chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Constipation
Clinical narrative: Constipation for 5 days.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Abnormal behaviour, Asocial behaviour, Crying, Decreased eye contact, Emotional disorder
Clinical narrative: Child woke up screaming and was unable to be calmed. Noted severe changes in behavior when responding to sensory input: becoming afraid of noises, motion sickness, suddenly adverse to tactile stimuli, seeking deep pressure. Noted decrease in verbal skills; using fewer words and more limited vocabulary. Regression in potty training and sleep behaviors. Child became fearful of movement activities such as swinging, climbing and jumping. Child became very emotionally fragile with periodic unprovoked crying and meltdowns. Decreased eye contact and social interactions. Unexplained vomiting 1-2 times a month for 10 months following vaccine. Treatment consisted of 9 months of intensive occupational therapy to address sensory processing concerns. Concerns have lessened but child continues to have difficulties with sensory processing.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Emotional distress, Fear, Motion sickness, Screaming, Sensory processing disorder
Clinical narrative: Child woke up screaming and was unable to be calmed. Noted severe changes in behavior when responding to sensory input: becoming afraid of noises, motion sickness, suddenly adverse to tactile stimuli, seeking deep pressure. Noted decrease in verbal skills; using fewer words and more limited vocabulary. Regression in potty training and sleep behaviors. Child became fearful of movement activities such as swinging, climbing and jumping. Child became very emotionally fragile with periodic unprovoked crying and meltdowns. Decreased eye contact and social interactions. Unexplained vomiting 1-2 times a month for 10 months following vaccine. Treatment consisted of 9 months of intensive occupational therapy to address sensory processing concerns. Concerns have lessened but child continues to have difficulties with sensory processing.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Sleep disorder, Speech disorder, Vomiting
Clinical narrative: Child woke up screaming and was unable to be calmed. Noted severe changes in behavior when responding to sensory input: becoming afraid of noises, motion sickness, suddenly adverse to tactile stimuli, seeking deep pressure. Noted decrease in verbal skills; using fewer words and more limited vocabulary. Regression in potty training and sleep behaviors. Child became fearful of movement activities such as swinging, climbing and jumping. Child became very emotionally fragile with periodic unprovoked crying and meltdowns. Decreased eye contact and social interactions. Unexplained vomiting 1-2 times a month for 10 months following vaccine. Treatment consisted of 9 months of intensive occupational therapy to address sensory processing concerns. Concerns have lessened but child continues to have difficulties with sensory processing.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a non health care professional on 17 September 2015. This case is linked to case 2015SA143288 (same reporter) This case involves a (age unknown) female patient who was vaccinated with a [dose not reported] intramuscular [dose series not reported] dose of FLUZONE QIV (batch number UI440AE, expiry date 30-JUN-2016) in "right and left deltoid" on 15 September 2015.  Illness at time of vaccination was not applicable and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA). Concomitant medications were not reported. On 16 September 2015, one day following the vaccination patient had had cellulitis and injection site redness, swelling, pain and warm to touch. Patient required emergency room (ER)/doctor visit. Patient laboratory investigation was not reported. It was reported that, patient treated for cellulitis with ABX (antibiotics). The outcome of event was not recovered. List of documents held by sender: none. Follow up information received non-healthcare professional on 16 November 2015. A 35-year-old female patient received vaccine in left deltoid. Patient did not have any Illness at time of vaccination and pre-existing physician-diagnosed allergies, birth defects and medical conditions was reported as no.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Angioedema, Urticaria
Clinical narrative: Upon internal review significant correction was performed to update suspect product coding on 30 Oct 2015. Initial unsolicited report received from a nurse on 25 September 2015. This case involves a 37-year-old female patient who was vaccinated with a [dose not reported] intramuscular (dose series not reported) dose of FLUZONE (batch number UI443AA, expiry date was not reported) in left deltoid on 25 September 2015. On an unspecified date of 2014 "previous year" patient had received a dose of Fluzone. Illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as iodine. Other medical history and concomitant medications were not reported. On 25 September 2015, an hour following the vaccination patient had facial angioedema hive like. It was reported that, patient required emergency room (ER)/doctor visit. Patient laboratory investigation and corrective treatment was not reported. The outcome of event was not recovered. Upon internal review, the company decided to consider the event serious because of important medical event facial angioedema hive like. List of documents held by sender: none. Addendum: 30 Oct 2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to change product coding. Sender's Comments: Angioedema is listed with INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This case is very poorly documented and additional information including patient's medical history of allergy as well as results of investigation identifying the culprit allergen are needed to further assess the case.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Mechanical ventilation, Myelitis transverse
Clinical narrative: Initial unsolicited misuse report received from a physician on 14 October 2015. This case involves a 67-year-old female patient who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number UI443AA, expiry date 30 Jun 2016) in left deltoid on 3 September 2015. The patient's medical history includes Renal Cell Carcinoma and also had lung nodules. Apart from this pre-existing physician diagnosed allergies, birth defects, medical conditions, illness at time of vaccination and concomitant medications were not reported. On an unspecified date, 2 weeks after the vaccination the patient experienced Transverse Myelitis. It was reported that the patient was hospitalized and was on ventilator and due to patient's condition of Renal Cell Carcinoma and lung nodules, biopsy was not performed for lung nodules. The patient required hospitalization. Laboratory investigations and corrective treatments were not reported. The final outcome was reported as not recovered. Documents held by sender: none. Sender's Comments: Transverse myelitis is listed with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Time to onset is compatible with of a role of the vaccine. However results etiological investigation such as infectious work-up, search for autoimmune disease, and damage to blood flow, were not provided and are needed to further assess this case. Based on the available information, a role of the vaccine cannot be established.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 15 October 2015. This case involves a 05-years-old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number: UI446AA, expiry date: 30 June 2016, dose, dose in series were not reported)  intramuscularly in left deltoid on 08 October 2015. Illness at time of vaccination was reported as unknown, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as cashews and pistachios and any other vaccinations within 4 weeks of vaccinations was reported as none. Concomitant medications were not reported. On 08 October 2015, same day following the vaccination, the patient had developed blister reaction in left arm with several small blisters with warmth and induration at the injection site. It was reported that smaller blisters were clear filled. The patient required ER/doctor visit. The patient's laboratory data and corrective treatment were not reported. The patient was not recovered from the events. Follow-up information received from a nurse on 21 December 2015. It was reported that patient was vaccinated with 0.5 ml dose of FLUZONE QIV. The patient required doctor visit. Patient was treated with Benadryl and cool compress as corrective treatment. On an unknown date patient recovered from all the events. List of documents held by sender: none.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial unsolicited report received from a nurse on 16 October 2015. This case involves a 52-years-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI446AA, expiry date: 30 June 2016) intramuscularly in left deltoid on 14 October 2015. The patient illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On 15 October 2015, one day following the vaccination, the patient had developed red, puffy left armpit. Laboratory data and corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none. Follow up report received from a nurse on 7 January 2016. The patient was recovered from the event (reported as patient was fine and no lumps).
Sex: F
Vaccine: FLU4
Symptoms: Altered state of consciousness, Feeling abnormal, Pallor, Paraesthesia
Clinical narrative: Initial unsolicited report received from a nurse on 19 October 2015. This case involves a [age 11 or 12] female patient who was vaccinated with a [route and dose in series were not reported] single dose of FLUZONE QIV MULTI DOSE VIAL (batch number, expiry date and site of administration were not reported) on an unspecified date. The medical history and concomitant medications were not reported. On an unspecified date, few seconds following the vaccination, the patient felt uneasy. On an unspecified date, few minute following the vaccination, the patient turned pale and had the sensation of passing out. It was reported that, after 30 minutes patient still felt like passing out and her face was tingly. Lab data was not reported. Corrective treatment was Benadryl and Solu-Medrol. The outcome of event was recovering (patient began to feel better). List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: International normalised ratio increased
Clinical narrative: Initial unsolicited report received from a Healthcare professional on 19 October 2015. This case involves a patient (age and gender not reported) who was vaccinated with a dose of FLUZONE QIV (from MDV) (batch number, dose in series route and site of administration were unknown and expiry date, dose were not reported) on an unknown date. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown. Concomitant medications were not reported. On an unknown date, following the vaccination the patient's International normalized ratio (INR) went from 2.7 up to 5.9. Laboratory data and corrective treatment was not reported. The outcome of event was unknown. List of documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Initial unsolicited report received from a nurse on 22 October 2015. This case involves a (51-year-old) male patient who was vaccinated with a intramuscular [dose series not reported] dose of FLUZONE QIV NP (batch number UI443AC, expiry date 30 June 2016) in left deltoid on 30 September 2015. Illness at time of vaccination was cold symptoms and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as not applicable. Concomitant medications was not reported. On 04 October 2015, four days "7 days after vaccination" following the vaccination patient developed left (L) arm weakness and had to use two hands to lift" now states right (R) arm weakness as well. It was reported that, patient was seen by primary care doctor and unknown specialist. It was reported that, patient required emergency room (ER)/doctor visit. Laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from non-health professional (consumer) on 30-October-2015. This case involves a 49 year old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI441AB, expiration date, dose, dose number, and site of administration not reported) given intramuscularly on 20-October-2015. The patient's medical history was reported as none. The patient denies of any vaccine as concomitant medication taken within 4 weeks of vaccination. On 30-october-2015, ten days following the vaccination, the patient developed red, raised, firm area at injection site that was warm to touch and also painful from neck to fingertips. Laboratory investigations were not reported. Corrective treatment was not reported. Outcome of the events was unknown. List of documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from non-health professional (consumer) on 30-October-2015. This case involves a 49 year old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI441AB, expiration date, dose, dose number, and site of administration not reported) given intramuscularly on 20-October-2015. The patient's medical history was reported as none. The patient denies of any vaccine as concomitant medication taken within 4 weeks of vaccination. On 30-october-2015, ten days following the vaccination, the patient developed red, raised, firm area at injection site that was warm to touch and also painful from neck to fingertips. Laboratory investigations were not reported. Corrective treatment was not reported. Outcome of the events was unknown. List of documents held by sender: none.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 04 November 2015. This case involves a 06-year-old male patient who was vaccinated with 0.5 ml dose of Fluzone quadrivalent multi-dose vial (batch number: UI443AC, expiry date, dose, route of administration were not reported) in left deltoid on 28 October 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed severe swelling of left upper arm with warmth and redness. It was reported that, reaction was seen on 30 October 2015. The patient's laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from a nurse on 04 November 2015. This case involves a 07-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT multi-dose vial (batch number: UI443AC, expiry date, dose, route of administration were not reported) in left deltoid on 29 October 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed severe swelling of entire upper arm with warmth and redness. It was reported that, reaction was seen on 02 November 2015. The patient's laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Impaired work ability, Malaise, Weight decreased
Clinical narrative: Initial unsolicited report received from a consumer on 13 November 2015. This case involves a 72-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number- UI443AB, expiry date-30 June 2016, route and site of administration were not reported) on an unspecified date. The patient's medical history includes illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced weight loss. The patient was feeling ill and unable to work. Laboratory data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Chills, Pruritus, Throat tightness, Urticaria
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office staff) on 13 November 2015. This case involves a male patient who was vaccinated with a dose of FLUZONE QIV) (batch number UI431AB, expiration date 30 June 2016, route, cycle in series and site of administration was not reported) on an unspecified date. Patient medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced itching, hives, throat closing, chills and anaphylactic. Lab data and corrective treatments were not reported. Outcome of events was not reported. Upon internal review, the case was considered to be serious due to important medical events: anaphylactic reaction, itching and hives. List of documents held by sender: none.; Sender's Comments: This is poorly documented medically not confirmed case. In which the office staff reported as anaphylactic reaction after administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case. Based on the information the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Initial unsolicited report received from a nurse on 23 November 2015. This case involves three patients (age and gender not reported) who was vaccinated with first dose of FLUZONE QIV (batch number: UI431AD, expiry date: 30 June 2016) intramuscularly in deltoid on 27 October 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed pain in the arm muscle and difficulty with ROM for close to a month. The reporter denied actual pain, redness and swelling at the injection site. The patient required ER/doctor visit. Laboratory data was not reported. The patients were prescribed ibuprofen, physical therapy and ROM exercises. The outcome of the event was unknown. List of documents held by sender: none.
Age: 54.0
Sex: M
Vaccine: HEPAB, TYP, HEPAB
Symptoms: Disorientation, Gaze palsy, Loss of consciousness, Seizure, Tremor
Clinical narrative: Initial unsolicited report received from other non health care professional (CMA) on 09 August 2016. This case involves a 54-year-old patient (gender was unknown) who was vaccinated with a first dose of TYPHIM VI (Batch number: M0102-1, expiration date, dose was not reported) intramuscularly in the left deltoid and with a dose of TWINRIX (Manufacturer: GSK, Batch number, expiration date, dose, route and site of administration was not reported) on 02 August 2016. Patient's illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions included PCN (allergy to penicillin). Concomitant medications were not reported. On 02 August 2016, immediately after the vaccines, patient was observed to pass out with eyes to back of head, convulsions and shaking with disorientation. The patient was sent to ER. Laboratory investigations and corrective treatment were not reported. The patient was not yet recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event Convulsions. List of documents held by sender: none. Sender's Comments: This is poorly documented medically not confirmed case where convulsions reported after administration of TYPHOID VI POLYSACCHARIDE VACCINE. Time to onset is compatible with the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Age: 54.0
Sex: M
Vaccine: HEPAB, TYP, HEPAB
Symptoms: Seizure, Syncope
Clinical narrative: Initial unsolicited report received from other non health care professional (CMA) on 09 August 2016. This case involves a 54-year-old patient (gender was unknown) who was vaccinated with a first dose of TYPHIM VI (Batch number: M0102-1, expiration date, dose was not reported) intramuscularly in the left deltoid and with a dose of TWINRIX (Manufacturer: GSK, Batch number, expiration date, dose, route and site of administration was not reported) on 02 August 2016. Patient's illness at time of vaccination was reported as none. Pre-existing physician diagnosed allergies, birth defects, medical conditions included PCN (allergy to penicillin). Concomitant medications were not reported. On 02 August 2016, immediately after the vaccines, patient was observed to pass out with eyes to back of head, convulsions and shaking with disorientation. The patient was sent to ER. Laboratory investigations and corrective treatment were not reported. The patient was not yet recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event Convulsions. List of documents held by sender: none. Sender's Comments: This is poorly documented medically not confirmed case where convulsions reported after administration of TYPHOID VI POLYSACCHARIDE VACCINE. Time to onset is compatible with the role of the vaccine. However, investigation results ruling out a concurrent infection and other etiologies would be helpful to further assess this case.
Sex: M
Vaccine: TTOX
Symptoms: Swelling
Clinical narrative: Initial unsolicited report received from a Non-health care professional via other company (Merck) on 10 August 2016. This case involves a male (age was reported as unknown) patient who was vaccinated with TETANUS TOXOID ADSORBED (batch number, expiry date, dose, route and site of administration were not reported) on an unknown date. The medical history and concomitant medications were reported as unknown. On an unknown date, after vaccination patient experienced swelling of the whole body. Lab data and corrective treatment were reported as unknown. The outcome of the event was unknown. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Anxiety, Arthralgia, Asthma, Back pain
Clinical narrative: This spontaneous report was received from a 62 year old female consumer who refers to herself. There were no concurrent conditions and medical history reported. The patient had no allergies or drug reactions. On 02-AUG-2016, the patient was vaccinated with the first dose of ZOSTAVAX (lot number and expiration date were not reported), 19400 plaque-forming unit (PFU), vial, 1 vial (19400 PFU) administered subcutaneously. Concomitant therapies included balsalazide disodium, SYNTHROID and inhaler (composition, brand and manufacturer unspecified). The patient reported that while sleeping on night of 05-AUG-2016, and into 06-AUG-2016, she experienced extreme joint pains, swollen joints, aching joints, cramping, back pain, swollen and inflamed stomach, diarrhea, headache and extreme swelling underneath her eyes. The patient also reported feelings of anxiousness and trouble breathing. She also had flu-like symptoms. After a week, the patient was still having the same symptoms. The patient did not go to the doctor nor the hospital. No treatment was given for the patient's symptoms and no diagnostic labs were drawn. It was also reported that the patient had ulcerative colitis (reported as "ulceric cholitis") and mild asthma. The outcome of colitis ulcerative and asthma was unknown at the time of the report. The patient did not recover from joint swelling, arthralgia, headache, diarrhoea, influenza like illness, anxiety, dyspnoea, eye swelling, gastritis, abdominal distension, back pain and muscle spasms at the time of the report. No further information was provided. No product quality complaint was involved in this case. The causality between all reported events and ZOSTAVAX was not reported. Upon internal review, ulcerative colitis was determined to be medically significant. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Colitis ulcerative, Diarrhoea, Dyspnoea, Gastritis, Headache
Clinical narrative: This spontaneous report was received from a 62 year old female consumer who refers to herself. There were no concurrent conditions and medical history reported. The patient had no allergies or drug reactions. On 02-AUG-2016, the patient was vaccinated with the first dose of ZOSTAVAX (lot number and expiration date were not reported), 19400 plaque-forming unit (PFU), vial, 1 vial (19400 PFU) administered subcutaneously. Concomitant therapies included balsalazide disodium, SYNTHROID and inhaler (composition, brand and manufacturer unspecified). The patient reported that while sleeping on night of 05-AUG-2016, and into 06-AUG-2016, she experienced extreme joint pains, swollen joints, aching joints, cramping, back pain, swollen and inflamed stomach, diarrhea, headache and extreme swelling underneath her eyes. The patient also reported feelings of anxiousness and trouble breathing. She also had flu-like symptoms. After a week, the patient was still having the same symptoms. The patient did not go to the doctor nor the hospital. No treatment was given for the patient's symptoms and no diagnostic labs were drawn. It was also reported that the patient had ulcerative colitis (reported as "ulceric cholitis") and mild asthma. The outcome of colitis ulcerative and asthma was unknown at the time of the report. The patient did not recover from joint swelling, arthralgia, headache, diarrhoea, influenza like illness, anxiety, dyspnoea, eye swelling, gastritis, abdominal distension, back pain and muscle spasms at the time of the report. No further information was provided. No product quality complaint was involved in this case. The causality between all reported events and ZOSTAVAX was not reported. Upon internal review, ulcerative colitis was determined to be medically significant. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Joint swelling, Muscle spasms, Swelling, Swelling face
Clinical narrative: This spontaneous report was received from a 62 year old female consumer who refers to herself. There were no concurrent conditions and medical history reported. The patient had no allergies or drug reactions. On 02-AUG-2016, the patient was vaccinated with the first dose of ZOSTAVAX (lot number and expiration date were not reported), 19400 plaque-forming unit (PFU), vial, 1 vial (19400 PFU) administered subcutaneously. Concomitant therapies included balsalazide disodium, SYNTHROID and inhaler (composition, brand and manufacturer unspecified). The patient reported that while sleeping on night of 05-AUG-2016, and into 06-AUG-2016, she experienced extreme joint pains, swollen joints, aching joints, cramping, back pain, swollen and inflamed stomach, diarrhea, headache and extreme swelling underneath her eyes. The patient also reported feelings of anxiousness and trouble breathing. She also had flu-like symptoms. After a week, the patient was still having the same symptoms. The patient did not go to the doctor nor the hospital. No treatment was given for the patient's symptoms and no diagnostic labs were drawn. It was also reported that the patient had ulcerative colitis (reported as "ulceric cholitis") and mild asthma. The outcome of colitis ulcerative and asthma was unknown at the time of the report. The patient did not recover from joint swelling, arthralgia, headache, diarrhoea, influenza like illness, anxiety, dyspnoea, eye swelling, gastritis, abdominal distension, back pain and muscle spasms at the time of the report. No further information was provided. No product quality complaint was involved in this case. The causality between all reported events and ZOSTAVAX was not reported. Upon internal review, ulcerative colitis was determined to be medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report was received from a registered nurse, refers to a 20 year old female patient. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. Concomitant medications were reported as none. On an unknown date, the patient was vaccinated with first dose in the series of GARDASIL lot # L005560, expiry date 18-DEC-2016, 0.5 ml, intramuscularly. The nurse reported that the patient experienced "Bell's palsy" 2 weeks after receiving the first vaccination in the series of GARDASIL. She sought medical attention at hospital emergency room on 03-AUG-2015. Treatment was prescribed for the Bell's palsy described as "Prednisone and eye drops" while in the Emergency Room. No lab diagnostics studies were performed. She recovered on an unspecified date. The reporter did not provide the relatedness of the event with GARDASIL. No product quality complaint (PQC) was involved. No further information provided. Upon internal review "Facial paralysis" was determined to be medically significant. 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 or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 22-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported. There was no adverse effect reported. This is one of several reporter received form the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Haemoglobin normal, Immediate post-injection reaction, Syncope
Clinical narrative: Immediately after receiving vaccines pt had a syncopal episode and fell to floor.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Soreness, tiredness, fatigue, headache, fever, chills, muscle pain.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: Soreness, tiredness, fatigue, headache, fever, chills, muscle pain.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect 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 or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administration vaccine underwent temperature excursion at 8.3 degrees Celsius for 19 minutes.There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
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. On 04-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of the reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
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 or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administration vaccine underwent temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received form a physician refers to multiple unspecified patients of an unknown age. The patients' pertinent medical history, concomitant medications and drug reactions/allergies are not reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA (lot # M011116 and expiry date 17-JUN-2017). Temperature excursion occurred at 46.8 F for 10 hours. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant/administrator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, intramuscularly, 0.5 ml, the second dose in series, lot # M000442, expiry date 31-MAR-2018 (anatomical location was not specified). The administered dose of RECOMBIVAX HB underwent temperature excursion of 32.2 Fahrenheit degrees for 5 hours. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse reporting on a fellow colleague. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was topically exposed to VARIVAX in an unspecified eye "during preparation". No adverse effects reported. The nurse stated it was unspecified how the VARIVAX vaccine got in to their colleague's eye however the nurse did confirm that no quality issue was involved. 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 demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 02-AUG-2016, the patient was vaccinated with his first dose of improperly stored VARIVAX lot # L046884, expiration date 23-NOV-2017, 0.5 ml, subcutaneous. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 23.9 degrees Fahrenheit for 1 hour and 25 minutes. 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: M
Vaccine: DTAP, HPV9, IPV, MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: GARDASIL 9 inadvertently given to patient; no adverse effects noted.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: GARDASIL 9 inadvertently given to patient; no adverse effects noted.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Malaise, Syncope
Clinical narrative: HPV vaccination was administered in right deltoid. MENACTRA was administered following HPV in Left deltoid. Immediately following administration of MENACTRA, patient stated that he didn't feel well and had a syncopal episode. The episode lasted 10-15 seconds. patient then became alert and oriented-returned to baseline.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Musculoskeletal pain, Rash macular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's concurrent conditions included high blood pressure. The patient had no drug reactions and no allergies. On 18-JUL-2016, the patient was vaccinated with the first dose of ZOSTAVAX 0.65 ml, subcutaneously, lot # M003486 with expiration date: 27-MAR-2017. The patient's concomitant medications included an unspecified blood pressure medication and an unspecified dose of warfarin. On 19-JUL-2016 (reported as "the next day"), the patient experienced "heat" at the injection site. On 05-AUG-2016, the patient presented with spots under his armpits and an exacerbated unspecified pain in the left shoulder. The patient received an unspecified treatment for the events. None lab diagnostics studies were performed. Product quality complaint (PQC) was not involved. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not provided. Addition information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. Their medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were administered improperly stored PROQUAD (rHA (recombinant human albumin), strength, dose, frequency and route were unknown; lot number M012986 with expiration date as 12-SEP-2017 and M015698 with and expiration date as 26-SEP-2017. No adverse effects were reported. This is one of the two reports that received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 13 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medication were not reported. Information regarding the patient's drug reactions or allergies were not provided. On an unknown, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (manufacturer unknown) (lot # L031196, expiry date 05-FEB-2017) 1 ml, once intramuscularly intended for adults instead of hepatitis a vaccine, inactivated (manufacturer unknown) intended for adolescents. No adverse event was specified. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients (age and gender not specified). Concurrent conditions, medical history and concomitant medication use were not provided. The physician reported that on 07-JUL-2016, 11-JUL-2016, 12-JUL-2016 and 13-JUL-2016 an unspecified number patients were vaccinated with M-M-R II (lot # L032044, expiration date 24-AUG-2017) that was improperly stored. No adverse effects were reported. No further information was provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L036823 and expiration date 24-DEC-2016, lot # M0017445 and expiration date 07-APR-2017; exact doses and route of administration were not provided). No previous temperature excursion was reported. Digital Data Logger was not involved. At the time of report, the temperature was back in range. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. Approximately in February 2014 (reported as "30 months ago"), the patient was vaccinated with the first dose of GARDASIL injection (lot number, expiry date, dose, route, frequency and indication were not reported). Approximately in August 2015 (reported as "18 months after the first dose,") the patient received the second dose of GARDASIL injection (lot number, expiry date, dose, route, frequency and indication were not reported). Concomitant therapies were not provided. No adverse effect was reported. No adverse effect was reported. No product quality complain (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple unspecified patients of an unknown age. The patients' pertinent medical history, concomitant medications and drug reactions/allergies are not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 (lot # L037554and expiry date 25-DEC-2017). Temperature excursion occurred at 46.8 F for 10 hours. No adverse events were reported This is one of the several reports received from same reporter. Additional information had 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 demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administration vaccine underwent temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.