chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at site/ muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. In September 2019, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: This case was reported by the patient's sister. The age at vaccination was not reported. The patient received a dose of Shingrix and the flu vaccine last week from the date of reporting on the same day in the separate arm. The reporter stated that, the patient experienced pain and muscle soreness in the Shingrix arm. This was the only information she had on the vaccine. This case has been linked with cases US2019172789 and US2019173375 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and developed flu-like symptoms. The reporter did not consent to follow up. This report 3 of 3 reported by the consumer. The consumer did not have any further information, did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; inappropriate schedule of vaccine; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The pharmacy student stated some patients at the pharmacy have missed the 2-6 month window for the second dose. The pharmacy student also mentioned that patients often report pain from the injection after getting Shingrix. Till the time of reporting patients did not received the 2nd dose, which led to incomplete course of vaccination. The pharmacy student consented to follow up. Additional details not provided at the time of this call, but pharmacy student granted permission to follow up. This case has been linked with US2019174653, reported by same reporter.
Sex: M
Vaccine: FLU4
Symptoms: Cardiovascular insufficiency, Foetal exposure during pregnancy, Low birth weight baby, Premature baby, Twin pregnancy
Clinical narrative: unable to get adequate blood flow; cord was not attached as it should; babies were in the same sack; Maternal exposure during pregnancy; Birth weight low; premature birth; Live birth; This case was reported by a nurse via call center representative and described the occurrence of cardiovascular insufficiency in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number D4E29, expiry date 30th June 2019) for prophylaxis.   On 26th October 2018, the patient received Fluarix Quadrivalent 2018-2019 season (transplacental) .5 ml. 118 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced birth weight low, premature birth and live birth. On an unknown date, the patient experienced cardiovascular insufficiency (serious criteria GSK medically significant), umbilical cord abnormality, monoamniotic twin pregnancy and maternal exposure during pregnancy. On an unknown date, the outcome of the cardiovascular insufficiency, umbilical cord abnormality, birth weight low, premature birth, live birth, monoamniotic twin pregnancy and maternal exposure during pregnancy were unknown.   It was unknown if the reporter considered the cardiovascular insufficiency, umbilical cord abnormality and birth weight low to be related to Fluarix Quadrivalent 2018-2019 season. The reporter considered the premature birth to be unrelated to Fluarix Quadrivalent 2018-2019 season.     See case US2018199479 for details regarding the baby case.   Additional details were provided as follows: The patient's mother did not had any known medical history. One hundred and eighteen days after receiving the vaccine to the patient's mother, premature delivery led to premature birth. The Nurse reported that the twin babies were in same sack and one twin did not get adequate blood flow also there was reverse blood flow to one twin. The reporter considered that the event premature birth was not due to the flu shot. It was unknown, if the reporter considered the event cardiovascular insufficiency was related to Flu Seasonal QIV Dresden. The VARS details were updated. This is 1 of 3 cases linked for parent-child cases.
Sex: M
Vaccine: FLU4
Symptoms: Umbilical cord abnormality
Clinical narrative: unable to get adequate blood flow; cord was not attached as it should; babies were in the same sack; Maternal exposure during pregnancy; Birth weight low; premature birth; Live birth; This case was reported by a nurse via call center representative and described the occurrence of cardiovascular insufficiency in a male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) (batch number D4E29, expiry date 30th June 2019) for prophylaxis.   On 26th October 2018, the patient received Fluarix Quadrivalent 2018-2019 season (transplacental) .5 ml. 118 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced birth weight low, premature birth and live birth. On an unknown date, the patient experienced cardiovascular insufficiency (serious criteria GSK medically significant), umbilical cord abnormality, monoamniotic twin pregnancy and maternal exposure during pregnancy. On an unknown date, the outcome of the cardiovascular insufficiency, umbilical cord abnormality, birth weight low, premature birth, live birth, monoamniotic twin pregnancy and maternal exposure during pregnancy were unknown.   It was unknown if the reporter considered the cardiovascular insufficiency, umbilical cord abnormality and birth weight low to be related to Fluarix Quadrivalent 2018-2019 season. The reporter considered the premature birth to be unrelated to Fluarix Quadrivalent 2018-2019 season.     See case US2018199479 for details regarding the baby case.   Additional details were provided as follows: The patient's mother did not had any known medical history. One hundred and eighteen days after receiving the vaccine to the patient's mother, premature delivery led to premature birth. The Nurse reported that the twin babies were in same sack and one twin did not get adequate blood flow also there was reverse blood flow to one twin. The reporter considered that the event premature birth was not due to the flu shot. It was unknown, if the reporter considered the event cardiovascular insufficiency was related to Flu Seasonal QIV Dresden. The VARS details were updated. This is 1 of 3 cases linked for parent-child cases.
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: Boostrix reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a 75-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix at an unknown dose. On an unknown date, unknown after receiving Boostrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient had a reaction to the Boostrix vaccine years ago. They suspect it was to the Equine blood used during manufacturing. The reporter was did not consent to follow-up. The reporter had no additional information on the previous vaccination
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number was not reported. The patient received Shingrix and had little bit of pain at the injection site that lasted for maybe a day or 2 days. The reporter did not consent to follow up. The pharmacist was retired, no information was available for vaccine used
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Tiredness; This case was reported by a nurse via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced headache and tiredness. On an unknown date, the outcome of the headache and tiredness were unknown.   It was unknown if the reporter considered the headache and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had headache and tiredness. The reporter did not consent to follow up. The caller was the patient and health care professional refused to give any additional details about themselves or the vaccine.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Feeling Sick to her stomach; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2019 12:00, the patient received the 1st dose of Shingrix. On 24th September 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, nausea and upset stomach. On an unknown date, the outcome of the fever, chills, nausea and upset stomach were unknown.   It was unknown if the reporter considered the fever, chills, nausea and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 12:00 pm and had fever, chills, and nausea.  She had to end the call because she was feeling sick to her stomach. The reporter unable to obtain additional details because the reporter felt sick to her stomach and ended the call.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on his hands and lower legs; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hand operation. Previously administered products included Xiaflex injections.   On 29th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, 30 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and approximately 1 month after receiving the vaccine, the patient developed an itchy rash on his hands and lower legs. The rash comes and goes. The reporter did not consent to follow up. The emergency room visit required. The caller did not want to provide his address.  The caller did not provide any additional information.
Sex: M
Vaccine: HEPA
Symptoms: Facial paralysis
Clinical narrative: Bells Palsy; This case was reported by a other health professional via call center representative and described the occurrence of bell's palsy in a child male patient who received HAV (Havrix) (batch number 3TG52, expiry date 26th June 2020) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix. On an unknown date, 3 days after receiving Havrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Havrix.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that the patient's mother, reported that the child developed Bells Palsy 3 to 5 days after receiving first dose of Havrix.  The reporter consented to follow up.
Age: 59.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Facial pain, Herpes zoster, Pain of skin, Rash, Skin lesion
Clinical narrative: Shingles/ Shingles flare up; facial/ scalp lesions; rash; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included scalp pain and facial pain.   On 11th September 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 12th September 2019, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced shingles, skin lesion and facial rash. The patient was treated with antivirals nos, antivirals nos, antivirals nos, antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles and facial rash were not recovered/not resolved and the outcome of the skin lesion was unknown.   It was unknown if the reporter considered the shingles, skin lesion and facial rash to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were provided as follows: The patient complained of soreness in the face and scalp area prior to vaccination. A day after the vaccination with Shingrix and Quadravalant vaccine, the patient developed facial or scalp lesion and rash with a confirmed diagnosis of Shingles. Antiviral therapy was given to the patient but the he reported that, rash was again developed on the same area on his face. The patient consented to follow up.
Age: 23.0
Sex: M
Vaccine: HEPAB
Symptoms: Hepatitis A, Hepatitis A virus test positive
Clinical narrative: Hepatitis A; This case was reported by a pharmacist via call center representative and described the occurrence of hepatitis a in a 23-year-old male patient who received HAB (Twinrix adult) (batch number 3597P, expiry date 12th March 2022) for prophylaxis.   Concomitant products included HAB (Twinrix adult).   On 30th August 2019, the patient received the 2nd dose of Twinrix adult (intramuscular). On 26th September 2019, less than a month after receiving Twinrix adult, the patient experienced hepatitis a. On an unknown date, the outcome of the hepatitis a was unknown.   It was unknown if the reporter considered the hepatitis a to be related to Twinrix adult.  Additional details were provided as follows; The pharmacist reported that a patient got Twinrix vaccine 1st dose and Twinrix vaccine 2nd dose on left arm. On 26th September 2019, the patient had some blood works done at the doctor's office and the doctor's office informed the pharmacist. In 2019, the patient tested positive for hepatitis A. The reporter was consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Hyperhidrosis, Hypersomnia, Injection site swelling
Clinical narrative: left shoulder pain; swelling at injection site; pain and tenderness in muscles; felt shaky; felt sweaty; lost appetite; felt dizzy; slept a lot; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than 3 weeks after receiving Shingrix, the patient experienced shoulder pain, injection site swelling, muscle pain, shaky feelings, sweating, appetite lost, dizziness and sleep excessive. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the injection site swelling, muscle pain, shaky feelings, sweating, appetite lost, dizziness and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the shoulder pain, injection site swelling, muscle pain, shaky feelings, sweating, appetite lost, dizziness and sleep excessive to be related to Shingrix.  Additional details were provided as follows: The patient experienced left shoulder pain, swelling at injection site, pain and tenderness in muscles of arm, upper back and neck, was shaky, felt sweaty, lost appetite, dizzy and slept a lot the following two days. The patient stated that the issues have all resolved except that her shoulder has still some sore at the time of reporting. The patient did not consent to follow up. This case was link with case US2019175456, reported by the same reporter.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Nervousness
Clinical narrative: left shoulder pain; swelling at injection site; pain and tenderness in muscles; felt shaky; felt sweaty; lost appetite; felt dizzy; slept a lot; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2019, the patient received the 1st dose of Shingrix. In September 2019, less than 3 weeks after receiving Shingrix, the patient experienced shoulder pain, injection site swelling, muscle pain, shaky feelings, sweating, appetite lost, dizziness and sleep excessive. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the injection site swelling, muscle pain, shaky feelings, sweating, appetite lost, dizziness and sleep excessive were recovered/resolved.   It was unknown if the reporter considered the shoulder pain, injection site swelling, muscle pain, shaky feelings, sweating, appetite lost, dizziness and sleep excessive to be related to Shingrix.  Additional details were provided as follows: The patient experienced left shoulder pain, swelling at injection site, pain and tenderness in muscles of arm, upper back and neck, was shaky, felt sweaty, lost appetite, dizzy and slept a lot the following two days. The patient stated that the issues have all resolved except that her shoulder has still some sore at the time of reporting. The patient did not consent to follow up. This case was link with case US2019175456, reported by the same reporter.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: pneumonia; had pneumonia after having Prevnar 13; Inappropriate dose of vaccine administered; This is a spontaneous report from a Pfizer-sponsored program, by a contactable consumer reported for herself.  This 93-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at single dose for pneumonia shot. She received her first Prevnar 13 in 2013 and a second Prevnar 13 in 2015. Medical history included that she had scarred lungs as a teen and when she gets a cold it goes to her chest. Concomitant medications were not reported. On an unspecified date in Nov2017, the patient had pneumonia after having Prevnar 13 with outcome of unknown.  The information on the lot number has been requested.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Dyspnoea, Throat tightness, Urticaria
Clinical narrative: Patient reported hives on lower right arm followed by "throat tightening" and difficulty breathing approximately 2 hours post Flublok administration. She received IV Benadryl from paramedics and observed in Emergency Room and discharged the same day.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Dyspnoea, Rash, Respiratory distress
Clinical narrative: Around 11am, child started with "heavy breathing."  Child's pediatrician was contacted.  Advised to bring child to ER - enroute child's respiratory distressed increased.  Generalized body rash and temp 100.6 R upon arrival at ER.  Family reports child given "injection" in ER - unsure of medication given.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Influenza virus test negative, Injection site pain, Injection site pruritus
Clinical narrative: Injection site swelling, itching and pain; chills, fever and headache.  It's been more than 72 hours and I still have low grade fever and injection site swelling and pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Injection site swelling, itching and pain; chills, fever and headache.  It's been more than 72 hours and I still have low grade fever and injection site swelling and pain.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash macular
Clinical narrative: Macular rash following influenza vaccine
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pharyngeal swelling, Urticaria
Clinical narrative: swelling, redness, whelp at injection site along with throat swelling
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Gait inability, Lumbar puncture, Muscle spasms, Myelitis transverse
Clinical narrative: my feet began to cramp a week after receiving the vaccine. I felt a sensation of tingling and cramping, accompanied by an unbearable burning. I was diagnosed with transverse myelitis caused by the vaccine. The treatment is with steroids, gabapentin, tramadol, pantoprasol, duloxetine. I could not walk. using a wheelchair with therapies and on the way with the help of a walker. I'm going for 5 months in this condition
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Paraesthesia, Walking aid user, Wheelchair user
Clinical narrative: my feet began to cramp a week after receiving the vaccine. I felt a sensation of tingling and cramping, accompanied by an unbearable burning. I was diagnosed with transverse myelitis caused by the vaccine. The treatment is with steroids, gabapentin, tramadol, pantoprasol, duloxetine. I could not walk. using a wheelchair with therapies and on the way with the help of a walker. I'm going for 5 months in this condition
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctival hyperaemia, Cough, Eye pruritus, Headache, Hypoaesthesia oral
Clinical narrative: I received the High Dose Vaccine at 4PM, at 8PM my arm started hurting, then I develop a continuous congested cough , over the next hour I slowly developed very itchy eyes, bilateral red conjunctiva, tingling and numbness of my lips and it felt like my throat was closing up. I as going to leave to go to the ER when the symptoms started to gradually dissipate but not completely go away, my lips were a little tingly . By midnight I had a headache and this morning I still have some residual tingling of my lips, I feel like I have the flu, frontal headache, achy all over, and nasal congestion.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Nasal congestion, Pain, Pain in extremity, Paraesthesia oral
Clinical narrative: I received the High Dose Vaccine at 4PM, at 8PM my arm started hurting, then I develop a continuous congested cough , over the next hour I slowly developed very itchy eyes, bilateral red conjunctiva, tingling and numbness of my lips and it felt like my throat was closing up. I as going to leave to go to the ER when the symptoms started to gradually dissipate but not completely go away, my lips were a little tingly . By midnight I had a headache and this morning I still have some residual tingling of my lips, I feel like I have the flu, frontal headache, achy all over, and nasal congestion.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Throat tightness
Clinical narrative: I received the High Dose Vaccine at 4PM, at 8PM my arm started hurting, then I develop a continuous congested cough , over the next hour I slowly developed very itchy eyes, bilateral red conjunctiva, tingling and numbness of my lips and it felt like my throat was closing up. I as going to leave to go to the ER when the symptoms started to gradually dissipate but not completely go away, my lips were a little tingly . By midnight I had a headache and this morning I still have some residual tingling of my lips, I feel like I have the flu, frontal headache, achy all over, and nasal congestion.
Age: 8.0
Sex: M
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There has not been any adverse reaction noted at this time. VAERS is being filed because child received DTaP instead of Tdap. He is 8 years old and just starting the tetanus containing vaccine series. Measures have been implemented to avoid this error in the future. Vaccine dose will count as first dose of tetanus containing vaccine.
Age: 12.0
Sex: M
Vaccine: HEP, HEPA, HPV9, MENB, TDAP
Symptoms: Syncope
Clinical narrative: After administering vaccines patient had a syncopal episode that lasted 3-5 seconds. Applied cold compress, had patient sip water slowly, made patient to continue to lay on exam table.  Monitored patient for 15 minutes and obtained vitals: b/p:120/74 left arm ,patient was alert, oriented x3.  Patient was seen  ambulating down hallway accompanied by mother with no signs of distress noted.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash, Varicella virus test positive
Clinical narrative: Patient developed a rash 1 year and 10 months that would not go away. Patient was tested and came back positive for Shingles.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: fever x 5 days, rash 3 days
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site pain, Pain in extremity, Swelling
Clinical narrative: Injection site very sore but no redness or swelling.   Redness and swelling below injection site with warmth to touch.  Arm is very sore.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: Patient called day after reporting around 12pm she has over a 104 degree temperature and experiencing flu-like symptoms: fever, body chills, achiness and a feeling of being unwell. I asked her to contact her prescriber and to visit urgent care due to her temperature being elevated at 104. Followed up with patient around 4pm and fever went down to 99. She contacted prescriber who recommended monitoring and take OTC pain meds.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Unevaluable event
Clinical narrative: Flu Vaccine was given from Private Stock and not VFC stock. Pt tolerated injection well with no known reaction.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blood test abnormal, Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: This vaccine is administered in two injections. The first was on 02/06/19 and the second on 04/09/19. A few days after the first injection, I had back and leg pain. After the second shot I could barely get out of bed. My hands, arms and shoulders were so sore I was unable to dress my self for several weeks. I contacted Dr. and he said the Shingrex was not a factor.  A few weeks later I went to a Rheumatoligst and was diagnosed with rheumatoid arthritis. I am currently taking methotrexate that has somewhat helped, but my shoulders remain very sore. I am unable to any lifting.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rheumatoid arthritis
Clinical narrative: This vaccine is administered in two injections. The first was on 02/06/19 and the second on 04/09/19. A few days after the first injection, I had back and leg pain. After the second shot I could barely get out of bed. My hands, arms and shoulders were so sore I was unable to dress my self for several weeks. I contacted Dr. and he said the Shingrex was not a factor.  A few weeks later I went to a Rheumatoligst and was diagnosed with rheumatoid arthritis. I am currently taking methotrexate that has somewhat helped, but my shoulders remain very sore. I am unable to any lifting.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: The morning after receiving the vaccine, patient felt light headed and measured blood pressure to be in 80s/40s. Happened the morning after both doses with no further problems.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: client notice large redden area around site of injection, No swelling , some tenderness at site. Otherwise client feels physically fine. RN recommended marking all area of redness with marker to watch for spreading. RN recommended ice occasionally and ibuprofen.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Dyskinesia, Feeling cold
Clinical narrative: Patient's husband states that a few hours after receiving the flu vaccine, the patient was swimming and became very cold. She then tried to warm up in the hot tub.  After that, her arms began uncontrollably flailing around. She was taken to the emergency room.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching from about 10 minutes after receiving the vaccine through now
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: chills, fever, rigors, redness at site of reaction.  Fever for 48 hrs.  Redness longer lasting for days after injection
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Gait disturbance, Walking aid user
Clinical narrative: severe chills almost to convulsing and then weakness unable to walk without assistance
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Large, inch-high by about 3-inch wide swelling and very painful at injection site; joint pain, fever, and fatigue to the extent that normal activity was impossible and going to bed was required. Felt much better after bed rest and limited activity for about 24 hours. Arm/injection site stayed very sore for about 5 days.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Large, inch-high by about 3-inch wide swelling and very painful at injection site; joint pain, fever, and fatigue to the extent that normal activity was impossible and going to bed was required. Felt much better after bed rest and limited activity for about 24 hours. Arm/injection site stayed very sore for about 5 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Fatigue, Local reaction, Pruritus, Swelling
Clinical narrative: Pt was given multiple vaccines as part of her WCC; she began to have reaction sxs this morning 9/25/19 , which started as what FOC describes as a "bug bite," but then progressed to include a large area of spreadig redness, significant swelling, and itching. Pt does not c/o pain, and has not had fevers or discharge from the area, though she has seemed a bit tired. No n/v, anorexia, malaise, paresthesia, or weakness of the leg. # Vaccines adverse reaction  (T50.Z95A): Consistent with a localized (though moderately/severe) reaction; not concerning for infection or anaphylaxis. Start with topical steroids; recommended close f/u friday which MOC will call to schedule. May consider oral steroids if not improving dt the degree of swelling. Will report to VAERS, close monitoring discussed. Plan printed and provided to patient: PRESCRIBE: triamcinolone 0.1% topical cream, Apply to affected area 2 times a day, # 100, RF: 0. (Transmitted by PA-C) The injection given in the left thigh was Kinrix, which includes DTap and Polio- these are both vaccines that she's had 3 ad 4 times prior respectively, so I am suspecting this is a localized reaction to carrier substances present in the specific Kinrix formulation of the vaccine, rather than a reaction to the specific polio or dtap components. She is finished with both of these series, and won't require another Dtap- (though she will eventually need a Tdap). Recommend a topical steroid cream as prescribed, with close monitoring for worsening problems, such as swelling of lips, tongue, or face, trouble breathing, coughing, or wheezing- which would warrant urgent follow up or ER visit. Otherwise we will report this reaction to the manufacturer and agency.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Middle insomnia, Nausea, Pain
Clinical narrative: Patient reported the day after receiving the vaccination that she woke up during the night with nausea and aching.  These symptoms persisted upon awakening.  She took acetaminophen and that helped to resolve the symptoms.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching  almost every day but not every minute for last 3 months
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Headache, Malaise, Muscular weakness, Nausea
Clinical narrative: The evening of oct. 1 started feeling ill with symptoms of headache. vomited in the middle of the night and had some diarrhea. extremely nausea all the next day, body aches, weak couldn't lift arms up. starting to fill better but still not 100 percent
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Vomiting
Clinical narrative: The evening of oct. 1 started feeling ill with symptoms of headache. vomited in the middle of the night and had some diarrhea. extremely nausea all the next day, body aches, weak couldn't lift arms up. starting to fill better but still not 100 percent
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of PEDVAX was administered to lhe patient on an unknown date; No adverse effects; This spontaneous report was received from a medical assistant and concerns to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.         On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # N024570 and expiration date 01-MAY-2020, for prophylaxis (dosage schedule, route, and anatomical location were not reported).  The administered dose of the vaccine experienced a temperature excursion below 36°F: 32.1 Fahrenheit (F) for 8 hours, as recorded by a data logger. No previous temperature excursion. There was no adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Rash vesicular, Vaccination complication
Clinical narrative: persistent zoster-like rash from her shoulder to her elbow on the outside of her arm, neck and back which were associated with blisters and severe burning sensations; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.   In or around 18-SEP-2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).    On an unknown date, reported as "shortly after receiving zoster vaccine live (ZOSTAVAX)", the pt suffered a reaction to the vaccine, causing persistent zoster-like rash from her shoulder to her elbow on the outside of her arm, neck and back which were associated with blisters and severe burning sensations. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt symptoms had resulted in physical limitations not present prior to using it. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution, and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The reporter considered the event to be related to zoster Vaccine Live (ZOSTAVAX). The event was considered as disabling events, due to the pt's permanent and incurable injuries.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; patient was administered improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 27-SEP-2019, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot number S007770 with expiration date on 24-JUL-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced temperature excursion below 36 degrees Fahrenheit (F) / 2 degrees Celsius (C) for 10 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Administered improperly stored PROQUAD; This spontaneous report was received from a Medical Assistant referring to a 4-year-old patient. The patient's concurrent conditions, medical history and drug allergies/ reactions were not reported. On 07-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, formulation, dose/frequency and route were unknown) (lot # S009759, expiry date: 27-SE-2020, therapy type: recombinant human albumin (rHa)) for prophylaxis. The diluent used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. On 07-SEP-2019, the patient was administered improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (product storage error). No adverse effects reported. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: MENB
Symptoms: Rash
Clinical narrative: Rash / rash on the face and body; This case was reported by a nurse via sales rep and described the occurrence of rash in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a day after receiving Bexsero, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The vaccine lot number and expiry date was unknown. The nurse reported to a field representative that a patient reported a rash within days of Bexsero administration.  The patient developed a rash after having Bexsero, not itchy, on the face and body. No other information was available. The reporter consented to follow up. This is 1 of the 5 linked cases reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; Got both shingrix vaccines and still broke out with shingles a month later; This case was reported by a physician and described the occurrence of suspected vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient who got both shingrix vaccines and still broke out with shingles a month later. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Feeling cold, Headache, Heart rate increased
Clinical narrative: chills; shaking; fever; dizziness; fast heart rate; headache; almost passed out; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a day after receiving Shingrix, the patient experienced chills, tremor, fever, dizziness, heart rate increased, headache and presyncope. On an unknown date, the outcome of the chills, tremor, fever, dizziness, heart rate increased, headache and presyncope were recovered/resolved.   It was unknown if the reporter considered the chills, tremor, fever, dizziness, heart rate increased, headache and presyncope to be related to Shingrix.  Additional case details were reported as follows: When the patient went to bed on 12th April 2019, evening she noticed that her heart rate was elevated.  At 2:30 AM on 13th April 2019, 1 day after vaccination she was woken from sleep by shaking because she was so cold. The patient had chills, fever of 101 degree Fahrenheit, dizziness such that she almost passed out, her heart rate was 115 and had headache.  The patient visited the clinic where she got the vaccine and was told the symptoms would resolve.  The symptoms resolved after 24 hours. Emergency room visit required. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Presyncope, Pyrexia, Tremor
Clinical narrative: chills; shaking; fever; dizziness; fast heart rate; headache; almost passed out; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a day after receiving Shingrix, the patient experienced chills, tremor, fever, dizziness, heart rate increased, headache and presyncope. On an unknown date, the outcome of the chills, tremor, fever, dizziness, heart rate increased, headache and presyncope were recovered/resolved.   It was unknown if the reporter considered the chills, tremor, fever, dizziness, heart rate increased, headache and presyncope to be related to Shingrix.  Additional case details were reported as follows: When the patient went to bed on 12th April 2019, evening she noticed that her heart rate was elevated.  At 2:30 AM on 13th April 2019, 1 day after vaccination she was woken from sleep by shaking because she was so cold. The patient had chills, fever of 101 degree Fahrenheit, dizziness such that she almost passed out, her heart rate was 115 and had headache.  The patient visited the clinic where she got the vaccine and was told the symptoms would resolve.  The symptoms resolved after 24 hours. Emergency room visit required. The reporter did not consent to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Herpes zoster, Influenza like illness
Clinical narrative: rash; swelling upper left arm; hardness upper left arm; headache; chills; body aches; felt hot; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of headache in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had 6 years ago). Previously administered products included Zostavax (received a few years ago).   On 13th September 2019, the patient received the 1st dose of Shingrix. On 14th September 2019, 1 days after receiving Shingrix, the patient experienced chills, general body pain, feeling hot and influenza-like symptoms. On 15th September 2019, the patient experienced headache. On an unknown date, the patient experienced rash, injection site swelling and injection site induration. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the chills, general body pain, feeling hot, influenza-like symptoms, rash, injection site swelling and injection site induration were recovered/resolved.   It was unknown if the reporter considered the headache, chills, general body pain, feeling hot, influenza-like symptoms, rash, injection site swelling and injection site induration to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The patient stated that, after vaccination with dose of Shingrix, had rash near injection site. The patient reported that upper left arm was swollen and hard. After vaccination with Shingrix, the patient had headache that came and gone. The patient did not received medication like Tylenol or Advil that seems to help with headache. No any additional information was provided. The patient consented to follow up.