chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: DT, HPV9
Symptoms: Dizziness, Headache, Injection site pain, Pallor
Clinical narrative: Moderate dizzy/light headedness 5 minutes following injection, lasting 30 minutes. Lab technician reported patient presented with pale/white lips/face, looked like patient was going to pass out. Severe headache beginning 7 hours after injection, ongoing. Moderate soreness at injection site beginning 3 hours after injection, ongoing.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concomitant medication and drug reactions/allergies was not provided. On an unknown date, the reporter reported an alleged expired vial of GARDASIL 9 mixed in with a box of a different lot number (Product quality issue). On an unknown date, the patient inadvertently received the expired dose of GARDASIL 9 (lot# reported as N030380 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast); lot # M030380 with expiration date 01-FEB-2019; strength and dose detail were not reported) intramuscularly for prophylaxis (Expired vaccine used).  No adverse effects were reported. The outcome of product quality issue was unknown. The causality of product quality issue was not provided.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Information has been received from a physician via a field employee referring to a female patient of unknown age. The patient's current conditions, concomitant medication and medical history were not reported. On 08-FEB-2019, the patient was vaccinated with GARDASIL 9 (1 dosage form; route of administration, lot number and expiration date were unknown) for prophylaxis. On 14-FEB-2019, the patient developed an unspecified rash in an unspecified location. On 15-FEB-2019, the patient visited physician who prescribed diphenhydramine (BENADRYL). On 18-FEB-2019, the rash resolved. The causality between the event and GARDASIL 9 was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was from a consumer regarding himself, a male patient of unknown age. There was no information provided about the patient's concomitant medication, pertinent medical history and drug reactions/allergies. In approximately 2009 (reported as: "about 8 to 10 years ago"), the patient received a dose of ZOSTAVAX (strength, dose, route, anatomical site, lot number and expiration date not provided) subcutaneously for "shingles" (prophylaxis). On an unspecified date, the patient developed "shingles". There was no treatment given for the adverse event and no lab diagnostics/studies were performed. It was reported that the patient did not seek medical attention. The outcome of herpes zoster was reported as not recovered. There was no causality assessment provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and a female patient referring to herself. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The female patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2012, the patient was administered the ZOSTAVAX by a healthcare provider at a health center (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider at a health center for the following injury resulting from the ZOSTAVAX use: Shingles. The patient claims damages including: injury to self and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (dose, route, anatomical location, lot# and expiry date were not reported) together with flu shot (influenza virus vaccine (unspecified)) on the same arm for prophylaxis. On an unknown date in 2018, the patient experienced rash and it extended all over her arms for which she was hospitalized for a couple of days. It was reported that people in the Emergency Room marked the area and told her to come back if the rash extended beyond the marked site. The outcome of the event was unknown. Causality assessment was not reported.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site rash
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a 11-year-old male patient. 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 GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced rash at the injection area. The patient's mother sought medical attention via calling the office. The outcome of the event was reported as recovered on an unknown date. The causality assessment was not reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1903USA003143:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster - related conditions. On or about 2012, a pharmacist at a pharmacy administered the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) to the patient. On or about JUNE 2017, the patient was treated by a family nurse practitioner at a medical office for shingles. The patent was diagnosed with shingles and /or other zoster related injuries after and despite being inoculated with the ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); and other losses and damages.  The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist regarding to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # R027993, 01-OCT-2020) (Strength, dose, frequency, anatomical location and route were not reported) for prophylaxis. It was reported that the vaccine was exposed to a temperature of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (F) (-9 degree Celsius to 8 degree Celsius) (7C) for 6 days (144 hours). There was previous temperature excursion reported. No adverse symptoms were reported. No further information provided. No product quality complaint (PQC) was associated with this report.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to a currently 14 years old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates in 2018, (reported as on or after 24-OCT-2018), the patient was vaccinated with RECOMBIVAX HB lot # R004185, expiration date 06-NOV-2020 (dose number, anatomical location and route of administration were not provided) that was improperly stored. It was reported that the vaccine was exposed to a temperature below of 32 degrees Fahrenheit (30.7 F) for 15 hours and 45 minutes. There was a previous temperature excursion of 32 degrees Fahrenheit to 35 (33.2 F) for 27 hours. No adverse event reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1811USA004847.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of bell's palsy in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 30th October 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown. It was unknown if the reporter considered the bell's palsy to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist did not have SHINGRIX batch number and expiry date available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Injection site pain, Myalgia, Rash pruritic
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 9th November 2018, the patient received the 2nd dose of SHINGRIX. On 13th September 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, muscle pain and influenza like illness. On 10th November 2018, the patient experienced injection site pain, muscle pain and influenza like illness. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the outcome of the vaccination failure and itchy rash were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the injection site pain, injection site pain, muscle pain, muscle pain, influenza like illness and influenza like illness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, muscle pain, influenza like illness and itchy rash to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, muscle pain, influenza like illness and itchy rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The patient had his first shot in left arm. The patient experienced a sore arm at the injection site the following day after both shots. The patient also experienced muscle aches like the flu the following day after both shots. The symptoms last a day. Three weeks ago before the date of reporting, a rash developed on his left arm and left side. His doctor said it was a mild case of shingles. The rash also itches. A new area of a few spots just appeared on the date of reporting on the inside of his left elbow. The reporter gave consented to follow up. This case was considered as suspected vaccination failure as time to onset for the event was unknown. This case was linked to the case US2019040249, reported by same reporter.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On 9th November 2018, the patient received the 2nd dose of SHINGRIX. On 13th September 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, muscle pain and influenza like illness. On 10th November 2018, the patient experienced injection site pain, muscle pain and influenza like illness. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. On an unknown date, the outcome of the vaccination failure and itchy rash were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the injection site pain, injection site pain, muscle pain, muscle pain, influenza like illness and influenza like illness were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, muscle pain, influenza like illness and itchy rash to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, injection site pain, muscle pain, influenza like illness and itchy rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The patient had his first shot in left arm. The patient experienced a sore arm at the injection site the following day after both shots. The patient also experienced muscle aches like the flu the following day after both shots. The symptoms last a day. Three weeks ago before the date of reporting, a rash developed on his left arm and left side. His doctor said it was a mild case of shingles. The rash also itches. A new area of a few spots just appeared on the date of reporting on the inside of his left elbow. The reporter gave consented to follow up. This case was considered as suspected vaccination failure as time to onset for the event was unknown. This case was linked to the case US2019040249, reported by same reporter.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Dizziness, Nausea
Clinical narrative: Nausea, dizziness, and chest pain within 10 minutes of immunization.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Viral test
Clinical narrative: X4 vesicles on erythematous basse.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Angina pectoris
Clinical narrative: Angina.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Ophthalmic herpes zoster, Pain
Clinical narrative: He comes in today for follow-up of the shingles. He developed the shingles in the ophthalmic division of the trigeminal nerve about 48 hours ago and was started on valacyclovir yesterday. He states that this is really helped his symptoms and, he did go to see his ophthalmologist this morning. He has had no visual changes. He still does have discomfort as a result of the shingles that is periodic and would like something for the pain. Shingles (ICD10-CM B02.9). Course: Progressing as expected. Plan: I gave him a prescription for tramadol and recommended cool compresses. I also told him to take valacyclovir 1 g every 8 hours and gave him an additional prescription for this as well. He will continue following with the ophthalmologist in 2 days as they have requested and have asked him to call me in the meantime for any other problems or questions.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received on 05-MAR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 25-NOV-2008, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 12-OCT-2011, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 01-MAR-2019, the patient was vaccinated with a dose of VARIVAX (lot # R027993 with expiry date 01-OCT-2020) and a dose of PROQUAD (lot # R027988 with expiry date 30-MAR-2020) for prophylaxis (dose, strength, dose number, route unspecified) during the same office visit. A sterile diluent of lot # R033667, expiry date 14-JUN-2021 was used to reconstitute VARIVAX and PROQUAD. No adverse effect was reported. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: HEP
Symptoms: Influenza, Polyarthritis, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of polyarthritis in a male patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced polyarthritis (serious criteria GSK medically significant), fever and flu symptoms. On an unknown date, the outcome of the polyarthritis, fever and flu symptoms were recovered/resolved. It was unknown if the reporter considered the polyarthritis, fever and flu symptoms to be related to Hepatitis B vaccine. Additional details were reported as follows: This case was reported by the physician's assistant. The age at vaccination was not reported. The reporter thought, the patient previously received Hepatitis B vaccine over 10 years before the time of reporting. The call was transferred to medical information for additional questions. The reporter consented to follow up. This case has been linked with case US2019040212, reported by the same reporter.
Sex: M
Vaccine: HEP
Symptoms: Blood test, Influenza, Polyarthritis, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of polyarthritis in a male patient who received ENGERIX B adult for prophylaxis. On 14th February 2019, the patient received ENGERIX B adult. On 16th February 2019, 2 days after receiving ENGERIX B adult, the patient experienced polyarthritis (serious criteria GSK medically significant), fever and flu symptoms. The patient was treated with ibuprofen. On an unknown date, the outcome of the polyarthritis, fever and flu symptoms were recovered/resolved. The reporter considered the polyarthritis and fever to be related to ENGERIX B adult. It was unknown if the reporter considered the flu symptoms to be related to ENGERIX B adult. Additional details were reported as follows: This case was reported by the physician's assistant. The age at vaccination was not reported. On Thursday 3 weeks before the time of reporting, the patient received a dose of ENGERIX B adult. Forty eight hours after vaccination, the patient experienced flu symptoms as low grade fever and polyarthritis for 24 hours. It was returned about 2:00 to 3:00pm every day at night. The only thing that helps was ibuprofen. The patient seen a physician this afternoon to had blood work drawn. The emergency room visit required. The call was transferred to medical information for additional questions. The reporter consented to follow up. This case has been linked with case US2019GSK043898, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold sores (usually in winter). On 28th February 2019, the patient received SHINGRIX (intramuscular). On 28th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 5th March 2019, the patient experienced cold sores. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the cold sores was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and cold sores to be related to SHINGRIX. Additional details were provided as follows: The patient experienced sore arm for couple days and also developed cold sores after receiving SHINGRIX vaccine.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Feeling abnormal, Irritability, Nasal congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, runny/stuffy nose, clingy and cranky, drowsy and generally not herself.
Age: 0.58
Sex: F
Vaccine: DTAP
Symptoms: Somnolence
Clinical narrative: Fever, runny/stuffy nose, clingy and cranky, drowsy and generally not herself.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Influenza like illness, Muscular weakness, Paraesthesia, Pyrexia
Clinical narrative: Developed flu like symptoms, chills, fever, muscle weakness, arm tingling lasting one week.
Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Dizziness, Nausea, Pallor, Unresponsive to stimuli
Clinical narrative: Child with mother here for travel vaccines. Mother states had fainted previously when leaving MD office for a vaccine years ago. Discussed vaccines to be administered and gave Flu/Meningitis and within approximately 45 seconds to one minute child was pale and not responding to commands. Ice pack applied to back of the neck NP as well as PHN assisted B/P 60/40 and HR 40 approximately 5 minutes after vaccination within 13 minutes Blood pressure was 112/68 and Heart rate 64 and child responded to commands yet had felt nausea and dizziness which resolved within 30 minutes.
Age: 28.0
Sex: M
Vaccine: HEPA
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Patient received Hep A vaccine today at 1300. Pt came to medical clinic 4 hours later with welts/hives to head, chest, back and arms. Appears as allergic reaction from vaccine. Provider contacted, new orders for Benadryl 100mg po now and Benadryl 50 mg po bid x 5 days. Pt for welfare check in 4 hours. Pt denies any shortness of breath or difficulty swallowing.
Age: 24.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site induration, Injection site pain, Pain
Clinical narrative: Phone call from patient's wife at 11:10 AM saying her husband can't lift both arms and they are very painful. Patient's EMR office visit notes of 2-28-19: History of Present Illness: Onset: 1 day ago.  Severity level is 8. It occurs constantly and is fluctuating. Location: bilateral shoulder. There is no radiation. The pain is aching and throbbing. The pain is aggravated by movement. There are no relieving factors. Associated symptoms include decreased mobility, nocturnal pain and swelling.  Additional information: received Tdap and flu vaccines in shoulders and having severe pain from injection site. Physical Exam: Body areas examined left and right upper extremities: tenderness with slight hardness of bilateral upper arms in conjuncture with previous injections sites, extreme tender to touch, no redness, not warm to touch, no streaks. Soft tissue discomfort noted in the left and right anterior and posterior shoulders. Assessment/Plan: Pain in both upper extremities. Toradol 60 mg IM given in office. Take ibuprofen every 6 - 8 hours for pain. Apply heat and ice to area, massage area as able. Discussed signs and symptoms to go to ER for cellulitis. 3-12-19 @ 11:29  I called to see how pt's arms are doing in preparation of filing a VEARS report re: bilateral arm pain after receiving immunizations (Tdap in right arm & IIV4 & PPSV23 both in left arm).  I talked to the pt's wife, pt was not available. She said his right arm is back to normal. His left arm is still slightly tender when he massages it, still some warmth; but much improved. She said he is not taking any pain relievers.
Age: 24.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Pain in extremity, Skin warm, Swelling, Tenderness
Clinical narrative: Phone call from patient's wife at 11:10 AM saying her husband can't lift both arms and they are very painful. Patient's EMR office visit notes of 2-28-19: History of Present Illness: Onset: 1 day ago.  Severity level is 8. It occurs constantly and is fluctuating. Location: bilateral shoulder. There is no radiation. The pain is aching and throbbing. The pain is aggravated by movement. There are no relieving factors. Associated symptoms include decreased mobility, nocturnal pain and swelling.  Additional information: received Tdap and flu vaccines in shoulders and having severe pain from injection site. Physical Exam: Body areas examined left and right upper extremities: tenderness with slight hardness of bilateral upper arms in conjuncture with previous injections sites, extreme tender to touch, no redness, not warm to touch, no streaks. Soft tissue discomfort noted in the left and right anterior and posterior shoulders. Assessment/Plan: Pain in both upper extremities. Toradol 60 mg IM given in office. Take ibuprofen every 6 - 8 hours for pain. Apply heat and ice to area, massage area as able. Discussed signs and symptoms to go to ER for cellulitis. 3-12-19 @ 11:29  I called to see how pt's arms are doing in preparation of filing a VEARS report re: bilateral arm pain after receiving immunizations (Tdap in right arm & IIV4 & PPSV23 both in left arm).  I talked to the pt's wife, pt was not available. She said his right arm is back to normal. His left arm is still slightly tender when he massages it, still some warmth; but much improved. She said he is not taking any pain relievers.
Age: 13.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Injection site extravasation, Muscle tightness, Underdose
Clinical narrative: This spontaneous report was received from a nurse, referring to a 13-year-old female. Information about her historical conditions, drug reactions or allergies and concomitant medications were not provided. On 28-FEB-2019, the patient was vaccinated in a private doctor's office/hospital with second dose of GARDASIL 9 by intramuscular route, in the right deltoid, for prophylaxis, lot number N026814 and expiration date 15-JUL-2020, but a nurse was pulled out the needle out, therefore, some of liquid shot out. The reporter mentioned that she felt that the patient did not get the full dose, she was removing the needle from the injection site and after the complete removal, the fluid shot out of the arm (underdose), subsequently she cleaned the side of injection and applied a band aid. However, it was confirmed with the nurse that none of the vaccine got on the patient or the nurse's skin. It was reported that the patient was anxious during the vaccination and that the deltoid was very tense. Also, it was reported that during the same day, the patient was vaccinated with first dose of VAQTA by intramuscular route, in the left arm, for prophylaxis, lot number R013515 and expiration date 30-MAY-2019 and fourth dose of INFECTOVAC FLU, by intramuscular route, in the left arm, for prophylaxis and lot number 4DY9K (expiration date were not reported). No adverse effects were reported. There was no Digital Data Logger involved.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin burning sensation
Clinical narrative: Information regarding a case in litigation was received from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 25-SEP-2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). "Shortly after" receiving the ZOSTAVAX vaccine, the patient suffered a painful rash on her scalp and was diagnosed with shingles. The patient continued to suffer from pain and/or burning sensations in her scalp following the outbreak requiring additional care and treatment. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due the resulting physical limitations and the seriousness of the patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of live, physical impairment and injury. As a direct and proximate result of ZOSTAVAX, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the shingles was considered to be not recovered. Shingles was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of allergy in a 69-year-old female patient who received Hepatitis B vaccine for prophylaxis. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown. It was unknown if the reporter considered the allergy to be related to Hepatitis B vaccine. Additional details were reported as follows: The age at vaccination was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of rash in a adult male patient who received 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 rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 66 or 67 years of age. The batch number was not reported. The doctor reported that about a week ago the patient received SHINGRIX and developed a rash. The rash was treated with Benadryl and has resolved. The injection was administered at a local pharmacy and not at the doctor's office. Because of this the doctor did not have the batch number or the exact date of administration.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever and general body pain. The patient was treated with ibuprofen (Motrin Ib). On an unknown date, the outcome of the fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were reported as follows: The pharmD reported that the reporters cousin, experienced high fever and body aches following SHINGRIX which he received about 2 months before the date of reporting. The symptoms were delayed occurring that night after 9pm following the injection earlier that day. The reporter was unsure how long the symptoms lasted but they had since resolved. The patient treated these symptoms with motrin or ibuprofen. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Product preparation issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of chills in a 60-year-old female patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 5th March 2019, the patient received SHINGRIX. On 5th March 2019, unknown after receiving SHINGRIX, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 6th March 2019, the patient experienced chills. On an unknown date, the outcome of the chills, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced chills 1 day after receiving ASO1B liquid adjuvant only portion of SHINGRIX, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reported batch number 465HX for SHINGRIX did not exist and was updated to 4G5HX as per the sales database.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of unwell in a adult patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 6th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. Nurse on the line reporting patients received their first SHINGRIX the day before reporting and got very ill. The reporter declined to provide patient details or any further information, would just like her question addressed.   No further information captured.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Allergy to vaccine, Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician. A 70-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) at a single dose and influenza vaccine (FLU) at an unspecified dose; both via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergies: flu vaccine, pneumococcal 13-valent conjugate vaccine, penicillins and sulfa drugs on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An adult female patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported redness and pain at the injection site and up to 5 inches away from the injection site. The outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: F
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves female patient (age unknown) who received vaccine ACT-HIB. The patients past medical history, concomitant medication and family history were not provided. On 07-Dec-2018, the patient received a first dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site. On 28-Feb-2019 she also received a second dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. It was an actual medication error due to inappropriate schedule of vaccine administered. It was reported that patient was administered the first ACTHIB on 07-Dec-2018 and the second on 28-Feb-2019. The reporter nurse stated that patient was given the vaccination earlier than the recommended intervals. It was unknown whether adverse event occurred after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2019SA066981 (same reporter). This case involves a 9 years old female patient who received a 0.25 mL dose of vaccine FLUZONE QUADRIVALENT (lot number, expiry date, dose in series and route was not reported) in the left arm on 05-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient did not receive any concomitant vaccines. It was a case of actual medication error due to vaccine underdose. It was unknown whether the adverse event occurred or not after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 07-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case is linked to case 2019SA066972, same reporter. This case involves a 15-years-old female patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 05-Mar-2019, the patient received a 0.25ml dose of pediatric prefilled of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date not reported via unknown route in the arm nos. It was a case of actual medication error due to vaccine underdose. It was reported that patient was administered pediatric prefilled FLUZONE QUADRIVALENT 0.25 mL in error to a 15-year-old. It was unknown whether adverse event occurred after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling cold, Feeling hot, Pain
Clinical narrative: Patient  states that the first SHINGRIX vaccine given on 8/14/2018 also given him a flu like symptoms effect - low temperature & shivers after 5-6 hrs when vaccine was given but did not reveal info at the time of the second immunization. The 2nd SHINGRIX dose  on 2/5/2019 patient state he thought it was given too high on his arm that causes more pain (excruciating) per patient in the first 15 hours and he experience cold feeling waist down and very hot feeling waist down but he also mention no flu symptoms. Per patient  the pain lasted for 3 days but he totally recovered at this time.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Blister, Hypersensitivity, Insomnia, Rash
Clinical narrative: On February 23, 2019, I woke up with a rash that started on top of my right thigh and left thigh. More red bumps on my right thigh. Went to see dr on Feb. 27, 2019, and she prescribed Medrol dose pak with atarax. The rash did not improve and in fact within 2 days was spreading to other parts of body, to the back of both arms, got worse on my right thigh, started itching terribly, could not relieve the itch with meds. Had to use ice to the rash on thigh and elsewhere to try and keep from scratching. I finished the Medrol dose pak on March 4, 2019.  The rash continued to increase in size on right thigh with whelps, and a vesicle showing on one of the bumps, spread more to both lower legs, back of arms, to my belly, to my hips, and increasing with itching and could not sleep because of itching and atarax did not relieve it. Went back to Dr on Friday, March 8, 2019. She did not know what is causing the rash. She thought in the beginning as I did that it might some kind of allergic reaction to maybe detergent or soap. I changed my detergent and soap and lotion to everything unscented without preservatives. Rash did not improve and got worse. Dr referred me to my dermatologist Dr. I saw Dr  on March 11, 2019. He said he did not think that the rash was shingles but he did think that since other things had been ruled out that the rash was a reaction to the SHINGRIX and stated that it was showing that the vaccine was working in my body and my immune system was fighting the vaccine by the allergic reaction to it. He prescribed prednisone 30 mg for 5 days; Prednisone 20 mg for 5 days. Atarax for itching. Also TMC cream to put on rash. I did not run a fever. Today is March 12, 2019, the rash is still present so far after one dose of Prednisone. I am to call Dr tomorrow if rash not improving. The rash is very itchy still and especially at night it is worse and keeps me awake.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rheumatoid factor negative, Urticaria
Clinical narrative: On February 23, 2019, I woke up with a rash that started on top of my right thigh and left thigh. More red bumps on my right thigh. Went to see dr on Feb. 27, 2019, and she prescribed Medrol dose pak with atarax. The rash did not improve and in fact within 2 days was spreading to other parts of body, to the back of both arms, got worse on my right thigh, started itching terribly, could not relieve the itch with meds. Had to use ice to the rash on thigh and elsewhere to try and keep from scratching. I finished the Medrol dose pak on March 4, 2019.  The rash continued to increase in size on right thigh with whelps, and a vesicle showing on one of the bumps, spread more to both lower legs, back of arms, to my belly, to my hips, and increasing with itching and could not sleep because of itching and atarax did not relieve it. Went back to Dr on Friday, March 8, 2019. She did not know what is causing the rash. She thought in the beginning as I did that it might some kind of allergic reaction to maybe detergent or soap. I changed my detergent and soap and lotion to everything unscented without preservatives. Rash did not improve and got worse. Dr referred me to my dermatologist Dr. I saw Dr  on March 11, 2019. He said he did not think that the rash was shingles but he did think that since other things had been ruled out that the rash was a reaction to the SHINGRIX and stated that it was showing that the vaccine was working in my body and my immune system was fighting the vaccine by the allergic reaction to it. He prescribed prednisone 30 mg for 5 days; Prednisone 20 mg for 5 days. Atarax for itching. Also TMC cream to put on rash. I did not run a fever. Today is March 12, 2019, the rash is still present so far after one dose of Prednisone. I am to call Dr tomorrow if rash not improving. The rash is very itchy still and especially at night it is worse and keeps me awake.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Generalised erythema, Pain in extremity, Urticaria, Vomiting
Clinical narrative: Within 10 mins of injections, 11:05. patient started coughing to the point of almost puking. Very wet sounding. He then started to yell his feet hurt and pulled his shoes off to start scratching. Within another 5 minutes his entire body was red and covered in hives. Took him to ER and they gave him epinephrine at 12:07, dexamethasone (Decasron) at 12:15, Diphenhydramine (Benadryl) at 12:14 and famotidine (pepcid) at 1:14.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Approx. 3 hrs after vaccine administration, Mom describes patient as non-stop screeching. This lasted from approx. 1 pm to 7 pm.