chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Mental status changes
Clinical narrative: Information was received from a physician via a company representative referring to a 16 years old male patient. The patient had a history of mental illness and unspecified drug use. On 13-JUL-2016 the patient received an injection of GARDASIL 9 intramuscularly (dose and frequency unknown). It was unspecified which dose within the series was received on 13-JUL-2016. Concomitant therapies included 3 unspecified injections on that day. On unknown dates, after receiving the injections, the patient developed an altered mental state (unspecified account of what actually took place) and went to the emergency room. It was unknown if the treatment was given for the event. The patient recovered from the event with no consequences on an unknown date in July 2016. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: HPVX
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 14 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 13-JUL-2015, the patient was vaccinated with a dose of GARDASIL 9 (dose and route of administration were not reported) that had experienced an excursion. Reporter reported GARDASIL 9 with lot# H021861 which was not valid for GARDASIL 9. However, lot # H021861 (expiration date 09-OCT-2015) was valid for GARDASIL. No adverse reaction was reported. This is one of several reports received form the same reporter. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse concerning to an unspecified patient (unknown age and gender). Medical history, concurrent conditions and concomitant therapies were not reported. On 20-JUL-2016 the patient was vaccinated with PNEUMOVAX23, lot # K009876 with expired date 19-MAR-2016. Concentration, dose, route and frequency were not provided. The nurse reported that an expired dose of properly stored PNEUMOVAX23 (lot # K009876, with expired date 19-MAR-2016, was administered to the patient on 20-JUL-2016. No adverse effects were reported. Action taken with the vaccine PNEUMOVAX23 and the patient's outcome were unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Thyroid disorder
Clinical narrative: This spontaneous report was received from an unknown woman via a company representative and refers to eight female patients of unknown age. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with GARDASIL (Lot#, expiration date and dose were not reported) intramuscularly to prevent HPV disease. Concomitant medications were not reported. The reporter stated that she heard that GARDASIL caused "thyroid issues". The outcome of thyroid disorder was unknown. The reporter considered thyroid disorder to be related to GARDASIL. Additional information is not expected as no contact details were provided.
Age: 0.4
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report concerning a 4 months old patient was received from a registered nurse. The patient's concurrent conditions and medical history were not provided. On 13-JUL-2016, the patient was inadvertently vaccinated with VAQTA (inappropriate schedule of drug administration)(lot # M022531, expiration date 23-FEB-2018, strength, dose and frequency were not provided) by intramuscular route. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 80 year old male patient, reporting on herself. The patient did not have any drug reactions or allergies. No information regarding the patient's pertinent medical history or concomitant therapies was provided. In approximately 2006 (reported as about 10 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, exact dose and route of administration were not reported). The patient reported that from time to time he got a rash in the back of his head (onset date was not reported). He used CORTAID cream and ointment for the event and the rash came and went. The patient did not seek any medical attention and no lab diagnostic studies were performed. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was assessed as possible. However, the patient was not sure if the vaccine was the one that had caused the rash. Additional information is not expected as there was no consent to contact the patient's physician.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse and 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 an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml, subcutaneously, lot # L044475, expiration date 12-MAY-2017. There was no adverse effect reported. Product quality complain (PQC) was not involved. Administered dose of vaccine experienced the temperature excursion of 51.2 degrees Fahrenheit for 2 hours. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients. No information on patient's pertinent medical history, drug reactions or allergies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX, subcutaneously (lot # L034370, expiration date: 08-SEP-2017, dose not reported). THE VARIVAX was stored in temperature of -11 C degrees for 4416 hours captured in Data Logger. There was no previous excursions. No adverse effects were reported. Additional information has been requested. This is one of the several reports from the same reporter source.
Sex: U
Vaccine: MMR
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. No concurrent conditions, historical conditions or concomitant therapies were reported. On 16-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (albumin status: rHA, lot # L024265, expiration date 01-JUL-2017, route of administration: not provided). The vaccine was stored in an improper temperature of 50.8F for a cumulative period of 38 hours. The temperature excursion was captured by digital data logger. No adverse effects were reported. Additional information has been requested. This is one of the reports received from the same reporter.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the dose of GARDASIL (lot # H021861, expiration date 09-OCT-2015; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. 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 pharmacist refers to a patient of unknown age and gender. No concurrent conditions, historical conditions or concomitant therapies were reported. On 26-JUN-2016, the patient was vaccinated with improperly stored M-M-R II (albumin status: rHA, lot # L024265, expiration date 01-JUL-2017, route of administration not provided). The vaccine was stored in an improper temperature of 50.8F for a cumulative period of 38 hours. The temperature excursion was captured by digital data logger. No adverse effects were reported. Additional information has been requested. This is one of the several reports received from the same reporter.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-AUG-2012, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported) (also reported as GARDASIL 9). The patient then received the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported) on 30-OCT-2012, and the third one on 23-JAN-2013 (dose, route of administration, lot# and expiry date were not reported). The reporter stated that the patient's third dose of GARDASIL was 1 month and 2 days early. There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Right deltoid/arm with approximately 2 cm area of erythema and tenderness. No induration. No fever. Rx: Ibuprofen 400 mg prn, BENADRYL 25 mg prn.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abnormal behaviour, Febrile convulsion, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: The father states, the patient received 3 shots in the AM. Father reports a change of behavior laying on couch all day after vaccines afterwards the patient was staring into space and unresponsive. Mother denies shaking during seizure. Pt was transported via EMS to hospital.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site pain, Swelling
Clinical narrative: Pain in arm at inj site. Slight swelling 1/2" area of redness.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Chest discomfort, Dizziness, Nausea, Pain
Clinical narrative: 2 hours after getting BEXSERO c/o chest tightness, nausea and dizziness c/o body aches. Will f/u with patient tomorrow.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diet refusal, Gastrooesophageal reflux disease, Grimacing, Musculoskeletal stiffness, Opisthotonus
Clinical narrative: Vaccine (PEDIARIX, Hib (OMP), PREVNAR, ROTARIX) given 7/21. On 7/23 sudden onset of repeated stiffening arm, legs, arching back and grimace for several seconds. He did not eat. Seen in ER - no findings and diagnosed 'reflux' - symptoms stopped after 12 hrs. and normal.
Age: 23.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No S/SX after injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site rash
Clinical narrative: On 7/16/16 patient went to Urgent Care for rash at injection site, diagnosed as cellulitis. Treated with antibiotics. Followed up 7/26/16. Rash cleared.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient developed big bump, redness and pain the whole left arm after 2 days after receiving the PNEUMOVAX 23 vaccine.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness of (L) upper arm. Applied ice packs every 4-6 hrs. OTC BENADRYL PRN, TYLENOL PRN.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 7.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 60.0
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: None, Patient given pediatric dose not adult dose, this was corrected.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash 7/25/16 legs, arms, trunk.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncopal event.
Age: 3.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Initial unsolicited report received from a pharmacist on 28 September 2015. This case linked to 2015SA149936 (same vaccine same reporter) This case involves a 51 years old female patient who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number UI422AA, expiration date 30 June 2016, dose was not reported) in left deltoid on 23 September 2015. The patient previously received dose of FLUZONE QIV. The patient did not have illness at time of vaccination and did not have known allergy. Concomitant medications were not reported. On 23 September 2015, same day following the vaccination, the patient experienced injection site redness, swelling, red rash at injection site, patient seen at pharmacy had 3-4 inch diameter area of redness around injection site. No other symptoms reported. Lab data and corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none. Follow-up information received from a pharmacist on 07 December 2015. It was reported that no any other vaccinations administered within 4 weeks prior to the date of vaccination. On an unknown date, patient recovered from all the events (within one week of onset).
Age: 0.58
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HIBV, MNQ
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome, Hypotonia
Clinical narrative: On May 2, 2016, patient was fatigued and lethargic. By May 3, 2016, patient could not hold her head up. She went to the emergency room and then was transferred to another hospital. She received multiple tests and it was determined that she had Guillain-Barre Syndrome from the flu shot she received on April 29, 2016. She was at Hospital until May 13, 2016 and then went Rehab until June 29, 2016. She is still trying to regain the use of her hands and arms.
Age: 0.58
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HIBV, MNQ
Symptoms: Blood test, Electromyogram, Fatigue, Guillain-Barre syndrome, Lethargy
Clinical narrative: On May 2, 2016, patient was fatigued and lethargic. By May 3, 2016, patient could not hold her head up. She went to the emergency room and then was transferred to another hospital. She received multiple tests and it was determined that she had Guillain-Barre Syndrome from the flu shot she received on April 29, 2016. She was at Hospital until May 13, 2016 and then went Rehab until June 29, 2016. She is still trying to regain the use of her hands and arms.
Age: 0.58
Sex: F
Vaccine: FLU4, HIBV, PNC13, FLUX, HIBV, MNQ
Symptoms: Lumbar puncture, Mobility decreased, Nuclear magnetic resonance imaging, Posture abnormal, Scan brain
Clinical narrative: On May 2, 2016, patient was fatigued and lethargic. By May 3, 2016, patient could not hold her head up. She went to the emergency room and then was transferred to another hospital. She received multiple tests and it was determined that she had Guillain-Barre Syndrome from the flu shot she received on April 29, 2016. She was at Hospital until May 13, 2016 and then went Rehab until June 29, 2016. She is still trying to regain the use of her hands and arms.
Age: 65.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: 7-11-16: I received vaccine at 2:30; at 7:30 pm I had hives, welts on chest and neck. I went to Emergency Room, Dr gave me Prednisone 10 mg and Famotidine 20mg, Also got a script and took as follows: Prednisone: 3 tabs a day for 2 days; 2 tabs for 3 days and 1 tab for 3 days. Famotidine: 1 tab twice a day for 5 days.
Age: 65.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Biopsy skin, Laboratory test, Urticaria
Clinical narrative: 7-11-16: I received vaccine at 2:30; at 7:30 pm I had hives, welts on chest and neck. I went to Emergency Room, Dr gave me Prednisone 10 mg and Famotidine 20mg, Also got a script and took as follows: Prednisone: 3 tabs a day for 2 days; 2 tabs for 3 days and 1 tab for 3 days. Famotidine: 1 tab twice a day for 5 days.
Age: 1.53
Sex: M
Vaccine: DTAP, IPV
Symptoms: Discomfort, Injection site swelling, Pain
Clinical narrative: Onset in the late afternoon/evening.  Tennis-ball sized swelling in left thigh, at site of DTaP vaccine, which causes the contour of the thigh to jut out at the hip.  Also some mild swelling of the right thigh, at site of IPV vaccine.  Mild pain/discomfort.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site discomfort, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Significant swelling of the lateral left thigh, with limping, minor discomfort, mild erythema, and taut skin.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Skin tightness
Clinical narrative: Significant swelling of the lateral left thigh, with limping, minor discomfort, mild erythema, and taut skin.
Age: 2.0
Sex: F
Vaccine: HIBV, IPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Erythema, diameter of approximately 10 cm around site of injection on the right thigh, with significant swelling of the lateral thigh.  Little to no discomfort.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in the study on 09 September 2015. The subject (gender and age were not reported) received a dose of Influenza vaccine (Manufacturer unknown) on an unspecified date (site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject reported a bad experience with last flu shot. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none
Sex: U
Vaccine: FLUX
Symptoms: Adverse reaction
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in the study on 09 September 2015. The subject (gender and age were not reported) received a dose of Influenza vaccine (manufacturer unknown) on an unspecified date (site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject reported that it was taken before and the subject did not like the reaction. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLUX
Symptoms: Vaccination complication
Clinical narrative: Initial solicited report received from a consumer (online market research respondent) in the study on 09 September 2015. The subject (gender and age were not reported) experienced an adverse event on an unspecified date, after receiving a dose of influenza vaccine (manufacturer unknown) (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapy details were not reported. The subject experienced an adverse reaction to Flu shot which was received in the past. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from a physician (patient's mother) on 15 June 2016. This case involves a 05-year-old female patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (manufacturer, batch number: unknown, dose in series, route of administration and expiry date: not reported) in thigh on an unspecified date in 1996. The patient's illness at time of vaccination was reported as none and reporter refused to provide pre-existing physician diagnosed allergies, birth defects, medical conditions. Other vaccinations within 4 weeks of vaccination was reported as unknown and other concomitant medications were not reported. On an unspecified date in 1996, after vaccination, patient's thigh swelled up to 2 times the normal size. It was reported that patient had taken TD since then without incident. The patient required ER/doctor visit. The patient's laboratory data was reported as unknown. Patient's corrective treatment was not reported. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.
Age: 84.0
Sex: M
Vaccine: TDAP
Symptoms: Herpes zoster, Rash, Rash pruritic
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 14 Jul 2016. This case involves an 84-year-old male patient who was administered with first dose of ADACEL (batch number: C4990AA, expiration date 27 May 2018) (dose detail was not reported) by intramuscularly in left deltoid on 07 July 2016. Patient's medical history and concomitant medications were not reported. The patient was allergic to penicillin, quinine and formaldehyde. On 08 July 2016, one day following vaccination, the patient developed itchy rash on left arm, it was reported that the patient was diagnosed with shingles of left arm after four days of vaccination. The patient required ER/doctor visit. Laboratory investigations were not reported. The patient was prescribed with antiviral valacyclovir (3 pills daily), calamine lotion and compresses. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (manufacturer report number - 2016333726) on 15 July 2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of Tetanus Vaccine (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date, post vaccination, patient was allergic to tetanus vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Pain, Pain in extremity, Peripheral swelling, Urticaria
Clinical narrative: Welting (2.5in by 4in) 3 inches down from where the injection was given. Pain and swelling in the arm. Difficulty in lifting arm without severe pain. This did occur in the last injection as well, we were told this was common. Did not see this reaction listed on the information leaflet. The last reaction lasted 6 days. We are on day 2 this time, welting still very evident. Child has not had this type of reaction to any other immunization.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Patient left office after getting vaccinated and passed out near the elevator.  She quickly came to and Mom brought her back into the office.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea and fatigue.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Initial unsolicited report received from a pharmacist on 28 September 2015. This case involves a (81-year-old) female patient who was vaccinated with a [dose not reported] intramuscular [dose series not reported] dose of FLUZONE HD (batch number UI448AA, expiry date not reported) in left deltoid 26 September 2015. Patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA) and patient had received CRESTOR, SINGULAIR "cingulair", lorazepam "Lorzepam", ropinorole "Ropeneral". Concomitant medications were not reported. On 26 September 2015, same day following the vaccination patient had developed injection site red, bruising from deltoid to bicep, warm to touch. Patient laboratory investigation and corrective treatment was not reported. The outcome of event was not recovered. Follow up information received from physician on 10 December 2015. No new information reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office staff) on 25 September 2015. This case involves 2 unknown patients (age and gender not reported) who were vaccinated with 0.5 ml dose of FLUZONE QIV (batch number, route and site of administration not reported) on an unspecified date. The medical history and concomitant medications were not reported. On an unspecified date within a short period of days after the vaccination the patient had experienced contracted flu type B. Laboratory investigations and corrective treatments were not reported. The event outcome was not reported. Documents held by sender: none. Sender's Comments: This is a very poorly documented case of influenza B virus infection few days post INFLUENZA QUADRIVAL A-B VACCINE administration. Time to event onset, detailed medical investigations including serology, viral culture, etc.. have not been provided. Based on the available information, a role of the vaccine cannot be established.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia
Clinical narrative: Initial unsolicited report received from a pharmacist on 29-Sep-2015. This case involves a 77 years old male patient (age reported as 76 years) who was vaccinated with a dose of FLUZONE HD (batch number: UI442AA, expiry date was not provided) via intramuscular route in the left arm on 22-Sep-2015. The patient had a history of elevated cholesterol. There was no illness at the time of vaccination. Concomitant medications were not reported. On 29-Sep-2015, 7 days post vaccination; the patient had a hoarse voice. Laboratory data and corrective treatment were not provided. The outcome of the event was reported as unknown. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Headache
Clinical narrative: Initial unsolicited report received from a pharmacist on 29 September 2015. This case involves a 50-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: U5310DA, expiry date, dose, dose in series were not reported) intramuscularly in left deltoid on 22 September 2015. The patient's medical history was not reported and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as pre-existing physician diagnosed allergies, birth defects, medical conditions reported as allergies: none known. Concomitant medications were not reported. On 26 September 2015, four days following the vaccination, the patient had experienced headache and a metallic taste. Laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none. Follow-up information received from a pharmacist on 06 November 2015. It was reported that patient received 0.5 ml of FLUZONE QIV. No additional information to provide.
Sex: U
Vaccine: FLU3
Symptoms: Rash, Skin warm, Tenderness
Clinical narrative: Based on additional information received on 07 December 2015, this case will be deleted as it is duplicate of 2015SA149927. Initial unsolicited report received from a pharmacist on 28 September 2015. This case involves two patients those were vaccinated with a dose of FLUZONE (batch number, dose, route and site of administration was not reported) on an unspecified date. Both patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the both patients experienced rash, very warm and tenderness. Lab data and corrective treatments were not reported. The outcome of events was unknown. Follow-up information received from a pharmacist on 07 December 2015. This case will be deleted as it is duplicate of 2015SA149927. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Hypersensitivity, Rash, Rash macular
Clinical narrative: Initial unsolicited report received from a physician (parent) via company representative on 02 October 2015. This case involves a male patient (age not reported), who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number, dose and site of administration was not reported) on unspecified date in September 2015. Medical history and concomitant medications were not provided. On an unspecified date in September 2015, unspecified period following vaccination, the patient had allergic reaction to FLUZONE QIV. Laboratory investigations and corrective treatments were not reported. Outcome of the event was reported as unknown. Follow-up information received from a non-healthcare professional on 09 November 2015. This case involves a 23 years old patient. The patient was vaccinated at private doctor's office/hospital. The pre-existing physician diagnosed allergies, birth defects; medical conditions were reported as none and adverse event following prior vaccination was reported as none. On an unspecified date, following the vaccination, the patient had developed fine erythematous macular rash over torso only and felt little tired. It was reported that the patient went to family doctor who stated that it was due to vaccine. On an unknown date, the patient was recovered from the event. Documents held by sender: none.
Age: 51.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Arthritis, Muscular weakness, Paraesthesia
Clinical narrative: Experiencing "electrical shocks" lasting up to 3 seconds radiating from Deltoid to elbow 3-4 times daily while at rest or during activity. Reports that elbow joint feels inflamed. No weakness, no change in ROM. Reports that hands feel weak during "electrical shock" but not losing grip of things in hands. Encouraged to take OTC Naproxen or Ibuprofen for anti-inflammatory help.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site on left deltoid swollen, erythematous, and painful. By 6:18 PM the swelling, erythema, and pain had spread from shoulder to elbow. Patient was advised to keep elevated and apply cool compress overnight, if more ill appearing overnight should go to ER. Patient was seen by Dr. on 12/31/14 and noted the following: 'There is a patch of erythematous skin overlying the left deltoid area consistent with the injection site. There are a oule of adjacent flat slightly raised similar patches medial to the arm, on the shoulder of the same side. No distant eruption. Initially tender only'. Parent was instructed to continue oral BENADRYL as needed for itching and instructed to call the office if not continuing to improve. No further symptoms were reported by the parent after this.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reactions.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Biopsy, Hypoaesthesia, Laboratory test, Pain, Pain in extremity
Clinical narrative: Pain and tingling in arms and feet, numbness, nummular lesions over entire body with scaling, itching and pain. Treated with prescription steroids and triamcinolone acetonide cream over several months.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Skin lesion
Clinical narrative: Pain and tingling in arms and feet, numbness, nummular lesions over entire body with scaling, itching and pain. Treated with prescription steroids and triamcinolone acetonide cream over several months.
Age: 19.0
Sex: F
Vaccine: HEPA, SMALL, TYP, HEPA, SMALL, TYP
Symptoms: Vaccination complication
Clinical narrative: Smallpox cross inoculation. Tiny whitehead popped up directly beneath pustule.
Age: 19.0
Sex: F
Vaccine: HEPA, SMALL, TYP, HEPA, SMALL, TYP
Symptoms: Post vaccination autoinoculation
Clinical narrative: Smallpox cross inoculation. Tiny whitehead popped up directly beneath pustule.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Patient noticed rash on arm at injection site on Wednesday 7/27 after receiving vaccine on Monday 7/25. Rash was approximately 3" long by 1" wide (redness, no swelling).
Age: 1.28
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives all over body.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a vaccine coordinator referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not applicable. On unspecified dates, the patients were vaccinated with improperly stored doses of MMR II (lot # L035674, expiration date 17-SEP-2017, dose and route not provided). The vaccines were stored at minus 13.21 degree C for 12 hours. No adverse effects were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Burning sensation, Rash
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 24 September 2015. This case involves an elderly male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number U5310CA, expiration date 30 June 2016, dose, route and site of administration was not reported) on 16 September 2015. The patient did not have any known allergies. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced burning rash over stomach and side areas. Lab data and corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling cold, Tremor
Clinical narrative: Initial unsolicited report received from a pharmacist on 29 September 2015. This case involves a 68-year-old female patient who was vaccinated with a dose of FLUZONE HD (batch number: UI459AB, expiry date: 30 April 2016, dose and dose in series were not reported) intramuscularly in left deltoid on 29 September 2015. The patient's illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions reported as no known allergy. Concomitant medications were not reported. On 29 September 2015, few minutes following the vaccination, the patient felt dizzy, shaking and cold. The patient had received many doses of FLUZONE HD previously. Laboratory data and corrective treatment were not reported. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received from a pharmacist on 02 November 2015. No new information reported.
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a consumer on 25 September 2015. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose, site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not provided. On an unspecified date, following the vaccination, the patient experienced a side effect (no other details were provided). Lab data and concomitant medications were not provided. The outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Initial unsolicited report received from a pharmacist on 28 September 2015. This case involves a female (age not reported) patient who was vaccinated with a dose of FLUZONE QIV (batch number, expiration date, frequency once, dose number, route and side of administration was not reported) on an unspecified date. The patient medical history of allergies and illness at time of vaccination was unknown reported. Concomitant medication was not reported. On an unspecified date, following the vaccination, the patient experienced metallic taste. Laboratory investigation and corrective treatment were not reported. The outcome of the event was unknown. Documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dysphonia, Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 28 September 2015. This case involves a (68-year-old) female patient who was vaccinated with a [route and dose series not reported] dose of FLUZONE HD (batch number UI448AA, expiry date 20 April 2016 and site of administration were not reported) on 22 September 2015. Patient had denied illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Other medical history and concomitant medications were not reported. On 24 September 2015, two days following the vaccination patient had hoarseness, cough, tightness of chest and fever. Patient laboratory investigation and corrective treatment were not reported. The outcome of event was not recovered. List of documents held by sender: none.
Age: 14.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with the dose GARDASIL (lot # L007560, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date in Jul 2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L002310, expiration date 08-JUL-2016, dose and route unknown). No adverse event was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been receive from a pharmacist referring to a 65 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. On 10-JUL-2016 (reported as 5 days ago), the patient was vaccinated with ZOSTAVAX (lot # L036823, expiration date 24-DEC-2016, 0.65 ml, subcutaneously). Concomitant  therapy included LIPITOR. In July 2016, the patient experienced swelling pain and redness at the injection site and was seeking medical attention with the pharmacist for a hoarse voice and sore throat and feeling tired. The pharmacist reported that there was no vesicles to test. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: Information has been receive from a pharmacist referring to a 65 year old female patient. The patient had no pertinent medical history and drug reactions or allergies. On 10-JUL-2016 (reported as 5 days ago), the patient was vaccinated with ZOSTAVAX (lot # L036823, expiration date 24-DEC-2016, 0.65 ml, subcutaneously). Concomitant  therapy included LIPITOR. In July 2016, the patient experienced swelling pain and redness at the injection site and was seeking medical attention with the pharmacist for a hoarse voice and sore throat and feeling tired. The pharmacist reported that there was no vesicles to test. No treatment was given for the events. The outcome of the events was reported as not recovered. The causality was not provided. Additional information has been requested.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 18 year old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9  (dose and route of administration were not reported), lot # L007560. No adverse reaction was reported at the time of the report. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 07-OCT-2015, the patient was vaccinated with first dose of unidentified Merck hpv vaccine (name and lot number not provided), (dosage not reported). On 30-DEC-2015, the patient was vaccinated with second dose of unidentified Merck hpv vaccine (name and lot number not provided). The patient's mother mentioned that the patient received an additional dose at an unspecified facility on an unspecified date. The Nurse reported that the patient might had received 4 doses of GARDASIL or GARDASIL 9. No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2016, the patient was vaccinated with the dose of GARDASIL (lot # L010596, expiration date unknown; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt given a pedi/adolescent dose of Hepatitis A. Pt was out of the age range of the vaccine and will need to be revaccinated.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Dizziness, Headache, Nausea, Skin warm
Clinical narrative: On Friday he woke up with headache, dizziness and nausea, symptoms continued to get worse, Monday was the worse day with the nausea. Mom reported that he felt feverish however did not take a temp. No diarrhea was reported. 07/27/16- I did send over a prescription of ZOFRAN to help the nausea.
Age: 14.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: MenB (BEXSERO) administered to a 14 year old who does not fit any of the criteria to obtain it before the age of 16.
Age: 0.2
Sex: U
Vaccine: HIBV, PNC13, RV5, HIBV, PNC13, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2-month-old patient. The patient's medical history was not reported. On 11-JUL-2016, the patient was vaccinated with an improperly stored first dose of ROTATEQ lot # M014544, expiration date reported as 27-NOV-2017 (dose was not reported), orally. On the same day, the patient was vaccinated with a dose of PREVNAR 13 and a dose of ACTHIB. On 21-JUL-2016, the patient was inadvertently vaccinated with an improperly stored second dose of ROTATEQ lot # M014544, expiration date reported as 27-NOV-2017 (dose was not reported), orally. On the same day, the patient was vaccinated with a second dose of PREVNAR 13 and a second dose of ACTHIB. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest X-ray, Chills, Cough, Decreased appetite
Clinical narrative: Employee works for daycare which requires her to receive certain vaccines to include hepatitis B vaccine. She received her first hep B vaccine on 6/1/2016 experiencing a sore arm otherwise no issues. She received her second hepatitis B vaccine on 7/7/2016. She advised she had had a slight cough the week or so before being vaccinated as she just stopped taking ZYRTEC (mid June). She had been using ZYRTEC from May-June for new environmental like allergies (cough, congestion, runny nose) per her HCP. She recalls day of 2nd vaccination, her left arm was again sore and she worked thru the pain not taking any medication. The next day, Friday, her arm was still sore but she could work. That evening, she began to feel more fatigued than usual stating she was weak. She described this weakness as a strong ure to sleep and no energy. She stated this fatigue persisted over the next 2 days with her sleeping most of the weekend, onset of chills/fever (100F) and her body ached. She stated she could only walk on bent knees Saturday due to discomfort. She again did not take any meds for pain/fever and had limited food intake (did not check blood sugars, did take daily medications). By Sunday she was dizzy, walked normally, and was feeling better so she ate/drank fluids and felt much better that evening. Monday she went to work feeling better; however that evening she had a fever of 100.5F, was coughing and overall felt bad. She stayed home Tuesday due to dizziness and went to clinic where physician did CXR and labs and diagnosed with pneumonia in her left lung. She was treated with Z-pak and ROBITUSSIN PM. She returned to work Thursday and was re-evaluated by Dr and again sent home to see her CIV HCP. By Sunday she was better and cleared to work on Monday 7/18/2016.