, began to have what I thought was a clogged ear.  Thought I was possibly starting with a cold or sinus.  By the following week, ear worsened, and  I felt pain/pressure on the left side of my face, around eye and ear and neck. By Thanksgiving I noticed my hearing was declining, and it felt very, very uncomfortable.  Again, I thought it was possibly a severe sinus infection.   The clogged feeling/noise / etc. increased - Dr. prescribed steroids and antibiotics - despite lack of any nasal discharge.  Advised to see an ENT.  Audiology report showed hearing loss in left ear, MRI was normal, loss pattern consistent  with damage to the nerve. I still have this very uncomfortable feeling on the left side of my neck, along with the pressure (hard to describe) feeling in my ear.  Also experiencing periods of hoarseness
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Ear discomfort, Ear pain, Facial pain, Hypoacusis
Clinical narrative: By that evening, I experienced severe body aches, chills and fever that lasted approximately 3 days.  Shortly afterward, began to have what I thought was a clogged ear.  Thought I was possibly starting with a cold or sinus.  By the following week, ear worsened, and  I felt pain/pressure on the left side of my face, around eye and ear and neck. By Thanksgiving I noticed my hearing was declining, and it felt very, very uncomfortable.  Again, I thought it was possibly a severe sinus infection.   The clogged feeling/noise / etc. increased - Dr. prescribed steroids and antibiotics - despite lack of any nasal discharge.  Advised to see an ENT.  Audiology report showed hearing loss in left ear, MRI was normal, loss pattern consistent  with damage to the nerve. I still have this very uncomfortable feeling on the left side of my neck, along with the pressure (hard to describe) feeling in my ear.  Also experiencing periods of hoarseness
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Magnetic resonance imaging normal, Musculoskeletal discomfort, Neck pain, Nerve injury, Ocular discomfort
Clinical narrative: By that evening, I experienced severe body aches, chills and fever that lasted approximately 3 days.  Shortly afterward, began to have what I thought was a clogged ear.  Thought I was possibly starting with a cold or sinus.  By the following week, ear worsened, and  I felt pain/pressure on the left side of my face, around eye and ear and neck. By Thanksgiving I noticed my hearing was declining, and it felt very, very uncomfortable.  Again, I thought it was possibly a severe sinus infection.   The clogged feeling/noise / etc. increased - Dr. prescribed steroids and antibiotics - despite lack of any nasal discharge.  Advised to see an ENT.  Audiology report showed hearing loss in left ear, MRI was normal, loss pattern consistent  with damage to the nerve. I still have this very uncomfortable feeling on the left side of my neck, along with the pressure (hard to describe) feeling in my ear.  Also experiencing periods of hoarseness
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia, Tinnitus
Clinical narrative: By that evening, I experienced severe body aches, chills and fever that lasted approximately 3 days.  Shortly afterward, began to have what I thought was a clogged ear.  Thought I was possibly starting with a cold or sinus.  By the following week, ear worsened, and  I felt pain/pressure on the left side of my face, around eye and ear and neck. By Thanksgiving I noticed my hearing was declining, and it felt very, very uncomfortable.  Again, I thought it was possibly a severe sinus infection.   The clogged feeling/noise / etc. increased - Dr. prescribed steroids and antibiotics - despite lack of any nasal discharge.  Advised to see an ENT.  Audiology report showed hearing loss in left ear, MRI was normal, loss pattern consistent  with damage to the nerve. I still have this very uncomfortable feeling on the left side of my neck, along with the pressure (hard to describe) feeling in my ear.  Also experiencing periods of hoarseness
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Audiogram abnormal, Deafness unilateral, Ear discomfort, Facial pain, Feeling abnormal
Clinical narrative: By that evening, I experienced severe body aches, chills and fever that lasted approximately 3 days.  Shortly afterward, began to have what I thought was a clogged ear.  Thought I was possibly starting with a cold or sinus.  By the following week, ear worsened, and  I felt pain/pressure on the left side of my face, around eye and ear and neck. By Thanksgiving I noticed my hearing was declining, and it felt very, very uncomfortable.  Again, I thought it was possibly a severe sinus infection.   The clogged feeling/noise / etc. increased - Dr. prescribed steroids and antibiotics - despite lack of any nasal discharge.  Advised to see an ENT.  Audiology report showed hearing loss in left ear, MRI was normal, loss pattern consistent  with damage to the nerve. I still have this very uncomfortable feeling on the left side of my neck, along with the pressure (hard to describe) feeling in my ear.  Also experiencing periods of hoarseness
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Neck pain, Nerve injury, Sinus disorder, Tinnitus
Clinical narrative: By that evening, I experienced severe body aches, chills and fever that lasted approximately 3 days.  Shortly afterward, began to have what I thought was a clogged ear.  Thought I was possibly starting with a cold or sinus.  By the following week, ear worsened, and  I felt pain/pressure on the left side of my face, around eye and ear and neck. By Thanksgiving I noticed my hearing was declining, and it felt very, very uncomfortable.  Again, I thought it was possibly a severe sinus infection.   The clogged feeling/noise / etc. increased - Dr. prescribed steroids and antibiotics - despite lack of any nasal discharge.  Advised to see an ENT.  Audiology report showed hearing loss in left ear, MRI was normal, loss pattern consistent  with damage to the nerve. I still have this very uncomfortable feeling on the left side of my neck, along with the pressure (hard to describe) feeling in my ear.  Also experiencing periods of hoarseness
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Fainted the next morning after the vaccination.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Malaise, Nausea, Visual impairment
Clinical narrative: At 2:57 PM, patient received immunizations. Instructed to wait 15 minutes in lobby and at approx. 3:20 PM, patient stated she wasn't feeling well, visual changes, and felt light-headed and nauseous. Patient laid on exam table with feet elevated, Vitals, right arm, sitting: 93/59, HR 56, Spo2% 99 and in no respiratory distress. Patient rested, given snack and drink, after approximately 20 minutes, patient stated she felt better. Vitals while sitting, right arm, BP: 111/74, HR 83, Spo2% 100
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Both arms and legs are sore (achy). Not specific to site of injection
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Abdominal pain, Anaphylactic reaction, Anxiety disorder, Asthma, Body temperature increased
Clinical narrative: 104+ Temperature evening  high-pitched, piercing cry convulsion or Febrile seizure Daytime - projectile vomiting, screaming & severe diarrhea in office & home Mid-March patient taken to ER - turning blue, could not breathe - Had to be suctioned - The following are reactions & life like conditions: In alpha order: Anaphylaxis to peanuts, Anxiety Disorder Asthma Asthma attack Belly pain, Digestive disorders Central Auditory Disorder Chickenpox despite being vaccinated Compromised Immune System Double Pneumonia Esophageal Encephalitis Failure to thrive - required gastro & nutritionist Food allergies to fruits, dairy, & nuts Irritable Bowel Syndrome Pneumonia Severe Eczema Seizure Disorder Sensory Disorder Sinus Infections Sleep Apnea Trichotillomania Vomiting Annual EEG testing 2013 Tested & Dignosed with MTHFR Gene Mutation  Dr's office informed
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Central auditory processing disorder, Chest X-ray, Computerised tomogram head, Cyanosis, Dairy intolerance
Clinical narrative: 104+ Temperature evening  high-pitched, piercing cry convulsion or Febrile seizure Daytime - projectile vomiting, screaming & severe diarrhea in office & home Mid-March patient taken to ER - turning blue, could not breathe - Had to be suctioned - The following are reactions & life like conditions: In alpha order: Anaphylaxis to peanuts, Anxiety Disorder Asthma Asthma attack Belly pain, Digestive disorders Central Auditory Disorder Chickenpox despite being vaccinated Compromised Immune System Double Pneumonia Esophageal Encephalitis Failure to thrive - required gastro & nutritionist Food allergies to fruits, dairy, & nuts Irritable Bowel Syndrome Pneumonia Severe Eczema Seizure Disorder Sensory Disorder Sinus Infections Sleep Apnea Trichotillomania Vomiting Annual EEG testing 2013 Tested & Dignosed with MTHFR Gene Mutation  Dr's office informed
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Diarrhoea, Dyspnoea, Eczema, Electroencephalogram, Encephalitis
Clinical narrative: 104+ Temperature evening  high-pitched, piercing cry convulsion or Febrile seizure Daytime - projectile vomiting, screaming & severe diarrhea in office & home Mid-March patient taken to ER - turning blue, could not breathe - Had to be suctioned - The following are reactions & life like conditions: In alpha order: Anaphylaxis to peanuts, Anxiety Disorder Asthma Asthma attack Belly pain, Digestive disorders Central Auditory Disorder Chickenpox despite being vaccinated Compromised Immune System Double Pneumonia Esophageal Encephalitis Failure to thrive - required gastro & nutritionist Food allergies to fruits, dairy, & nuts Irritable Bowel Syndrome Pneumonia Severe Eczema Seizure Disorder Sensory Disorder Sinus Infections Sleep Apnea Trichotillomania Vomiting Annual EEG testing 2013 Tested & Dignosed with MTHFR Gene Mutation  Dr's office informed
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Failure to thrive, Febrile convulsion, Food allergy, Gastrointestinal disorder, High-pitched crying
Clinical narrative: 104+ Temperature evening  high-pitched, piercing cry convulsion or Febrile seizure Daytime - projectile vomiting, screaming & severe diarrhea in office & home Mid-March patient taken to ER - turning blue, could not breathe - Had to be suctioned - The following are reactions & life like conditions: In alpha order: Anaphylaxis to peanuts, Anxiety Disorder Asthma Asthma attack Belly pain, Digestive disorders Central Auditory Disorder Chickenpox despite being vaccinated Compromised Immune System Double Pneumonia Esophageal Encephalitis Failure to thrive - required gastro & nutritionist Food allergies to fruits, dairy, & nuts Irritable Bowel Syndrome Pneumonia Severe Eczema Seizure Disorder Sensory Disorder Sinus Infections Sleep Apnea Trichotillomania Vomiting Annual EEG testing 2013 Tested & Dignosed with MTHFR Gene Mutation  Dr's office informed
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Immunodeficiency, Irritable bowel syndrome, Methylenetetrahydrofolate reductase gene mutation, Pneumonia, Screaming
Clinical narrative: 104+ Temperature evening  high-pitched, piercing cry convulsion or Febrile seizure Daytime - projectile vomiting, screaming & severe diarrhea in office & home Mid-March patient taken to ER - turning blue, could not breathe - Had to be suctioned - The following are reactions & life like conditions: In alpha order: Anaphylaxis to peanuts, Anxiety Disorder Asthma Asthma attack Belly pain, Digestive disorders Central Auditory Disorder Chickenpox despite being vaccinated Compromised Immune System Double Pneumonia Esophageal Encephalitis Failure to thrive - required gastro & nutritionist Food allergies to fruits, dairy, & nuts Irritable Bowel Syndrome Pneumonia Severe Eczema Seizure Disorder Sensory Disorder Sinus Infections Sleep Apnea Trichotillomania Vomiting Annual EEG testing 2013 Tested & Dignosed with MTHFR Gene Mutation  Dr's office informed
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Seizure, Sensory processing disorder, Sinusitis, Skull X-ray, Sleep apnoea syndrome
Clinical narrative: 104+ Temperature evening  high-pitched, piercing cry convulsion or Febrile seizure Daytime - projectile vomiting, screaming & severe diarrhea in office & home Mid-March patient taken to ER - turning blue, could not breathe - Had to be suctioned - The following are reactions & life like conditions: In alpha order: Anaphylaxis to peanuts, Anxiety Disorder Asthma Asthma attack Belly pain, Digestive disorders Central Auditory Disorder Chickenpox despite being vaccinated Compromised Immune System Double Pneumonia Esophageal Encephalitis Failure to thrive - required gastro & nutritionist Food allergies to fruits, dairy, & nuts Irritable Bowel Syndrome Pneumonia Severe Eczema Seizure Disorder Sensory Disorder Sinus Infections Sleep Apnea Trichotillomania Vomiting Annual EEG testing 2013 Tested & Dignosed with MTHFR Gene Mutation  Dr's office informed
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Trichotillomania, Ultrasound kidney, Varicella, Vomiting, Vomiting projectile
Clinical narrative: 104+ Temperature evening  high-pitched, piercing cry convulsion or Febrile seizure Daytime - projectile vomiting, screaming & severe diarrhea in office & home Mid-March patient taken to ER - turning blue, could not breathe - Had to be suctioned - The following are reactions & life like conditions: In alpha order: Anaphylaxis to peanuts, Anxiety Disorder Asthma Asthma attack Belly pain, Digestive disorders Central Auditory Disorder Chickenpox despite being vaccinated Compromised Immune System Double Pneumonia Esophageal Encephalitis Failure to thrive - required gastro & nutritionist Food allergies to fruits, dairy, & nuts Irritable Bowel Syndrome Pneumonia Severe Eczema Seizure Disorder Sensory Disorder Sinus Infections Sleep Apnea Trichotillomania Vomiting Annual EEG testing 2013 Tested & Dignosed with MTHFR Gene Mutation  Dr's office informed
Sex: U
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no additional AE information; a patient was administered bolh PNEUMOV AX 23 and PREVNAR 13 on l/14/2020 due to human error, not a product confusion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 14-JAN-2020, the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot # S029265 has been verified to be a valid lot number, expiration date: 31-MAR-2021 (exact dose, dose number, route and site of administration date were not reported) for prophylaxis and on the same date the patient received pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) due to human error, not a product confusion. No adverse events were reported.
Sex: M
Vaccine: PNC13
Symptoms: Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rheumatic; This is a spontaneous report from a contactable physician reported for himself. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in Dec2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had the vaccine in December of last year, after that he was diagnosed with polymyalgia rheumatic on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event polymyalgia rheumatic with pneumococcal 13-valent conjugate vaccine can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: E R for treatment
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Decreased eye contact, Speech disorder, Tic
Clinical narrative: Speech regression, loss of eye contact, tick in the wrist
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Muscle spasms, Pyrexia
Clinical narrative: Fever, chills, fatigue, muscle cramping and severe headache
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Medical assistant administered high dose flu vaccine to pediatric patient by mistake. Patient has not adverse reaction. Provider was made aware and parent notified.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Muscle spasms, Nausea
Clinical narrative: ear ringing, headache, panic, sobbing, weakness, shaking, chills, muscle spasms, nausea
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Panic attack, Tinnitus, Tremor
Clinical narrative: ear ringing, headache, panic, sobbing, weakness, shaking, chills, muscle spasms, nausea
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Muscular weakness
Clinical narrative: In calling patient to schedule her second dose of the shingles vaccine, patient expressed some concerns and hesitations in getting the second dose.  Patient reports she had a reaction with first dose of Shingrix-- states she had flu like symptoms following the first dose for the next 1-2 days, and then significant pain and soreness in her left arm where it was administered leading her to favor that arm and subsequent muscle weakness for the next couple months.  She was seen by her physician about 3 months later and discussed her arm pain and weakness at that time and was prescribed physical therapy to help strengthen those muscles in her arm again.   She is still undergoing physical therapy to strengthen the muscles in her left arm and would like the second dose, but requesting an alternative injection site such as in the gluteal muscle.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Chills, severe muscle pain, nausea, tiredness
Age: 14.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Itchy, hive like rash, redness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Infant was inadvertently given MMRV and Varicella on same day. No known adverse event at this time
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: FEVER, CHILLS, HEAD AND PAIN  MUSCLE PAIN
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Oropharyngeal pain, Pyrexia
Clinical narrative: an hour after injection I could feel lymph nodes beginning to swell in the neck accompanied by a sore throat. late in the day I began to  feel feverish . At 3:00AM the next morning I woke up with a 103 degree  fever and a stiff neck.  my fever lasted over 24 hours  with 103 being the highest temp and 99 being the average. neck stiffness and swollen lymph nodes lasted an extra 2 days.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: swelling, erythema, warm to touch x 2 days
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling cold, Influenza virus test negative, Injection site discomfort
Clinical narrative: 18 hours after injection:    general malaise, body aches (even my hair follicles hurt), low grade temp 99.2, nausea, diarrhea.  Shivering, I was freezing.   Sinus congestion (thought I was getting the flu, had to get swabbed, it was negative).  Needed to use my inhaler, haven't needed it in months, wheezing.  Injection site significant discomfort.       The following day, mild nausea, mild chills Despite all of this,  I would probably take vaccine again but do it when I had 3 days off of work, to recover.   I supposed it's better than lifelong post herpetic neuralgia
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: 18 hours after injection:    general malaise, body aches (even my hair follicles hurt), low grade temp 99.2, nausea, diarrhea.  Shivering, I was freezing.   Sinus congestion (thought I was getting the flu, had to get swabbed, it was negative).  Needed to use my inhaler, haven't needed it in months, wheezing.  Injection site significant discomfort.       The following day, mild nausea, mild chills Despite all of this,  I would probably take vaccine again but do it when I had 3 days off of work, to recover.   I supposed it's better than lifelong post herpetic neuralgia
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinus congestion, Wheezing
Clinical narrative: 18 hours after injection:    general malaise, body aches (even my hair follicles hurt), low grade temp 99.2, nausea, diarrhea.  Shivering, I was freezing.   Sinus congestion (thought I was getting the flu, had to get swabbed, it was negative).  Needed to use my inhaler, haven't needed it in months, wheezing.  Injection site significant discomfort.       The following day, mild nausea, mild chills Despite all of this,  I would probably take vaccine again but do it when I had 3 days off of work, to recover.   I supposed it's better than lifelong post herpetic neuralgia
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient stopped by the pharmacy on Monday, Feb 10 stating he had a lot of pain when he tried to raise his left arm.
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Back pain, Injection site pain, Pain, Painful respiration
Clinical narrative: Pt states she received flu vaccine on 2/11/20 & then began having "extreme back pain" later that evening. States "it hurts to breath in low back, but not in chest", "hurts to walk" despite taking 4 ibuprofen, but states she is able to walk. Reports mild soreness to arm at flu injection site Offered for pt to come in and be seen given symptoms post flu vaccine; however, states she doesn't have time to be seen today, but just wanted to report the side effects of "extreme low back pain" so that we could report it.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient said she experienced pain at injection site at time of the vaccination. She was thinking it would go away but it did not. When she came in on 2/8/2020 she said she was still experiencing pain at the site. There was no swelling, nodules or swelling during those times, just pain. She felt like the vaccination may have been given to high up on the arm and may have been given with too much force, she was not sure if that may have contributed to the problem.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired driving ability, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal disorder, Nerve injury
Clinical narrative: 2/13/20: Pt reports nerve damage from the shingles vaccine (administered 2/5/2020 7:20pm). Pt reports shot was administered almost at the top of her shoulder. Pt was wearing a sweater and reports she took her arm out of the sweater to get the shot. Pt noted hearing a loud "weird sound" when the shot was given. After describing the type of syringes we use she said it sounded like a broken spring or something. By 9pm she was having so much pain that she called her insurance nurse line, they directed her to call her clinic doctor on call. Pt spoke to the doctor on call, they directed her to the ER because she couldn't even speak at that point because she was in so much pain. Couldn't use her arm at all, so couldn't drive. Had to call her family to come help her. Went to ER with excruciating pain and whole body was shaking up and down. Dr did an ultrasound of her shoulder to make sure there wasn't any blood clot. The doctor removed the band aid from her arm, so patient says they know where the shot was given. Pt states that the ER doctor said maybe the syringe was faulty and the needle was angled. We currently have 80 syringes in our VanishPoint Syringe box, 3mL 25G 1". Ref # 10391. Lot A190101. 2019-01-03. 2023-12-28.  2/11/20 Pt went in to her doctor. Couldn't even lift arm to shoulder level. 2/13/20 Pt can lift arm to shoulder level now, but not all the way up (to get things out of the cabinet). Still having pain. Pt is going to neurology tomorrow 2/14/2020.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: 2/13/20: Pt reports nerve damage from the shingles vaccine (administered 2/5/2020 7:20pm). Pt reports shot was administered almost at the top of her shoulder. Pt was wearing a sweater and reports she took her arm out of the sweater to get the shot. Pt noted hearing a loud "weird sound" when the shot was given. After describing the type of syringes we use she said it sounded like a broken spring or something. By 9pm she was having so much pain that she called her insurance nurse line, they directed her to call her clinic doctor on call. Pt spoke to the doctor on call, they directed her to the ER because she couldn't even speak at that point because she was in so much pain. Couldn't use her arm at all, so couldn't drive. Had to call her family to come help her. Went to ER with excruciating pain and whole body was shaking up and down. Dr did an ultrasound of her shoulder to make sure there wasn't any blood clot. The doctor removed the band aid from her arm, so patient says they know where the shot was given. Pt states that the ER doctor said maybe the syringe was faulty and the needle was angled. We currently have 80 syringes in our VanishPoint Syringe box, 3mL 25G 1". Ref # 10391. Lot A190101. 2019-01-03. 2023-12-28.  2/11/20 Pt went in to her doctor. Couldn't even lift arm to shoulder level. 2/13/20 Pt can lift arm to shoulder level now, but not all the way up (to get things out of the cabinet). Still having pain. Pt is going to neurology tomorrow 2/14/2020.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV1
Symptoms: Ear swelling, Erythema, Flushing, Rash macular, Vomiting
Clinical narrative: According to mom at 1545 pm emesis, 1615 emesis, 1645 emesis, bath given, approximately 1845 left ear swollen, cheeks flushed, neck red, chest red and splotchy.  Mom requested doc call her at this time.  Approx 1920 doc called and mom reports she was "clearing up" at this time.  She nursed her and the infant then began chewing on a teething ring.  Doc advised mom to keep an eye on her and make sure the adverse event was documented.
Age: 79.0
Sex: M
Vaccine: FLUR4, PNC13
Symptoms: Computerised tomogram normal, Dizziness, Hearing aid user
Clinical narrative: Pt had onset of unexplained dizziness about a week after receiving the vaccinations. He is still experiencing this.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pruritus
Clinical narrative: Patient developed rash underneath the injection site that spread down her arm within two hours of vaccine administration.  She also reported that the rash had been there prior to the vaccine but was very small and not visible.  She experienced slight itching for two weeks prior to receiving the vaccine but the rash spread "about two hours" after administration.  The rash was observed in the pharmacy to be approximately 2-3 inches below the injection site, spanning most of her upper arm.  The patient says the rash has not worsened but only minimally improved since it flared up.  She felt "just fine" otherwise.  Her blood pressure at the pharmacy was 126/85 mmHg.