chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 15:28, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 18:37, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 11-DEC-2015 at 15:43, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.8 and 5.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-DEC-2015 at 07:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 7.9 and 4.6 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-NOV-2015 at time- 06:44, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperatures at which the product was stored were 3.4 and 2.5 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-NOV-2015 at time- 10:19, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperatures at which the product was stored were 3.2 and 2.6 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-DEC-2015 at 08:25, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 (for a duration of 9 hours 20 minutes) and 6.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-JAN-2016 at 09:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 (13 hours 13 minutes) and 7.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 10-DEC-2015 at 03:57, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-JAN-2016 at 00:20, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 (23 hours 32 minutes) and 8.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015 at 18:58, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.2 and 4.7 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015 at 10:58, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.2 and 4.7 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015 at 04:10, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 12.0 and 0.5 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-DEC-2015 at 14:58, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.6 and 1.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 62 year old male patient. No pertinent medical history was reported. On 20-JAN-2016, the patient was vaccinated with ZOSTAVAX (dosing details and lot/expiration were not reported). No concomitant therapies were reported. On 01-MAR-2016, the patient called to the pharmacy and stated he experienced soreness at the injection site (onset date approximated to 2016). The pharmacist has not seen the patient since 20-JAN-2016 and she stated the patient denied redness, swelling or rash of any kind at the injection site. The patient did not seek medical attention and no treatment was given for the event. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concomitant conditions and concomitant medications was provided. On unknown (unspecified) dates, improperly stored doses of GARDASIL (lot # K007264, expiration date: 02-MAR-2017, dose, route of administration and injection site were not reported) were administered to an unspecified number of unspecified patients. Administered doses of GARDASIL underwent temperature excursions at 32 Fahrenheit degrees, for 12 hours. Information about the previous temperature excursions was not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015 at 12:42, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.2 and 4.7 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The reporter initially called to report improperly storage conditions for improperly stored PNEUMOVAX 23. Subsequently, it was reported that on 25-FEB-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L029306 and expiry date on 26-MAR-2017, (route, strength, dose and frequency were not reported). No adverse effect was reported and no product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 15:34, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-DEC-2015 at 09:51, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.6 and 1.4 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-NOV-2015 at time- 14:50, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperatures at which the product was stored were 3.1 and 1.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-NOV-2015 at time- 11:11, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose *, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature at which the product was stored were 4.3 and 2.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-DEC-2015 at 04:27, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.0 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-DEC-2015 at 18:09, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.6 and 6.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-DEC-2015 at 11:40, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 7.9 and 4.6 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Awoke with mildly pruritic urticarial lesions at site of injection, face, neck, forearm, abd. Resolved after taking her Rxd meds listed below.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Madarosis, Rash vesicular
Clinical narrative: Had chicken pox in 1959. First pox appeared rt. lower eye lid at point where eye lashes grow (center of lid) after those blisters healed, no eye lashes ever grew back. Day after I received shingles,
Age: 20.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Muscular weakness, Papule
Clinical narrative: Pt developed .5-1 mm papules scattered on upper chest and anterior and lateral neck. Not pruritic or painful-not vesicular or pustular and minimal underlying erythema. Also reported UE and LE muscle weakness. Symptoms started within a couple of hours after getting vaccines.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Feeling abnormal, Feeling cold, Headache, Myalgia
Clinical narrative: Chills. Aches- legs- muscular cough and copius plucous from deep in lungs. Headache-fogginess. Fever 99.5. Going to doctor!
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills. Aches- legs- muscular cough and copius plucous from deep in lungs. Headache-fogginess. Fever 99.5. Going to doctor!
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Blister, Pruritus
Clinical narrative: About 2 months after injection, a small blister developed that was itchy. Continue to be itchy intermittently now for 2 months since it developed.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Sudden onset shortness of breath, wheezing started several minutes after leaving office. Pt still with same symptoms today.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Pyrexia, Vaccination site cellulitis, Vaccination site inflammation
Clinical narrative: Fever, red cellulitic inflammation of left arm at vaccine.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Rash - papules, erythematous. No pustules or vesicles. Clustered on LLE occurred approximately 8 days after MMR given. No fever, rhinorrhea, cough.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Myalgia, Oropharyngeal pain
Clinical narrative: Bumps on face, neck, leg and back. Swelling, redness and heavy feeling at injection site. Muscle aches in thighs and calf on left side. Urination every hour the night of administration. Extreme sore throat.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Pollakiuria, Rash
Clinical narrative: Bumps on face, neck, leg and back. Swelling, redness and heavy feeling at injection site. Muscle aches in thighs and calf on left side. Urination every hour the night of administration. Extreme sore throat.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 28-NOV-2015 at time- 18:39, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse effects were reported. The high temperature and low temperature at which the product was stored were 2.3 and 1.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL (lot # L040459, expiration date 06-APR-2017) (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature 1.5 degrees Centigrade for 1 hour. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-DEC-2015 at 17:35, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.8 (for 24 hours) and 8.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 11:29, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified) respectively. There were no product quality complaints (PQC) involved No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Pneumococcal vaccine received on 3-4-16. States "hurt immediately" then "became sore". Does not report any swelling or redness. No edema or redness at site noted this visit 3/7/16.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional and refers to unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unknown dates in 2016 (reported as "starting on or after 02-FEB-2016"), the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L013193, expiration date: 20-JAN-2017 (exact doses were not reported). There were no concomitant medications provided. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 34.4 degrees Fahrenheit for 15 hours. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # reported as L030872, expiration date 11-JUN-2018; lot # L019297, expiration date 18-AUG-2017 (exact dose and route of administration were not reported). Administered doses of the vaccine experienced the temperature excursion of 0 degrees Celsius for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L030872, expiration date 11-JUN-2018; lot # L033690, expiration date 14-JUN-2018 (exact dose and route of administration were not reported). Administered doses of the vaccine experienced the temperature excursion of 0 degrees Celsius for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # reported as L031065, expiration date 18-AUG-2017; lot # L037562, expiration date 29-SEP-2017; lot # L013824, expiration date 21-APR-2017, lot # L019127, expiration date 27-MAY-2017 (exact dose and route of administration were not reported). The nurse indicated that those vaccines were subjected to multiple defrost cycles (no more than 4 cycles per day lasting 30 minutes for each cycle and not exceeding temperatures over -14.5 degrees Celsius). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 1 hours after administration, pt became fatigue followed by body aches, fever and headache. Symptoms lasted 2 days. No s/sx of injection site reaction.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L031065, expiration date 18-AUG-2017; lot # L034366, expiration date 08-SEP-2017) (dose and route of administration not reported). The vaccines were exposed to the following conditions: temperature (-) minus 9.5 degrees Centigrade for 10 hours and 7 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # reported as L047307, expiration date 23-MAY-2017 (dose and route of administration were not reported). The nurse indicated that those vaccines were subjected to multiple defrost cycles (no more than 4 cycles per day lasting 30 minutes for each cycle and not exceeding temperatures over -14.5 degrees Celsius). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-DEC-2015 at 15:31, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 5.2 and 4.8 (units unspecified). There were no product quality complaints (PQC) involved No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were unknown. The certified medical assistant reported that on 15-FEB-2015 the patient was vaccinated with the first dose of VARIVAX (Lot # L023587, expiry date 26-JUN-2017, dose and route were not reported), and that the vaccine had been improperly stored. The vaccine was exposed at -14 C for a cumulative time frame of 30 hours (3 hours on 10 separate days). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one out of two reports received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Information has been received from an approximately 19 years old female patient referring to herself. The patient's concurrent conditions, concomitant medication and medical history were nor provided. On 02-JAN-2007, when the patient was 19 years old she was vaccinated with one dose of GARDASIL (0.5 ml, intramuscular, lot # was reported as 1246F, expiration date unspecified). However she never completed the 3 series vaccination. No adverse effect was reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Interchange of vaccine products
Clinical narrative: This spontaneous report has been received from a nurse referring to a 13 year old female patient with no pertinent medical history or drug reactions/allergies. The nurse reported the patient received the first dose of GARDASIL (lot # H019495, exp date 26-JUN-2015), on 22-APR-2013 and the second dose of GARDASIL (lot # K008335, exp date 23-JUN-2016) on 10-SEP-2014 (inappropriate schedule of drug administration). On 01-MAR-2016 the patient was vaccinated with the third dose of GARDASIL 9 (lot # L036245, exp date 09-FEB-2018) 0.5 ml, intramuscularly in the left deltoid (interchange of vaccine products). There was no concomitant medication. The nurse reported the patient experienced numbness, which began in the left thumb, after receiving the GARDASIL 9. The nurse was notified by the patient's mother that the numbness had extended to the left arm, since the patient left the office. No treatment was given for the event. No lab diagnostics studies were performed. At the time of the report, the outcome of events was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 67 year old patient of unknown gender. The patient's medical history, concurrent conditions and drug reactions/ allergies were not reported. On 04-MAR-2016, the patient was vaccinated intramuscularly with a dose of ZOSTAVAX in the right upper deltoid muscle (lot # reported as L036823 with expiration date 24-DEC-2016). After the pharmacist realized her error, she administered on the same day, on 04-MAR-2016, another dose of ZOSTAVAX by subcutaneous route, in the right upper posterior deltoid region (lot # reported as L036823 with expiration date 24-DEC-2016) in the same vaccination session. No concomitant medications were reported. The patient did not report any adverse effects. No product quality complaint was involved. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: This spontaneous report was received from a register nurse, refers to a 33 year old female patient with iodine allergy and food allergy. The patient's medical history included skin disorder. The register nurse reported that on 24-FEB-2016, the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) intradermally in her forearm, lot # L035126, expiration date> 14-SEP-2017. Concomitant therapies included tramadol hydrochloride. The register nurse also stated that the same day immediately following the vaccination, the patient developed redness, irritation and tenderness at the injection site. The patient sought medical attention by an office visit and started treatment with an unspecified oral antihistamine, application of hydrocortisone 1% cream and cool packs to the area. Subsequently the patient recovered within 20 minutes. The patient was given a prescription for betamethasone cream to apply to the area as well. There were not laboratories diagnostics performed. The patient did not return to the office for follow up, but per the patient's husband all symptoms have completely resolved as of 04-MAR-2016. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 26-NOV-2015 at time- 23:01, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 16-NOV-2015 at time- 16:04, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.1 and 2.3 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not reported. The certified medical assistant reported that on 14-FEB-2015 the patient was vaccinated with the second dose of VARIVAX (Merck) (Lot # L028277, expiry date 28-JUL-2017, dose and route were not reported), and that the vaccine had been improperly stored. The vaccine was exposed at -14C for a cumulative time frame of 30 hours (3 hours on 10 separate days). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 10-FEB-2016 the patient was vaccinated wit M-M-R II (dosing details were not reported) lot # L015282 with an expiry date 30-APR-2017 which was improperly stored at 47 F for a time frame of less than an hour. There was no previous temperature excursion. No information was provided regarding concomitant medications. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-DEC-2015 at 08:53, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.5 and 7.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On 10-FEB-2016 the patient was vaccinated with MMRII (dosing details were not reported) lot # L015282 with an expiry date 30-APR-2017 which was improperly stored at 47 F for a time frame of less than an hour. There was no previous temperature excursion. No information was provided regarding concomitant medications. No adverse effects were reported. There was no product quality complaint involved This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 19-DEC-2015 at 11:15, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.5 and 7.9 (units unspecified). There were no product quality complaints (PQC) involved No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.23
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Full blood count, Platelet count, Pyrexia, Rash
Clinical narrative: Low grade fever and rash appeared 9 days after vaccination. Onset of rash started at neck (mom describes it as welts) which spread to trunk area from anterior trunk -> nape and back. Now fading (3/2/16 seen for f/u from Urgent Care) w/ red dots not blanching.
Age: 1.23
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Low grade fever and rash appeared 9 days after vaccination. Onset of rash started at neck (mom describes it as welts) which spread to trunk area from anterior trunk -> nape and back. Now fading (3/2/16 seen for f/u from Urgent Care) w/ red dots not blanching.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Chills, Fatigue, Full blood count, Injection site warmth, Palpitations
Clinical narrative: Low grade fevers (99 degrees F) very fatigued, chills, palpitations, warmth at injection site.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Low grade fevers (99 degrees F) very fatigued, chills, palpitations, warmth at injection site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Headache, large localized reaction of swelling, redness, itching at site of injection - left arm.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Received Tdap 3-4-16. Felt a "knot" at site of inj. 3-5-16 Noticed redness, pain. 3-6-16 more red and more painful. Iced the site. 3-7-16 area 8x8 cm redness 4 mm induration still painful warm to touch.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: Patient became dizzy after receiving shots. Did not lose consciousness. Dizzy for next 3 day on and off.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal pain, Emotional distress, Imaging procedure, Irritability, Ultrasound scan
Clinical narrative: Had 4 mo vaccines 1/8/16 in the days following was increasingly fussy and difficult to console. Seen in our office 1/11/16 for abdominal pain sent for KUB which was concerning for intussusception transferred to ER for further imaging which was unremarkable.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urinary system X-ray, X-ray
Clinical narrative: Had 4 mo vaccines 1/8/16 in the days following was increasingly fussy and difficult to console. Seen in our office 1/11/16 for abdominal pain sent for KUB which was concerning for intussusception transferred to ER for further imaging which was unremarkable.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Local reaction with redness and induration on the thigh.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: This spontaneous report was received from a female patient who was over the age of 60 concerning to herself. The patient's concurrent conditions included penicillin and codeine allergy. There was no pertinent medical history. On 01-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, (Lot # not reported), 0.5 ml, intramuscularly. There were no concomitant medications. On 01-MAR-2016, the patient developed a hard lump at the injection site as well as soreness. She started that the next day, on 02-MAR-2016, she developed a red ring around the injection site. On 04-MAR-2016, the red ring around the injection site was larger. The patient did not receive treatment for the events and there were no laboratory diagnostic tests performed. The patient did not seek medical attention. At the time of the report the outcome of the injection site mass, injection site induration, injection site erythema and injection site pain was not recovered. Additional information is not expected as there was no permission to contact the physician.