chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Immediate post-injection reaction, Influenza like illness, Injection site pain
Clinical narrative: chills; tiredness; achiness; flu like symptoms; Pain during the injection; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd January 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On 23rd January 2020, the patient experienced chills, tiredness, pain and influenza-like symptoms. On an unknown date, the outcome of the chills, tiredness, pain and influenza-like symptoms were recovering/resolving and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the chills, tiredness, pain, influenza-like symptoms and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 71 or 72 years. The patient received the dose of Shingrix and experiencing chills, tiredness and flu-like symptoms also experienced pain during the injection. The follow up consent was not granted. This case has been linked with case US2020013021, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: chills; tiredness; achiness; flu like symptoms; Pain during the injection; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 22nd January 2020, immediately after receiving Shingrix, the patient experienced injection site pain. On 23rd January 2020, the patient experienced chills, tiredness, pain and influenza-like symptoms. On an unknown date, the outcome of the chills, tiredness, pain and influenza-like symptoms were recovering/resolving and the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the chills, tiredness, pain, influenza-like symptoms and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 71 or 72 years. The patient received the dose of Shingrix and experiencing chills, tiredness and flu-like symptoms also experienced pain during the injection. The follow up consent was not granted. This case has been linked with case US2020013021, reported by same reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: RIGHT THIGHAS RED,HOT, &SWOLLEN MOM WAS TOLD TO APPLY COLD PADS TO THE AREA CHILD WAS WAS SEEN AT ER  AND PRESCRIBED CEPHALEXIN
Age: 41.0
Sex: M
Vaccine: HEP, HEPA, TDAP
Symptoms: Chills, Malaise, Skin warm, Tremor
Clinical narrative: Chills all over the body, with no fever, warm to touch approximately 6pm.  Overall not feeling well.   Around 9:00pm right side of body began trembling and occurred for approximately 2 hours.
Age: 3.0
Sex: F
Vaccine: IPV
Symptoms: Pyrexia
Clinical narrative: Fever of 104.5 measured axillary for approximately 24 hours. No other symptoms noted. The fever was first noted at 2am on 01/24/2020 (16 hours after vaccine administration) and ended the morning of 01/25/2020.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None, client didn't even cry when flu shot was administered.  Follow up phone call to parent, 2 days later, client had no redness or swelling to his arm.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: redness ictching  swelling  painful at this time
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Erythema, Muscle tightness
Clinical narrative: Redness in neck and rt ear.  Feeling of tightness in neck, bilateral
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Decreased appetite, Frequent bowel movements, Haematochezia, Mucous stools, Skin test negative
Clinical narrative: 1 day after receiving 2 month vaccines, patient developed mucousy stools, frequent. Persisted for almost 2 weeks. No fever, appetite appeared diminished but not dehydrated. Then 10 days after symptoms started, developed blood in stools.  Mother had been avoiding dairy already due to concern for milk protein intolerance. Strong family history of food allergies
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Ultrasound abdomen normal
Clinical narrative: 1 day after receiving 2 month vaccines, patient developed mucousy stools, frequent. Persisted for almost 2 weeks. No fever, appetite appeared diminished but not dehydrated. Then 10 days after symptoms started, developed blood in stools.  Mother had been avoiding dairy already due to concern for milk protein intolerance. Strong family history of food allergies
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Computerised tomogram head, Dizziness, Face injury, Fall, Head injury
Clinical narrative: Patient lost consciousness after receiving immunizations.  Patient fell off exam table and hit her head/face on nurses foot when she hit the floor.  Patient had  a abrasion  and small cut to bottom lip.  Patient regained conscious in about 1 minute. Patient was provided first aid at the site and when stable was transferred by parents private car  to local ED for evaluation of loss of consciousness, dizziness and headache.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Headache, Injection site reaction, Lip injury, Loss of consciousness, Skin abrasion
Clinical narrative: Patient lost consciousness after receiving immunizations.  Patient fell off exam table and hit her head/face on nurses foot when she hit the floor.  Patient had  a abrasion  and small cut to bottom lip.  Patient regained conscious in about 1 minute. Patient was provided first aid at the site and when stable was transferred by parents private car  to local ED for evaluation of loss of consciousness, dizziness and headache.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: X-ray limb
Clinical narrative: Patient lost consciousness after receiving immunizations.  Patient fell off exam table and hit her head/face on nurses foot when she hit the floor.  Patient had  a abrasion  and small cut to bottom lip.  Patient regained conscious in about 1 minute. Patient was provided first aid at the site and when stable was transferred by parents private car  to local ED for evaluation of loss of consciousness, dizziness and headache.
Age: 30.0
Sex: M
Vaccine: HEPA
Symptoms: Dyspnoea, Injection site pruritus, Pruritus, Urticaria
Clinical narrative: Hives, itching at injection site down rt arm and chest, SOB
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Muscle soreness at site of injection, chills, headache, stomach ache, muscle aches, tiredness.  Lasted approximately 48 hours.  The symptoms were worse in the first 24 hours and gradually tapered off.  I felt fine, back to normal after 72 hours.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness at site of injection, chills, headache, stomach ache, muscle aches, tiredness.  Lasted approximately 48 hours.  The symptoms were worse in the first 24 hours and gradually tapered off.  I felt fine, back to normal after 72 hours.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Headache, Pain, Syncope
Clinical narrative: whole body aches, chills, fainting, vomiting, headache, weakness 12 hours after vaccine Weakness and headache continued for 4 days
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: whole body aches, chills, fainting, vomiting, headache, weakness 12 hours after vaccine Weakness and headache continued for 4 days
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Blood test normal, Laboratory test normal, Myalgia, Pain in extremity, Scan normal
Clinical narrative: Since july, over 6 months I have had calf, thigh and arm muscle pain and aches. had all kinds of tests done. all normal.Pain still persists every day.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The patient reported on 1/29/2020 that the area was itching, red and swollen from shoulder to elbow on left extremity
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 31-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 02-JAN-2020, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 27-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) hepatitis a vaccine, inactivated (VAQTA), (Therapy type: Digital Data Logger), lot number S025258 and expiration date 05-NOV-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Iritis, Ophthalmic herpes zoster, Pain, Rash
Clinical narrative: herpes zoster iridocyclitis; iritis; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 87-year-old male patient. His medical history, concurrent conditions and concomitant medications were not provided.  On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about December 2009, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, route of administration, site of administration, lot # and expiration date were not provided). On unknown dates, the patient suffered the following injuries as a result of zoster vaccine live (ZOSTAVAX): pain, rash, herpes zoster, iritis, and herpes zoster iridocyclitis. The outcome of the events was not provided.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of herpes zoster iridocyclitis was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: feeling a little nauseous; dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 2nd dose of Shingrix. On 18th January 2020, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were unknown.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient felt a little nauseous and dizzy. The patient asked whether the event occurred are from vaccine. This case has been linked to US2020AMR011237 and US2020AMR011215, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: feeling a little nauseated; dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 2nd dose of Shingrix. On 18th January 2020, 1 days after receiving Shingrix, the patient experienced nausea and dizziness. On an unknown date, the outcome of the nausea and dizziness were unknown.   It was unknown if the reporter considered the nausea and dizziness to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. After vaccination, the patient felt a little nauseous and dizzy. The patient asked whether the event occurred are from vaccine. This case has been linked to US2020AMR011237 and US2020AMR011209, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Headachea; Achy; This case was reported by a other health professional via interactive digital media and described the occurrence of headache in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2020, the patient received Shingrix. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were unknown.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix 2 weeks before the time of reporting. Till the time of reporting, the patient had headaches and achy. This case has been linked to US2020AMR011237, reported by the same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Red area below 3 inches below the injection site; Swollen area below 3 inches below the injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix. On 22nd January 2020, 2 days after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling 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 the vaccine indication. The patient received Shingrix and had deep red swollen area below 3 inches below the injection site.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: Every year that she takes the flu shot she gets the flu/ Suspected VF; Flu; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine.  Additional information was received as follows: The age at vaccination was not reported. It was reported that the every year the patient received flu shot and experienced flu. This case was considered as suspected vaccination failure since details regarding the completion of the primary immunization for infuenza, the time to onset and laboratory confirmation was not provided for influenza.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site papule, Injection site pruritus, Injection site rash
Clinical narrative: itching; 3 or 4 bumps the size of mosquito bites at the site; 3 or 4 bumps the size of mosquito bites at the site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix. On 28th October 2019, 9 days after receiving Shingrix, the patient experienced injection site itching, injection site rash and injection site papule. On 29th October 2019, the outcome of the injection site itching and injection site rash were recovered/resolved. On an unknown date, the outcome of the injection site papule was recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site rash and injection site papule to be related to Shingrix.  Additional details were provided as follows: The patient developed itching at the injection site and 3 or 4 bumps the size of mosquito bites at the site that lasted for 1 day and resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Somnolence
Clinical narrative: put her to sleep. She slept for a full day and night; Adverse reaction; This case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hip discomfort and sulfonamide allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sleepiness and adverse reaction. On an unknown date, the outcome of the sleepiness and adverse reaction were recovered/resolved.   It was unknown if the reporter considered the sleepiness and adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced slight reaction on the 1st doseof Shingrix.  The first dose put her to sleep. She slept for a full day and night. Consent to follow up was provided. For tolerance with 2nd dose of Shingrix refer case US2020AMR012125.
Age: 1.17
Sex: F
Vaccine: HEPA
Symptoms: Adenovirus infection, Adenovirus test positive, Corona virus infection, Coronavirus test positive, Cough
Clinical narrative: coughing; runny nose; foam around mouth; meta pnuemonia virus; coronavirus HUK 1 diagnosis; adenovirus diagnosis; dehydrated; rash on right thigh; screaming; stopped eating/ stopped drinking; fever; could not stay asleep/ began to feel sleepy, had trouble staying asleep, was waking up every hour; This case was reported by a consumer via call center representative and described the occurrence of metapneumovirus infection in a 14-month-old female patient who received HAV (Havrix 720) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   On 14th January 2020, the patient received Havrix 720 (intramuscular). On 16th January 2020, 2 days after receiving Havrix 720, the patient experienced sleep disturbance. On 18th January 2020, the patient experienced screaming, appetite absent and fever. On 19th January 2020, the patient experienced metapneumovirus infection (serious criteria GSK medically significant), coronavirus infection, adenovirus infection, dehydration and rash. On 20th January 2020, the patient experienced cough, runny nose and foaming at mouth. On an unknown date, the outcome of the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever and dehydration were not recovered/not resolved and the outcome of the rash, cough, runny nose and foaming at mouth were recovering/resolving.   It was unknown if the reporter considered the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever, dehydration, rash, cough, runny nose and foaming at mouth to be related to Havrix 720.  Additional information was provided as follows: On 18th January 2020, 4 days after receiving Havrix 720, the patient began to feel sleepy, had trouble staying asleep, was waking up every hour, had a fever of 103 degrees C, stopped eating and drinking. On 19th January 2020, 5 days after receiving vaccine, the patient had a rash on her right thigh and was dehydrated. The patient went to the emergency department and was hydrated venously. In January 2020, the patient had an X-ray which was negative. The patient had nose swab and the swab results showed the patient had coronavirus HUK1, adenovirus, and metapneumonia virus. The next day after the hospital visit, 6 days after receiving vaccine, the patient experienced cough, runny nose and white foam-like liquid around her mouth. At the time of reporting, all symptoms had not resolved or improved and were becoming worse. The patient required emergency room visit. The reporter consented to follow up.
Age: 1.17
Sex: F
Vaccine: HEPA
Symptoms: Culture, Decreased appetite, Dehydration, Foaming at mouth, Human metapneumovirus test positive
Clinical narrative: coughing; runny nose; foam around mouth; meta pnuemonia virus; coronavirus HUK 1 diagnosis; adenovirus diagnosis; dehydrated; rash on right thigh; screaming; stopped eating/ stopped drinking; fever; could not stay asleep/ began to feel sleepy, had trouble staying asleep, was waking up every hour; This case was reported by a consumer via call center representative and described the occurrence of metapneumovirus infection in a 14-month-old female patient who received HAV (Havrix 720) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   On 14th January 2020, the patient received Havrix 720 (intramuscular). On 16th January 2020, 2 days after receiving Havrix 720, the patient experienced sleep disturbance. On 18th January 2020, the patient experienced screaming, appetite absent and fever. On 19th January 2020, the patient experienced metapneumovirus infection (serious criteria GSK medically significant), coronavirus infection, adenovirus infection, dehydration and rash. On 20th January 2020, the patient experienced cough, runny nose and foaming at mouth. On an unknown date, the outcome of the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever and dehydration were not recovered/not resolved and the outcome of the rash, cough, runny nose and foaming at mouth were recovering/resolving.   It was unknown if the reporter considered the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever, dehydration, rash, cough, runny nose and foaming at mouth to be related to Havrix 720.  Additional information was provided as follows: On 18th January 2020, 4 days after receiving Havrix 720, the patient began to feel sleepy, had trouble staying asleep, was waking up every hour, had a fever of 103 degrees C, stopped eating and drinking. On 19th January 2020, 5 days after receiving vaccine, the patient had a rash on her right thigh and was dehydrated. The patient went to the emergency department and was hydrated venously. In January 2020, the patient had an X-ray which was negative. The patient had nose swab and the swab results showed the patient had coronavirus HUK1, adenovirus, and metapneumonia virus. The next day after the hospital visit, 6 days after receiving vaccine, the patient experienced cough, runny nose and white foam-like liquid around her mouth. At the time of reporting, all symptoms had not resolved or improved and were becoming worse. The patient required emergency room visit. The reporter consented to follow up.
Age: 1.17
Sex: F
Vaccine: HEPA
Symptoms: Injection site rash, Metapneumovirus infection, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: coughing; runny nose; foam around mouth; meta pnuemonia virus; coronavirus HUK 1 diagnosis; adenovirus diagnosis; dehydrated; rash on right thigh; screaming; stopped eating/ stopped drinking; fever; could not stay asleep/ began to feel sleepy, had trouble staying asleep, was waking up every hour; This case was reported by a consumer via call center representative and described the occurrence of metapneumovirus infection in a 14-month-old female patient who received HAV (Havrix 720) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   On 14th January 2020, the patient received Havrix 720 (intramuscular). On 16th January 2020, 2 days after receiving Havrix 720, the patient experienced sleep disturbance. On 18th January 2020, the patient experienced screaming, appetite absent and fever. On 19th January 2020, the patient experienced metapneumovirus infection (serious criteria GSK medically significant), coronavirus infection, adenovirus infection, dehydration and rash. On 20th January 2020, the patient experienced cough, runny nose and foaming at mouth. On an unknown date, the outcome of the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever and dehydration were not recovered/not resolved and the outcome of the rash, cough, runny nose and foaming at mouth were recovering/resolving.   It was unknown if the reporter considered the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever, dehydration, rash, cough, runny nose and foaming at mouth to be related to Havrix 720.  Additional information was provided as follows: On 18th January 2020, 4 days after receiving Havrix 720, the patient began to feel sleepy, had trouble staying asleep, was waking up every hour, had a fever of 103 degrees C, stopped eating and drinking. On 19th January 2020, 5 days after receiving vaccine, the patient had a rash on her right thigh and was dehydrated. The patient went to the emergency department and was hydrated venously. In January 2020, the patient had an X-ray which was negative. The patient had nose swab and the swab results showed the patient had coronavirus HUK1, adenovirus, and metapneumonia virus. The next day after the hospital visit, 6 days after receiving vaccine, the patient experienced cough, runny nose and white foam-like liquid around her mouth. At the time of reporting, all symptoms had not resolved or improved and were becoming worse. The patient required emergency room visit. The reporter consented to follow up.
Age: 1.17
Sex: F
Vaccine: HEPA
Symptoms: Screaming, Sleep disorder, Somnolence, X-ray normal
Clinical narrative: coughing; runny nose; foam around mouth; meta pnuemonia virus; coronavirus HUK 1 diagnosis; adenovirus diagnosis; dehydrated; rash on right thigh; screaming; stopped eating/ stopped drinking; fever; could not stay asleep/ began to feel sleepy, had trouble staying asleep, was waking up every hour; This case was reported by a consumer via call center representative and described the occurrence of metapneumovirus infection in a 14-month-old female patient who received HAV (Havrix 720) (batch number 3HR79, expiry date 16th September 2021) for prophylaxis.   On 14th January 2020, the patient received Havrix 720 (intramuscular). On 16th January 2020, 2 days after receiving Havrix 720, the patient experienced sleep disturbance. On 18th January 2020, the patient experienced screaming, appetite absent and fever. On 19th January 2020, the patient experienced metapneumovirus infection (serious criteria GSK medically significant), coronavirus infection, adenovirus infection, dehydration and rash. On 20th January 2020, the patient experienced cough, runny nose and foaming at mouth. On an unknown date, the outcome of the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever and dehydration were not recovered/not resolved and the outcome of the rash, cough, runny nose and foaming at mouth were recovering/resolving.   It was unknown if the reporter considered the metapneumovirus infection, coronavirus infection, adenovirus infection, sleep disturbance, screaming, appetite absent, fever, dehydration, rash, cough, runny nose and foaming at mouth to be related to Havrix 720.  Additional information was provided as follows: On 18th January 2020, 4 days after receiving Havrix 720, the patient began to feel sleepy, had trouble staying asleep, was waking up every hour, had a fever of 103 degrees C, stopped eating and drinking. On 19th January 2020, 5 days after receiving vaccine, the patient had a rash on her right thigh and was dehydrated. The patient went to the emergency department and was hydrated venously. In January 2020, the patient had an X-ray which was negative. The patient had nose swab and the swab results showed the patient had coronavirus HUK1, adenovirus, and metapneumonia virus. The next day after the hospital visit, 6 days after receiving vaccine, the patient experienced cough, runny nose and white foam-like liquid around her mouth. At the time of reporting, all symptoms had not resolved or improved and were becoming worse. The patient required emergency room visit. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Bruises in the lower arm; This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bruising of arm. On an unknown date, the outcome of the bruising of arm was unknown.   It was unknown if the reporter considered the bruising of arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report.  No information was available data from patient. The batch number was not reported. The patient received Shingrix and experienced bruises lower in their arms. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site pain, Injection site swelling
Clinical narrative: not yet received a second dose; Pain at the injection site; Swelling 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.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received 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, injection site swelling and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age at vaccination was not applicable for 2nd dose. The patient received 1st dose of Shingrix in the right arm and had pain and swelling at the injection site that lasted approximately 2 weeks. The patient had not yet received a second dose, which led to incomplete course of vaccination. The reporter did not consent to follow up. The patient declined to answer additional questions.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out into shingles; This case was reported by a physician via call center representative and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix last week on unspecified date and broke out into shingles. The health care professional declined to provide patient or vaccination information.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had an anaphylactic reaction t o an unknown influenza vaccine that was administered in a previous season. Health care professional (HCP) did not provide any further details regarding patient or vaccine administered. The patient did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reports that following the injection his whole left arm was swollen and painful.  Per pt report the diameter of the arm increased by ~1".  Patient reports that the swelling is going down 2 days following administration.  Denies redness, or discharge from arm
Age: 14.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HPV vaccination should have been given. Prevnar 13, was given instead. No adverse effects noted in patient, per patient
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Injection site mass, Injection site pain, Injection site warmth, Magnetic resonance imaging normal
Clinical narrative: The shoot hurt right away, had golf ball size lump, warm to the touch and really bad night sweets for about a week. Arm still hurts to this day at injection site. (21 years later) Lost 50% strength in my left arm.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: Mass, Night sweats, Pain in extremity, Skin warm, Ultrasound scan
Clinical narrative: The shoot hurt right away, had golf ball size lump, warm to the touch and really bad night sweets for about a week. Arm still hurts to this day at injection site. (21 years later) Lost 50% strength in my left arm.
Age: 42.0
Sex: M
Vaccine: ANTH
Symptoms: X-ray normal
Clinical narrative: The shoot hurt right away, had golf ball size lump, warm to the touch and really bad night sweets for about a week. Arm still hurts to this day at injection site. (21 years later) Lost 50% strength in my left arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: redness, pain, swelling, a hard oval lump 3in x 2in and  bruising at the injection site, headache, fatigue
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: redness, pain, swelling, a hard oval lump 3in x 2in and  bruising at the injection site, headache, fatigue
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: 6 to 8 hours of Fever, Aches, chills, nausea.  Resolved the next morning
Age: 1.67
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Parent called 1/30/2020 to report child had a fever between 101-103 last night and reports Right leg pain at injection site. He pulls away when parents try to touch leg. Parents gave a fever reducer that brought the temp down to 101. Instructed to apply ice to injection site for inflammation/pain, and monitor. Report to us tomorrow.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site inflammation, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: THE DAY AFTER THE SHOT WAS GIVEN THE SITE BECAME LARGE AND INFLAMED, IT IS HOT TO THE TOUCH AND THE SITE SKING VERY TIGHT.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV, PNC13
Symptoms: Pyrexia
Clinical narrative: Parent called 1/30 to report fever was 102.5, reduced to 101.0 F after fever reducer given last evening. Pt still has fever today. No other symptoms at this time. Told parent to continue to monitor for 2-3 days, see doctor if worsens, not controlled by Tylenol beyond 2-3 days in case of viral infection instead of the common vaccine reaction.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Headache, pain at injection site radiating down left arm, mild body aches, tiredness. Mild chills. Occasional stomach ache. Loss of appetite.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Headache, pain at injection site radiating down left arm, mild body aches, tiredness. Mild chills. Occasional stomach ache. Loss of appetite.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Muscle spasms, Nausea, Pain
Clinical narrative: Fever of 102, aches, cramping legs, nausea, shivers - severe flu like symptoms
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever of 102, aches, cramping legs, nausea, shivers - severe flu like symptoms
Age: 74.0
Sex: M
Vaccine: FLUR4
Symptoms: Injection site pain
Clinical narrative: left deltoid tenderness noted. No swelling, no redness. Treated with topical NSAID. Advised to rest, apply topical heat and follow up with PT for needling.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Influenza like illness, Muscle spasms
Clinical narrative: Fever, chills, dizziness, muscle aches, leg cramps, weakness, (flu-like symptoms) lasted approx 36 hours
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, chills, dizziness, muscle aches, leg cramps, weakness, (flu-like symptoms) lasted approx 36 hours
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, aches, fatigue, and chills
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Nausea, Oropharyngeal discomfort, Peripheral coldness
Clinical narrative: At 4:03 pm on 1/29/2020 Pt. called RN at Clinic. Pt. reported to RN that at about 3:30 pm she had started to experience what she referred to as hives on her chest and like her skin felt "chilled like it was touched with an ice pack", that the back of her head was "itchy", and that her throat felt a little "full". Pt. reported that her s/s had not gotten any worse in the past 30ish minutes she had been experiencing them. RN reinforced education on s/s of progressing allergic reaction, that there is a spectrum of mild to severe allergic reactions however there is no definitive answer on how fast anaphylaxis can set in, and encouraged pt to report to ER or Outpatient at Hospital for assessment. Noted that today was the first time pt had received an influenza vaccine in 10 years (according to statewide vaccine tracking system, pt received an influenza vaccine on 10/29/2009. Pt. was confident in assessing her own status to monitor if s/s progressed to anaphylaxis reporting she believed she was having a "mild reaction" and would "go to the ER after work if it got worse". RN will continue to monitor by F/U via phone with pt.  Pt. reported to Health Center Outpatient Department for assessment on 1/29/2020. At about 6:30 pm Dr. assessed pt and reported the following: "Patient, a 55 yo female with PMHx including GERD, HLD, and anxiety, presents to clinic today after having a reaction to her flu shot.  Was sick last year for about 3 months and states her illnesses began with influenza.  Wanted to get an influenza vaccination.  Has never had a flu shot in the past.  As her mother has come to stay with her, she decided she needed to get one now.  Went to Health Center today shortly before noon and received a flu shot.  About 1530 she developed a headache with nausea.  Felt that her chest was cool to the touch so went to the restroom and noted that she had hives all over her chest.  States her throat felt scratchy "like it is after vomiting."  Felt she had "extra saliva and had to swallow hard."  Around 1600 she tasted a medicine taste.  Her scalp also began to itch.  Called nurse and was told to present to clinic to be checked out.  States her symptoms all stopped around 1700 and she has no new symptoms at this time.  Denies any shortness of breath or difficulty breathing.  Denies any food allergies.  Endorses having hives after taking Augmentin but denies any other reactions. Currently still endorses headache, nausea, hives, itching, and scratchy throat.  Denies any fatigue, chest pain, shortness of breath, abdominal pain, or joint pain." Dr. administered Benadryl 50 mg IM in clinic and encouraged pt to take Benadryl as needed for hives/itching.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Salivary hypersecretion, Throat irritation, Urticaria
Clinical narrative: At 4:03 pm on 1/29/2020 Pt. called RN at Clinic. Pt. reported to RN that at about 3:30 pm she had started to experience what she referred to as hives on her chest and like her skin felt "chilled like it was touched with an ice pack", that the back of her head was "itchy", and that her throat felt a little "full". Pt. reported that her s/s had not gotten any worse in the past 30ish minutes she had been experiencing them. RN reinforced education on s/s of progressing allergic reaction, that there is a spectrum of mild to severe allergic reactions however there is no definitive answer on how fast anaphylaxis can set in, and encouraged pt to report to ER or Outpatient at Hospital for assessment. Noted that today was the first time pt had received an influenza vaccine in 10 years (according to statewide vaccine tracking system, pt received an influenza vaccine on 10/29/2009. Pt. was confident in assessing her own status to monitor if s/s progressed to anaphylaxis reporting she believed she was having a "mild reaction" and would "go to the ER after work if it got worse". RN will continue to monitor by F/U via phone with pt.  Pt. reported to Health Center Outpatient Department for assessment on 1/29/2020. At about 6:30 pm Dr. assessed pt and reported the following: "Patient, a 55 yo female with PMHx including GERD, HLD, and anxiety, presents to clinic today after having a reaction to her flu shot.  Was sick last year for about 3 months and states her illnesses began with influenza.  Wanted to get an influenza vaccination.  Has never had a flu shot in the past.  As her mother has come to stay with her, she decided she needed to get one now.  Went to Health Center today shortly before noon and received a flu shot.  About 1530 she developed a headache with nausea.  Felt that her chest was cool to the touch so went to the restroom and noted that she had hives all over her chest.  States her throat felt scratchy "like it is after vomiting."  Felt she had "extra saliva and had to swallow hard."  Around 1600 she tasted a medicine taste.  Her scalp also began to itch.  Called nurse and was told to present to clinic to be checked out.  States her symptoms all stopped around 1700 and she has no new symptoms at this time.  Denies any shortness of breath or difficulty breathing.  Denies any food allergies.  Endorses having hives after taking Augmentin but denies any other reactions. Currently still endorses headache, nausea, hives, itching, and scratchy throat.  Denies any fatigue, chest pain, shortness of breath, abdominal pain, or joint pain." Dr. administered Benadryl 50 mg IM in clinic and encouraged pt to take Benadryl as needed for hives/itching.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid rash, Rash
Clinical narrative: Patient experienced a painful rash on the left corner eye lid about 3 days after receiving the vaccine
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Abdominal discomfort, Abdominal pain, Blood test, Capsule endoscopy, Colonoscopy
Clinical narrative: Upper and Lower GI issues that included abdominal pain and discomfort, felt like something was "stuck in his throat",  and constimation
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Constipation, Crohn's disease, Endoscopy, Gastrointestinal disorder, Magnetic resonance imaging
Clinical narrative: Upper and Lower GI issues that included abdominal pain and discomfort, felt like something was "stuck in his throat",  and constimation
Age: 14.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Scan with contrast, Sensation of foreign body, Stool analysis
Clinical narrative: Upper and Lower GI issues that included abdominal pain and discomfort, felt like something was "stuck in his throat",  and constimation