chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Malaise, Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 68 year old female patient. The patient's current condition included nerve pain, high blood pressure, acid reflux, seasonal allergies, cholesterol, thyroid dysfunction and diabetes. The patient's historical medication (last year) (unknown date in 2017)) included PREVNAR13 (Pfizer/Lot R48403 and expiration 01-MAR-2018) and patient developed skin warm, peripheral swelling, malaise and pyrexia. The patient's historical conditions included malaise, pyrexia, skin warm and peripheral swelling. Concomitant therapies included gabapentin, carvedilol, potassium (unspecified), omeprazole, furosemide, montelukast sodium (manufacturer unknown), isosorbide, lovastatin (manufacturer unknown), lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 03-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (anatomical location not reported) (lot # N022303, expiration date 01-MAR-2019) intramuscularly for pneumonia prevention. It was reported that the patient called and visited pharmacy on 04-MAR-2018 to report that on 04-MAR-2018 she had woken up this morning with a swollen left arm that felt hard and warm to the touch (peripheral swelling and skin warm). It was also reported patient had a fever. The patient called the pharmacy on 05-MAR-2018 to report not feeling well (malaise) and the entire left arm was swollen. It was reported that the patient would see an unspecified physician on 05-MAR-2018. The patient was treated for the events. The patient sought medical attention: called and visited pharmacist on 04-MAR-2018, would see physician on 05-MAR-2018. There was no intervention to prevent serious criteria. The outcome of the events was reported as not recovered/not resolved. The reporter did not assess the causality of the events. The reporter considered the events skin warm and peripheral swelling to be serious due to disability as the patient had difficulty using left arm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 68 year old female patient. The patient's current condition included nerve pain, high blood pressure, acid reflux, seasonal allergies, cholesterol, thyroid dysfunction and diabetes. The patient's historical medication (last year) (unknown date in 2017)) included PREVNAR13 (Pfizer/Lot R48403 and expiration 01-MAR-2018) and patient developed skin warm, peripheral swelling, malaise and pyrexia. The patient's historical conditions included malaise, pyrexia, skin warm and peripheral swelling. Concomitant therapies included gabapentin, carvedilol, potassium (unspecified), omeprazole, furosemide, montelukast sodium (manufacturer unknown), isosorbide, lovastatin (manufacturer unknown), lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 03-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (anatomical location not reported) (lot # N022303, expiration date 01-MAR-2019) intramuscularly for pneumonia prevention. It was reported that the patient called and visited pharmacy on 04-MAR-2018 to report that on 04-MAR-2018 she had woken up this morning with a swollen left arm that felt hard and warm to the touch (peripheral swelling and skin warm). It was also reported patient had a fever. The patient called the pharmacy on 05-MAR-2018 to report not feeling well (malaise) and the entire left arm was swollen. It was reported that the patient would see an unspecified physician on 05-MAR-2018. The patient was treated for the events. The patient sought medical attention: called and visited pharmacist on 04-MAR-2018, would see physician on 05-MAR-2018. There was no intervention to prevent serious criteria. The outcome of the events was reported as not recovered/not resolved. The reporter did not assess the causality of the events. The reporter considered the events skin warm and peripheral swelling to be serious due to disability as the patient had difficulty using left arm.
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site bruising, Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist (also reported as pharmacy manager) refers to a 67 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 03-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 from lot N019983 expiry date 03-MAR-2019 for immunisation. On 03-MAR-2018, the patient experienced bruising and redness at the injection site and felt really hot on the underside of her arm (feeling hot).  No lab diagnostics/studies were performed. The outcome of injection site bruising, feeling hot and injection site erythema was reported as not recovered. Causality assessment was not provided by reporter.
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Decreased eye contact, Developmental delay, Pyrexia
Clinical narrative: This spontaneous report was received from the patient's mother referring to her son, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date in approximately 2013, reported as "about 4 to 5 years ago", the patient was vaccinated with a dose of M-M-R II subcutaneously, for prophylaxis (strength, lot # and expiration date were not reported). On an unknown date, after receiving the shot, the patient developed a fever (pyrexia) which lasted for an unspecified number of days. Then, on an unknown date, reported as after the fever resolved, the patient's demeanor/behaviour changed and his development progress slowed. Also, on an unknown date, the patient began to no longer make direct eye contact. At the reporting time, the outcome of abnormal behaviour, decreased eye contact and developmental delay was unknown. The causality assessment between the events and vaccination with M-M-R II was not provided.
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Seroconversion test negative
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's current condition, historical condition, historical drug, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, unit, route not reported) (expiration date and lot number not specified) as prophylaxis. On an unknown date the patient was failed to seroconvert for 14 of the serotypes in the vaccine. No adverse effects or pneumococcal disease was reported in the patient. Pneumococcal titers was performed on an unknown date. The patient was not treated for the adverse event. The patient sought medical attention by seeing a nurse practitioner. There was no intervention to prevent serious criteria. The outcome of the event was unknown. The reporter did not assess the causality of the event with suspect therapy. Product quality complaint was not involved. No other information was available.
Sex: M
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an adult male patient of unknown age. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of paediatric formulation of VAQTA (dosing details, lot # and expiry date unknown) for prophylaxis (incorrect product formulation administered). No adverse effects reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patient. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 06-MAR-2018, the patient received an improperly stored dose of VAQTA (lot # N031940; expiry date: 23-NOV-2018) for prophylaxis (product storage error). Dosing details were not reported. The temperature excursion ranged at -0.4 C for 10 minutes and between 0 degree Celsius (°C) to 1°C (1.4C) for 30 minutes. There were no previous temperature excursions. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, units frequency and route not reported) (lot# and expiration date not reported) too early. Reporter stated that, patient received doses of GARDASIL 9 on unspecified dates at 0 I 2 months I 3 months. No additional clarifying information provided and no adverse effects reported. No product quality complaint was involved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This spontaneous report as received from a 64 year old female patient referring to herself. The patient's pertinent medical history included asthma and no drug reactions or allergies. On an unknown date in February 2018, a little over three weeks ago, the patient was vaccinated with ZOSTAVAX (dosing details, lot # and expiry date unknown) underneath the left arm for prophylaxis. Concomitant therapies included VENTOLIN, QVAR and venlafaxine ER. On an unknown date in 2018, the patient began experiencing fever, chills, and terrible headaches that lasted for approximately three and a half days. The patient sought medical attention by calling the pharmacist. It was reported that her husband saw on television something about a class action law suit filed in relation to ZOSTAVAX. It was reported that the patient experienced the symptoms after she received the vaccine. No treatment was provided for the events. The outcome of pyrexia, headache and chills was reported as recovered. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1803USA004165.
Sex: F
Vaccine: HPV9
Symptoms: Headache
Clinical narrative: This spontaneous report was received from a 26 year old female patient who was also a pharmacist, referring to herself. Concomitant therapies included propranolol and XANAX. Patient stated that she does not have any pertinent medical history or drug reactions or allergies. On 03-MAR-2018, the patient was vaccinated with first dose of GARDASIL 9 (strength, dose, frequency, route, lot number and expiry date not reported) for prophylaxis. On the same day, within 3 to 4 hours, the patient experienced headache. She stated that on a pain scale from 0-10, headache was about 5. The patient was treated with 400 mg of ibuprofen twice daily for headache. The outcome of headache was reported as not recovered. Causality assessment was not provided. No further information was provided. Product quality complaint was not present.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent. On 06-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. No adverse effects reported. Product quality complaint was not involved. VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. There was no previous temperature excursion reported. The digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent(STERILE DILUENT). On 15-FEB-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. No adverse effects reported. Product quality complaint was not involved. VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. There was no previous temperature excursion reported. The digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (STERILE DILUENT). On 01-MAR-2018 the patient was vaccinated with one dose of improperly stored VARIVAX (lot # N023960, expiry date: 01-SEP-2019), (dose, frequency and route were not reported) for prophylaxis. No adverse effects reported. Product quality complaint was not involved. VARIVAX was exposed to temperature of 6 degree Fahrenheit (F) to 14 F for 36 minutes. There was no previous temperature excursion reported. The digital data logger was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (DILUENT MRK INJ). On 07-MAR-2018, the patient was vaccinated with expired dose of ZOSTAVAX (dose, units, frequency and route not reported) (lot # N009777 and expiration date: 08-JUN-2018). No adverse effects and no additional information was provided. No product quality complaint was involved.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 6 month old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 27-FEB-2018 the patient was vaccinated with third dose of LIQUID PEDVAXHIB from lot N022167 expiry date 08-FEB-2020 for prophylaxis (inappropriate schedule of drug administration).  No adverse effect reported. No additional information was provided.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Joint swelling, Oedema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old male patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 05-MAR-2018 the patient was administered a dose of PNEUMOVAX 23 in an unspecified arm from lot N030847 expiry date 09-JUN-2019, 0.5 ml, once by intramuscular route for prophylaxis. Later in the day on 05-MAR-2018, patient developed redness at the injection site. On 06-MAR-2018, patient developed swelling from the injection site down to the elbow of the vaccinated arm, described as very swollen(joint swelling), edematous, like there is fluid accumulating under the skin (skin oedema). Treatment included application of ice to the affected area and unspecified NSAIDs. The outcome of injection site erythema, skin oedema, joint swelling and injection site swelling was reported as not recovered. Causality assessment was not provided by reporter.
Age: 12.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown recent date, the patient was vaccinated with a dose of PROQUAD (lot # and expiry date were not reported) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported in the patient. No other information was available.
Sex: U
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a medical assistant refers to 1 of the two different patients of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis. On an unknown date within minutes after receiving the GARDASIL 9 the patient experienced arm pain. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of pain in extremity was unknown. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality compliant reported. This is one of the two reports from the same source. Sender's Comments: US-009507513-1803USA004532.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 1 of the two different patients of unknown age and gender. The patient's concurrent conditions, concomitant medications, historical conditions and historical drug allergies/reactions were not reported. On an unknown date the patient was vaccinated with GARDASIL 9 (dosing regimen and frequency unknown) (lot number and expiry date unknown) for prophylaxis. On an unknown date within minutes after receiving the GARDASIL 9 the patient experienced arm pain. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of pain in extremity was unknown. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality compliant reported. This is one of the two reports from the same source. Sender's Comments: US-009507513-1803USA004279.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Blood pressure decreased, Pallor, Vomiting
Clinical narrative: After child was given vaccine and waited 5 minutes she and mom walked out of clinic. As child was walking down hall mom yelled for help and she got child to chair. Child stayed coherent during episode. Child vomited twice and was very pale. After lying in long chair she sat up and drank a bottle of water. Blood pressure was 80/60 then 10 minutes later it was 104/68. Child stated she felt better and she was able to walk around lobby without dizziness or issues. Child was walked to car and left in care of mom who is a nurse.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: I had strong pain in my arm the night of the injection and wasn't able to sleep it was so bad. I have never had any reaction to a flu shot before. After the first night the pain eased up slightly but I wasn't able to bend my arm in certain positions without excruciating pain. My husband had to help me dress with anything I needed to put over my head. I presumed the pain would go away. It is now 5 months later and the pain is still there although somewhat better but I still need help with some clothes. There is one position when I bend my arm which still gives me awful pain.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Allergy to animal, Diarrhoea, Lethargy, Pruritus, Throat irritation
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a 55-year-old male patient who received RABAVERT (batch number 564011A, expiry date unknown). Concomitant products included RABAVERT. On 15th February 2018, the patient received the 2nd dose of RABAVERT. On 15th February 2018, 7 hrs after receiving RABAVERT, the patient experienced hives (serious criteria other: As per reporter), pruritus (serious criteria other: As per reporter) and lethargy. In February 2018, the patient experienced itchy throat (serious criteria other: As per reporter), diarrhea and allergic to dogs. The patient was treated with BENADRYL. In February 2018, the outcome of the hives, pruritus, lethargy and diarrhea were recovered/resolved. On an unknown date, the outcome of the itchy throat was not recovered/not resolved and the outcome of the allergic to dogs was unknown. It was unknown if the reporter considered the hives, pruritus, itchy throat, lethargy, diarrhea and allergic to dogs to be related to RABAVERT. Additional details were provided as follows: The patient was following pre exposure RABAVERT vaccination. On 15th February 2018 at 9:30 hours, the patient received RABAVERT. On 15th February 2018 at 16:30 hours, 7 hours after receiving RABAVERT, the patient experienced hives and itching. On 15th February 2018 at 18:00 hours, 8 hours 30 minutes after receiving RABAVERT, the patient was lethargy. On 16 February 2018, 12 hours after receiving RABAVERT, the patient experienced itchy throat and diarrhea. In February 2018, less than a day after receiving the RABAVERT, the patient shaved a dog and there was a fan on. The patient was highly allergic to dog hair. The patient treated himself with BENADRYL.
Age: 55.0
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a 55-year-old male patient who received RABAVERT (batch number 564011A, expiry date unknown). Concomitant products included RABAVERT. On 15th February 2018, the patient received the 2nd dose of RABAVERT. On 15th February 2018, 7 hrs after receiving RABAVERT, the patient experienced hives (serious criteria other: As per reporter), pruritus (serious criteria other: As per reporter) and lethargy. In February 2018, the patient experienced itchy throat (serious criteria other: As per reporter), diarrhea and allergic to dogs. The patient was treated with BENADRYL. In February 2018, the outcome of the hives, pruritus, lethargy and diarrhea were recovered/resolved. On an unknown date, the outcome of the itchy throat was not recovered/not resolved and the outcome of the allergic to dogs was unknown. It was unknown if the reporter considered the hives, pruritus, itchy throat, lethargy, diarrhea and allergic to dogs to be related to RABAVERT. Additional details were provided as follows: The patient was following pre exposure RABAVERT vaccination. On 15th February 2018 at 9:30 hours, the patient received RABAVERT. On 15th February 2018 at 16:30 hours, 7 hours after receiving RABAVERT, the patient experienced hives and itching. On 15th February 2018 at 18:00 hours, 8 hours 30 minutes after receiving RABAVERT, the patient was lethargy. On 16 February 2018, 12 hours after receiving RABAVERT, the patient experienced itchy throat and diarrhea. In February 2018, less than a day after receiving the RABAVERT, the patient shaved a dog and there was a fan on. The patient was highly allergic to dog hair. The patient treated himself with BENADRYL.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site reaction, Pain, Rash erythematous
Clinical narrative: The patient was vaccinated Friday 3/9/18. That evening she complained of chills, aches, soreness and a red colored reaction at the site of injection (approximately 3 inches in diameter). She stated that most symptoms improved by Saturday evening 3/10/18. Today 3/12/18 she still has the red arm rash and will see her physician.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash generalised
Clinical narrative: The vaccine was administered on Wednesday 3/7/2018. On Friday she experienced a generalized rash on arms and chest. Today is Monday 3/12/18 and the rash has not improved. She states that she has used topical Hydrocortisone without improvement. Today she'll try ALLEGRA, ZYRTEC or CLARITIN. The patient was instructed to notify her prescriber.
Sex: M
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a male customer (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date the patient was vaccinated with PNEUMOVAX 23 (total dosage, lot#, and route were unknown), (NOC #00006-4837-03). The third party claims administrator reported that the patient suffered an adverse reaction (NOS) to PNEUMOVAX 23 and was hospitalized for 36 days (onset date not provided). Treatment and outcome of the adverse reaction were not reported. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 11-MAR-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2016, the patient was treated at a hospital for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse via office manager (also reported as physician) refers to a 12 month old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 08-MAR-2018, the patient was vaccinated with VARIVAX, lot # M009767, expiration date 23-FEB-2018 for prophylaxis (expired product administered). The sterile diluent (Diluent Mrk inj) (unknown lot and expiration date) used for reconstitution of VARIVAX was properly stored. The expired VARIVAX had no temperature excursions prior to being administered. No adverse effects reported. No further information provided. No PQC involved.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Induration, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: On immediate injection I felt very sick but it passed. I went home. My arm became swollen and hot and painful. Arm was about 3x as big-very hard. Arm stayed like this 5 or 6 days. Took BENADRY.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: On immediate injection I felt very sick but it passed. I went home. My arm became swollen and hot and painful. Arm was about 3x as big-very hard. Arm stayed like this 5 or 6 days. Took BENADRY.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pain in extremity, Rash macular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received SHINGRIX. On 5th March 2018, the patient received SHINGRIX. On 7th March 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, pain in arm and erythromacular rash. On an unknown date, the outcome of the injection site erythema, pain in arm and erythromacular rash were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, pain in arm and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The patient's arm was very sore and she had a large red area around the injection site. She also had some red spots on her face.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 102 degrees F and vomiting X 1.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Abdominal pain upper, Decreased appetite, Fatigue, Muscular weakness
Clinical narrative: Starting Fri am: extreme fatigue, limb muscle weakness. Fri night: added upper belly pain, nausea. Sat am: extreme fatigue, weakness in limbs. Sat pm: added lower right side abdominal pain. Sun am: fatigue weakness in limbs, lower right side abdominal pain. Sun pm: added fever of 101.3. Mon am:  weakness, nausea. Since Fri am, thru Mon am, overall loss of appetite, fatigue, weakness in limbs.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Starting Fri am: extreme fatigue, limb muscle weakness. Fri night: added upper belly pain, nausea. Sat am: extreme fatigue, weakness in limbs. Sat pm: added lower right side abdominal pain. Sun am: fatigue weakness in limbs, lower right side abdominal pain. Sun pm: added fever of 101.3. Mon am:  weakness, nausea. Since Fri am, thru Mon am, overall loss of appetite, fatigue, weakness in limbs.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Body temperature increased, Irritability
Clinical narrative: Rectal temp to 101.7. C/O fussiness, no redness or swelling.
Age: 16.0
Sex: F
Vaccine: HEP, HPV9, IPV, MENB, MMR, TD, VARCEL
Symptoms: Syncope
Clinical narrative: 16 year old patient fainted after receiving the HPV vaccine. Vitals checked BP/ 100/60 ,Temp 98, Hr 60. Treatment was given and inhaled ammonia she responded immediately. The patient was observed by the nurse for 15- 20  minutes. She was able to be discharged with no further complications.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left upper arm swelling redness and pain X 3 days. Resolved after 3 days with ICE.
Age: 29.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Complement factor, Computerised tomogram, Full blood count, Hypersensitivity, Metabolic function test
Clinical narrative: Within 10-15 minutes patient notes his throat began to feel 'scratchy' and felt as if his throat was swelling. Did not experience respiratory distress. Presented to the emergency department where he was treated for allergic reaction. Was sent home with symptomatic care and due to an exacerbation of his symptoms a few days later he presented for re-evaluation.
Age: 29.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Within 10-15 minutes patient notes his throat began to feel 'scratchy' and felt as if his throat was swelling. Did not experience respiratory distress. Presented to the emergency department where he was treated for allergic reaction. Was sent home with symptomatic care and due to an exacerbation of his symptoms a few days later he presented for re-evaluation.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced pain at injection site for 4 days (included the day of vaccination) which did not interfere with his daily activities. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a pharmacist and described the occurrence of adverse event in a patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was received via web call. The pharmacist reported that the doses of SHINGRIX need to be restarted if the 2nd dose was not given within the 2-6 month time frame and asked that if the patient did not want to receive the 2nd dose due to side effects then what was the percentage of protection. It may sound like this pharmacist may had the patient who experienced an adverse event and did not want another shot.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 09-MAR-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 01-APR-2017, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 10-JUL-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-FEB-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expense, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 28-OCT-2014, the patient was inoculated with ZOSTAVAX at a medical office for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-MAR-2016, the patient was treated at a family practice for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a identifiable patient. The patient's medical history and concurrent medications were not reported. On 08-MAR-2018 the patient was inadvertently vaccinated with expired dose of VARIVAX (lot # M006157 expiration date 05-FEB-2018), by subcutaneous route for prophylaxis (expired product administered). Concomitant therapies included sterile diluent (DILUENT MRK INJ). There was no temperature excursion involved. No adverse effects were reported. No additional information provided.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from an office manager via a company representative referring to a 65 year old female patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 01-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # N025384 with expiration date 19-APR-2019), for prophylaxis (dose and route of administration were not reported). It was stated that no other vaccine was administered to the patient on the same date. On 08-MAR-2018, the patient went to the physician's office with swelling and pain at the injection site. On the same date, the patient was diagnosed with cellulitis (injection site cellulitis). At the time of reporting, the outcome of the event was unknown. The causality assessment between injection site cellulitis and PNEUMOVAX 23 was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 10-OCT-2009, the patient was inoculated with ZOSTAVAX, given by a physician at the physician's office for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During 2015, the patient was treated at the same physician's office for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 22-JUL-2012, the patient was inoculated with ZOSTAVAX at a pharmacy for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at medical clinic for a persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting.  Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a non-contactable nurse via a Pfizer company representative. This nurse reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age, race and ethnicity received TRUMENBA at single dose on the arm (deltoid) via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling at the vaccination area (on the shoulder) on an unspecified date. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018102267 same reporter/product/event, different patient.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a non-contactable nurse via a Pfizer company representative. This nurse reported similar events for two patients. This is the first of two reports. A female patient of an unspecified age, race and ethnicity received TRUMENBA at single dose on the arm (deltoid) via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling at the vaccination area (on the shoulder) on an unspecified date. Outcome was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018100908 same reporter/product/event, different patient.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. got reaction from VARIVAX 3 days after vaccination, on injection area redness, swelling and itching. Pt. reported to clinic 2 weeks after vaccination, stated getting better.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injection site erythema, Vaccination site streaking, Vaccination site warmth
Clinical narrative: Streak of redness from vaccine site (deltoid) to inner elbow (Right) warm to touch treated with AUGMENTIN. Course of Tx began today.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling to right deltoid/PAC gave pt. BENADRYL, Ibuprofen and KEFLEX.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: Patient came to the store on 3/9/18 and reported an adverse reaction to the flu shot he received on 1/28/18. He said he woke up the next day with half of the face paralyzed. He went to see his PCP he was diagnosed with Bell's Palsy. We called MD, he said it was unrelated to the vaccine.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness, Pallor, Syncope
Clinical narrative: The client became pale and dizzy and appeared to faint after the immunization. The client's mother and myself laid him down on the floor and called his name and he opened his eyes and started talking to us after a few seconds. The client then seemed fine and walked out the clinic a few minutes later with his mother. The client's mother called today (3-12-18) and stated that the client had been pale this weekend and had "passed out " two other times since the immunization on 3-8-18. I advised client's mother to call her Dr. and see about getting an appointment for follow up as soon as possible.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: The patient said that her whole body itched. She was given VISTARIL 25mg, BENADRYL 50mg and PANADOL.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain
Clinical narrative: Patient states that she has pain at the injection site and did not immediately associate the pain with the vaccination, however, she states that the pain in her muscle at the injection site has not gone away after the vaccination.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling in hand, hip pain, arm and joint pain, weakness and fatigue.
Age: 74.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Burning sensation, Inflammation, Paraesthesia
Clinical narrative: Patient is noticing tingling sensation in both hands, burning and inflammation sensation as well, no swelling or redness reported. Patient stating it is getting better now.
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event. Patient received an IIV4 vaccine at 4 months old.
Age: 64.0
Sex: F
Vaccine: TD
Symptoms: Feeling cold, Headache, Hyperaesthesia, Peripheral swelling, Pyrexia
Clinical narrative: On the next day after receiving the shot, I became extremely cold late in the evening about 7:30 p.m. but, later at 1:00 a.m. until about 6-8 am, I experienced mild fevers, mild headaches, swollen and sensitive arm.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored VARIVAX (dosing details were not reported) (lot # N026071, expiry date: 20-SEP-2019) for prophylaxis which was reconstituted with sterile diluent (product storage error). The vaccine was stored at a temperature of -9 degree centigrade to 8 degree centigrade (5.8 degree centigrade) for a time frame of 42 hours. No previous temperature excursions reported. There was a digital data logger involved. No product quality complaint involved.