chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Redness, pain, inflammation, heat at injection site.
Age: 25.0
Sex: M
Vaccine: UNK
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Constant vomiting, diarrhea, nausea.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Irritability, Urinary system x-ray normal
Clinical narrative: 2 month-old male with abdominal pain and irritability after Rotavirus vaccine. Seen at Emergency Room. KUB negative.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient came to our pharmacy and stated that after receiving ZOSTAVAX, she's experiencing stabbing pain from elbows and radiating down to wrists. The pain happens on both arms but more on the right.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle spasms, Pruritus, Pyrexia
Clinical narrative: Per MD note on 9/16/16: patient presented status post receiving a flu vaccine immunization over half an hour ago. She had noted that she had some chest tightness and wheezing but this has since gone away. She is getting itchy over her skin and her arms and trunk. She has had allergic reactions before mainly to crawfish and soy. In addition she also is allergic to penicillin and sulfa drugs. Physical exam lungs clear but urticarial lesions noted. Assessment allergy to flu vaccine will treat with ZYRTEC 10 mg daily and prednisone taper also flu vaccine listed as an allergy. Urticaria pruritus and chest tightness/wheezing. Cetirizine 10 mg, Prednisone.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy to vaccine, Chest discomfort, Pruritus, Skin lesion, Urticaria
Clinical narrative: Per MD note on 9/16/16: patient presented status post receiving a flu vaccine immunization over half an hour ago. She had noted that she had some chest tightness and wheezing but this has since gone away. She is getting itchy over her skin and her arms and trunk. She has had allergic reactions before mainly to crawfish and soy. In addition she also is allergic to penicillin and sulfa drugs. Physical exam lungs clear but urticarial lesions noted. Assessment allergy to flu vaccine will treat with ZYRTEC 10 mg daily and prednisone taper also flu vaccine listed as an allergy. Urticaria pruritus and chest tightness/wheezing. Cetirizine 10 mg, Prednisone.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Wheezing
Clinical narrative: Per MD note on 9/16/16: patient presented status post receiving a flu vaccine immunization over half an hour ago. She had noted that she had some chest tightness and wheezing but this has since gone away. She is getting itchy over her skin and her arms and trunk. She has had allergic reactions before mainly to crawfish and soy. In addition she also is allergic to penicillin and sulfa drugs. Physical exam lungs clear but urticarial lesions noted. Assessment allergy to flu vaccine will treat with ZYRTEC 10 mg daily and prednisone taper also flu vaccine listed as an allergy. Urticaria pruritus and chest tightness/wheezing. Cetirizine 10 mg, Prednisone.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Congenital syphilitic osteochondritis, Dysphagia, Ear congestion, Laboratory test
Clinical narrative: 9/20/2016 - Some sinus drainage, pressure in right ear, inj. site redness from vaccine. 10/6/16 - Increased phlegm production, development of hearing loss in right ear with sensations of fullness and pressure, no fevers/chills. Thought to have caused reoccurrence of Granulomatosis with polyangiitis that had been in remission for several years. Treatment: Prednisone and rituximab.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Productive cough
Clinical narrative: 9/20/2016 - Some sinus drainage, pressure in right ear, inj. site redness from vaccine. 10/6/16 - Increased phlegm production, development of hearing loss in right ear with sensations of fullness and pressure, no fevers/chills. Thought to have caused reoccurrence of Granulomatosis with polyangiitis that had been in remission for several years. Treatment: Prednisone and rituximab.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Deafness unilateral, Ear discomfort, Granulomatosis with polyangiitis, Injection site erythema
Clinical narrative: 9/20/2016 - Some sinus drainage, pressure in right ear, inj. site redness from vaccine. 10/6/16 - Increased phlegm production, development of hearing loss in right ear with sensations of fullness and pressure, no fevers/chills. Thought to have caused reoccurrence of Granulomatosis with polyangiitis that had been in remission for several years. Treatment: Prednisone and rituximab.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paranasal sinus hypersecretion, Productive cough
Clinical narrative: 9/20/2016 - Some sinus drainage, pressure in right ear, inj. site redness from vaccine. 10/6/16 - Increased phlegm production, development of hearing loss in right ear with sensations of fullness and pressure, no fevers/chills. Thought to have caused reoccurrence of Granulomatosis with polyangiitis that had been in remission for several years. Treatment: Prednisone and rituximab.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Paraesthesia
Clinical narrative: Patient experienced severe pain. Patient saw multiple doctor's and it was determined that the immunization was administered incorrectly (into the bursa).
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Incorrect route of drug administration, Pain, X-ray
Clinical narrative: Patient experienced severe pain. Patient saw multiple doctor's and it was determined that the immunization was administered incorrectly (into the bursa).
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Enema administration, Intussusception
Clinical narrative: RECEIVED ROTAVIRUS VACCINE ON 9/20/16. ONSET OF FEVER, CRYING, VOMITING, DIARRHEA ON 9/22/2016. SYMPTOMS PROGRESSLY WORSE BY FRIDAY. STOOLS TURNING BLOODY AND MUCUS LIKE. CONTACTED PRIMARY DOCTOR, TOLD TO MONITOR OR GO TO ED. CHILD TRANSPORTED TO HOSPITAL EMERGENCY ROOM, 9/24. ULTRASOUND PERFORMED AND CONFIRMED intussusception. AIR ENEMA PERFORMED AND WAS SUCCESSFUL. CHILD RELEASED HOME. SYMPTOMS CONTINUE AT HOME AND RETURN TO ER, 9/25. CHILD ADMITTED X 3 DAYS FOR MONITOR. THEN RELEASED. PRESENTLY CHILD STILL HAVE BOUTS OF INTERMITTENT CRYING AND VOMITING.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying, Diarrhoea, Enema administration, Haematochezia, Intussusception
Clinical narrative: RECEIVED ROTAVIRUS VACCINE ON 9/20/16. ONSET OF FEVER, CRYING, VOMITING, DIARRHEA ON 9/22/2016. SYMPTOMS PROGRESSLY WORSE BY FRIDAY. STOOLS TURNING BLOODY AND MUCUS LIKE. CONTACTED PRIMARY DOCTOR, TOLD TO MONITOR OR GO TO ED. CHILD TRANSPORTED TO HOSPITAL EMERGENCY ROOM, 9/24. ULTRASOUND PERFORMED AND CONFIRMED intussusception. AIR ENEMA PERFORMED AND WAS SUCCESSFUL. CHILD RELEASED HOME. SYMPTOMS CONTINUE AT HOME AND RETURN TO ER, 9/25. CHILD ADMITTED X 3 DAYS FOR MONITOR. THEN RELEASED. PRESENTLY CHILD STILL HAVE BOUTS OF INTERMITTENT CRYING AND VOMITING.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Mucous stools, Pyrexia, Ultrasound scan abnormal, Vomiting
Clinical narrative: RECEIVED ROTAVIRUS VACCINE ON 9/20/16. ONSET OF FEVER, CRYING, VOMITING, DIARRHEA ON 9/22/2016. SYMPTOMS PROGRESSLY WORSE BY FRIDAY. STOOLS TURNING BLOODY AND MUCUS LIKE. CONTACTED PRIMARY DOCTOR, TOLD TO MONITOR OR GO TO ED. CHILD TRANSPORTED TO HOSPITAL EMERGENCY ROOM, 9/24. ULTRASOUND PERFORMED AND CONFIRMED intussusception. AIR ENEMA PERFORMED AND WAS SUCCESSFUL. CHILD RELEASED HOME. SYMPTOMS CONTINUE AT HOME AND RETURN TO ER, 9/25. CHILD ADMITTED X 3 DAYS FOR MONITOR. THEN RELEASED. PRESENTLY CHILD STILL HAVE BOUTS OF INTERMITTENT CRYING AND VOMITING.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Blood test, Cellulitis, Chest X-ray, Dysphonia, Dyspnoea
Clinical narrative: Had redness, swelling, "hot to the touch", pain, tingling going up and down the arm, joints felt tight, fever, was put on antibiotics, then developed a rash, was put on singular.  Symptoms were noted the night of injection.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Pain, Peripheral swelling
Clinical narrative: Had redness, swelling, "hot to the touch", pain, tingling going up and down the arm, joints felt tight, fever, was put on antibiotics, then developed a rash, was put on singular.  Symptoms were noted the night of injection.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Photophobia, Pulmonary function test, Pyrexia, Rash, Rash erythematous
Clinical narrative: Had redness, swelling, "hot to the touch", pain, tingling going up and down the arm, joints felt tight, fever, was put on antibiotics, then developed a rash, was put on singular.  Symptoms were noted the night of injection.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Swelling, Swelling face
Clinical narrative: Had redness, swelling, "hot to the touch", pain, tingling going up and down the arm, joints felt tight, fever, was put on antibiotics, then developed a rash, was put on singular.  Symptoms were noted the night of injection.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Antibody test, Blood creatine phosphokinase, C-reactive protein, Erythema, Joint stiffness
Clinical narrative: Had redness, swelling, "hot to the touch", pain, tingling going up and down the arm, joints felt tight, fever, was put on antibiotics, then developed a rash, was put on singular.  Symptoms were noted the night of injection.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Pain, Paraesthesia, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Had redness, swelling, "hot to the touch", pain, tingling going up and down the arm, joints felt tight, fever, was put on antibiotics, then developed a rash, was put on singular.  Symptoms were noted the night of injection.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Red blood cell sedimentation rate decreased, Skin warm
Clinical narrative: Had redness, swelling, "hot to the touch", pain, tingling going up and down the arm, joints felt tight, fever, was put on antibiotics, then developed a rash, was put on singular.  Symptoms were noted the night of injection.
Age: 84.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in right shoulder, elbow. Restricted movement. Vaccine injected 11/3/16 still problem on 12/2/16.
Age: 84.0
Sex: M
Vaccine: FLU3, UNK
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Severe pain in right shoulder, elbow. Restricted movement. Vaccine injected 11/3/16 still problem on 12/2/16.
Age: 85.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain in shoulder and arm. Patient received injection on 11/3/16. Problem still exists on 12/2/16.
Age: 85.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain in shoulder and arm. Patient received injection on 11/3/16. Problem still exists on 12/2/16.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood glucose decreased, Decreased appetite, Nodule, Ultrasound scan, Vision blurred
Clinical narrative: A few minutes after injection, dizziness, vision affected, nausea, quite ill. Heavy pain in left armpit, left node very painful, size of a tennis ball, right armpit moderately painful, moderate swelling. Still have problem letting arm rest at side because of pain even though swelling has gone down. Can't sleep too well at nights sometimes. Appetite seemed to have changed. Sugar count dropped. 10/27/2016.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Appetite disorder, Axillary pain, Blood glucose decreased, Dizziness, Local swelling
Clinical narrative: A few minutes after injection, dizziness, vision affected, nausea, quite ill. Heavy pain in left armpit, left node very painful, size of a tennis ball, right armpit moderately painful, moderate swelling. Still have problem letting arm rest at side because of pain even though swelling has gone down. Can't sleep too well at nights sometimes. Appetite seemed to have changed. Sugar count dropped. 10/27/2016.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Lymph node pain, Malaise, Nausea, Poor quality sleep, Ultrasound scan
Clinical narrative: A few minutes after injection, dizziness, vision affected, nausea, quite ill. Heavy pain in left armpit, left node very painful, size of a tennis ball, right armpit moderately painful, moderate swelling. Still have problem letting arm rest at side because of pain even though swelling has gone down. Can't sleep too well at nights sometimes. Appetite seemed to have changed. Sugar count dropped. 10/27/2016.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Visual impairment
Clinical narrative: A few minutes after injection, dizziness, vision affected, nausea, quite ill. Heavy pain in left armpit, left node very painful, size of a tennis ball, right armpit moderately painful, moderate swelling. Still have problem letting arm rest at side because of pain even though swelling has gone down. Can't sleep too well at nights sometimes. Appetite seemed to have changed. Sugar count dropped. 10/27/2016.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLUX
Symptoms: Pyrexia
Clinical narrative: High fever of 103.3.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: The pain was immediate (no lag time) and intense enough over the following two weeks to be distracting during the day and to prevent sleep. Fever evening 11/16/2016; fever went away in about 24 hours. As of 12/13/2016 the pain continues but at a lower intensity. Still I cannot rest or sleep while laying on my right side and any sudden of my right arm is painful. The flu vaccination is clearly the source of this lingering pain. Should I be concerned about further adverse reaction?
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to one unspecified patient of unknown age and gender. The patient's pertinent medical history and concomitant therapies were not reported. On 24-AUG-2016, the patient received a dose of improperly stored PROQUAD (lot # L033698, expiration date: 28-AUG-2017) (dose and route of administration were not provided) for prophylaxis. There were no adverse effects reported. This is one of two reports received from the same reporter. Follow up information was received on 14-NOV-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: US-009507513-1609USA004115:, MERCK 1608USA015655:Mfr number.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse reporting to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot #M000760 with an expiration date: 06-JAN-2018, lot # L000455 with an expiration date: 06-JAN-2017, lot #M019641 with an expiration date: 20-APR-2018, lot #M010482 with an expiration date: 01-MAR-2018 and lot #M019643 with an expiration date: 20-APR-2018 for prophylaxis (strength, dose, anatomical location and route of administration were not reported). Administered doses of VARIVAX experienced temperature excursion with temperature 21 degrees Fahrenheit for 2760 hours for lot# M00760, 1 640 hours for lot#L000455, 720 hours for lot# M019641, 888 hours for lot#M010482, 576 hours for lot# M019643. There was no previous temperature excursion. Digital data logger was not involved. No adverse effect was reported. Follow up information has been received on 14-NOV-2016. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1609USA001235:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, medical history or concomitant therapies was not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (dose lot number and expiry date not reported), intramuscular for prophylaxis. On an other unknown date, the patient was vaccinated with a second dose of GARDASIL 9 (dose, lot number and expiry date not reported), intramuscular for prophylaxis. It was reported that the patient missed his/her third dose. No adverse effects reported. There was no quality complaint involved. As of 05-DEC-2016, there reporter had no additional information to provide. Additional information has been requested is not expected as further information is not available. Sender's Comments: MERCK 1609USA012202: Mfr number.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to 4 unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy was not provided. On 07-OCT-2016, the patients were vaccinated with doses of GARDASIL 9 (dose: 0.5 ml, lot # L043214, expiry date: 30-AUG-2017) and VAQTA (lot # L023936, expiry date: 15-MAR-2017). The pharmacist reported that the vaccines underwent temperature excursion at 28 F for 27 hours (dates were unspecified). No data logger was involved. No adverse effects were reported. Follow up information has been received from the reporting pharmacist on 05-DEC-2016. The pharmacist stated that she did not have any further information. Additional information is not expected as no additional information is available. Sender's Comments: MERCK 1610USA005742: Mfr number.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to multiple patients of unknown age and gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On unspecified dates, the patients were vaccinated with a dose of improperly stored PROQUAD subcutaneously, lot # M022400, expiration date: 01-NOV-2017 (strength and dose  were not provided) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same reporter. Follow up information has been received on 12-DEC-2016 that all telephone attempts to obtain follow-up information had been unsuccessful. Additional information is not requested as no further information was available. Sender's Comments: US-009507513-1611USA000114: MERCK 1610USA011591: Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant, refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of GARDASIL 9 lot # M007764, expiration date 30-JAN-2018 (dosing details were not reported) for prophylaxis. The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The temperature excursion was recorded by a data logger. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Follow up information was received on 09-DEC-2016. As of 09-DEC-2016, All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1611USA000222: US-009507513-1611USA000223: US-009507513-1610USA001301: US-009507513-1611USA000221: US-009507513-1611USA000221: MERCK 1611USA000221: Mfr number.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant, refers to multiple unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were administered improperly stored doses of RECOMBIVAX HB lot # M001578, expiration date 21-NOV-2018 and lot#M010212, expiration date 21-JAN-2019 for prophylaxis. The vaccines were exposed to temperatures ranging from 33F to 35F for cumulative total time frame of 72 hours out of recommended storage range. There were no previous excursions reported. The temperature excursion was recorded by a data logger. No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of the several reports received from the same reporter. Follow up information was received on 09-DEC-2016. As of 09-DEC-2016, All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1611USA000221: US-009507513-1610USA001301: US-009507513-1611USA000223: MERCK 1611USA000222: Mfr number.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Nausea
Clinical narrative: Information has been received from a nurse via a company representative referring to a 17 years old female patient who was not pregnant. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 24-OCT-2016, reported as last Monday, the patient was to be given an unspecified meningococcal vaccine (manufacturer unknown) and instead was administered GARDASIL 9, (patient's specific history with GARDASIL 9 was unspecified, therefore it was unknown if the patient had received prior doses within the series). It was reported that "over the weekend (29-OCT-2016 and 30-OCT-2016)",  the patient was having "nausea and abdominal pain". The patient called to physician to seek medical attention. The outcome of the events was unknown. Follow up information has been received from the same representative on 08-DEC-2016, to confirmed that the unspecified meningococcal vaccine was PNEUMOVAX 23 (lot#: M037669). Additional information has been requested. Product, event and narrative were undated. Sender's Comments: MERCK 1611USA000427: Mfr number.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This report was received from Glaxo Smith Kline and was assigned manufacturer report number 269534. This was originally reported by a consumer. This spontaneous report refers to a male patient of an unknown age concerning himself. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On an unknown date, the patient had received ZOSTAVAX(dosage scheduled, route of administration, lot # and expiration date were not provided) for prophylaxis. It was stated that "my shingles is still recurring" on an unspecified date. There was no product quality complaint (PQC) involved. At the time of reporting, the outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patients, whose ages and genders were not reported. The patients' concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M021124, expiry date 02-FEB-2018; dose and route were not reported) for prophylaxis. The doses of the vaccine were exposed to a temperature excursion of 32.3 degrees Fahrenheit for a time frame of 67 hours, 8 minutes (date unspecified). A digital data logger was involved. There were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA008195.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Pain
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a 44-year-old male patient. The patient denied any pre-existing physician diagnosed allergies, birth defects or medical conditions. On 23-NOV-2016 at 01:48 p.m., the patient was vaccinated in the private's doctor's office/ hospital with the first dose of PNEUMOVAX23 (lot # M006141) (dose was not provided), intramuscular in the left deltoid for prophylaxis. There was no illness at the time of vaccination. Concomitant therapies included FLONASE. On 23-NOV-2016, he experienced a sharp pain in the left wrist and there was a drawing that pointed to the left wrist of the patient. The outcome of the event was reported as recovered, on an unknown date in November 2016. The relatedness between the event and PNEUMOVAX23 was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager concerning multiple patients of unknown age and gender. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapies were unknown. On multiple unspecified dates, the patients were each vaccinated with a dose of improperly stored ROTATEQ (dose and frequency were unknown, lot # M019707 with expiration date 25-OCT-2017) orally for prophylaxis.  No adverse effect was reported. The vaccines had been exposed under temperature 29.6 Fahrenheit and were out of range for 55 minutes. Temperatures were not recorded with a data logger and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003274: US-009507513-1612USA003275: US-009507513-1612USA003276.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has received from a nurse referring to a female patient of unknown age with clindamycin allergy. Patient's concomitant medications was unknown. The patient was pregnant and she was vaccinated with a dose of VARIVAX (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis on 27-OCT-2016. The date of last menstrual period (LMP), estimated date of conception (EDC) and estimated date of delivery (EDD) were unknown. The patient was now receiving "monthly growth scans and seeing a high-risk doctor." No adverse effect was reported. No treatment was given for the patient. The pregnancy outcome was pending. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Asthma, Condition aggravated
Clinical narrative: Information has been received from a medical assistant referring to a currently 62 year old female patient with diverticulitis and pleurisy. The patient had no drug reactions/allergies. Her medical history included pulmonary embolism (3 episodes). In approximately 2009 (reported as "approximately seven years ago"), the patient was vaccinated with an unspecified pneumococcal vaccine (lot #, expiration date, dose and route were not reported) for prophylaxis. It was not known if the PNEUMOVAX23. On an unknown date, the patient experienced aggravation of her asthma. No treatment was given for the event. The medical assistant reported there was no current issues with the patient. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report received from a nurse referred to a unspecified patients. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that an unspecified number of improperly stored doses of GARDASIL 9 (lot number: M030380; expiry date: 01-FEB-2019, lot number: M024261; expiry date: 30-JUL-2018, lot number: M023169; expiry date: 13-JUN-2018, lot number: M018810; expiry date: 28-MAY-2018) was administered to an unspecified number of unspecified patients. The vaccines were stored at 32 F for 13 cumulative hours. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006253: US-009507513-1612USA006253.
Sex: U
Vaccine: MMRV
Symptoms: Product name confusion, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, a dose of of PROQUAD (strength, lot# and expiration date were not reported) was reconstituted for a patient instead M-M-R II (strength, lot# and expiration date were not provided). The reporter stated that this product confusion was due to insufficient knowledge of the staff and confirmed that the patient was not administered and incorrect product and did not missed the scheduled vaccination of the correct product M-M-R II. Additional information is not expected as the reporter did not consent for follow up attempts.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incoherent, Oxygen saturation decreased
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 01-DEC-2016, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route were not reported) for prophylaxis. On 02-DEC-2016, the patient had redness on her arms, legs, and face, and her oxygen level was low. The pharmacist described the patient as being "incoherent" (start date: unspecified date in December 2016) and was later hospitalized for an unspecified amount of time in an unspecified location. The patient was discharged from the hospital on an unspecified date in December 2016. At the reporting time, it was unknown if the patient was still experiencing the symptoms. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager concerning multiple patients of unknown age and gender. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapies were unknown. On multiple unspecified dates, the patients were each vaccinated with a dose of improperly stored GARDASIL 9 (dose and route were unknown, lot # M023169 with expiration date 13-JUN-2018) for prophylaxis.  No adverse effect was reported. The vaccines had been exposed under temperature 29.6 Fahrenheit and were out of range for 55 minutes. Temperatures were not recorded with a data logger and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1612USA003275: US-009507513-1612USA003276: US-009507513-1612USA000738.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager concerning multiple patients of unknown age and gender. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapies were unknown. On multiple unspecified dates, the patients were each vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # M020926 with expiration date 11-AUG-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 29.6 Fahrenheit and were out of range for 55 minutes. Temperatures were not recorded with a data logger and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003274: US-009507513-1612USA003276: US-009507513-1612USA000738.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from an office manager concerning multiple patients of unknown age and gender. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapies were unknown. On multiple unspecified dates, the patients were each vaccinated with a dose of improperly stored VAQTA (dose and route were unknown, lot # M036459 with expiration date 18-JAN-2018) for prophylaxis. No adverse effect was reported. The vaccines had been exposed under temperature 29.6 Fahrenheit and were out of range for 55 minutes. Temperatures were not recorded with a data logger and there was no previous excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003274: US-009507513-1612USA003275: US-009507513-1612USA000738.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 45 year old female consumer with high blood pressure, high blood cholesterol and drug allergy to doxycycline referring to herself. On 07-DEC-2016, the patient was vaccinated with GARDASIL 9, (1 dose, intramuscular, lot number and expiration date not provided) for the prevention of the recurrence of HPV, which was other-than-indicated in the prescribing information. Concomitant therapies included ZOLOFT, mesalamine, lisinopril(manufacturer unknown), LAMICTAL and atorvastatin. On 07-DEC-2016, her arm with the injection site was sore. She did not seek medical attention and there was no lab diagnostics studies performed. The outcome of injection site pain was reported as recovering/resolving. The outcome of other events was unknown. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Medical history, concurrent conditions and concomitant therapies were not reported. On 07-DEC-2016, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L022795, expiration date 05-NOV-2016, intramuscularly for prophylaxis (strength, dose and anatomical location were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of PROQUAD, subcutaneous, lot # M021428 with expiry: 29-OCT-2017, for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature of 22 degree Fahrenheit for 4 hours 23 minutes. It had a previous temperature excursions of 32 degree Fahrenheit for 2 hours 5 minutes. The call was because of data logger. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005501.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of VARIVAX, lot# M008171 with expiry: 16-FEB-2018, (dose and route reported), for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature of 22 degree Fahrenheit for 4 hours 23 minutes. It had previous temperature excursions of 2 hours 5 minutes at a 32 degree Fahrenheit. The call was because of data logger. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005176.
Age: 0.17
Sex: U
Vaccine: HEPA
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 02 month old infant of an unknown gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 09-DEC-2016, 02 month old infant was inadvertently vaccinated with VAQTA injection (lot number/expiry date and dose not reported) for prophylaxis. No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient has been having problem moving his arm since he received the vaccine and it has been 3 month with no improvement.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Blood test, Injected limb mobility decreased, Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Intense pain in the shoulder going down my right arm approximately 1 hr after the shot was administered. Could not raise arm above the shoulder. Emergency room doctor diagnosed as inflamed bicep tendon. Got better w/anti-inflammatories but then got really worse, had trouble lifting arm and getting dressed. MRI showed tendinitis in bicep tendon and rotator cuff and slight tear in labrum tendon from previous shoulder dislocation 12 yrs ago. Physical therapy and more anti-inflammatories were prescribed.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Tendon rupture, Tendonitis, X-ray
Clinical narrative: Intense pain in the shoulder going down my right arm approximately 1 hr after the shot was administered. Could not raise arm above the shoulder. Emergency room doctor diagnosed as inflamed bicep tendon. Got better w/anti-inflammatories but then got really worse, had trouble lifting arm and getting dressed. MRI showed tendinitis in bicep tendon and rotator cuff and slight tear in labrum tendon from previous shoulder dislocation 12 yrs ago. Physical therapy and more anti-inflammatories were prescribed.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, Skin warm, Tenderness
Clinical narrative: Arm had fever in it. Sore to the touch. Can't raise above head. Weak in the arm and still in pain.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Joint swelling, Knee operation, Staphylococcal infection
Clinical narrative: Developed MRSA in right knee. No open wounds. Knee swelled had to have 3 operations.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Cerebral disorder, Deafness, Dizziness, Headache
Clinical narrative: Please note that this inquiry is about an influenza vaccine which I received a year ago on November 6, 2015. Unfortunately, I did not known about VAERS until recently or I would have written earlier. I am a registered nurse, and have received the influenza vaccine yearly for about 30 years without any other reaction than a sore arm for a few days. It is time to get another influenza vaccine, but because of what happened after last year's vaccination, I am afraid to get another shot. For a few days after the vaccine was given, I had a dull headache which was followed by light headedness. Then the following symptoms gradually occurred. I felt as if my brain was irritated or overactive. I could not watch TV or work on the computer because it seemed to irritate my brain. I could not listen to music because that also bothered my brain and even the ticking of the clock was troublesome. Sudden noises seemed to startle my brain. I could not read for more than 1/2 hour when I normally could read a whole day and I did not have patience to do word puzzles. When I was going to sleep, I would sometimes see flashes of light and I experienced buzzing sounds in my brain. Most of the symptoms gradually went away. It took about 4-5 months with the hearing sensitivity lasting the longest. At this time, I do not have any symptoms except for the buzzing sounds which is very minimal and may be tinnitus. I spoke with my family physician and she thought it was possible that it could be a reaction to the influenza vaccine although she said that it was not cited in the literature. I would appreciate hearing from you, particularly if you think the symptoms could have been a reaction to the vaccine and if it is likely to occur again with another influenza vaccination. Thank you.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperacusis, Impaired work ability, Nuclear magnetic resonance imaging normal, Photopsia, Tinnitus
Clinical narrative: Please note that this inquiry is about an influenza vaccine which I received a year ago on November 6, 2015. Unfortunately, I did not known about VAERS until recently or I would have written earlier. I am a registered nurse, and have received the influenza vaccine yearly for about 30 years without any other reaction than a sore arm for a few days. It is time to get another influenza vaccine, but because of what happened after last year's vaccination, I am afraid to get another shot. For a few days after the vaccine was given, I had a dull headache which was followed by light headedness. Then the following symptoms gradually occurred. I felt as if my brain was irritated or overactive. I could not watch TV or work on the computer because it seemed to irritate my brain. I could not listen to music because that also bothered my brain and even the ticking of the clock was troublesome. Sudden noises seemed to startle my brain. I could not read for more than 1/2 hour when I normally could read a whole day and I did not have patience to do word puzzles. When I was going to sleep, I would sometimes see flashes of light and I experienced buzzing sounds in my brain. Most of the symptoms gradually went away. It took about 4-5 months with the hearing sensitivity lasting the longest. At this time, I do not have any symptoms except for the buzzing sounds which is very minimal and may be tinnitus. I spoke with my family physician and she thought it was possible that it could be a reaction to the influenza vaccine although she said that it was not cited in the literature. I would appreciate hearing from you, particularly if you think the symptoms could have been a reaction to the vaccine and if it is likely to occur again with another influenza vaccination. Thank you.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Haemoptysis, Pneumonia pneumococcal
Clinical narrative: 3 weeks after I got the PCV 13 shot I was in the hospital 6 days with streptococcus pneumoniae. I coughed up thickened blood for about 30 min. before going to emergency room. They didn't diagnose it immediately and ready to send me to Hospice care!
Age: 9.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness and warmth at site of injections.
Age: 51.0
Sex: M
Vaccine: FLUX
Symptoms: Gait disturbance, Pain, Rash generalised, Skin exfoliation, Urticaria
Clinical narrative: Hives and rash developed over body. Hands and feet developed a shingles like pain. Could barely walk or touch anything with out severe pain. All the skin on hands and feet peeled off. Very, very painful.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives to (L) arm.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: "Muscle ache and pain of (R) arm. Joint pain down to the bone; traveling to forearm - down to the top outside forearm. Started getting worse 11/5. No problems for a couple of days after getting shot. Pharmacist friend told me to take Naproxen."
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Bronchitis, Gastritis viral
Clinical narrative: Severe weakening of the immune system: Bronchitis contracted 24 hours after shot, followed by pneumococcal pneumonia and viral gastritis. One illness after the other lasting 2 1/2 months and counting.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: The evening after receiving PREVNAR vaccine patient states she began having pain and redness at the injection site. She also experienced body aches, headache, fever and dizziness. Arm remains red and painful. Still has occasional dizziness.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: The evening after receiving PREVNAR vaccine patient states she began having pain and redness at the injection site. She also experienced body aches, headache, fever and dizziness. Arm remains red and painful. Still has occasional dizziness.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: This is a prospective pregnancy case. This 37-year-old female subject was enrolled in an open label study. The subject received Flu Seasonal QIV Dresden (intramuscular) on 17th October 2016. Concurrent medical conditions included head cold. Concomitant products included DELSYM, Prenatal Vitamins and TYLENOL. The subject's estimated date of delivery was 10th June 2017. The subject received Flu Seasonal QIV Dresden at week 6 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden, the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details were provided as follows: The case was previously reported to doctor. At the time of the vaccination, the patient noted that she had a sinus cold. She had this cold for several days prior to this vaccination. This was not related to the vaccination. The patient received FLUARIX QUADRIVALENT in her left deltoid. The batch number reported for FLUARIX QUADRIVALENT was 3CG9P with an expiry date as 22nd June 2017. The date of last menstrual period was not reported. Follow up information was received from consumer on 30th November 2016: This case was upgraded to serious due to an event miscarriage (serious criteria: GSK medically significant). The patient's last date of menstrual period was reported as 2nd September 2016. The patient gave consent to contact her healthcare provider for medical records dated between 2nd September 2016 to 2nd September 2017 and provided contact details for the same. According to ultrasound done on 8th November 2016, the miscarriage occurred at 6 weeks and 3 days of gestation (same day of vaccination). According to the ultrasound scan done on 14th November 2016, the patient had a miscarriage at 5 weeks and 5 days of gestation.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Erythema, Injection site pain, Injection site pruritus, Localised infection, Skin irritation
Clinical narrative: MEMBER HAD SORENESS AND ITCHING AT INJECTION SITE. NOTED IRRITATION AND REDNESS. WAS ADVISED BY MEDICS AT WORKSITE TO GO TO EMERGENCY ROOM FOR FURTHER TREATMENT. UPON, ARRIVAL AT EMERGENCY ROOM MEMBER WAS DIAGNOSED WITH LOCALIZED INFECTION AND TOLD THAT IF SYMPTOMS WORSEN, HE HAD FEVER, OR SITE WORSENED TO RETURN FOR ANTIBIOTICS.