chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Culture throat positive, Pharyngitis streptococcal, Streptococcus test positive
Clinical narrative: Strep throat; Spontaneous report received on 06DEC2019.  A caregiver (consumer's mother) reported that her 12-year-old daughter developed "strep throat" (PT: Pharyngitis streptococcal), while being on oral Vivotif for typhoid fever prophylaxis. On 30NOV2019, she started taking Vivotif. It was reported that after taking the second dose, she developed the symptoms of strep throat. She underwent for test culture and the result was positive for strep, which was confirmed on 05DEC2019. On 06DEC2019, she took the last dose of Vivotif. Treatment medication included antibiotic (unspecified name starting with cef)), which she started taking after three days of her last dose of Vivotif on 09DEC2019. At the time of report, the reported event was not resolved.  Medical history included allergy to amoxicillin, allergy NOS and had strep throat previously.  Concomitant medication included cetirizine (over the counter) for allergies.  Company Comment: A consumer developed streptococcal sore throat after taking the second dose of Vivotif. In response to the event, the consumer started taking antibiotic after three days of her last dose of Vivotif. Considering the infectious nature of the event, and consumer's medical history of strep throat, the causality of the event is assessed as not related.; Sender's Comments: A consumer developed streptococcal sore throat after taking the second dose of Vivotif. In response to the event, the consumer started taking antibiotic after three days of her last dose of Vivotif. Considering the infectious nature of the event, and consumer's medical history of strep throat, the causality of the event is assessed as not related.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Diarrhea; Severe abdominal pain; Spontaneous report received on 05DEC2019.  A male consumer reported he had severe abdominal pain (PT: Abdominal pain) and diarrhea (PT: Diarrhoea), while being on oral Vivotif for typhoid fever. On 03DEC2019, the consumer took the first dose of Vivotif and developed severe abdominal pain, which was resolved completely by the next day. On 05DEC2019, he took his second dose in the morning about 08:00 am, one hour prior to eating. On the same day at 01:00 pm, he had severe abdominal pain and diarrhea, so he was on the toilet for all the day. He stated that the pain was worse than the first day he took the first dose. The pain persisted for about six hours. Action taken with Vivotif with respect to the reported events was unknown. The reported events were not resolved at the time of report.  Company Comment: A consumer experienced severe abdominal pain and diarrhea after a few hours of Vivotif doses. Considering the potential of Vivotif to cause abdominal pain, diarrhea and case information, the causality of both the events is assessed as possible with Vivotif.; Sender's Comments: A consumer experienced severe abdominal pain and diarrhea after a few hours of Vivotif doses. Considering the potential of Vivotif to cause abdominal pain, diarrhea and case information, the causality of both the events is assessed as possible with Vivotif.
Sex: F
Vaccine: FLUX
Symptoms: Seizure
Clinical narrative: Sizure; Initial information was received on 27-Jan-2020 regarding an unsolicited valid serious case received from a pharmacist.  This case involves adult female patient (currently 29 year old) who experienced sizure (seizure), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date five years ago the patient developed a serious sizure (seizure) on an unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.  Final diagnosis was seizure.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of seizure.  Information on the batch number was requested.; Sender's Comments: This case concerns an adult female patient who experienced seizure after vaccination with INFLUENZA VACCINE from unknown manufacturer. The time to onset was unknown. Patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLU3
Symptoms: Carotid artery dissection
Clinical narrative: he was diagnosed with dissection of his internal carotid artery; Initial information received on 27-Jan-2020 regarding an unsolicited valid serious case received from a physician.  This case involves a male patient (of unknown age) who was diagnosed with dissection of his internal carotid artery (carotid artery dissection), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  On 06-Dec-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported, of unknown Expiration date) via unknown route at an unknown administration site for prophylactic vaccination.  On 13-DEC-2019, the patient underwent (serious) dissection of his internal carotid artery (carotid artery dissection) 7 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  Laboratory data was not provided.  Final diagnosis was carotid artery dissection.   It was not reported if the patient received any corrective treatment.  The patient outcome is reported as Unknown for dissection of his internal carotid artery.  Information on the batch number was requested.; Sender's Comments: This case concerns a male patient (of unknown age) who was diagnosed with carotid artery dissection after vaccination with FLUZONE HIGH DOSE. The time to onset is compatible. However, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 3.0
Sex: F
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: none
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: headache; nausea; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old patient who received Herpes zoster (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 headache and nausea. On an unknown date, the outcome of the headache and nausea were not recovered/not resolved.   It was unknown if the reporter considered the headache and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After received dose of Shingrix the patient experienced headache and nausea. The patient inquired how long do the side effects last from the shingles shot. The patient wanted to know would he/she had the same reactions with the second dose.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Some soreness at the injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and had some soreness at the injection site. The reporter consented to follow up. This case linked with US2020AMR014607, reported by same reporter. This case linked with US2020013944, reported by same reporter for the same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Stinging on administration; Arm pain lasting ~5 days; This case was reported by a physician via sales rep and described the occurrence of pain in extremity in a male patient who received Herpes zoster (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 pain in extremity and injection site stinging. On an unknown date, the outcome of the pain in extremity was recovered/resolved and the outcome of the injection site stinging was unknown.   It was unknown if the reporter considered the pain in extremity and injection site stinging to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on and experienced stinging on administration and arm pain. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Extreme pain in head; This case was reported by a consumer via call center representative and described the occurrence of temporal headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th January 2020, the patient received Shingles vaccine. In January 2020, less than 2 weeks after receiving Shingles vaccine, the patient experienced temporal headache. On an unknown date, the outcome of the temporal headache was unknown.   It was unknown if the reporter considered the temporal headache to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received new Shingles vaccine 8 days prior to reporting date. The patient had extreme pain in left temple of head. The patient was wondering if these could be reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome, Respiratory failure
Clinical narrative: Death; Respiratory failure; GBS(Guillain Barre syndrome ); This case was reported by a lawyer and described the occurrence of death in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown). On an unknown date, unknown after receiving Shingrix, the patient experienced death (serious criteria death and GSK medically significant), respiratory failure (serious criteria GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the death was fatal and the outcome of the respiratory failure and guillain barre syndrome were unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death, respiratory failure and guillain barre syndrome to be related to Shingrix.  Additional information: The patient had death claim involving GBS and respiratory failure.; Reported Cause(s) of Death: Unknown cause of death
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Inappropriate schedule of product administration, Injection site pain, Myalgia, Nausea
Clinical narrative: Received the second dose past the six month mark; Extreme nausea; Pain involving her local site of injection; Muscle pain; Back pain; Leg pain/finger pain; Her hair, finger all hurt; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 7th June 2019, refer case US2020AMR014606).   On 23rd January 2020 03:30, the patient received the 2nd dose of Shingrix. In January 2020, 10 hrs 30 min after receiving Shingrix, the patient experienced nausea, injection site pain, myalgia, back pain, leg pain and general body pain. On 23rd January 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, injection site pain, myalgia, back pain, leg pain, general body pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the nausea, injection site pain, myalgia, back pain, leg pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on 23th January 2020 at around 3:30 pm in her left arm and stated she woke up at around 2 am with extreme nausea, pain involving her local site of injection and, muscle pain, back pain, leg pain. She was stating her hair, finger all hurt. She states she received the second dose past the six month mark, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case linked with US2020AMR014607, reported by same reporter. This case linked with US2020013944, reported by same reporter for the same patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Received the second dose past the six month mark; Extreme nausea; Pain involving her local site of injection; Muscle pain; Back pain; Leg pain/finger pain; Her hair, finger all hurt; This case was reported by a nurse via call center representative and described the occurrence of nausea in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 7th June 2019, refer case US2020AMR014606).   On 23rd January 2020 03:30, the patient received the 2nd dose of Shingrix. In January 2020, 10 hrs 30 min after receiving Shingrix, the patient experienced nausea, injection site pain, myalgia, back pain, leg pain and general body pain. On 23rd January 2020, the patient experienced drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea, injection site pain, myalgia, back pain, leg pain, general body pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the nausea, injection site pain, myalgia, back pain, leg pain and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on 23th January 2020 at around 3:30 pm in her left arm and stated she woke up at around 2 am with extreme nausea, pain involving her local site of injection and, muscle pain, back pain, leg pain. She was stating her hair, finger all hurt. She states she received the second dose past the six month mark, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case linked with US2020AMR014607, reported by same reporter. This case linked with US2020013944, reported by same reporter for the same patient.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Injection site swelling, Rash, Rash macular
Clinical narrative: Blotchy rash; Rash looked like tiny bumps/rash on the underside of her breast; Headache; Did not get the second dose of the vaccine within the recommended period; Swelling at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number T2CS3, expiry date 1st December 2021) for prophylaxis.   Previously administered products included Shingrix  (1st dose received on an unknown date, a year ago from the reporting date).   On 22nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd January 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling and drug dose administration interval too long. On 23rd January 2020, the patient experienced headache. On 24th January 2020, the patient experienced blotchy rash and rash. On an unknown date, the outcome of the injection site swelling, rash and drug dose administration interval too long were unknown and the outcome of the blotchy rash was not recovered/not resolved and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the injection site swelling, blotchy rash, rash and headache to be related to Shingrix.  Additional details were received as follows: The patient did not get the second dose of the vaccine within the recommended period and that she was prescribed to restart the Shingrix vaccine series.   On 22nd January 2020, the caller received another dose of the Shingrix more than recommended interval, which led to lengthening of vaccination schedule. She stated that she experienced swelling at the injection site. The patient said that today at the day of reporting when she woke up, she noticed that she has a blotchy rash that spans from her neck and from her chin to her ear She also described having the rash on the underside of her breast.  She stated that the rash looked like tiny bumps, but did not appear to look likes hives and was not raised. She said that she had experienced rashes (not on her neck) before but it was usually associated with a fever and she did not have a fever this time. Caller also mentioned experiencing a headache after the vaccine was administered.  Caller was referred to reach out to her HCP for further guidance. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: muscle pain/local injection site pain; This case was reported by a nurse via call center representative and described the occurrence of injection site muscle pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased. Concomitant products included pravastatin sodium (Pravachol).   On 9th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient received a dose of Shingrix in left deltoid via intramuscular route. She stated that she had some local injection site pain along with the left deltoid muscle pain which persisted for about 10 days. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Bedridden, Headache, Nausea, Pyrexia
Clinical narrative: bed ridden; fever; stomach pain; head pain; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in October 2019, refer linked case US2020AMR014559).   On 18th January 2020 14:00, the patient received the 2nd dose of Shingrix. On 18th January 2020, 3 hrs after receiving Shingrix, the patient experienced fever, stomach pain, headache and nausea. On 19th January 2020, the patient experienced bedridden. On 19th January 2020, the outcome of the fever, stomach pain, headache, nausea and bedridden were recovered/resolved.   It was unknown if the reporter considered the fever, stomach pain, headache, nausea and bedridden to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. Around 5pm, the patient had fever of 101.0, stomach pain, head pain and nausea. On Sunday, one day after receiving Shingrix, the patient was bedridden for a day. The event lasted through Sunday night and by Monday the patient was better.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Severe Diarrhea for over 1 month; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe diarrhea for over 1 month.  The patient was considering not receiving 2nd dose. The reporter denied to provide any further information or demographics.
Sex: F
Vaccine: VARZOS
Symptoms: Pericarditis
Clinical narrative: Diagnosed with pericarditis; This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, between 2 and 3 months after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis was unknown.   It was unknown if the reporter considered the pericarditis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and last week from reporting date patient was diagnosed with pericarditis. Reporter declined consent to follow-up with physician but it was okay with herself.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Patient came in for a visit on 01/31/2020 with a redness and swelling to injection area which was also warm to the touch.  Patient only had a local reaction and at time of the visit she notified Dr. she felt the reaction was getting better.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Fall, Lip injury, Skin abrasion, Syncope
Clinical narrative: Patient was given the vaccinations in office without difficulty.  On 2/1/20, mother called the on-call provider and informed that the night before , about 2.5-3 hours after receiving vaccinations, patient fainted at home after standing up quickly from his desk chair.  Mom did not witness the event.  By the time she got to his room, he was already standing back up but her reports that he did pass out.  At the time of this call, it was the next day after the event and patient was doing well despite a cut on his lip from falling.  Patient did end up being seen at immediate care on 2/3/20 for his lip abrasion
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Progressive erythema around the site of infection.  Induration and warmth.  Felt to be c/w cellulitis.  Started the day after the vaccine was given and was progressive the next day
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema
Clinical narrative: Diarrhea resolved within 3 days, redness around administration site about 12 inches in diameter still present 4 days after administration but decreasing in size
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the patient was administered a dose of VARIVAX on 12/19/2019, that had been improperly stored; This spontaneous report was received from a office menager and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 19-DEC-2019, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX), lot # S021926, expiration date 15-JUL-2021 (dose, frequency, route of administration were not provided) reconstituted with properly stored sterile diluent. Administered doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion 1.2 C for 3 hours 9 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: Neuropathy; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around July 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route not specified) for routine health maintenance and for its intended purpose: the prevention of singles (herpes zoster). Shortly, on an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt. suferred singles and neuropathy(neuropathy peripheral ). As a direct and proximate result of use of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations, not present prior to vaccination, The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further, as a tragic consequence the pt suffered severe and permanent personal injuries, as well as significant conscious pain and suffering, mental aguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of singles and neuropathy peripheral  was not recovered.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling.  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: Neuropathy; Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around October 2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for routine health maintenance and for its intended purpose: the prevention of singles (herpes zoster). Shortly, on an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt. suferred singles and neuropathy(neuropathy peripheral ). As a direct and proximate result of use of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations, not present prior to vaccination. The pt. also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further, as a tragic consequence the pt. suffered severe and permanent personal injuries, as well as significant conscious pain and suffering, mental aguish, loss of enjoyment of life, physical impairment and injury.  The outcome of singles and neuropathy peripheral  was not recovered.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling.  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: Injection site extravasation
Clinical narrative: no adverse event; vaccine leaked out of patient's arm; while administering PNEUMOVAX 23 by intramuscular injection to the patient, some of the vaccine liquid leaked out out of the patient's arm resulting in possible partial dose; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's concurrent condition, pertinent medical history and concomitant medications were not provided. On 27-JAN-2020, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose # and schedule were not reported) lot #S006777 expiration date 20-NOV-2020 via intramuscular route for prophylaxis, while administering the vaccine some of the vaccine liquid came out of the patient's arm (injection site extravasation) resulted in possible partial dose (incorrect dose administered). No addition adverse effect information provided (No adverse event). The outcome of the event injection site extravasation was not reported. The causality assessment was not provided.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous report as received from a lawyer refers to an approximately 70-year-old female patient. Her concurrent conditions included high cholesterol, high blood pressure, diabetes, bronchospasm, chronic obstructive pulmonary disease (COPD), gastrooesophageal reflux disease (GERD), depression, allergies, anxiety and constipation. Her medical history included shingles and chickenpox. She had a history of smoking cigarettes. Her historical vaccine included zoster vaccine live (ZOSTAVAX). Concomitant therapies included calcium (unspecified), ergocalciferol, atorvastatin, fluticasone, metformin, docusate sodium, olmesartan medoxomil, albuterol, ipratropium bromide, pantoprazole, sertraline hydrochloride, sertraline hydrochloride (ZOLOF) and atorvastatin calcium (LIPITOR).    On an unknown date in 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and unspecified flu vaccine (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date in 2019, the patient experienced fever for a few days. The outcome of the event was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided.  This is one of two cases concerning the same patient.; Sender's Comments:  US-009507513-1908USA000416:
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported however patient could be 57 or 58 years old. The patient experinced fever after receiving 1st dose of Shingrix vaccine which was lasted for 3 days. For tolerance to 2nd dose refer linked case US2020014000, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Experienced lesser side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse event in a adult patient who received Herpes zoster (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 adverse event. On an unknown date, the outcome of the adverse event was recovered/resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patient received Shingrix stated that the doctors at her workplace are stating that it was their general finding in their clinical setting that patients who got the 2nd dose further apart from the 1st dose experienced lesser side effects. The reporter consented to follow up. This case linked with US2020AMR014606 and US2020013944, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test abnormal, Rash, Vaccination failure
Clinical narrative: Suspected Vaccination failure; rash / ater diagnosed as herpes zoster; rash / ater diagnosed as herpes zoster; This case was reported by a pharmacist and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th December 2019, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and rash. On an unknown date, the outcome of the vaccination failure, herpes zoster and rash were unknown.   It was unknown if the reporter considered the vaccination failure, herpes zoster and rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received dose of Shingrix vaccine and suffered from rash on the side which was later diagnosed as herpes zoster. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease were unknown at the time of reporting.      Lab Comments: On an unknown date Lab test was performed.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Cough, Influenza like illness, Malaise, Nasopharyngitis, Respiratory symptom
Clinical narrative: Common cold; flu/ common cold symptoms; Sinus congestion; Coughing; Feeling sick; Upper respiratory symptom; This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received Shingrix. On 23rd January 2020, 1 days after receiving Shingrix, the patient experienced cold symptoms, influenza-like symptoms, sinus congestion, cough, feeling unwell and upper respiratory symptom. On an unknown date, the outcome of the cold symptoms, influenza-like symptoms, sinus congestion, cough, feeling unwell and upper respiratory symptom were recovering/resolving.   It was unknown if the reporter considered the cold symptoms, influenza-like symptoms, sinus congestion, cough, feeling unwell and upper respiratory symptom to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed flu or common cold like symptoms, sinus congestion, coughing and feeling sick. The patient was fine at the time of reporting. The patient inquired if anyone can get upper respiratory and common cold symptoms from Shingrix vaccine. The reporter consented to follow up.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Sinus congestion
Clinical narrative: Common cold; flu/ common cold symptoms; Sinus congestion; Coughing; Feeling sick; Upper respiratory symptom; This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received Shingrix. On 23rd January 2020, 1 days after receiving Shingrix, the patient experienced cold symptoms, influenza-like symptoms, sinus congestion, cough, feeling unwell and upper respiratory symptom. On an unknown date, the outcome of the cold symptoms, influenza-like symptoms, sinus congestion, cough, feeling unwell and upper respiratory symptom were recovering/resolving.   It was unknown if the reporter considered the cold symptoms, influenza-like symptoms, sinus congestion, cough, feeling unwell and upper respiratory symptom to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and developed flu or common cold like symptoms, sinus congestion, coughing and feeling sick. The patient was fine at the time of reporting. The patient inquired if anyone can get upper respiratory and common cold symptoms from Shingrix vaccine. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Balance disorder, Chills, Decreased appetite, Dizziness
Clinical narrative: loss of appetite; back pain; Felt wobbly; sore arm; body stiffness; body aches; dizziness; headache; Trouble sleeping; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On 22nd January 2020, 4 hrs after receiving Shingrix, the patient experienced pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever and chills. On 23rd January 2020, the patient experienced appetite lost, back pain and unsteadiness. On an unknown date, the outcome of the pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever, chills, appetite lost, back pain and unsteadiness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever, chills, appetite lost, back pain and unsteadiness to be related to Shingrix.  Additional details were received as follows: About 4 hours later, the patient experienced a sore arm, body stiffness, body aches, dizziness and headache.  Later in the day, about 8 hours later, the patient had trouble sleeping, had fever and chills.   The next day, 1 day after administration,  the patient had loss of appetite, back pain, and felt wobbly.  At time of report, patient reports symptoms are slightly improving. The reporter did not consented to follow up.  The reporter did not wish to provide demographic information and lot number was not known.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: loss of appetite; back pain; Felt wobbly; sore arm; body stiffness; body aches; dizziness; headache; Trouble sleeping; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On 22nd January 2020, 4 hrs after receiving Shingrix, the patient experienced pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever and chills. On 23rd January 2020, the patient experienced appetite lost, back pain and unsteadiness. On an unknown date, the outcome of the pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever, chills, appetite lost, back pain and unsteadiness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever, chills, appetite lost, back pain and unsteadiness to be related to Shingrix.  Additional details were received as follows: About 4 hours later, the patient experienced a sore arm, body stiffness, body aches, dizziness and headache.  Later in the day, about 8 hours later, the patient had trouble sleeping, had fever and chills.   The next day, 1 day after administration,  the patient had loss of appetite, back pain, and felt wobbly.  At time of report, patient reports symptoms are slightly improving. The reporter did not consented to follow up.  The reporter did not wish to provide demographic information and lot number was not known.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: loss of appetite; back pain; Felt wobbly; sore arm; body stiffness; body aches; dizziness; headache; Trouble sleeping; fever; chills; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On 22nd January 2020, 4 hrs after receiving Shingrix, the patient experienced pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever and chills. On 23rd January 2020, the patient experienced appetite lost, back pain and unsteadiness. On an unknown date, the outcome of the pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever, chills, appetite lost, back pain and unsteadiness were recovering/resolving.   It was unknown if the reporter considered the pain in arm, stiffness, general body pain, dizziness, headache, difficulty sleeping, fever, chills, appetite lost, back pain and unsteadiness to be related to Shingrix.  Additional details were received as follows: About 4 hours later, the patient experienced a sore arm, body stiffness, body aches, dizziness and headache.  Later in the day, about 8 hours later, the patient had trouble sleeping, had fever and chills.   The next day, 1 day after administration,  the patient had loss of appetite, back pain, and felt wobbly.  At time of report, patient reports symptoms are slightly improving. The reporter did not consented to follow up.  The reporter did not wish to provide demographic information and lot number was not known.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Red spots at the injection site; Red area is hot; Red area is painful to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included factor v leiden mutation.   On 22nd January 2020, the patient received the 1st dose of Shingrix. On 23rd January 2020, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter noticed three red spots at the injection site.   At the reporting date, on January 24, 2020, the red spots have come together and formed one red spot that was three inches in circumference.  The red area was hot and painful to the touch. The reporter consented to follow up . Reporter gave permission for her physician to be contacted.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site pain, Pain
Clinical narrative: hot to the touch; Tired; Arm redness; Felt Pain /achy; Soreness at injection site /achiness returned and the area 10 inches below the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th January 2020, less than a day after receiving Shingrix, the patient experienced pain, injection site pain, tiredness and erythema of extremities. On 23rd January 2020, the patient experienced skin warm. On an unknown date, the outcome of the pain, injection site pain, skin warm and erythema of extremities were not recovered/not resolved and the outcome of the tiredness was recovering/resolving.   It was unknown if the reporter considered the pain, injection site pain, skin warm, tiredness and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient received a dose of Shingrix in an unknown arm. The patient felt pain, soreness and redness at the injection site. She stated that she also felt achy and tired. One day after the injection, the patient said that the symptoms began to resolve.  On 23rd January 2020, the achiness returned and the area 10 inches below the injection site was red and hot to touch.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: hot to the touch; Tired; Arm redness; Felt Pain /achy; Soreness at injection site /achiness returned and the area 10 inches below the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 17th January 2020, less than a day after receiving Shingrix, the patient experienced pain, injection site pain, tiredness and erythema of extremities. On 23rd January 2020, the patient experienced skin warm. On an unknown date, the outcome of the pain, injection site pain, skin warm and erythema of extremities were not recovered/not resolved and the outcome of the tiredness was recovering/resolving.   It was unknown if the reporter considered the pain, injection site pain, skin warm, tiredness and erythema of extremities to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The patient received a dose of Shingrix in an unknown arm. The patient felt pain, soreness and redness at the injection site. She stated that she also felt achy and tired. One day after the injection, the patient said that the symptoms began to resolve.  On 23rd January 2020, the achiness returned and the area 10 inches below the injection site was red and hot to touch.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 3JD32, expiry date 6th April 2021) for an unknown indication.   On 24th January 2020, the patient received Engerix B pediatric. On 24th January 2020, unknown after receiving Engerix B pediatric, the patient experienced inappropriate age at vaccine administration. The action taken with Engerix B pediatric was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were received as follows: The 20 year old patient who received a third pediatric dose of Engerix-B because the first two doses were administered when the patient was 19 but turn 20 before the third dose, which led to inappropriate age at vaccine administration. The reporter consented to follow up.