chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Tremor
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Shingrix for prophylaxis. Previously administered products included shingrix with an associated reaction of headache (1st dose received on 10th May 2018, refer case US2018GSK168586). On 14th August 2018, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced influenza-like symptoms, pain in arm, cold, sweating, headache, nausea, tremor, neuralgia, diarrhea, stomach cramps, dizziness, ear noises, sore throat and head discomfort. On an unknown date, the outcome of the influenza-like symptoms, pain in arm, cold, sweating, headache, nausea, tremor and neuralgia were recovered/resolved and the outcome of the diarrhea, stomach cramps, dizziness, ear noises, sore throat and head discomfort were not recovered/not resolved. It was unknown if the reporter considered the influenza-like symptoms, pain in arm, cold, sweating, headache, nausea, tremor, neuralgia, diarrhea, stomach cramps, dizziness, ear noises, sore throat and head discomfort to be related to Shingrix. Additional details were provided as follows: The reporter is a dentist. He was reporting this adverse event for his wife. The patient experienced experienced flu like symptoms, sore arm, cold, sweats, headaches, nausea, shakiness, neuralgia, diarrhea and stomach cramps. The patient recovered from all the symptoms within 6 days except diarrhea and stomach cramps. The sore arm was recovered within 4 to 5 days. After 6 days at the time of reporting she was experiencing dizziness, waves of something in her head, sounds in her ear, sore throat, diarrhea, and stomach cramps.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a dentist via call center representative and described the occurrence of pain in arm in a 72-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 year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 71 or 72 years old. The reporter stated that his friend experienced sore arm for several days and then he recovered. No further details were provided. This case was one of the 4 cases, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received Shingrix for prophylaxis. On 24th August 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix on the left arm. The patient experienced redness, about the size described as 2 by 4 inches, which originated at the injection site. The patient reported that, the site was warm to the touch. The events had not improved. The pharmacist did not know the time to onset of symptoms after the injection.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of chills in a 61-year-old male patient who received Shingrix (batch number 7X3EJ, expiry date 13th October 2020) for prophylaxis. Concomitant products included Shingrix. On 6th September 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 6th September 2018, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In September 2018, the patient experienced chills, fever and pain. On 7th September 2018, the outcome of the chills, fever and pain were recovering/resolving. On an unknown date, the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the chills, fever and pain to be related to Shingrix. Additional details were provided as follows: On 30th July 2018, the patient received 1st dose of Shingrix (intramuscularly) (batch number 7X3EJ) in left deltoid. The patient received 2nd dose of Shingrix on left deltoid, about 6 weeks after his first dose of Shingrix, earlier than the recommended schedule, which led to shortening of vaccination schedule between 1st dose and 2nd dose. The physician thought that there might had been a computer flagging error that contributed to the patient receiving the dose early (rather than waiting the recommended 2-6 months). Following the 2nd dose of Shingrix within hours of administration, the patient developed aches and fever. Within 24 hours after receiving 2nd dose of Shingrix, the patient experienced large amounts of chills and rigors. Till 7th September 2018, the patient continued to experience large amounts of chills and rigors.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced varicella-like rash. On an unknown date, the outcome of the varicella-like rash was unknown. It was unknown if the reporter considered the varicella-like rash 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. The healthcare professional stated, the patient was given Shingrix and developed a few isolated spot two days later that resembled chicken pox. The healthcare professional did not have vaccine information.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female 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 year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided  as follows: The age at vaccination was not reported. The reporter herself is the patient. The reporter stated that her arm hurt after her first dose of SHINGRIX. The reporter also stated that her mother also experienced flu like symptoms, refer case US2018GSK164084. The reporter did not agree to be contacted for follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination were not reported. The reporter (daughter of the patient) stated that the patient experienced pain at injection site and flu like symptoms after receiving the SHINGRIX. This case has been linked with case US2018GSK077003 and US2018GSK168550 reported by the same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea. On an unknown date, the outcome of the pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea were recovered/resolved. It was unknown if the reporter considered the pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by other health professional for himself. The patient received 1st dose of SHINGRIX in the right arm. After receiving SHINGRIX, the patient experienced sore arm, diarrhea, tiredness, sweats, chills, neuralgia and flu like symptoms which lasted for total of 4 days. This case has been linked with case US2018163104, reported by same reporter.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea. On an unknown date, the outcome of the pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea were recovered/resolved. It was unknown if the reporter considered the pain in arm, tiredness, sweating, influenza-like symptoms, neuralgia, shivering and diarrhea to be related to SHINGRIX. Additional details were provided as follows: This case was reported by other health professional for himself. The patient received 1st dose of SHINGRIX in the right arm. After receiving SHINGRIX, the patient experienced sore arm, diarrhea, tiredness, sweats, chills, neuralgia and flu like symptoms which lasted for total of 4 days. This case has been linked with case US2018163104, reported by same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of muscle soreness in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. The patient's past medical history included genital herpes (since 1980). On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was recovered/resolved. It was unknown if the reporter considered the muscle soreness to be related to Flu vaccine. Additional details were reported as follows: This case was not previously reported to the physician. The patient received Flu vaccine in unknown arm. The patient had muscle soreness in the same arm in which the patient received vaccine. The patient stated that the muscle soreness usually starts that same evening or the next day following the vaccine and usually subsides after a couple of days. The patient had limited information regarding the flu vaccine. Patient did want to provide her DOB and provided her age instead. This case was link to case US2018160791, reported by the same reporter for the same patient.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old male patient who experienced patient received expired FLUZONE QUADRIVALENT vaccine, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event was occurred or not following the vaccination. 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 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 the sender: none.
Age: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA258563 (same reporter). This case involves a five-years old patient (gender not reported) who received a 0.5 mL dose of FLUZONE QUADRIVALENT lot UI998AC via intramuscular route in the left deltoid on 24-Aug-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the FLUZONE QUADRIVALENT as delivered later than it should have and the product was out of temperature range (shipping stability). It was unknown if any adverse event was occurred or not following the vaccination. 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 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 the sender: none.
Age: 87.0
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 87 years old patient who experienced an expired dose of FLUZONE HIGH DOSE lot UI892AB, 06-Jun-2018, via intramuscular route in the left deltoid on 12-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was reported that last years vaccine in the refrigerator was there and the Medical Assistant inadvertently gave the wrong one. It was reported that the patient did not experience any adverse event following the vaccination. 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 the sender: none.
Sex: F
Vaccine: TYP
Symptoms: Exposure via skin contact
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a female patient of an unknown age who was exposed to vaccine while receiving a dose of TYPHIM VI, lot number not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to exposure via skin contact. It was reported that she felt/saw some of the vaccine leak out onto her skin when being vaccinated and was concerned that she might not be appropriately protected. It was not reported if the patient experienced any adverse event. 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 the sender: none.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 12-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA258705 (same reporter). This case involves a 11 years old male patient who received a dose of MENACTRA lot R011628, expiry date: 11-Dec-2020, in the left arm on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ADACEL for Immunisation; and GARDASIL for Immunisation. It was a case of actual medication error due to incorrect product storage and deteriorated drug administered. It was reported that some vaccines that arrived after 72 hours rather than 48 and that vaccines should not be used. It was not reported if the patient experienced any adverse event. 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 and Module VI of the 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 the sender: none.
Sex: M
Vaccine: DTAPIPVHIB, PPV, RVX
Symptoms: Product preparation error
Clinical narrative: Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three-months old male patient who received a dose of PENTACEL on 05-Sep-2018 (lot number, route and site of administration, expiry date not reported). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL 13 VALENT VACCINE for Immunisation; and ROTAVIRUS VACCINE for Immunisation. This is actual medication error case due to inappropriate reconstitution technique (reported as nurse administering the powder portion of PENTACEL with sterile water instead of the required diluent). It was not reported if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Blood test, Erythema, Fatigue, Guttate psoriasis
Clinical narrative: Daily stomach pain that continues to this day. Fatigue and disruption of sleep patterns. Small red circles appeared first on the right lower leg, then both legs, now up to 3cm diameter. Dermatologist diagnosed me with Guttate Psoriasis in April 2018.
Age: 65.0
Sex: F
Vaccine: DTAP
Symptoms: Sleep disorder
Clinical narrative: Daily stomach pain that continues to this day. Fatigue and disruption of sleep patterns. Small red circles appeared first on the right lower leg, then both legs, now up to 3cm diameter. Dermatologist diagnosed me with Guttate Psoriasis in April 2018.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Feeling cold, Insomnia, Loss of personal independence in daily activities, Nausea
Clinical narrative: 9/15/2018 - Within 6-7 hours after Shingles injection, begun feeling achy, weakened, distracted. Had fits of coldness, but not shivering. No fever present. Difficulty sleeping. 9/16/2018 - Aches presented more severely, more pronounced weakness, nausea. Could not perform daily activities. 9/17/2018 - Aches subsiding somewhat, weakness still present. Worked from home due to weakness. 9/18/2018 Aches diminished, weakness still present with some nausea. Working from home once more. Will hope these side effects leave as I am a very active guy: cycling, running, weights, and have not been this sick in many years. Have had flu vaccines for years (dosed same time different arm as SHINGRIX) and had 2016 Shingles vaccine with no side effects.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: 9/15/2018 - Within 6-7 hours after Shingles injection, begun feeling achy, weakened, distracted. Had fits of coldness, but not shivering. No fever present. Difficulty sleeping. 9/16/2018 - Aches presented more severely, more pronounced weakness, nausea. Could not perform daily activities. 9/17/2018 - Aches subsiding somewhat, weakness still present. Worked from home due to weakness. 9/18/2018 Aches diminished, weakness still present with some nausea. Working from home once more. Will hope these side effects leave as I am a very active guy: cycling, running, weights, and have not been this sick in many years. Have had flu vaccines for years (dosed same time different arm as SHINGRIX) and had 2016 Shingles vaccine with no side effects.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Disorientation, Dizziness
Clinical narrative: Tightness in chest, ache radiating through chest, lightheaded and disorientation. Symptoms eased and passed within about an hour.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fever, shivering, muscle pain, join pain, headache, nausea, fatigue, stuffy nose. Took Tylenol migraine and sudafed.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasal congestion, Nausea, Pyrexia
Clinical narrative: Fever, shivering, muscle pain, join pain, headache, nausea, fatigue, stuffy nose. Took Tylenol migraine and sudafed.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Chest pain, Rash, Vaccination complication
Clinical narrative: Per nurse on 10/25/17: Patient arrived with daughter for complaint of reaction to flu that was received on 10/11/17. Patient states on 10/11/17 his arm broke out in a rash and experienced chest tightness. States he took two BENADRYL and went to sleep. States the rash went away and he had not had any further chest pain since then. States he does have leg pain at night and has had for years. States he had to takes an ibuprofen at bedtime about 3 times a week. States he has had episodes of chest burning and times. Will obtain EKG.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Rash all over body; red, flat dots.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Facial pain, Immediate post-injection reaction, Swelling face
Clinical narrative: Immediately after injection pt stated the left side of her face hurt. She was talking and laughing and no other symptoms. I told mother they could stay and wait after 10 minutes she stated she felt fine and they left facility. 30-40 minutes later returned to the unit stating that the left side of her face was swollen. They were instructed to go to the ER with the immunization record.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt had swelling, warmth, redness, and slight itching to her left arm - the reaction was not at the injection site - it was further down the patients arm and towards the inside of her arm and elbow.  Pt stated showing symptoms on Sunday 9/16, and when I consulted (immunization coordinator) she stated this was a common ADR and no reporting would be needed. On Monday 9/17 the rash was slightly better, but not resolved and I advised pt to go to MD. The MD was unsure what caused the skin reaction - however, he believes it is related to the vaccine. He gave the patient BACTRIM DS number 20 tk 1 tablet by mouth every 12 hours.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site reaction, Subcutaneous abscess
Clinical narrative: Cutaneous abscess of the left lower extremity.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Hypersomnia, Urticaria
Clinical narrative: I woke up with an extremely bad headache and hives to forehead only. I took tylenol & benadryl and went back to sleep. When I woke both were gone. Slept abt 12 hrs total.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Vaccination site bruising
Clinical narrative: Patient had significant bruising on arm in area of vaccine administration. It was her right arm, which is the one her flu shot was given in.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Ear pain, Muscle tightness, Pain, Pain in jaw, Swelling face
Clinical narrative: Minutes after receiving the flu shot I experienced a dull "tightening" in my left, upper jaw. As it got worse I felt an aching, throbbing sensation in it. That night I took an ADVIL which relieved the pain but as the ADVIL wore off I felt an ache in my left ear as well as the jaw. I already have tinnitus and the ringing became even louder. My cheek was slightly swollen. I became concerned that this feeling might become permanent. The aching in my ear and jaw has mostly subsided (It is now Tuesday, Sept 18) but the tinnitus remains louder than usual.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Tinnitus
Clinical narrative: Minutes after receiving the flu shot I experienced a dull "tightening" in my left, upper jaw. As it got worse I felt an aching, throbbing sensation in it. That night I took an ADVIL which relieved the pain but as the ADVIL wore off I felt an ache in my left ear as well as the jaw. I already have tinnitus and the ringing became even louder. My cheek was slightly swollen. I became concerned that this feeling might become permanent. The aching in my ear and jaw has mostly subsided (It is now Tuesday, Sept 18) but the tinnitus remains louder than usual.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dyspnoea, Full blood count, Pyrexia, Urine analysis, Use of accessory respiratory muscles
Clinical narrative: Patient's mother called on 7/19/18 to notify us that she had taken patient to the ER for fever the evening of 7/18/18. ER visit found no cause for elevated temperature and she was instructed to follow up with PCP the following day. Patient was seen in office on 7/19/18 and noted to have rectal temperature of 101.6 at 0945, with TYLENOL on board given by mother at home at 0800. PCP also noted patient was dyspneic and using accessory muscles to breathe. Patient was sent to ER again on 7/19/18. ER report showed elevated WBC, but no other possible cause for fever. Diagnosis at ER was fever of unknown origin. Patient has not followed up with our office since, although, we did call patient's mother on 7/20/18 to check on him. Mother reported patient no longer had a fever and breathing had returned to normal.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: White blood cell count increased
Clinical narrative: Patient's mother called on 7/19/18 to notify us that she had taken patient to the ER for fever the evening of 7/18/18. ER visit found no cause for elevated temperature and she was instructed to follow up with PCP the following day. Patient was seen in office on 7/19/18 and noted to have rectal temperature of 101.6 at 0945, with TYLENOL on board given by mother at home at 0800. PCP also noted patient was dyspneic and using accessory muscles to breathe. Patient was sent to ER again on 7/19/18. ER report showed elevated WBC, but no other possible cause for fever. Diagnosis at ER was fever of unknown origin. Patient has not followed up with our office since, although, we did call patient's mother on 7/20/18 to check on him. Mother reported patient no longer had a fever and breathing had returned to normal.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Two days after vaccine patient left arm was slightly swollen a few inches around injection site and red three quarters of upper arm, slightly itchy. Patient advised to monitor site for worsening and go to Dr. if it got worse. Patient advised to take BENADRYL, ice the site, and ibuprofen. One day later followup with patient redness and swelling subsided.
Sex: U
Vaccine: HEP
Symptoms: Medication error
Clinical narrative: This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB for prophylaxis. On an unknown date the patient experienced medication error.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-AUG-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 06-SEP-2016, the patient was treated by a physician for the onset of severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2006, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 24-MAY-2015, the patient was treated at emergency department by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed oxycodone and VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. ; Sender's Comments: US-009507513-1804USA005153:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1804USA005153:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 14-SEP-2018, the patient was vaccinated with a dose of VAQTA lot# N020503, which expired on 04-SEP-2018 (exact dose, frequency, site and route of administration were not reported). No adverse effect was reported.
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient came in for her 2nd SHINGRIX, but complaining that she is still in pain from the last shot. Per patient, she has been feeling pain at the injection site, and restricted movement of her arm since her shots. Every time she moves her arm she feels the pain. She has been taking ADVIL and is feeling better. However, she is not completely pain-free.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Feeling cold, Influenza like illness, Pain
Clinical narrative: Flu like symptom, chills, body discomfort and generalized muscle pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: C-reactive protein, Epstein-Barr virus test, Erythema, Hypophagia, Irritability
Clinical narrative: 2 months after the administration of the MMR, patient developed a gold ball size lump on the right side of neck just below the jaw line. Patient also started with fevers at this time. Patient has continued with fevers for a total of 6 days now and very minimal decrease in swelling of lump. Now the lump is red and warm to the touch, which was not the case until about day 4-5. Since we are working on day 6 of fevers and the change in how the area looks he was given IM ROCEPHIN in the office 9/18/18 and will start a course of oral antibiotics (AUGMENTIN). He is irritable but consolable, eating has decreased but fluid intake is still good. No rashes noted other than the redness on the lump itself.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Mononucleosis heterophile test negative, Mumps antibody test, Mumps antibody test positive, Neck mass, Parotid gland enlargement
Clinical narrative: 2 months after the administration of the MMR, patient developed a gold ball size lump on the right side of neck just below the jaw line. Patient also started with fevers at this time. Patient has continued with fevers for a total of 6 days now and very minimal decrease in swelling of lump. Now the lump is red and warm to the touch, which was not the case until about day 4-5. Since we are working on day 6 of fevers and the change in how the area looks he was given IM ROCEPHIN in the office 9/18/18 and will start a course of oral antibiotics (AUGMENTIN). He is irritable but consolable, eating has decreased but fluid intake is still good. No rashes noted other than the redness on the lump itself.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Red blood cell sedimentation rate, Skin warm, Ultrasound scan abnormal
Clinical narrative: 2 months after the administration of the MMR, patient developed a gold ball size lump on the right side of neck just below the jaw line. Patient also started with fevers at this time. Patient has continued with fevers for a total of 6 days now and very minimal decrease in swelling of lump. Now the lump is red and warm to the touch, which was not the case until about day 4-5. Since we are working on day 6 of fevers and the change in how the area looks he was given IM ROCEPHIN in the office 9/18/18 and will start a course of oral antibiotics (AUGMENTIN). He is irritable but consolable, eating has decreased but fluid intake is still good. No rashes noted other than the redness on the lump itself.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Head injury, Loss of consciousness, Pyrexia
Clinical narrative: Patient began experiencing fevers of 99-100 degrees F the next evening, and the fever increased to 102 degrees F before bedtime. Thursday morning around 3am, the patient woke up and went to the kitchen to get water and passed out, hitting her head in the process. Ambulance was called and the patient was taken to the ED.
Age: 89.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Couldn't sleep on arm it was raised, next day had chills, felt bad, had redness around injection site with pain. 5.75 x 4.25 area of erythema and warmth. Did take BENADRYL and now taking Sulfamethoxazole-Trimethoprim.
Age: 89.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Sleep disorder
Clinical narrative: Couldn't sleep on arm it was raised, next day had chills, felt bad, had redness around injection site with pain. 5.75 x 4.25 area of erythema and warmth. Did take BENADRYL and now taking Sulfamethoxazole-Trimethoprim.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Feeling cold, Injection site pain, Pain in extremity
Clinical narrative: Fatigue, chills, achy feeling in lower back and legs. Began mid-morning of the day following the vaccine. Went to sleep at 8:30 or 9:00 pm and woke up the following day symptom free, except for pain at the site of the shot. This lasted for five days.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Asthenia, Cellulitis, Culture, Differential white blood cell count, Full blood count
Clinical narrative: Fever 102 degrees, Headache, Weakness, Swelling and Hives/Welts from Shoulder under arm and on top to elbow, Painful, Basic Metabolic Panel (8), CBC w/differential, CBC w/differential w platelet, Urinalysis w/culture reflex.