chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown name and gender. No concomitant medications, medical history, drug reactions or allergies were reported. On an unknown date, the patients were vaccinated with improperly stored ZOSTAVAX (dose and route of administration were not reported, lot # M041669, expiration date 09-JAN-2018), for prophylaxis. The vaccines were stored at the temperature of 11.7 farenheit degrees for 63 hours. Previous temperature excursion was also reported (storage at temperature of 6 to 14 Farenheit degrees for 13 hours). Temperature excursion was detected by a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004364:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This information has been received from a medical assistant concerning multiple patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 with lot number M034780 and expiration date on 15-APR-2019 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 Fahrenheit degrees and 77 Fahrenheit degrees for 30 minutes. There was no previous temperature excursion. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1704USA011951:
Sex: U
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a physician via Pfizer (manufacturer number 2017064371) referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date unknown) for prophylaxis. On an unknown date, the patient experienced a severe reaction to their last dose of PNEUMOVAX 23 a few years ago. The physician would like to administer PREVNAR 13 for the patient but wanted to know whether PREVNAR 13 would cause similar reaction to the patient. The physician wanted to know what would be the likelihood of a reaction to a patient who had already had this reaction to a PNEUMOVAX 23 in the past? The outcome of the event was unknown. The reporter considered adverse reaction to be related to PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse who was referring to an unspecified patient of unknown age and gender. On 05-APR-2017, the patient was vaccinated with expired dose of PNEUMOVAX23 lot number L019836, expiration date 24-MAR-2017, for prophylaxis (exact dose and route of administration were not provided). No adverse effect was reported. There was no product quality complaint involved in this case. Additional information has been requested.
Sex: U
Vaccine: HPV4, MNQ
Symptoms: Facial paralysis
Clinical narrative: Information has been received from a physician via company representative referring to numerous unspecified patients of unknown age and gender, reported in an unspecified article published in a scientific (unspecified publication date). The patients medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with GARDASIL for prophylaxis (route  of administration, lot #, expiration date, dose and anatomical location were not provided) and with MENVEO (route  of administration, lot #, expiration date, dose and anatomical location were not provided) for prophylaxis. Following this, on an unknown date, after receiving both vaccines the patients experienced Bell's palsy which upon internal review, was determined to be medically significant. At the time of reporting, the physician stated that according with the article most of the patients recovered fine without the need of medication. Additionally, the reporter did no provided causal relationship between the Bell's palsy and therapy with suspect therapies. There was no product quality complaint involved. Additional information is not expected as there was no consent to contact reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date in April 2017 (reported as "this weeks"), the patient was administered an expired dose of ZOSTAVAX (19400 plaque-forming units, PFU) injection (lot # L040442 with expiration date at 15-JAN-2017; dose, route of administration and anatomical location were not reported) for prophylaxis, which was reconstituted with sterile diluent (STERILE DILUENT) (lot # reported as K012927 with expiration date at 20-JUN-2017; strength and dose were not reported). The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, from 22-DEC-2016 to 21-APR-2017, the patients were vaccinated with improperly stored ROTATEQ, by oral route, lot number M034799, expiration date 01-FEB-2018, (dose, dose number and frequency were not reported), for prophylaxis. The ROTATEQ experienced a temperature excursion from 47 Fahrenheit Degrees to 77 Fahrenheit Degrees during a time frame of 10 minutes. The ROTATEQ did not experienced any previous excursion. The digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 20-APR-2017, the patient may have been vaccinated with an improperly stored dose of VARIVAX injection (dose, frequency and route were not reported) lot # M025869 with expiration date of 24-MAY-2018, or an improperly stored dose of PROQUAD (dose, frequency and route were not reported) lot # M019233 with expiration date of 17-OCT-2017, for prophylaxis. The medical assistant was not sure which one of the vaccines the patient received. The temperature of the VARIVAX and the PROQUAD was between 15 °F and 46 °F (32.4 °F) for a time frame of 2 hours and 30 minutes. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. There was no product quality complaint (PQC) involved. Additional information has been requested.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 69 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot number M037013, expiration date 22-NOV-2017 (dose and route were not reported) for prophylaxis.  The temperature involved was 7° F, for 45 minutes. It was not previous temperature excursion, and a data logger was involved. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies or concomitant medications were not reported. On unknown dates in April 2017 (reported as "vaccinations were from 17-APR-2017 through today 24-APR-2017"), patients were vaccinated with improperly stored doses of ROTATEQ oral liquid (strength and dose were not reported) lot number: M040270, expiration date: 29-APR-2018, orally for prophylaxis, as part of immunization series. According to the reporter, ROTATEQ doses were exposed to the following temperature excursions: 5 minutes at 0.9 Celsius degrees (C) (0C to 1C) and 46.9 Fahrenheit (F) (47F to 77F). Previous temperature excursions were 5 minutes at 35.2F, and 5 minutes at 46.9F. No adverse effects were reported. A digital data logger was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported.    On 18-APR-2017, the patient was vaccinated with PROQUAD lot # M039447, expiry date 20-MAR-2018 (anatomical site of administration, dose and route were not reported); administered along with a dose of VARIVAX lot # M028551, expiry date 07-JUN-2018 (anatomical site of administration, dose and route were not reported); due to a human error. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Arthralgia, Asthenia, Chills, Conversion disorder, Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 17 year old female patient. The patient's historical drug included TYLENOL WITH CODEINE. The patient's concurrent condition included fatigue. On 24-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L025737, expiry date: not reported) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included TRUMENBA (lot # J28923, intramuscular in the left arm) and meningococcal conj vaccine (unspecified) (dose 1, lot #U5272AA, intramuscular in the left arm). On the same day after vaccination, the patient experienced chills, subjective fever, cold intolerance, weakness, nausea, vomiting, muscle aches, painful joints, dizziness, pain and tingling/numbness to lower extremities. On an unknown date, she was hospitalized. An unknown lab test confirmed conversion disorder on 24-MAY-2016. The outcome of the events were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Hypoaesthesia, Laboratory test abnormal, Muscular weakness, Myalgia, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 17 year old female patient. The patient's historical drug included TYLENOL WITH CODEINE. The patient's concurrent condition included fatigue. On 24-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L025737, expiry date: not reported) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included TRUMENBA (lot # J28923, intramuscular in the left arm) and meningococcal conj vaccine (unspecified) (dose 1, lot #U5272AA, intramuscular in the left arm). On the same day after vaccination, the patient experienced chills, subjective fever, cold intolerance, weakness, nausea, vomiting, muscle aches, painful joints, dizziness, pain and tingling/numbness to lower extremities. On an unknown date, she was hospitalized. An unknown lab test confirmed conversion disorder on 24-MAY-2016. The outcome of the events were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Temperature intolerance, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 17 year old female patient. The patient's historical drug included TYLENOL WITH CODEINE. The patient's concurrent condition included fatigue. On 24-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L025737, expiry date: not reported) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included TRUMENBA (lot # J28923, intramuscular in the left arm) and meningococcal conj vaccine (unspecified) (dose 1, lot #U5272AA, intramuscular in the left arm). On the same day after vaccination, the patient experienced chills, subjective fever, cold intolerance, weakness, nausea, vomiting, muscle aches, painful joints, dizziness, pain and tingling/numbness to lower extremities. On an unknown date, she was hospitalized. An unknown lab test confirmed conversion disorder on 24-MAY-2016. The outcome of the events were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report was received from an unknown reporter refers to a 16 year old female patient. The patient had concurrent condition of duplex kidney. The medical history and concomitant medications were not reported. On 02-NOV-2015 at 11:00 am, the patient was vaccinated with GARDASIL lot # L016428, dose 2 in the right arm for prophylaxis. On 02-NOV-2015, the patient felt dizzy after vaccination. The diagnostic tests and laboratory tests were none. Illness at the time of vaccination was none. The outcome of the event was reported as recovered/resolved. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Dizziness, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales representative. A patient of an unspecified ethnicity and gender in his/her 50s, received PREVNAR 13, via an unspecified route of administration in Apr2017 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient was not feeling well, feeling "crummy" 48 hours after administration. Patient had also experienced dizziness since administration. No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Chills, Hot flush, Nausea, Pallor
Clinical narrative: This is a spontaneous report from a contactable nurse via a company representative. This nurse reported same events for two patients. This is the first of two reports. A patient of unspecified age ethnicity and gender received TRUMENBA (Lot R56659), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, vomiting, chills, hot flash, abdominal pain, shakes and turn very pale on an unspecified date. The outcome for all the events was unknown. The reporter considered all the events related to meningococcal group b rlp2086. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017181830 same reporter/drug/event, different patient.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via a company representative. This nurse reported same events for two patients. This is the first of two reports. A patient of unspecified age ethnicity and gender received TRUMENBA (Lot R56659), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, vomiting, chills, hot flash, abdominal pain, shakes and turn very pale on an unspecified date. The outcome for all the events was unknown. The reporter considered all the events related to meningococcal group b rlp2086. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017181830 same reporter/drug/event, different patient.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain, Chills, Hot flush, Nausea, Pallor
Clinical narrative: This is a spontaneous report from a contactable nurse via a company representative. This nurse reported same events for two patients. This is the second of two reports. A patient of unspecified age ethnicity and gender received TRUMENBA (Lot N16808), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, vomiting, chills, hot flash, abdominal pain, shakes and turn very pale on an unspecified date. The outcome for all the events was unknown. The reporter considered all the events related to meningococcal group b rlp2086. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017181368 same reporter/drug/event, different patient.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Tremor, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse via a company representative. This nurse reported same events for two patients. This is the second of two reports. A patient of unspecified age ethnicity and gender received TRUMENBA (Lot N16808), via an unspecified route of administration on an unspecified date at 0.5 ml, single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced nausea, vomiting, chills, hot flash, abdominal pain, shakes and turn very pale on an unspecified date. The outcome for all the events was unknown. The reporter considered all the events related to meningococcal group b rlp2086. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017181368 same reporter/drug/event, different patient.
Age: 29.0
Sex: M
Vaccine: YF
Symptoms: Diarrhoea, Fatigue, Muscular weakness, Pyrexia, Tremor
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 13 April 2017. This case involves a 29-year-old male patient who was vaccinated with dose of YELLOW FEVER VACCINE (Batch number:172VFA0072, expiry date, dose, route and site of administration were not reported) on 10 April 2017. Patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Concomitant medication was not reported. On 12 April 2017, two days following the vaccination, patient had fever, shaking, diarrhea, tiredness and muscle weakness. Laboratory investigation and corrective treatment were not reported. Patient was not recovered from events. List of documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: In 4-25-2017 patient complained of pain in deltoid area. She thinks it is from vaccine administered on 10-27-16-. She claims the pain she felt on October never fade.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Hives, redness, heat at site. Hives appeared 2 days after injection of vaccine.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Electromyogram, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Most painful shot ever-felt like it hit bone. With swelling, fever, and redness in left arm from elbow to shoulder-left arm redness, sore for several weeks (still tender at site of injection). Within three months-left hand lost motor skills.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Lumbar puncture, Motor dysfunction, Nuclear magnetic resonance imaging, X-ray
Clinical narrative: Most painful shot ever-felt like it hit bone. With swelling, fever, and redness in left arm from elbow to shoulder-left arm redness, sore for several weeks (still tender at site of injection). Within three months-left hand lost motor skills.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Electrocardiogram, Electroencephalogram, Seizure
Clinical narrative: Patient had a prolonged seizure and was admitted hospital on 12/05/15.
Age: 11.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Felt faint and collapsed, VS stable, ammonia salts provided, patient awake but still feeling weak, EMT arrived and patient monitored in ER then discharged home. DX syncope.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUX, HEPA, MMRV, DTAPIPV, FLUX, HEPA, MMR, VARCEL
Symptoms: Injection site discomfort, Injection site dryness, Injection site erythema, Rash erythematous, Rash pruritic
Clinical narrative: In the evening of patient's vaccines, we noticed that patient's skin had become red and raised in the area surrounding his vaccines - specifically on his Right thigh, but also to a lesser degree on his left. This rash continued to expand and worsen in the days to follow, getting red raised bumps that extended in a roughly circular area 8 inches in diameter beyond his vaccine site. The red bumps worsened in the presence of warm water. We applied Aveeno lotion to try to calm skin, minimizing bath times. One month following the vaccine, we took a photo of his continued rash - still worse on his Right thigh, but also present on his Left. It was red, itchy, raised with pimple-like bumps (they didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by this time, but stopped increasing). Now, nearly 5 months post-vaccine, patient continues to have a dry patchy skin in the area around his vaccine site on both legs. His Right leg (the more severe reaction) is now about 4 inches in diameter, the bumps are gone but the redness, raised, dry, itchy skin persists. Aveeno provides relief from the dry itch, but does not take the redness or raised skin away. I've reported this to Dr. and he asked that I file a formal report of the incident here. I'm indicating that patient has recovered (below) - his symptoms are improving, though not gone.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUX, HEPA, MMRV, DTAPIPV, FLUX, HEPA, MMR, VARCEL
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: In the evening of patient's vaccines, we noticed that patient's skin had become red and raised in the area surrounding his vaccines - specifically on his Right thigh, but also to a lesser degree on his left. This rash continued to expand and worsen in the days to follow, getting red raised bumps that extended in a roughly circular area 8 inches in diameter beyond his vaccine site. The red bumps worsened in the presence of warm water. We applied Aveeno lotion to try to calm skin, minimizing bath times. One month following the vaccine, we took a photo of his continued rash - still worse on his Right thigh, but also present on his Left. It was red, itchy, raised with pimple-like bumps (they didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by this time, but stopped increasing). Now, nearly 5 months post-vaccine, patient continues to have a dry patchy skin in the area around his vaccine site on both legs. His Right leg (the more severe reaction) is now about 4 inches in diameter, the bumps are gone but the redness, raised, dry, itchy skin persists. Aveeno provides relief from the dry itch, but does not take the redness or raised skin away. I've reported this to Dr. and he asked that I file a formal report of the incident here. I'm indicating that patient has recovered (below) - his symptoms are improving, though not gone.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUX, HEPA, MMRV, DTAPIPV, FLUX, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash erythematous, Vaccination site dryness
Clinical narrative: In the evening of patient's vaccines, we noticed that patient's skin had become red and raised in the area surrounding his vaccines - specifically on his Right thigh, but also to a lesser degree on his left. This rash continued to expand and worsen in the days to follow, getting red raised bumps that extended in a roughly circular area 8 inches in diameter beyond his vaccine site. The red bumps worsened in the presence of warm water. We applied Aveeno lotion to try to calm skin, minimizing bath times. One month following the vaccine, we took a photo of his continued rash - still worse on his Right thigh, but also present on his Left. It was red, itchy, raised with pimple-like bumps (they didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by this time, but stopped increasing). Now, nearly 5 months post-vaccine, patient continues to have a dry patchy skin in the area around his vaccine site on both legs. His Right leg (the more severe reaction) is now about 4 inches in diameter, the bumps are gone but the redness, raised, dry, itchy skin persists. Aveeno provides relief from the dry itch, but does not take the redness or raised skin away. I've reported this to Dr. and he asked that I file a formal report of the incident here. I'm indicating that patient has recovered (below) - his symptoms are improving, though not gone.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUX, HEPA, MMRV, DTAPIPV, FLUX, HEPA, MMR, VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: In the evening of patient's vaccines, we noticed that patient's skin had become red and raised in the area surrounding his vaccines - specifically on his Right thigh, but also to a lesser degree on his left. This rash continued to expand and worsen in the days to follow, getting red raised bumps that extended in a roughly circular area 8 inches in diameter beyond his vaccine site. The red bumps worsened in the presence of warm water. We applied Aveeno lotion to try to calm skin, minimizing bath times. One month following the vaccine, we took a photo of his continued rash - still worse on his Right thigh, but also present on his Left. It was red, itchy, raised with pimple-like bumps (they didn't rupture or ooze or anything, but were uncomfortable), extending about 6-8 inches (it had not decreased in size by this time, but stopped increasing). Now, nearly 5 months post-vaccine, patient continues to have a dry patchy skin in the area around his vaccine site on both legs. His Right leg (the more severe reaction) is now about 4 inches in diameter, the bumps are gone but the redness, raised, dry, itchy skin persists. Aveeno provides relief from the dry itch, but does not take the redness or raised skin away. I've reported this to Dr. and he asked that I file a formal report of the incident here. I'm indicating that patient has recovered (below) - his symptoms are improving, though not gone.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Blood potassium decreased, Blood pressure increased, Blood test, Cardiac monitoring, Cough
Clinical narrative: Extremely sore arm at injection site, Friday PM. Mild headache, stuffy nose Saturday AM, very sore arm. Cough. Sunday AM and PM. Extreme headache, sinuses very sore and "full", ringing ears, hearing loss, dizzy, nausea. Sunday AM go to ER. Heavy cough. Extreme unrelenting nausea, headache, sinus pain. Sunday PM go to hospital. Cough, phlegm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Deafness, Dizziness, Headache, Injection site pain, Nasal congestion
Clinical narrative: Extremely sore arm at injection site, Friday PM. Mild headache, stuffy nose Saturday AM, very sore arm. Cough. Sunday AM and PM. Extreme headache, sinuses very sore and "full", ringing ears, hearing loss, dizzy, nausea. Sunday AM go to ER. Heavy cough. Extreme unrelenting nausea, headache, sinus pain. Sunday PM go to hospital. Cough, phlegm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain in extremity, Productive cough, Sinus congestion, Sinus pain
Clinical narrative: Extremely sore arm at injection site, Friday PM. Mild headache, stuffy nose Saturday AM, very sore arm. Cough. Sunday AM and PM. Extreme headache, sinuses very sore and "full", ringing ears, hearing loss, dizzy, nausea. Sunday AM go to ER. Heavy cough. Extreme unrelenting nausea, headache, sinus pain. Sunday PM go to hospital. Cough, phlegm.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Tinnitus
Clinical narrative: Extremely sore arm at injection site, Friday PM. Mild headache, stuffy nose Saturday AM, very sore arm. Cough. Sunday AM and PM. Extreme headache, sinuses very sore and "full", ringing ears, hearing loss, dizzy, nausea. Sunday AM go to ER. Heavy cough. Extreme unrelenting nausea, headache, sinus pain. Sunday PM go to hospital. Cough, phlegm.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Antinuclear antibody negative, Anxiety, Arthralgia, Blood creatine phosphokinase increased, Blood thyroid stimulating hormone decreased
Clinical narrative: 7/21/16 Urgent Care cephalexin 500mg 3x day for folliculitis to chin. 9/24/16 Urgent Care for severe left knee pain (previous right TKA), x-rays noted some arthritis, given indomethacin and hydrocodone/APAP. 9/26/16 Given PNEUMOVAX in left deltoid; PCP note states Immunizations: flu shot this year, pneumonia vaccine 2009 (but this reporter can find no other mention of recent vaccinations). 10/5/2016 Dental examination and cleaning without abnormal findings. 10/10/2016 Appt with Orthopedic PA for L knee f/u, given fitted brace and NSAIDs; Notes the L knee pain has been present for about 4-5 months with worsening symptoms over the past 3 weeks. 10/11/2016 Excerpt from Urgent Care note: 67 y/o M presenting for: bilateral forearm pain 4-5 days ago, initially a passing pain, but constant and worsening since late yesterday very painful 7/10 since this morning, even with attempt to lift cereal bowl worse on the left side, anterior forearms, doesn't radiate into shoulders. Labs: CBC: unremarkable. CMP: unremarkable. ESR: 25. TSH: 0.46. CPK: 1307. Bilateral forearm pain and edema. Mild rhabdomyolysis. Unclear etiology- labs argue against an obvious malignant/myeloproliferative process, infection. ?Inflammation ?inflammatory process such as myopathy or neuropathy, the distribution argues against an orthopedic process. Non-con CT bilat ext to evaluate for clot. Start IVF 1 bolus, continue. IV pain PRN. Stop statin medication. Stop testosterone supplement. 10/12/16 Urgent care- given Hydrocodone/APAP and TYLENOL #3. Left knee pain. Pt also has bilateral arm pain with marked edema to both upper extremities. Pt has no leg edema. Pt is here with wife for follow up. Pt endorses 8/10 pain L>R of his bilateral forearms. His pain and anxiety are so exacerbated that he can't sleep and is worried that it'll only get worse. 10/18/16 Urgent Care and hospital admission. By history, exam, and labs he appears to have acute Polymyositis. I do not appreciate a rash that would suggest dermatomyositis. The patient can no longer even get out of bed without help. He needs further workup, in particular an EMG and an MRI to further evaluate his myositis and arthralgias. Myasthenic like syndrome overlapping with Issac syndrome. Prednisone 40 mg every day, Pyridostigmine 60 mg QID, Globulinimmune 2 g/kg over 3 days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Computerised tomogram, Condition aggravated, Dental examination normal, Differential white blood cell count, Full blood count normal
Clinical narrative: 7/21/16 Urgent Care cephalexin 500mg 3x day for folliculitis to chin. 9/24/16 Urgent Care for severe left knee pain (previous right TKA), x-rays noted some arthritis, given indomethacin and hydrocodone/APAP. 9/26/16 Given PNEUMOVAX in left deltoid; PCP note states Immunizations: flu shot this year, pneumonia vaccine 2009 (but this reporter can find no other mention of recent vaccinations). 10/5/2016 Dental examination and cleaning without abnormal findings. 10/10/2016 Appt with Orthopedic PA for L knee f/u, given fitted brace and NSAIDs; Notes the L knee pain has been present for about 4-5 months with worsening symptoms over the past 3 weeks. 10/11/2016 Excerpt from Urgent Care note: 67 y/o M presenting for: bilateral forearm pain 4-5 days ago, initially a passing pain, but constant and worsening since late yesterday very painful 7/10 since this morning, even with attempt to lift cereal bowl worse on the left side, anterior forearms, doesn't radiate into shoulders. Labs: CBC: unremarkable. CMP: unremarkable. ESR: 25. TSH: 0.46. CPK: 1307. Bilateral forearm pain and edema. Mild rhabdomyolysis. Unclear etiology- labs argue against an obvious malignant/myeloproliferative process, infection. ?Inflammation ?inflammatory process such as myopathy or neuropathy, the distribution argues against an orthopedic process. Non-con CT bilat ext to evaluate for clot. Start IVF 1 bolus, continue. IV pain PRN. Stop statin medication. Stop testosterone supplement. 10/12/16 Urgent care- given Hydrocodone/APAP and TYLENOL #3. Left knee pain. Pt also has bilateral arm pain with marked edema to both upper extremities. Pt has no leg edema. Pt is here with wife for follow up. Pt endorses 8/10 pain L>R of his bilateral forearms. His pain and anxiety are so exacerbated that he can't sleep and is worried that it'll only get worse. 10/18/16 Urgent Care and hospital admission. By history, exam, and labs he appears to have acute Polymyositis. I do not appreciate a rash that would suggest dermatomyositis. The patient can no longer even get out of bed without help. He needs further workup, in particular an EMG and an MRI to further evaluate his myositis and arthralgias. Myasthenic like syndrome overlapping with Issac syndrome. Prednisone 40 mg every day, Pyridostigmine 60 mg QID, Globulinimmune 2 g/kg over 3 days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Immunoglobulin therapy, Insomnia, Metabolic function test normal, Mobility decreased, Muscular weakness
Clinical narrative: 7/21/16 Urgent Care cephalexin 500mg 3x day for folliculitis to chin. 9/24/16 Urgent Care for severe left knee pain (previous right TKA), x-rays noted some arthritis, given indomethacin and hydrocodone/APAP. 9/26/16 Given PNEUMOVAX in left deltoid; PCP note states Immunizations: flu shot this year, pneumonia vaccine 2009 (but this reporter can find no other mention of recent vaccinations). 10/5/2016 Dental examination and cleaning without abnormal findings. 10/10/2016 Appt with Orthopedic PA for L knee f/u, given fitted brace and NSAIDs; Notes the L knee pain has been present for about 4-5 months with worsening symptoms over the past 3 weeks. 10/11/2016 Excerpt from Urgent Care note: 67 y/o M presenting for: bilateral forearm pain 4-5 days ago, initially a passing pain, but constant and worsening since late yesterday very painful 7/10 since this morning, even with attempt to lift cereal bowl worse on the left side, anterior forearms, doesn't radiate into shoulders. Labs: CBC: unremarkable. CMP: unremarkable. ESR: 25. TSH: 0.46. CPK: 1307. Bilateral forearm pain and edema. Mild rhabdomyolysis. Unclear etiology- labs argue against an obvious malignant/myeloproliferative process, infection. ?Inflammation ?inflammatory process such as myopathy or neuropathy, the distribution argues against an orthopedic process. Non-con CT bilat ext to evaluate for clot. Start IVF 1 bolus, continue. IV pain PRN. Stop statin medication. Stop testosterone supplement. 10/12/16 Urgent care- given Hydrocodone/APAP and TYLENOL #3. Left knee pain. Pt also has bilateral arm pain with marked edema to both upper extremities. Pt has no leg edema. Pt is here with wife for follow up. Pt endorses 8/10 pain L>R of his bilateral forearms. His pain and anxiety are so exacerbated that he can't sleep and is worried that it'll only get worse. 10/18/16 Urgent Care and hospital admission. By history, exam, and labs he appears to have acute Polymyositis. I do not appreciate a rash that would suggest dermatomyositis. The patient can no longer even get out of bed without help. He needs further workup, in particular an EMG and an MRI to further evaluate his myositis and arthralgias. Myasthenic like syndrome overlapping with Issac syndrome. Prednisone 40 mg every day, Pyridostigmine 60 mg QID, Globulinimmune 2 g/kg over 3 days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Neuromyotonia, Oedema peripheral, Orthosis user, Pain in extremity, Polymyositis
Clinical narrative: 7/21/16 Urgent Care cephalexin 500mg 3x day for folliculitis to chin. 9/24/16 Urgent Care for severe left knee pain (previous right TKA), x-rays noted some arthritis, given indomethacin and hydrocodone/APAP. 9/26/16 Given PNEUMOVAX in left deltoid; PCP note states Immunizations: flu shot this year, pneumonia vaccine 2009 (but this reporter can find no other mention of recent vaccinations). 10/5/2016 Dental examination and cleaning without abnormal findings. 10/10/2016 Appt with Orthopedic PA for L knee f/u, given fitted brace and NSAIDs; Notes the L knee pain has been present for about 4-5 months with worsening symptoms over the past 3 weeks. 10/11/2016 Excerpt from Urgent Care note: 67 y/o M presenting for: bilateral forearm pain 4-5 days ago, initially a passing pain, but constant and worsening since late yesterday very painful 7/10 since this morning, even with attempt to lift cereal bowl worse on the left side, anterior forearms, doesn't radiate into shoulders. Labs: CBC: unremarkable. CMP: unremarkable. ESR: 25. TSH: 0.46. CPK: 1307. Bilateral forearm pain and edema. Mild rhabdomyolysis. Unclear etiology- labs argue against an obvious malignant/myeloproliferative process, infection. ?Inflammation ?inflammatory process such as myopathy or neuropathy, the distribution argues against an orthopedic process. Non-con CT bilat ext to evaluate for clot. Start IVF 1 bolus, continue. IV pain PRN. Stop statin medication. Stop testosterone supplement. 10/12/16 Urgent care- given Hydrocodone/APAP and TYLENOL #3. Left knee pain. Pt also has bilateral arm pain with marked edema to both upper extremities. Pt has no leg edema. Pt is here with wife for follow up. Pt endorses 8/10 pain L>R of his bilateral forearms. His pain and anxiety are so exacerbated that he can't sleep and is worried that it'll only get worse. 10/18/16 Urgent Care and hospital admission. By history, exam, and labs he appears to have acute Polymyositis. I do not appreciate a rash that would suggest dermatomyositis. The patient can no longer even get out of bed without help. He needs further workup, in particular an EMG and an MRI to further evaluate his myositis and arthralgias. Myasthenic like syndrome overlapping with Issac syndrome. Prednisone 40 mg every day, Pyridostigmine 60 mg QID, Globulinimmune 2 g/kg over 3 days.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Protein total normal, Red blood cell sedimentation rate increased, Rhabdomyolysis, Thyroid function test normal, West Nile virus test negative
Clinical narrative: 7/21/16 Urgent Care cephalexin 500mg 3x day for folliculitis to chin. 9/24/16 Urgent Care for severe left knee pain (previous right TKA), x-rays noted some arthritis, given indomethacin and hydrocodone/APAP. 9/26/16 Given PNEUMOVAX in left deltoid; PCP note states Immunizations: flu shot this year, pneumonia vaccine 2009 (but this reporter can find no other mention of recent vaccinations). 10/5/2016 Dental examination and cleaning without abnormal findings. 10/10/2016 Appt with Orthopedic PA for L knee f/u, given fitted brace and NSAIDs; Notes the L knee pain has been present for about 4-5 months with worsening symptoms over the past 3 weeks. 10/11/2016 Excerpt from Urgent Care note: 67 y/o M presenting for: bilateral forearm pain 4-5 days ago, initially a passing pain, but constant and worsening since late yesterday very painful 7/10 since this morning, even with attempt to lift cereal bowl worse on the left side, anterior forearms, doesn't radiate into shoulders. Labs: CBC: unremarkable. CMP: unremarkable. ESR: 25. TSH: 0.46. CPK: 1307. Bilateral forearm pain and edema. Mild rhabdomyolysis. Unclear etiology- labs argue against an obvious malignant/myeloproliferative process, infection. ?Inflammation ?inflammatory process such as myopathy or neuropathy, the distribution argues against an orthopedic process. Non-con CT bilat ext to evaluate for clot. Start IVF 1 bolus, continue. IV pain PRN. Stop statin medication. Stop testosterone supplement. 10/12/16 Urgent care- given Hydrocodone/APAP and TYLENOL #3. Left knee pain. Pt also has bilateral arm pain with marked edema to both upper extremities. Pt has no leg edema. Pt is here with wife for follow up. Pt endorses 8/10 pain L>R of his bilateral forearms. His pain and anxiety are so exacerbated that he can't sleep and is worried that it'll only get worse. 10/18/16 Urgent Care and hospital admission. By history, exam, and labs he appears to have acute Polymyositis. I do not appreciate a rash that would suggest dermatomyositis. The patient can no longer even get out of bed without help. He needs further workup, in particular an EMG and an MRI to further evaluate his myositis and arthralgias. Myasthenic like syndrome overlapping with Issac syndrome. Prednisone 40 mg every day, Pyridostigmine 60 mg QID, Globulinimmune 2 g/kg over 3 days.
Age: 0.0
Sex: M
Vaccine: UNK
Symptoms: Allergy test positive, Eczema, Food allergy, Gluten sensitivity, Milk allergy
Clinical narrative: Severe eczema, Food allergies to eggs and peanuts, Food sensitivities to milk, gluten, coconut oil, cashews, almonds.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to unspecified patient of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapy were not provided. On an unspecified date, the patient was vaccinated with improperly stored dose of VARIVAX, lot# M027886 expiration date 30-JUN-2018) for prophylaxis (strength and route were not provided). The medical assistant was unable to provide the lot number and expiration date for the properly stored sterile diluent that was used to reconstitute the vaccine. The vaccine was exposed to a temperature excursion between 6 degrees Fahrenheit to 14 degrees Fahrenheit for 5 hours and 47 minutes. The call was placed because of a Digital data logger. No previous temperature excursions and no adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 21-APR-2017, the patient was vaccinated with an expired dose of VAQTA lot # K008333, expiration date on 10-MAR-2017 (strength, dose number, route and anatomical location were not provided) for prophylaxis. No adverse event reported. No product quality complaint was involved. Additional information is not expected, since no consent to contact the reporter was provided.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history and historical drugs were not reported. On 25-APR-2017, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot number L013826, expiration date 21-APR-2017 (dose and route were not reported) for prophylaxis. The patient's concomitant medication included sterile diluent (STERILE DILUENT) which was not post expiry. The reporter also confirmed that the VARIVAX and sterile diluent (STERILE DILUENT) did not have a temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule, Pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 4/12/17 The evening that the pt got her shot her arm swelled, and she got a knot. A few days later the knot became the size of a baseball and it was hot to the touch. It hurt when she touched it and her arm was sore when she tried to raise it. 4/23-4/26 the knot was still the size of an inch all the way around.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: 4/12/17 The evening that the pt got her shot her arm swelled, and she got a knot. A few days later the knot became the size of a baseball and it was hot to the touch. It hurt when she touched it and her arm was sore when she tried to raise it. 4/23-4/26 the knot was still the size of an inch all the way around.
Age: 63.0
Sex: F
Vaccine: FLU4, HEP, HEPA, MMR, TDAP, VARCEL, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Redness at injection site, measuring 7cm long and approximately 2cm wide to back of right arm.  Area warm to touch and hard when palpated.  Client states that it burns and itches.  Voices discomfort when area touched.  Client took Tylenol on night of 4/23/2017 for soreness to left arm.
Age: 63.0
Sex: F
Vaccine: FLU4, HEP, HEPA, MMR, TDAP, VARCEL, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Redness at injection site, measuring 7cm long and approximately 2cm wide to back of right arm.  Area warm to touch and hard when palpated.  Client states that it burns and itches.  Voices discomfort when area touched.  Client took Tylenol on night of 4/23/2017 for soreness to left arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness and sweeling of upper right arm. Firm and warm to touch.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Laboratory test
Clinical narrative: Pt.'s mother began noticing several dirty diapers that contained blood and took baby to the emergency room at Hospital.
Age: 14.0
Sex: M
Vaccine: HEP, HEPA, HPV9, TDAP
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy and light headed. 12:00 PM BP 110/60 pulse 76 resp 20 12:20 PM PB 110/70, pulse 76, resp 18. Placed in Trendelenburg position. 12:20 PM, stable, got up on his own and ambulatory.
Age: 33.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Headache, Irritability
Clinical narrative: Symptoms included headache and irritability. was seen in the emergency room.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received on 04-APR-2017 from a female pharmacist referring to a pregnant female patient of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided.  The pharmacist reported that on an unspecified date, an unspecified pregnant female patient was inadvertently given a dose of GARDASIL 9 (Site of administration, route of administration, Lot number, expiration date, and indication not provided.)  No adverse effects reported. No additional information was provided. Additional information has been requested.