chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.75
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Rash, Rash erythematous, Rash macular
Clinical narrative: Parent walked back into clinic with child. She states she received her Hep A #2 approx. 5-10 mins prior. Child has rash on torso and legs - small and lightly erythematous macular lesions. Not particularly itchy. Lesions on the legs appear like they have slight degree of halo around the lesions. Child's cheeks are brightly erythematous and this does appear to be diminishing in the time we are talking with the child. Child was otherwise playful and alert. Temp checked temporally and 98.8F. Mother states child attends daycare and has had rhinorrhea and congestion off and on throughout the last 1-2 months. No Hx of immunization associated rashes in the past. Suspect a cutaneous reaction to hepatitis A vaccine vs viral exanthema. Child was very well appearing. I administered a dose of ZYRTEC 2.5 mg and observe. After 10 minutes, parent stated that she felt comfortable leaving, requested this to be added to the medical record. Precautions given. Given child does not require any further Hep A doses, this does not affect her immunization status and add to her allergy record.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: I have a severe welt 3' by 3' below the injection site and a rash also on the injection site arm. I have  pain and tingling throughout the entire arm and fever, chills and flu like symptoms. The fever lasted 36 hours. The injection site giving off heat and is extremely warm to the touch. I have pain in back shoulder on the left side and stiffness in neck and even my teeth hurt. Its been 48 hours and sign of relief.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Pyrexia, Rash
Clinical narrative: I have a severe welt 3' by 3' below the injection site and a rash also on the injection site arm. I have  pain and tingling throughout the entire arm and fever, chills and flu like symptoms. The fever lasted 36 hours. The injection site giving off heat and is extremely warm to the touch. I have pain in back shoulder on the left side and stiffness in neck and even my teeth hurt. Its been 48 hours and sign of relief.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Toothache, Urticaria
Clinical narrative: I have a severe welt 3' by 3' below the injection site and a rash also on the injection site arm. I have  pain and tingling throughout the entire arm and fever, chills and flu like symptoms. The fever lasted 36 hours. The injection site giving off heat and is extremely warm to the touch. I have pain in back shoulder on the left side and stiffness in neck and even my teeth hurt. Its been 48 hours and sign of relief.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: I have a severe welt 3' by 3' below the injection site and a rash also on the injection site arm. I have  pain and tingling throughout the entire arm and fever, chills and flu like symptoms. The fever lasted 36 hours. The injection site giving off heat and is extremely warm to the touch. I have pain in back shoulder on the left side and stiffness in neck and even my teeth hurt. Its been 48 hours and sign of relief.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness postural, Impaired driving ability, Influenza, Influenza virus test negative
Clinical narrative: Nausea, vomiting, joint pain, overall flu symptoms but tested negative for flu, dizzy when standing, unable to drive, difficulty functioning because my elbows, wrists, hands and fingers hurt the most. Went to walk in clinic the day after the shot and my rheumatologist the next day.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea, vomiting, joint pain, overall flu symptoms but tested negative for flu, dizzy when standing, unable to drive, difficulty functioning because my elbows, wrists, hands and fingers hurt the most. Went to walk in clinic the day after the shot and my rheumatologist the next day.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Per nurse, pt called 3/14/19 - 1243 stating he had the following reaction to vaccine: Pain, redness and soreness at injection site. HA, Fever of 101.6, muscle aches, shivering, fatigue, and nausea. States to be feeling much room/doctor visit better on day of call, and reported temp of 99.0. States he had been taking TYLENOL for fever. Nurse provided ER precautions to pt and informed pt to call back if symptoms should worsen.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Per nurse, pt called 3/14/19 - 1243 stating he had the following reaction to vaccine: Pain, redness and soreness at injection site. HA, Fever of 101.6, muscle aches, shivering, fatigue, and nausea. States to be feeling much room/doctor visit better on day of call, and reported temp of 99.0. States he had been taking TYLENOL for fever. Nurse provided ER precautions to pt and informed pt to call back if symptoms should worsen.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Pain upon injections. Rash and swelling from pt. of injection to elbow. Starting to get better now (several days later) according to patient.
Age: 44.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported swelling/pain on Tuesday 3/26 to MD. Vaccines TDaP and PNEUMOVAX were administered by this nurse on Monday 3/25. MD notified this nurse Wed 3/27/19. Note vaccines administered on left arm and patient reported left arm pain/swelling. He went to ER 3/26 and was given IV Abx.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Dysphagia, Insomnia, Joint stiffness
Clinical narrative: 3-19-19 -All joints stiff and painful, backache, fingers stiff and sensitive, throat, hard to swallow, rash on upper back-took TYLENOL. 3-20 -Same as above -called pharmacist -Took TYLENOL. 3-12 -Same as above -called my family Dr -took Naproxen at night to sleep -stopped TYLENOL. 3-23 and 24 -feeling better -Naproxen at night. 3-25 -better -stopped meds.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Rash, Sensitive skin
Clinical narrative: 3-19-19 -All joints stiff and painful, backache, fingers stiff and sensitive, throat, hard to swallow, rash on upper back-took TYLENOL. 3-20 -Same as above -called pharmacist -Took TYLENOL. 3-12 -Same as above -called my family Dr -took Naproxen at night to sleep -stopped TYLENOL. 3-23 and 24 -feeling better -Naproxen at night. 3-25 -better -stopped meds.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Febrile convulsion, Respiratory syncytial virus test positive
Clinical narrative: Febrile seizure.
Age: 20.0
Sex: F
Vaccine: MENB, VARCEL
Symptoms: Blood test, Chest discomfort, Muscular weakness, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging neck
Clinical narrative: 16 days later B/L U/E and L/E weakness, B/L arm pain. Chest pressure.
Age: 20.0
Sex: F
Vaccine: MENB, VARCEL
Symptoms: Pain in extremity
Clinical narrative: 16 days later B/L U/E and L/E weakness, B/L arm pain. Chest pressure.
Age: 11.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Wrong product administered
Clinical narrative: After lengthy discussion with Dad regarding needed immunizations, permission received for Tdap and MMR. Inadvertently drew up Varicella instead of MMR. Parent notified of error. Returned to clinic. Received MMR. Follow up Appointment made to continue catch-up sched.
Age: 53.0
Sex: F
Vaccine: MMR
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site induration, Swelling
Clinical narrative: Swelling immediately (with out hives) at injection site. Now 4cm indurated swelling and discomfort.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain upper, Chills, Hyperhidrosis, Myalgia, Nausea
Clinical narrative: Donor reported mild reaction 24 hours after first rabies injection; nausea/vomiting, stomach and muscle pains, sweating and shivering. Unknown if fever.
Age: 44.0
Sex: M
Vaccine: RAB
Symptoms: Vomiting
Clinical narrative: Donor reported mild reaction 24 hours after first rabies injection; nausea/vomiting, stomach and muscle pains, sweating and shivering. Unknown if fever.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Within 5 min of receiving TdaP, pt developed redness and pruritis at site of injection. Ice applied; BENADRYL given PO; pt observed for 30 min without escalation of symptoms. No wheezing or angioedema. (Event occurred in office).
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Patient awoke the following morning after having received the vaccine and noticed a red, patchy, rash on the arm she had gotten the vaccine. The arm was also sore. After a few days, the symptoms resolved and her arm returned to normal. Patient did not contact her PCP nor did she seek emergency care.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Patient awoke the following morning after having received the vaccine and noticed a red, patchy, rash on the arm she had gotten the vaccine. The arm was also sore. After a few days, the symptoms resolved and her arm returned to normal. Patient did not contact her PCP nor did she seek emergency care.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Disorientation, Dysstasia, Vision blurred
Clinical narrative: Evening following the first shot of the series I felt a little flu feeling.  Middle of night I was very restless and had difficulty sleeping. The morning following the shot when I tried to get up I was so dizzy to the point of blacking out.  I was unable to get up for the entire day, Dizzy, brain was so foggy I couldn't figure out anything. Second day following the shot I was better and able to get up, but very foggy and tired. By 3 PM day two my brain suddenly could not look at something and figure out what to do with it. I tried to start a load of laundry and my vision was so blurred that I could not see the small indicator lights on the washer or focus to read the settings. Was once again very disorientated, dizzy and now my vision was blurred. Day 3 I was better, vision was back, but still slightly dizzy and tired. Day 4 I was on the road to better. I found a Blog site that had so many stories from others who have had much more severe side effects than me and many of those stories the side effects have, to date, been permanent. After my experience and reading some of the Blog stories I have decided the take my chances with the Shingles and not take the second shot.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Disorientation, Dizziness, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Evening following the first shot of the series I felt a little flu feeling.  Middle of night I was very restless and had difficulty sleeping. The morning following the shot when I tried to get up I was so dizzy to the point of blacking out.  I was unable to get up for the entire day, Dizzy, brain was so foggy I couldn't figure out anything. Second day following the shot I was better and able to get up, but very foggy and tired. By 3 PM day two my brain suddenly could not look at something and figure out what to do with it. I tried to start a load of laundry and my vision was so blurred that I could not see the small indicator lights on the washer or focus to read the settings. Was once again very disorientated, dizzy and now my vision was blurred. Day 3 I was better, vision was back, but still slightly dizzy and tired. Day 4 I was on the road to better. I found a Blog site that had so many stories from others who have had much more severe side effects than me and many of those stories the side effects have, to date, been permanent. After my experience and reading some of the Blog stories I have decided the take my chances with the Shingles and not take the second shot.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Loss of consciousness, Mobility decreased, Restlessness, Vision blurred
Clinical narrative: Evening following the first shot of the series I felt a little flu feeling.  Middle of night I was very restless and had difficulty sleeping. The morning following the shot when I tried to get up I was so dizzy to the point of blacking out.  I was unable to get up for the entire day, Dizzy, brain was so foggy I couldn't figure out anything. Second day following the shot I was better and able to get up, but very foggy and tired. By 3 PM day two my brain suddenly could not look at something and figure out what to do with it. I tried to start a load of laundry and my vision was so blurred that I could not see the small indicator lights on the washer or focus to read the settings. Was once again very disorientated, dizzy and now my vision was blurred. Day 3 I was better, vision was back, but still slightly dizzy and tired. Day 4 I was on the road to better. I found a Blog site that had so many stories from others who have had much more severe side effects than me and many of those stories the side effects have, to date, been permanent. After my experience and reading some of the Blog stories I have decided the take my chances with the Shingles and not take the second shot.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bradycardia, Computerised tomogram head normal, Full blood count normal, Injection site pain, Metabolic function test normal
Clinical narrative: Syncope, with bradycardia, likely vasovagal? Severe arm pain at injection site. Required ED visit and hospital observation (the latter for pain management). Subsequent PCP office visit.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Scan with contrast normal, Syncope, Troponin normal, Urine analysis normal, X-ray limb normal
Clinical narrative: Syncope, with bradycardia, likely vasovagal? Severe arm pain at injection site. Required ED visit and hospital observation (the latter for pain management). Subsequent PCP office visit.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site urticaria, Musculoskeletal stiffness, Myalgia
Clinical narrative: Fever of at least 100.4 (Temp not taken until after taking several TYLENOL). Muscle ache and stiffness. Chills (Could not get warm). Tired. Hives (These developed at the injection site three days after injection).
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of at least 100.4 (Temp not taken until after taking several TYLENOL). Muscle ache and stiffness. Chills (Could not get warm). Tired. Hives (These developed at the injection site three days after injection).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site mass
Clinical narrative: Mom called office on 4/1/2019 to report that child has a flesh colored marble sized lump at injection site. Lump is non tender, no C/O itchiness or drainage from area. Will monitor and follow-up as needed.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram, Limb discomfort, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: This was the second in a two shot series of this vaccine, the first given one year ago. I did not have a reaction at the time of the first shot in the spring of 2018. I have never had a reaction from any of my vaccinations received at this Pharmacy in the past, and I trust them completely in this regard. Approximately four hours after receiving the injection, I noticed my arm had begun to ache from the elbow to the shoulder in the tricep and bicep. When I touched the arm, I also noticed it was swollen as though a long balloon had been inserted in that section of it. I called the pharmacy and reported it. The pharmacist provided some suggestions for easing the discomfort (alternating ice and heat on the arm), and I also took a TYLENOL in the early evening. As of this morning, there is still swelling and some tenderness, but not to the degree of yesterday afternoon's discomfort. If it continues throughout today, I will visit a walk-in clinic of my healthcare provider. I reported it to my primary care provider's patient portal this morning.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to a currently 15 years old male patient. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On 16-FEB-2016, the 12 years old patient was vaccinated with first dose of GARDASIL 9(lot#: L027282, Expiration Date: 21-SEP-2017) for intramuscular for prophylaxis. On 28-APR-2016, the 12 years old patient received the second dose of GARDASIL 9) (lot#: L024993, Expiration Date: 17-OCT-2017). On 12-FEB-2019, the 15 years old patient received the third dose of GARDASIL 9 (lot#: 1581027, Expiration Date: 03-JUN-2021)(inappropriate schedule of product administration). No adverse effects were reported.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a medical assistant referring to a 19 year old unknown gender patient. Information about concomitant medications, pertinent medical history and drug reactions/allergies was not reported. On an unknown date, the patient inadvertently received a pediatric dose of VAQTA 25/0.5 intramuscular for prophylaxis (lot # R010368, expiration date: 25-MAR-2019, frequency were not reported)(incorrect dose administered). No adverse effects reported. Information about treatment given for the event, lab diagnostics/studies and medical attention was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous has been received from a medical assistant, concerning 3 patients' of unknown age and gender. The patients' concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. On an unknown date, 3 patients received unspecified dose of ROTATEQ (lot # N030996 and expiration date 08-SEP-2019), taken orally as prophylaxis. Those vaccines were improperly stored after initial excursion in September 2018 (Product storage error). The temperature excursion was 48.4 Fahrenheit (F), time frame: 25 minutes; and previous temperature excursion was 33.8 F for 61 minutes. The excursion call was made by a data logger. No adverse effects reported. This is a non-valid case due to the lack of a patient identifier.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report has been received from a register nurse, via company representative, concerning a 14 year old female patient. The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with second dose of GARDASIL 9 (route and anatomical location, lot and expiration date were not reported) as prophylaxis. On an unknown date, she developed a "red ring" around the injection site, and she recovered from the event, "a year later". No additional information was provided. The causal relationship between the event injection site erythema and GARDASIL 9 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a medical assistant referring to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2019, the patient was vaccinated with an improperly stored dose of VARIVAX, for prophylaxis lot # N027995 expiring on 01-OCT-2020 (strength, dose, dose number and route of administration were not reported).   Varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored diluent.  The administered dose of the vaccine experienced a temperature excursion of 6°F to 14°F for 13 hours, as recorded by a data logger. The vaccine had a previous temperature excursion of 6.6°F for 2.5 hours.  There was no adverse effect reported. No product quality complaint was involved.  Lot number (N027995) is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX).
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a physician via company representative regarding multiple unspecified female patients. Information on the patients past medical history, other concurrent conditions, drug reactions or allergies and concomitant medications were not provided. On an unknown date, the patients were vaccinated with GARDASIL 9 (strength, dose, frequency, route of administration, batch/lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patients return to physician office to report being HPV positive (human papilloma virus test positive). Outcome of human papilloma virus test positive was unknown. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on the patient's past medical history, other concurrent condition, drug reactions or allergies and concomitant medications were not reported. On 29-MAR-2019, the patient was vaccinated with PROQUAD one dose with lot # N022972 and expiry date 19-FEB-2019 (strength, frequency and route of administration were not provided) for prophylaxis (expired product administered). No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Eye irritation, Headache, Hypersomnia, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache 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, 22 hrs after receiving SHINGRIX, the patient experienced headache, burning in eyes, fever, general body pain and sleep excessive. On an unknown date, the outcome of the headache, burning in eyes, fever, general body pain and sleep excessive were recovered/resolved. It was unknown if the reporter considered the headache, burning in eyes, fever, general body pain and sleep excessive to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving SHINGRIX, the patient had a horrific headache, burning of eyes, and the body temperature was recorded 100 degree F, along with all over pain and slept a lot. The patient was much better in 30 hours. The patient asked that, if is it safe for to her to have the next shot. The reporter wanted to know would the reaction be worse. Lab Comments: On an unknown date, patient's body temperature was noted as 100 degree F.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old patient who received SHINGRIX for prophylaxis. On 26th March 2019, the patient received SHINGRIX. On 27th March 2019, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for themselves. The patient stated that they got the shingles booster and at the time of reporting, they felt like they had the flu. The patient stated that they would call their doctor.
Sex: U
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC
Symptoms: Bronchitis, Cough, Nasal congestion, Pyrexia, Respiratory tract infection
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of acute respiratory tract infection in a patient who received HAVRIX for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, PENTACEL for prophylaxis and PREVNAR for prophylaxis.  On 17th January 2019, the patient received HAVRIX, Hepatitis B vaccine, PENTACEL and PREVNAR. On 25th February 2019, 39 days after receiving HAVRIX and Hepatitis B vaccine, the patient experienced acute respiratory tract infection (serious criteria GSK medically significant), acute bronchitis, vomiting and nasal congestion. On 13th March 2019, the patient experienced fever, cough, runny nose and sneezing. On an unknown date, the outcome of the acute respiratory tract infection, acute bronchitis, vomiting, nasal congestion, fever, cough, runny nose and sneezing were unknown. It was unknown if the reporter considered the acute respiratory tract infection, acute bronchitis, vomiting, nasal congestion, fever, cough, runny nose and sneezing to be related to HAVRIX and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. On 25th February 2019, the patient came back and was experiencing congestion and vomiting, no fever and was diagnosed with acute respiratory infection. When the patient came back in on 13th March 2019, 55 days after receiving HAVRIX and Hepatitis B vaccine, the patient was experiencing fever, cough, runny nose, sneezing and was diagnosed with acute bronchitis. The reporter was unsure if the patient was still experiencing these symptoms. The reporter gave permission for follow up. It was unknown if the reporter considered the acute respiratory tract infection, vomiting, nasal congestion, acute bronchitis, fever, cough, runny nose and sneezing to be related to PENTACEL and PREVNAR vaccine.
Sex: U
Vaccine: DTAPIPVHIB, HEP, HEPA, PNC
Symptoms: Rhinorrhoea, Sneezing, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of acute respiratory tract infection in a patient who received HAVRIX for prophylaxis. Co-suspect products included Hepatitis B vaccine for prophylaxis, PENTACEL for prophylaxis and PREVNAR for prophylaxis.  On 17th January 2019, the patient received HAVRIX, Hepatitis B vaccine, PENTACEL and PREVNAR. On 25th February 2019, 39 days after receiving HAVRIX and Hepatitis B vaccine, the patient experienced acute respiratory tract infection (serious criteria GSK medically significant), acute bronchitis, vomiting and nasal congestion. On 13th March 2019, the patient experienced fever, cough, runny nose and sneezing. On an unknown date, the outcome of the acute respiratory tract infection, acute bronchitis, vomiting, nasal congestion, fever, cough, runny nose and sneezing were unknown. It was unknown if the reporter considered the acute respiratory tract infection, acute bronchitis, vomiting, nasal congestion, fever, cough, runny nose and sneezing to be related to HAVRIX and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. On 25th February 2019, the patient came back and was experiencing congestion and vomiting, no fever and was diagnosed with acute respiratory infection. When the patient came back in on 13th March 2019, 55 days after receiving HAVRIX and Hepatitis B vaccine, the patient was experiencing fever, cough, runny nose, sneezing and was diagnosed with acute bronchitis. The reporter was unsure if the patient was still experiencing these symptoms. The reporter gave permission for follow up. It was unknown if the reporter considered the acute respiratory tract infection, vomiting, nasal congestion, acute bronchitis, fever, cough, runny nose and sneezing to be related to PENTACEL and PREVNAR vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 60-year-old female patient who received SHINGRIX (batch number 353S5, expiry date 29th May 2021) for prophylaxis. On 21st March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. In March 2019, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. The patient was treated with Cream (Nos). On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right arm. The patient experienced redness and warmth at the injection site covering size of 6 inches by 6 inches approximately the size of softball. The patient used rattlesnake cream and the redness and warmth went away. No further details were provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Rash, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 76-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (has shingles 3 times previously with most recent episode occurred 1 year before reporting). On 19th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th February 2019, less than a day after receiving SHINGRIX, the patient experienced rash, vesicular rash and muscle pain. On 20th February 2019, the patient experienced insomnia. On an unknown date, the outcome of the rash, vesicular rash and insomnia were not recovered/not resolved and the outcome of the muscle pain was recovered/resolved. It was unknown if the reporter considered the rash, vesicular rash, muscle pain and insomnia to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she received SHINGRIX and that evening she got undressed and saw a rash on her arm and there was one spot with two separate bubbles on it that have faded at the time of reporting. She also experienced pain in her muscle which went away after a few days. The night of her injection, she could sleep that night, however, she has experienced insomnia for the past two weeks at the time of reporting. The patient has a history of shingles three times previously with her most recent episode occurring a year ago. The patient claims that her pharmacist already reported this information to GlaxoSmithKline. The reporter gave consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown 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 age at vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. After initial dose of SHINGRIX, the patient developed a Shingles outbreak.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular, Rash pruritic, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash urticaria-like in a 79-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date unknown) for prophylaxis. On 7th December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In December 2018, less than a month after receiving SHINGRIX, the patient experienced rash urticaria-like and itchy rash. On an unknown date, the patient experienced blotchy rash. The patient was treated with Triamcinolone Cream. On an unknown date, the outcome of the rash urticaria-like, itchy rash and blotchy rash were recovered/resolved. It was unknown if the reporter considered the rash urticaria-like, itchy rash and blotchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient provided lot number but did not have expiration date for his dose. The patient received SHINGRIX in the right arm. Later in Dec 2018, the patient experienced rash that looked like hives and was itchy. It was resolved with use of triamcinolone cream. Less than a year after receiving vaccination, the patient also reported that, later if the rash would occur on another part of his body in a blotch, he would treat it and it would go away. The patient gave consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lyme disease
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lyme disease in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 18th December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced lyme disease (serious criteria GSK medically significant). On an unknown date, the outcome of the lyme disease was unknown. The reporter considered the lyme disease to be unrelated to SHINGRIX. Additional details were provided as follows: Batch number and expiry date of vaccine were not available. The patient was diagnosed with lyme disease some time after she had received SHINGRIX. The reporter did not seemed to think it to be related.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced adverse reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse reaction was recovered/resolved. It was unknown if the reporter considered the adverse reaction to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient had a severe reaction to a flu vaccine around 10 plus years ago before the date of reporting. It was unknown which flu vaccine the patient received, they did not have records for her prior to joining the practice. The reporter gave consent to follow up.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a other health professional via Pfizer (E2B # US-PFIZERINC-US19012812) and refers to a currently 91-years-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date (reported as in 204), the patient was vaccinated with dose of PNEUMOVAX 23 injection (exact dose, dose number, route and site of administration, lot # and expiration date were not reported). On an unknown date the patient experienced severe burning at the injection site, but did not present swelling, fever or shortness of breath. The outcome of the event and the relatedness between the event and PNEUMOVAX 23 were not reported.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Fluid retention, Headache, Impaired work ability, Nausea
Clinical narrative: "Got a really bad headache, shortness of breath, began swelling, fluid up, nausea." Went to ED and given 1 day off work.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: "Got a really bad headache, shortness of breath, began swelling, fluid up, nausea." Went to ED and given 1 day off work.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Flushing, Pruritus, Rash, Skin warm
Clinical narrative: Vaccinations given at 1:30 3/13/19, approx 0730 AM 03/14/19 friends at school noted her face was flushed, no swelling or itching. Patient noticed arms felt warm. Given 25 mg BENADRYL 200 mg MOTRIN and mother brought to office at 10 AM 03/14/19 - Arms were fine, rash on face largely gone slight itch. Rash resolved after 2 days per mother.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: I am experiencing achy pain from head to toe and feel like I'm running a slight fever. Taking TYLENOL every 4 hrs. No redness or swelling. No shivering.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given to an adult patient.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Abnormal behaviour, Asthenia, Constipation, Crying
Clinical narrative: An apparent hypersensitivity. Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting. Significant change in demeanor, dizziness, fatigue, Weakness, Eyes roll back, Sweats, Rapid breathing, Tiredness, Nausea, Insomnia, High pitched cry lasting hours.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Dizziness, Eye movement disorder, Fatigue, High-pitched crying
Clinical narrative: An apparent hypersensitivity. Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting. Significant change in demeanor, dizziness, fatigue, Weakness, Eyes roll back, Sweats, Rapid breathing, Tiredness, Nausea, Insomnia, High pitched cry lasting hours.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Hyperhidrosis, Hypersensitivity, Insomnia, Nausea, Respiratory rate increased
Clinical narrative: An apparent hypersensitivity. Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting. Significant change in demeanor, dizziness, fatigue, Weakness, Eyes roll back, Sweats, Rapid breathing, Tiredness, Nausea, Insomnia, High pitched cry lasting hours.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: Vomiting
Clinical narrative: An apparent hypersensitivity. Abdominal pain/cramps, constipation, diarrhea, nausea, vomiting. Significant change in demeanor, dizziness, fatigue, Weakness, Eyes roll back, Sweats, Rapid breathing, Tiredness, Nausea, Insomnia, High pitched cry lasting hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Heart rate increased, Injection site pain, Injection site swelling
Clinical narrative: Extreme chills, achy muscles, dizziness, and fast heartbeat. Injection site is swollen and painful.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Extreme chills, achy muscles, dizziness, and fast heartbeat. Injection site is swollen and painful.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Symptoms: myalgia and headache and then chills and fever. Treatment: used acetaminophen and helped symptoms. Outcome: fever broke and myalgia has subsided, still headache. Over the course of 8 hours (since 2:30A).
Sex: U
Vaccine: MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning multiple patients' of an unknown age and gender. The patients' concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. On an unknown date, the patients' were vaccinated with M-M-R II (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported). The M-M-R II vaccine was reconstituted with properly stored sterile diluent. In addition, improper storage dosis of with ROTATEQ (Lot#R016790 and expiration date 20-APR-2020) taken orally, were administered to some unknown patients. Both vaccines were taken as prophylaxis. No adverse effects reported. Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger. This is a non-valid case due to the lack of a patient identifier.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-MAR-2019 the patient was vaccinated with a 0.5 ml dose of M-M-R II albumin status rHA, diluted in sterile diluent, lot # N009798, expiry date 24-MAR-2019, subcutaneously, in the left arm, for prophylaxis. The vaccine was expired for three days when it was given and the pharmacist was concerned about this being an invalid dose.
Age: 23.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 23-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-MAR-2019, the patient was inadvertently vaccinated with an expired dose of M-M-R II, subcutaneously in right arm, lot # N009799, expiry date: 24-MAR-2019 (dose was not provided) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a male patient who received 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 pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were recovered/resolved. It was unknown if the reporter considered the injection site pain and general body pain to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's son at conference, medical booth. The patient's age at vaccination was not reported. The patient received SHINGRIX and experienced local pain at the site of injection that progressed through out his body. All these events lasted for 3 months. This case has been linked to case US2019GSK058297, reported by the same reporter for the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Product use issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of enlargement of lymph nodes in a 30-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced enlargement of lymph nodes and product use in unapproved population. On an unknown date, the outcome of the enlargement of lymph nodes and product use in unapproved population were unknown. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 29 or 30 years old. The patient wanted protection from shingles. The patient worked with insurance to gain approval for use outside of approved indication of 50 years and up, which led to product use in unapproved population. The patient had reaction of swollen lymph nodes after 2nd dose of SHINGRIX. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a 74-year-old female patient who received SHINGRIX for prophylaxis. On 24th January 2019, the patient received the 1st dose of SHINGRIX .5 ml. In February 2019, 14 days after receiving SHINGRIX, the patient experienced rash and shingles. On an unknown date, the outcome of the rash and shingles were unknown. It was unknown if the reporter considered the rash and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 74 years old at the time of reporting. The patient did not receive any concomitant medications. About 2 weeks after receiving SHINGRIX, the patient in the office experienced rash and was diagnosed with and treated for shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The reporter did not agreed to follow.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved. The reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that the patient had 102 Fahrenheit fever lasting 1 day, which resolved on its own and believed it was related to the vaccine. The physician did agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a patient who received SHINGRIX for prophylaxis. On 26th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, feeling unwell and feeling bad. On an unknown date, the outcome of the influenza-like symptoms, feeling unwell and feeling bad were unknown. It was unknown if the reporter considered the influenza-like symptoms, feeling unwell and feeling bad to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient had the SHINGRIX vaccine on Tuesday in afternoon. The patient was having the flu like symptoms and felt awful. The patient was asking how long did this generally last.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Nasopharyngitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chills in a 62-year-old female patient who received SHINGRIX (batch number H7JY4, expiry date 1st July 2021) for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced chills and cold. On an unknown date, the outcome of the chills and cold were unknown. It was unknown if the reporter considered the chills and cold to be related to SHINGRIX. Additional information was provided as follows: The patient experienced chills down to the bone for about a week, shivering and cold for several days.