chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Eye swelling, Injection site swelling, Local reaction, Pruritus, Swelling face
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Anaphylactic reaction, Eye swelling, Injection site induration, Injection site swelling, Injection site urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Lip swelling, Swelling face, Swollen tongue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Anaphylactic reaction, Eye swelling, Hypersensitivity, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged.
Age: 19.0
Sex: M
Vaccine: MENB, MENB, MENB
Symptoms: Injection site urticaria, Laryngeal oedema, Lip swelling, Swelling face, Swollen tongue
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of anaphylactic reaction in a 19-year-old male patient who received BEXSERO (batch number 166801A, expiry date 31st May 2017). On 13th March 2017, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 13th March 2017, less than a day after receiving BEXSERO, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling. The patient was treated with prednisone. On an unknown date, the outcome of the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling were unknown. It was unknown if the reporter considered the anaphylactic reaction, injection site hives, injection site induration, injection site swelling, swollen tongue, lip swelling, eye swelling and facial swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on the left deltoid. On 13th March 2017, in the evening, the patient began to have a reaction which began initially as hives, then progressed to an anaphylactic reaction. The patient had swelling of the tongue, lips, eyes and face. The patient also had swelling, hardness, and hives at the injection site. On the same date, the patient was seen in the emergency room, treated with Prednisone, and discharged.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Headache, Myalgia, Pyrexia
Clinical narrative: Patient has Headaches muscle aches weakness and low grade fever.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus, Nausea
Clinical narrative: Patient experienced a golf ball sized red area at injection site which grew the next day to the size of a baseball which was slightly tender and itchy; also complained of nausea and chills; advised to take Benadryl, unknown if actually taken.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient experiencing softball sized red area at injection site that is tender to touch; Benadryl recommended, unknown if taken.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Skin discolouration
Clinical narrative: Tingling on upper part of back, looks like a semi light brown patch, no pain, no fever, no aches. nothing has been used.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Severe debilitating neck, shoulder, arm and finger pain. Patient could not find a comfortable position to lie in. Patient took Ibuprofen and symptoms subsided by morning.
Age: 46.0
Sex: F
Vaccine: PER
Symptoms: Erythema, Pain, Rash, Swelling
Clinical narrative: Swelling and pain for the first 2 days. Rash and some swelling and redness after that. 26th and still have it.
Sex: M
Vaccine: MENB
Symptoms: Headache, Injection site pain, Malaise, Nausea, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, 5 days after receiving BEXSERO, the patient experienced nausea, feeling unwell, vomiting, headache and injection site pain. On an unknown date, the outcome of the nausea, feeling unwell, vomiting, headache and injection site pain were unknown. The reporter considered the nausea, feeling unwell, vomiting and headache to be possibly related to BEXSERO. The reporter considered the injection site pain to be related to BEXSERO. Additional details were reported as follows: This case was not previously reported to anyone. This case was reported by the patient's mother. The patient's age at the time of reporting was 18 years. The age at vaccination was not reported. The mother reported the patient did not have any allergies and reaction to any vaccine in the past. The information captured was from the comments provided by the patient's mother, related to whether her son experienced a reaction to BEXSERO or caught an illness unrelated to the vaccine. It was not clear on which arm the patient received the vaccine. The arm hurting happened on the same day as the vaccination, date was not provided by the reporter. The patient had denied the permission to contact his physician. The mother declined to provide information for report. The mother was questioning whether the patient would experience this again and she was referred to her son's healthcare provider for discussion.
Sex: U
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced swelling in the arm like an abscess for one week. The patient received the second dose. This case is one of the 3 cases reported by the same reporter for 3 different patients.
Sex: U
Vaccine: MENB
Symptoms: Incomplete course of vaccination, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a patient who received BEXSERO (batch number unknown, expiry date unknown). On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm. The patient was treated with antibiotics. On an unknown date, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced swelling in the arm like an abscess for one week and was treated with antibiotics. The patient refused the second dose.
Sex: U
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a patient who received BEXSERO (batch number unknown, expiry date unknown). On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm. The patient was treated with antibiotics nos. On an unknown date, the outcome of the swelling arm was recovered/resolved. It was unknown if the reporter considered the swelling arm to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced swelling in the arm like an abscess for one week. The patient received the second dose. This case is one of the 3 cases reported by the same reporter for 3 different patients.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a patient who received MENVEO. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, an unknown time after receiving MENVEO the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown. The reporter considered the injection site erythema and injection site rash to be possibly related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. The reporting sales representative stated that the office manager reported excessive redness and rash at injection site for a patient between the age of 10 and 16 years old.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Eyelid operation, Guillain-Barre syndrome, Lumbar puncture abnormal, Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of Guillain Barre syndrome in a adult male patient who received BEXSERO. On 14th August 2016, the patient received the 1st dose of BEXSERO. On an unknown date, several weeks after receiving BEXSERO, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was unknown. The reporter considered the Guillain Barre syndrome to be probably related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. At the time of reporting, the patient was 18 years. The patient never received the second dose of BEXSERO. The patient became sick within a few weeks after the first dose. The Guillain Barre syndrome was confirmed with a lumbar puncture and the patient required eyelid surgery.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Death
Clinical narrative: Initial unsolicited report received from a nurse on 13-Mar-2017. This case involves a two-month-old female patient, who was vaccinated with first dose of IPOL (batch number: N1A451M, expiry date, route and dose not reported) in left thigh and with first dose of DAPTACEL (batch number: C5101AA, expiry date, route and dose not reported) in left thigh and with first dose of HAEMOPHILUS TYPE B (HIB) VACCINE (HIB) (manufacturer: unknown) (batch number: U510AAA, expiry date, route and dose not reported) in left thigh and with first dose of PREVNAR (manufacturer: Wyeth) (batch number: N05078, expiry date, route and dose not reported) in right thigh and with first dose of ROTAVIRUS VACCINE (ROTAVIRUS) (manufacturer: Wyeth) via oral route (batch number: M005733, expiry date and dose not reported) and with second dose of HEPATITIS B VACCINE (HEP B) (manufacturer: MERCK) (batch number: M019671, expiry date, route and dose not reported) in right thigh on 18-Jan-2017. The patient was vaccinated at private doctor's office/hospital with public funds. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagonosed allergies, birth defects, medical conditions were also reported as none. Patient's concomitant medication was not reported. On 21-Jan-2017, three days after the vaccination, patient passed away (died) (date of death was also reported as 22-Jan-2017). The patient previously vaccinated with first dose of HEPATITIS B VACCINE (HEP B) (manufacturer: MERCK) (batch number: M010671, expiry date, route and dose not reported) in left thigh on 21-Nov-2016. Lab test and concomitant medication was not reported. It was not reported whether autopsy was done or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 2-months-old female who died 4 days after receiving a first dose of DTaP, IPV, Hib, pneumococcal, rotavirus and hepatitis b vaccines. Reportedly the patient had no illness at the time of vaccination and no relevant medical history. Cause of death, and the sequence of events during the 3 days between vaccination date and onset of adverse events (not further specified) were not reported. No information is also provided on conditions at the time of death, sleeping position, autopsy and results of investigations, etc. This case of unexplained death is insufficiently documented to draw a conclusion on a relationship with vaccines administration. Reported Cause(s) of Death: Infant passed away.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Autopsy, Death, Vomiting
Clinical narrative: Initial unsolicited report received from a nurse on 13-Mar-2017. This case involves a two-month-old female patient, who was vaccinated with first dose of IPOL (batch number: N1A451M, expiry date, route and dose not reported) in left thigh and with first dose of DAPTACEL (batch number: C5101AA, expiry date, route and dose not reported) in left thigh and with first dose of HAEMOPHILUS TYPE B (HIB) VACCINE (HIB) (manufacturer: unknown) (batch number: U510AAA, expiry date, route and dose not reported) in left thigh and with first dose of PREVNAR (manufacturer: Wyeth) (batch number: N05078, expiry date, route and dose not reported) in right thigh and with first dose of ROTAVIRUS VACCINE (ROTAVIRUS) (manufacturer: Wyeth) via oral route (batch number: M005733, expiry date and dose not reported) and with second dose of HEPATITIS B VACCINE (HEP B) (manufacturer: MERCK) (batch number: M019671, expiry date, route and dose not reported) in right thigh on 18-Jan-2017. The patient was vaccinated at private doctor's office/hospital with public funds. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagonosed allergies, birth defects, medical conditions were also reported as none. Patient's concomitant medication was not reported. On 21-Jan-2017, three days after the vaccination, patient passed away (died) (date of death was also reported as 22-Jan-2017). The patient previously vaccinated with first dose of HEPATITIS B VACCINE (HEP B) (manufacturer: MERCK) (batch number: M010671, expiry date, route and dose not reported) in left thigh on 21-Nov-2016. Lab test and concomitant medication was not reported. It was not reported whether autopsy was done or not. Documents held by sender: none. Sender's Comments: This is a poorly documented death case of a 2-months-old female who died 4 days after receiving a first dose of DTaP, IPV, Hib, pneumococcal, rotavirus and hepatitis b vaccines. Reportedly the patient had no illness at the time of vaccination and no relevant medical history. Cause of death, and the sequence of events during the 3 days between vaccination date and onset of adverse events (not further specified) were not reported. No information is also provided on conditions at the time of death, sleeping position, autopsy and results of investigations, etc. This case of unexplained death is insufficiently documented to draw a conclusion on a relationship with vaccines administration. Reported Cause(s) of Death: Infant passed away.
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Pain in extremity
Clinical narrative: Per client (dated 3/23/2017) I had flu shot on the second of November 2016. Since then, my upper arm gradually increases pain when the arm moves at certain directions. Now pain is serious so that it is difficult to put on cloth and it is painful when I sleep on left arm. MRI shows some issue but my doctor cannot find root cause. I research this subject on website. It looks to me there are tons of discussions on the upper arm pain due to flu shot. Please advise me what to do. Do I need contact with flu shot provider for this? Thank you in advance!
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Pain in extremity
Clinical narrative: Per client (dated 3/23/2017) I had flu shot on the second of November 2016. Since then, my upper arm gradually increases pain when the arm moves at certain directions. Now pain is serious so that it is difficult to put on cloth and it is painful when I sleep on left arm. MRI shows some issue but my doctor cannot find root cause. I research this subject on website. It looks to me there are tons of discussions on the upper arm pain due to flu shot. Please advise me what to do. Do I need contact with flu shot provider for this? Thank you in advance!
Age: 57.0
Sex: M
Vaccine: FLUX, FLU4, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Per client (dated 3/23/2017) I had flu shot on the second of November 2016. Since then, my upper arm gradually increases pain when the arm moves at certain directions. Now pain is serious so that it is difficult to put on cloth and it is painful when I sleep on left arm. MRI shows some issue but my doctor cannot find root cause. I research this subject on website. It looks to me there are tons of discussions on the upper arm pain due to flu shot. Please advise me what to do. Do I need contact with flu shot provider for this? Thank you in advance!
Age: 50.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Monoplegia, Muscular weakness, Pain in extremity
Clinical narrative: Both my husband and I were vaccinated with the Hepatitis B Vaccine and started to have an insidious reaction about two weeks later. On February 13 I woke up with severe neck, shoulder and arm pain and a partially paralyzed upper left arm. My husband had similar symptoms that began a bit earlier and are still active. I have been diagnosed with Parsonage Turner Syndrome.
Age: 50.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Blood test, Computerised tomogram, Electromyogram, Injection site reaction, Monoplegia
Clinical narrative: Both my husband and I were vaccinated with the Hepatitis B Vaccine and started to have an insidious reaction about two weeks later. On February 13 I woke up with severe neck, shoulder and arm pain and a partially paralyzed upper left arm. My husband had similar symptoms that began a bit earlier and are still active. I have been diagnosed with Parsonage Turner Syndrome.
Age: 50.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Musculoskeletal pain, Neck pain, Neuralgic amyotrophy, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Both my husband and I were vaccinated with the Hepatitis B Vaccine and started to have an insidious reaction about two weeks later. On February 13 I woke up with severe neck, shoulder and arm pain and a partially paralyzed upper left arm. My husband had similar symptoms that began a bit earlier and are still active. I have been diagnosed with Parsonage Turner Syndrome.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms, fever, fatigue, muscle aches and pains, headache, tiredness, blocked sinuses, chills. Took pain relief and congestion tablets, slept. Chills, fever and headaches still persisting up to today 03/26/2017.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Sinus congestion
Clinical narrative: Flu like symptoms, fever, fatigue, muscle aches and pains, headache, tiredness, blocked sinuses, chills. Took pain relief and congestion tablets, slept. Chills, fever and headaches still persisting up to today 03/26/2017.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site rash, Pain in extremity
Clinical narrative: Localized Rash medial to injection site on L. Deltoid. Bruising at injection site on L. Deltoid. General Left arm soreness. Symptoms occurred 24-48 hours post-vaccination.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Infection, Swelling
Clinical narrative: Swelling with infection.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 01-MAR-2017, the patient was vaccinated with a dose of M-M-R II that was reconstituted with sterile water (reported as "which was not a DILUENT of Merck") (product use issue) for prophylaxis, (dose, frequency, route, lot number and expiration date were not provided), therapy type (HSA). No adverse effect were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Adverse event, Hepatitis B antibody positive
Clinical narrative: This spontaneous report was received from a 58 year-old male physician referring to himself. The patient did not have concurrent conditions, medical history, drug reactions or allergies or concomitant medications. On an unspecified dates in 1986 and 1987, the patient was vaccinated with 3 doses of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) injection (dose, frequency, route, lot # and expiration date were not reported), for prevention of hepatitis B. On an unspecified date in March 2015 (reported as "2 years ago"), the patient had a hepatitis B titer test with "positive titers" as result. The outcome of the adverse event was unknown. No product quality complaint was involved (PQC). The causality between the adverse event and Hepatitis B Vaccine (Recombinant) (manufacturer unknown) was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not provided. The patients were vaccinated with the following improperly stored doses of VARIVAX (dose and route unknown) for prophylaxis: on 30-JAN-2017, 1 doses with lot# M030138 and expiration date 15-JUN-2018, 2 doses with lot# M033214 and expiration date 13-JUL-2018; on 31-JAN-2017, 1 dose with lot# M033214 and expiration date 13-JUL-2018, 1 dose with M009764 with expiration date 23-FEB-2018; on 01-FEB-2017, 1 doses with lot# M030138 and expiration date 15-JUN-2018, 1 dose with lot# M033214 and expiration date 13-JUL-2018, 1 dose with M027344 with expiration date 01-JUN-2018; 02-FEB-2017, 4 doses with lot# M030138 and expiration date 15-JUN-2018; 03-FEB-2017, 2 dose with lot# M030138 and expiration date 15-JUN-2018, 1 dose with M009764 with expiration date 23-FEB-2018, 1 dose with lot#M027344 with expiration date 01-JUN-2018; on 06-FEB-2017, 2 dose with lot# M030138 and expiration date 15-JUN-2018; on 07-FEB-2017, 2 dose with lot# M030138 and expiration date 15-JUN-2018; on 09-FEB-2017, 3 dose with lot# M030138 and expiration date 15-JUN-2018; on 10-FEB-2017, 2 dose with lot# M030138 and expiration date 15-JUN-2018; on 13-FEB-2017, 1 dose with lot# M030138 and expiration date 15-JUN-2018; on 14-FEB-2017, 1 dose with lot# M030138 and expiration date 15-JUN-2018, 2 dose with lot# M033214 and expiration date 13-JUL-2018; on 15-FEB-2017, 1 dose with lot# M033214 and expiration date 13-JUL-2018, 1 dose with lot#M030138 with expiration date 15-JUN-2018; on 16-FEB-2017, 2 dose with lot# M033214 and expiration date 13-JUL-2018; on 17-FEB-2017, 2 dose with lot#M033124 with expiration date 13-JUL-2018. The temperature excursions that VARIVAX experienced were as follows: lot# M030138 with expiration date 15-JUN-2018, lot# M033214 with expiration date 13-JUL-2018 and lot# M009764 with expiration date 23-FEB-2018, at -3 to 61 degrees Fahrenheit (F) for 27.5 hours on 28-JAN-2017 and at -11 to 48 degrees F for 4 hours on 17-FEB-2017. It was also reported that the vaccine also experienced the following temperature excursion previously: > 14 but < 46 degrees F (>-10 but < 8 degrees Centigrade (C)) for 23 hours 30 minutes; also: >46 but < 77 degrees F (>8 but < 25 degrees C) for 12 hours 45 minutes. This is one of two reports received from the same reporter. Additional information is not expected as there is no consent to contact the reporter. Sender's Comments: US-009507513-1702USA010259.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II injection, lot number M011666; expiration date: 08-MAR-2018, lot number M032485; expiration date: 06-JUL-2018, lot number M035388; expiration date: 05-DEC-2018 or lot number M035389; expiration date: 02-AUG-2018 (strength, dose and route of administration were not reported) for prophylaxis. The temperature excursion with M-M-R II was 30 minutes between 9 to 25 Celsius degrees. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of three cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005140: US-009507513-1703USA009374: US-009507513-1703USA009372.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection, lot number L018503; expiration date 16-MAR-2017, lot number M036728; expiration date: 20-MAY-2018, lot number M037669; expiration date: 09-MAY-2018, lot number M042599; expiration date: 17-JUN-2018, or lot number M042785; expiration date: 17-JUN-2018 (strength, dose and route of administration were not reported) for prophylaxis. The temperature excursion with PNEUMOVAX 23 was 30 minutes between 9 to 25 Celsius degrees. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA009373: US-009507513-1703USA005140: US-009507513-1703USA009372.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Vaccination error
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 21-MAR-2017, the patient was inadvertently vaccinated with ZOSTAVAX lot # L012478 with expiration date on 10-JUL-2016 (anatomical route of vaccination was not provide) for prophylaxis. No adverse events were suffered due to the vaccination and no product quality issue was involved. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Blood test, Erythema, Peripheral swelling, Pruritus, Skin burning sensation
Clinical narrative: Left lower leg has swollen up to about twice normal size, has turned red like a harsh sunburn, feels like a harsh sunburn.
Age: 66.0
Sex: M
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Ultrasound scan, Urticaria
Clinical narrative: Left lower leg has swollen up to about twice normal size, has turned red like a harsh sunburn, feels like a harsh sunburn.
Age: 66.0
Sex: M
Vaccine: DTAP, FLUX, HEPAB, TD, FLU3, HEPAB, TDAP, DTAP, FLUX, HEPAB, TD
Symptoms: Blood test, Cellulitis, Myalgia, Ultrasound scan
Clinical narrative: Left lower leg has swollen up to about twice normal size, has turned red like a harsh sunburn, feels like a harsh sunburn.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Syncopal episode.
Age: 44.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Severe pain in upper left shoulder.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Asthenia, Balance disorder, Blood test, Bradyphrenia, Clumsiness
Clinical narrative: Began dragging left foot/loss of muscle tone - pronated arms and feet - extreme mood changes - sudden pneumonia - refractory seizures - vitamin D depleted - speech changed - core weakness - slower processing - somnolence - hyper metabolic temporal lobes - clumsiness/constant falling - loss of balance.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Electroencephalogram, Fall, Gait disturbance, Hypermetabolism, Hypotonia
Clinical narrative: Began dragging left foot/loss of muscle tone - pronated arms and feet - extreme mood changes - sudden pneumonia - refractory seizures - vitamin D depleted - speech changed - core weakness - slower processing - somnolence - hyper metabolic temporal lobes - clumsiness/constant falling - loss of balance.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hypovitaminosis, Mood altered, Pneumonia, Positron emission tomogram, Posture abnormal
Clinical narrative: Began dragging left foot/loss of muscle tone - pronated arms and feet - extreme mood changes - sudden pneumonia - refractory seizures - vitamin D depleted - speech changed - core weakness - slower processing - somnolence - hyper metabolic temporal lobes - clumsiness/constant falling - loss of balance.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Seizure, Somnolence, Speech disorder
Clinical narrative: Began dragging left foot/loss of muscle tone - pronated arms and feet - extreme mood changes - sudden pneumonia - refractory seizures - vitamin D depleted - speech changed - core weakness - slower processing - somnolence - hyper metabolic temporal lobes - clumsiness/constant falling - loss of balance.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Discomfort, Impaired work ability, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Loss of strength and mobility in arm. Shooting pain when used. Pressure and loss of strength in wrist. Severe pain at night unable to rest, unable to perform daily tasks, for the last 10 days. Have been off work due to inability to function!
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Restlessness
Clinical narrative: Loss of strength and mobility in arm. Shooting pain when used. Pressure and loss of strength in wrist. Severe pain at night unable to rest, unable to perform daily tasks, for the last 10 days. Have been off work due to inability to function!
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Respiratory syncytial virus infection, Respiratory syncytial virus test positive, Streptococcus test negative
Clinical narrative: Febrile seizure activity within 7 days of receiving MMR vaccination, also diagnosed with RSV.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra HPV vaccine was given after patient had already received 3 doses.
Age: 4.0
Sex: M
Vaccine: DTPIPV, MMRV
Symptoms: Injection site rash
Clinical narrative: Rash around injection site. No fever. No C/O itchiness.
Age: 30.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Large, red rash developed which is warm to the touch and itchy. The area measures 4inx2in where vax was given.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Pain in extremity, Swelling
Clinical narrative: REDNESS, SWELLING AND PAIN IN RIGHT ARM; NAUSEA; PALPITATIONS; DIFFICULTY BREATHING.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: Death; patient was discovered unresponsive, prone in crib.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: Death; patient was discovered unresponsive, prone in crib.
Age: 1.67
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Autopsy, Death, Laboratory test
Clinical narrative: Death; patient was discovered unresponsive, prone in crib.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M035692 with an expiration date 07-NOV-2017 for prophylaxis (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered doses of ZOSTAVAX experienced the temperature excursion from more than 5 degrees Fahrenheit to less than 14 degrees Fahrenheit for 1 hour. There was previous temperature excursion from more than 14 degrees Fahrenheit to less than 46 degrees Fahrenheit for 12 hours. The digital data logger was involved. Product quality complaint (PQC) was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1703USA002290.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a multiple patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, starting from 27-FEB-2017 the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # M039642 with an expiration date 03-JUL-2019 for prophylaxis (dose, route of administration and anatomical location were not reported). No adverse effects were reported. Administered doses of RECOMBIVAX HB experienced temperature excursion from 0 till 2 degrees Celsius for 1 hour and 26 minutes. There was no previous temperature excursion. The digital data logger was involved. Product quality complaint (PQC) was not reported.  this is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1703USA005122: US-009507513-1703USA005123: US-009507513-1703USA001517.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to a 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with GARDASIL 9 dose 2 series (strength, dose, route of administration, lot # and expiration date were not reported) separated by 1 year and 1 day. No adverse effect were reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: HEP
Symptoms: Epstein-Barr virus antigen positive, Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a physician via medical records and refers to a 17-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-FEB-2000, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot# reported as 1919H, dose and injection site were not provided), intramuscularly. On 12-MAR-2000, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot# reported as 0291K, dose and injection site were not provided), intramuscularly and on 21-MAR-2000, he received a third dose of RECOMBIVAX HB (lot# reported as 1637K, dose and injection site were not provided), intramuscularly. On 24-FEB-2017, the patient's laboratory results showed that hepatitis B Surface antibody was non-reactive. This result confirmed that despite the patient have received 3 doses of RECOMBIVAX HB in childhood, he had no immunity to Hepatitis B. The results from the same day also showed that Epstein-Barr capsid antigen antibody/IgM was positive and Epstein-Barr capsid antigen antibody/IgG was negative. The outcome of the events was not reported. The relatedness between the events and RECOMBIVAX HB was not provided. This is one of the two reports received from the same reporter. All available medical records will be provided upon request. Additional information has been requested. Sender's Comments: US-009507513-1702USA011530.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unspecified patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB injection, lot number M034187; expiration date 17-MAY-2019, lot number M034188; expiration date 20-MAY-2019 or lot number M045206; expiration date: 27-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis. The temperature excursion with LIQUID PEDVAXHIB was 30 minutes between 9 to 25 Celsius degrees. There was no previous temperature excursion and the temperature excursions were detected by a data logger. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA005140: US-009507513-1703USA009373: US-009507513-1703USA009374:
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative
Clinical narrative: Information was received from a female patient of unknown age via Pfizer, referring to herself. The patient had received PREVNAR 13, and it was not 100 percent effective. The patient's concurrent conditions and concomitant therapies were not provided. On an unknown date , the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot#, expiration date, frequency, concentration and route were unknown) for prophylaxis. No longer than five weeks after receiving pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown), the patient got blood test to see if her resistance to pneumonia went up. The patient's entire chart was exactly same after the pneumonia shot. The pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) should have had more protection, but did not find anything. The patient stated she was not protected from pneumonia by vaccine, and her titer was low, nothing, no protection. Titer was less than 3. The patient stated the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) shot did not work. The outcome of event was unknown. The causality between event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided. Additional information has been requested.