chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Psychomotor hyperactivity
Clinical narrative: This medically confirmed literature report (initial receipt 03-May-2016) concerns a 7 month old female patient. The patient was healthy prior to vaccination. On an unspecified date, the patient received an influenza virus vaccine, (manufacturer and batch number not reported). On an unspecified date, 48 hours after vaccination, the patient presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted, and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices, and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and may be due to delayed start of treatment, as well as the cumulative effect of unrecognized seizures early in her illness course. The outcome was recovering. Reporter's comments: The author reported that this case described the youngest patient with anti-NMDA receptor encephalitis yet reported, and the first to suggest correlation with recent influenza vaccination. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, anti-NMDA receptor encephalitis and all related events are unlisted. Causality: Possible. Time to onset is 48 hours following vaccination. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid analysis. As per the authors comment, this is the youngest patient with anti-NMDA receptor encephalitis reported. Of note, this was a booster dose indicating the infant had prior exposure to influenza vaccination. Causality considered possibly related due to temporal association and absence of other attributable risk.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Anti-NMDA antibody positive, Central venous catheterisation, Decreased activity, Demyelination, Drug administered to patient of inappropriate age
Clinical narrative: This medically confirmed literature report (initial receipt 03-May-2016) concerns a 7 month old female patient. The patient was healthy prior to vaccination. On an unspecified date, the patient received an influenza virus vaccine, (manufacturer and batch number not reported). On an unspecified date, 48 hours after vaccination, the patient presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted, and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices, and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and may be due to delayed start of treatment, as well as the cumulative effect of unrecognized seizures early in her illness course. The outcome was recovering. Reporter's comments: The author reported that this case described the youngest patient with anti-NMDA receptor encephalitis yet reported, and the first to suggest correlation with recent influenza vaccination. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, anti-NMDA receptor encephalitis and all related events are unlisted. Causality: Possible. Time to onset is 48 hours following vaccination. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid analysis. As per the authors comment, this is the youngest patient with anti-NMDA receptor encephalitis reported. Of note, this was a booster dose indicating the infant had prior exposure to influenza vaccination. Causality considered possibly related due to temporal association and absence of other attributable risk.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Encephalitis autoimmune, Eye movement disorder, Gastrointestinal tube insertion, Immunoglobulin therapy, Intensive care
Clinical narrative: This medically confirmed literature report (initial receipt 03-May-2016) concerns a 7 month old female patient. The patient was healthy prior to vaccination. On an unspecified date, the patient received an influenza virus vaccine, (manufacturer and batch number not reported). On an unspecified date, 48 hours after vaccination, the patient presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted, and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices, and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and may be due to delayed start of treatment, as well as the cumulative effect of unrecognized seizures early in her illness course. The outcome was recovering. Reporter's comments: The author reported that this case described the youngest patient with anti-NMDA receptor encephalitis yet reported, and the first to suggest correlation with recent influenza vaccination. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, anti-NMDA receptor encephalitis and all related events are unlisted. Causality: Possible. Time to onset is 48 hours following vaccination. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid analysis. As per the authors comment, this is the youngest patient with anti-NMDA receptor encephalitis reported. Of note, this was a booster dose indicating the infant had prior exposure to influenza vaccination. Causality considered possibly related due to temporal association and absence of other attributable risk.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mental status changes, Neurological examination abnormal, Opisthotonus, Psychomotor hyperactivity, Seizure
Clinical narrative: This medically confirmed literature report (initial receipt 03-May-2016) concerns a 7 month old female patient. The patient was healthy prior to vaccination. On an unspecified date, the patient received an influenza virus vaccine, (manufacturer and batch number not reported). On an unspecified date, 48 hours after vaccination, the patient presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted, and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices, and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and may be due to delayed start of treatment, as well as the cumulative effect of unrecognized seizures early in her illness course. The outcome was recovering. Reporter's comments: The author reported that this case described the youngest patient with anti-NMDA receptor encephalitis yet reported, and the first to suggest correlation with recent influenza vaccination. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, anti-NMDA receptor encephalitis and all related events are unlisted. Causality: Possible. Time to onset is 48 hours following vaccination. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid analysis. As per the authors comment, this is the youngest patient with anti-NMDA receptor encephalitis reported. Of note, this was a booster dose indicating the infant had prior exposure to influenza vaccination. Causality considered possibly related due to temporal association and absence of other attributable risk.
Age: 0.6
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Tonic posturing
Clinical narrative: This medically confirmed literature report (initial receipt 03-May-2016) concerns a 7 month old female patient. The patient was healthy prior to vaccination. On an unspecified date, the patient received an influenza virus vaccine, (manufacturer and batch number not reported). On an unspecified date, 48 hours after vaccination, the patient presented with acute onset of altered mental status, decreased activity, roving eye movements and opisthotonic posturing. She was initially diagnosed with acute demyelinating encephalomyelitis (ADEM) and treated with a short burst of corticosteroids followed by a taper. Symptoms subjectively improved during steroid therapy but did not persist, prompting further diagnostic evaluations. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid antibody titer 68 days after onset of symptoms. Treatment was then undertaken with serial courses of intravenous immunoglobulin (IVIG) and rituximab. The patient's hospital course was protracted, and she required utilization of intensive care unit resources due to aspiration risk, surgical placement of nutritional and vascular access devices, and paroxysmal autonomic hyperactivity (PAH). Minimal improvement in her neurologic exam was observed at time of hospital discharge and may be due to delayed start of treatment, as well as the cumulative effect of unrecognized seizures early in her illness course. The outcome was recovering. Reporter's comments: The author reported that this case described the youngest patient with anti-NMDA receptor encephalitis yet reported, and the first to suggest correlation with recent influenza vaccination. Sender's Comments: Seriousness: Serious. Medically significant. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, anti-NMDA receptor encephalitis and all related events are unlisted. Causality: Possible. Time to onset is 48 hours following vaccination. Anti-NMDA receptor encephalitis was confirmed by cerebrospinal fluid analysis. As per the authors comment, this is the youngest patient with anti-NMDA receptor encephalitis reported. Of note, this was a booster dose indicating the infant had prior exposure to influenza vaccination. Causality considered possibly related due to temporal association and absence of other attributable risk.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Arthralgia, Injection site swelling, Rash erythematous
Clinical narrative: Initial unsolicited report received from a non- healthcare professional on 29 April 2016. This case involves a 04-year-old (gender not reported) patient who was vaccinated with a dose of DAPTACEL; with a dose of IPOL with a dose of HEPATITIS B; with a dose of PROQUAD (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (different dates for all vaccines). The patient's medical history and Concomitant medications were reported as unknown by reporter. On an unknown date, following the vaccination, the patient had experienced swelling of leg between knee and upper thigh and had red bumps around joints of fingers and possibly elbow joints and joint pain. The patient's laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Pyrexia, Varicella post vaccine
Clinical narrative: Red, fluid filled blisters started on face then moved to arms and hands and in mouth. Grandmother states more than 10 blisters all together. fever of 101. Client was exposed to shingles prior to being vaccinated on 5/4/2016. physician said (per grandmother) client has light case of chicken pox.
Age: 73.0
Sex: M
Vaccine: RAB
Symptoms: Deafness, Labyrinthitis, Tinnitus
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hearing loss in a 73-year-old male patient who received RABAVERT. On 27th April 2016, the patient received the 3rd dose of RABAVERT. On 30th April 2016, 3 days after receiving RABAVERT, the patient experienced labyrinthitis. On 1st May 2016, the patient experienced hearing loss (serious criteria GSK medically significant) and ear buzzing. On an unknown date, the outcome of the hearing loss, labyrinthitis and ear buzzing were recovering/resolving. The reporter considered the hearing loss, labyrinthitis and ear buzzing to be possibly related to RABAVERT. Additional details were provided as follows: The patient who was a physician, reported that after 3rd dose of RABAVERT, he experienced acute labyrinthitis. The issue was bad, but it was improving. On 1st May 2016, 4 days after vaccination, the patient also noted that he was experiencing buzzing and had hearing loss. The patient was asking about the use of steroids for this with the product. The patient was transferred to Medical Information.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Drug ineffective, Rotavirus infection, Rotavirus test positive
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 10 year old male patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date when the patient was an infant he was vaccinated with ROTATEQ full series 1 DF (one shot/3 dose series). On an unknown date the patient experienced diarrhea which eventually resulted in the patient being admitted to the hospital and sought medical attention for at least four days due to the dehydration. The patient was tested for and diagnosed with rotavirus in the hospital. The reporter stated that the vaccine was ineffective or if there was a strain of the virus that the vaccine does not work against. The physician stated that the patient was "ok" (recovering/resolving). The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vaccination failure
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 10 year old male patient. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date when the patient was an infant he was vaccinated with ROTATEQ full series 1 DF (one shot/3 dose series). On an unknown date the patient experienced diarrhea which eventually resulted in the patient being admitted to the hospital and sought medical attention for at least four days due to the dehydration. The patient was tested for and diagnosed with rotavirus in the hospital. The reporter stated that the vaccine was ineffective or if there was a strain of the virus that the vaccine does not work against. The physician stated that the patient was "ok" (recovering/resolving). The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Myalgia, Pyrexia, Tremor
Clinical narrative: Shaking chills, muscle aches, fever 100.2 approximately 8 hrs duration, took Extra Strength TYLENOL.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Pt had fever and chills and the injection site became red and inflamed. The redness and inflammation has persisted down her arm from the injection site past her elbow and into her forearm. The site is noticeably inflamed and red. The site also is warm to the touch. The reaction has limited her range of motion as she is unable to fully bend or extend her arm at the elbow.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pt had fever and chills and the injection site became red and inflamed. The redness and inflammation has persisted down her arm from the injection site past her elbow and into her forearm. The site is noticeably inflamed and red. The site also is warm to the touch. The reaction has limited her range of motion as she is unable to fully bend or extend her arm at the elbow.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Robust take following exposure to vaccinia virus, Skin warm, Swelling, Vaccinia virus infection
Clinical narrative: Vaccinia vaccination. Redness/swelling/warmth 120 cm diameter not extending past the elbow, considered to be a robust take. There is no streaking present, and pt denies any cardiac symptoms. No other symptoms aside from the expected minor side effects. Consulted with  IDC, who concurs with findings.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Motor dysfunction
Clinical narrative: PATIENT STATES THAT SHE EXPERIENCED ARM NUMBNESS AND LOSS OF FINE MOTOR SKILL IN FINGERS.
Age: 1.19
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 14 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor
Clinical narrative: Patient looked pale and passed out in chair after last vaccine (HPV) was given.  Elevated patient legs up in another chair, began fanning patient and also gave patient cookies to eat.  Asked patient how she was feeling and she stated she was dizzy.  Checked patient's blood pressure and it was 110/70.  After 10 minutes, asked patient if she was alright and she stated she was not dizzy anymore.  Told patient and family to wait another 10 minutes before leaving.
Age: 0.65
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema
Clinical narrative: Parents noticed redness to right side of neck/shoulder area that radiated partially down back. Tried hydrocortisone OTC cream with no improvement. Parents took child to ER where he was given BENADRYL cream and BENADRYL PO.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Local swelling, Pruritus, Skin warm
Clinical narrative: Swelling 3 1/2" - 4" wide with redness, heat, et itching. Reported by child 24 hours after injection was given. Child was taken to Dr 5-6-16. Mom reports that doctor was unsure if this was inflammation or infection. She was treated with BACTRIM et triamcinolone. 5-11-16 Area/rash is resolving per mom.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stores doses of ZOSTAVAX (lot # L006382 with expiration date 25-MAY-2016, lot # L024999 with expiration date 06-OCT-2016, lot # L040445 with expiration date 15-JAN-2017, dose and route unknown). The vaccines were stored under 6.6 F for 20 minutes without previous excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot # L047305 with expiration date 23-MAY-20`7, lot  # L051098 with expiration date 17-JAN-2017, dose and route unknown). The vaccines were stored under 6.6 F for 20 minutes without previous excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection lot# reported as L048466 with expiration date 02-DEC-2017, lot# reported as L045955 with expiration date 17-NOV-2017, lot# L043624 with expiration date 03-NOV-2017 and lot# L048465 with expiration date 02-DEC-2017 (dose and route of administration were not reported). It was reported that vaccines were stored in temperature -7.8 degrees Celsius for 6 hours 47 minutes (also reported as previous temperature excursion), then stored in temperature -7.3 degrees Celsius for 2 hours, 58 minutes and then the back in range (also reported as the total time out of range was 9 hours, 45 minutes). No adverse effects were reported. The call was made because of data logger. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history and drug reactions/allergies was not reported. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L049536, expiration date 08-DEC-2017, dose and route unknown). Concomitant medication was not reported. No adverse effect was reported. The vaccine was exposed under 36 F for 2 hours and 7 minutes without previous temperature excursion. The call was because of data logger. This is one of several reports received from the same source. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a nurse via a field employee refers to a 36 year old female patient. The concurrent condition and medical history was not reported. On unknown dates the patient (when she was a child) was vaccinated with dose 1 and dose 2 of M-M-R II. The concomitant medication was not reported. On an unknown date, the patient had titers drawn which showed that she had no immunity at all for measles, mumps or rubella (antibody test negative). The patient sought medical attention by making a visit to the nurse. The outcome of antibody test negative was unknown. The causality was unknown. Additional information is not expected due to lack of consent for follow up.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 4 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 9 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # L035510, expiry: 13-MAY-2017, lot # L029615, expiry: 15-MAY-2017 (dosing details and route of administration were not reported). The vaccines were exposed to a temperature of 34.6 F for 1 hour. There was no previous temperature excursion. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to patients of unknown age and gender. No concurrent conditions, medical history allergy/drug reactions and concomitant medications were reported. On an unknown date, 4 patient were vaccinated with improperly stored GARDASIL 9 lot # L038237, expiry: 08-MAY-2017 (dosing details and route of administration were not reported). The vaccines were exposed to a temperature of 34.6 for 1 hour. There was no previous temperature excursion. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The pharmacist reported that on 27-APR-2016, the patient was inadvertently administered an expired dose of ZOSTAVAX with lot # J010447 and expiration date 22-APR-2014 (strength, dose number, dosage and route unspecified). No adverse effect was reported. Product quality complaint (PQC) was involved. No further details was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to a male patient of "70ish year old". The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route, dose, dose number, lot number, expiration date and frequency were not provided). The reporter also stated that the patient did not receive the vaccine from his primary care physician and it was unknown where he received the ZOSTAVAX. Concomitant medications were not reported. On an unknown date, the patient experienced herpes zoster with long lasting pain while he was in a nursing home. The patient sought medical attention on an unknown date and in a unspecified way. However, there was no intervention to prevent serious criteria. There was no product quality complaint (PQC) involved. The outcome of herpes zoster was reported as not recovered. The primary reporter did not provide the causal relationship between ZOSTAVAX and the event. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a licensed practical nurse concerning a currently 23 year old female patient with a history of unrelated pregnancy miscarriage in December 2015. The concurrent condition and concomitant therapy were not reported. On 19-APR-2016 the patient was vaccinated with M-M-R II (strength, dose, route and lot number not provided) at a different unspecified facility. The patient was pregnant with the unspecified pregnancy test done. The last menstrual period was 23-MAR-2016. The estimated date of delivery (EDD) was 28-DEC-2016. At the time of reporting, the outcome of pregnancy was unknown. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, Erythema
Clinical narrative: This spontaneous report as received from a health professional via other company Pfizer (manufacturer control #2016222216) refers to a 61 year old Caucasian female patient. The patient's concurrent conditions included coronary artery disease, rheumatoid arthritis, seasonal allergy and hyperlipidaemia. The patient was immunocompromised. On 15-NOV-2015, the patient was vaccinated with the first dose of ZOSTAVAX (dose, route of administration, lot # and expiry date were not reported). The vaccine was given only once. Concomitant therapies included atorvastatin, methotrexate (manufacturer unknown) and loratadine (manufacturer unknown). On an unknown date in 2015, the patient experienced redness. The outcome of redness was unknown. The relatedness between the event of redness 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 patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, 2 patients were vaccinated with VAQTA (lot#L003011 (non-valid), expiry: 15-NOV-2017, lot#L014068, expiry: 12-NOV-2017, dosing details and route of administration were not reported). The vaccines were exposed to a temperature of 34.6 F for 1 hour. There was no previous temperature excursion. No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Initial unsolicited report received from other non-health care professional on 13 April 2016. This case is linked with case 2016SA074914 (same reporter, same lot number) and case 2016SA074966 (same reporter). This case involves a 48-year-old female patient who was vaccinated with a dose of ADACEL (Batch number: U5288BA, expiration date: 30 March 2018, dose number, route and site of administration were not reported) on 30 March 2016. Patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination (reported as one week later), the patient had experienced sore arm that she could not lift it and was swollen and red. Laboratory investigations and corrective treatment were not reported. The outcome of the events were not reported. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Right arm went numb from injection site down to fingers, throat started hurting, then cold like symptoms appeared.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Eye pruritus, Throat irritation, Wheezing
Clinical narrative: Child with history of anaphylaxis, c/o itchy throat and eyes approximately 10 min after receiving vaccines, brought to urgent care and noted to be wheezing, given SOLU MEDROL and nebulizer and transferred by ambulance to hospital. Given epinephrine and IV BENADRYL and observed for 4 hours prior to discharge home.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Localised infection
Clinical narrative: Patient received a pneumonia vaccine on 9/16. Daughter called on 9/23/2015 and said that mother's right arm was red and looked infected. Advised patient to have it checked and let us know what happens.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Cardiac failure congestive, Chills, Influenza like illness, Pain
Clinical narrative: Got PCV 13 the 24th of March, the 27 of March I started getting chills, fever, ached all over like the flu - cough with green phlegm. I got worse every day, finally went to the hos. admitted. Pneumonia and congestive heart failure. I was ok when I got the shot. Still recovering very weak.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Productive cough, Pyrexia
Clinical narrative: Got PCV 13 the 24th of March, the 27 of March I started getting chills, fever, ached all over like the flu - cough with green phlegm. I got worse every day, finally went to the hos. admitted. Pneumonia and congestive heart failure. I was ok when I got the shot. Still recovering very weak.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray normal, Chest discomfort, Electrocardiogram abnormal, Erythema, Pain in extremity
Clinical narrative: Redness, swelling, pain in same arm as vaccination. Some subjective chest tightness on R side of chest without vital sign changes or abnormalities on chest x-ray.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Sinus tachycardia, Supraventricular extrasystoles, White blood cell count increased
Clinical narrative: Redness, swelling, pain in same arm as vaccination. Some subjective chest tightness on R side of chest without vital sign changes or abnormalities on chest x-ray.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV, SMALL, ANTH, JEV, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest pain, Electrocardiogram ST segment elevation, Myocarditis
Clinical narrative: Patient started to develop positional, dull, left chest pain that worsened over the next 2 days and was diagnosed as pericarditis on 10May2016.  He was subsequently transferred to a hospital on the evening of 10May and admitted for further evaluation.  Was again diagnosed with myopericarditis while on the Cardiology service.  Myopericarditis was felt to be possibly related to recent vaccination for smallpox and Japanese encephalitis.
Age: 20.0
Sex: M
Vaccine: ANTH, JEV, SMALL, ANTH, JEV, SMALL
Symptoms: N-terminal prohormone brain natriuretic peptide increased, Pericarditis, Troponin increased
Clinical narrative: Patient started to develop positional, dull, left chest pain that worsened over the next 2 days and was diagnosed as pericarditis on 10May2016.  He was subsequently transferred to a hospital on the evening of 10May and admitted for further evaluation.  Was again diagnosed with myopericarditis while on the Cardiology service.  Myopericarditis was felt to be possibly related to recent vaccination for smallpox and Japanese encephalitis.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site pain
Clinical narrative: Patient received ADACEL and ZOSTAVAX immunizations in her Left arm on 4/25/16. Patient called 5/10/16 and stated that her arm was sore where she received the ADACEL vaccine. The pain occured the following day, which is as expected with ADACEL. But the patient stated that the pain went away and then came back and still feels sore and was concerned that it was caused by the vaccine. I called her today to follow up and she stated that it is feeling a lot better and thinks that it was caused by something else besides the vaccine. And will follow up with her doctor next week if she feels the pain is still lingering.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: None.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on legs and arms starting at 10:00 PM, worse when woke up, extreme itching. Sought medical treatment at ED at 08:30 AM. Benadryl 25 mg x 2 pills given.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Petechiae
Clinical narrative: Petechiae rash only on bilateral legs that started approximately four hours after vaccines were given. This child also presented with irritability and very fussy. No treatment was given at this time. Continued monitoring of the child was in place. Rash cleared on 5/9/16.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema
Clinical narrative: Some redness at injection site. Standing Protocol M.D.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Soreness at injection shot.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Soreness briefly at site of injection, last several days, redness.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This vaccination was received as a reaction to a scratch received while shaving. Swelling, sore, red, lasting several days.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Varicella vaccination 4/27/16 at 0900 and next day at about 1700 noticed reddened, raised area at site of injection. Some discomfort and some itching.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Injection site warmth, Rash
Clinical narrative: Left back arm hot to the touch. Erythematous condition, unspecified, rash and other nonspecific skin eruption.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash
Clinical narrative: 1 week after injection, developed pain and 1.5 inch diameter pink, non-raised rash. Rash started to fade and symptoms fully resolved by 5-3-16.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Sat after Tdap, 5 minutes later fainted-slid to floor from sitting position. Responded to verbal directions immediately-opened eyes. To Left lying position for 10 minutes. BP 112/66 pulse 64. To sitting position-tolerated water and crackers - BP 104/61, pulse 75 oxygen saturation 100%. MD evaluated patient and spoke to Mom. To standing position - tolerated well - to home within 30 minutes.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt received vaccine (FLUZONE HD) on 11/24/15. Came today complaining of sore left arm! Pt received vaccine on right arm. Informed pt to see Dr. May not be correlated to vaccine.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Injected limb mobility decreased, Injection site pain
Clinical narrative: Throbbing pain in left arm from shoulder to elbow. Broke out in a sweat. Doctor said I should go to ER. Could not lift arm. It lasted until Thursday 2 days. Was given injection of pain medication.
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Haematocrit normal, Haemoglobin normal, Injection site abscess, Metabolic function test normal, Platelet count normal
Clinical narrative: Onset of rash one day after vaccination. Also developed abscess (L) thigh (not injection site).
Age: 0.63
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Rash, White blood cell count increased
Clinical narrative: Onset of rash one day after vaccination. Also developed abscess (L) thigh (not injection site).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 4 year old child vaccinated 4/29/16 (L) upper arm; DTAP 5 Pertussis Antigens 0.5 mL left deltoid IM, IPV 0.5 mL left deltoid SQ (subcutaneous). The morning of 4/30, noted left arm swelling, itching and redness. Taken to hospital ED. 5/1/16 hospital ED visit - after initial visit 4/30/16 - begin on BENADRYL 5 mL QID prn, ibuprofen 100 mg po q 4-6 hours prn, cephalexin 250 mg po TID X 7 days. Follow-up primary care as needed.  Visited hospital 5/3/16.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Per Mom's report - patient had a rash on her face that appeared the day after she received the vaccine. She was seen at facility and was given Prednisone, CEPHALEXIN and Hydroxyzine.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Blood potassium normal, Dizziness, Full blood count normal, Human chorionic gonadotropin negative, Injection site pruritus
Clinical narrative: Itching at injection site occurred after 10 min - no redness or warmth - denied throat/mouth itching or swelling, VSS 30 min after injection c/o nausea and dizziness, VSS - 1230 evaluated by ED provider, VSS - 1356 Discharged home stable DX: dizziness, vertigo.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Metabolic function test normal, Nausea, Vertigo
Clinical narrative: Itching at injection site occurred after 10 min - no redness or warmth - denied throat/mouth itching or swelling, VSS 30 min after injection c/o nausea and dizziness, VSS - 1230 evaluated by ED provider, VSS - 1356 Discharged home stable DX: dizziness, vertigo.
Age: 53.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Mass, Pyrexia, Skin warm, Swelling
Clinical narrative: I was the patient. I went to another doctors office the following day urgent care had a latent adverse reaction. Fever/lump/swelling- hot to the touch.