chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant regarding a 49 year old male patient (also reported as turned 50 years of age). Information regarding the patient's medical history, drug reactions or allergies, and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date in 2014, the patient was vaccinated with PROQUAD (strength, dose, route, anatomical location, lot# and expiration date were not provided) for prophylaxis. On an unknown date a titer was performed in which the patient came up low. Therefore, the second time the vaccination was administered to the patient on 30-JAN-2018 (lot# N010114 with expiration date: 24-SEP-2018) in left arm. No adverse effects were reported. This is one of the report received from the same reporter.
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site reaction, Injection site swelling, Injection site warmth, Wound
Clinical narrative: Seriousness criteria: Important medical event. Initial unsolicited report received from nurse on 19-Apr-2018. This case involves female patient (age and gender not reported) who was vaccinated with a dose of IPV (batch number: N1G51), DTAP (batch number: C5180AA), VARICELLA VACCINE (LIVE) (batch number: N029634), MMR (batch number: N023153) and HEPATITIS A VACCINE (Batch number: N030286) (expiration date, dose, route was not reported for all vaccines) in leg (on record it says 2 shots on left leg and 3 on right leg but was told that it was wrong. They are not sure which shots were given on which leg) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient left leg had three puncture wounds. One was a given a little high up, two puncture wounds on right leg. On an unspecified date, following the vaccination, the higher puncture on left leg had swelling and was raised, a little warm to the touch which indicate of cellulitis 2 degree. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. Upon internal review, the company decided to consider the event serious because of important medical event cellulitis. List of documents held by sender: none. Sender's Comments: This is a poorly documented case in which patient was given 5 parenteral vaccinations on the thighs simultaneously, one of them being Polio vaccine. One of the 5 vaccination sites developed Cellulitis. It is not known as to which vaccine corresponds to which puncture site. The time to onset is not reported, neither is the etiology of the cellulitis confirmed by lab tests. Based upon the reported information, it is not possible to comment on the role of any particular vaccine in this case.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema
Clinical narrative: Patient phoned pharmacy to report adverse reaction to ADACEL vaccine. Patient stated that an area the size of her palm appeared the day after the vaccine was administered. The area is red and elevated. Pharmacist spoke with ordering physician, and scheduled a follow up for the patient to see the physician the day of the reported adverse reaction (4/27/2018 @ 04:15 pm).
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Patient is developing fever blisters. Got prescription for Valacyclovir 500 BID x 3 days on 4/20/18. Vaccine given on 3/22/18.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Back pain, Dysstasia, Gait disturbance, Influenza like illness
Clinical narrative: Pt began with the following symptoms 48 hours after vaccine administration: -flu-like/achy -lower back, hip, pelvic pain -can't sit, bend, roll out of bed -can't sit/bend w/o excruciating pain - difficult walking/standing -right leg paralyzing pain.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Pain in extremity, Pelvic pain
Clinical narrative: Pt began with the following symptoms 48 hours after vaccine administration: -flu-like/achy -lower back, hip, pelvic pain -can't sit, bend, roll out of bed -can't sit/bend w/o excruciating pain - difficult walking/standing -right leg paralyzing pain.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: On 4/18/18, developed a large raised bump the size of a lime under the injection site surrounded with erythema and discomfort. Examined by physician on 4/26 and area had decreased to dime size wheel with mild erythema and tenderness to the site. No reaction with previous 2 injections.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Bronchial wall thickening, Bronchitis, Chest X-ray abnormal
Clinical narrative: Patient had right arm pain immediately after vaccine was given on 4/6/18 (i.e. pain in left shoulder deltoid region later the same day). The pain resolved on 4/12/18, but he developed tonsillar pain that same day. He developed joint pains in his hands, fatigue, generalized muscle weakness, and elevated temperature to 100° F. He was seen in the Family Medicine Clinic on 4/16/18, was diagnosed with acute pharyngitis, and started on a 10-day course of AUGMENTIN. Over the next few days, he developed right-sided pleuritic chest pain and chest congestion for which he went to the Clinic emergency room on 4/22/18. He was diagnosed with acute bronchitis and pleuritic chest pain, and was admitted to the hospital service. He was given IV ceftriaxone and discharged home on 4/23/18. He presented back to the same ER that evening with worsening right-sided pleuritic chest pain, but did not require readmission. He was discharge on cefuroxime and doxycycline. Over the next couple of days, he developed an erythematous maculopapular rash over his chest, abdomen, back, and extremities. He held cefuroxime, but continued doxycycline. I saw him on 4/26/18 for hospital/ER follow-up where he noted that the pleuritic chest pain on the right had resolved, but was now on the left in his mid-chest with deep inspiration. Also, I visualized the diffuse rash which had been stable. We continued doxycycline and added azithromycin. His chest x-ray revealed slight bilateral pleural effusions, greater on the right and right-sided bronchial cuffing suggestive of acute bronchitis. Plan is to continue doxycycline and azithromycin for now with close follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Patient had right arm pain immediately after vaccine was given on 4/6/18 (i.e. pain in left shoulder deltoid region later the same day). The pain resolved on 4/12/18, but he developed tonsillar pain that same day. He developed joint pains in his hands, fatigue, generalized muscle weakness, and elevated temperature to 100° F. He was seen in the Family Medicine Clinic on 4/16/18, was diagnosed with acute pharyngitis, and started on a 10-day course of AUGMENTIN. Over the next few days, he developed right-sided pleuritic chest pain and chest congestion for which he went to the Clinic emergency room on 4/22/18. He was diagnosed with acute bronchitis and pleuritic chest pain, and was admitted to the hospital service. He was given IV ceftriaxone and discharged home on 4/23/18. He presented back to the same ER that evening with worsening right-sided pleuritic chest pain, but did not require readmission. He was discharge on cefuroxime and doxycycline. Over the next couple of days, he developed an erythematous maculopapular rash over his chest, abdomen, back, and extremities. He held cefuroxime, but continued doxycycline. I saw him on 4/26/18 for hospital/ER follow-up where he noted that the pleuritic chest pain on the right had resolved, but was now on the left in his mid-chest with deep inspiration. Also, I visualized the diffuse rash which had been stable. We continued doxycycline and added azithromycin. His chest x-ray revealed slight bilateral pleural effusions, greater on the right and right-sided bronchial cuffing suggestive of acute bronchitis. Plan is to continue doxycycline and azithromycin for now with close follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Painful respiration, Pharyngitis, Pleural effusion, Pleuritic pain, Rash
Clinical narrative: Patient had right arm pain immediately after vaccine was given on 4/6/18 (i.e. pain in left shoulder deltoid region later the same day). The pain resolved on 4/12/18, but he developed tonsillar pain that same day. He developed joint pains in his hands, fatigue, generalized muscle weakness, and elevated temperature to 100° F. He was seen in the Family Medicine Clinic on 4/16/18, was diagnosed with acute pharyngitis, and started on a 10-day course of AUGMENTIN. Over the next few days, he developed right-sided pleuritic chest pain and chest congestion for which he went to the Clinic emergency room on 4/22/18. He was diagnosed with acute bronchitis and pleuritic chest pain, and was admitted to the hospital service. He was given IV ceftriaxone and discharged home on 4/23/18. He presented back to the same ER that evening with worsening right-sided pleuritic chest pain, but did not require readmission. He was discharge on cefuroxime and doxycycline. Over the next couple of days, he developed an erythematous maculopapular rash over his chest, abdomen, back, and extremities. He held cefuroxime, but continued doxycycline. I saw him on 4/26/18 for hospital/ER follow-up where he noted that the pleuritic chest pain on the right had resolved, but was now on the left in his mid-chest with deep inspiration. Also, I visualized the diffuse rash which had been stable. We continued doxycycline and added azithromycin. His chest x-ray revealed slight bilateral pleural effusions, greater on the right and right-sided bronchial cuffing suggestive of acute bronchitis. Plan is to continue doxycycline and azithromycin for now with close follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash maculo-papular, Respiratory tract congestion, Tonsillar disorder
Clinical narrative: Patient had right arm pain immediately after vaccine was given on 4/6/18 (i.e. pain in left shoulder deltoid region later the same day). The pain resolved on 4/12/18, but he developed tonsillar pain that same day. He developed joint pains in his hands, fatigue, generalized muscle weakness, and elevated temperature to 100° F. He was seen in the Family Medicine Clinic on 4/16/18, was diagnosed with acute pharyngitis, and started on a 10-day course of AUGMENTIN. Over the next few days, he developed right-sided pleuritic chest pain and chest congestion for which he went to the Clinic emergency room on 4/22/18. He was diagnosed with acute bronchitis and pleuritic chest pain, and was admitted to the hospital service. He was given IV ceftriaxone and discharged home on 4/23/18. He presented back to the same ER that evening with worsening right-sided pleuritic chest pain, but did not require readmission. He was discharge on cefuroxime and doxycycline. Over the next couple of days, he developed an erythematous maculopapular rash over his chest, abdomen, back, and extremities. He held cefuroxime, but continued doxycycline. I saw him on 4/26/18 for hospital/ER follow-up where he noted that the pleuritic chest pain on the right had resolved, but was now on the left in his mid-chest with deep inspiration. Also, I visualized the diffuse rash which had been stable. We continued doxycycline and added azithromycin. His chest x-ray revealed slight bilateral pleural effusions, greater on the right and right-sided bronchial cuffing suggestive of acute bronchitis. Plan is to continue doxycycline and azithromycin for now with close follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling hot, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Patient received the 1st dose of SHINGRIX on 4/19/18 at around 3:45 PM. She stated later that afternoon she start feeling "crappy". She was feeling tired and feeling some body aches. The next day on 4/20/18 her symptoms worsened. She said she had "flu like symptoms", that she was extremely tired to the point that she didn't want to get out of bed. She had a fever (she did not know how high her temp was but she was feeling warm), her body aches increased, and she has shooting pain which traveled down her extremities. She described that the pain started from her upper arm and her thigh, and traveled down to her finger tips and her toes. She stated that the pain was pulsating in nature and it was a sharp shooting pain. She said even though she has chronic back pain, this pain was different than what she normally experiences and it was more severe. That same afternoon she went to her physician. She said he examined the injection site, which looked normal except for some minor swelling, and told her that he thinks this is the adverse effect she is experiencing from the SHINGRIX vaccine. As her systemic symptoms improved over time, patient said the injection site started to swell after about 3 days, and it was red and warm to touch. Patient said that all of her symptoms resolved after about 1 week.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient received the 1st dose of SHINGRIX on 4/19/18 at around 3:45 PM. She stated later that afternoon she start feeling "crappy". She was feeling tired and feeling some body aches. The next day on 4/20/18 her symptoms worsened. She said she had "flu like symptoms", that she was extremely tired to the point that she didn't want to get out of bed. She had a fever (she did not know how high her temp was but she was feeling warm), her body aches increased, and she has shooting pain which traveled down her extremities. She described that the pain started from her upper arm and her thigh, and traveled down to her finger tips and her toes. She stated that the pain was pulsating in nature and it was a sharp shooting pain. She said even though she has chronic back pain, this pain was different than what she normally experiences and it was more severe. That same afternoon she went to her physician. She said he examined the injection site, which looked normal except for some minor swelling, and told her that he thinks this is the adverse effect she is experiencing from the SHINGRIX vaccine. As her systemic symptoms improved over time, patient said the injection site started to swell after about 3 days, and it was red and warm to touch. Patient said that all of her symptoms resolved after about 1 week.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Red (pink) itchy area to upper arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: RED RASH AND SWELLING OF INJECTION SITE OF BILATERAL.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, VARCEL
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: TRUMENBA was given as an alternative to MENACTRA. No adverse reaction reported to this facility.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Blister, Injection site erythema, Injection site reaction, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report was received from a 51 year old female patient (who was also a nurse) along with the follow up received from a physician. The patient's current conditions included asthma, environmental allergy, hypothyroidism and anxiety. The patient had drug allergies to doxycycline and COMPAZINE. Concomitant therapies included CELEXA, CYTOMEL, levothyroxine sodium (manufacturer unknown) and allergy shots (details unspecified). On 26-MAR-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N030986, expiry date 11-MAY-2019) (dosing regimen and frequency unknown) injection subcutaneously in the right arm for prevention because the patient had asthma. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (lot number U5793AA, expiry date unknown) (dosing regimen and frequency unknown) intramuscularly in the right deltoid for prophylaxis. There was no illness at the time of vaccination. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with other/unknown funds. On 27-MAR-2018, evening the patient developed red, huge welts at the injection site and lower on her arm. The lower part of the arm was swollen tender/sore. The patient had blebs that welted which was achy and was feverish. The nurse treated herself with ibuprofen (manufacturer unknown) and reported that the welts got even bigger about 3 inches by 4 inches leaving her with a sore arm to point where she could barely move her arm (pain in extremity). On 28-MAR-2018 the patient also developed a high fever with a temperature of 101.6 and she went to her doctor's office. The patient's physician recommended ice packs, ibuprofen (manufacturer unknown), BENADRYL, TYLENOL (manufacturer unknown) as needed for treatment. On 29-MAR-2018 the patient was seen at the physician's office again during when she had swelling of the upper arm length over triceps. On 29-MAR-2018, the patient's body temperature was 100.7 (units unspecified). The patient was started with KEFLEX 500 mg for 10 days. The outcome of the events was reported as recovering. The relatedness of the events to the suspect drug therapy was unknown. There was no product quality complaint reported. It was reported that a temperature excursion did not occur as a result of a reading from a Digital Data Logger. It was reported that the patient had not reported these adverse events previously. The event "sore arm to point where she could barely move her arm" was considered to be serious due to disability.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Peripheral swelling, Pyrexia, Tenderness, Urticaria
Clinical narrative: This spontaneous report was received from a 51 year old female patient (who was also a nurse) along with the follow up received from a physician. The patient's current conditions included asthma, environmental allergy, hypothyroidism and anxiety. The patient had drug allergies to doxycycline and COMPAZINE. Concomitant therapies included CELEXA, CYTOMEL, levothyroxine sodium (manufacturer unknown) and allergy shots (details unspecified). On 26-MAR-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N030986, expiry date 11-MAY-2019) (dosing regimen and frequency unknown) injection subcutaneously in the right arm for prevention because the patient had asthma. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (lot number U5793AA, expiry date unknown) (dosing regimen and frequency unknown) intramuscularly in the right deltoid for prophylaxis. There was no illness at the time of vaccination. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with other/unknown funds. On 27-MAR-2018, evening the patient developed red, huge welts at the injection site and lower on her arm. The lower part of the arm was swollen tender/sore. The patient had blebs that welted which was achy and was feverish. The nurse treated herself with ibuprofen (manufacturer unknown) and reported that the welts got even bigger about 3 inches by 4 inches leaving her with a sore arm to point where she could barely move her arm (pain in extremity). On 28-MAR-2018 the patient also developed a high fever with a temperature of 101.6 and she went to her doctor's office. The patient's physician recommended ice packs, ibuprofen (manufacturer unknown), BENADRYL, TYLENOL (manufacturer unknown) as needed for treatment. On 29-MAR-2018 the patient was seen at the physician's office again during when she had swelling of the upper arm length over triceps. On 29-MAR-2018, the patient's body temperature was 100.7 (units unspecified). The patient was started with KEFLEX 500 mg for 10 days. The outcome of the events was reported as recovering. The relatedness of the events to the suspect drug therapy was unknown. There was no product quality complaint reported. It was reported that a temperature excursion did not occur as a result of a reading from a Digital Data Logger. It was reported that the patient had not reported these adverse events previously. The event "sore arm to point where she could barely move her arm" was considered to be serious due to disability.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Back pain, Cellulitis, Chills, Erythema, Hypokinesia
Clinical narrative: This spontaneous report was received from a 51 year old female patient (who was also a nurse) along with the follow up received from a physician. The patient's current conditions included asthma, environmental allergy, hypothyroidism and anxiety. The patient had drug allergies to doxycycline and COMPAZINE. Concomitant therapies included CELEXA, CYTOMEL, levothyroxine sodium (manufacturer unknown) and allergy shots (details unspecified). On 26-MAR-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N030986, expiry date 11-MAY-2019) (dosing regimen and frequency unknown) injection subcutaneously in the right arm for prevention because the patient had asthma. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (lot number U5793AA, expiry date unknown) (dosing regimen and frequency unknown) intramuscularly in the right deltoid for prophylaxis. There was no illness at the time of vaccination. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with other/unknown funds. On 27-MAR-2018, evening the patient developed red, huge welts at the injection site and lower on her arm. The lower part of the arm was swollen tender/sore. The patient had blebs that welted which was achy and was feverish. The nurse treated herself with ibuprofen (manufacturer unknown) and reported that the welts got even bigger about 3 inches by 4 inches leaving her with a sore arm to point where she could barely move her arm (pain in extremity). On 28-MAR-2018 the patient also developed a high fever with a temperature of 101.6 and she went to her doctor's office. The patient's physician recommended ice packs, ibuprofen (manufacturer unknown), BENADRYL, TYLENOL (manufacturer unknown) as needed for treatment. On 29-MAR-2018 the patient was seen at the physician's office again during when she had swelling of the upper arm length over triceps. On 29-MAR-2018, the patient's body temperature was 100.7 (units unspecified). The patient was started with KEFLEX 500 mg for 10 days. The outcome of the events was reported as recovering. The relatedness of the events to the suspect drug therapy was unknown. There was no product quality complaint reported. It was reported that a temperature excursion did not occur as a result of a reading from a Digital Data Logger. It was reported that the patient had not reported these adverse events previously. The event "sore arm to point where she could barely move her arm" was considered to be serious due to disability.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Induration, Injection site mass, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: This spontaneous report was received from a 51 year old female patient (who was also a nurse) along with the follow up received from a physician. The patient's current conditions included asthma, environmental allergy, hypothyroidism and anxiety. The patient had drug allergies to doxycycline and COMPAZINE. Concomitant therapies included CELEXA, CYTOMEL, levothyroxine sodium (manufacturer unknown) and allergy shots (details unspecified). On 26-MAR-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N030986, expiry date 11-MAY-2019) (dosing regimen and frequency unknown) injection subcutaneously in the right arm for prevention because the patient had asthma. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (lot number U5793AA, expiry date unknown) (dosing regimen and frequency unknown) intramuscularly in the right deltoid for prophylaxis. There was no illness at the time of vaccination. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with other/unknown funds. On 27-MAR-2018, evening the patient developed red, huge welts at the injection site and lower on her arm. The lower part of the arm was swollen tender/sore. The patient had blebs that welted which was achy and was feverish. The nurse treated herself with ibuprofen (manufacturer unknown) and reported that the welts got even bigger about 3 inches by 4 inches leaving her with a sore arm to point where she could barely move her arm (pain in extremity). On 28-MAR-2018 the patient also developed a high fever with a temperature of 101.6 and she went to her doctor's office. The patient's physician recommended ice packs, ibuprofen (manufacturer unknown), BENADRYL, TYLENOL (manufacturer unknown) as needed for treatment. On 29-MAR-2018 the patient was seen at the physician's office again during when she had swelling of the upper arm length over triceps. On 29-MAR-2018, the patient's body temperature was 100.7 (units unspecified). The patient was started with KEFLEX 500 mg for 10 days. The outcome of the events was reported as recovering. The relatedness of the events to the suspect drug therapy was unknown. There was no product quality complaint reported. It was reported that a temperature excursion did not occur as a result of a reading from a Digital Data Logger. It was reported that the patient had not reported these adverse events previously. The event "sore arm to point where she could barely move her arm" was considered to be serious due to disability.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date ("around 13 and 14 years old"), the patient was vaccinated with two doses of GARDASIL injection (strength, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. It was unspecified if the doses were administered on schedule. No adverse effect was reported. No additional information was provided. There was no product quality complaint (PQC) reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 16 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 27-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 15 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 13-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 22-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 13 year old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 15-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
Sex: M
Vaccine: PPV
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways. A contactable physician reported a 58-year-old male patient of an unspecified ethnicity started to receive gabapentin (unknown manufacturer), with an unspecified route of administration, therapy dates, dose, frequency and indication; and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) via unspecified route of administration, on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergy to gabapentin and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The action taken in response to the event for gabapentin and pneumococcal vaccine was unknown and outcome of the event were unknown. Pfizer is a Marketing Authorization Holder for gabapentin and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report in cases where another Marketing Authorization Holder of gabapentin and pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities. Follow up (11Apr2018): New information via a Pfizer sponsored program Pfizer RXPathways from contactable physician includes: suspect drug details, event term update and course of events. Follow-up (20Apr2018): This is a follow-up report combining information from duplicate reports 2018152818 and 2018134102. The current and all subsequent information will be reported under manufacturer report number 2018134102. The new information reported from a contactable physician includes: co suspect vaccine was updated (from pneumococcal vaccine). The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Back pain, Carpal tunnel decompression, Carpal tunnel syndrome, Chest X-ray
Clinical narrative: This is a spontaneous report from a contactable 72-year-old female consumer reporting for herself. A 72-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration on Apr2017 at single dose for immunisation. Medical history included thyroid disorder from an unknown date treated with unspecified thyroid medicine. The patient experienced swollen hands/swollen legs, swollen feet/had to buy large slippers to wear because feet were so swollen/had to wear sweats because she couldn't zip her pants on Jul2017, pain/hurt all night long/she needs two hands to pull up her blanket and yells from the pain, couldn't get rid of the pain/not able to do anything because she hurt so badly, it hurt to turn the steering wheel on Aug2017, feeling miserable on an unspecified date, exhaustion, so tired that she has to lay in bed three times on an unspecified date, swollen ankles on Jul2017, joint pain/pain in wrist, elbows, open and close car doors she has to reach across to open it, can't use left wrist to twist and open car door if she drives on an unspecified date, shoulder pain on an unspecified date, not able to use her hands, hands and fingers did not work to sit down coffee cup can't lift a glass, can't hold pills in her hand, she can't hold money/needs two hands to lift coffee cup, can't hold coffee pot, cook,  hold spoon to stir on an unspecified date, carpal tunnel in both hands/had to have 2 carpal tunnel surgeries on an unspecified date, lump on the back of her hand  on an unspecified date, chills on an unspecified, kept getting so cold on an unspecified date, woke up in the night from pain in shoulders and back on an unspecified date, up at 04:00 because she couldn't sleep on an unspecified date, sleep is terrible on an unspecified date, can't get her little finger and ring finger to close on an unspecified date, pain in fingers/pain on side of upper arm/pain in her left arm on an unspecified date, she had pain on the side of upper arm that she would describe as muscle pain on an unspecified date, can't stand for long on an unspecified date, moans and groans when putting socks on on an unspecified date. The patient underwent lab tests and procedures which included chest x-ray, electrocardiogram: didn't have a heart attack, neurological examination: she had carpal tunnel in both hands, nuclear magnetic resonance imaging, x-ray limb, x-ray limb: no arthritis. Therapeutic measures were taken as a result of the events includes pain pills, water pill  , gabapentin 300 mg capsule, escitalopram, REMICADE, methotrexate. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Electrocardiogram normal, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: This is a spontaneous report from a contactable 72-year-old female consumer reporting for herself. A 72-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration on Apr2017 at single dose for immunisation. Medical history included thyroid disorder from an unknown date treated with unspecified thyroid medicine. The patient experienced swollen hands/swollen legs, swollen feet/had to buy large slippers to wear because feet were so swollen/had to wear sweats because she couldn't zip her pants on Jul2017, pain/hurt all night long/she needs two hands to pull up her blanket and yells from the pain, couldn't get rid of the pain/not able to do anything because she hurt so badly, it hurt to turn the steering wheel on Aug2017, feeling miserable on an unspecified date, exhaustion, so tired that she has to lay in bed three times on an unspecified date, swollen ankles on Jul2017, joint pain/pain in wrist, elbows, open and close car doors she has to reach across to open it, can't use left wrist to twist and open car door if she drives on an unspecified date, shoulder pain on an unspecified date, not able to use her hands, hands and fingers did not work to sit down coffee cup can't lift a glass, can't hold pills in her hand, she can't hold money/needs two hands to lift coffee cup, can't hold coffee pot, cook,  hold spoon to stir on an unspecified date, carpal tunnel in both hands/had to have 2 carpal tunnel surgeries on an unspecified date, lump on the back of her hand  on an unspecified date, chills on an unspecified, kept getting so cold on an unspecified date, woke up in the night from pain in shoulders and back on an unspecified date, up at 04:00 because she couldn't sleep on an unspecified date, sleep is terrible on an unspecified date, can't get her little finger and ring finger to close on an unspecified date, pain in fingers/pain on side of upper arm/pain in her left arm on an unspecified date, she had pain on the side of upper arm that she would describe as muscle pain on an unspecified date, can't stand for long on an unspecified date, moans and groans when putting socks on on an unspecified date. The patient underwent lab tests and procedures which included chest x-ray, electrocardiogram: didn't have a heart attack, neurological examination: she had carpal tunnel in both hands, nuclear magnetic resonance imaging, x-ray limb, x-ray limb: no arthritis. Therapeutic measures were taken as a result of the events includes pain pills, water pill  , gabapentin 300 mg capsule, escitalopram, REMICADE, methotrexate. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Grip strength decreased, Insomnia, Joint swelling, Limb mass, Loss of personal independence in daily activities
Clinical narrative: This is a spontaneous report from a contactable 72-year-old female consumer reporting for herself. A 72-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration on Apr2017 at single dose for immunisation. Medical history included thyroid disorder from an unknown date treated with unspecified thyroid medicine. The patient experienced swollen hands/swollen legs, swollen feet/had to buy large slippers to wear because feet were so swollen/had to wear sweats because she couldn't zip her pants on Jul2017, pain/hurt all night long/she needs two hands to pull up her blanket and yells from the pain, couldn't get rid of the pain/not able to do anything because she hurt so badly, it hurt to turn the steering wheel on Aug2017, feeling miserable on an unspecified date, exhaustion, so tired that she has to lay in bed three times on an unspecified date, swollen ankles on Jul2017, joint pain/pain in wrist, elbows, open and close car doors she has to reach across to open it, can't use left wrist to twist and open car door if she drives on an unspecified date, shoulder pain on an unspecified date, not able to use her hands, hands and fingers did not work to sit down coffee cup can't lift a glass, can't hold pills in her hand, she can't hold money/needs two hands to lift coffee cup, can't hold coffee pot, cook,  hold spoon to stir on an unspecified date, carpal tunnel in both hands/had to have 2 carpal tunnel surgeries on an unspecified date, lump on the back of her hand  on an unspecified date, chills on an unspecified, kept getting so cold on an unspecified date, woke up in the night from pain in shoulders and back on an unspecified date, up at 04:00 because she couldn't sleep on an unspecified date, sleep is terrible on an unspecified date, can't get her little finger and ring finger to close on an unspecified date, pain in fingers/pain on side of upper arm/pain in her left arm on an unspecified date, she had pain on the side of upper arm that she would describe as muscle pain on an unspecified date, can't stand for long on an unspecified date, moans and groans when putting socks on on an unspecified date. The patient underwent lab tests and procedures which included chest x-ray, electrocardiogram: didn't have a heart attack, neurological examination: she had carpal tunnel in both hands, nuclear magnetic resonance imaging, x-ray limb, x-ray limb: no arthritis. Therapeutic measures were taken as a result of the events includes pain pills, water pill  , gabapentin 300 mg capsule, escitalopram, REMICADE, methotrexate. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Moaning, Mobility decreased, Musculoskeletal pain, Myalgia, Neurological examination abnormal
Clinical narrative: This is a spontaneous report from a contactable 72-year-old female consumer reporting for herself. A 72-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration on Apr2017 at single dose for immunisation. Medical history included thyroid disorder from an unknown date treated with unspecified thyroid medicine. The patient experienced swollen hands/swollen legs, swollen feet/had to buy large slippers to wear because feet were so swollen/had to wear sweats because she couldn't zip her pants on Jul2017, pain/hurt all night long/she needs two hands to pull up her blanket and yells from the pain, couldn't get rid of the pain/not able to do anything because she hurt so badly, it hurt to turn the steering wheel on Aug2017, feeling miserable on an unspecified date, exhaustion, so tired that she has to lay in bed three times on an unspecified date, swollen ankles on Jul2017, joint pain/pain in wrist, elbows, open and close car doors she has to reach across to open it, can't use left wrist to twist and open car door if she drives on an unspecified date, shoulder pain on an unspecified date, not able to use her hands, hands and fingers did not work to sit down coffee cup can't lift a glass, can't hold pills in her hand, she can't hold money/needs two hands to lift coffee cup, can't hold coffee pot, cook,  hold spoon to stir on an unspecified date, carpal tunnel in both hands/had to have 2 carpal tunnel surgeries on an unspecified date, lump on the back of her hand  on an unspecified date, chills on an unspecified, kept getting so cold on an unspecified date, woke up in the night from pain in shoulders and back on an unspecified date, up at 04:00 because she couldn't sleep on an unspecified date, sleep is terrible on an unspecified date, can't get her little finger and ring finger to close on an unspecified date, pain in fingers/pain on side of upper arm/pain in her left arm on an unspecified date, she had pain on the side of upper arm that she would describe as muscle pain on an unspecified date, can't stand for long on an unspecified date, moans and groans when putting socks on on an unspecified date. The patient underwent lab tests and procedures which included chest x-ray, electrocardiogram: didn't have a heart attack, neurological examination: she had carpal tunnel in both hands, nuclear magnetic resonance imaging, x-ray limb, x-ray limb: no arthritis. Therapeutic measures were taken as a result of the events includes pain pills, water pill  , gabapentin 300 mg capsule, escitalopram, REMICADE, methotrexate. The outcome of the events was unknown. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Peripheral swelling, X-ray limb
Clinical narrative: This is a spontaneous report from a contactable 72-year-old female consumer reporting for herself. A 72-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration on Apr2017 at single dose for immunisation. Medical history included thyroid disorder from an unknown date treated with unspecified thyroid medicine. The patient experienced swollen hands/swollen legs, swollen feet/had to buy large slippers to wear because feet were so swollen/had to wear sweats because she couldn't zip her pants on Jul2017, pain/hurt all night long/she needs two hands to pull up her blanket and yells from the pain, couldn't get rid of the pain/not able to do anything because she hurt so badly, it hurt to turn the steering wheel on Aug2017, feeling miserable on an unspecified date, exhaustion, so tired that she has to lay in bed three times on an unspecified date, swollen ankles on Jul2017, joint pain/pain in wrist, elbows, open and close car doors she has to reach across to open it, can't use left wrist to twist and open car door if she drives on an unspecified date, shoulder pain on an unspecified date, not able to use her hands, hands and fingers did not work to sit down coffee cup can't lift a glass, can't hold pills in her hand, she can't hold money/needs two hands to lift coffee cup, can't hold coffee pot, cook,  hold spoon to stir on an unspecified date, carpal tunnel in both hands/had to have 2 carpal tunnel surgeries on an unspecified date, lump on the back of her hand  on an unspecified date, chills on an unspecified, kept getting so cold on an unspecified date, woke up in the night from pain in shoulders and back on an unspecified date, up at 04:00 because she couldn't sleep on an unspecified date, sleep is terrible on an unspecified date, can't get her little finger and ring finger to close on an unspecified date, pain in fingers/pain on side of upper arm/pain in her left arm on an unspecified date, she had pain on the side of upper arm that she would describe as muscle pain on an unspecified date, can't stand for long on an unspecified date, moans and groans when putting socks on on an unspecified date. The patient underwent lab tests and procedures which included chest x-ray, electrocardiogram: didn't have a heart attack, neurological examination: she had carpal tunnel in both hands, nuclear magnetic resonance imaging, x-ray limb, x-ray limb: no arthritis. Therapeutic measures were taken as a result of the events includes pain pills, water pill  , gabapentin 300 mg capsule, escitalopram, REMICADE, methotrexate. The outcome of the events was unknown. The information on the batch number has been requested.