chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Asthenia, Blood test, Computerised tomogram, Fall, Guillain-Barre syndrome
Clinical narrative: The patient was directed to redo her varicella and HepB series after blood tests for medical school showed a non-response to the first series. A week after the injections, the patient woke up with a numb lower left leg. Three days after, the patient tried to get out of bed and collapsed, unable to support her own weight. In the ER that day a lumbar puncture was performed for suspected Guillain-Barre. After being admitted to the hospital the next day, other tests were run to rule out anything other than Guillain-Barre. She was first given 5 treatments of intravenous immunoglobulins, and showed little response. She then underwent five plasma exchange treatments. The first hospital stay lasted three weeks, and then the patient was discharged to a physical rehabilitation hospital. After showing little improvement there for a week, she was re-admitted to the hospital because her weakness was worsening and underwent plasma exchange again. After two and a half more weeks in rehab, she was readmitted to the hospital due to more weakness and received 5 treatments of IVIG. She then completed two weeks of further rehab and was discharged to a day treatment therapy program three days a week.
Age: 22.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture, Nerve conduction studies, Nuclear magnetic resonance imaging
Clinical narrative: The patient was directed to redo her varicella and HepB series after blood tests for medical school showed a non-response to the first series. A week after the injections, the patient woke up with a numb lower left leg. Three days after, the patient tried to get out of bed and collapsed, unable to support her own weight. In the ER that day a lumbar puncture was performed for suspected Guillain-Barre. After being admitted to the hospital the next day, other tests were run to rule out anything other than Guillain-Barre. She was first given 5 treatments of intravenous immunoglobulins, and showed little response. She then underwent five plasma exchange treatments. The first hospital stay lasted three weeks, and then the patient was discharged to a physical rehabilitation hospital. After showing little improvement there for a week, she was re-admitted to the hospital because her weakness was worsening and underwent plasma exchange again. After two and a half more weeks in rehab, she was readmitted to the hospital due to more weakness and received 5 treatments of IVIG. She then completed two weeks of further rehab and was discharged to a day treatment therapy program three days a week.
Age: 22.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Plasmapheresis, Weight bearing difficulty
Clinical narrative: The patient was directed to redo her varicella and HepB series after blood tests for medical school showed a non-response to the first series. A week after the injections, the patient woke up with a numb lower left leg. Three days after, the patient tried to get out of bed and collapsed, unable to support her own weight. In the ER that day a lumbar puncture was performed for suspected Guillain-Barre. After being admitted to the hospital the next day, other tests were run to rule out anything other than Guillain-Barre. She was first given 5 treatments of intravenous immunoglobulins, and showed little response. She then underwent five plasma exchange treatments. The first hospital stay lasted three weeks, and then the patient was discharged to a physical rehabilitation hospital. After showing little improvement there for a week, she was re-admitted to the hospital because her weakness was worsening and underwent plasma exchange again. After two and a half more weeks in rehab, she was readmitted to the hospital due to more weakness and received 5 treatments of IVIG. She then completed two weeks of further rehab and was discharged to a day treatment therapy program three days a week.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Hypoaesthesia, Injection site erythema, Injection site pain
Clinical narrative: Patient was given a TDAP vaccine in right deltoid muscle by Health Department on 8/28/17. For the past two days the patient experience redness, swelling, warm to touch, and tenderness at site of injection. Maculopapular rash noted on right posterior shoulder. Associated with right axillary lymph node swelling and tenderness. Associated with chills and intermittent right arm numbness and tingling. Denies itching, SOB, or chest pain. Patient will be treated with Keflex 500 MG BID 7 DAYS for cellulitis of right arm. Patient has tolerated DTap vaccines in the past per mother without difficulty.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient was given a TDAP vaccine in right deltoid muscle by Health Department on 8/28/17. For the past two days the patient experience redness, swelling, warm to touch, and tenderness at site of injection. Maculopapular rash noted on right posterior shoulder. Associated with right axillary lymph node swelling and tenderness. Associated with chills and intermittent right arm numbness and tingling. Denies itching, SOB, or chest pain. Patient will be treated with Keflex 500 MG BID 7 DAYS for cellulitis of right arm. Patient has tolerated DTap vaccines in the past per mother without difficulty.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Paraesthesia, Rash maculo-papular
Clinical narrative: Patient was given a TDAP vaccine in right deltoid muscle by Health Department on 8/28/17. For the past two days the patient experience redness, swelling, warm to touch, and tenderness at site of injection. Maculopapular rash noted on right posterior shoulder. Associated with right axillary lymph node swelling and tenderness. Associated with chills and intermittent right arm numbness and tingling. Denies itching, SOB, or chest pain. Patient will be treated with Keflex 500 MG BID 7 DAYS for cellulitis of right arm. Patient has tolerated DTap vaccines in the past per mother without difficulty.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Syncope
Clinical narrative: Vasovagal syncope; stated that she was having difficulty breathing. She was taken to the ED, where she was observed and deemed to NOT be in anaphylaxis.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash generalised, Rash macular
Clinical narrative: Rash that began several hours after vaccine was given IM . No recent new foods, medications, personal care products. Rash was generalized small macule rash with no blistering or drainage. No difficulty breathing or swallowing. DECADRON injection given. Told to go to ER with any SOB or difficulty breathing/swallowing. Instructed her that I would coordinate with Employee health future vaccines to hold patient in clinical setting and have epi available and pre-dose with antihistamine.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash
Clinical narrative: Rash that began several hours after vaccine was given IM . No recent new foods, medications, personal care products. Rash was generalized small macule rash with no blistering or drainage. No difficulty breathing or swallowing. DECADRON injection given. Told to go to ER with any SOB or difficulty breathing/swallowing. Instructed her that I would coordinate with Employee health future vaccines to hold patient in clinical setting and have epi available and pre-dose with antihistamine.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash generalised, Rash macular
Clinical narrative: Employee presented with a latent reaction to the vaccine - she had a rash that covered her arms, trunk neck chest and face, she was seen by a LIP and given steroid injection.
Age: 23.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Rash
Clinical narrative: Employee presented with a latent reaction to the vaccine - she had a rash that covered her arms, trunk neck chest and face, she was seen by a LIP and given steroid injection.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Paraesthesia, Swelling
Clinical narrative: Patient developed cellulitis. She was seen by a physician and given an antibiotic. The site of the cellulitis was not improving, so the patient went to her local ER and was given another stronger antibiotic. The second antibiotic treated the cellulitis. Her arm is currently healed, but she is still experience some tingling in the area. She reported some swelling and redness after vaccine, but did not report the cellulitis until coming back to the pharmacy for additional vaccines needed.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 16-AUG-2017, the patient was inadvertently administered a properly stored but expired dose of M-M-R II injection, lot # L029266 with expiration date on 04-AUG-2017, for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and referred to unspecified patients of unknown age and gender. On unknown dates in August 2017 (reported as since 02-AUG-2017), the patients were vaccinated with improperly stored doses of VARIVAX (doses, routes of administration, lot# and expiration date were unknown). The VARIVAX was reconstituted with sterile diluent. No adverse effects were reported. The digital data logger was involved in recording the excursion. The excursion lasted 1 hour and 5 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA010885.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Hypersensitivity, Mass
Clinical narrative: This spontaneous report was received from a 80 year old female patient regarding herself. The patient had no medical history, drug allergies/reactions and was not on any concomitant medication. On 26-JUL-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, frequency and lot# not provided) for prevention of shingles. The patient stated that about an hour after receiving the ZOSTAVAX (reported as on 26-JUL-2017), the patient experienced nausea, sweaty, the palms of her hands turned red, pain in her shoulder blades, dizziness, and began to vomit a clear gelatin type fluid, hot and sweating, lump in back, redness, rash to hands. The patient called back to the pharmacy to inquire if this was normal. The whole ordeal lasted about an hour. The patient notified her physician by phone, but did not go to the hospital to visit her physician. The patient was recommended by the pharmacy to take some BENADRYL for her symptoms. The patient stated that once her symptoms stopped (an hour later), she felt much better. The patient thought she was having an allergic reaction to ZOSTAVAX. No laboratory tests were performed. The outcome of vomiting, hypersensitivity, dizziness, musculoskeletal pain, palmar erythema, nausea, rash, erythema, mass, hyperhidrosis and feeling hot was reported as recovered on an unknown date in July-2017. Causality assessment was not provided. No product quality complaint (PQC) was involved. No other information provided on this matter.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea, Palmar erythema, Rash, Vomiting
Clinical narrative: This spontaneous report was received from a 80 year old female patient regarding herself. The patient had no medical history, drug allergies/reactions and was not on any concomitant medication. On 26-JUL-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously (dose, frequency and lot# not provided) for prevention of shingles. The patient stated that about an hour after receiving the ZOSTAVAX (reported as on 26-JUL-2017), the patient experienced nausea, sweaty, the palms of her hands turned red, pain in her shoulder blades, dizziness, and began to vomit a clear gelatin type fluid, hot and sweating, lump in back, redness, rash to hands. The patient called back to the pharmacy to inquire if this was normal. The whole ordeal lasted about an hour. The patient notified her physician by phone, but did not go to the hospital to visit her physician. The patient was recommended by the pharmacy to take some BENADRYL for her symptoms. The patient stated that once her symptoms stopped (an hour later), she felt much better. The patient thought she was having an allergic reaction to ZOSTAVAX. No laboratory tests were performed. The outcome of vomiting, hypersensitivity, dizziness, musculoskeletal pain, palmar erythema, nausea, rash, erythema, mass, hyperhidrosis and feeling hot was reported as recovered on an unknown date in July-2017. Causality assessment was not provided. No product quality complaint (PQC) was involved. No other information provided on this matter.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from medical assistant refers to an unspecified number patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (dosing details unknown) (lot # M047303, expiry date 29-MAY-2018, lot # N012491, expiry date 17-OCT-2018) for prophylaxis. The vaccine was exposed to a temperature between 6 degree Fahrenheit (F) to 14 degree F for 50 minutes. The vaccine was previous exposed to a temperature between 6 to 14 degree F for 7 hours and 40 minutes. The sterile diluent (lot, and expiration date unknown) used for reconstitution did not underwent a temperature excursion. No adverse effects were reported. Data logger was involved. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA008993.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to a multiple patients of an unknown age. On unknown dates, the patients were vaccinated with M-M-R II lot # M045393 for prophylaxis. On unknown dates, the patients experienced incorrect product storage. No adverse effects were reported. Temperature excursion ranged from 47 degrees Fahrenheit to 77 degrees Fahrenheit within time frame of 1 hour. The outcome of incorrect product storage and was unknown. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010558: US-009507513-1708USA010541.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with an improperly stored doses of M-M-R II lot # M45101 an expiration date: 10-NOV-2018. The M-M-R II was reconstituted with sterile diluent (manufacturer unknown) which did not undergo a temperature excursion. No adverse effects were reported. The digital data logger was involved in recording the temperature excursion. This is one of four reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA010646: US-009507513-1708USA010647: US-009507513-1708USA008059.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and referred to unspecified patients of unknown age and gender. On unknown dates in August 2017 (reported as since 02-AUG-2017), the patients were vaccinated with improperly stored doses of PROQUAD (doses, routes of administration, lot# and expiration date were unknown). The PROQUAD was reconstituted with sterile diluent. No adverse effects were reported. The digital data logger was involved in recording the excursion. The excursion lasted 1 hour and 5 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA008066.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA lot#M021124 with expiry date: 02-FEB-2018, lot#M015290 with expiry date: 20-SEP-2017, lot#M018644 with expiry date: 20-SEP-2017, lot#M033611 with expiry date:02-MAR-2018, lot#M047658 with expiry date: 28-OCT-2017, lot#M022924 with expiry date: 24-JAN-2018, lot#M038572 with expiry date: 11-MAR-2018 and lot#M030598 with expiry date: 13-OCT-2017 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that all lots of VAQTA vaccines were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot# M021124, lot# M015290, lot# M018644; 37 minutes for lot# M033611, lot# M047658; 70 minutes for lot# M022924, lot# M038572 and 66 minutes for lot#M030598. The duration of exposure was 33 minutes for lot# L024993, lot# L043214, lot#L036301; 37 minutes for lot# M041212; 66 minutes for lot# M016193 and 70 minutes for lot#M018810, lot#M032650. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA012447: US-009507513-1708USA012445: US-009507513-1708USA012444: US-009507513-1708USA012446: US-009507513-1708USA012448.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Burning sensation, Chest pain, Computerised tomogram normal, Discomfort
Clinical narrative: This literature marketed report as received from the authors of the published article refers to an 89 year old female patient with arterial hypertension and mild cognitive impairment. The patient was otherwise very functional and independent. She was immunocompetent. In 2009 she received zoster vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date not reported). In early 2013, she developed sudden onset pain over her right hemithorax, which extended in a half-belt fashion from below the lower portion of the scapula, radiating forward along the right costal margin co the right upper quadrant of the abdomen. The pain was a constant, deep burning sensation that was not associated with meals and worsened at night. Analgesics, antacids, or bowel movements did not relieve it. It was made worse by touching the affected area, even by the rubbing of her clothing. There were no skin abnormalities present. The patient presented to her local emergency room, where the workup included ultrasound and computerized tomography (CT) scans, both of which were noncontributory. She was discharged home with no additional treatment other than analgesic agents. She returned to geriatric primary care clinic 7 days later, because the pain and discomfort were not resolved. Again, the work up was unrevealing. She was given a prescription for codeine plus acetaminophen. She returned to the geriatric clinic within 10 days, because her pain was unchanged. Again, other than the very sensitive area on her thorax, there were no signs of a rash or other abnormalities. A broader set of diagnostic laboratory tests were performed, including a polymerase chain reaction (PCR) for Varicella Zoster Virus. The patient was ultimately diagnosed with herpes zoster shingles variant, zoster sine herpete, on the basis of her clinical presentation and the description of her pain. Her differential diagnoses initially included liver and/or gallbladder disease or radiculopathic pain. Because an etiology for her pain was not determined at presentation, treatment was delayed for several weeks, during which she endured significant discomfort. The fact that she had received the zoster vaccine (manufacturer unknown)  may have suppressed the appearance of the shingles rash, which would have provided a strong clue to the diagnosis. By the time serologic studies were reported as positive for VZV, more than 3 weeks had elapsed since her initial presentation. Because the area was still very painful, she was treated with prednisone (manufacturer unknown) 40 mg per day and tapered over a 2-week period. In addition, she received gabapentin 200 mg three times per day for 6 weeks. She reported significant pain reduction within 1.5 weeks. Three months later, she was symptom-free, suggesting she was not affected with post-herpetic neuralgia. The authors concluded that when shingles occurs despite vaccination, the extent of the rash and the severity of neuropathic pain may be less.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Ultrasound scan normal
Clinical narrative: This literature marketed report as received from the authors of the published article refers to an 89 year old female patient with arterial hypertension and mild cognitive impairment. The patient was otherwise very functional and independent. She was immunocompetent. In 2009 she received zoster vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date not reported). In early 2013, she developed sudden onset pain over her right hemithorax, which extended in a half-belt fashion from below the lower portion of the scapula, radiating forward along the right costal margin co the right upper quadrant of the abdomen. The pain was a constant, deep burning sensation that was not associated with meals and worsened at night. Analgesics, antacids, or bowel movements did not relieve it. It was made worse by touching the affected area, even by the rubbing of her clothing. There were no skin abnormalities present. The patient presented to her local emergency room, where the workup included ultrasound and computerized tomography (CT) scans, both of which were noncontributory. She was discharged home with no additional treatment other than analgesic agents. She returned to geriatric primary care clinic 7 days later, because the pain and discomfort were not resolved. Again, the work up was unrevealing. She was given a prescription for codeine plus acetaminophen. She returned to the geriatric clinic within 10 days, because her pain was unchanged. Again, other than the very sensitive area on her thorax, there were no signs of a rash or other abnormalities. A broader set of diagnostic laboratory tests were performed, including a polymerase chain reaction (PCR) for Varicella Zoster Virus. The patient was ultimately diagnosed with herpes zoster shingles variant, zoster sine herpete, on the basis of her clinical presentation and the description of her pain. Her differential diagnoses initially included liver and/or gallbladder disease or radiculopathic pain. Because an etiology for her pain was not determined at presentation, treatment was delayed for several weeks, during which she endured significant discomfort. The fact that she had received the zoster vaccine (manufacturer unknown)  may have suppressed the appearance of the shingles rash, which would have provided a strong clue to the diagnosis. By the time serologic studies were reported as positive for VZV, more than 3 weeks had elapsed since her initial presentation. Because the area was still very painful, she was treated with prednisone (manufacturer unknown) 40 mg per day and tapered over a 2-week period. In addition, she received gabapentin 200 mg three times per day for 6 weeks. She reported significant pain reduction within 1.5 weeks. Three months later, she was symptom-free, suggesting she was not affected with post-herpetic neuralgia. The authors concluded that when shingles occurs despite vaccination, the extent of the rash and the severity of neuropathic pain may be less.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to unspecified number of patients unknown age and gender. On unknown dates, the patients were vaccinated with M-M-R II (recombinant human albumin (rHA)) lot # M044351, expiration date 04-NOV-2018. Concomitant therapies included sterile diluent. On an unknown date, the patients experienced incorrect product storage and no adverse event. Additional information has been requested. Sender's Comments: US-009507513-1708USA012441: US-009507513-1708USA012440.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB lot#M001813 with expiry date:14-OCT-2018, lot#M014926 with expiry date:17-FEB-2019, lot#M027883 with expiry date:15-APR-2019, lot#M032149 with expiry date:18-APR-2019, lot#M036058 with expiry date:19-MAY-2019 and lot#M036057 with expiry date: 18-MAY-2019 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that all lots of PEDVAXHIB were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot# M001813, lot#M014926, lot# M027883, lot#M032149; 37 minutes for lot#M036058, lot#M036057 and 66 minutes for lot#M020101. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot#L024993 with expiry date:17-OCT-2017 lot#L043214 with expiry date:30-AUG-2017, lot#L036301 with expiry date:20-DEC-2017, lot#M041212 with expiry date:21-JUN-2019, lot#M016193 with expiry date:24-APR-2018, lot#M018810 with expiry date:28-MAY-2018, lot#M032650 with expiry date:31-MAR-2019 (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that all lots of GARDASIL 9 were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot# L024993, lot# L043214, lot#L036301; 37 minutes for lot# M041212; 66 minutes for lot# M016193 and 70 minutes for lot#M018810, lot#M032650. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II lot#L024268 with expiry date: 01-JUL-2017,lot#M002418 with expiry date: 12-JAN-2018, lot#M015930 with expiry date:29-MAR-2018 lot#L030162 with expiry date: 01-AUG-2017 (reported as 11-AUG-2017) or lot#M010426 with expiry date:01-MAR-2018 (dosing details, anatomical location, route were unknown) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored diluent (lot#, expiry unknown). All doses of M-M-R II lot# L024268 and lot# L030162 were administered prior to expiration dates. It was reported that all lots of M-M-R II were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot#L024268 and lot#M002418; 1 hour 43 minutes for lot#M015930 and lot#L030162; and 70 minutes for lot#M010426. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ lot#L033693 with expiry date: 31-MAY-2017, lot#M014544 with expiry date:27-NOV-2017, lot#M025568 with expiry date: 07-NOV-2017, lot#L029617 with expiry date: 19-MAY-2017 and lot#M007311 with expiry date: 30-NOV-2017 (dosing details, anatomical location, were unknown) via oral route for prophylaxis. All doses of ROTATEQ with lot# L029617 and lot# L033693 were administered prior to expiration dates. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On unknown dates, the patients were vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ZOSTAVAX. Sender's Comments: US-009507513-1708USA012861.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On unknown dates, the patients were vaccinated with VARIVAX for prophylaxis. Concomitant therapies included sterile diluent. On unknown dates, the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Sender's Comments: US-009507513-1708USA012769.
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Pneumonia
Clinical narrative: This is spontaneous report from a contactable physician. A 68-year-old female patient of unknown race/ethnicity received on an unknown date a single dose of PREVNAR 13 for immunization. Medical history and concomitant medications were not reported. In Feb2016 the patient experienced pneumonia and was hospitalized. It was mentioned that pneumonia occurred right after receiving a dose of pneumococcal 13-val conj vac (dipht crm197 protein). The patient has been treated and followed. Outcome was unknown. No follow up attempts are possible. No further information is expected. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and vaccination date are needed for full medical assessment.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth, Malaise, Nausea, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her daughter. A 18-year-old female patient received a single dose of TRUMENBA in 22Aug2017 for immunisation. There were no concomitant medications. Patient was fine until she had the vaccine. On 23Aug2017 evening, the patient wasn't feeling well, she felt sick. On 24Aug2017 the arm where she got the injection was red, it's warm to touch and she had like couple of red patches on her arm. Since an unknown date patient got a little nauseous and her throat did not look good. Therapeutic measures taken in response to the events included 2 EXTRA STRENGTH TYLENOL. Outcome for nausea was unknown, while patient did not recover from the other events.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rash erythematous, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her daughter. A 18-year-old female patient received a single dose of TRUMENBA in 22Aug2017 for immunisation. There were no concomitant medications. Patient was fine until she had the vaccine. On 23Aug2017 evening, the patient wasn't feeling well, she felt sick. On 24Aug2017 the arm where she got the injection was red, it's warm to touch and she had like couple of red patches on her arm. Since an unknown date patient got a little nauseous and her throat did not look good. Therapeutic measures taken in response to the events included 2 EXTRA STRENGTH TYLENOL. Outcome for nausea was unknown, while patient did not recover from the other events.
Sex: M
Vaccine: MENB
Symptoms: Insomnia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, received from a contactable physician. A male (pediatric) patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had trouble sleeping two nights after receiving meningococcal group b rlp2086. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Erythema, Hypersensitivity, Injection site urticaria, Urticaria
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable medical assistant calling on behalf of a physician reported that a 4-month-old male patient received in Apr2017 a single dose of PREVNAR 13, ROTATEQ and PENTACEL, all for immunization. Concomitant medications included nystatin. Medical history was not reported. In Apr2017 the patient had an allergic reaction after receiving pneumococcal 13-val conj vac (dipht crm197 protein). The patient broke out in hives on his legs the next day after receiving the vaccines. The hives progressed to all over his body and his face turned red. Outcome was recovered in Apr2017. The reporter considered the allergic reaction as not serious.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Herpangina
Clinical narrative: Herpangina.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given the HIB part of the PENTACEL reconstituted with Sterile Water. Parents aware and will be coming in for correct dose.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Induration, Skin warm, Swelling, Tenderness
Clinical narrative: 17x14cm hard swollen area, red, warm and tender to touch. Pt placed on Cephalexin 250mg/5mL, 10mL TID for 7 days. Pt was given BENADRYL and TYLENOL in office also.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Patient was complaining of symptoms that started on 8/25 : pain lasting for 5 days, swelling, and itching. She said she felt feverish but she reported a temperature of 98. She used motrin for some relief. I suggested using ice as well, and offered complimentary Benadryl cream for the itching.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Localized swelling and erythema to vaccination site. Painful to touch it is firm, area is hot. Swelling has increased from day 2 to day 3. Subcutaneous injection to rt arm at 0822am 8/28/17. Noticed swelling and pain on 8/29/17. Swelling has increased in size 8/30/17.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination site warmth
Clinical narrative: Localized swelling and erythema to vaccination site. Painful to touch it is firm, area is hot. Swelling has increased from day 2 to day 3. Subcutaneous injection to rt arm at 0822am 8/28/17. Noticed swelling and pain on 8/29/17. Swelling has increased in size 8/30/17.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Chills, Dizziness, Headache
Clinical narrative: 8/28/2017 Bad headache - 7:00 pm Backache - 7:00 pm Weak - 7:00 Severe chills - 7:00 pm - the chills lasted approximately 30 minutes 8/29/2017 Perspiration - 9:00 am Dizziness - 9:00 am Weak - 9:00 am Vomiting - 7:00 pm 8/30/2017 Weak, no energy - all day.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Vomiting
Clinical narrative: 8/28/2017 Bad headache - 7:00 pm Backache - 7:00 pm Weak - 7:00 Severe chills - 7:00 pm - the chills lasted approximately 30 minutes 8/29/2017 Perspiration - 9:00 am Dizziness - 9:00 am Weak - 9:00 am Vomiting - 7:00 pm 8/30/2017 Weak, no energy - all day.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Oral herpes, Peripheral swelling
Clinical narrative: Patient reported soreness & redness at the site of the injection beginning the evening after the injection was given (8/28). Also reports shivers and a "cold core" beginning that same evening. She discussed with her husband going to the ER, however they did not seek medical treatment at the time. The next day (8/29), the left arm (injection arm) became real swollen. Today (8/30), a rash developed  on her injection arm and down her left torso area; and was just developing to a lesser extent on her right arm. Seeking medical treatment was advised (and her PCP, Drs office was contacted).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Patient reported soreness & redness at the site of the injection beginning the evening after the injection was given (8/28). Also reports shivers and a "cold core" beginning that same evening. She discussed with her husband going to the ER, however they did not seek medical treatment at the time. The next day (8/29), the left arm (injection arm) became real swollen. Today (8/30), a rash developed  on her injection arm and down her left torso area; and was just developing to a lesser extent on her right arm. Seeking medical treatment was advised (and her PCP, Drs office was contacted).
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Fall, Fatigue, Head injury, Headache, Somnolence
Clinical narrative: Pt was seated on exam table and all three shots were administered. Pt looked good was talking to mom and I. I told her to stay seated till I came back in since it was her first HPV. About 2 minutes later I heard a loud bang.  I ran into room where I found Pt laying on the ground shaking. The pt had fallen off exam table hit her head on desk and ended on the floor. At first pt not responding but within seconds she was answering mom and myself. When I asked pt if she had tried to stand up she said no, there was no warning or anything. Pt was very tired after reaction. she was monitored here in the office for about 40 mins. Checked by the Dr and sent home. When I checked on pt later in the day mom states she is sleepy and has a head ache.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Pt was seated on exam table and all three shots were administered. Pt looked good was talking to mom and I. I told her to stay seated till I came back in since it was her first HPV. About 2 minutes later I heard a loud bang.  I ran into room where I found Pt laying on the ground shaking. The pt had fallen off exam table hit her head on desk and ended on the floor. At first pt not responding but within seconds she was answering mom and myself. When I asked pt if she had tried to stand up she said no, there was no warning or anything. Pt was very tired after reaction. she was monitored here in the office for about 40 mins. Checked by the Dr and sent home. When I checked on pt later in the day mom states she is sleepy and has a head ache.
Sex: U
Vaccine: PPV
Symptoms: Arthralgia, Injection site discomfort, Injection site erythema, Injection site pain, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010106, intramuscular for prophylaxis. On 24-AUG-2017, 5 days after onset of therapy the patient experienced injection site erythema, arthralgia, vomiting, nausea, injection site pain and injection site discomfort. The outcome of injection site erythema, arthralgia, vomiting, nausea, injection site pain and injection site discomfort is unknown. Sender's Comments: US-009507513-1708USA012002.
Sex: U
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N010106, intramuscular for prophylaxis. On 24-AUG-2017, 5 days after onset of therapy the patient experienced injection site erythema, arthralgia, vomiting, nausea, injection site pain and injection site discomfort. The outcome of injection site erythema, arthralgia, vomiting, nausea, injection site pain and injection site discomfort is unknown. Sender's Comments: US-009507513-1708USA012002.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Joint swelling, Juvenile idiopathic arthritis, Laboratory test, Measles antibody positive, Mumps antibody test negative
Clinical narrative: This spontaneous report was received from a currently 41 years old female, regarding herself. There were no concomitant medications, concurrent conditions and medical history. In July 1977,  the patient was vaccinated with her first dose of M-M-R II (dose, route, lot#, expiration date and anatomical place of vaccination were not provided), for normal child vaccine. On an unspecified date on July 1977, 24 to 48 hours after receiving the vaccination (when the patient had 17 month old), the patient's ankles and joints swelled and subsequently was diagnosed with Juvenile Rheumatoid Arthritis. Therefore, she received an unspecified treatment and "many" unspecified test were performed, but no results were reported. On an unknown date in 1980, she recovered from juvenile idiopathic arthritis because her Rheumatoid (RA) factor test was negative. On an unknown date (also reported as "now), she got titers pulled and found out she had immunity for measles and rubella but not mump (mumps antibody test negative). At the time of reporting, the outcome of mumps antibody test negative was unknown. Nevertheless, the reporter did not provide a causality assessment between M-M-R II, juvenile idiopathic arthritis and mumps antibody test negative. The reporter considered the events to be serious for the following reasons: disability, life threatening and hospitalization on unspecified dates. Upon internal review, juvenile idiopathic arthritis was determined to be medically significant.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody positive
Clinical narrative: This spontaneous report was received from a currently 41 years old female, regarding herself. There were no concomitant medications, concurrent conditions and medical history. In July 1977,  the patient was vaccinated with her first dose of M-M-R II (dose, route, lot#, expiration date and anatomical place of vaccination were not provided), for normal child vaccine. On an unspecified date on July 1977, 24 to 48 hours after receiving the vaccination (when the patient had 17 month old), the patient's ankles and joints swelled and subsequently was diagnosed with Juvenile Rheumatoid Arthritis. Therefore, she received an unspecified treatment and "many" unspecified test were performed, but no results were reported. On an unknown date in 1980, she recovered from juvenile idiopathic arthritis because her Rheumatoid (RA) factor test was negative. On an unknown date (also reported as "now), she got titers pulled and found out she had immunity for measles and rubella but not mump (mumps antibody test negative). At the time of reporting, the outcome of mumps antibody test negative was unknown. Nevertheless, the reporter did not provide a causality assessment between M-M-R II, juvenile idiopathic arthritis and mumps antibody test negative. The reporter considered the events to be serious for the following reasons: disability, life threatening and hospitalization on unspecified dates. Upon internal review, juvenile idiopathic arthritis was determined to be medically significant.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot# M020521 with expiry date: 17-NOV-2017, lot# M024673 with expiry date: 17-NOV-2017, lot# M038216 with expiry date: 09-MAY-2018, lot# M043987 with expiry date: 30-JUN-2018, lot# M039060 with expiry date: 22-MAY-2018, (dosing details, anatomical location, route were unknown) for prophylaxis. It was reported that all lots except lot# M039060 of PNEUMOVAX 23 were exposed to a temperature range of 47F to 77F. The duration of exposure was 33 minutes for lot# M020521, lot# M024673, lot# M038216 and 70 minutes for lot#M043987. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA011339.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. Since 22-AUG-2017 through 28-AUG-2017 (reported as today), the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 for prophylaxis. No adverse effects reported. Sender's Comments: US-009507513-1708USA012428: US-009507513-1708USA012501.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematochezia, Intussusception, Rotavirus infection
Clinical narrative: Pt has had rotavirus twice now-1st time on 6/21/17 and 2nd time on 8/28/17. A few hours after vaccine, pt had bloody stools and treated for intussusception that same day.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Postictal state, Tardive dyskinesia, Tremor, Vomiting
Clinical narrative: Patient had complex febrile seizure, with right upper and lower extremity shaking, as well as lip smacking, with subsequent emesis and postictal phase for a total of 3 events within a 2 hour time.