chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash papular
Clinical narrative: bumps; cold sore; felt like flu; tired; sore arm; felt sick; This case was reported by a consumer via call center representative and described the occurrence of influenza like illness in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 5th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 29th October 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 6th June 2019, 1 days after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced influenza like illness, tiredness and pain in arm. On 4th November 2019, the patient experienced cold sores. On 10th November 2019, the patient experienced papular rash. On an unknown date, the patient experienced feeling unwell. On an unknown date, the outcome of the influenza like illness, tiredness, pain in arm and feeling unwell were recovered/resolved and the outcome of the cold sores and papular rash were not recovered/not resolved.   It was unknown if the reporter considered the influenza like illness, tiredness, pain in arm, feeling unwell, cold sores and papular rash to be related to Shingrix. It was unknown if the reporter considered the cold sores and papular rash to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received dose of Shingrix and felt like flu and was tired and had a sore arm. The patient felt sick for about 1 week before the symptoms resolved. On 4th November 2019, the patient experienced cold sore and last night before day of reporting, the patient noticed some bumps coming up on body. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received the first dose of Shingrix about 2 months before and his arm hurt for 2-3 days after the injection. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, 3 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The RN called in to inquire on how to proceed with Shingrix series. The patient broke out with Shingles 3 weeks after receiving 1st dose of Shingrix. The reporter did not consented to follow-up.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Lethargy, Malaise
Clinical narrative: feel tired; inability to lift her arms or legs; Weak; Shaky; overall Malaise; Lethargic; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix. On 15th November 2019, the dose was an unknown dose. On 16th November 2019, 1 days after receiving Shingrix, the patient experienced tiredness, mobility decreased, weakness, tremor, malaise, lethargy and influenza-like symptoms. On 18th November 2019, the outcome of the tiredness, mobility decreased, tremor, malaise, lethargy and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the weakness was recovered/resolved.   It was unknown if the reporter considered the tiredness, mobility decreased, weakness, tremor, malaise, lethargy and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: On Friday, the patient received Shingrix and started to feel tired.  The next day on Saturday he was in bed all day with flu-like symptoms, including the inability to lift his arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. On Sunday, he started to feel better.  All symptoms had resolved and he went in to work. The reporter was unable to provide any additional details and her husband was not home at the time of the call. For tolerances of 2nd dose, refer case US2019AMR230021, reported by same reporter for the same patient.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Tremor
Clinical narrative: feel tired; inability to lift her arms or legs; Weak; Shaky; overall Malaise; Lethargic; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix. On 15th November 2019, the dose was an unknown dose. On 16th November 2019, 1 days after receiving Shingrix, the patient experienced tiredness, mobility decreased, weakness, tremor, malaise, lethargy and influenza-like symptoms. On 18th November 2019, the outcome of the tiredness, mobility decreased, tremor, malaise, lethargy and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the weakness was recovered/resolved.   It was unknown if the reporter considered the tiredness, mobility decreased, weakness, tremor, malaise, lethargy and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: On Friday, the patient received Shingrix and started to feel tired.  The next day on Saturday he was in bed all day with flu-like symptoms, including the inability to lift his arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. On Sunday, he started to feel better.  All symptoms had resolved and he went in to work. The reporter was unable to provide any additional details and her husband was not home at the time of the call. For tolerances of 2nd dose, refer case US2019AMR230021, reported by same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2019, the patient received Shingrix. On 12th December 2019, 5 days after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. The patient had receive the Shingrix vaccine and then he experienced adverse reaction. The reporter denied consent to follow-up.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abnormal dreams, Nervousness, Pain, Parkinson's disease, Somnambulism
Clinical narrative: sleep walking; Parkinson's Disease; Internal tremors; vivid dreams; Ache; This case was reported by a pharmacist via call center representative and described the occurrence of parkinson's disease in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included influenza virus vaccine inactivated (Fluzone Hd) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix and Fluzone Hd at an unknown dose and frequency. On 18th October 2019, 1 days after receiving Shingrix, the patient experienced pain. On 20th October 2019, the patient experienced parkinson's disease (serious criteria GSK medically significant), shaking inside and vivid dreams. On an unknown date, the patient experienced sleep walking. On an unknown date, the outcome of the parkinson's disease, pain, shaking inside, vivid dreams and sleep walking were unknown.   The reporter considered the parkinson's disease, shaking inside and vivid dreams to be related to Shingrix. It was unknown if the reporter considered the pain and sleep walking to be related to Shingrix.  Additional information was provided as follows: The first dose of Shingrix was received and on the next day the patient complained of achiness.  On 20th October 2019 the following Sunday, patient experienced vivid dreams ,then went on to develop interior(Internal) like tremors. The patient was diagnosed with Parkinson's disease. The patient experienced 2 episodes of sleep walking, unsure if still experiencing. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Tremor
Clinical narrative: sleep walking; Parkinson's Disease; Internal tremors; vivid dreams; Ache; This case was reported by a pharmacist via call center representative and described the occurrence of parkinson's disease in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included influenza virus vaccine inactivated (Fluzone Hd) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix and Fluzone Hd at an unknown dose and frequency. On 18th October 2019, 1 days after receiving Shingrix, the patient experienced pain. On 20th October 2019, the patient experienced parkinson's disease (serious criteria GSK medically significant), shaking inside and vivid dreams. On an unknown date, the patient experienced sleep walking. On an unknown date, the outcome of the parkinson's disease, pain, shaking inside, vivid dreams and sleep walking were unknown.   The reporter considered the parkinson's disease, shaking inside and vivid dreams to be related to Shingrix. It was unknown if the reporter considered the pain and sleep walking to be related to Shingrix.  Additional information was provided as follows: The first dose of Shingrix was received and on the next day the patient complained of achiness.  On 20th October 2019 the following Sunday, patient experienced vivid dreams ,then went on to develop interior(Internal) like tremors. The patient was diagnosed with Parkinson's disease. The patient experienced 2 episodes of sleep walking, unsure if still experiencing. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Local injection site reaction; This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was resolved with sequelae.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient experienced local injection site reaction after vaccination. This case has been linked with the cases US2019AMR231309 and US2019230529, reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: Patient given vaccine on 12/05/2019 - right gluteal (at patient's request-did not want deltoid injection), patient reported to ER on 12/13/19 with cellulitis/right gluteal area - given keflex 500 mg q6 hours to finish 7 day course from emergency room.  Seen in follow up on 12/16/19-SKIN large area of pink/erythema well demaracated over majority of right glute, no TTP. Advised to finished Keflex as prescribed. Seen again on 12/20/19-SKIN no suspicious lesions in exposed areas of skin, warm and dry, the area on the right buttocks where injection was is clean without induration or swelling. There is slight tenderness to deep palpation.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Mobility decreased, Pyrexia
Clinical narrative: PT EXPERIENCED SIGNIFICANT INJECTION SITE REDNESS AND PAIN (UNABLE TO LIFT ARM THE FIRST 24 HOURS AFTER. HE EXPERIENCED CHILLS AND FEVER UP TO 103 DEGREES.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: not known adverse event; a patient received an expired dose of M-M-R; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On 05-DEC-2019, the patient was vaccinated an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, lot # N034411, expiration date 04-DEC-2019 (dose and route of administration were not provided) for prophylaxis. No adverse event was reported.   The outcome was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune hepatitis, Systemic lupus erythematosus
Clinical narrative: Lupus; autoimmune hepatitis; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In or around 03-NOV-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In approximately December 2016 (approximately one month after receiving the vaccine), the pt suffered and was diagnosed with lupus and autoimmune hepatitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt was looking for compensatory damages for past, present, and future damages, including but not limited to pain and suffering for severe and permanent personal injuries, health and medical care costs, lost wages, together with interest and costs as provided by law.   The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, lupus and autoimmune hepatitis were considered to be disabling and medically significant events.
Sex: M
Vaccine: PPV
Symptoms: Death, Fatigue, Gastrointestinal haemorrhage, Packed red blood cell transfusion, Pneumonia bacterial
Clinical narrative: gastrointestinal bleed; bacterial pneumonia; failure of his lungs and kidneys; failure of his lungs and kidneys; died; nursing center; fatigue; adverse event; This spontaneous report was received from a consumer (a patient's wife) and refers to a male patient of unknown age. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided.   On an unspecified date in 2000, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, frequency, route of administration, lot# and expiration dates were not provided) for prophylaxis. On an unknown date in 2017, he received second dose (lot # and expiry date were not provided).  On an unspecified date in 2017, the patient experienced adverse event. On an unspecified date, the patient experienced gastrointestinal bleeding and was hospitalized, he received two units of packed red blood cells. During this stay, in 2019, the patient received his third dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot # and expiry date were not provided) and unspecified "flu shot". On an unspecified date in 2019, after about three weeks after being discharged from the hospital, the patient started experiencing fatigue. The patient sought medical attention and was admitted to the hospital for a second time, where he was diagnosed with bacterial pneumonia. The patient was given unspecified antibiotics and experienced failure of his lungs and kidneys (approximately in 2019, exact date was not provided). On an unspecified date in 2019, the patient died, after being transferred to nursing center. Cause of death was not reported. It was unknown if an autopsy was performed. The outcome of pneumonia bacterial, fatigue, gastrointestinal haemorrhage, renal failure and respiratory failure was reported as not recovered/not resolved. The outcome of adverse event was unknown. The causality assessment between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events was not provided.  Upon internal review, the events of renal failure, respiratory failure, pneumonia bacterial and gastrointestinal haemorrhage were determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Renal failure, Respiratory failure
Clinical narrative: gastrointestinal bleed; bacterial pneumonia; failure of his lungs and kidneys; failure of his lungs and kidneys; died; nursing center; fatigue; adverse event; This spontaneous report was received from a consumer (a patient's wife) and refers to a male patient of unknown age. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided.   On an unspecified date in 2000, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(strength, frequency, route of administration, lot# and expiration dates were not provided) for prophylaxis. On an unknown date in 2017, he received second dose (lot # and expiry date were not provided).  On an unspecified date in 2017, the patient experienced adverse event. On an unspecified date, the patient experienced gastrointestinal bleeding and was hospitalized, he received two units of packed red blood cells. During this stay, in 2019, the patient received his third dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot # and expiry date were not provided) and unspecified "flu shot". On an unspecified date in 2019, after about three weeks after being discharged from the hospital, the patient started experiencing fatigue. The patient sought medical attention and was admitted to the hospital for a second time, where he was diagnosed with bacterial pneumonia. The patient was given unspecified antibiotics and experienced failure of his lungs and kidneys (approximately in 2019, exact date was not provided). On an unspecified date in 2019, the patient died, after being transferred to nursing center. Cause of death was not reported. It was unknown if an autopsy was performed. The outcome of pneumonia bacterial, fatigue, gastrointestinal haemorrhage, renal failure and respiratory failure was reported as not recovered/not resolved. The outcome of adverse event was unknown. The causality assessment between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) and the events was not provided.  Upon internal review, the events of renal failure, respiratory failure, pneumonia bacterial and gastrointestinal haemorrhage were determined to be medically significant.
Sex: M
Vaccine: FLUX, MENB
Symptoms: Adverse reaction, Erythema, Lymphadenopathy, Pain
Clinical narrative: had a reaction to vaccine; She stated there was pain, redness and lymph; She stated there was pain, redness and lymph node swelling; She stated there was pain, redness and lymph node swelling; This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Bexsero and not applicable after receiving Flu vaccine, the patient experienced adverse reaction, pain, erythema and enlargement of lymph nodes. On an unknown date, the outcome of the adverse reaction was recovered/resolved and the outcome of the pain, erythema and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Bexsero. It was unknown if the reporter considered the pain, erythema and enlargement of lymph nodes to be related to Flu vaccine.  Additional details were provided as follows: The age at vaccintion was not reported. The nurse stated that, the patient received dose of Bexsero and experienced adverse reaction to vaccine. The nurse stated that, it was most likely from immune response, that the patient had other reactions to various vaccines including flu like, pain, redness and lymph node swelling. Immediately after shared the information, the nurse had to leave to tend to the patients. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Incorrect route of product administration
Clinical narrative: cellulitis; wrong route of; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a male patient who received Herpes zoster (Shingrix) (batch number 5552S, expiry date 26th February 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, 2 days after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant) and intramuscular formulation administered by other route. The patient was treated with ibuprofen (Motrin) and antibiotics nos. On an unknown date, the outcome of the cellulitis was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a potential cellulitis after receiving Shingrix. The patient received Shingrix subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route. The patient was treated with ice and Motrin, might have also received antibiotics (reporter was unsure).
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: pain, redness and swelling, headache, shivering, tiredness.  Last 24 hours. Tylenol 500mg/twice a day
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: pain, redness and swelling, headache, shivering, tiredness.  Last 24 hours. Tylenol 500mg/twice a day
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction
Clinical narrative: pain, redness and swelling, headache, shivering, tiredness.  Last 24 hours. Tylenol 500mg/twice a day
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Constipation, Diarrhoea, Fatigue
Clinical narrative: Six hrs after injection I began to feel a malaise that intensified such that the following morning, I had to cancel a meeting.  About 24 hrs after injection, I began to experience intestinal distress with periods of cramps. The distress came in the form of either diarrhea or constipation where each alternating symptom would last for several days. The severity of the symptoms became less intense after about 30 days. However, the symptoms 60 days later are less severe but still continue. There is also a lack of energy that persists, and tiredness.  The feeling is my sense that I'm not fully free of the effects that began after the injection. On the day of the injection, my wife also had the shingrix and fluzone vaccine, and my son had just the fluzone. My wife has experienced similar symptoms to myself which also continue 60 days later. My son did not have any symptoms from which we inferred the Shingrix was the cause of our symptoms and not the Fluzone.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Gastrointestinal pain, Malaise
Clinical narrative: Six hrs after injection I began to feel a malaise that intensified such that the following morning, I had to cancel a meeting.  About 24 hrs after injection, I began to experience intestinal distress with periods of cramps. The distress came in the form of either diarrhea or constipation where each alternating symptom would last for several days. The severity of the symptoms became less intense after about 30 days. However, the symptoms 60 days later are less severe but still continue. There is also a lack of energy that persists, and tiredness.  The feeling is my sense that I'm not fully free of the effects that began after the injection. On the day of the injection, my wife also had the shingrix and fluzone vaccine, and my son had just the fluzone. My wife has experienced similar symptoms to myself which also continue 60 days later. My son did not have any symptoms from which we inferred the Shingrix was the cause of our symptoms and not the Fluzone.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Local reaction, Nausea, Pain in extremity, Swelling
Clinical narrative: Patient calling office c/o right arm pain, swelling nausea, dizziness, blurry vision.  Patient sent to Urgent Care. At Urgent care patient was transferred to ER d/t localized reaction to immunization vs TIA.  At patient was worked up and sent home with adverse reaction to immunization.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication, Vision blurred
Clinical narrative: Patient calling office c/o right arm pain, swelling nausea, dizziness, blurry vision.  Patient sent to Urgent Care. At Urgent care patient was transferred to ER d/t localized reaction to immunization vs TIA.  At patient was worked up and sent home with adverse reaction to immunization.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Lethargy, Myalgia, Pyrexia
Clinical narrative: The same evening that the patient recieved the vaccine she felt muscle aches all over, lethargy, fever, rash at the injection site
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abdominal discomfort, Asthenia, Constipation, Diarrhoea, Fatigue
Clinical narrative: Six hrs after injection I began to feel a malaise that intensified such that the following morning, I had to cancel a meeting.   About 24 hrs after injection, I began to experience intestinal distress with periods of cramps. The distress came in the form of either diarrhea or constipation where each alternating symptom would last for several days. The severity of the symptoms became less intense after about 30 days. However, the symptoms 60 days later are less severe but still continue. There is also a lack of energy that persists, and tiredness.  The feeling is my sense that I'm not fully free of the effects that began after the injection. On the day of the injection, my wife also had the shingrix and fluzone vaccine, and my son had just the fluzone. My wife has experienced similar symptoms to myself which also continue 60 days later. My son did not have any symptoms from which we inferred the Shingrix was the cause of our symptoms and not the Fluzone.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Gastrointestinal pain, Loss of personal independence in daily activities, Malaise
Clinical narrative: Six hrs after injection I began to feel a malaise that intensified such that the following morning, I had to cancel a meeting.   About 24 hrs after injection, I began to experience intestinal distress with periods of cramps. The distress came in the form of either diarrhea or constipation where each alternating symptom would last for several days. The severity of the symptoms became less intense after about 30 days. However, the symptoms 60 days later are less severe but still continue. There is also a lack of energy that persists, and tiredness.  The feeling is my sense that I'm not fully free of the effects that began after the injection. On the day of the injection, my wife also had the shingrix and fluzone vaccine, and my son had just the fluzone. My wife has experienced similar symptoms to myself which also continue 60 days later. My son did not have any symptoms from which we inferred the Shingrix was the cause of our symptoms and not the Fluzone.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Chills, Condition aggravated, Feeding disorder, Headache
Clinical narrative: Headache ,body aches, 10 times the flu, chills, unable to eat, nausea, body asthma , injection site pain, reaction to site, soze of a grapefruit itching and throbbing pain, even pain upon administering shot
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Headache ,body aches, 10 times the flu, chills, unable to eat, nausea, body asthma , injection site pain, reaction to site, soze of a grapefruit itching and throbbing pain, even pain upon administering shot
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Headache ,body aches, 10 times the flu, chills, unable to eat, nausea, body asthma , injection site pain, reaction to site, soze of a grapefruit itching and throbbing pain, even pain upon administering shot
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Extensive swelling of vaccinated limb, Fatigue, Feeling cold
Clinical narrative: Headache ,body aches, 10 times the flu, chills, unable to eat, nausea, body asthma , injection site pain, reaction to site, soze of a grapefruit itching and throbbing pain, even pain upon administering shot
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hot flush, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Headache ,body aches, 10 times the flu, chills, unable to eat, nausea, body asthma , injection site pain, reaction to site, soze of a grapefruit itching and throbbing pain, even pain upon administering shot
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Loss of personal independence in daily activities, Malaise, Pain, Tenderness
Clinical narrative: Headache ,body aches, 10 times the flu, chills, unable to eat, nausea, body asthma , injection site pain, reaction to site, soze of a grapefruit itching and throbbing pain, even pain upon administering shot
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse effects were reported in the patient.; a patient received an improerly stored dose of PROQUAD; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 05-NOV-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot #: S012472, expiration date: 20-OCT-2020; strength, frequency, route and dose details were unknown) for prophylaxis (product storage error).         The vaccine was stored between 6 degrees Fahrenheit to 14 degrees Fahrenheit (7.9 degrees Fahrenheit) (-14 degrees Celsius to -10 degrees Celsius) for 20 minutes. There was previous temperature excursion included between 6 degrees Fahrenheit to 14 degrees Fahrenheit (8.2 degrees Fahrenheit) (-14 degrees Celsius to -10 degrees Celsius) for 40 minutes. The digital data logger was involved. No other adverse effects were reported to the patient.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Diarrhoea, Gastrooesophageal reflux disease, Pain
Clinical narrative: Unbelievable gastric reflux/Coughing up stomach acid; Diarrhea; Body aches with pain; This is a spontaneous report based on the information received by Pfizer from company (Ref.# PFT-000448560). A contactable female consumer reported for herself.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on an unspecified date for immunisation.   The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced unbelievable gastric reflux, diarrhea, body aches with pain, coughing up stomach acid.  The outcome of the events was unknown.  Information for Lot/Batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Muscle spasms, Myalgia
Clinical narrative: extreme pain in her back and arms; the area she got the vaccine was still red; The area where the injection site is red is still a bit hard and swollen; The area where the injection site is red is still a bit hard and swollen; muscle spasms; extreme pain in her back and arms; muscle pain; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer. A 62-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria 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 includes ongoing ankylosing spondylitis and neurologic issues. The patient was not in any medication for ankylosing spondylitis, the reason why the doctor gave her the vaccine. Concomitant medications were not reported. On an unspecified date, since her vaccination in Dec2019, the patient has been experiencing extreme muscle pain going into her back and the area she got the vaccine was still red and it's been a week. The patient added that area of the injection site was red and was still a bit hard and swollen. The patient thought that the injection caused muscle spasms that got into her trapezius muscle in the back. The patient was taking periodic muscle relaxants to try and relieve the muscle pains in addition to having Ankylosing spondylitis which causes extreme pain in her back and arms. The patient added that she has neurologic issues as a result of what's going on with her spine. The patient reported that the physician was looking to put her on Consentyx. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Never experienced anything like this, this was extremely painful and the worst being limitation of arm movement; Never experienced anything like this, this was extremely painful and the worst being limitation of arm movement; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiration date were unknown), via an unspecified route of administration in the arm on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received influenza vaccine years ago for immunization and would have a little fever and soreness. It was reported that the patient had all the vaccines for years and never experienced anything like this, this was extremely painful and the worst being limitation of arm movement.  Today had 95% range of motion, yesterday 85 % range of motion. The outcome of the events was unknown. The patient asked what the carrier for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) was. The physician also asked how long was the average for arm limitation.  Information on lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: limitation of movement of left arm/she was unable to use her arm for the entire week/She had limitation of movement/Her arm was immobile for 3 days; Low grade fever; Pain in the left arm/tenderness at the site; swelling in the left arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable 75-year-old Female Physician reported for herself that she received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at deltoid left on 09Dec2019 around 13: 00 at single dose for immunization at physician office. Medical history and concomitant medications were none. After she received the vaccine on 09Dec2019, she was unable to use her arm for the entire week. Her arm was immobile for 3 days, pain and swelling in the left arm. She had a low grade fever for 3 days and it was tender. She had limitation of movement of left arm. It still hurt but she had 95% function back again. She said that the events started within a few hours of receiving the vaccine. Swelling was gone. She still had tenderness at the site. The reporter seriousness for limitation of movement of left arm was medically significant. The outcome of the limitation of movement of left arm was resolving, the outcome of low grade fever was resolved on 12Dec2019, pain in the left arm was not resolved, swelling in the left arm was resolved in Dec2019.; Sender's Comments: Based on the information currently available, a contributory role of the suspected vaccine towards the occurrence of events cannot be fully exclu considering the temporal association and the known adverse event profile of the suspect vaccine.  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: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: limitation of movement of left arm/she was unable to use her arm for the entire week/She had limitation of movement/Her arm was immobile for 3 days; Low grade fever; Pain in the left arm/tenderness at the site; swelling in the left arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable 75-year-old Female Physician reported for herself that she received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at deltoid left on 09Dec2019 around 13: 00 at single dose for immunization at physician office. Medical history and concomitant medications were none. After she received the vaccine on 09Dec2019, she was unable to use her arm for the entire week. Her arm was immobile for 3 days, pain and swelling in the left arm. She had a low grade fever for 3 days and it was tender. She had limitation of movement of left arm. It still hurt but she had 95% function back again. She said that the events started within a few hours of receiving the vaccine. Swelling was gone. She still had tenderness at the site. The reporter seriousness for limitation of movement of left arm was medically significant. The outcome of the limitation of movement of left arm was resolving, the outcome of low grade fever was resolved on 12Dec2019, pain in the left arm was not resolved, swelling in the left arm was resolved in Dec2019.; Sender's Comments: Based on the information currently available, a contributory role of the suspected vaccine towards the occurrence of events cannot be fully exclu considering the temporal association and the known adverse event profile of the suspect vaccine.  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: 93.0
Sex: M
Vaccine: FLU4
Symptoms: Feeling abnormal, General physical health deterioration, Hospice care, Incontinence, Loss of personal independence in daily activities
Clinical narrative: Patient received flu shot on Wednesday, 10/30/19. On 12/2/19, patient was admitted to emergency room with incontinence, feeling poorly, and being unable to care for self.  Patient was later admitted to nursing home for continued care.  On 12/5, patient was admitted to hospice/end of life care due to his heart block, Hodgkin's lymphoma, as well as his untreated AAA. Patient's daughter requested we submit an adverse event report due to the timing of the immunization and decline in health.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Arm pain, not as bad as first Shingrix.  Severe shivers, body ache, headache, tiredness all day on 12/22/2019.  Weakness still on 12/23/2019.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain, not as bad as first Shingrix.  Severe shivers, body ache, headache, tiredness all day on 12/22/2019.  Weakness still on 12/23/2019.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities, Pain
Clinical narrative: Pain in L shoulder started 2-3 hrs after flu vaccine.  Describes pain as pain with any abduction of her shoulder.  No redness or swelling.  Prevents her from doing her usual activities.  Instructed to use warm pack, ibuprofen and referred for physical therapy for range of motion.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Product administered at inappropriate site
Clinical narrative: Shot was given very high up in arm.  Within 1 hour had severe pain in shoulder and couldn't raise my arm. Can't sleep at night pain is so bad.  Talked to nurse that gave me the shot next morning and she said it would be sore for awhile.  Told her it was pain not sore and I would give it a couple days.  Seen PA on November 12,2019 was still having severe pain and hard time raising my arm. Was put on a Medrol dose. On November 18, 2019 done with steriod and still not better so was referred to and orthopedic doctor. Seen the orthopedic Dr on November 19,2019 and the results were shot was given in the nerve not the muscle! No treatment said it would take time could be weeks or months before pain goes away.  60 days later still have pain and can't raise arm above head.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Rash
Clinical narrative: Patient stated she had allergic total body rash. First rx filled for this was 12/13, 2nd 12/18/19 and 3rd 12/21/2019 -
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Palpitations, Pyrexia, Vaccination complication
Clinical narrative: Pt daughter informed me yesterday that pt had severe rxn to imz.  Fever 108, pain all over body, and palpitations.  She had to be taken to hospital by ambulance but has since been released and is feeling better.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cerebrovascular accident, Disorientation, Laboratory test, Nausea, Pain in extremity
Clinical narrative: Patient experienced arm soreness and swelling from elbow to shoulder on 12-4-19.  Patient reported to urgent care and emergency room after experiencing  "stroke-like" symptoms (patient experienced nausea, disorientation) later that week.
Age: 74.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient experienced arm soreness and swelling from elbow to shoulder on 12-4-19.  Patient reported to urgent care and emergency room after experiencing  "stroke-like" symptoms (patient experienced nausea, disorientation) later that week.
Sex: F
Vaccine: FLUN4
Symptoms: Headache, Muscular weakness, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: FEVER; VOMITING; MUSCLE WEAKNESS; HEADACHE; SORE THROAT; A spontaneous report has been received from a consumer via the regulatory authority concerning a 10 year old female patient with height of 148 centimetres and with weight of 32 kilograms.    No medical history was reported. No concomitant products were reported.    On 27-Nov-2019, the patient started receiving a treatment with Fluenz Tetra (influenza virus vaccine live, intranasal) 0.2 ml unknown, via nasal route, for flu vaccination.     On 30-Nov-2019, the patient experienced sore throat (preferred term: Oropharyngeal pain) and headache (preferred term: Headache). On 01-DEC-2019, the patient experienced fever (preferred term: Pyrexia), vomiting (preferred term: Vomiting) and muscle weakness (preferred term: Muscular weakness).     At the time of reporting, the event of fever, sore throat, vomiting, muscle weakness and headache was ongoing.     The events were considered serious (disability and important medical event) by the reporter.; Sender's Comments: Oropharyngeal pain, vomiting and muscular weakness are not listed in the company core data sheet for Q/LAIV (Fluenz Tetra). Pyrexia has been associated with use of LAIV in children but not in adults.  Due to limited information on concurrent diseases, concomitant medication, relevant medical history, risk factors (respiratory infections), etiologic and diagnostic workup, it is not possible to make conclusive assessment of causal relationship of events with suspect drug.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No symptoms reported; PNEUMOVAX 23 was leaking from where the needle attaches to the hub; the patient was unable to receive the full dose of PNEUMOVAX; PQC: YES; This spontaneous report was received from a registered nurse and refers to a 66-year-old patient of un unknown gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided. On 02-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S006777, expiration date 28-NOV-2020, intramuscular (dose was not provided) for prophylaxis. The pre-filled syringe of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was leaking from where the needle attached to the hub. The leaking occurred when the nurse was giving the injection. The patient was unable to received the full dose of the vaccine, because of the leaking. No symptoms were reported.   The outcome was unknown.
Sex: U
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: no adverse event; expired diluent administered; reconstituted with expired diluent; This spontaneous report was received from a pharmacy student regarding a patient of unknown gender and age. Information on patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 09-DEC-2019, the patient inadvertently received Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot# S018593 with expiry date of 17-JUN-2021 reconstituted with expired sterile diluent (DILUENT MRK) lot# M009800 with expiry date of 12-SEP-2018 for prophylaxis (dose and route of administration was not reported) (Product preparation issue and Expired product administered). No adverse effects were reported. No product quality complaint (PQC) was reported.