chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 76-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received the 2nd dose of SHINGRIX. On 30th June 2018, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles and chest pain. On an unknown date, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and incomplete course of vaccination. The patient was treated with VALTREX. In July 2018, the outcome of the shingles and chest pain were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, shingles and chest pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for 2nd dose of SHINGRIX. The patient received the 1st dose of SHINGRIX vaccine on left arm. The next day she experienced a red spot at the injection site in size of 1 inch and which increased to 4 to 5 inches in size, along with swelling and heating at the injection site which spread down to the arm. This lasted for about a week and she recovered. On 30th June 2018, the patient experienced a mild case of shingles and pain around the chest above the left breast area. On 3rd July 2018, the patient visited her doctor. She was prescribed generic of VALTREX. The patient recovered in a week. Till the date of this report, the patient had not received the 2nd dose of SHINGRIX, which led to incomplete course of vaccination. The reporter had consented to follow up and had provided physician's contact details.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had a reaction after first dose of SHINGRIX. The reporter did not gave consent to follow up. The reporter was unable to collect any additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a elderly 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 details were provided as follows: The age at vaccination was not reported. The health care professional stated that patient developed shingles after first dose of SHINGRIX. The first dose was administered at a different pharmacy, reporter did not had details. The reporter gave consent to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Condition aggravated, Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of blister in a 67-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included shingles (yearly for the past 4 to 5 years) and lymphadenopathy cervical. On 2nd November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced blister. On an unknown date, the outcome of the blister was unknown. It was unknown if the reporter considered the blister to be related to SHINGRIX. Additional details were reported as follows: The caller reported that she had shingles yearly for the past 4 to 5 years. She had a bad case over the summer of 2018. She was advised by her infectious disease doctor to get SHINGRIX. Prior to getting the dose of SHINGRIX her shingles was mostly resolved, though she thinks it might had lurking at a low level. Within a week or 2 of getting SHINGRIX she started having little shingles blisters pop out, and it had popping out ever since. She had swollen lymph nodes in the left side of her neck since summer. The swelling was up and down since summer, and this had continued since getting SHINGRIX. The reporter consented to follow up.
Age: 0.25
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Mass, Skin warm
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of induration in a 37-year-old female patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received the 1st dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced induration, mass, skin warm and redness of legs. On an unknown date, the outcome of the induration, mass, skin warm and redness of legs were recovered/resolved. It was unknown if the reporter considered the induration, mass, skin warm and redness of legs to be related to DTaP vaccine. Additional details were provided as follows: The patient received 3 doses of the Tdap vaccine starting when she was 3 months old. The patient developed a hard knot in her left leg the size of a pea or a walnut. The area was also red and warm to touch and resolved after a week. The reporter reached out through the whooping cough website and was instructed to call the agency. The reason for reporter call was to advocate for vaccines not to report an adverse event (AE). The reporter had 3 kids and the advice of the physician, she did not vaccinate the other two because of the reactions her first child experienced but now she wishes she had vaccinated them as well because the other 2 kids had bad cases of whooping cough but the first child (the patient in this report) never had it. For tolerance to further doses, refer cases US2018GSK232635 (2rd dose) and US2018GSK232634 (3th dose).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test, Pruritus generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized pruritus in a 70-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 25th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, several weeks after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved. It was unknown if the reporter considered the generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: On 20th February 2018, the patient received 1st dose of the SHINGRIX vaccine on left arm. Few weeks after getting the 2nd dose, the patient experienced itching all over the body. The patient visited their allergy doctor. The patient went through allergy test, had molds checked in her house, changed detergent and perfumes. The patient at the time of reporting was experiencing itching. Emergency visit was required. No further details were provided.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 87-year-old female patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 14th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 16th December 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. The patient was treated with ANTIHISTAMINE and HYDROCORTISONE (CORTISONE (HYDROCORTISONE)). On an unknown date, the outcome of the injection site erythema was recovered/resolved and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX.  Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced redness and pain at the injection site. The patient also described that the redness was 6 inches long, 2.5 inches wide at the bottom of the injection site and 4 inches wide at the injection site. The patient called the doctor but did not visit. The patient's sister was a doctor and stopped to look at the patient's arm. The reporter gave consent to follow up.
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUARIX QUADRIVALENT 2018-2019 season for prophylaxis. On 13th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and FLUARIX QUADRIVALENT 2018-2019 season (intramuscular). On 13th December 2018, less than a day after receiving SHINGRIX and FLUARIX QUADRIVALENT 2018-2019 season, the patient experienced fever. On 14th December 2018, the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX and FLUARIX QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. The reporter was a retired nurse and also the mother in law of patient who received SHINGRIX along with a flu shot (unknown formulation). The patient experienced a fever of 102.2 degrees F at 8 PM that evening and that by the next day the fever resolved. The reporter did not wish to provide further specific information regarding the patient but stated she would encourage him to call back to provide more details.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 77-year-old female patient who received SHINGRIX for prophylaxis. On 18th December 2018, the patient received the 1st dose of SHINGRIX. On 18th December 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and headache. The patient was treated with PARACETAMOL (TYLENOL). On an unknown date, the outcome of the chills and headache were not recovered/not resolved and the outcome of the fever was recovering/resolving. It was unknown if the reporter considered the chills, fever and headache to be related to SHINGRIX. Additional details were provided as follows: On 18th December 2018 at night, the patient experienced chills, fever and headache. The patient received Tylenol and the fever went down a little bit. The reporter did not consent to follow up and the patient did not want to receive any follow up for the adverse event.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Decreased appetite, Dizziness, Influenza, Nasal congestion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 54-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included BREO ELLIPTA inhalation powder (batch number 8ZP2569, expiry date 31st May 2020) for chronic obstructive pulmonary disease and VENTOLIN HFA inhaler (batch number 8ZP2225, expiry date 31st December 2019) for chronic obstructive pulmonary disease. On 7th December 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, the patient started BREO ELLIPTA (inhaled) at an unknown dose and frequency and VENTOLIN HFA (inhaled) 2 puff(s) 4 times daily (8 puff(s) daily). In December 2018, several days after receiving Influenza vaccine Quadrivalent 2018-2019 season and less than a month after starting BREO ELLIPTA and VENTOLIN HFA, the patient experienced influenza, nasal congestion, appetite lost, lightheadedness, weakness and product use in unapproved indication. On an unknown date, the outcome of the influenza, nasal congestion, appetite lost, lightheadedness, weakness and product use in unapproved indication were unknown. It was unknown if the reporter considered the influenza, nasal congestion, appetite lost, lightheadedness and weakness to be related to Influenza vaccine Quadrivalent 2018-2019 season, BREO ELLIPTA and VENTOLIN HFA. Additional details were provided as follows: Approximately 2 weeks before the date of reporting, the patient received an unknown manufacturer's flu shot. The vaccination date of Flu vaccine was reported as 7th November 2018, however, as per the description it was changed to 7th December 2018. A few days after the Flu shot, she came down with the flu. At the time of the flu, the patient was taking BREO 200/25 once daily for COPD and also taking VENTOLIN HFA, as needed, but as of developing flu symptoms, she had increased her dosing, which led to product used for unapproved indication. The patient experienced lightheadedness, losss of appetite, and head congestion. The patient was also weak. The reporter did not consent for follow-up.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Product use in unapproved indication
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza in a 54-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included BREO ELLIPTA inhalation powder (batch number 8ZP2569, expiry date 31st May 2020) for chronic obstructive pulmonary disease and VENTOLIN HFA inhaler (batch number 8ZP2225, expiry date 31st December 2019) for chronic obstructive pulmonary disease. On 7th December 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, the patient started BREO ELLIPTA (inhaled) at an unknown dose and frequency and VENTOLIN HFA (inhaled) 2 puff(s) 4 times daily (8 puff(s) daily). In December 2018, several days after receiving Influenza vaccine Quadrivalent 2018-2019 season and less than a month after starting BREO ELLIPTA and VENTOLIN HFA, the patient experienced influenza, nasal congestion, appetite lost, lightheadedness, weakness and product use in unapproved indication. On an unknown date, the outcome of the influenza, nasal congestion, appetite lost, lightheadedness, weakness and product use in unapproved indication were unknown. It was unknown if the reporter considered the influenza, nasal congestion, appetite lost, lightheadedness and weakness to be related to Influenza vaccine Quadrivalent 2018-2019 season, BREO ELLIPTA and VENTOLIN HFA. Additional details were provided as follows: Approximately 2 weeks before the date of reporting, the patient received an unknown manufacturer's flu shot. The vaccination date of Flu vaccine was reported as 7th November 2018, however, as per the description it was changed to 7th December 2018. A few days after the Flu shot, she came down with the flu. At the time of the flu, the patient was taking BREO 200/25 once daily for COPD and also taking VENTOLIN HFA, as needed, but as of developing flu symptoms, she had increased her dosing, which led to product used for unapproved indication. The patient experienced lightheadedness, losss of appetite, and head congestion. The patient was also weak. The reporter did not consent for follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult female patient who received SHINGRIX (batch number KB99G, expiry date 22nd February 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced fever, general body pain and injection site pain. On an unknown date, the outcome of the fever, general body pain and injection site pain were unknown. It was unknown if the reporter considered the fever, general body pain and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received dose 1 of SHINGRIX and reported symptoms of fever, body aches, injection site pain starting the day after injection and lasting approximately for 24 hours. The patient then reported another episode of these symptoms few days later, which lasted up to 3 days. The reporter did not give consent to follow up. The health care professional contacted to GSK, because the patient thought it was unusual to had a second round of adverse events after being symptom free for a few days.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain, general body pain and fever. On an unknown date, the outcome of the injection site pain, general body pain and fever were unknown. It was unknown if the reporter considered the injection site pain, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. These symptoms began the day after vaccination and lasted 24 hours. The patient was symptom free up until 6 days later where the patient began experienced the same symptoms again. The reporter did not consent to follow-up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 73-year-old male patient who received SHINGRIX for prophylaxis. On 16th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th December 2018, 2 days after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. The patient planned to follow-up with his physician on an unknown date. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Mouth swelling, Rash, Rash erythematous, Swelling face
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of facial swelling in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 28th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, 7 days after receiving SHINGRIX, the patient experienced facial swelling, lip swelling, swollen mouth and red rash. On an unknown date, the outcome of the facial swelling, lip swelling, swollen mouth and red rash were recovered/resolved. It was unknown if the reporter considered the facial swelling, lip swelling, swollen mouth and red rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 58 or 59 years old. The patient received vaccine on left arm. It was reported that that 7 days after vaccination, the patient woke up in the morning and his face was swollen along with his mouth, lips and jaw. The patient also had a red rash on the chest and abdomen. The patient had not taken any new medications or changed anything other than received the SHINGRIX vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Eosinophilia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of eosinophilia in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several days after receiving SHINGRIX, the patient experienced eosinophilia. On an unknown date, the outcome of the eosinophilia was unknown. It was unknown if the reporter considered the eosinophilia to be related to SHINGRIX. Additional details were provided as follows: The physician unable to provide patient's demographics. The age group was not reported but it was selected as adult as per vaccine indication. The patient had mild eosinophilia a few days after administration of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 13th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site itching. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)) and antihistamine. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were unknown. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter did not provide patient's initials or date of birth. The patient received SHINGRIX on the left deltoid. After vaccination, the patient experienced redness, swelling and severe itchiness on her left deltoid. The patient went to the emergency room to had it checked out and treated with an antibiotic and an antihistamine for the reaction.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number 9KT7T, expiry date 13th March 2021) for prophylaxis. On 18th December 2018, the patient received SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovering/resolving. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX.  Additional details were reported as follows: The patient experienced injection site reaction, which was red and warm. The events were recovering but it was unsure how soon after vaccination the patient developed the reaction. The patient was able to perform daily activities like swimming and yoga. The reporter had consented to follow up.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Cerumen removal, Diarrhoea, Excessive cerumen production, Headache, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 83-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in 2015). On 14th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 16th December 2018, the patient experienced pain, feeling unwell, headache and neck pain. On 19th December 2018, the patient experienced diarrhea. On an unknown date, the outcome of the pain, feeling unwell, headache, neck pain, diarrhea and injection site pain were unknown. It was unknown if the reporter considered the pain, feeling unwell, headache, neck pain, diarrhea and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's father-in-law. The patient received SHINGRIX on an unknown arm. After vaccination, the patient felt achy. the patient had his ears cleaned at a recent doctor appointment because the patient had lots of wax. The physician did not know the origin of the neck pain. The reported information regarding the onset date of injection site pain was discrepant with the vaccination date, so the partial onset date for injection site pain was captured. This case has been linked with case US2018230551, reported by the same reporter.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Neck pain, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 83-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received in 2015). On 14th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On 16th December 2018, the patient experienced pain, feeling unwell, headache and neck pain. On 19th December 2018, the patient experienced diarrhea. On an unknown date, the outcome of the pain, feeling unwell, headache, neck pain, diarrhea and injection site pain were unknown. It was unknown if the reporter considered the pain, feeling unwell, headache, neck pain, diarrhea and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was the reporter's father-in-law. The patient received SHINGRIX on an unknown arm. After vaccination, the patient felt achy. the patient had his ears cleaned at a recent doctor appointment because the patient had lots of wax. The physician did not know the origin of the neck pain. The reported information regarding the onset date of injection site pain was discrepant with the vaccination date, so the partial onset date for injection site pain was captured. This case has been linked with case US2018230551, reported by the same reporter.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, HEPA
Symptoms: Injection site rash
Clinical narrative: (R) thigh, half dollar size rash. No fever, no behavior changes. 12/27/18.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Rash vesicular, Skin exfoliation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 75-year-old female patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. Previously administered products included ZOSTAVAX with an associated reaction of rash vesicular (received several years before the date of reporting with a smaller, similar rash, described as looking like shingles). On 14th December 2018, the patient received the 1st dose of SHINGRIX. In December 2018, less than a week after receiving SHINGRIX, the patient experienced vesicular rash, injection site warmth, injection site pain, skin scaly and injection site erythema. On 20th December 2018, the outcome of the injection site warmth was recovered/resolved. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved and the outcome of the injection site pain, skin scaly and injection site erythema were unknown. It was unknown if the reporter considered the vesicular rash, injection site warmth, injection site pain, skin scaly and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in the left deltoid. The patient developed a softball-sized area approximately half inch below the injection site. The area was red, very warm to the touch and somewhat painful. The pharmacist saw the patient 6 days after vaccination and stated that, the area looked a little red and a little scaly. The reporter was unable to provide time from vaccination to development of rash. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dry mouth, Injection site pain, Nausea, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 7th December 2018, the patient received SHINGRIX. On 7th December 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 15th December 2018, the patient experienced nausea, dry mouth, tremor and chills. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the nausea, dry mouth, tremor and chills were recovered/resolved. It was unknown if the reporter considered the injection site pain, nausea, dry mouth, tremor and chills to be related to SHINGRIX. Additional details were reported as follows: The patient was the caller's mother in law. On 15th December 2018, 8 day after vaccination the patient experienced nausea, dry mouth, tremor and chills. The patient experienced side effects. This case has been linked with US2018230517, reported by same reporter.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of visual disturbance in a 51-year-old male patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. On 20th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th December 2018, less than a day after receiving SHINGRIX, the patient experienced visual disturbance. On an unknown date, the outcome of the visual disturbance was unknown. It was unknown if the reporter considered the visual disturbance to be related to SHINGRIX. Additional details were reported as follows: The physician assistant reported that she administered SHINGRIX on left arm within the last 3 hours. He contacted her to report seeing a white line in one eye while working on his computer. The line did not move and there was no pain. The physician assistant did not know which of the patient's eyes was affected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX (batch number 7X743, expiry date 22nd May 2021) for prophylaxis. On 20th October 2018, the patient received SHINGRIX (intramuscular). On 20th October 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On 26th October 2018, the outcome of the injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient experienced injection site hot to touch. Limited information was provided by the pharmacist.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX (intramuscular). On 20th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On 26th July 2018, the outcome of the injection site erythema and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. The patient experienced injection site hot to touch. Limited information was provided by the pharmacist.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 20-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 18 years old female patient who received partial 0.5 ml dose as the syringe malfunctioned during injection, and some went in and some squirted out, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Nov-2018, the patient received a partial 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA, expiry date - 30-Jun-2019 via intramuscular route in the left arm. It was also a case of actual medication error due to vaccine underdose. It was also a case of syringe issue. The patient outcome is reported as Not Applicable for received partial 0.5 ml dose and as Not Applicable for the syringe malfunctioned during injection, and some went in and some squirted out. 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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who received vaccine before being reconstituted only diluent was administered, while she received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient also received Rotavirus & PREVENAR 13 concomitantly. On 19-Nov-2018, the patient received a only liquid DTaP/IPV dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE not reconstituted with the lyophilized ACTHIB component lot number - C5592AA, expiry date- 15-Nov-2019 intramuscularly in right thigh. It was a case of actual medication error due to inappropriate reconstitution technique. The patient outcome is reported as Not Applicable for vaccine that was administered to a patient before being reconstituted only diluent was administered. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves patient of unknown demography who experienced side effects, while he/she received vaccine Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious having side effects (unevaluable event) (Unknown latency) following the administration of Influenza Vaccine. (Other relevant tests included No lab data reported.) Final diagnosis was having side effects. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for having side effects. List of documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Product storage error
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA324602, 2018SA324603, 2018SA324604, 2018SA324606, 2018SA324607, 2018SA324608, 2018SA324605, 2018SA324596 (same reporter). This case involves a male patient of unknown age who received vaccines FLUZONE QUADRIVALENT and FLUZONE HIGH DOSE after vaccines were exposed to the temperature excursion. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ048AB via intramuscular route in the left deltoid. It was a case of actual medication error due to incorrect product storage. It was reported that the refrigerator temperature dropped overnight to 29.1 degrees Fahrenheit and was out of range for 11 hours. It was also reported that eight patients were administered a dose from the box that was exposed to the temperature excursion. It was unknown if patient experienced 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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse via consumer/non-HCP. This case involves 11 patients (age was reported as 3-18 years, gender not reported) who received vaccine FLUZONE QUADRIVALENT which was shipped late (more than 2 days) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 29-Nov-2018 and 30-Nov-2018, the patients received a dose of 0.5 ml suspect Influenza Quadrival A-B Vaccine (lot number: UJ087AA and expiry date: 30-Jun-2019) (dose in series and site of administration was not reported) via intramuscular route in leg or arm. It was a case of actual medication error due to incorrect product storage. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation error
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender unknown) who received vaccine PENTACEL. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5543AA, expiry date 08-Sep-2019 via unknown route in unknown administration site. It was an actual medication error due to inappropriate reconstitution technique. It was reported that staff members grabbed the HIB for PENTACEL and rehydrated it with a re-hydrant like saline instead of the DTaP mixture. Caller stated he is not sure what patient was injected with this mixture as no one has admitted to making the mistake yet but he knows it is one of 5 patients that received this mixture. PENTACEL was discovered with a missing lypholized (ACTHIB) powder dose that was given using saline diluent and not the liquid DTAP IPV portion of the PENTACEL. It was discovered yesterday on 17-Dec-2018. It was unknown whether patient experienced any adverse reaction after the injection. 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 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: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years old patient who was vaccinated with a 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (lot UT6259LA and Exp. Date 30-JUN-2019) via unknown route in the left thigh on 17-Dec-2018. The patient's medical history not reported. No other vaccines were given to patient. It was an actual medication error case due to vaccine underdose. It was unknown whether the patient experienced any 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.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non HCP (office staff). This case involves a 12 months old male patient who was vaccinated with the only diluent dose of ACT-HIB lot UA905AA via unknown route in the left thigh on 17-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE; MMR; and PNEUMOCOCCAL VACCINE POLYSACCH 23V and Varicella vaccine for Immunisation on 17-Dec-2018. It was an actual medication error case due to inappropriate reconstitution technique. It was reported that the patient was given just the diluent from the ACTHIB vaccination. It was not reported whether the patient 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 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: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 20 year old adult male patient who received a 0.25ml dose of vaccine FLUZONE QUADRIVALENT (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date. The patient's past medical history included Crohn's disease. Concomitant medications included REMICADE for Crohn's disease. It was a case of actual medication error due to underdose. It was reported that due to the REMICADE, the patient's mother does not want him to receive a whole 0.5ml dose. He received a 0.25ml dose previously, at his "college campus". It was not reported if the patient 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 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: U
Vaccine: TYP
Symptoms: Therapeutic product cross-reactivity
Clinical narrative: Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult patient who experienced we are getting a cross reaction typhoid vaccine for a patient who had a reaction with DEMEROL, while received vaccine TYPHIM VI. The patient's past vaccination(s) included DEMEROL with had a reaction with DEMEROL. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TYPHIM VI (lot number and Expiry date unknown) via unknown route in unknown administration site. The patient developed a non-serious we are getting a cross reaction typhoid vaccine for a patient who had a reaction with DEMEROL (therapeutic product cross-reactivity) (Unknown latency) following the administration of TYPHIM VI. (Other relevant tests included No lab data.). Final diagnosis was we are getting a cross reaction typhoid vaccine for a patient who had a reaction with DEMEROL. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown. Additional information was received on 19-Dec-2018 by the same reporter. List of documents held by sender: none.