chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of "data logger". No concomitant medications were reported. No adverse effect was reported. This is one several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Swelling for four days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB, HEPA, MMR, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Patient was given KINRIX and PENTACEL at the same date and time instead of Hib vaccine only. Patient also received MMR, Hep A and MMR in the same day.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Neck pain, Pyrexia
Clinical narrative: Pt has returned to pharmacy with complaint: pain to left arm injection site. Pain radiates up over left sholder and up left side of neck, as well as down left arm to elbow. Site is red and inflamed to a 2.5 inch diameter. Pt complains of fever.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 21-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Activated partial thromboplastin time normal, Differential white blood cell count, Full blood count, Petechiae, Prothrombin time normal
Clinical narrative: Petechial rash.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an unspecified patient of unknown age. The patient's pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On 14-JUL-2016, the patient was vaccinated with an improperly stored (Oka/Merck) VARIVAX (lot # M000761 and expiry date 06-JAN-2018). The temperature excursion was at 10.4F for 15 minutes. There was no previous temperature excursion. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-JUL-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # M000442, expiration date 31-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple unspecified patients of an unknown age. The patients' pertinent medical history, concomitant medications and drug reactions/allergies are not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # M012495 and expiry date 10-SEP-2017). Temperature excursion occurred at 46.8 F for 10 hours. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information had been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple unspecified patients of an unknown age. The patients' pertinent medical history, concomitant medications and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L048236 and expiry date 31-MAR-2018). Temperature excursion occurred at 46.8 F for 10 hours. No adverse events were reported. This is one of several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Dysmenorrhoea
Clinical narrative: Information has been received from a consumer regarding her 18 year old daughter. Information pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly. On an unknown date, the patient experienced severe cramping during her first period after receiving the initial dose of GARDASIL 9. The patient did not seek medical attention and did not receive any treatment for the event. The outcome of severe cramping was reported as not recovered. The causality of severe cramping was unknown. Additional information is not expected as the reporter did not provide consent for follow up.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received form a registered nurse referring to a 22 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not provided. The patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown)(strength, dose, frequency, route, lot number and expiration date were unknown) on the following dates: one dose administered on 19-MAY-1994, second dose on 28-JUN-1994 and the final dose on 07-NOV-1994 (product use issue). On an unknown date, the patient had "negative titers" after vaccinated with 3 doses of hepatitis b vaccine (recombinant)(manufacturer unknown). The outcome of negative titers was unknown. The causal relationship between the hepatitis b vaccine (recombinant)(manufacturer unknown) and the event was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 15-AUG-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # K010523, expiry date: 25-FEB-2016. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an adult dose of VAQTA, 50 U/1.0 ml, 1.0 ml (route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information had been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ oral liquid (lot # M002252 with expiry date: 28-FEB-2017, orally; exact dose was unspecified). There were no concomitant medications provided. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 86 year old female patient with hypertension. The patient had no drug reactions or allergies. In 2009, the patient was vaccinated subcutaneously with an unknown dose of ZOSTAVAX (lot # and expiry date were not reported). Concomitant therapies included NORVASC, DIOVAN and hydrochlorothiazide (manufacturer unknown). On an unknown date (reported as recently), the patient was diagnosed with shingles on the left side of her head and left eye. The patient sought medical attention and she was evaluated by her physician. It was unknown if the patient received medical treatment. At the time of the report, the patient was recovering, but still had neuralgia in the area of her left eye. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of shingles on the left eye was considered to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Asthenia, Contusion, Fall, Head injury, Malaise
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. An 18-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot number M68769), intramuscular at 0.5 ml, single and GARDASIL, via an unspecified route of administration at 1 DF, single, both on 21Jun2016. The patient medical history and concomitant medications were not reported. On 21Jun2016, the patient experienced faint with outcome of recovering, fell off the table and hit her head on the floor with outcome of unknown, contusion with outcome of recovering, weakness with outcome of recovering, she did not feel well with outcome of recovering. The adverse events occurred in the exam room at the doctor's office and the patient fainted while sitting on the exam table and she fell off the table and hit her head on the floor, she had a contusion as a result and for about two to three days she did not feel well after having TRUMENBA and she was also administered with another vaccine GARDASIL at the same time. The nurse stated that because there was another vaccine was administered at the same time so they did not know that what was actually causing this. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. An 18-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot number M68769), intramuscular at 0.5 ml, single and GARDASIL, via an unspecified route of administration at 1 DF, single, both on 21Jun2016. The patient medical history and concomitant medications were not reported. On 21Jun2016, the patient experienced faint with outcome of recovering, fell off the table and hit her head on the floor with outcome of unknown, contusion with outcome of recovering, weakness with outcome of recovering, she did not feel well with outcome of recovering. The adverse events occurred in the exam room at the doctor's office and the patient fainted while sitting on the exam table and she fell off the table and hit her head on the floor, she had a contusion as a result and for about two to three days she did not feel well after having TRUMENBA and she was also administered with another vaccine GARDASIL at the same time. The nurse stated that because there was another vaccine was administered at the same time so they did not know that what was actually causing this. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: HPV4, MENB, HPV4, MENB
Symptoms: Asthenia, Contusion, Fall, Head injury, Immediate post-injection reaction
Clinical narrative: This is a spontaneous report from a contactable nurse communicated to a Pfizer sales representative. An 18-year-old female patient of an unspecified ethnicity received TRUMENBA (Lot number M68769), intramuscular at 0.5 ml, single and GARDASIL, via an unspecified route of administration at 1 DF, single, both on 21Jun2016. The patient medical history and concomitant medications were not reported. On 21Jun2016, the patient experienced faint with outcome of recovering, fell off the table and hit her head on the floor with outcome of unknown, contusion with outcome of recovering, weakness with outcome of recovering, she did not feel well with outcome of recovering. The adverse events occurred in the exam room at the doctor's office and the patient fainted while sitting on the exam table and she fell off the table and hit her head on the floor, she had a contusion as a result and for about two to three days she did not feel well after having TRUMENBA and she was also administered with another vaccine GARDASIL at the same time. The nurse stated that because there was another vaccine was administered at the same time so they did not know that what was actually causing this. No follow-up attempts possible. No further information expected.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Asthma, Chest X-ray abnormal, Choking, Cough, Pertussis
Clinical narrative: This is a spontaneous report from a contactable consumer. An 84-year-old female patient received PREVNAR 13 via an unspecified route of administration on 16Mar2015 at single dose. The patient medical history and concomitant medications were not reported. Since 16March2015 she have had a hacking cough which sounds like whooping cough. Within two weeks from the shot she had started with the cough and she had experienced all the symptoms of pneumonia and it was horrible, consumer could not eat a meal without coughing and choking. She was prescribed a Nebulizer to use. The patient was in emergency room in April2015 where she had gone through a chest Xray and they said it was bronchial asthma, so they started her on antibiotics but still the symptoms did not go away. At the time of reporting the patient was doing much better and consumer did not have to use Nebulizer as much as now she had a kind of little cough. She was much better but was not 100% better. At the time of reporting the patient stated the all the symptoms of pneumonia were better now and it was over the last year that she had all the problems, X-rays and the hacking cough so she took medications for it and everything. She was recovering from hacking cough which sounds like whooping cough, experienced all the symptoms of pneumonia, bronchial asthma. The outcome of she could not eat a meal without coughing and choking was unknown. The patient stated that she would be 86 years old and before she received PREVNAR 13, she was in excellent health and then everything got changed after she received PREVNAR 13. After a year and half later she had started feeling herself like she was, it took that long to remove out that shot from her body. The patient stated that she know that all the problems were because of PREVNAR 13 that went into her body because she was a healthy woman, she was in her 80s and she would be going to 86 but she was very healthy, she never had a cold, she never had anything so she decided to have the Pneumonia shot (PREVNAR 13) which would be better at her age but she would never consent to have that shot.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer. An 84-year-old female patient received PREVNAR 13 via an unspecified route of administration on 16Mar2015 at single dose. The patient medical history and concomitant medications were not reported. Since 16March2015 she have had a hacking cough which sounds like whooping cough. Within two weeks from the shot she had started with the cough and she had experienced all the symptoms of pneumonia and it was horrible, consumer could not eat a meal without coughing and choking. She was prescribed a Nebulizer to use. The patient was in emergency room in April2015 where she had gone through a chest Xray and they said it was bronchial asthma, so they started her on antibiotics but still the symptoms did not go away. At the time of reporting the patient was doing much better and consumer did not have to use Nebulizer as much as now she had a kind of little cough. She was much better but was not 100% better. At the time of reporting the patient stated the all the symptoms of pneumonia were better now and it was over the last year that she had all the problems, X-rays and the hacking cough so she took medications for it and everything. She was recovering from hacking cough which sounds like whooping cough, experienced all the symptoms of pneumonia, bronchial asthma. The outcome of she could not eat a meal without coughing and choking was unknown. The patient stated that she would be 86 years old and before she received PREVNAR 13, she was in excellent health and then everything got changed after she received PREVNAR 13. After a year and half later she had started feeling herself like she was, it took that long to remove out that shot from her body. The patient stated that she know that all the problems were because of PREVNAR 13 that went into her body because she was a healthy woman, she was in her 80s and she would be going to 86 but she was very healthy, she never had a cold, she never had anything so she decided to have the Pneumonia shot (PREVNAR 13) which would be better at her age but she would never consent to have that shot.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Computerised tomogram, Erythema, Hypersensitivity, Myalgia, Skin warm
Clinical narrative: This is a spontaneous report received from a Pfizer-sponsored program. A 75-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in arm in Apr2016 at single dose. Medical history included Iodine contrast dye allergy 10 years earlier during a cat-scan with urticaria and swelling face on and off for 4 months. Concomitant medication included ongoing levothyroxine 50mg once daily since 20 years, and ongoing CENTRUM SILVER once daily since 20 years. The patient previously received a pneumococcal vaccine and experienced sore muscle, and flu vaccine and experienced sore muscle. The patient experienced sore muscles and redness with outcome of recovered, the top part of the arm became very red and hot for about a week after vaccination with outcome of recovered, allergic reaction with outcome of recovered, and slightly swollen on an unspecified date with outcome of unknown. The patient was admitted to the hospital 7 days after onset and was treated with cool shower and ice packs.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report received from a Pfizer-sponsored program. A 75-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in arm in Apr2016 at single dose. Medical history included Iodine contrast dye allergy 10 years earlier during a cat-scan with urticaria and swelling face on and off for 4 months. Concomitant medication included ongoing levothyroxine 50mg once daily since 20 years, and ongoing CENTRUM SILVER once daily since 20 years. The patient previously received a pneumococcal vaccine and experienced sore muscle, and flu vaccine and experienced sore muscle. The patient experienced sore muscles and redness with outcome of recovered, the top part of the arm became very red and hot for about a week after vaccination with outcome of recovered, allergic reaction with outcome of recovered, and slightly swollen on an unspecified date with outcome of unknown. The patient was admitted to the hospital 7 days after onset and was treated with cool shower and ice packs.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, dose and site of administration were unspecified). The administered vaccine underwent temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. It was a case of a "data logger". No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Brain scan normal, Headache, Hyperacusis, Hypertension, Migraine
Clinical narrative: This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. This is a report from a Pfizer sponsored interventional study. Follow-up received from the treating hospital provided a change in the wording of the event, additional medical history, event details, test results and consultant comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding a 38-year-old female participant in a study who experienced severe headache consistent with migraine headache. The participant received the first dose on 04Jun2009. On day 6 through 12 following administration of Pneumococcal Conjugate Vaccine, 13-Valent the patient developed intermittent headaches resolved with over-the-counter analgesics. On the evening of 18Jun2009, post-vaccination day 14, the patient developed a severe headache that did not resolve after three hours. She was instructed to go to the emergency room where she was admitted for observation with the diagnosis of acute headache, nausea with no vomiting and hypertension. The patient reported her own blood pressure to be 150/110 prior to admission however at the hospital it was within appropriate range in the 110s-140s/50s-90s. Treatment included DILAUDID, ZOFRAN, DECADRON, PHENERGAN and IV fluids. No further episodes of hypertension were noted. On 19Jun2009 the patient was examined by a neurologist and discharged from the hospital with a final diagnosis of severe headache consistent with migraine headache. The outcome was reported as recovered. The neurologist commented that the patient clearly admits to a family history of migraine in her mother. He also stated that "whether or not this is related to her Pneumococcal experimental vaccine approximately two weeks previous to current evaluation will be very difficult to definitively characterize". On 22Jun2009 the patient reported that her headache was relieved in the hospital with DILAUDID and had not returned. No additional information was available at the time of this report. The investigator considered migraine possibly related to the study product. The medical monitor considered migraine not related to the study product. Follow-up (09Aug2016): This is a follow-up report from study. No further information provided.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Photophobia
Clinical narrative: This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMS I or MedWatch report may indicate in the appropriate field that it is an initial report. This is a report from a Pfizer sponsored interventional study. Follow-up received from the treating hospital provided a change in the wording of the event, additional medical history, event details, test results and consultant comments. Information regarding Pneumococcal Conjugate Vaccine, 13-Valent (injection) was received from an investigator regarding a 38-year-old female participant in a study who experienced severe headache consistent with migraine headache. The participant received the first dose on 04Jun2009. On day 6 through 12 following administration of Pneumococcal Conjugate Vaccine, 13-Valent the patient developed intermittent headaches resolved with over-the-counter analgesics. On the evening of 18Jun2009, post-vaccination day 14, the patient developed a severe headache that did not resolve after three hours. She was instructed to go to the emergency room where she was admitted for observation with the diagnosis of acute headache, nausea with no vomiting and hypertension. The patient reported her own blood pressure to be 150/110 prior to admission however at the hospital it was within appropriate range in the 110s-140s/50s-90s. Treatment included DILAUDID, ZOFRAN, DECADRON, PHENERGAN and IV fluids. No further episodes of hypertension were noted. On 19Jun2009 the patient was examined by a neurologist and discharged from the hospital with a final diagnosis of severe headache consistent with migraine headache. The outcome was reported as recovered. The neurologist commented that the patient clearly admits to a family history of migraine in her mother. He also stated that "whether or not this is related to her Pneumococcal experimental vaccine approximately two weeks previous to current evaluation will be very difficult to definitively characterize". On 22Jun2009 the patient reported that her headache was relieved in the hospital with DILAUDID and had not returned. No additional information was available at the time of this report. The investigator considered migraine possibly related to the study product. The medical monitor considered migraine not related to the study product. Follow-up (09Aug2016): This is a follow-up report from study. No further information provided.
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Cough, Pneumothorax
Clinical narrative: This is a spontaneous report from a contactable female consumer reported for her husband and one other person. This case is for her husband. An 83-year-old patient received PREVNAR 13 via an unspecified route of administration at 0.5 ml, single in the arm on 30Jun2015. Medical history included ongoing short of breath. The patient's concomitant medications were not reported. The patient experienced coughing on 01Jul2015 or 02Jul2015 that required hospitalization with outcome of recovering, due to extreme coughing, airway to his right lung was collapsed 90% and to his left lung 80% on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of coughing included acetylcysteine nebulizer. Reporter mentioned that her husband was doctored four days and there was tried to clean out his (consumer) lungs, but because of his bad coughing they could not get it all done.
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Cough
Clinical narrative: This is a spontaneous report from a contactable female consumer reported for her husband and one other person. This case is for her husband. An 83-year-old patient received PREVNAR 13 via an unspecified route of administration at 0.5 ml, single in the arm on 30Jun2015. Medical history included ongoing short of breath. The patient's concomitant medications were not reported. The patient experienced coughing on 01Jul2015 or 02Jul2015 that required hospitalization with outcome of recovering, due to extreme coughing, airway to his right lung was collapsed 90% and to his left lung 80% on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of coughing included acetylcysteine nebulizer. Reporter mentioned that her husband was doctored four days and there was tried to clean out his (consumer) lungs, but because of his bad coughing they could not get it all done.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 08-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591, rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reported received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 12-JUL-2016 a dose of improperly stored M-M-R II (lot# L027591 rHA, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). Immediately after receiving the dose of GARDASIL 9, the patient felt dizzy. She laid down and rested for a few minutes before leaving physician's office and recovered. The relatedness between the event and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 18-JUL-2016 a dose of improperly stored MMR II (lot# L027591, expiration date 23-JUL-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received from the same source. Additional information is not expected as there is no consent to contact the physician.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Headache, Hyperacusis, Neck pain, Oropharyngeal pain
Clinical narrative: Neck pain, Fever of 102F, sore throat, hands hurt, headache, dizziness, noise sensitivity.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Pain in extremity, Pyrexia, Streptococcus test negative
Clinical narrative: Neck pain, Fever of 102F, sore throat, hands hurt, headache, dizziness, noise sensitivity.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Rash vesicular
Clinical narrative: HEADACHE AND VESICULAR RASH ON BILATERAL ANTERIOR UPPER ARMS AND MIDLINE OF CHEST.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: No adverse event
Clinical narrative: This happened this morning. We will follow up with parent. Private Medical Physician notified and will follow up with parent. No adverse reactions at this time.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant (CMA) refers to multiple unknown patients of unknown age. On an multiple unknown dates, these patients were vaccinated with VAQTA (lot # M015290, Expiration Date: 20-SEP-2017). It was called because of Digital Data Logger. These vaccines were stored under 1.2 degree Celsius for one hour. There was no temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product quality issue
Clinical narrative: This spontaneous report was received from a Registered Nurse (R.N.) referring to a patient of unknown age and gender. No pertinent medical history, concurrent conditions and concomitant therapies were provided. On an unknown date the patient was vaccinated with M-M-R II. Dose, route, anatomical location and lot # were not reported. Then, 11 days after vaccination (unknown date), the patient was vaccinated with VARIVAX, 0.5 ml, subcutaneous. Anatomical location and lot # not reported. No adverse effects were reported. It was not a product quality complaint involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received on 08-AUG-2016 from a consumer referring to a 77 year old female patient. The patient's medical history and concomitant medications were not reported. The patient reported "over a year ago" she was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. On an unknown date after she received the vaccination, she developed shingles. The patient sought medical treatment from her doctor. The patient has been provided with multiple unspecified treatments for the shingles, but "one are helping her recover from the pain she is expecting with the shingles." The patient is requesting compensation for the time she has missed from work because of the time she has to spend at her doctor's office trying to get treatment for the pain, and since she has missed work she has not been getting paid for the days that were missed. The outcome of herpes zoster and pain was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ oral liquid (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, exact dose was unspecified). The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ oral liquid (lot # M002252 with expiry date: 28-FEB-2017, orally; strength, exact dose was unspecified). There were no concomitant medications provided. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year 7 months old patient of unknown gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The patient had completed the (meningococcal protein conjugate) PEDVAXHIB vaccination series in 2005. On 15-JUL-2016, the patient was inadvertently vaccinated with PEDVAXHIB lot # L038501, expiry date: 16-AUG-2018, 0.5 ml once, instead of GARDASIL 9. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Headache, Injection site nodule, Nausea, Pain
Clinical narrative: Initial unsolicited report received from a Nurse on 26 October 2015. This case was linked to 2015SA176376 and 2015SA172486 (same vaccine). This case involves a patient (age not reported) who was vaccinated with a dose of Fluzone (batch number, route and site of administration were not reported) and on the same day also received a dose of Pneumovax (batch number- L003188, expiry date- 06 July 2016, route and site of administration, dose, dose in series were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced nausea, headache, and "terribly achy body", fever, both arms were red and had knot of the size of baseball at the injection site. Laboratory data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Loss of consciousness is unlisted after INFLUENZA VACCINE. Time to onset is not reported. In the current case, there is no information on medical history and complementary investigations. Insufficient information in this report precludes a complete medical assessment.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a Nurse on 26 October 2015. This case was linked to 2015SA176376 and 2015SA172486 (same vaccine). This case involves a patient (age not reported) who was vaccinated with a dose of Fluzone (batch number, route and site of administration were not reported) and on the same day also received a dose of Pneumovax (batch number- L003188, expiry date- 06 July 2016, route and site of administration, dose, dose in series were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced nausea, headache, and "terribly achy body", fever, both arms were red and had knot of the size of baseball at the injection site. Laboratory data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Loss of consciousness is unlisted after INFLUENZA VACCINE. Time to onset is not reported. In the current case, there is no information on medical history and complementary investigations. Insufficient information in this report precludes a complete medical assessment.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Feeding disorder, Heart rate increased
Clinical narrative: Initial unsolicited misuse report received from a consumer on 04 November 2015. This case involves a 53-year-old female patient who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in right deltoid on 03 November 2015. Illness at time of vaccination was reported as no illness, pre-existing physician diagnosed allergies included history of allergies, sensitivity to many items. Birth defects, and medical conditions were not reported. Concomitant medications were not reported. On 13 November 2015, few minutes following the vaccination, the patients lips became itchy, she had an increased heart rate, felt faint, nauseous, had diarrhea, stomach upset, right deltoid developed swelling that looked like a mosquito bite, it was the size of a dime, itchy and painful to touch. Under the skin surface, at the injection site swelled up 2x the size of a quarter, which could not be seen, but could be felt. Same day few hours, following the vaccination (once home), the patient fell asleep for 2.5 hours, after she woke up she still had stomach upset, was not able to eat anything all day, but did take in fluids. During the night, the patient woke up with up from pain in her right arm. On an unknown date, (next day) following the vaccination most symptoms were alleviated. The patient was given the vaccine via intramuscular route which led to wrong route of administration. The patient's laboratory data was reported as none. The patient treated with BENADRYL which eased most of the symptoms. It was reported that, the patient still had some swelling at the injection site about the size of a dime, the area is still itchy. The patient was not recovered from the events. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site pain, Injection site pruritus, Injection site swelling, Lip pruritus
Clinical narrative: Initial unsolicited misuse report received from a consumer on 04 November 2015. This case involves a 53-year-old female patient who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in right deltoid on 03 November 2015. Illness at time of vaccination was reported as no illness, pre-existing physician diagnosed allergies included history of allergies, sensitivity to many items. Birth defects, and medical conditions were not reported. Concomitant medications were not reported. On 13 November 2015, few minutes following the vaccination, the patients lips became itchy, she had an increased heart rate, felt faint, nauseous, had diarrhea, stomach upset, right deltoid developed swelling that looked like a mosquito bite, it was the size of a dime, itchy and painful to touch. Under the skin surface, at the injection site swelled up 2x the size of a quarter, which could not be seen, but could be felt. Same day few hours, following the vaccination (once home), the patient fell asleep for 2.5 hours, after she woke up she still had stomach upset, was not able to eat anything all day, but did take in fluids. During the night, the patient woke up with up from pain in her right arm. On an unknown date, (next day) following the vaccination most symptoms were alleviated. The patient was given the vaccine via intramuscular route which led to wrong route of administration. The patient's laboratory data was reported as none. The patient treated with BENADRYL which eased most of the symptoms. It was reported that, the patient still had some swelling at the injection site about the size of a dime, the area is still itchy. The patient was not recovered from the events. List of documents held by sender: none.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain in extremity
Clinical narrative: Initial unsolicited misuse report received from a consumer on 04 November 2015. This case involves a 53-year-old female patient who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series, were not reported) intramuscularly in right deltoid on 03 November 2015. Illness at time of vaccination was reported as no illness, pre-existing physician diagnosed allergies included history of allergies, sensitivity to many items. Birth defects, and medical conditions were not reported. Concomitant medications were not reported. On 13 November 2015, few minutes following the vaccination, the patients lips became itchy, she had an increased heart rate, felt faint, nauseous, had diarrhea, stomach upset, right deltoid developed swelling that looked like a mosquito bite, it was the size of a dime, itchy and painful to touch. Under the skin surface, at the injection site swelled up 2x the size of a quarter, which could not be seen, but could be felt. Same day few hours, following the vaccination (once home), the patient fell asleep for 2.5 hours, after she woke up she still had stomach upset, was not able to eat anything all day, but did take in fluids. During the night, the patient woke up with up from pain in her right arm. On an unknown date, (next day) following the vaccination most symptoms were alleviated. The patient was given the vaccine via intramuscular route which led to wrong route of administration. The patient's laboratory data was reported as none. The patient treated with BENADRYL which eased most of the symptoms. It was reported that, the patient still had some swelling at the injection site about the size of a dime, the area is still itchy. The patient was not recovered from the events. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Cough, Dizziness, Injected limb mobility decreased, Malaise
Clinical narrative: Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) on 24 November 2015. Manufacturing control number: 2015406182. This case involves a 73-year-old female patient who was vaccinated with a first dose of Season flu double dose (batch number, expiration date, dose, dose number, route and site of administration were not reported) in right arm and a dose of PREVENAR 13 (batch number, expiration date, dose, dose number and site of administration were not reported) in left arm on 10 November 2015 at 10:00 hours. The patient's medical history and concomitant medication were not reported. The patient taking flu shot every year. The patient had the regular pneumonia shot 5 or more years ago. On 11 November 2015, one day following the vaccination the patient experienced feverish, coughing, lightheaded, lousy, all joints hurt, really painful in the muscles, couldn't move arm, pain in arm and feeling sick. Laboratory investigation and corrective treatment were not reported. The patient was not recovered from events. List of documents held by sender: none.