chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: sweating; pain; redness; knot on arm; fever; fatigue; muscle fatigue; Mental Fatigue; flu-like symptoms; arm tenderness/ extreme arm soreness; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 27th November 2019, 1 days after receiving Shingrix, the patient experienced fatigue, muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm and headache. On 28th November 2019, the patient experienced pain, erythema, local swelling and fever. On 29th November 2019, the patient experienced sweating. The patient was treated with paracetamol (Tylenol). On 29th November 2019, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm, headache, pain, erythema, local swelling, fever and sweating were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm, headache, pain, erythema, local swelling, fever and sweating to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left deltoid. The patient took Tylenol 500 mg to treat the pain and fever. Two days after receiving Shingrix, the patient experienced pain, erythema, local swelling, fever and 3 days after experienced sweating. Extreme arm soreness 28th November 2019 On 29th November 2019, friday, the fatigue was gone, the arm soreness was about the same an the redness were not as bad as they were before. On Sunday, the arm was not tender and the redness was fading. Consent to follow up was provided
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Mental fatigue, Muscle fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: sweating; pain; redness; knot on arm; fever; fatigue; muscle fatigue; Mental Fatigue; flu-like symptoms; arm tenderness/ extreme arm soreness; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 27th November 2019, 1 days after receiving Shingrix, the patient experienced fatigue, muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm and headache. On 28th November 2019, the patient experienced pain, erythema, local swelling and fever. On 29th November 2019, the patient experienced sweating. The patient was treated with paracetamol (Tylenol). On 29th November 2019, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm, headache, pain, erythema, local swelling, fever and sweating were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm, headache, pain, erythema, local swelling, fever and sweating to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left deltoid. The patient took Tylenol 500 mg to treat the pain and fever. Two days after receiving Shingrix, the patient experienced pain, erythema, local swelling, fever and 3 days after experienced sweating. Extreme arm soreness 28th November 2019 On 29th November 2019, friday, the fatigue was gone, the arm soreness was about the same an the redness were not as bad as they were before. On Sunday, the arm was not tender and the redness was fading. Consent to follow up was provided
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: sweating; pain; redness; knot on arm; fever; fatigue; muscle fatigue; Mental Fatigue; flu-like symptoms; arm tenderness/ extreme arm soreness; headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 27th November 2019, 1 days after receiving Shingrix, the patient experienced fatigue, muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm and headache. On 28th November 2019, the patient experienced pain, erythema, local swelling and fever. On 29th November 2019, the patient experienced sweating. The patient was treated with paracetamol (Tylenol). On 29th November 2019, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm, headache, pain, erythema, local swelling, fever and sweating were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle fatigue, mental fatigue, influenza-like symptoms, pain in arm, headache, pain, erythema, local swelling, fever and sweating to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left deltoid. The patient took Tylenol 500 mg to treat the pain and fever. Two days after receiving Shingrix, the patient experienced pain, erythema, local swelling, fever and 3 days after experienced sweating. Extreme arm soreness 28th November 2019 On 29th November 2019, friday, the fatigue was gone, the arm soreness was about the same an the redness were not as bad as they were before. On Sunday, the arm was not tender and the redness was fading. Consent to follow up was provided
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional via sales rep and described the occurrence of shingles in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th October 2019, the patient received Shingrix. On 30th November 2019, 52 days 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 patient first noticed symptoms of shingles on 30th November 2019, and  her physician diagnosed her with shingles on 2nd December 2019. The shingles rash appeared on her bra line toward the back. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: After the vaccine, she says she regulary gets them; This case was reported by a pharmacist via call center representative and described the occurrence of fever blister in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 7RK7K, expiry date 26th November 2021) for prophylaxis.   The patient's past medical history included fever blister.   On 1st November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had fever blisters, but reported they had not been occurring often. Then after the vaccine, she says she regularly gets them. Once one resolves, another one pops up. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray, Chills, Dehydration, Haemoglobin decreased, Infection
Clinical narrative: Infection; Fever of 103 degrees; Chills; Vomiting; Low Platelets; Low Hemoglobin; Low WBCs; Low RBCs; Dehydrated; This case was reported by a physician via call center representative and described the occurrence of infection in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced infection, fever, chills, vomiting, platelets decreased, hemoglobin decreased, white blood cell decreased, red blood cell count decreased and dehydration. On an unknown date, the outcome of the infection was unknown and the outcome of the fever, chills, vomiting and dehydration were recovered/resolved and the outcome of the platelets decreased, hemoglobin decreased, white blood cell decreased and red blood cell count decreased were recovering/resolving.   The reporter considered the infection, fever, chills, vomiting, platelets decreased, hemoglobin decreased, white blood cell decreased, red blood cell count decreased and dehydration to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received Shingrix vaccine on 9th December 2019. On 10th December 2019, at 03:00 AM, the patient went to bed and woke up in midnight because he started vomiting. He had a fever of 103 degree and he had chills. He went to urgent care later in the day and he was given fluids because he was dehydrated and given an antinausea medication. Tests were performed which included a chest xray and blood work. The blood work came with back with his platelets, hemoglobin, wbcs, and rbcs all low. She stated that his platelets were 138 at that time. On 11th December 2019, he went back to the urgent care and his blood counts were worse than they were on the 10th December 2019. She noted that his platelets were 110. She said that the physician described that everything pointed to an infection but they cannot find one.At the time of this report, the physician believed that her husband's symptoms were related to the Shingrix vaccine. She indicated that her husband had no adverse reactions to the first dose. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count decreased, Pyrexia, Red blood cell count decreased, Vomiting, White blood cell count decreased
Clinical narrative: Infection; Fever of 103 degrees; Chills; Vomiting; Low Platelets; Low Hemoglobin; Low WBCs; Low RBCs; Dehydrated; This case was reported by a physician via call center representative and described the occurrence of infection in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced infection, fever, chills, vomiting, platelets decreased, hemoglobin decreased, white blood cell decreased, red blood cell count decreased and dehydration. On an unknown date, the outcome of the infection was unknown and the outcome of the fever, chills, vomiting and dehydration were recovered/resolved and the outcome of the platelets decreased, hemoglobin decreased, white blood cell decreased and red blood cell count decreased were recovering/resolving.   The reporter considered the infection, fever, chills, vomiting, platelets decreased, hemoglobin decreased, white blood cell decreased, red blood cell count decreased and dehydration to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received Shingrix vaccine on 9th December 2019. On 10th December 2019, at 03:00 AM, the patient went to bed and woke up in midnight because he started vomiting. He had a fever of 103 degree and he had chills. He went to urgent care later in the day and he was given fluids because he was dehydrated and given an antinausea medication. Tests were performed which included a chest xray and blood work. The blood work came with back with his platelets, hemoglobin, wbcs, and rbcs all low. She stated that his platelets were 138 at that time. On 11th December 2019, he went back to the urgent care and his blood counts were worse than they were on the 10th December 2019. She noted that his platelets were 110. She said that the physician described that everything pointed to an infection but they cannot find one.At the time of this report, the physician believed that her husband's symptoms were related to the Shingrix vaccine. She indicated that her husband had no adverse reactions to the first dose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: hip pain/Arthritic pain; This case was reported by a physician via sales rep and described the occurrence of pain in hip in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date). Concurrent medical conditions included ulcerative colitis. Concomitant products included mercaptopurine.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in hip. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory). On an unknown date, the outcome of the pain in hip was recovered/resolved.   It was unknown if the reporter considered the pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had receive the 2nd dose and within 3 days he experienced hip pain. No trauma was identified till the time of reporting. The pain was described as arthritic pain. The hip pain was treated with anti-inflammatory and resolved after three weeks. The reporter consented to follow up. This case has been linked with case US2019227101, reported by the same reporter.
Sex: U
Vaccine: UNK
Symptoms: Erythema, Induration, Pain
Clinical narrative: Induration; Redness; Pain after injection; This case was reported by a physician via call center representative and described the occurrence of induration in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced induration, erythema and pain. On an unknown date, the outcome of the induration, erythema and pain were unknown.   It was unknown if the reporter considered the induration, erythema and pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced induration, redness and pain during three days after receiving Fluarix vaccine. The reporter denied consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Side effects; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, 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 Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A healthcare professional reported about a possible adverse event for Shingrix via online chat. The adverse event was not specified, only described as side effects. The reporter denied consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness; This case was reported by a physician via call center representative and described the occurrence of erythema in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema. On an unknown date, the outcome of the erythema was not recovered/not resolved.   It was unknown if the reporter considered the erythema to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced redness for three days after receiving Shingrix and it was getting larger, not recovered. The batch number and expiration date were not available since the physician did not call from the facility were the vaccine was administered.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: flu like symptoms; fever; chills; nausea; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unspecified day and had no issues).   On 16th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, chills, nausea and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, fever, chills, nausea and general body pain were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, nausea and general body pain to be related to Shingrix.  Additional details were provided as follows.  This case was reported by the patient's husband. The patient was vaccinated in the afternoon day before the reporting. On 17th December 2019, the patient awoke early morning with fever, chills, nausea and body aches and also reported flu like symptoms. The pharmacy was called and the patient was recommended tylenol. The reporter called GlaxoSmithKline and seeked advice on how to treat symptoms.  The reporter was referred to the patient's physician and the call center reviewed prescribing information for common side effects and median duration of time of events in clinical trials.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Pain in extremity
Clinical narrative: swelling; pain; redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb 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, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm and erythema. The patient was treated with prednisone. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm and erythema were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm and erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had swelling, redness, and pain on the injected arm from elbow to shoulder. The patient was started on prednisone. No additional information was available. The reporter did not consent to follow up. This case has been linked with case US2019230503 and US2019230505, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling; pain; redness; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb 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, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, pain in arm and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb, pain in arm and erythema of extremities were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, pain in arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had pain, swelling and redness of the injected arm from elbow to shoulder. No additional information was available. The reporter did not consent to follow up. This case has been linked with case US2019230500 and US2019230505, reported by the same reporter.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: hives; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3RN95, expiry date 6th December 2021) for prophylaxis.   On 10th December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2019, less than a week after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional case details were reported as follows: The patient developed hives sometime after vaccination with Shingrix. The patient did visit her doctor as a result of the hives. Caller did not have any further details regarding the event.
Sex: U
Vaccine: VARZOS
Symptoms: Colon operation, Gastrointestinal disorder
Clinical narrative: Required colon surgery after 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of lower gastrointestinal disorder 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, unknown after receiving Shingrix, the patient experienced lower gastrointestinal disorder. On an unknown date, the outcome of the lower gastrointestinal disorder was unknown.   It was unknown if the reporter considered the lower gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. It was reported that, the patient required colon surgery after receiving Shingrix. The reporter did not consent to follow-up.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: soreness at injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 49-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number YH595, expiry date 30th June 2020) for prophylaxis.   On 24th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season (intramuscular). On 24th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site pain. The patient was treated with STEROIDS NOS (STEROID (NOT SPECIFIED)). On an unknown date, the outcome of the injection site pain was recovering/resolving.   It was unknown if the reporter considered the injection site pain to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows: The medical assistant (MA) reported that the patient was given a steroid injection at the site of the soreness. The medical assistant reported that the patient planned to continue follow-up with the physician on an unknown date. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Decreased appetite, Fatigue, Headache, Injection site induration, Insomnia
Clinical narrative: Headache; Loss of Appetite; Fatigue; Muscle Aches; Injection Site Hardness; pain everywhere; extreme Pain in Legs; trouble sleeping at night; This case was reported by a consumer via call center representative and described the occurrence of headache in a 20-year-old female patient who received Men B NVS (Meningococcal B vaccine) (batch number not known, expiry date unknown) for prophylaxis.   On 18th December 2019, the patient received Meningococcal B vaccine (intramuscular). On 18th December 2019, 10 hrs after receiving Meningococcal B vaccine, the patient experienced headache, appetite lost, fatigue, muscle pain, injection site induration, general body pain, leg pain and difficulty sleeping. On an unknown date, the outcome of the headache, appetite lost and fatigue were recovering/resolving and the outcome of the muscle pain, injection site induration, general body pain and leg pain were resolved with sequelae and the outcome of the difficulty sleeping was unknown.   It was unknown if the reporter considered the headache, appetite lost, fatigue, muscle pain, injection site induration, general body pain, leg pain and difficulty sleeping to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's mother. The age at vaccination was not reported. The reporter stated that the patient received meningitis B vaccine (unknown manufacturer).  The patient had a headache, fatigue, muscle aches, injection site hardness, loss of appetite, pain everywhere, extreme pain in legs, and trouble sleeping at night due to pain.
Age: 20.0
Sex: F
Vaccine: MEN
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Headache; Loss of Appetite; Fatigue; Muscle Aches; Injection Site Hardness; pain everywhere; extreme Pain in Legs; trouble sleeping at night; This case was reported by a consumer via call center representative and described the occurrence of headache in a 20-year-old female patient who received Men B NVS (Meningococcal B vaccine) (batch number not known, expiry date unknown) for prophylaxis.   On 18th December 2019, the patient received Meningococcal B vaccine (intramuscular). On 18th December 2019, 10 hrs after receiving Meningococcal B vaccine, the patient experienced headache, appetite lost, fatigue, muscle pain, injection site induration, general body pain, leg pain and difficulty sleeping. On an unknown date, the outcome of the headache, appetite lost and fatigue were recovering/resolving and the outcome of the muscle pain, injection site induration, general body pain and leg pain were resolved with sequelae and the outcome of the difficulty sleeping was unknown.   It was unknown if the reporter considered the headache, appetite lost, fatigue, muscle pain, injection site induration, general body pain, leg pain and difficulty sleeping to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by patient's mother. The age at vaccination was not reported. The reporter stated that the patient received meningitis B vaccine (unknown manufacturer).  The patient had a headache, fatigue, muscle aches, injection site hardness, loss of appetite, pain everywhere, extreme pain in legs, and trouble sleeping at night due to pain.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: tiredness; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On 17th December 2019, less than a day after receiving Shingrix, the patient experienced injection site pain. On 18th December 2019, the patient experienced tiredness. On an unknown date, the outcome of the tiredness and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the tiredness and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Age: 35.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: MMRV given as MMR,  Phone call to client stating she may get feverish today, recommended taking ibuprofen if this happens, client verbalized understanding and had no further concerns.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Apnoea, Blood lactic acid, Chest X-ray, Cyanosis central, Full blood count
Clinical narrative: Patient experienced a BRUE manifest as stiffening followed by apnea and central cyanosis
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Metabolic function test, Musculoskeletal stiffness, Urine analysis
Clinical narrative: Patient experienced a BRUE manifest as stiffening followed by apnea and central cyanosis
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: 48 HOURS AFTER RECEIVING INJECTION NOTED SWELLING, WARM TO TOUCH AND REDNESS ON RIGHT THIGH FROM APPROXIMATELY UPPER THIGH TO KNEE - LOW GRADE FEVER 100.-101., AND DIFFICULTY WALKING DUE TO SWELLING. ON 12/26/19, SWELLING AND REDNESS DECREASED, TEMP 99. BUT WALKING BETTER.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Apnoea, Chest X-ray, Cyanosis, Electrocardiogram, Full blood count
Clinical narrative: Patient brought to ED by parent who reported patient had period of apnea and cyanosis. PLEASE NOTE THAT I AM NOT COMPLETELY CERTAIN AS TO THE MANUFACTURER OR "TYPE" OF FLU VACCINE GIVEN BUT ACCORDING TO PARENTAL HX THE PATIENT DID RECEIVE FLU VACCINE 2 DAYS PRIOR TO EVENT BEING REPORTED
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Metabolic function test
Clinical narrative: Patient brought to ED by parent who reported patient had period of apnea and cyanosis. PLEASE NOTE THAT I AM NOT COMPLETELY CERTAIN AS TO THE MANUFACTURER OR "TYPE" OF FLU VACCINE GIVEN BUT ACCORDING TO PARENTAL HX THE PATIENT DID RECEIVE FLU VACCINE 2 DAYS PRIOR TO EVENT BEING REPORTED
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever to 102.3 responded to Tylenol.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Myalgia, Pyrexia
Clinical narrative: Patient experienced symptoms approximately 12 hours after the shingrix injection. The symptoms included muscle aches and pains, stomach aches, fever, and chills. Patient managed these symptoms by taking Tylenol and drinking Gatorade.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Hyperhidrosis, Injection site pain
Clinical narrative: On 08/25/19, I received dose 2 of Shingrix. Pharmacy has this date wrong in their system. Within a couple of hours I was beginning to feel very ill. By night, I was sweating, freezing, running 101.5 fever, terrible pain in arm, vomiting, congestion all night. Almost went to ED. The next day and subsequent days very fatigued. A rash and pox like thing erupted at the injection site on my left arm. It was horribly painful. By mid-September, I am still feeling terrible and my arm is worse, I make an appt. with my primary care. She sends me to a Derma Surgeon specializing in Mohs surgery. She does biopisies. My arm, has rare form of squamous cell cancer that erupts upon trauma. 2 surgeries and more spots appearing.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Malaise, Pain in extremity, Pyrexia, Rash vesicular
Clinical narrative: On 08/25/19, I received dose 2 of Shingrix. Pharmacy has this date wrong in their system. Within a couple of hours I was beginning to feel very ill. By night, I was sweating, freezing, running 101.5 fever, terrible pain in arm, vomiting, congestion all night. Almost went to ED. The next day and subsequent days very fatigued. A rash and pox like thing erupted at the injection site on my left arm. It was horribly painful. By mid-September, I am still feeling terrible and my arm is worse, I make an appt. with my primary care. She sends me to a Derma Surgeon specializing in Mohs surgery. She does biopisies. My arm, has rare form of squamous cell cancer that erupts upon trauma. 2 surgeries and more spots appearing.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Respiratory tract congestion, Squamous cell carcinoma of skin, Surgery, Vomiting
Clinical narrative: On 08/25/19, I received dose 2 of Shingrix. Pharmacy has this date wrong in their system. Within a couple of hours I was beginning to feel very ill. By night, I was sweating, freezing, running 101.5 fever, terrible pain in arm, vomiting, congestion all night. Almost went to ED. The next day and subsequent days very fatigued. A rash and pox like thing erupted at the injection site on my left arm. It was horribly painful. By mid-September, I am still feeling terrible and my arm is worse, I make an appt. with my primary care. She sends me to a Derma Surgeon specializing in Mohs surgery. She does biopisies. My arm, has rare form of squamous cell cancer that erupts upon trauma. 2 surgeries and more spots appearing.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: severe right arm injection site pain; This spontaneous report as received from a pharmacist refers to a 82-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. Historical vaccine included pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (administered last year).  On 04-DEC-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) intramuscularly in the right deltoid, lot # S018405, expiration date 28-MAR-2021 (exact dose was not reported) for prophylaxis(reported also as because she received PREVNAR 13 last year). On the same date, the patient experienced severe right arm injection site pain and she could not touch her arm. The patient was taking acetaminophen (TYLENOL) every four hours. She did not sought medical attention.  The outcome of injection site pain was not recovered at the reporting time. The causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection
Clinical narrative: fue patient was diagnosed wifu "unspecified HPV related disease".; This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) fill series (lot #, expiration date, route of administration and frequency were not reported) for prophylaxis.        On an unknown date, the patient was diagnosed with unspecified HPV related disease.The outcome of papilloma viral infection was unknown. the causality assessment between the event and suspect therapy was not provided.
Age: 97.0
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Mouth swelling
Clinical narrative: Angioedema & ORAL SWELLING
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Dyspnoea, Erythema, Hyperhidrosis
Clinical narrative: note while patient was receiving his pneumonia vaccination he became diaphoretic and having some sob and dizziness. it was noted some redness on skin but not urticarial vitals were taken q2 mins and were stable the whole time Benadryl IM was ordered but not needed as patient quickly started to feel better and less diaphoretic or sob. within approx. 10 mins patient was baseline. he left room to be observed for 30 mins more walking with no assistance and not having anymore s/s as above.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Neuralgia, Pain
Clinical narrative: Since receiving Flu vaccine on 10/16/19 I have and is currently experiencing nerve pain in left shoulder at site of injection. The pain is excruciating with arm movement and especially when trying to dress myself in clothing
Age: 60.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received flu vaccine (after verbal and written confirmation that was correct), but wanted his second Shingrix vaccine.  He had previously received a flu vaccine dose through employer, so this was his second flu vaccine of the season. No adverse events reported as of 12/27/19 (next day).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Dizziness, Heart rate increased
Clinical narrative: While standing, patient felt faint and almost collapsed. Patient then sat down. Patient reported increased heart rate and dizziness,. Blood pressure was elevated when checked via manual blood pressure. She was given water and advised to remain seated. Advised to go to the hospital, but patient refused. Patient was then observed for 20min. After 20min, patient reported a decrease in symptoms and was able to stand on her own. Before leaving, patient's blood pressure was checked again manually. Second manual blood pressure check revealed a decrease in previously high blood pressure.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Patient was only given the Diluent part of vaccine.  This was noticed 6 days later while doing inventory.  Pt was notified.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Foaming at mouth, Hyperventilation, Irritability
Clinical narrative: Mother states pt was foaming at the mouth and breathing heavy, when she got home after reciving vaccines. Mom was instructed to take child to the emergency room or call EMS. she did not. Spoke with mom today 12/27/2019 mom states t is doing fine now just fussy.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; Vaccine exposureduring pregnancy; This spontaneous prospective pregnancy report was received from a physician referring to a female patient of an unknown age. The patient's concurrent conditions medical history, drug allergies/ reactions and concomitant medications were not reported. On 17-DEC-2019 (reported as last week), the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, formulation, dose/frequency, route, lot# and expiry date were not reported) (exposure during pregnancy) for prophylaxis. The last menstrual period was estimated as 32 weeks and estimated date of delivery to be on 18-FEB-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 31 week(s). The pregnancy outcome was unknown. No additional adverse events reported. The outcome of exposure during pregnancy and no adverse event was unknown.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Extradose administered; This spontaneous report as received from a consumer referring to her son of an unknown age. The patient's concurrent conditions, medical history, drug allergies/ reactions and concomitant medications were not reported. On 23-DEC-2019, the patient was vaccinated with 2 doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose/frequency, lot#, expire date and route were unknown) (extra dose administered) for prophylaxis. No adverse effects were reported. The outcome of extra dose administered and no adverse event was unknown.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: the patient was administered an improperly stored dose of PEDVAXHIB; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.      On 12-DEC-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # S006471 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 22-JAN-2022) for prophylaxis (strength, dose, anatomical location, and route of administration were not reported).  The dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), was exposed to a temperature excursion of 48.5 degrees Fahrenheit (°F) during a time frame of 1 hour, which was detected by the data logger. There was no prior temperature excursion.
Sex: U
Vaccine: FLU4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product packaging confusion, Wrong product administered
Clinical narrative: 9 months old patient gotten the Flublock quadrivalent instead of the Fluzone Quadrivalent, no advesre event; patient gotten the Flublock quadrivalent instead of the Fluzone Quadrivalent, no advesre event; the boxes and the syringes of these two vaccines were so similar; Initial information was received on 05-Nov-2019 regarding an unsolicited valid non-serious case from a physician.  This case involves a nine month old patient (gender not reported) who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] because the boxes and the syringes of these two vaccines were so similar (lot number and other dosing details were not reported).  Medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration, Product packaging confusion and wrong vaccine administered.  No adverse event was reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: fluzone Quad was delayed in transit with no AE.; fluzone Quad was delayed in transit with no AE.; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 85 patients of unknown demographics who were received quadrivalent influenza vaccine (Fluzone Quadrivalent), that was delayed in transit (Incorrect product storage and Product distribution issue).  The medical history, medical treatments, vaccinations and family history were not provided.  On unknown date, the patient received a 0.5 mL dose of suspect quadrivalent influenza vaccine [lot UT6695JA Expiry Date: 30-JUN-2020] via unknown route for Prophylactic vaccination.  It was a case of Incorrect product storage and Product distribution issue.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3, FLU4
Symptoms: Myalgia, Pain in extremity, Wrong product administered
Clinical narrative: rash on thighs; Patient took Fluzone Quadrivalent multidose vial  instead of prefilled syringe; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves patient who experienced rash on thighs (rash), while he/she received vaccines INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE]. The patient was asked to receive vaccine from a prefilled syringe (INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]) only.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious rash on thighs (rash) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It is also a case of actual medication error due to Wrong vaccine administered.  Other relevant tests were not reported.  Final diagnosis was rash on thighs and pain in lower legs.  It was not reported if the patient received a corrective treatment.  The patient outcome for the event rash on thighs and muscle aches was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok was given to a 16 months old/ no ae; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is a linked case with 2019SA331932 (same reporter)  This case involves a 16 months old patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] via unknown route and site of administration (lot number and expiry date not reported) on an 04-Nov-2019.  The patient's medical history, treatment(s) vaccination(s), family history not reported.  It was a case of actual medication error due to product administered to patient of inappropriate age.  At the time of report no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number of FLUBLOCK QUADRIVALENT was requested.