chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site warmth, Metabolic function test
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 67 years old female patient. The patient did not have any drug reactions or allergies. Information about pertinent medical history included hyperlipidemia and the concomitant therapy included atorvastatin. On an unknown date in 2018, the patient was vaccinated with PREVNAR. On 20-MAR-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # R033343 with expiration date 03-AUG-2020, intramuscularly in the left deltoid for prophylaxis (reported as received PREVNAR 2018 and she was 67 years old). On the same date, the patient stated her left arm was hot, red, and swollen to the elbow. On 21-MAR-2019, the patient went to an unspecified urgent care and received treatment with ANCEF 2 grams via intravenous (IV), made a complete blood count and the C-reactive protein test with result of 45.5. On the same date, the patient was discharged to home with oral BACTRIM. The patient was made intervention to prevent serious criteria. The reporter requested a lot check and the request was time sensitive. The outcome of events and the causality assessments between events and PNEUMOVAX 23 were not reported. The reporter considered all the events to be medically significant.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein increased, Erythema, Full blood count, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 67 years old female patient. The patient did not have any drug reactions or allergies. Information about pertinent medical history included hyperlipidemia and the concomitant therapy included atorvastatin. On an unknown date in 2018, the patient was vaccinated with PREVNAR. On 20-MAR-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # R033343 with expiration date 03-AUG-2020, intramuscularly in the left deltoid for prophylaxis (reported as received PREVNAR 2018 and she was 67 years old). On the same date, the patient stated her left arm was hot, red, and swollen to the elbow. On 21-MAR-2019, the patient went to an unspecified urgent care and received treatment with ANCEF 2 grams via intravenous (IV), made a complete blood count and the C-reactive protein test with result of 45.5. On the same date, the patient was discharged to home with oral BACTRIM. The patient was made intervention to prevent serious criteria. The reporter requested a lot check and the request was time sensitive. The outcome of events and the causality assessments between events and PNEUMOVAX 23 were not reported. The reporter considered all the events to be medically significant.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Aggression, Anaphylactic reaction, Cough, Eye swelling, Lethargy
Clinical narrative: PT STARTED SNEEZING, VOMITING, FACIAL SWELLING, NON RESPOSIVE WITHIN 10 MINS AFTER ADMIN. PT WAS GIVEN 02, EPI PEN WAS ADMINISTERED 9-11 CALLED, TRANSPORTED TO NEAREST HOSPITAL.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Oxygen saturation decreased, Retching, Rhinorrhoea, Sneezing, Swelling face
Clinical narrative: PT STARTED SNEEZING, VOMITING, FACIAL SWELLING, NON RESPOSIVE WITHIN 10 MINS AFTER ADMIN. PT WAS GIVEN 02, EPI PEN WAS ADMINISTERED 9-11 CALLED, TRANSPORTED TO NEAREST HOSPITAL.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Vomiting
Clinical narrative: PT STARTED SNEEZING, VOMITING, FACIAL SWELLING, NON RESPOSIVE WITHIN 10 MINS AFTER ADMIN. PT WAS GIVEN 02, EPI PEN WAS ADMINISTERED 9-11 CALLED, TRANSPORTED TO NEAREST HOSPITAL.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Cough, Lethargy, Periorbital swelling, Retching, Secretion discharge
Clinical narrative: PT STARTED SNEEZING, VOMITING, FACIAL SWELLING, NON RESPOSIVE WITHIN 10 MINS AFTER ADMIN. PT WAS GIVEN 02, EPI PEN WAS ADMINISTERED 9-11 CALLED, TRANSPORTED TO NEAREST HOSPITAL.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Sneezing, Swelling face, Vomiting
Clinical narrative: PT STARTED SNEEZING, VOMITING, FACIAL SWELLING, NON RESPOSIVE WITHIN 10 MINS AFTER ADMIN. PT WAS GIVEN 02, EPI PEN WAS ADMINISTERED 9-11 CALLED, TRANSPORTED TO NEAREST HOSPITAL.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Sneezing, Swelling face, Unresponsive to stimuli, Vomiting
Clinical narrative: PT STARTED SNEEZING, VOMITING, FACIAL SWELLING, NON RESPOSIVE WITHIN 10 MINS AFTER ADMIN. PT WAS GIVEN 02, EPI PEN WAS ADMINISTERED 9-11 CALLED, TRANSPORTED TO NEAREST HOSPITAL.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Full blown shingles on back around left side and across abdomen. Commenced on Feb 25, 2019 began prescribed Valacyclovir 500 MG on March 1, 2019 for seven days. Did not relieve pain. Then began prescribed Naproxen Sodium 275 MG for 7 days on 03/13/2019 but still have pain but rash is diminished.
Age: 59.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Fever, swelling at injection site of left arm. Throw up later of same day of vaccination. Fever is down from 104 to 100. Patient took TYLENOL for fever.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Diarrhoea, Injection site pain, Middle insomnia, Myalgia
Clinical narrative: At about 3:00 AM on 3/31/2019 I awoke feeling nauseous. It wasn't long before I was vomiting. I only vomited once but felt nauseous for about 4 hours. I also had 2-3 episodes of diarrhea and a slight fever. Minor adverse event was a very sore spot at the sight of the injection along with slight general muscle and joint pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: At about 3:00 AM on 3/31/2019 I awoke feeling nauseous. It wasn't long before I was vomiting. I only vomited once but felt nauseous for about 4 hours. I also had 2-3 episodes of diarrhea and a slight fever. Minor adverse event was a very sore spot at the sight of the injection along with slight general muscle and joint pain.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided.  On an unknown date the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX lot # N032103 expiration date 11-FEB-2019 (strength, dose, frequency were not reported), subcutaneously for prophylaxis. No adverse effects were reported in the patient.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning to a patient of an unknown age and gender. Information regarding the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications was not reported. On 20-MAR-2019, the patient was vaccinated with a dose of PROQUAD 0.5ml, intramuscularly, lot # R026721, expiration date 17-MAR-2020 for prophylaxis. The vaccine were reconstituted with sterile diluent (lot # and expiration date not provided). On the same date, the patient's parent insisted that PROQUAD was administered intramuscularly instead of subcutaneously (incorrect route of product administration). No adverse events were reported. On 21-MAR-2019, the patient would be seen in office for evaluation. At the reporting time, the outcome of incorrect route of product administration was unknown.
Age: 14.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Laboratory test, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 year old female patient. The patient's medical history included asthma and seasonal allergy. The patient's concomitant medications were not reported. The patient's drug reactions or allergies include allergy to amoxicillin (rash). On 18-MAR-2019, the patient was vaccinated with PNEUMOVAX 23 intramuscular in left arm, lot number R017475 and expiration date 26-MAR-2020, (dosage schedule date was not reported). On 19-MAR-2019, the patient experienced injection site erythema, pain and a injection site mass on left arm at injection site. The patient received treatment for the symptoms with MOTRIN and TYLENOL and her pharmacist recommended taking BENADRYL. The patient threw up TYLENOL when she took them on an empty stomach. Symptoms did not resolve after these treatments. On 25-MAR-2019, the patient went to see physician because she was still having symptoms. Laboratory diagnostics and studies were performed but the results were not provided. At the time of the report, the patient had not recovered from the events. The causality between the aforementioned events and PNEUMOVAX 23 was not provided.
Age: 4.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician, concerning a 4 year old patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was inadvertently vaccinated with GARDASIL 9 1 dose, for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of two reports received from the same reporter.
Sex: M
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician, via company representative, referring to a male patient, age reported as "in his 20's". The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unknown date, the patient received two doses of M-M-R II for prophylaxis (strength, frequency, therapy type, lot # and expiration date were not provided). On an unspecified date, reported as "in the 1990's", the patient had an unspecified blood titre test performed which showed a low titre result (rubella antibody negative, measles antibody negative and mumps antibody test negative). It was unknown by the reporter if any treatment was given due to the adverse events, or if the patient sought any medical attention. The outcome of rubella antibody negative, measles antibody negative and mumps antibody test negative was unknown.
Sex: U
Vaccine: HIBV, RV5
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a 4 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 26-MAR-2019, the patient received an improperly stored dose of LIQUID PEDVAXHIB, intramuscular, lot # R013571, expiration date 19-MAR-2021 for prophylaxis (dose was not reported) and ROTATEQ, orally, lot # R002701, expiration date 07-SEP-2019 for prophylaxis (dose was not reported) (product storage error). The administered dose of both vaccines experienced a temperature excursion above 47 degrees fahrenheit ° F/ 9 degrees Celsius ° C (12.6 C) for  4 hours and 45 minutes, as recorded by a data logger. The outcome of the event product storage error was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician, referring to a patient of unknown age and gender. Concomitant therapy included sterile diluent. No information was provided regarding the patient's medical history and concurrent conditions. On 28-MAR-2019, the patient was vaccinated with an expired dose of M-M-R II lot # N009172 (expiration date: 20-MAR-2019), for prophylaxis (strength, dose, frequency and route of administration were not reported). No adverse effect was reported.
Sex: M
Vaccine: HPV9
Symptoms: Costochondritis, Ligament rupture, Ligamentitis
Clinical narrative: This spontaneous report was received from a physician referring to a 17 year old male patient. Patient's current conditions, medical history, concomitant medications, drug allergies or reactions were not reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 first dose (strength, dose, administration route, anatomical site of injection, lot number and expiration date was not reported) for prophylaxis. On an unspecified date, the patient experienced inflammation of a ligament in his knee (unspecified), it was reported that the patient continued to play sports and tore the ligament in his unspecified knee (ligament rupture), date not provided. Additionally it was reported that on an unspecified date the patient received his second dose of GARDASIL 9 and experienced severe costochondritis of his rib cage and chest wall. The patient saw a health care professional (HCP) although it was unknown if the patient received treatment for the events, if lab diagnostics or studies were performed . At the reporting time, the patient was healthy (recovered). And the reported did not assess the causal relationship between the events ant therapy GARDASIL 9.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patients' medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided. On 27-MAR-2019, the patient was vaccinated with an expired dose of VAQTA intramuscularly, lot # R010368 and expiration date: 25-MAR-2019 (anatomical site was not reported), for prophylaxis. No known adverse effects.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 28-MAR-2019, the patient was vaccinated with M-M-R II (rHA) lot # N014483 with expiration date of 10-MAY-2019, 0.5 milliliter once, via intramuscular route for prophylaxis. The vaccine was reconstituted with Merck sterile diluent, lot number N022038 with expiration date of 27-NOV-2019. No adverse effects were reported.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, and refers to a 14 year old patient of unknown  gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided. On 28-MAR-2019, the patient was inadvertently vaccinated with an expired dose of VAQTA (lot # R010368 with an expiration date in 25-MAR-2019), intramuscularly, for prophylaxis (strength, dose and frequency were not provided). No adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a physician, concerning a 1 year old patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was inadvertently vaccinated with GARDASIL 9 1 dose, for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA011516.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, fever, muscle pain, joint pain and sickness. On an unknown date, the outcome of the chills, fever, muscle pain, joint pain and sickness were unknown. It was unknown if the reporter considered the chills, fever, muscle pain, joint pain and sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The patient received the SHINGRIX few months ago and within 5 or 6 hours the patient was sick as a dog, temperature, chills, muscle aches, joint pain. The patient talked with the pharmacist and they decided and picked up a bug while wandering through the store. There was no way the patient had a reaction to the shot, it just was not possible. For tolerance of 2nd dose, refer case US2019GSK056824.
Sex: F
Vaccine: MENB
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site erythema in a 12-year-old female patient who received 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 injection site erythema, injection site pain and allergy. On an unknown date, the outcome of the injection site erythema and injection site pain were recovered/resolved and the outcome of the allergy was unknown. It was unknown if the reporter considered the injection site erythema, injection site pain and allergy to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient received BEXSERO in an unknown arm. This evening, a patient relative had reported pain and redness at injection site (arm). It had lasted several days. The patient had returned to the public health clinic and the nurses said it was an allergy through this was not clear. Its painful and worrisome enough for her mother that they called to reporter and asked what they should do. The reporter had suggested they speak with their pediatrician and referred them to the BEXSERO risks and side effects page on the web.
Sex: U
Vaccine: FLUX
Symptoms: Drug hypersensitivity
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of drug allergy in a patient who received Influenza vaccine for prophylaxis. Concurrent medical conditions included, adhesive tape allergy (refer case US2019GSK032238), bee sting hypersensitivity (refer case US2019GSK032238) and drug allergy (Cefaclor, CEFITIN, Codeine-Nausea, Vomiting, KEFLEX-Diarrhea, Nifedipine-Swelling (refer case US2019GSK032238)). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced drug allergy. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced nausea, vomiting due to Codeine and diarrhea due to KEFLEX. It was unknown, if the reporter consented to further follow-up. It was unknown, if the patient/consumer/caregiver provide consent to contact the prescribing healthcare professional.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Corneal graft rejection, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of corneal graft rejection in a elderly male patient who received SHINGRIX for prophylaxis. Co-suspect products included ZOSTAVAX for prophylaxis. The patient's past medical history included corneal transplant. Concurrent medical conditions included Fuchs' Disease. On an unknown date, the patient received the 1st dose of SHINGRIX and ZOSTAVAX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced corneal graft rejection (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and adverse reaction. SHINGRIX was discontinued. On an unknown date, the outcome of the corneal graft rejection, ophthalmic herpes zoster and adverse reaction were unknown. The reporter considered the corneal graft rejection to be related to SHINGRIX. It was unknown if the reporter considered the ophthalmic herpes zoster and adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife who was also a pharmacist. The age at vaccination was not reported. He was about 70 years old at the time of reporting. Previous to the receipt of ZOSTAVAX (ZVL), the patient a corneal transplant. The patient's wife reported that, the patient experienced severe reaction and rejection of transplant (no timeline given post dose). The patient's treating physician stated that, the SHINGRIX had caused transplant rejection. The patient required another transplant, hence the patient would not receive 2nd dose of SHINGRIX. The patient's wife was counseling patients or friends to not get the vaccine if they previously received ZOSTAVAX as she felt that was somehow related. The patient's wife was suggesting perhaps a herpes ophthalmicus relationship.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Laboratory test
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (1st dose received few months ago from the reporting and experienced temperature, chills, muscle aches, joint pain). On 18th March 2019, the patient received the 2nd dose of SHINGRIX. On 18th March 2019, 10 hrs after receiving SHINGRIX, the patient experienced chills, fever, muscle pain, joint pain, headache and restlessness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, fever, muscle pain, joint pain, headache and restlessness were unknown. It was unknown if the reporter considered the chills, fever, muscle pain, joint pain, headache and restlessness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. About 10 hours later the patient had a temperature of 101, chills all night, muscle and joint aching and a headache. On 18th March 2019, lab test was performed. The patient tried to sleep but just tossed and turned 1 sheet, 1 blanket, 2nd blanket and stayed in sweat pants and long sleeve tee shirt and still shook. On the day of reporting, the patient was dragging and had a headache. The pharmacists did not know about the side effects or they were not very forthcoming about it.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia, Restlessness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (1st dose received few months ago from the reporting and experienced temperature, chills, muscle aches, joint pain). On 18th March 2019, the patient received the 2nd dose of SHINGRIX. On 18th March 2019, 10 hrs after receiving SHINGRIX, the patient experienced chills, fever, muscle pain, joint pain, headache and restlessness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the chills, fever, muscle pain, joint pain, headache and restlessness were unknown. It was unknown if the reporter considered the chills, fever, muscle pain, joint pain, headache and restlessness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. About 10 hours later the patient had a temperature of 101, chills all night, muscle and joint aching and a headache. On 18th March 2019, lab test was performed. The patient tried to sleep but just tossed and turned 1 sheet, 1 blanket, 2nd blanket and stayed in sweat pants and long sleeve tee shirt and still shook. On the day of reporting, the patient was dragging and had a headache. The pharmacists did not know about the side effects or they were not very forthcoming about it.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 51-year-old female patient who received SHINGRIX for prophylaxis. On 22nd September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 23rd September 2018, 1 days after receiving SHINGRIX, the patient experienced feeling unwell, tiredness, chills and fever. On an unknown date, the outcome of the feeling unwell, tiredness, chills and fever were recovered/resolved. It was unknown if the reporter considered the feeling unwell, tiredness, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine at 5:30 PM and she awoke the next morning and she spent the first half of the day in bed and did not feel great. The patients side effects resolved later that day. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash herpetiform in a male patient who received SHINGRIX for prophylaxis. On 6th March 2019, the patient received SHINGRIX. On 9th March 2019, 3 days after receiving SHINGRIX, the patient experienced rash herpetiform. In March 2019, the patient experienced fever. The patient was treated with acyclovir. On an unknown date, the outcome of the rash herpetiform was recovering/resolving and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the rash herpetiform and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated three to four days after the vaccination, he developed a rash on his back. The patient went to his physician who said it looked like Herpes and prescribed to take Acyclovir. The rash on his upper back resolved, but then returned on his lower back.  The patient had a little fever with the vaccination but otherwise felt fine. Emergency room visit was required. The reporter had to use interpreter. Limited information was requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis (Previously exeperienced with rheumatoid arthritis). Concomitant products included tofacitinib citrate (Xeljanz). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX a week ago. Two days post vaccination her face and chest became red. The patient referred to the physician. No further information were provided.
Sex: F
Vaccine: HEPA
Symptoms: Diarrhoea, Immediate post-injection reaction, Lactose intolerance
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of diarrhea in a female patient who received HAVRIX (batch number 37RY4, expiry date 6th March 2021) for prophylaxis. On 19th September 2018, the patient received the 1st dose of HAVRIX 1 ml. On 19th September 2018, immediately after receiving HAVRIX, the patient experienced diarrhea and lactose intolerance. HAVRIX was discontinued. On an unknown date, the outcome of the diarrhea was unknown and the outcome of the lactose intolerance was not recovered/not resolved. It was unknown if the reporter considered the diarrhea and lactose intolerance to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient thought HAVRIX caused her to become lactose intolerant. The patient started having diarrhea after eating dairy products shortly after getting the 1st dose. The batch number of HAVRIX was reported as 37R44, which was corrected to 37RY4 as per sales data sheet. The patient did not want to get the 2nd dose now.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age group was not provided, but it was taken as adult, as per vaccine indication. The patient had reported experiencing redness and swelling at the injection site and at the time of this report, the injection site was hot to the touch. No additional details provided by the sales representative. The health care professional office could not be immediately reached for additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of body temperature increased in a adult male patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received SHINGRIX. On 21st March 2019, less than a day after receiving SHINGRIX, the patient experienced body temperature increased and heart rate increased. On an unknown date, the outcome of the body temperature increased and heart rate increased were unknown. It was unknown if the reporter considered the body temperature increased and heart rate increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient normally had low body temperature of 96 to 97 degrees F. On the day of reporting (later in the evening) after receiving SHINGRIX the patient's body temperature was elevated to 99.2 degrees F and the pulse rate was increased from the 60 to the 80. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Gait inability, Lethargy, Malaise, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced exhaustion, unable to walk, facial rash, nausea, lethargy and feeling unwell. On an unknown date, the outcome of the exhaustion, unable to walk, facial rash, nausea, lethargy and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the exhaustion, unable to walk, facial rash, nausea, lethargy and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for himself. The patient was not feeling right in the morning of 14th March 2019, he felt exhausted and couldn't even walk. He was feeling progressively worse, he got a rash on the forehead and the right side of face, had nausea and felt lethargic. On 18th March 2019, the patient felt better and was fine on 19th March 2019 but the symptoms came back on 20th March 2019. The patient had all the symptoms at the time of reporting. The patient did not provide the consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced exhaustion, unable to walk, facial rash, nausea, lethargy and feeling unwell. On an unknown date, the outcome of the exhaustion, unable to walk, facial rash, nausea, lethargy and feeling unwell were not recovered/not resolved. It was unknown if the reporter considered the exhaustion, unable to walk, facial rash, nausea, lethargy and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient for himself. The patient was not feeling right in the morning of 14th March 2019, he felt exhausted and couldn't even walk. He was feeling progressively worse, he got a rash on the forehead and the right side of face, had nausea and felt lethargic. On 18th March 2019, the patient felt better and was fine on 19th March 2019 but the symptoms came back on 20th March 2019. The patient had all the symptoms at the time of reporting. The patient did not provide the consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The pharmacist did not know if the patient had a history of shingles. It was unknown whether when the patient received the dose at reporter's facility or the patient got it somewhere. The patient was getting over shingles now. The pharmacist did not know how long the patient waited between having the SHINGRIX shot and developing shingles.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Aneurysm, Atrioventricular block, Coronary arterial stent insertion, Hypertension, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX (batch number 32ZG4, expiry date 29th February 2020) for prophylaxis. On 14th July 2018, the patient received the 1st dose of SHINGRIX. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, 2 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain (serious criteria hospitalization), injection site erythema (serious criteria hospitalization), injection site swelling (serious criteria hospitalization) and pain in arm. In February 2019, the patient experienced obstruction (serious criteria hospitalization) and aneurysm (serious criteria hospitalization). On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and pain in arm were recovered/resolved and the outcome of the obstruction, aneurysm and product supply issue were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, obstruction, aneurysm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Two days after receiving SHINGRIX, the patient had redness, pain and swelling at the injection site. Her arm hurt for 3 to 4 weeks. In February 2019, less than a year after receiving SHINGRIX, the patient saw a cardiologist and was diagnosed with a 99 percent blockage in her heart, as well as an aneurysm. Her blood pressure was also very high. She had surgery on 8th February 2019 to place a stent. Between the shortage and her surgery she was unable to get the 2nd dose until the date of reporting. The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Obstruction, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX (batch number 32ZG4, expiry date 29th February 2020) for prophylaxis. On 14th July 2018, the patient received the 1st dose of SHINGRIX. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, 2 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain (serious criteria hospitalization), injection site erythema (serious criteria hospitalization), injection site swelling (serious criteria hospitalization) and pain in arm. In February 2019, the patient experienced obstruction (serious criteria hospitalization) and aneurysm (serious criteria hospitalization). On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and pain in arm were recovered/resolved and the outcome of the obstruction, aneurysm and product supply issue were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, obstruction, aneurysm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Two days after receiving SHINGRIX, the patient had redness, pain and swelling at the injection site. Her arm hurt for 3 to 4 weeks. In February 2019, less than a year after receiving SHINGRIX, the patient saw a cardiologist and was diagnosed with a 99 percent blockage in her heart, as well as an aneurysm. Her blood pressure was also very high. She had surgery on 8th February 2019 to place a stent. Between the shortage and her surgery she was unable to get the 2nd dose until the date of reporting. The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX (batch number 32ZG4, expiry date 29th February 2020) for prophylaxis. On 14th July 2018, the patient received the 1st dose of SHINGRIX. On 25th March 2019, the patient received the 2nd dose of SHINGRIX. On 16th July 2018, 2 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain (serious criteria hospitalization), injection site erythema (serious criteria hospitalization), injection site swelling (serious criteria hospitalization) and pain in arm. In February 2019, the patient experienced obstruction (serious criteria hospitalization) and aneurysm (serious criteria hospitalization). On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and pain in arm were recovered/resolved and the outcome of the obstruction, aneurysm and product supply issue were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, obstruction, aneurysm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: Two days after receiving SHINGRIX, the patient had redness, pain and swelling at the injection site. Her arm hurt for 3 to 4 weeks. In February 2019, less than a year after receiving SHINGRIX, the patient saw a cardiologist and was diagnosed with a 99 percent blockage in her heart, as well as an aneurysm. Her blood pressure was also very high. She had surgery on 8th February 2019 to place a stent. Between the shortage and her surgery she was unable to get the 2nd dose until the date of reporting. The reporter did not consent to follow-up.
Sex: M
Vaccine: DTAP, HIBV, RVX
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 28-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 2 months old male patient who was vaccinated with ACT-HIB (lot number: UI803AAA, expiry date: 01-July-2018), via intramuscular route in the left thigh, on 28-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included DAPTACEL and Rotavirus. It was an actual medication error due to expired vaccine used. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 22-Mar-2019 regarding an unsolicited non-valid non-serious case received from a other health professional. This case involves a 6 months old female patient who received vaccine PENTACEL (lot U6138AA and expiry date 07-Jul-2020) via intramuscular route with DTaP-IPV portion given separately from the HIB component on 22-Mar-2019.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccination included Hepatitis B, pneumococcal conjugate vaccine and rotavirus vaccine. It was a case of actual medication error due to inappropriate reconstitution technique. Patient did not had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 16 years old male patient who was vaccinated with a 0.5 ml dose of expired vaccine MENACTRA (lot U5835AB and Exp. Date 27-FEB-2019) via unknown route in the left arm on 22-Mar-2019. The patient's medical history was not reported and No concomitant vaccines were given. It was a case of actual medication error case due to expired vaccine used. No side effects were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: DTAP, FLUX, HEPA, PNC13
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case from a health care professional. This case involves 18 months old female patient who received fourth dose of 0.5 mL dose of vaccine DAPTACEL lot C5171AA, expiry date- 23-Mar-2019 via unknown route in the left thigh on 26-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; HEPATITIS A VACCINE; and INFLUENZA VACCINE. It was a case of actual medication error due to Expired vaccine used. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 28-Mar-2018 regarding an unsolicited valid serious case received from a other health professional. This case involves a 4 years old male patient who was inadvertently vaccinated with an expired dose of DAPTACEL (lot C5157AA expiry date: 23-Feb-2019, via unknown route in the left deltoid) on 27-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used. It was unknown whether the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Dry skin, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: It began as swelling at the injection site with a few small welts leading from it until it slowly spread from right leg to belly, left leg up the torso and onto all arms, legs, face. Also two small dry spots looking like eczema appeared on both elbow areas on right and left side.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Induration, Nausea, Pain, Skin warm
Clinical narrative: Very larger area of induration with warmth, pain, and tenderness on palpitation, body aches, nausea and vomiting, headaches.