chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Three children received a dose of the VARIVAX that was stored out of recommended temperature range.; Information has been received from the office manager and refers to a child patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (VARIVAX) lot # R035226 and expiration date of 04-DEC-2020 (route of administration and anatomical location were not reported), for prophylaxis, which were stored in the range of 57.9 Fahrenheit degrees for 49 hours. No previous temperature excursion was reported. Unable to retreive the vial as it was disposed of after administration of vaccine.  Digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2009USA001660: US-009507513-2009USA001387: US-009507513-2009USA002057:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Three children received a dose of the VARIVAX that was stored out of recommended temperature range.; Information has been received from the office manager and refers to a child patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On an unknown date, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R035226 and expiration date of 04-DEC-2020 (route of administration and anatomical location were not reported), for prophylaxis, which were stored in the range of 57.9 Fahrenheit degrees for 49 hours. No previous temperature excursion was reported. Unable to retreive the vial as it was disposed of after administration of vaccine.  Digital data logger was involved.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2009USA001660: US-009507513-2009USA001387: US-009507513-2009USA002056:
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored PROQUAD; This spontaneous report was received from a nurse referring to a 5 years old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 03-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella virus vaccine live (rHA) (PROQUAD) (strength, dose and route were not reported; lot # T012422, expiration date 06-OCT-2021) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot number and expiration date were not reported).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (12.15 degrees Fahrenheit) for 50 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
Age: 54.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Dizziness, Fall, Fatigue, Feeling abnormal, Head injury
Clinical narrative: One injection every 3 to 5 years; One injection every 3 to 5 years; "blacking out"; fell and hit his head/gash on head; perspiring profusely; he had flu-like symptoms; feeling lethargic; left arm was very sore after the injection; generally felt bad the entire day; feeling light-headed/ incredibly dizzy; began feeling light-headed and nauseous; This spontaneous report was received from a consumer concerning to himself as a 54-years-old male patient. The patient's medical history included quadruple bypass surgery. The patient concurrent conditions were unknown, drug allergies reported as none. Concomitant therapies included vitamins (unspecified), isosorbide, aspirin, metoprolol and atorvastatin.     On 05-SEP-2020 (also reported as on Saturday around 12:30pm), the patient was vaccinated with one injection of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), for prophylaxis (one injection every 3 to 5 years) (inappropriate schedule of product administration (+) circumstance or information capable of leading to a medication error) and with influenza virus vaccine (unspecified) (strengths, routes of administrations, formulations, lot numbers, and expiration dates were not reported) both in the left arm.   On 06-SEP-2020 at approximately 1:00 am on Sunday, the patient woke up and went to use the restroom and began feeling light-headed (dizziness) and nauseous; he was "blacking out" (loss of consciousness) and fell and hit his head (head injury). Subsequently, his wife came into the bathroom and helped him stand up and go back to bed. At approximately 2 and a half hours later, he woke up again and went to the restroom and the same thing happened again. However, when he began feeling light-headed (dizziness), he laid down on the floor, so he did not fall again.   He also reported that he was perspiring profusely (hyperhidrosis) and being incredibly dizzy (dizziness) for approximately 15 minutes. Moreover, he had flu-like symptoms including feeling "achy," having a low-grade fever, feeling tired (influenza like-illness) and lethargic and generally felt "bad the entire day" (feeling abnormal). Also, the patient's left arm was very sore after the injection (pain in extremity) (also reported as "soreness at site pain")  By Monday morning he felt better and by Monday evening (07-SEP-2020), he was fully recovered other than "gash on head" (head injury) which was a result of the fall. It was stated that the patient did not received any treatment and did not performed any laboratories or studies for the events. However, the patient saw his cardiologist.   The causal relationship between the events and the suspect vaccine was not provided.  Upon internal review, the event loss of consciousness was determined to be medically significant.
Age: 54.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, Influenza like illness, Lethargy, Loss of consciousness
Clinical narrative: One injection every 3 to 5 years; One injection every 3 to 5 years; "blacking out"; fell and hit his head/gash on head; perspiring profusely; he had flu-like symptoms; feeling lethargic; left arm was very sore after the injection; generally felt bad the entire day; feeling light-headed/ incredibly dizzy; began feeling light-headed and nauseous; This spontaneous report was received from a consumer concerning to himself as a 54-years-old male patient. The patient's medical history included quadruple bypass surgery. The patient concurrent conditions were unknown, drug allergies reported as none. Concomitant therapies included vitamins (unspecified), isosorbide, aspirin, metoprolol and atorvastatin.     On 05-SEP-2020 (also reported as on Saturday around 12:30pm), the patient was vaccinated with one injection of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), for prophylaxis (one injection every 3 to 5 years) (inappropriate schedule of product administration (+) circumstance or information capable of leading to a medication error) and with influenza virus vaccine (unspecified) (strengths, routes of administrations, formulations, lot numbers, and expiration dates were not reported) both in the left arm.   On 06-SEP-2020 at approximately 1:00 am on Sunday, the patient woke up and went to use the restroom and began feeling light-headed (dizziness) and nauseous; he was "blacking out" (loss of consciousness) and fell and hit his head (head injury). Subsequently, his wife came into the bathroom and helped him stand up and go back to bed. At approximately 2 and a half hours later, he woke up again and went to the restroom and the same thing happened again. However, when he began feeling light-headed (dizziness), he laid down on the floor, so he did not fall again.   He also reported that he was perspiring profusely (hyperhidrosis) and being incredibly dizzy (dizziness) for approximately 15 minutes. Moreover, he had flu-like symptoms including feeling "achy," having a low-grade fever, feeling tired (influenza like-illness) and lethargic and generally felt "bad the entire day" (feeling abnormal). Also, the patient's left arm was very sore after the injection (pain in extremity) (also reported as "soreness at site pain")  By Monday morning he felt better and by Monday evening (07-SEP-2020), he was fully recovered other than "gash on head" (head injury) which was a result of the fall. It was stated that the patient did not received any treatment and did not performed any laboratories or studies for the events. However, the patient saw his cardiologist.   The causal relationship between the events and the suspect vaccine was not provided.  Upon internal review, the event loss of consciousness was determined to be medically significant.
Age: 54.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Skin laceration
Clinical narrative: One injection every 3 to 5 years; One injection every 3 to 5 years; "blacking out"; fell and hit his head/gash on head; perspiring profusely; he had flu-like symptoms; feeling lethargic; left arm was very sore after the injection; generally felt bad the entire day; feeling light-headed/ incredibly dizzy; began feeling light-headed and nauseous; This spontaneous report was received from a consumer concerning to himself as a 54-years-old male patient. The patient's medical history included quadruple bypass surgery. The patient concurrent conditions were unknown, drug allergies reported as none. Concomitant therapies included vitamins (unspecified), isosorbide, aspirin, metoprolol and atorvastatin.     On 05-SEP-2020 (also reported as on Saturday around 12:30pm), the patient was vaccinated with one injection of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), for prophylaxis (one injection every 3 to 5 years) (inappropriate schedule of product administration (+) circumstance or information capable of leading to a medication error) and with influenza virus vaccine (unspecified) (strengths, routes of administrations, formulations, lot numbers, and expiration dates were not reported) both in the left arm.   On 06-SEP-2020 at approximately 1:00 am on Sunday, the patient woke up and went to use the restroom and began feeling light-headed (dizziness) and nauseous; he was "blacking out" (loss of consciousness) and fell and hit his head (head injury). Subsequently, his wife came into the bathroom and helped him stand up and go back to bed. At approximately 2 and a half hours later, he woke up again and went to the restroom and the same thing happened again. However, when he began feeling light-headed (dizziness), he laid down on the floor, so he did not fall again.   He also reported that he was perspiring profusely (hyperhidrosis) and being incredibly dizzy (dizziness) for approximately 15 minutes. Moreover, he had flu-like symptoms including feeling "achy," having a low-grade fever, feeling tired (influenza like-illness) and lethargic and generally felt "bad the entire day" (feeling abnormal). Also, the patient's left arm was very sore after the injection (pain in extremity) (also reported as "soreness at site pain")  By Monday morning he felt better and by Monday evening (07-SEP-2020), he was fully recovered other than "gash on head" (head injury) which was a result of the fall. It was stated that the patient did not received any treatment and did not performed any laboratories or studies for the events. However, the patient saw his cardiologist.   The causal relationship between the events and the suspect vaccine was not provided.  Upon internal review, the event loss of consciousness was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: felt awful for 4-5 days; fever; muscle ache; headache; This case was reported by a physician via call center representative and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included lung cancer (on therapy for lung cancer).   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced feels awful, fever, muscle pain and headache. On an unknown date, the outcome of the feels awful, fever, muscle pain and headache were recovered/resolved.   It was unknown if the reporter considered the feels awful, fever, muscle pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination were not reported but adult has been selected as age group according to the vaccine. The patient stated to physician that he/she felt awful for 4 to 5 days with fever, muscle ache, headache. The patient was on therapy for lung cancer. The reporter consented to follow up. This case is 1 of 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178096:same reporter US-GLAXOSMITHKLINE-US2020178097:same reporter US-GLAXOSMITHKLINE-US2020178099:Original Case : US2020178099 (same reporter)
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient was administered with only the liquid DTap-IPV portion of the Pentacel vaccine and did not received the ActHib portion/No AE; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves female patient (unknown demographics) who was administered with 0.5 mL  dose of only the liquid Dtap-IPV portion of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination and she did not received the ActHib portion (product preparation issue) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was an actual medication error case due to inappropriate reconstitution technique. It was reported that when administering Pentacel vaccine only the liquid portion gets injected.  At a time of reporting no adverse event 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.  There will be no information available on the batch number for this case.
Age: 0.5
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received a dose of Menactra instead of Hepatitis A / No Ae; Initial information was received on 02-Sep-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a six years old female patient who on 21-Aug-2020 received 0.5 mL first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6585AB and expiry date 11-Apr-2021) via intramuscular route in the right deltoid for prophylactic vaccination instead of HEPATITIS A VACCINE (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to wrong vaccine administered.  Case details: Reporter stated that Menactra was given in error instead of a different vaccine which was intended. Patient was supposed to receive a dose of Hepatitis A, but received a dose of Menactra.  At the time of reporting no adverse reaction 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.
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Faeces soft, Nausea, Rhinorrhoea
Clinical narrative: runny nose; nausea after eating; soft stools; abdominal pain and cramping; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patient herself).  This case involves a female patient (age not reported) who experienced nausea after eating (nausea), soft stools (faeces soft), abdominal pain and cramping (abdominal pain) and runny nose (rhinorrhoea), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  On 01-Sep-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 02-Sep-2020, the patient developed a non-serious nausea after eating (nausea), soft stools (faeces soft), abdominal pain and cramping (abdominal pain) one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious runny nose (rhinorrhoea) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of this report, outcome of the events were not reported (unknown).  There will be no information available on the batch number for this case.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Renal pain
Clinical narrative: fever body aches kidney pain
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: after administering Shingrix the patient realized she had already completed both Shingrix s vaccines. She has no adverse effects, she did receive one additional vaccine which was not needed
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea, Erythema, Fatigue, Impaired work ability
Clinical narrative: SYMPTOMS STARTED SHORTLY AFTER LUNCH--APPROXIMATELY 1PM.  PATIENT REPORTED TO PHARMACIST AT 3:30PM.  SHORTNESS OF BREATH, RED, SWELLING, TINGLING AT SITE OF INJECTION, RADIATING TO ENTIRE ARM AND SHOULDER.  FELT CHEST TIGHTNESS/PRESSURE; HEAD CONGESTION, THROAT SWOLLEN.  ADVISED TO ICE INJECTION SITE, TAKE TYLENOL AND DIPHENHYDRAMINE TO ALLEVIATE SYMPTOMS.  USE ALBUTEROL NEBULIZER TO MANAGE SHORTNESS OF BREATH.  FOLLOWED UP THAT EVENING: BREATHING BETTER, STILL TIRED AND FATIGUED, FLU LIKE SYMPTOMS; FOLLOWED UP WITH PATIENT NEXT DAY.  WASN'T ABLE TO SLEEP WELL.  TOOK A TRAMADOL 50MG TABLET TO EASE PAIN.  TOOK A DAY OFF FROM WORK.  FOLLOW UP WITH PATIENT MONDAY, 08/31/2020, FEELING BETTER.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site paraesthesia, Injection site swelling, Paraesthesia
Clinical narrative: SYMPTOMS STARTED SHORTLY AFTER LUNCH--APPROXIMATELY 1PM.  PATIENT REPORTED TO PHARMACIST AT 3:30PM.  SHORTNESS OF BREATH, RED, SWELLING, TINGLING AT SITE OF INJECTION, RADIATING TO ENTIRE ARM AND SHOULDER.  FELT CHEST TIGHTNESS/PRESSURE; HEAD CONGESTION, THROAT SWOLLEN.  ADVISED TO ICE INJECTION SITE, TAKE TYLENOL AND DIPHENHYDRAMINE TO ALLEVIATE SYMPTOMS.  USE ALBUTEROL NEBULIZER TO MANAGE SHORTNESS OF BREATH.  FOLLOWED UP THAT EVENING: BREATHING BETTER, STILL TIRED AND FATIGUED, FLU LIKE SYMPTOMS; FOLLOWED UP WITH PATIENT NEXT DAY.  WASN'T ABLE TO SLEEP WELL.  TOOK A TRAMADOL 50MG TABLET TO EASE PAIN.  TOOK A DAY OFF FROM WORK.  FOLLOW UP WITH PATIENT MONDAY, 08/31/2020, FEELING BETTER.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pharyngeal swelling, Sinus congestion, Sleep disorder
Clinical narrative: SYMPTOMS STARTED SHORTLY AFTER LUNCH--APPROXIMATELY 1PM.  PATIENT REPORTED TO PHARMACIST AT 3:30PM.  SHORTNESS OF BREATH, RED, SWELLING, TINGLING AT SITE OF INJECTION, RADIATING TO ENTIRE ARM AND SHOULDER.  FELT CHEST TIGHTNESS/PRESSURE; HEAD CONGESTION, THROAT SWOLLEN.  ADVISED TO ICE INJECTION SITE, TAKE TYLENOL AND DIPHENHYDRAMINE TO ALLEVIATE SYMPTOMS.  USE ALBUTEROL NEBULIZER TO MANAGE SHORTNESS OF BREATH.  FOLLOWED UP THAT EVENING: BREATHING BETTER, STILL TIRED AND FATIGUED, FLU LIKE SYMPTOMS; FOLLOWED UP WITH PATIENT NEXT DAY.  WASN'T ABLE TO SLEEP WELL.  TOOK A TRAMADOL 50MG TABLET TO EASE PAIN.  TOOK A DAY OFF FROM WORK.  FOLLOW UP WITH PATIENT MONDAY, 08/31/2020, FEELING BETTER.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX had a temperature excursion and was administered after the excursion occurred; This spontaneous report as received from a reporter refers to two patients of unknown age and gender. The patients' medical history, current conditions, previous drug reactions or allergies and concomitant therapies were unknown.   On 2020 the patient was vaccinated with varicella virus vaccine live (VARIVAX) (lot # S038177, expiration date 26-NOV-2021) for prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination unknown).      On 30-JUL-2020 the administrated varicella virus vaccine live (VARIVAX) experienced product storage error with temperature excursion: 12 F, time frame: 1 hour and 45 minutes, no previous temperature excursion as recorded by data logger. In 2020, after the excursion occurred, two patients received varicella virus vaccine live (VARIVAX) (lot # S038177, expiration date 26-NOV-2021) for prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination unknown).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: frozen vaccines temperature excursion that occurred last night; This spontaneous report was received from a clinical lead referring to a patient of unknown age and gender. The patient's medical history and concomitant therapy were not provided. Concomitant therapy included sterile diluent.      On 28-AUG-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# S021326, expiration date 05-JAN-2021, therapy type rHA; dose detail, strength and route were not provided) for prophylaxis (product storage error). The temperature excursions included 10.56 Fahrenheit degree to for 50 minutes. Temperature previously excursion was 8.47 Fahrenheit degree for 30 minutes (on 26-AUG-2020). There was a data logger involved.
Age: 63.0
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Dizziness, Fatigue
Clinical narrative: I am dizzy; very exhausted/extremely exhausted; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 26th August 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 27th August 2020, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced dizziness and exhaustion. On an unknown date, the outcome of the dizziness and exhaustion were unknown.   It was unknown if the reporter considered the dizziness and exhaustion to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: After receiving Shingrix and Influenza vaccine, the patient was dizzy and very exhausted.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: hives around his waist band and on both legs / was given prednisone; hives aggravated; This case was reported by a consumer via call center representative and described the occurrence of hives in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th October 2019, the patient received the 1st dose of Shingrix. On 23rd December 2019, the patient received the 2nd dose of Shingrix. In October 2019, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hives. In December 2019, the patient experienced hives. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the hives and hives were unknown.   It was unknown if the reporter considered the hives to be related to Shingrix. It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and shortly after receiving the vaccine he began to have hives around his waist band and on both legs. The patient went to see his HCP and was given prednisone.  The patient received Shingrix and since then the urticaria has began to worsen, spreading to his back, the corners of his eyes and around his mouth and was scheduled to see his HCP soon. The patient could not find HCP information for consent or follow up. The reporter did not consent to follow up. This case US2020AMR175939 is a duplicate of US2020175291. All future correspondence will be submitted to US2020175291.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Muscle spasms, Musculoskeletal chest pain, Pain
Clinical narrative: feel pain in his left arm / had pain later that day in his right arm; feverish; abdominal pain; muscle cramps; body aches/left side pain; had pain /  in his right-sided joints; pain / under his rib cage on his left side; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix. On 29th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, abdominal pain, muscle cramp, general body pain, joint pain and rib pain. On an unknown date, the outcome of the pain in arm, fever, abdominal pain, muscle cramp, general body pain, joint pain and rib pain were not recovered/not resolved.   The reporter considered the pain in arm, fever, abdominal pain, muscle cramp, general body pain, joint pain and rib pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and he began to feel pain in his left arm feverish, and abdominal pain that afternoon.  He also stated he had muscle cramps and body aches.   He had pain later that day in his right arm and in his right-sided joints and pain that he felt was under his rib cage on his left side. The patient wanted to know if these were side effects common with Shingrix and how long would they last because at the time of reporting he had them. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: feel pain in his left arm / had pain later that day in his right arm; feverish; abdominal pain; muscle cramps; body aches/left side pain; had pain /  in his right-sided joints; pain / under his rib cage on his left side; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2020, the patient received the 1st dose of Shingrix. On 29th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, fever, abdominal pain, muscle cramp, general body pain, joint pain and rib pain. On an unknown date, the outcome of the pain in arm, fever, abdominal pain, muscle cramp, general body pain, joint pain and rib pain were not recovered/not resolved.   The reporter considered the pain in arm, fever, abdominal pain, muscle cramp, general body pain, joint pain and rib pain to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and he began to feel pain in his left arm feverish, and abdominal pain that afternoon.  He also stated he had muscle cramps and body aches.   He had pain later that day in his right arm and in his right-sided joints and pain that he felt was under his rib cage on his left side. The patient wanted to know if these were side effects common with Shingrix and how long would they last because at the time of reporting he had them. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site injury, Injection site scab, Injection site vesicles
Clinical narrative: small wound / at the injection site; blister / at the injection site; formed a scab at at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site injury in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 24DP5, expiry date 8th April 2022) for prophylaxis.   Concurrent medical conditions included multiple sclerosis. Concomitant products included ocrelizumab (Ocrevus).   On 26th March 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site injury, injection site blisters and injection site scab. On an unknown date, the outcome of the injection site injury was recovered/resolved and the outcome of the injection site blisters and injection site scab were unknown.   It was unknown if the reporter considered the injection site injury, injection site blisters and injection site scab to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine via intramuscular route in the left deltoid.  On an unknown date after receiving the vaccine the patient developed a small wound that was blister like and formed a scab at at the injection site.  The event resolved on its own without treatment on an unknown date 2 months after receiving the Shingrix vaccine. The reporter consented to follow up.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapeutic response decreased
Clinical narrative: Titer was low; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 35-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Engerix B. On 6th February 2020, the patient received the 2nd dose of Engerix B. On 7th July 2020, the patient received the 3rd dose of Engerix B. On 26th August 2020, 230 days after receiving Engerix B, 202 days after receiving Engerix B and 50 days after receiving Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist patient received the Engerix series and titer was low and might had the series repeated.  The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incorrect dose administered, Injection site pain, Product preparation issue
Clinical narrative: the first one was painful; did not shake the pre-filled syringe prior to administering with the first shot / the suspension was not uniform and hazy white; with the first shot / the suspension was not uniform and hazy white; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received HAB (Twinrix adult) for prophylaxis.   On an unknown date, the patient received the 1st dose of Twinrix adult. On an unknown date, unknown after receiving Twinrix adult, the patient experienced injection site pain, inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain to be related to Twinrix adult.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported receiving two Twinrix vaccines and the first one was painful and the second one was not. The patient stated the nurse did not shake the pre-filled syringe prior to administering with the first shot, and that the suspension was not uniform and hazy white. The reporter did not consent to follow-up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: he completed the series of the Shingrix / last injection was in 12/2019; shingles on his left flank, back, and stomach; still has nerve pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, mepolizumab (Nucala) solution for injection in pre-filled syringe for prophylaxis and mepolizumab autoinjector device administration system for asthma.   Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix. On 1st December 2019, the patient received the 2nd dose of Shingrix. On 1st June 2019, the patient started Nucala (subcutaneous) 100 mg at variable dosing and mepolizumab autoinjector device. On 15th June 2020, less than 2 years after receiving Shingrix, 197 days after receiving Shingrix, not applicable after starting Nucala and 380 days after starting Nucala and mepolizumab autoinjector device, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and gabapentin. Nucala was discontinued on 1st June 2020. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and mepolizumab autoinjector device. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix, Nucala and mepolizumab autoinjector device. It was unknown if the reporter considered the shingles to be related to Nucala and mepolizumab autoinjector device.  Additional details were provided as follows: After receiving Shingrix, the patient experienced shingles on his left flank, back and stomach. Till the time of reporting, the patient still had nerve pain at the site where he experienced the shingles. The patient reported that, he was in discussion with his physician if he was going to restart the Nucala. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Headache; This case was reported by a physician via call center representative and described the occurrence of headache in a 29-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TG597, expiry date 9th March 2021) for prophylaxis.   In March 2019, the patient received Boostrix. In March 2019, immediately after receiving Boostrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Boostrix and had experienced a headache since the dose was administered. The reporter consent to follow up.
Age: 59.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Burning sensation, Chills, Headache, Myalgia, Pain
Clinical narrative: fever, headache, chills, muscle aches for 8 hours. Took 1 Advil & that reduced symptoms but still have all of same symptoms just not as bad.  Very sore right arm - hurts to lift arm; burning sensation in right arm.
Age: 59.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever, headache, chills, muscle aches for 8 hours. Took 1 Advil & that reduced symptoms but still have all of same symptoms just not as bad.  Very sore right arm - hurts to lift arm; burning sensation in right arm.
Age: 77.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site rash, Skin irritation
Clinical narrative: Rash on Left Arm.  Skin was irritated. Rash went from deltoid to mid biceps.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Limb mass, Nausea, Pyrexia, Seizure like phenomena, Tremor
Clinical narrative: I developed a fever of 102.9 and sever shaking resembling convulsions as well as nausea.  One week later I developed a lump in my upper right outer thigh.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Ultrasound scan
Clinical narrative: I developed a fever of 102.9 and sever shaking resembling convulsions as well as nausea.  One week later I developed a lump in my upper right outer thigh.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Patient had redness on arm, Patient received abx from pcp
Age: 77.0
Sex: M
Vaccine: FLUA4
Symptoms: Pain in extremity, Pyrexia, Restlessness
Clinical narrative: Low grade fever, restlessness, thigh pain
Age: 71.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Asthenia, Hyperhidrosis, Nausea, Syncope
Clinical narrative: 2:30 INJECTION, 6:30 Stomach Pain,7:30 Nausea,  8:30 Profuse Sweating, Fainting, Weakness...called ER...Called MD....described symptoms...directed to hydrate and rest...no more fainting after 9 pm....hydrated, rested, stomach ache continued till around 11 pm, next day weak and shaky no fainting or nausea
Age: 71.0
Sex: F
Vaccine: VARCEL
Symptoms: Tremor
Clinical narrative: 2:30 INJECTION, 6:30 Stomach Pain,7:30 Nausea,  8:30 Profuse Sweating, Fainting, Weakness...called ER...Called MD....described symptoms...directed to hydrate and rest...no more fainting after 9 pm....hydrated, rested, stomach ache continued till around 11 pm, next day weak and shaky no fainting or nausea
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Impaired driving ability, Impaired work ability, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: Right arm is swelling to twice the normal size, painful to the touch, unable to move the arm to drive or do work and patient had to call out sick. The symptoms were highest in intensity on 9/9/20 after going home after receiving shot, and swelling/pain has gone down a little bit today (9/10/20) AM. Advised to take some OTC antihistamine to reduce the swelling and OTC analgesics to help with pain
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Right arm is swelling to twice the normal size, painful to the touch, unable to move the arm to drive or do work and patient had to call out sick. The symptoms were highest in intensity on 9/9/20 after going home after receiving shot, and swelling/pain has gone down a little bit today (9/10/20) AM. Advised to take some OTC antihistamine to reduce the swelling and OTC analgesics to help with pain
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Rash
Clinical narrative: Reported soreness 24 hours post, then ring of redness around injection site and rash on opposite arm. Took Aleve to alleviate symptoms . No itching, told pt to monitor, if worsens contact doctor.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Contusion, Injected limb mobility decreased, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Patient states she is in a lot of pain in her left arm and that she can not even raise her arm up.  In addition, she has  bruising, fever, rash and feels sick.
Age: 68.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Rash
Clinical narrative: Patient states she is in a lot of pain in her left arm and that she can not even raise her arm up.  In addition, she has  bruising, fever, rash and feels sick.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Incorrect product storage; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The Information regarding the patient's concurrent conditions, medical history, concurrent conditions, drugs reactions or allergies were not provided.   On 13-AUG-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (lot #S020963, expiration date: 07-JUL-2021) (dose, strength, route of administration and injection site were not reported) for prophylaxis. The vaccine was stored in temperature from 2 degrees Celsius (C) to 8 degrees Celsius (8.4 C) for a time frame of 34 hours and 41 minutes and in above 9 degrees Celsius (10.5 C) for 6 hours. The call was made due to a digital data logger. No previous temperature excursion was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: a patient received a VARIVAX shot yesterday from a vial which expired; This spontaneous report was received from a medical assistant who refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 24-AUG-2020, also reported as yesterday, the patient was vaccinated with shot of expired varicella virus vaccine live (oka/merck) (VARIVAX) vial, once, lot # S021729 (an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX)), expiration date was reported as 20-AUG-2020 (expired vaccine used) (route of administration and anatomical location were not reported), for vaccination. There were no temperature excursions on the product which was administered.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Chills, Laboratory test, Pyrexia
Clinical narrative: 101.1; shivering; experience the entire list of Shingrix vaxx side effects; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, shivering and adverse drug reaction. On an unknown date, the outcome of the fever, shivering and adverse drug reaction were unknown.   It was unknown if the reporter considered the fever, shivering and adverse drug reaction to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient experienced 101.2 degrees C, Shivering like at end. The patient mentioned that you experience the entire list of Shingrix vaccine side effects and it was dramatically better than getting shingles again. At least this was his/her 2nd dose so done.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Fainted within 15 mins of administration; This case was reported by a nurse via sales rep and described the occurrence of faint in a 15-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA58BA, expiry date 30th September 2021) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Bexsero. On 2nd September 2020, less than an hour after receiving Bexsero, the patient experienced faint (serious criteria GSK medically significant). On 2nd September 2020, the outcome of the faint was recovered/resolved.   It was unknown if the reporter considered the faint to be related to Bexsero.  Additional information was provided as follows: The patient fainted within 15 minutes of administration,in less than 10 seconds was aroused right away. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 7XY2P, expiry date 4th April 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 week 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 reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed shingles 1 week later.  The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: "shooting pain down right arm" / shooting pain through both legs; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles). Previously administered products included shingles vaccine (received year ago). Concurrent medical conditions included tick bite (tick bite of the stomach).   On 11th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th January 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.Additional details were provided as follows: The patient received Shingrix in the left arm and within a day she had shooting pain down the right arm. The patient reported that after a tick bite of the stomach, she had shooting pain through both legs. The patient had shingles before receiving the Shingrix vaccine and had other shingles vaccine years before receiving Shingrix.  The patient was unable to confirm the name of the other shingles vaccine.  The patient gives consent to follow up with doctor.  The patient unable to provide lot number and expiration date from dose but was able to provide NDC number. The reporter consented to follow up. The NDC Number reported as 58160082311.