chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 03-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician assistant for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 17-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route were not specified) for the long-term prevention of shingles and zosterrelated conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 69-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 27-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event of herpes zoster was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 59-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event of shingles was not reported.   The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; multiple unspecified patients received improperly stored M-M-R II; This spontaneous report as received from a nurse manager (registered nurse), refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions or concomitant medications was not provided.  The Nurse Manager reported that since 12-MAY-2019 the multiple unspecified patients received improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, route of administration, lot number and expiration date were not reported), for prophylaxis, reconstituted with properly stored sterile diluent. No adverse effects reported.   The total time and highest temperature was reported as above 47°F for 24 hours. There was no previous temperature excursion, and the call was because of a "data logger'  This report was considered as non-valid due to lack of patient identifiers.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 79-year-old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 17-AUG-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot #, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported.   The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: MMR, UNK
Symptoms: Measles antibody negative, Sarcoidosis
Clinical narrative: Titers for measles were negative; Sarcoidosis on an unspecified date in 2007; This spontaneous report was received from a Nurse Prescriber, referring to a 30 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and known allergies was not provided. The patient stated that he was on "23 other unspecified medications" and infliximab-dyyb (INFLECTRA) as concomitant therapies.     On an unknown date (reported as "when he was younger"), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), diluted on sterile diluent (MERCK STERILE DILUENT) (strength, route of vaccination, lot # and expiration date were not provided) as routine vaccination.          In 2007, the patient developed sarcoidosis. It was reported that, the patient was treated on unspecified dates with methotrexate, and at the reporting time, is on therapy with infliximab-dyyb (INFLECTRA) which was started on an unspecified date. It was also reported that, on an unknown date, the patient titers for measles were negative (measles antibody negative).      At the time of the report, the outcome of sarcoidosis was reported as recovering and the outcome of measles antibody negative was unknown. The causality between the adverse events and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.        Upon internal review, sarcoidosis was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an unspecified number of "booster shots of a hepatitis A vaccine"; No adverse effects reported; This spontaneous report was received from a physician of unknown age and gender, via company representative, referring to him/herself. Patient's medical history, concurrent conditions or concomitant medications, were not reported.  It was reported that on unspecified dates, the patient may have received an unspecified number of "booster shots of a hepatitis A vaccine" (manufacturer unknown) (Extra dose administered) (strength, dose, route of administration, lot number and expiration date were not reported). No adverse effects reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported.; VARIVAX was administered too soon after MMR II; This spontaneous report has been received from a registered nurse referring to a 20 months old patient of unknown gender. The patient's concomitant medication included sterile diluent. Pertinent medical history and drug reactions/allergies were not reported.     On 06-MAR-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot# R028225, expiration date 02-OCT-2020; dose number and route were unknown) for prophylaxis.  On 26-MAR-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R023735, expiration date 20-AUG-2020; dose number and route were unknown) for prophylaxis. The nurse reported that varicella virus vaccine live (oka/merck) (VARIVAX) was administered too soon after measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of vaccine administered). No adverse effects reported. The outcome of the events was unknown. No product quality complaint presented.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 85-year-old male patient. No information was provided regarding medical history, concurrent conditions or concomitant medications.  On an unknown date in 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure
Clinical narrative: heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 62-year-old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by healthcare provider in a clinic. On an unspecified date, the patient experienced heart failure. On an unspecified date, the patient was treated by a physician for heart failure. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review the event of heart failure was considered to be medically significant.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 15-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles (herpes zoster). On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 62 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 06-JAN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; Nurse states patient inadvertently received a first dose of ROTA TEQ that was expired.; This spontaneous report was received from a registered nurse concerning to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions, allergies, and concomitant therapies were not reported.     On 23-JUL-2019, the patient inadvertently received an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported; lot # R002060 with expiration date 05-JUN-2019) for prophylaxis. No adverse effects reported.   Lot number and expiration date were reported in the source document. But, when entering the lot number in the system automatically auto-populated the correct expiration date, which sometimes may differs from the expiration date reported by the source.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; on 7/23/2019, one female patient was administered properly stored but expired VARIVAX (lot N019840 & expiration 7/13/2019).; This spontaneous report as received from an office manager referring to a 36-year-old female patient.      The patient's concurrent conditions, medical history, previously drug reactions and drug allergies were not provided. Concomitant therapies included sterile diluent.  On 23-JUL-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency and anatomical location were not provided) lot # N019840 and expiration date 13-JUL-2019, for prophylaxis; which was properly stored and was reconstituted with a properly stored sterile diluent (lot # and expiration date were unknown). No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Chills, Decreased appetite, Headache, Joint range of motion decreased, Joint swelling
Clinical narrative: the patient was unable to put weight on her right knee or bent it; a swollen left knee in which she was unable to put weight on her knee or bend it; face became swollen; headaches; nauseous; Sore throat; the chills; lack of appetite; This spontaneous report was received from a 54-year-old non-pregnant female patient referring to herself.  The patient had not relevant medical history and concomitant medications. Her concurrent conditions included seasonal allergy.  On 28-JUN-2019, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# R031629 has been verified to be a valid lot number, expiration date reported as 20-NOV-2020, but upon internal validation established as 01-NOV-2020) (dose and frequency not reported) subcutaneously in the left arm for the prevention of Measles, Mumps and Rubella.   On 12-JUL-2019, the patient experienced a swollen left knee and she was unable to put weight on it or bent it (joint swelling). The following day, on 13-JUL-2019, the patient was unable to put weight on her right knee or bent it (arthropathy). Additionally, on an unspecified date in 2019, the patient's face became swollen, she developed headaches, the chills, nauseous, lack of appetite and sore throat. No treatments were given for the events and no laboratory tests were performed.  At the time of the report, the patient had not recovered from the events.  The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the events was not reported.
Sex: F
Vaccine: MMR
Symptoms: Nausea, Oropharyngeal pain, Swelling face, Weight
Clinical narrative: the patient was unable to put weight on her right knee or bent it; a swollen left knee in which she was unable to put weight on her knee or bend it; face became swollen; headaches; nauseous; Sore throat; the chills; lack of appetite; This spontaneous report was received from a 54-year-old non-pregnant female patient referring to herself.  The patient had not relevant medical history and concomitant medications. Her concurrent conditions included seasonal allergy.  On 28-JUN-2019, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# R031629 has been verified to be a valid lot number, expiration date reported as 20-NOV-2020, but upon internal validation established as 01-NOV-2020) (dose and frequency not reported) subcutaneously in the left arm for the prevention of Measles, Mumps and Rubella.   On 12-JUL-2019, the patient experienced a swollen left knee and she was unable to put weight on it or bent it (joint swelling). The following day, on 13-JUL-2019, the patient was unable to put weight on her right knee or bent it (arthropathy). Additionally, on an unspecified date in 2019, the patient's face became swollen, she developed headaches, the chills, nauseous, lack of appetite and sore throat. No treatments were given for the events and no laboratory tests were performed.  At the time of the report, the patient had not recovered from the events.  The causal relationship between Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and the events was not reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Lymphadenopathy, Pain in extremity
Clinical narrative: Since GARDASIL 9 was administered 10 days ago, the patient had a sore arm, swelling at injection site and supraclavicular lymph node swelling; Since GARDASIL 9 was administered 10 days ago, the patient had a sore arm, swelling at injection site and supraclavicular lymph node swelling; Since GARDASIL 9 was administered 10 days ago, the patient had a sore arm, swelling at injection site and supraclavicular lymph node swelling; This spontaneous report has been received from a nurse via a company representative, concerning a 16 year old female patient.     The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, anatomical location, lot number and expiration date were not reported) for prophylaxis  On 14-JUL-2019 (also reported as "since 10 days ago"), after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered, the patient had a sore arm (injection site pain), swelling at injection site (injection site swelling) and supraclavicular lymph node swelling (lymphadenopathy). At the reporting time, she had not recovered from all the events.   The causal relationship between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he/she understood there was pain at the injection site and aked the reason for this. The reporter also asked how long should pain last.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Headache; low grade temperature; achy; sore throat; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced influenza-like symptoms, headache, slight temperature, pain and sore throat. On an unknown date, the outcome of the influenza-like symptoms, headache, slight temperature, pain and sore throat were not recovered/not resolved.   The reporter considered the influenza-like symptoms, headache, slight temperature, pain and sore throat to be possibly related to Shingrix.  Additional details were provided as follows: The patient was running a low-grade temperature, achy (flu-like symptoms) headache and sore throat.  The patient believed those were side effects. The reporter asked information regarding the treatment for the side effects.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: Redness; Swelling; This case was reported by a nurse via sales rep and described the occurrence of erythema in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   The reporter considered the erythema and swelling to be related to Bexsero.  Additional details were provided as follows: The patient experienced redness and swelling. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Scar
Clinical narrative: scars; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included scar (has scars from her previous shingles outbreaks). Previously administered products included Zostavax with an associated reaction of herpes zoster (she had 4 to 5 shingles outbreaks in 2018.) and Shingrix with an associated reaction of pain in extremity (received 1st dose of Shingrix 6 months ago and experienced arm soreness and tiredness, refer case US2019129959).   On 1st July 2019, the patient received the 2nd dose of Shingrix. On 5th July 2019, 4 days after receiving Shingrix, the patient experienced shingles. On 12th July 2019, the patient experienced scar. On an unknown date, the outcome of the shingles and scar were unknown.   It was unknown if the reporter considered the shingles and scar to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. On 5th or 6th July 2019, the patient developed shingles. She has scars from her previous shingles outbreaks in addition to the most recent episode. There is a discrepancy regarding outcome on narrative as in source document mentioned as RECOVEREDRESOLVED WITH SEQUEL for shingles and in Database core mentioned as unknown.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Injection site pain, Injection site rash
Clinical narrative: rash appeared at the site; peeling of skin; tenderness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number Z9E99, expiry date 2nd June 2021) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix. On 29th June 2019, 1 days after receiving Shingrix, the patient experienced injection site tenderness. On 1st July 2019, the patient experienced injection site rash and rash desquamating. On an unknown date, the outcome of the injection site tenderness, injection site rash and rash desquamating were not recovered/not resolved.   The reporter considered the injection site tenderness, injection site rash and rash desquamating to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid. The patient stated that, 72 hours after vaccination, experienced rash appeared at the site, later began to peel. The pharmacist suspected the patient may have let a bag of frozen peas lay on the area too long. The peas were suggested as a way to reduce site pain. This case is 1 of the 2 linked cases, reported by same reporter. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Blood test normal, Computerised tomogram normal, Diarrhoea, Feeling abnormal
Clinical narrative: not steady on his feet; diarrhea; stumbles; Felt bad; nausea; slight headache; difficulty focusing after turning head; Weird eyesight; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, immediately after receiving Shingrix, the patient experienced nausea, headache, difficulty focusing eyes and abnormal vision. On 15th July 2019, the patient experienced feeling bad. On an unknown date, the patient experienced unsteadiness, diarrhea and walking difficulty. On an unknown date, the outcome of the nausea, headache, difficulty focusing eyes, unsteadiness, diarrhea, walking difficulty and feeling bad were not recovered/not resolved and the outcome of the abnormal vision was unknown.   It was unknown if the reporter considered the nausea, headache, difficulty focusing eyes, abnormal vision, unsteadiness, diarrhea, walking difficulty and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. Less than a year after vaccination, the patient experienced unsteadiness, diarrhea and walking difficulty. The patient went to his physicain for stool sample and had ultrasound. The stool analysis and ultrasound came back normal. On 15th July 2019, the patient felt bad, so he went to the emergency room and did CT scan with blood check, but could not found anything wrong. The patient claimed that, his side effects were worsening. The patient consented to follow up. There was the discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).      Lab Comments: On an unknown date, stool analysis, ultrasound, CT scan and blood test were performed.
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Immediate post-injection reaction, Nausea, Stool analysis normal
Clinical narrative: not steady on his feet; diarrhea; stumbles; Felt bad; nausea; slight headache; difficulty focusing after turning head; Weird eyesight; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, immediately after receiving Shingrix, the patient experienced nausea, headache, difficulty focusing eyes and abnormal vision. On 15th July 2019, the patient experienced feeling bad. On an unknown date, the patient experienced unsteadiness, diarrhea and walking difficulty. On an unknown date, the outcome of the nausea, headache, difficulty focusing eyes, unsteadiness, diarrhea, walking difficulty and feeling bad were not recovered/not resolved and the outcome of the abnormal vision was unknown.   It was unknown if the reporter considered the nausea, headache, difficulty focusing eyes, abnormal vision, unsteadiness, diarrhea, walking difficulty and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. Less than a year after vaccination, the patient experienced unsteadiness, diarrhea and walking difficulty. The patient went to his physicain for stool sample and had ultrasound. The stool analysis and ultrasound came back normal. On 15th July 2019, the patient felt bad, so he went to the emergency room and did CT scan with blood check, but could not found anything wrong. The patient claimed that, his side effects were worsening. The patient consented to follow up. There was the discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).      Lab Comments: On an unknown date, stool analysis, ultrasound, CT scan and blood test were performed.
Sex: M
Vaccine: VARZOS
Symptoms: Ultrasound scan normal, Vision blurred, Visual impairment
Clinical narrative: not steady on his feet; diarrhea; stumbles; Felt bad; nausea; slight headache; difficulty focusing after turning head; Weird eyesight; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, immediately after receiving Shingrix, the patient experienced nausea, headache, difficulty focusing eyes and abnormal vision. On 15th July 2019, the patient experienced feeling bad. On an unknown date, the patient experienced unsteadiness, diarrhea and walking difficulty. On an unknown date, the outcome of the nausea, headache, difficulty focusing eyes, unsteadiness, diarrhea, walking difficulty and feeling bad were not recovered/not resolved and the outcome of the abnormal vision was unknown.   It was unknown if the reporter considered the nausea, headache, difficulty focusing eyes, abnormal vision, unsteadiness, diarrhea, walking difficulty and feeling bad to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. Less than a year after vaccination, the patient experienced unsteadiness, diarrhea and walking difficulty. The patient went to his physicain for stool sample and had ultrasound. The stool analysis and ultrasound came back normal. On 15th July 2019, the patient felt bad, so he went to the emergency room and did CT scan with blood check, but could not found anything wrong. The patient claimed that, his side effects were worsening. The patient consented to follow up. There was the discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).      Lab Comments: On an unknown date, stool analysis, ultrasound, CT scan and blood test were performed.
Sex: F
Vaccine: VARZOS
Symptoms: Exfoliative rash, Pruritus
Clinical narrative: Itching; Rash that peeled; This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced pruritus and rash desquamating. The patient was treated with antihistamine and medication unknown (Unknown Topical Medication). On an unknown date, the outcome of the pruritus and rash desquamating were unknown.   It was unknown if the reporter considered the pruritus and rash desquamating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date of Shingrix was unknown. The pharmacist reported that, the patient complaint that, after injection experienced itching and rash that kind peeled. The reporter reported that, this was happened more than 6 months ago. The reporter consented to follow up. This case was 1 of the 2 linked cases, reported by same reporter.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Blood glucose increased
Clinical narrative: High blood sugar; This case was reported by a pharmacist via call center representative and described the occurrence of blood sugar increased in a 78-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 15th July 2019, the patient received Boostrix (intramuscular). In July 2019, less than a week after receiving Boostrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was unknown.   It was unknown if the reporter considered the blood sugar increased to be related to Boostrix.  Additional details were provided as follows: The patient blood sugar was high. The patient did not report to pharmacist when the blood sugar changes occurred. The reporter consented to follow up. The reporter stated that he had no further details available at the time of reporting, however he gave permission for safety to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Immediate post-injection reaction, Injection site pain, Underdose
Clinical narrative: Pain in arm; Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix .5 ml. On 15th July 2019, immediately after receiving Shingrix, the patient experienced pain in arm and underdose. On an unknown date, the outcome of the pain in arm and underdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: This pharmacist reported that the patient had pulled away from while being injected due to pain in their arm.  It was not pain from the needle being injected but was felt when the solution was being administered. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold sweat, Injection site pain, Injection site swelling
Clinical narrative: Injection site pain; Injection site swelling; Cold sweats; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site swelling and cold sweat. On an unknown date, the outcome of the injection site pain and injection site swelling were resolved with sequelae and the outcome of the cold sweat was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and cold sweat to be related to Shingrix.  Additional details were reported as follows: The reporter stated that, the patient received the first dose of Shingrix and went to emergency room complaining of swelling and pain at the injection site and cold sweats. The symptoms have subsided. Emergency room visit was required.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Injection site pain, Underdose
Clinical narrative: Pain in arm; Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 15th July 2019, immediately after receiving Shingrix, the patient experienced pain in arm and underdose. On an unknown date, the outcome of the pain in arm and underdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: This pharmacist reported that the patient had pulled away from while being injected due to pain in their arm.  It was not pain from the needle being injected but was felt when the solution was being administered. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient demographic details were not provided. The patient stated that, experienced sore arm after 1st dose of Shingrix. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling hot, Pyrexia
Clinical narrative: fever; hot; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2019, 1 days after receiving Shingrix, the patient experienced fever and feeling hot. On an unknown date, the outcome of the fever and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the fever and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. On 16th July 2019, in the morning at 9:30 am, the patient felt hot and took temperature and it was 99. Two hours later, the patient again took temperature and it was 99.4. The patient did not consent to follow up. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain
Clinical narrative: TIRED; ACHY; WEAK; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2018).   In March 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced tiredness, weakness and pain. On an unknown date, the outcome of the tiredness and pain were unknown and the outcome of the weakness was recovered/resolved.   It was unknown if the reporter considered the tiredness, weakness and pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. After the 2nd dose of Shingrix, the patient felt weak, tired and achy for a day 1 or 2. The symptoms were resolved. For the past month, the patient had been feeling achy and tired. No additional information was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sore; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 53RF3, expiry date 17th October 2021) for prophylaxis.   On 16th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th July 2019, 4 hrs after receiving Shingrix, the patient experienced cold sores. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. The pharmacist reported that the patient developed a cold sore approximately 4 hours after receiving dose 2 of Shingrix series. The patient took Valtrex to treat the cold sore. The reporter gave permission to follow up. In the sheet outcome of event reported as RECOVERING/RESOLVING, but in database it was mentioned as not recovered/not resolved so outcome kept as reported in database.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age group of the patient was not reported, but selected as an adult as per vaccine indication. The caller stated that, the health care professional called her and wanted to know if a rash after the 1st dose of Shingrix was common. The health care professional stated that, he had the patient who experienced rash after vaccinaion with 1st dose of Shingrix. The reporter did not consent to follow up. The reporter did not have details about the patient or vaccine as she was not the one that gave the vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Palpitations
Clinical narrative: Shivering; Dizziness; heart palpitations; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shivering, dizziness and palpitation. On an unknown date, the outcome of the shivering, dizziness and palpitation were unknown.   It was unknown if the reporter considered the shivering, dizziness and palpitation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient's husband. The reporter stated that, the patient received the Shingrix vaccine at a pharmacy and had a multiple adverse reactions. The reporter did not provide additional information to document the adverse event. The events reported were shivering, dizziness and heart palpitations. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Multiple allergies
Clinical narrative: pronounced allergies; This case was reported by a nurse via call center representative and described the occurrence of multiple allergies 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 multiple allergies. On an unknown date, the outcome of the multiple allergies was unknown.   It was unknown if the reporter considered the multiple allergies to be related to Shingrix.  Additional details were provided as follows: The reporter did not have patient's date of birth. The batch number and expiration date was not reported. The nurse called and reported that patient had more pronounced allergies after receiving Shingrix. The reporter consented to follow up.
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abdominal pain, Asthma, Condition aggravated, Confusional state, Headache
Clinical narrative: High fever, headache, abdominal pain, nausea, confusion, paleness, lethargy, exasperation of asthma
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Lethargy, Nausea, Pallor, Pyrexia
Clinical narrative: High fever, headache, abdominal pain, nausea, confusion, paleness, lethargy, exasperation of asthma
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Decreased appetite, Dizziness, Fatigue, Feeling hot, Gait disturbance
Clinical narrative: The morning of 07/19, she woke with "severe exhaustion", fever at that point, no number but felt like she was burning up some point in the day. Patient found it hard to move that day, arms and legs were tired "she did not want to move", she was drinking well, water and pedialyte. On 7/20 arms and legs felt heavy the next day, fever resolved, appetite coming back, mother helped her she was dizzy. 7/21 improved, easier to walk, arms and legs hurt still, can't walk as far, she gets pain upper arms and thighs but it is improving. "knees have been locking a lot". Seen in the office on 07/25/2019 her exam was normal and her symptoms better. Referred to Neurology for further examination. The Neurologist findings were " Given the normal strength and reflexes and lack of any sensory complaints, there is no concern for an autoimmune post-vaccine demyelinating process. Most likely this represents a post-vaccine reaction with flu-like symptoms which seem to be improving." The patient is feeling better and will follow up in office on 07/30/2019.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Influenza like illness, Joint lock, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: The morning of 07/19, she woke with "severe exhaustion", fever at that point, no number but felt like she was burning up some point in the day. Patient found it hard to move that day, arms and legs were tired "she did not want to move", she was drinking well, water and pedialyte. On 7/20 arms and legs felt heavy the next day, fever resolved, appetite coming back, mother helped her she was dizzy. 7/21 improved, easier to walk, arms and legs hurt still, can't walk as far, she gets pain upper arms and thighs but it is improving. "knees have been locking a lot". Seen in the office on 07/25/2019 her exam was normal and her symptoms better. Referred to Neurology for further examination. The Neurologist findings were " Given the normal strength and reflexes and lack of any sensory complaints, there is no concern for an autoimmune post-vaccine demyelinating process. Most likely this represents a post-vaccine reaction with flu-like symptoms which seem to be improving." The patient is feeling better and will follow up in office on 07/30/2019.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: The morning of 07/19, she woke with "severe exhaustion", fever at that point, no number but felt like she was burning up some point in the day. Patient found it hard to move that day, arms and legs were tired "she did not want to move", she was drinking well, water and pedialyte. On 7/20 arms and legs felt heavy the next day, fever resolved, appetite coming back, mother helped her she was dizzy. 7/21 improved, easier to walk, arms and legs hurt still, can't walk as far, she gets pain upper arms and thighs but it is improving. "knees have been locking a lot". Seen in the office on 07/25/2019 her exam was normal and her symptoms better. Referred to Neurology for further examination. The Neurologist findings were " Given the normal strength and reflexes and lack of any sensory complaints, there is no concern for an autoimmune post-vaccine demyelinating process. Most likely this represents a post-vaccine reaction with flu-like symptoms which seem to be improving." The patient is feeling better and will follow up in office on 07/30/2019.