chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: FLUX
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves a two years old patient who administered a 0.5 ml dose of Influenza Quadrival A-B Vaccine instead of a 0.25 ml. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Overdose. It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a four years old patient who was received 0.5 ml dose  of QUADRACEL (batch number, expiry date not reported) via subcutaneous instead of intramuscularly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Inappropriate route of vaccination. It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who received vaccine MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On 13-Nov-2014, at the age of 14 yrs. the patient received a second dose 0.5ml of suspect MENACTRA lot U4833CA, expiry date 15-Jan-2016 via unknown route in the right deltoid. On unknown date, at the age of 11 yrs. he also received a first dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On unknown dated, at the age of 18 yrs. he also received a third dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. It was an actual medication error due to extra dose administered. It was reported that patient received 3 doses total of MENACTRA, at ages 11y, 14y, and 18y. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Injection site pain, Injection site rash, Pain
Clinical narrative: Pain began hours after receiving the injection. The next day (1/13/19) she wore a long sleeve shirt and did not notice the rash. Rash and pain is below the injection site, into the muscle and up into the armpit. Feels like she pulled the entire muscle.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Injection site pain, redness, general aching, weakness, second day-insatiable thirst and sweating, general tiredness, by 5th day, symptoms have subsided, 7th day, no residual effects or soreness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Thirst
Clinical narrative: Injection site pain, redness, general aching, weakness, second day-insatiable thirst and sweating, general tiredness, by 5th day, symptoms have subsided, 7th day, no residual effects or soreness.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Computerised tomogram head normal, Dyskinesia, Eye movement disorder, Pyrexia, Seizure
Clinical narrative: 1 minute seizure with eyes deviated, left leg rhythmic movements. Seen at the ER. Normal head CT. No other fevers, seizures or other symptoms since event. Fever of 102.2 F noted prior to seizure.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose, Body temperature decreased, Cardiac arrest, Cyanosis, Death
Clinical narrative: Per ER report, patient received his Flu vaccine at his 9 month well check. Parents took him home. He fed and then went down for a nap. One to two hours later mother reports finding the child cyanotic and unresponsive. EMS called and found him in asystole. EMS attempted resuscitation en route to ER by placing IO and attempted intubation. He was given epinephrine x 2. CPR continued in the ED. Warmed to 35.4, intubated with 3.5 cuffed ET and received multiple rounds of epinephrine. Chest compressions were recorded for 18 minutes. Time of death was called at 1814.
Age: 0.75
Sex: M
Vaccine: FLU4
Symptoms: Endotracheal intubation, Resuscitation, Unresponsive to stimuli
Clinical narrative: Per ER report, patient received his Flu vaccine at his 9 month well check. Parents took him home. He fed and then went down for a nap. One to two hours later mother reports finding the child cyanotic and unresponsive. EMS called and found him in asystole. EMS attempted resuscitation en route to ER by placing IO and attempted intubation. He was given epinephrine x 2. CPR continued in the ED. Warmed to 35.4, intubated with 3.5 cuffed ET and received multiple rounds of epinephrine. Chest compressions were recorded for 18 minutes. Time of death was called at 1814.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 04-FEB-2016, a pharmacist administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 07-AUG-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Initial information received on 07-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 28 years old female patient who received a partial dose/less than 0.5 ml of vaccine TYPHIM VI (lot number: N1K81(M), reporter had trouble reading the lot number, expiry date: Oct-2019) via intramuscular in the unknown administration site (also reported as right) on 05-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HAVRIX for Immunisation. It was a case of actual medication error due to vaccine underdose. It was also a case of syringe issue because the administrating pharmacist had difficulty removing the cap off of the prefilled syringe and it stripped the top somehowneedle attached to the top, however the vaccine leaked from  the hub. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 22.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Initial information received on 08-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 22 years old female patient who was vaccinated with MENACTRA (lot details, dose, route and site of administration were not reported) instead of MENINGOCOCCAL VACCINE B. The patient's past vaccination(s) included MENACTRA in 2008 and 2013. It was an actual medication error due to wrong vaccine administered and extra dose administered. It was reported that that she received a meningitis A,C,Y,W-135 vaccine in 2008, another in 2013, and again in 2017. One of them was supposed to be a meningitis B vaccine, but they gave her the same one again. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 82.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Injection site pain, Peripheral swelling, Pruritus
Clinical narrative: Pain at injection site that resolves but started to have redness and swelling in the arm. No shortness of breath. Has intense itching.
Age: 0.42
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None. Parent and child will do international travel.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Irritability
Clinical narrative: Beginning about 2-3 hrs after shots were administered the baby cried and was inconsolable for approx. 3 hrs. Mother spoke with medical through Hospital during this time (three different times). Mom stated that at some point during the crying she was extremely concerned about his breathing. Took him to hospital in which he was diagnosed with "fussy infant". His crying resolved during the ED visit. No further intervention was needed.
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: We called the patients mother and let her know what had happened and asked if patient has had any signs or symptoms the patients mother said no.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: The whole left arm is in pain since Dec. 4. I have seen my Doctor and I was told that this abnormal. I went to pharmacy to complain and the nurse who gave me the shot apologize and told me that she gave me the shot in the wrong location in my arm. I need a resolution to this situation as my Doctor cannot treat me.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain, Pyrexia, Tracheal disorder
Clinical narrative: The patient came to the Pharmacy on January 12 2019 and told the me (pharmacist) that the vaccine SHINGRIX given to him on 11/17/2018 gave him some reactions, ten hours after the shot was given. He complained about shortness of breath, narrowing of his trachea, fever and body pain. He went to the Dr and the Dr. told him to take a BENADRYL 50 mg capsule and not to take the second dose.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness, Seizure like phenomena, Syncope
Clinical narrative: Patient passed out immediately after being given the shot while lying down. Had some seizure-like activity during syncope.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: I received shot about 10:30 AM. About an hour later I noticed soreness and itching. About 12:00 PM arm was paiful, hot and swollen. Also redness expanded to half of upper arm. By the night, arm was swollen 2 times size and hot and red whole upper arm and pain. By 4:00 PM arm was very swollen and painful. By 6:30 very red and large swelling (no temp). Took 2 ADVIL for pain.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: I received shot about 10:30 AM. About an hour later I noticed soreness and itching. About 12:00 PM arm was paiful, hot and swollen. Also redness expanded to half of upper arm. By the night, arm was swollen 2 times size and hot and red whole upper arm and pain. By 4:00 PM arm was very swollen and painful. By 6:30 very red and large swelling (no temp). Took 2 ADVIL for pain.
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did not experience adverse reaction. Pt was given TDAP in error. He should've received DTAP.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed vocational nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications, was not reported. On 08-JAN-2019 (also reported as 08-JAN-2018), the patient was vaccinated with an expired dose of VARIVAX and with the sterile diluent, subcutaneously, lot # M042858 and expiration date 21-OCT-2018, (dose and frequency were not provided), for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse drug reaction in a adult patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown. It was unknown if the reporter considered the adverse drug reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had first dose of SHINGRIX at doctor's office in November 2018 and no side effects except expected ones. For tolerance to the 2nd dose of SHINGRIX, refer case US2019GSK001365.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 18-year-old female patient who received BEXSERO for prophylaxis. Concurrent medical conditions included latex allergy. On 3rd January 2019, the patient received the 1st dose of BEXSERO. On 3rd January 2019, less than a day after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb and injection site burning. The patient was treated with BENADRYL. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown and the outcome of the injection site burning was recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site burning to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO was 1st dose of series. After leaving office the patients arm burned and was swollen from shoulder to elbow (extensive swelling of vaccinated limb). The reaction occurred in time between the patient received the vaccine and got in the car to go home. The patient was treated at home with BENADRYL. The office followed up with the patient in 24 hours and the patient reported that the burning and swelling was gone but there was still a little pain. The reporter stated that, there were no respiratory symptoms and symptoms were localized to the injection arm only. The reporter did not agreed to follow up from GlaxoSmithKline. No further medical follow up required.
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Asthenia, Depressed mood
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a female patient who received Hepatitis A vaccine for prophylaxis. Concurrent medical conditions included brace user. On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful were unknown. It was unknown if the reporter considered the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving the Hepatitis A vaccine in right arm, the patient experienced extreme tiredness drive down. Eyes hard to keep open. Right wrist was hurted badly, palm was also hurted. The patient forgot brace at home (patient had not enough sleep prior night, hard to wake up), little stressful. The patient's weight went back to 201 (unknown units). The patient experienced shot hurt, and arm hot at injection site. She ate and was walking around the patient, felt little stressful (maybe suspicious looking and followed). The patient was anxious and would get in trouble to drove home, had to get concentrate new brace helped, but still right shoulder, wrist hurting bad and Hurting all over. After household work shoulder hurt was increased. The patient had supper chicken strips. The patient was hurt all over shoulder, wrist, stomach, acid reflux was bad. Felt very nauseous and weak terrible. Finally started to pass. Showered, which helped in bed. The patient had Headache, hurting still, but not as bad.
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Feeling abnormal, Gastrooesophageal reflux disease, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a female patient who received Hepatitis A vaccine for prophylaxis. Concurrent medical conditions included brace user. On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful were unknown. It was unknown if the reporter considered the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving the Hepatitis A vaccine in right arm, the patient experienced extreme tiredness drive down. Eyes hard to keep open. Right wrist was hurted badly, palm was also hurted. The patient forgot brace at home (patient had not enough sleep prior night, hard to wake up), little stressful. The patient's weight went back to 201 (unknown units). The patient experienced shot hurt, and arm hot at injection site. She ate and was walking around the patient, felt little stressful (maybe suspicious looking and followed). The patient was anxious and would get in trouble to drove home, had to get concentrate new brace helped, but still right shoulder, wrist hurting bad and Hurting all over. After household work shoulder hurt was increased. The patient had supper chicken strips. The patient was hurt all over shoulder, wrist, stomach, acid reflux was bad. Felt very nauseous and weak terrible. Finally started to pass. Showered, which helped in bed. The patient had Headache, hurting still, but not as bad.
Sex: F
Vaccine: HEPA
Symptoms: Injection site warmth, Insomnia, Musculoskeletal pain, Nausea, Pain
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a female patient who received Hepatitis A vaccine for prophylaxis. Concurrent medical conditions included brace user. On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful were unknown. It was unknown if the reporter considered the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving the Hepatitis A vaccine in right arm, the patient experienced extreme tiredness drive down. Eyes hard to keep open. Right wrist was hurted badly, palm was also hurted. The patient forgot brace at home (patient had not enough sleep prior night, hard to wake up), little stressful. The patient's weight went back to 201 (unknown units). The patient experienced shot hurt, and arm hot at injection site. She ate and was walking around the patient, felt little stressful (maybe suspicious looking and followed). The patient was anxious and would get in trouble to drove home, had to get concentrate new brace helped, but still right shoulder, wrist hurting bad and Hurting all over. After household work shoulder hurt was increased. The patient had supper chicken strips. The patient was hurt all over shoulder, wrist, stomach, acid reflux was bad. Felt very nauseous and weak terrible. Finally started to pass. Showered, which helped in bed. The patient had Headache, hurting still, but not as bad.
Sex: F
Vaccine: HEPA
Symptoms: Pain in extremity, Somnolence, Stress
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a female patient who received Hepatitis A vaccine for prophylaxis. Concurrent medical conditions included brace user. On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful. The patient was treated with medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful were unknown. It was unknown if the reporter considered the general body pain, tiredness, wrist pain, pain in hand, nausea, weakness, esophageal acid reflux, shoulder pain, anxiety, injection site warmth, stress, sleeplessness, hard to awaken, stomach pain, headache, feeling sad, injection site pain and feels awful to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving the Hepatitis A vaccine in right arm, the patient experienced extreme tiredness drive down. Eyes hard to keep open. Right wrist was hurted badly, palm was also hurted. The patient forgot brace at home (patient had not enough sleep prior night, hard to wake up), little stressful. The patient's weight went back to 201 (unknown units). The patient experienced shot hurt, and arm hot at injection site. She ate and was walking around the patient, felt little stressful (maybe suspicious looking and followed). The patient was anxious and would get in trouble to drove home, had to get concentrate new brace helped, but still right shoulder, wrist hurting bad and Hurting all over. After household work shoulder hurt was increased. The patient had supper chicken strips. The patient was hurt all over shoulder, wrist, stomach, acid reflux was bad. Felt very nauseous and weak terrible. Finally started to pass. Showered, which helped in bed. The patient had Headache, hurting still, but not as bad.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced injection site pain after receiving 1st dose of SHINGRIX. For tolerance of 2nd dose, refer case US2019GSK000771.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old male patient who received SHINGRIX for prophylaxis. On 3rd January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd January 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and tiredness. On an unknown date, the outcome of the injection site pain and tiredness were unknown. It was unknown if the reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient experienced feeling the medicine going into his tissue during the injection, soreness at the injection site and feeling tired. The patient had taken ibuprofen for the soreness. The patient declined to provide full demographics details only gave phone and zip code. The patient received 1st dose of SHINGRIX on 4th January 2019 was erroneously mentioned. The reporter did not gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sweating in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 hrs after receiving SHINGRIX, the patient experienced sweating, chills, pain in arm, fever, cough and headache. On an unknown date, the outcome of the sweating, chills, pain in arm, fever, cough and headache were recovered/resolved. It was unknown if the reporter considered the sweating, chills, pain in arm, fever, cough and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. About 3 hours post vaccination the patient experienced sweating and chills which lasted for 1 day and pain in the arm which lasted for 5 days. Next day the patient experienced low fever of 100.4 degrees which lasted for 1 day, along with cough and headache which lasted for 3 days. The caller did not want to provide any additional information. Lab Comments: lab test performed on an unknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sweating in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 3 hrs after receiving SHINGRIX, the patient experienced sweating, chills, pain in arm, fever, cough and headache. On an unknown date, the outcome of the sweating, chills, pain in arm, fever, cough and headache were recovered/resolved. It was unknown if the reporter considered the sweating, chills, pain in arm, fever, cough and headache to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. About 3 hours post vaccination the patient experienced sweating and chills which lasted for 1 day and pain in the arm which lasted for 5 days. Next day the patient experienced low fever of 100.4 degrees which lasted for 1 day, along with cough and headache which lasted for 3 days. The caller did not want to provide any additional information. Lab Comments: lab test performed on an unknown date.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Hypertension, Laboratory test, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2019GSK004286). On 29th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nausea, chills, generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath. The patient was treated with Intravenous Fluids. On an unknown date, the outcome of the nausea and chills were recovered/resolved and the outcome of the generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath were not recovered/not resolved. It was unknown if the reporter considered the nausea, chills, generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath to be related to SHINGRIX. Additional details were provided as follows: The patient experienced nausea, chills for 2 days, itching, tingling, pin pricking pain all over her body with no sign of rash or discoloration. The patient also experienced high blood pressure and shortness of breath. The patient was referred to the emergency room and on 3rd January 2019, the patient was seen and administered IV fluids. The patient was tested for infection and then released to home without admission. The reporter had consented to follow up. The case has been linked with case US2019GSK004286 for the same patient reported by the same reporter. Lab Comments: The patient was referred to emergency room and tested for infection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Pruritus generalised
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 66-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (for tolerance of 1st dose refer case US2019GSK004286). On 29th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nausea, chills, generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath. The patient was treated with Intravenous Fluids. On an unknown date, the outcome of the nausea and chills were recovered/resolved and the outcome of the generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath were not recovered/not resolved. It was unknown if the reporter considered the nausea, chills, generalized pruritus, tingling, general body pain, blood pressure high and shortness of breath to be related to SHINGRIX. Additional details were provided as follows: The patient experienced nausea, chills for 2 days, itching, tingling, pin pricking pain all over her body with no sign of rash or discoloration. The patient also experienced high blood pressure and shortness of breath. The patient was referred to the emergency room and on 3rd January 2019, the patient was seen and administered IV fluids. The patient was tested for infection and then released to home without admission. The reporter had consented to follow up. The case has been linked with case US2019GSK004286 for the same patient reported by the same reporter. Lab Comments: The patient was referred to emergency room and tested for infection.
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect, received from a contactable nurse (patient). A 67-year-old female patient received PREVNAR 13, via an unspecified route of administration in the deltoid on an unspecified date in 2016 (reported about 3 years ago) at a single dose for immunization. Medical history included ongoing rheumatoid arthritis where patient reported that she had symptoms years before but diagnosed 15-20 years ago - probably closer to 15 years ago; multiple orthopedic operations where patient received Encef IV, pneumonia, upper respiratory infections and immune compromised. Concomitant medication included prednisone, etanercept (ENBREL) and methotrexate; all at unknown dose from unspecified date and ongoing for rheumatoid arthritis. The patient previously took keflex cefalexin monohydrate (KEFLEX). The patient reported that the next day after receiving the vaccine, the patient developed rash that lasted for more that a few days. The patient added that the rash was mostly the trunk and back, her neck, chest, and abdomen which may have been on the inner aspect of her arms but she isn't sure. The patient also reported that her rheumatologist wants her to get "PREVNAR 23" and at her pharmacy they won't give her the vaccine if they know that the rash was an allergic reaction. The patient would like to know if the her rash was a side effect of the medication or an allergic reaction. The patient assessed the event as non-serious. The outcome of the event was recovered on an unspecified date.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain, Chest discomfort, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received PREVNAR 13 via unspecified route of administration on 07Jan2019 at 0.5 ml, single (arm left) for immunization. Patient medical history and concomitant medications were not reported. It was reported that the patient got vaccinated with PREVNAR on Monday 07Jan2019. Since the injection, she has had a great deal of left deltoid pain (the worst pain she has ever had after any injection) that it was her whole left arm not just in the injection site, sleep disturbances (she can't sleep and then the next day and sleeps all day into late morning), very irritable, stomach issues (diarrhea, abdominal pain and some nausea); she says she went in perfectly healthy and Tuesday woke up with a heavy feeling in her chest (felt it on the first day it has but has subsided to some degree); feeling like a different person; she mentions tiredness and feeling fatigue. The patient also reported that today, she noticed tiny red dots (rash) on her left arm. Outcome of the event "woke up with a heavy feeling in her chest (felt it on the first day it has but has subsided to some degree)" was recovering. Outcome of other events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Gastric disorder, Injection site pain, Irritability, Nausea, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received PREVNAR 13 via unspecified route of administration on 07Jan2019 at 0.5 ml, single (arm left) for immunization. Patient medical history and concomitant medications were not reported. It was reported that the patient got vaccinated with PREVNAR on Monday 07Jan2019. Since the injection, she has had a great deal of left deltoid pain (the worst pain she has ever had after any injection) that it was her whole left arm not just in the injection site, sleep disturbances (she can't sleep and then the next day and sleeps all day into late morning), very irritable, stomach issues (diarrhea, abdominal pain and some nausea); she says she went in perfectly healthy and Tuesday woke up with a heavy feeling in her chest (felt it on the first day it has but has subsided to some degree); feeling like a different person; she mentions tiredness and feeling fatigue. The patient also reported that today, she noticed tiny red dots (rash) on her left arm. Outcome of the event "woke up with a heavy feeling in her chest (felt it on the first day it has but has subsided to some degree)" was recovering. Outcome of other events was unknown.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash erythematous, Sleep disorder, Somnolence
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received PREVNAR 13 via unspecified route of administration on 07Jan2019 at 0.5 ml, single (arm left) for immunization. Patient medical history and concomitant medications were not reported. It was reported that the patient got vaccinated with PREVNAR on Monday 07Jan2019. Since the injection, she has had a great deal of left deltoid pain (the worst pain she has ever had after any injection) that it was her whole left arm not just in the injection site, sleep disturbances (she can't sleep and then the next day and sleeps all day into late morning), very irritable, stomach issues (diarrhea, abdominal pain and some nausea); she says she went in perfectly healthy and Tuesday woke up with a heavy feeling in her chest (felt it on the first day it has but has subsided to some degree); feeling like a different person; she mentions tiredness and feeling fatigue. The patient also reported that today, she noticed tiny red dots (rash) on her left arm. Outcome of the event "woke up with a heavy feeling in her chest (felt it on the first day it has but has subsided to some degree)" was recovering. Outcome of other events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Irritability, Limb discomfort
Clinical narrative: This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced minor irritation and arm felt heavier. The action taken in response to the events for the vaccine was not applicable. The clinical outcome for the event was recovered, as reported a couple weeks late, the patient returned and the symptoms were not present.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (R) arm warm to touch red/swollen at injection site.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: The patient reported experiencing a sore shoulder joint a few days after receiving the vaccination. He said the pain then moved to his elbow and eventually to his hand where he still experiences pain off and on. He did say he does have arthritis.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immunodeficiency, Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of immunocompromised in a patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced immunocompromised (serious criteria GSK medically significant), shingles and product supply issue. On an unkown date, the outcome of the immunocompromised, shingles and product supply issue were unknown. It was unknown if the reporter considered the immunocompromised and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles within the past year having had the previous vaccine. The patient took medications that caused to be immuno-compromised. At the time of reporting, the patient 2 months behind in dosing. The reporter asked, how the GlaxoSmithKline came along with production of the 2nd dose of SHINGRIX and if delayed of the 2nd dose cause any compromise in outcome.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose, refer case US2019GSK005180). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, immediately after receiving SHINGRIX, the patient experienced pain in arm and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm and general body pain were recovered/resolved. The reporter considered the pain in arm and general body pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. Both immunizations given at same pharmacy. Lot number was not known. Arm began to hurt immediately upon immunization of both doses. Immunized person reported never being so aware of where arm was even if the patient was not moving. With both doses, side effects lasted about 2 days. The patient thought experienced events were related to immunization. For tolerance after 2nd dose refer case US2019GSK002321. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient was over 50 years old. The patient received dose of SHINGRIX around holiday weekend and the patient experienced pain or soreness at injection site that lasted about a day. The reporter agreed to be followed up from GlaxoSmithKline. For tolerance to 2nd dose see case US2019GSK005377, reported for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of swelling in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling, erythema, pain and fever. On an unknown date, the outcome of the swelling, erythema, pain and fever were unknown. It was unknown if the reporter considered the swelling, erythema, pain and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a Certified Medical Assistant. The age at vaccination was not reported. The patient experienced swelling, redness, pain, body aches and fever. The reporter had agreed to follow up.