chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: having a fever; Pain at injection site; developed redness at the injection site; heat at the injection site; hardness at the injection site; 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 Herpes zoster (Shingrix) for prophylaxis.   On 1st August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st August 2020, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site warmth and injection site induration. On 2nd August 2020, the patient experienced fever. The patient was treated with benadryl (nos) (Benadryl). On 4th August 2020, the outcome of the injection site pain, injection site erythema, injection site warmth, injection site induration and fever were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth, injection site induration and fever to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and immediately after vaccination had a pain at the injection site. Later that evening, the patient developed redness, heat and hardness at the injection site. The next day after vaccination, patient reportes fever. The patient took a Benedryl for symptoms and they cleared up within 2 and half days. The patient asked about receiving the 2nd vaccine. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: arm is sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. On 20th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix and less than a day, arm was sore at the injection site. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest discomfort, Chills, Headache, Lymphadenopathy
Clinical narrative: horrible chills; fever; felt like someone on her chest; big painful lesion in groin / spread on left side up buttocks; painful lesion in groin; Lymph nodes in groin are swollen / Injection / arm has swollen lymph nodes / she can't put arm down it's so puffy; nonstop headache; pain in back; cannot walk or lay down; legs have cramps when walking; This case was reported by a consumer via call center representative and described the occurrence of skin lesion in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 33TL7, expiry date 30th September 2022) for prophylaxis.   The patient's past medical history included lymph node excision and breast cancer.   On 15th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced skin lesion, wound pain, enlargement of lymph nodes, headache, back pain, mobility decreased and leg cramps. On 15th October 2020, the patient experienced chills, fever and chest abnormal feeling of. The patient was treated with acyclovir, paracetamol (Tylenol) and antibiotics nos (Antibiotic Ointment (Unknown Ingredients)). On 17th October 2020, the outcome of the chills, fever and chest abnormal feeling of were recovered/resolved. On an unknown date, the outcome of the skin lesion was resolved with sequelae and the outcome of the wound pain was not recovered/not resolved and the outcome of the enlargement of lymph nodes, headache, back pain, mobility decreased and leg cramps were unknown.   It was unknown if the reporter considered the skin lesion, wound pain, enlargement of lymph nodes, headache, back pain, mobility decreased, leg cramps, chills, fever and chest abnormal feeling of to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The has no lymph nodes on the left arm due to breast cancer surgery. The patient had 1st dose of Shingrix in right arm via intramuscular route. The patient said that she never had shingles and was perfectly healthy before Shingrix administration. The patient had a big painful lesion in groin. The lesion required treatment with Acyclovir and antibiotic ointment. The lymph nodes in groin were swollen and lesion had spread on left side up buttocks. The patient took nonstop Tylenol for nonstop headache. The patient reported that the complete located from kidneys to all the way down the pain in back and could not walk or lay down. The patient had legs cramps when walking. The injection right arm had swollen lymph nodes and could not put arm down as it was so puffy. The patient had horrible chills at beginning, fever, felt like someone on her chest and had resolved till the time of report. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscle spasms, Pyrexia, Skin lesion, Wound complication
Clinical narrative: horrible chills; fever; felt like someone on her chest; big painful lesion in groin / spread on left side up buttocks; painful lesion in groin; Lymph nodes in groin are swollen / Injection / arm has swollen lymph nodes / she can't put arm down it's so puffy; nonstop headache; pain in back; cannot walk or lay down; legs have cramps when walking; This case was reported by a consumer via call center representative and described the occurrence of skin lesion in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 33TL7, expiry date 30th September 2022) for prophylaxis.   The patient's past medical history included lymph node excision and breast cancer.   On 15th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced skin lesion, wound pain, enlargement of lymph nodes, headache, back pain, mobility decreased and leg cramps. On 15th October 2020, the patient experienced chills, fever and chest abnormal feeling of. The patient was treated with acyclovir, paracetamol (Tylenol) and antibiotics nos (Antibiotic Ointment (Unknown Ingredients)). On 17th October 2020, the outcome of the chills, fever and chest abnormal feeling of were recovered/resolved. On an unknown date, the outcome of the skin lesion was resolved with sequelae and the outcome of the wound pain was not recovered/not resolved and the outcome of the enlargement of lymph nodes, headache, back pain, mobility decreased and leg cramps were unknown.   It was unknown if the reporter considered the skin lesion, wound pain, enlargement of lymph nodes, headache, back pain, mobility decreased, leg cramps, chills, fever and chest abnormal feeling of to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The has no lymph nodes on the left arm due to breast cancer surgery. The patient had 1st dose of Shingrix in right arm via intramuscular route. The patient said that she never had shingles and was perfectly healthy before Shingrix administration. The patient had a big painful lesion in groin. The lesion required treatment with Acyclovir and antibiotic ointment. The lymph nodes in groin were swollen and lesion had spread on left side up buttocks. The patient took nonstop Tylenol for nonstop headache. The patient reported that the complete located from kidneys to all the way down the pain in back and could not walk or lay down. The patient had legs cramps when walking. The injection right arm had swollen lymph nodes and could not put arm down as it was so puffy. The patient had horrible chills at beginning, fever, felt like someone on her chest and had resolved till the time of report. The reporter consented to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Pharyngeal swelling
Clinical narrative: allergic reaction; throat started swelling up; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction and throat swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction and throat swelling were recovered/resolved.   It was unknown if the reporter considered the allergic reaction and throat swelling to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient mentioned that 6 years prior to the date of report, had a flu vaccine and had an allergic reaction and throat started swelling up. The patient immediately took 2 Benadryl and used her rescue inhaler. The reaction lasted approximately 30 minutes. The patient thought it was from the egg protein in the flu vaccine. The patient did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Incorrect route of product administration
Clinical narrative: cellulitis; was administered subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number CA374, expiry date 28th June 2021) for prophylaxis.   On 16th October 2020, the patient received Shingrix (subcutaneous). On 16th October 2020, unknown after receiving Shingrix, the patient experienced wrong route of administration. On 18th October 2020, the patient experienced cellulitis (serious criteria GSK medically significant). The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the cellulitis was not recovered/not resolved and the outcome of the wrong route of administration was unknown.   It was unknown if the reporter considered the cellulitis to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm. After receiving dose of Shingrix, the patient experienced cellulitis. The patient received Shingrix subcutaneously instead of intramuscularly, which led to wrong route of administration. On 18th October 2020, the patient went to emergency room. The caller reported that the cellulitis was nearly resolved. The caller reported that the patient was still taking antibiotic. The patient required emergency ER. The reporter did not consent to follow up. The case was considered as medication error with harm.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Aches; Pain on her left arm; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced general body pain and pain in arm. On an unknown date, the outcome of the general body pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. Consumer herself reported that she received the 1st dose of Shingrix vaccine in her left arm and on the same day she got a Pneumonia vaccine in her right arm and after the vaccination patient experienced symptoms such as aches and pain on her left arm and that last 3 to 4 days. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash appeared after that (but specific timing unknown), located on her chest/ rash on back; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were as follows: The age at vaccination was not reported. PharmD reported that the patient was vaccinated with the Shingrix and after that patient experienced rash which was  located on her chest and back. She did not thought that it to be Shingles rash and still had the rash after 1 month later also. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills; body aches; mild fever; This case was reported by a nurse via call center representative and described the occurrence of chills in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the chills, general body pain and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The nurse reported that multiple patient experienced mild fever, body aches and chills after receiving the 2nd dose of Shingrix. These events occurred 24 to 48 hours after the dose was administered and resolved within 24 to 48 hours. The reporter did not consent to follow-up. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211994:same reporter US-GLAXOSMITHKLINE-US2020211991:same reporter US-GLAXOSMITHKLINE-US2020211989:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Chills, Influenza, Influenza like illness, Malaise, Pain
Clinical narrative: sick as a dog; flu like symptoms; aches; fever; chills; actual flu; Based on information previously received, the case assessed as non-case was reassessed as valid.  Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient (unknown demographics) who was sick as a dog (malaise), flu like symptoms (influenza like illness), aches (pain), fever (pyrexia), chills and actual flu (influenza), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick as a dog (malaise), flu like symptoms (influenza like illness), aches (pain), fever (pyrexia), chills and had the actual flu twice (influenza) (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE.  The patient did not receive vaccine since 1989. It was gone after 24 hours. The patient had no medications and was not hospitalized  No laboratory data was provided  At the time of report (after 24 hours), the events recovered.  There will be no information available on lot number.
Sex: U
Vaccine: FLUX
Symptoms: Pyrexia
Clinical narrative: sick as a dog; flu like symptoms; aches; fever; chills; actual flu; Based on information previously received, the case assessed as non-case was reassessed as valid.  Initial information was received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves patient (unknown demographics) who was sick as a dog (malaise), flu like symptoms (influenza like illness), aches (pain), fever (pyrexia), chills and actual flu (influenza), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick as a dog (malaise), flu like symptoms (influenza like illness), aches (pain), fever (pyrexia), chills and had the actual flu twice (influenza) (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE.  The patient did not receive vaccine since 1989. It was gone after 24 hours. The patient had no medications and was not hospitalized  No laboratory data was provided  At the time of report (after 24 hours), the events recovered.  There will be no information available on lot number.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a female patient (age unspecified) who became sick (malaise) five times when she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient became sick (malaise) five times (unknown latency, non-serious event) everytime following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got flu twice that year; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case is linked with cases 2020SA290238, 2020SA290167, 2020SA297164 (same reporter).  This case involves a patient(unknown demographics) who had reaction and got flu twice that year (influenza) while he/she received vaccine INFLUENZA VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient had non serious reaction and got flu twice that year (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Case Details: Product name was not provided. It was assumed that they were referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient began experiencing symptoms of Covid-19; Initial information was received on 12-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 22 year-old male patient who began experiencing symptoms of Covid-19 (suspected covid-19), while he received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.   On 06-Oct-2020, the patient received 1 mL first dose (once) of suspect RABIES (HDC) VACCINE (lot P1E521M and expiry date 30-Oct-2020) via unknown route in the left deltoid for pre-exposure.  On an unknown date in Oct-2020, the patient began experiencing mild symptoms of Covid-19 (suspected covid-19) (Unknown latency) following the administration of RABIES (HDC) VACCINE.  Case Details: The patient was scheduled to receive a second pre-exposure prophylaxis dose next day (Day 7). He was tested that day for Covid-19 with the results expected in 5 to 7 days.  If he was Covid-negative, then Imovax Rabies pre-exposure prophylaxis would be proceeded. Patient needed the pre-exposure prophylaxis due to taking a job working with dead animals in studying white-tailed deer wasting disease.  Laboratory test results included: COVID-19 - On an unknown date in october 2020: [results expected in 5 to 7 days].  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Age: 70.0
Sex: M
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient came in complaining vaccination arm still sore, stiff, hard time lifting
Age: 43.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Arthralgia, Burning sensation, Pain, Pain of skin, Paraesthesia
Clinical narrative: On 10/27/2020 left side of face from below the cheekbone to brow felt like a sunburn and pins and needle sensation. Left ankle had intermittent bee sting ,burning, sharp sensation. On 10/28/2020 left temple and eye area sensitive to touch. No problem with the left ankle.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Ear pain, Headache, Myalgia
Clinical narrative: fever (100.6),  shivering, fever, earache (only L ear), headache, muscle/joint pain (general aches), nausea
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: fever (100.6),  shivering, fever, earache (only L ear), headache, muscle/joint pain (general aches), nausea
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Night sweats, Pain
Clinical narrative: body aches, chills, night sweats, took Tylenol and Advil
Age: 9.0
Sex: M
Vaccine: MMRV
Symptoms: Disseminated varicella zoster virus infection, Insomnia, Lethargy, Somnolence
Clinical narrative: Herpetic eruption on face, mouth and rash covering head, neck, face. Herpetic eruption was on 9/29/20 and rash began on 10/4/20. Patient also experienced increased lethargy and sleepiness, sleeping 1-2 hours longer each day. Insomnia symptoms have worsened over the past week.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Fatigue, Injection site pain, Pain in extremity
Clinical narrative: One day after vaccination patient experienced diarhea, pain in arm, knee and fingers, fatigue and blurry vision, injection site pain. Two days after vaccination patient experienced vomiting, fatigue, blurry vision, injection site pain. Day 3, symptoms all resolved.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Vision blurred, Vomiting
Clinical narrative: One day after vaccination patient experienced diarhea, pain in arm, knee and fingers, fatigue and blurry vision, injection site pain. Two days after vaccination patient experienced vomiting, fatigue, blurry vision, injection site pain. Day 3, symptoms all resolved.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Pain in extremity, Pruritus, Sensitive skin
Clinical narrative: Patient experienced fatigue, and was not able to sleep the night of the vaccination;  Arms and back were sore.  This morning when patient woke up,  legs were  sensitive and scratchy. Patient took aleve this morning
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Patient experienced fatigue, and was not able to sleep the night of the vaccination;  Arms and back were sore.  This morning when patient woke up,  legs were  sensitive and scratchy. Patient took aleve this morning
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral coldness
Clinical narrative: Sensation of cold feet / cold feet; This case was reported by a physician via call center representative and described the occurrence of cold feet in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. On 4th March 2020, less than a day after receiving Shingrix, the patient experienced cold feet. On an unknown date, the outcome of the cold feet was recovered/resolved.   It was unknown if the reporter considered the cold feet to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself, who was dentist. The age at vaccination was not reported. The patient did not have prior health conditions. He stated that after he received 1st dose, he had the sensation of cold feet for one month. The cold feet was resolved in warmer weather. The reporter did not consent to follow up. For tolerance of 2nd dose refer case US2020211125.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211125:same patient, same reporter, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neuralgia
Clinical narrative: charlie horse / muscle cramps; stiff neck; nerve pain in neck area; This case was reported by a consumer via media and described the occurrence of charley horse in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix. In October 2020, 30 min after receiving Shingrix, the patient experienced charley horse, stiff neck and nerve pain. On an unknown date, the outcome of the charley horse, stiff neck and nerve pain were unknown.   It was unknown if the reporter considered the charley horse, stiff neck and nerve pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. 3 days before the date of reporting, the patient received Shingrix and experienced Charlie horse and stiff neck approximately 1/2 hours after injection. The reporter asked if any reports of muscle cramps or nerve pain in neck area after injection. The reporter also asked if any side effects reported of Charlie horse and stiff neck after first injection.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Bedridden, Chills, Fatigue, Feeling abnormal
Clinical narrative: felt tired; felt off; trouble sleeping most of the night; body aches from head to toe; aching legs / aching arms; aching back; chills; lethargy; headache on the top front of the head / is getting worse; she would not be able to get out of bed; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 18th October 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular). On 18th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and bedridden. On 18th October 2020 22:00, the patient experienced tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy and headache. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain, tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy, headache and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy, headache and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix in left deltoid. After vaccination patient felt tired, felt off, had trouble sleeping most of the night, body aches from head to toe, aching legs, aching back, and aching arms, pain at injection site all theses symptoms were ongoining till the time of reporting. The patient also had chills, lethargy and headache on the top front of the head all of these were ongoing at till the  time of reporting and the headache was getting worse. Patient reported she took Motrin for the headache and body aches but it did not resolve the issues. Patient reported she would not be able to get out of bed if she did not take the Motrin. Patient preferred not to give any additional personal information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Insomnia, Lethargy, Pain
Clinical narrative: felt tired; felt off; trouble sleeping most of the night; body aches from head to toe; aching legs / aching arms; aching back; chills; lethargy; headache on the top front of the head / is getting worse; she would not be able to get out of bed; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 18th October 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular). On 18th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and bedridden. On 18th October 2020 22:00, the patient experienced tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy and headache. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain, tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy, headache and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy, headache and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix in left deltoid. After vaccination patient felt tired, felt off, had trouble sleeping most of the night, body aches from head to toe, aching legs, aching back, and aching arms, pain at injection site all theses symptoms were ongoining till the time of reporting. The patient also had chills, lethargy and headache on the top front of the head all of these were ongoing at till the  time of reporting and the headache was getting worse. Patient reported she took Motrin for the headache and body aches but it did not resolve the issues. Patient reported she would not be able to get out of bed if she did not take the Motrin. Patient preferred not to give any additional personal information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: felt tired; felt off; trouble sleeping most of the night; body aches from head to toe; aching legs / aching arms; aching back; chills; lethargy; headache on the top front of the head / is getting worse; she would not be able to get out of bed; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 23B54, expiry date 25th September 2022) for prophylaxis.   On 18th October 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular). On 18th October 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and bedridden. On 18th October 2020 22:00, the patient experienced tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy and headache. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain, tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy, headache and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, tiredness, feeling abnormal, difficulty sleeping, general body pain, leg pain, back pain, chills, lethargy, headache and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with 1st dose of Shingrix in left deltoid. After vaccination patient felt tired, felt off, had trouble sleeping most of the night, body aches from head to toe, aching legs, aching back, and aching arms, pain at injection site all theses symptoms were ongoining till the time of reporting. The patient also had chills, lethargy and headache on the top front of the head all of these were ongoing at till the  time of reporting and the headache was getting worse. Patient reported she took Motrin for the headache and body aches but it did not resolve the issues. Patient reported she would not be able to get out of bed if she did not take the Motrin. Patient preferred not to give any additional personal information. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: area of skin on the right lower bicep that is warm to the touch and feels bumpy and raised; area of skin on the right lower bicep that is warm to the touch and feels bumpy and raised; tiredness; body aches; chills; fever; This case was reported by a nurse via call center representative and described the occurrence of local swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced local swelling, skin warm, tiredness, general body pain, chills and fever. On an unknown date, the outcome of the local swelling, skin warm, tiredness, general body pain and chills were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the local swelling, skin warm, tiredness, general body pain, chills and fever to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix vaccine in right deltoid and within 24 hours after receiving the vaccine had a fever that lasted 2 days and resolved. Within 24 hours after receiving the vaccine, patient had chills, body aches, and tiredness and these were better but still ongoing. The patient also developed an area of skin on the right lower bicep that was warm to the touch and feels bumpy and raised, within 24 hours of receiving the vaccine and this was still ongoing. The reporter did not consent to follow-up. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211991:same reporter US-GLAXOSMITHKLINE-US2020211992:same reporter US-GLAXOSMITHKLINE-US2020211994:same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: area of skin on the right lower bicep that is warm to the touch and feels bumpy and raised; area of skin on the right lower bicep that is warm to the touch and feels bumpy and raised; tiredness; body aches; chills; fever; This case was reported by a nurse via call center representative and described the occurrence of local swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3454N, expiry date 23rd August 2022) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced local swelling, skin warm, tiredness, general body pain, chills and fever. On an unknown date, the outcome of the local swelling, skin warm, tiredness, general body pain and chills were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the local swelling, skin warm, tiredness, general body pain, chills and fever to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose of Shingrix vaccine in right deltoid and within 24 hours after receiving the vaccine had a fever that lasted 2 days and resolved. Within 24 hours after receiving the vaccine, patient had chills, body aches, and tiredness and these were better but still ongoing. The patient also developed an area of skin on the right lower bicep that was warm to the touch and feels bumpy and raised, within 24 hours of receiving the vaccine and this was still ongoing. The reporter did not consent to follow-up. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211991:same reporter US-GLAXOSMITHKLINE-US2020211992:same reporter US-GLAXOSMITHKLINE-US2020211994:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Pain, Pyrexia, Rash
Clinical narrative: first dose of Shingrix on 1/2/20 and the second dose on 8/11/20; full body rash; swelling; chills; body aches; fever over 100 degrees; This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 34RS7, expiry date 6th February 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd January 2020).   On 11th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 11th August 2020, less than an hour after receiving Shingrix, the patient experienced generalized rash, swelling, chills, general body pain, fever and drug dose administration interval too long. The patient was treated with prednisone and benadryl (nos) (Benadryl). In August 2020, the outcome of the generalized rash, swelling, chills, general body pain and fever were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the generalized rash, swelling, chills, general body pain and fever to be related to Shingrix.  Additional details were reported as follows: The patient received the second dose of Shingrix in right deltoid and within 15 minutes the patient had a full body rash, fever over 100 degrees F, body aches, chills, and swelling. The reporter reported these events lasted 2 to 3 days and then resolved. The patient was treated with Prednisone and Benadryl for these events. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211992:same reporter US-GLAXOSMITHKLINE-US2020211994:same reporter US-GLAXOSMITHKLINE-US2020211989:same reporter
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: first dose of Shingrix on 1/2/20 and the second dose on 8/11/20; full body rash; swelling; chills; body aches; fever over 100 degrees; This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 34RS7, expiry date 6th February 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2nd January 2020).   On 11th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 11th August 2020, less than an hour after receiving Shingrix, the patient experienced generalized rash, swelling, chills, general body pain, fever and drug dose administration interval too long. The patient was treated with prednisone and benadryl (nos) (Benadryl). In August 2020, the outcome of the generalized rash, swelling, chills, general body pain and fever were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the generalized rash, swelling, chills, general body pain and fever to be related to Shingrix.  Additional details were reported as follows: The patient received the second dose of Shingrix in right deltoid and within 15 minutes the patient had a full body rash, fever over 100 degrees F, body aches, chills, and swelling. The reporter reported these events lasted 2 to 3 days and then resolved. The patient was treated with Prednisone and Benadryl for these events. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This is 1 of the 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211992:same reporter US-GLAXOSMITHKLINE-US2020211994:same reporter US-GLAXOSMITHKLINE-US2020211989:same reporter
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Pain in extremity
Clinical narrative: arm was sore; bruise where she was injected; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a consumer.  This case involves a female patient (age unspecified) whose arm was sore (pain in extremity) and had a bruise where she was injected (vaccination site bruising), after she received vaccine INFLUENZA VACCINE.  The patient had an allergic reaction to the preservatives in a Novo Nordisk brand of insulin, where her throat closed up (throat tightness).  The past vaccination(s), concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing diabetes (because she took another, unspecified medicine, which she said was no longer on the market).   On an unknown date in 2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient's arm was sore (pain in extremity) and had a bruise where she was injected (vaccination site bruising) for a little while (unknown latency, non-serious events) following the administration of INFLUENZA VACCINE. Otherwise, she tolerated the vaccine well. She did not know which brand of flu shot she got last year.  The patient was planning to get a flu shot and asked whether there was any mercury or preservatives in the Fluzone regular or the Fluzone High-Dose.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of events were unknown.  There will be no information available on lot number.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: pt is complaining about pain, and unable to move shoulder all way up. pt will see her md if not issue not resolve in a month
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Vaccine positive rechallenge
Clinical narrative: Patient developed upper arm soreness and swelling  with heat beginning the day following the immunization.  The patient reported having a previous similar reaction after receiving PPSV23 from another provider.  The patient was advised to use home treatment consisting of cold compresses and over the counter NSAIDS.  It was also recommended she seek medical treatment if the symptoms worsen.  She will report the event to her allergist and her PCP.  The pharmacist recommended any future immunizations to be done in a clinic setting.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Rash
Clinical narrative: localized rash , itching, ad swelling over injection site
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Culture urine, Full blood count, Pyrexia, Urine analysis, White blood cell count
Clinical narrative: Temporal Fever in patient up to 102. Sleeping well. Not fussy. No rash, redness, or swelling at sites. No other symptoms. seen on 10/2 and 10/6
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Headache extreme body aches. Fatigue soreness in arm
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Extreme itching at body-wide sites with rashes on both shoulders/arms. Persistent for two weeks plus. Only now declining (slowly).
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Dyspnoea, Feeling abnormal, Movement disorder, Pallor
Clinical narrative: called mom to check on patient told mom she wasn't feeling good but when mom spoke to her she was not responding her, mom got on interstate. Mom stated that she involuntary motions, mouth and eyes open, arms straight in front of her, pale like all color drained. Mom stated it took at least 3-5 min to get back to normal to where she was responding to her. patient told her that she couldn't move and couldn't breathe but could hear mom-she told mom she was frozen.   Mom took to hospital and vitals were good when she got there, she was moving and talking back to normal self  Mom stated it was approximate 20-25 min from time it was given in office that the event happened.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: called mom to check on patient told mom she wasn't feeling good but when mom spoke to her she was not responding her, mom got on interstate. Mom stated that she involuntary motions, mouth and eyes open, arms straight in front of her, pale like all color drained. Mom stated it took at least 3-5 min to get back to normal to where she was responding to her. patient told her that she couldn't move and couldn't breathe but could hear mom-she told mom she was frozen.   Mom took to hospital and vitals were good when she got there, she was moving and talking back to normal self  Mom stated it was approximate 20-25 min from time it was given in office that the event happened.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Rash macular
Clinical narrative: Mother called the store and talked with floating pharmacist on duty who administered the vaccine. The pt had itchy, red, blotchy bumps on her forearm on the same side as the vaccine was given. The pharmacist told the mother to give Benadaryl to  her to help with the reaction. When I called pts mother the next morning she said the symptoms had resolved with the Benadryl.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: He developed an urticarial rash on his left arm the night of the vaccines, and it spread down to his left hand the next morning.