chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 13-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time for the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 09-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-215; exact dose and route of administration were not reported. There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 816 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 14-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 40 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 23-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manger via company representative referring to a patient of unknown age and gender. On 18-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 19-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 1172 hours with the highest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the second time was 88 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the third time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the fourth time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 30-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the second time was 1172 hours with the lowest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the third time was 296 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the fourth time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 13-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 80 hour with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the second time was 248 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the fourth time was 1172 hours with the highest recorded temperature of -3 Celsius degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. 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. Information about concurrent condition, concomitant medication and medical history was not provided. On 12-OCT-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 (lot # K010522, expiration date: 25-FEB-2016) (0.5 ml/once) intramuscularly. No adverse effects were reported. The outcome of the events was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Information has been received from a physician via a company representative referring to a 62 year old female patient. The patient's medical history, concurrent condition medication were unknown. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (0.5 ml, lot# reported as M018768, expiration date: 15-OCT-2017) subcutaneously. On 19-SEP-2016, the patient experienced warmth and erythema (of the skin). The patient sought medical attention by visit the physicians. The outcome of the events were unknown. The causal relationship between the events and PNEUMOVAX 23 was unknown. Lot number M018768 is not valid for pneumococcal vaccine, polyvalent (23-valent). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Hypotension, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received MENVEO (batch number M15144, expiry date 31st July 2017). On 5th August 2016, the patient received MENVEO (intramuscular) .5 ml. On 5th August 2016, an unknown time after receiving MENVEO, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional details were provided as follows: The reporter stated that, the patient only received the MenCYW-135 liquid conjugate vaccine component in left deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide any further details at the time of reporting. The patient's physician was not notified at this time. Follow up information was received from pharmacist on 4th October 2016: The patient's weight and height was unknown. The reporter's contact details were updated. The patient received 1st dose of MENVEO. The patient experienced severe low blood pressure, dizziness and light headedness within minutes after vaccination with MENVEO. The VAERS details were updated.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Arthralgia, Arthritis, Balance disorder, Depression
Clinical narrative: Arthritis, depression, joint pain, spots on the skin, imbalance, dizziness, erectile dysfunction, anxiety.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Erectile dysfunction, Rash
Clinical narrative: Arthritis, depression, joint pain, spots on the skin, imbalance, dizziness, erectile dysfunction, anxiety.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 04-JUN-2014, the patient was vaccinated with an improperly stored dose PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 696 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Skin warm, Swelling
Clinical narrative: Red, swollen area, warm to touch; swelling occurred immediately; redness a couple of hours later.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 08-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 3000 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 17-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 1008 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injection site cellulitis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a female patient who received FLULAVAL TETRA (batch number 7KK33, expiry date 30th April 2017). On 3rd October 2016, the patient received FLULAVAL TETRA 0.5 ml. On 3rd October 2016, an unknown time after receiving FLULAVAL TETRA, the patient experienced intramuscular formulation administered by other route. In October 2016, the patient experienced injection site cellulitis. On an unknown date, the outcome of the injection site cellulitis and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site cellulitis to be related to FLULAVAL TETRA. Additional details were provided as follows: The age at vaccination was not reported. The patient accidentally received FLULAVAL TETRA subcutaneously, which led to intramuscular formulation administered by other route. In October 2016, less than a week after receiving FLULAVAL TETRA, the patient experienced injection site cellulitis. No other information was known about the event.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 25-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-215; exact dose and route of administration were not reported. There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 1200 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. 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: This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 07-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, intramuscularly, lot # L003228, expiration date 30-JUL-2016 (dose and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. No further information was provided. 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 03-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 672 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: VARZOS
Symptoms: Injury associated with device, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist (age and gender unknown) refers to himself. The pharmacist reported, that on an unknown date, he accidentally stuck himself with a needle that was on syringe contained reconstituted ZOSTAVAX (lot#, expiration date were not provided). Needle punctured his ring finger. No adverse events were reported. 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 registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX subcutaneously (dose not reported) from lot # L042267 with expiry date of 27-OCT-2017 which was exposed to a temperature excursion of 44 degree Fahrenheit (F) for 1 hour, -14.86 degree Celsius (C) for 1 minute, 8.36 F for 1 hour and -14.23 C for 1 hour. No adverse effects were reported. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored 0.5 ml doses of GARDASIL 9 (route of administration was not reported) with the following lot numbers: lot # L013429 with expiration date on 21-JUL-2017; lot # L043214 with expiration date on 30-AUG-2017; lot # M007764 with expiration date on 30-JAN-2018; lot # M009378 with expiration date on 23-APR-2018; lot # L024993 with expiration date on 17-OCT-2017. The vaccines were stored at the temperature of 0.3 degrees Celsius for 45 minutes. No adverse effects were reported. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 09-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 3024 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 16-MAY-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 240 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 20-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 1080 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 05-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 2928 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 12-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 888 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 05-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 720 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 13-JUN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 912 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received 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 physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 11-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 injection (lot # J011042, expiry date: 04-MAR-2015; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to the temperature excursion lasting 3072 hours with the lowest recorded temperature of 20 degrees Fahrenheit (-6.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown date, 11 days before the patient's fourth birthday, she was vaccinated subcutaneously with the second dose of M-M-R II (dose, lot # and expiry date were not reported). No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: Feeling of stomachache, nausea started 24 hrs after receiving vaccine and lasted approx. 36 hrs.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Sleep disorder
Clinical narrative: I had the Booster shot for PREVNAR 13 yesterday. My left arm/shoulder is very swollen and the pain kept me from sleeping last night. It's still very painful very warm to hot and it hurts just to touch my skin anywhere on my shoulder. The Pharmacist did the injection. I've never had a reaction to any injection before and I've been having them since the polio vaccine was prevalent. It Hurts. I'm 73.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Mobility decreased, Pain in extremity
Clinical narrative: Pt had a PNEUMOVAX-23 vaccination. Her arm became painful, lost strength and poor mobility. She saw an MD. It improved and now is back to normal.
Age: 79.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: On Friday 10/14/16 (R) arm started to itch and by Sunday 10/16/16 noticeable swelling, dull ache, redness and warmth on (R) deltoid - redness apx. 15 x 20 cm.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Pain, Pyrexia, Skin warm, Swelling
Clinical narrative: Pain, fever, sweating, warm to touch, slight swelling.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Day after immunization, localized red bump at site of injection a little bigger than golf ball. Pt. requested MEDROL dose pak from primary MD.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen, redness at injection site.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient noticed after 1 wk. she had a quarter (1") size rash not going away for few days. She came to store/pharmacy on 10-16-16. When she put ice, doesn't itch much but redness still there. Store/pharmacy contact Doctor's office, MD ask us to instruct patient call MD any time if she has concerns or condition get worse. Also report to Merck by phone.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient noticed after 1 wk. she had a quarter (1") size rash not going away for few days. She came to store/pharmacy on 10-16-16. When she put ice, doesn't itch much but redness still there. Store/pharmacy contact Doctor's office, MD ask us to instruct patient call MD any time if she has concerns or condition get worse. Also report to Merck by phone.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Pyrexia, Rash macular, Somnolence
Clinical narrative: Red blotchy skin near site of injection. Low grade fever. Feeling groggy.
Age: 23.0
Sex: M
Vaccine: MNQ
Symptoms: Altered state of consciousness, Blood glucose normal, Eye movement disorder, Syncope
Clinical narrative: Pt fainted after vaccination. Pt was nervous and does not like needles. Pt's eyes rolled and awake but not aware; laid pt on floor spoke to patient and responded to external chest rub. EMS responded. BP 110/80, glucose okay. Pt refused transport to hospital. Pt was awake and aware and father drove home.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Peripheral sensory neuropathy
Clinical narrative: Sensory peripheral neuropathy in feet up to mid-calf - spread to over knees- after vaccine.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Peripheral sensory neuropathy
Clinical narrative: Sensory peripheral neuropathy in feet up to mid-calf - spread to over knees- after vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4, PPV, FLU4, PPV
Symptoms: Burning sensation, Diarrhoea, Injection site erythema, Injection site pruritus, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old non pregnant female patient with diabetes, hypertension, allergy to nickel and amlodipine. On 22-SEP-2016, during the same visit, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly and with a dose of FLUZONE (reported as "routine vaccination") (doses, lot # and expiration dates were not reported). The patient was taking concomitantly ONGLYZA, JANUVIA, AMARYL, COREG, lisinopril (manufacturer unknown), aspirin (manufacturer unknown; reported as "Baby aspirin"), ZANTAC, PREMARIN and "a few (unspecified) diabetic medications". On 23-SEP-2016, the patient was feeling tired. On 24-SEP-2016, the patient had a diarrhea. On 25-SEP-2016, the patient developed a rash on her face, which she described as being "red, itchy and burning". When the patient experienced these symptoms, she emailed her physician, who then forwarded the email to the pharmacist. The pharmacist reported that aforementioned symptoms had improved at the time of the report, but it was unknown if the patient was fully recovered. The pharmacist reported, that the patient had a "similar experience" previously, when she was given an insulin injection (unspecified). The patient did not receive any treatment for reported adverse events. No laboratory diagnostic studies were performed. The reporter did not provide a causal relationship between the adverse events and the vaccination with PNEUMOVAX 23 and FLUZONE. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4, PPV, FLU4, PPV
Symptoms: Pruritus, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old non pregnant female patient with diabetes, hypertension, allergy to nickel and amlodipine. On 22-SEP-2016, during the same visit, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly and with a dose of FLUZONE (reported as "routine vaccination") (doses, lot # and expiration dates were not reported). The patient was taking concomitantly ONGLYZA, JANUVIA, AMARYL, COREG, lisinopril (manufacturer unknown), aspirin (manufacturer unknown; reported as "Baby aspirin"), ZANTAC, PREMARIN and "a few (unspecified) diabetic medications". On 23-SEP-2016, the patient was feeling tired. On 24-SEP-2016, the patient had a diarrhea. On 25-SEP-2016, the patient developed a rash on her face, which she described as being "red, itchy and burning". When the patient experienced these symptoms, she emailed her physician, who then forwarded the email to the pharmacist. The pharmacist reported that aforementioned symptoms had improved at the time of the report, but it was unknown if the patient was fully recovered. The pharmacist reported, that the patient had a "similar experience" previously, when she was given an insulin injection (unspecified). The patient did not receive any treatment for reported adverse events. No laboratory diagnostic studies were performed. The reporter did not provide a causal relationship between the adverse events and the vaccination with PNEUMOVAX 23 and FLUZONE. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4, PPV, FLU4, PPV
Symptoms: Burning sensation, Diarrhoea, Fatigue, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old non pregnant female patient with diabetes, hypertension, allergy to nickel and amlodipine. On 22-SEP-2016, during the same visit, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly and with a dose of FLUZONE (reported as "routine vaccination") (doses, lot # and expiration dates were not reported). The patient was taking concomitantly ONGLYZA, JANUVIA, AMARYL, COREG, lisinopril (manufacturer unknown), aspirin (manufacturer unknown; reported as "Baby aspirin"), ZANTAC, PREMARIN and "a few (unspecified) diabetic medications". On 23-SEP-2016, the patient was feeling tired. On 24-SEP-2016, the patient had a diarrhea. On 25-SEP-2016, the patient developed a rash on her face, which she described as being "red, itchy and burning". When the patient experienced these symptoms, she emailed her physician, who then forwarded the email to the pharmacist. The pharmacist reported that aforementioned symptoms had improved at the time of the report, but it was unknown if the patient was fully recovered. The pharmacist reported, that the patient had a "similar experience" previously, when she was given an insulin injection (unspecified). The patient did not receive any treatment for reported adverse events. No laboratory diagnostic studies were performed. The reporter did not provide a causal relationship between the adverse events and the vaccination with PNEUMOVAX 23 and FLUZONE. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU4, PPV, FLU4, PPV
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old non pregnant female patient with diabetes, hypertension, allergy to nickel and amlodipine. On 22-SEP-2016, during the same visit, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly and with a dose of FLUZONE (reported as "routine vaccination") (doses, lot # and expiration dates were not reported). The patient was taking concomitantly ONGLYZA, JANUVIA, AMARYL, COREG, lisinopril (manufacturer unknown), aspirin (manufacturer unknown; reported as "Baby aspirin"), ZANTAC, PREMARIN and "a few (unspecified) diabetic medications". On 23-SEP-2016, the patient was feeling tired. On 24-SEP-2016, the patient had a diarrhea. On 25-SEP-2016, the patient developed a rash on her face, which she described as being "red, itchy and burning". When the patient experienced these symptoms, she emailed her physician, who then forwarded the email to the pharmacist. The pharmacist reported that aforementioned symptoms had improved at the time of the report, but it was unknown if the patient was fully recovered. The pharmacist reported, that the patient had a "similar experience" previously, when she was given an insulin injection (unspecified). The patient did not receive any treatment for reported adverse events. No laboratory diagnostic studies were performed. The reporter did not provide a causal relationship between the adverse events and the vaccination with PNEUMOVAX 23 and FLUZONE. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, DTAP, HEPA, IPV, VARCEL
Symptoms: Cough, Defaecation urgency, Dyspnoea, Laboratory test, Lip swelling
Clinical narrative: This spontaneous report was received from a nurse through a company representative regarding a 6 year old male patient. The patient's concurrent condition included asthma and he was allergic to amoxicillin. On 17-JUN-2015 the patient was vaccinated with M-M-R II lot # L036853 (expiry date unknown) (dosing regimen unknown), subcutaneously. Concomitant therapies included DTaP, VAQTA Pediatric, IPV and VARIVAX on '22-AUG-2016'. On 22-AUG-2016, the patient experienced cough, shortness of breath, skin rash, rhinorrhea, facial swelling, wheezing and skin rash (It was also reported that patient was "initially diagnosed with anaphylaxis"). Patient first visited the emergency room and was then hospitalized on the same day and was treated with albuterol (5 mg) delivered as a nebulizer. Patient was also given dexamethasone (manufacturer unknown), 0.5 mg per kg, intravenously. Patient was then given 'J-PIP' buffered lidocaine (0.25 ml). All these products were only administered once. Laboratory findings included measurement of air movement in both the lungs, heart rate, and range of motion of all the patient's extremities. Vaccination with M-M-R II was discontinued "on 22-AUG-2016". The outcome of the events was reported as recovered/resolved. There was no product quality complaint reported. The reporter did not provide a causality assessment for the events. The reporter considered the events to be serious due to hospitalization and they were also considered to be life threatening. Upon internal review, anaphylaxis was considered to be medically significant. Additional information is not expected since there was no consent to contact the reporter.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, DTAP, HEPA, IPV, VARCEL
Symptoms: Rash, Rhinorrhoea
Clinical narrative: This spontaneous report was received from a nurse through a company representative regarding a 6 year old male patient. The patient's concurrent condition included asthma and he was allergic to amoxicillin. On 17-JUN-2015 the patient was vaccinated with M-M-R II lot # L036853 (expiry date unknown) (dosing regimen unknown), subcutaneously. Concomitant therapies included DTaP, VAQTA Pediatric, IPV and VARIVAX on '22-AUG-2016'. On 22-AUG-2016, the patient experienced cough, shortness of breath, skin rash, rhinorrhea, facial swelling, wheezing and skin rash (It was also reported that patient was "initially diagnosed with anaphylaxis"). Patient first visited the emergency room and was then hospitalized on the same day and was treated with albuterol (5 mg) delivered as a nebulizer. Patient was also given dexamethasone (manufacturer unknown), 0.5 mg per kg, intravenously. Patient was then given 'J-PIP' buffered lidocaine (0.25 ml). All these products were only administered once. Laboratory findings included measurement of air movement in both the lungs, heart rate, and range of motion of all the patient's extremities. Vaccination with M-M-R II was discontinued "on 22-AUG-2016". The outcome of the events was reported as recovered/resolved. There was no product quality complaint reported. The reporter did not provide a causality assessment for the events. The reporter considered the events to be serious due to hospitalization and they were also considered to be life threatening. Upon internal review, anaphylaxis was considered to be medically significant. Additional information is not expected since there was no consent to contact the reporter.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, DTAP, HEPA, IPV, VARCEL
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Pulmonary function test, Rash
Clinical narrative: This spontaneous report was received from a nurse through a company representative regarding a 6 year old male patient. The patient's concurrent condition included asthma and he was allergic to amoxicillin. On 17-JUN-2015 the patient was vaccinated with M-M-R II lot # L036853 (expiry date unknown) (dosing regimen unknown), subcutaneously. Concomitant therapies included DTaP, VAQTA Pediatric, IPV and VARIVAX on '22-AUG-2016'. On 22-AUG-2016, the patient experienced cough, shortness of breath, skin rash, rhinorrhea, facial swelling, wheezing and skin rash (It was also reported that patient was "initially diagnosed with anaphylaxis"). Patient first visited the emergency room and was then hospitalized on the same day and was treated with albuterol (5 mg) delivered as a nebulizer. Patient was also given dexamethasone (manufacturer unknown), 0.5 mg per kg, intravenously. Patient was then given 'J-PIP' buffered lidocaine (0.25 ml). All these products were only administered once. Laboratory findings included measurement of air movement in both the lungs, heart rate, and range of motion of all the patient's extremities. Vaccination with M-M-R II was discontinued "on 22-AUG-2016". The outcome of the events was reported as recovered/resolved. There was no product quality complaint reported. The reporter did not provide a causality assessment for the events. The reporter considered the events to be serious due to hospitalization and they were also considered to be life threatening. Upon internal review, anaphylaxis was considered to be medically significant. Additional information is not expected since there was no consent to contact the reporter.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, DTAP, HEPA, IPV, VARCEL
Symptoms: Rhinorrhoea, Swelling face, Wheezing
Clinical narrative: This spontaneous report was received from a nurse through a company representative regarding a 6 year old male patient. The patient's concurrent condition included asthma and he was allergic to amoxicillin. On 17-JUN-2015 the patient was vaccinated with M-M-R II lot # L036853 (expiry date unknown) (dosing regimen unknown), subcutaneously. Concomitant therapies included DTaP, VAQTA Pediatric, IPV and VARIVAX on '22-AUG-2016'. On 22-AUG-2016, the patient experienced cough, shortness of breath, skin rash, rhinorrhea, facial swelling, wheezing and skin rash (It was also reported that patient was "initially diagnosed with anaphylaxis"). Patient first visited the emergency room and was then hospitalized on the same day and was treated with albuterol (5 mg) delivered as a nebulizer. Patient was also given dexamethasone (manufacturer unknown), 0.5 mg per kg, intravenously. Patient was then given 'J-PIP' buffered lidocaine (0.25 ml). All these products were only administered once. Laboratory findings included measurement of air movement in both the lungs, heart rate, and range of motion of all the patient's extremities. Vaccination with M-M-R II was discontinued "on 22-AUG-2016". The outcome of the events was reported as recovered/resolved. There was no product quality complaint reported. The reporter did not provide a causality assessment for the events. The reporter considered the events to be serious due to hospitalization and they were also considered to be life threatening. Upon internal review, anaphylaxis was considered to be medically significant. Additional information is not expected since there was no consent to contact the reporter.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site urticaria, Vaccination site swelling
Clinical narrative: Swelling, redness with mild itching developed approximately 36-45 hrs after injection. Redness and swelling approximately 5x7 cm inferior to sire of infection. Treated with BENADRYL.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Swelling, redness with mild itching developed approximately 36-45 hrs after injection. Redness and swelling approximately 5x7 cm inferior to sire of infection. Treated with BENADRYL.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discolouration
Clinical narrative: Injection site reaction consisting of discoloration of the area around the injection site to dark brown with no itching, swelling or pain about 4-5 hours after the injection. The size of area is about 1 inch in diameter. The color appears to be lightening over the past two days.