chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer (Pfizer Employee reporting behalf of her daughter) and from a contactable Pharmacist. A 19-year-old female patient received the 1st dose of TRUMENBA Batch/Lot # M95612 and expiration date Jul2017, on 05Jul2016 at 11:39 AM, intramuscular in Left upper arm. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe arm pain at the injection site at 1:40 PM and severe nausea after the injection, both on 05Jul2016. Patient went to bed, woke up, and still had nausea and severe arm pain. Patient woke up with same symptoms the following morning. At the time of the report the patient was recovering. The pharmacist considered there is a reasonable possibility that the event was related to suspect product. Follow-up (26Jul2016): New information form a contactable Pharmacist included: Batch/Lot # and expiration date, route of administration outcome, causality assessment. Follow-up attempts completed. No further information expected.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable nurse. A 21-year-old male patient of an unspecified ethnicity started to receive TRUMENBA, intramuscular at 0.5 ml, single on unknown date. The patient medical history and concomitant medications were not reported. On 17Jun2016, the patient experienced flu like symptoms, fatigue, chills, sweat, fever, sore throat, nasal congestion, headache. The outcome of the events was unknown. Follow-up (18AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 21-year-old male patient of an unspecified ethnicity started to receive TRUMENBA, intramuscular at 0.5 ml, single on unknown date. The patient medical history and concomitant medications were not reported. On 17Jun2016, the patient experienced flu like symptoms, fatigue, chills, sweat, fever, sore throat, nasal congestion, headache. The outcome of the events was unknown. Follow-up (18AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Altered state of consciousness, Blood pressure increased, Chills, Dysphagia, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for her daughter. A 17 year-old Other ethnic group female patient received the first single dose of TRUMENBA intramuscular in Jun2016 (unknown if on 13Jun2016 or 14Jun2016) at 10:15 am intramuscular in the left upper arm. The patient had ongoing drug hypersensitivity to MOTRIN emerged when she was 11 year-old and after having taken it for toothache she had itchy mouth and lips became swollen. The patient was not taking any concomitant medication. No other vaccines were administered the same day or within four weeks prior to TRUMENBA. It was reported that at first TRUMENBA really hurt when it was administered and the pain in the patient's arm took about 4 days to completely go away. Then about 40 to 45 minutes after she had received the vaccine she became very pale, which lasted about 1 1/2 hours and complained of headaches, which lasted about 1 1/2 days. She also felt as though she was going to pass out, was nauseated, and had shaking chills, which just lasted that day. When the mother got her daughter home she gave her BENADRYL and continued to check on her every few minutes. A few hours after vaccination she checked her blood pressure and heart rate and noticed that they were respectively elevated and fast, but they were back to normal the next day. She noticed that her daughter's lips looked swollen, but that went away by the next day. Her daughter also complained of feeling very tired and slept on and off for about 12 hours. The next day her daughter complained of a sore throat and having a hard time swallowing. The sore throat and hard time swallowing lasted about 2 days. The caller reported that she had experienced anaphylaxis in the past and that was how it started, so she thought that her daughter was allergic to TRUMENBA. No relevant tests were performed, no physician or emergency room visit were needed. Follow-up (12AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Heart rate increased, Injection site pain, Lip swelling, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for her daughter. A 17 year-old Other ethnic group female patient received the first single dose of TRUMENBA intramuscular in Jun2016 (unknown if on 13Jun2016 or 14Jun2016) at 10:15 am intramuscular in the left upper arm. The patient had ongoing drug hypersensitivity to MOTRIN emerged when she was 11 year-old and after having taken it for toothache she had itchy mouth and lips became swollen. The patient was not taking any concomitant medication. No other vaccines were administered the same day or within four weeks prior to TRUMENBA. It was reported that at first TRUMENBA really hurt when it was administered and the pain in the patient's arm took about 4 days to completely go away. Then about 40 to 45 minutes after she had received the vaccine she became very pale, which lasted about 1 1/2 hours and complained of headaches, which lasted about 1 1/2 days. She also felt as though she was going to pass out, was nauseated, and had shaking chills, which just lasted that day. When the mother got her daughter home she gave her BENADRYL and continued to check on her every few minutes. A few hours after vaccination she checked her blood pressure and heart rate and noticed that they were respectively elevated and fast, but they were back to normal the next day. She noticed that her daughter's lips looked swollen, but that went away by the next day. Her daughter also complained of feeling very tired and slept on and off for about 12 hours. The next day her daughter complained of a sore throat and having a hard time swallowing. The sore throat and hard time swallowing lasted about 2 days. The caller reported that she had experienced anaphylaxis in the past and that was how it started, so she thought that her daughter was allergic to TRUMENBA. No relevant tests were performed, no physician or emergency room visit were needed. Follow-up (12AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Oropharyngeal pain, Pallor, Somnolence, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer, reporting for her daughter. A 17 year-old Other ethnic group female patient received the first single dose of TRUMENBA intramuscular in Jun2016 (unknown if on 13Jun2016 or 14Jun2016) at 10:15 am intramuscular in the left upper arm. The patient had ongoing drug hypersensitivity to MOTRIN emerged when she was 11 year-old and after having taken it for toothache she had itchy mouth and lips became swollen. The patient was not taking any concomitant medication. No other vaccines were administered the same day or within four weeks prior to TRUMENBA. It was reported that at first TRUMENBA really hurt when it was administered and the pain in the patient's arm took about 4 days to completely go away. Then about 40 to 45 minutes after she had received the vaccine she became very pale, which lasted about 1 1/2 hours and complained of headaches, which lasted about 1 1/2 days. She also felt as though she was going to pass out, was nauseated, and had shaking chills, which just lasted that day. When the mother got her daughter home she gave her BENADRYL and continued to check on her every few minutes. A few hours after vaccination she checked her blood pressure and heart rate and noticed that they were respectively elevated and fast, but they were back to normal the next day. She noticed that her daughter's lips looked swollen, but that went away by the next day. Her daughter also complained of feeling very tired and slept on and off for about 12 hours. The next day her daughter complained of a sore throat and having a hard time swallowing. The sore throat and hard time swallowing lasted about 2 days. The caller reported that she had experienced anaphylaxis in the past and that was how it started, so she thought that her daughter was allergic to TRUMENBA. No relevant tests were performed, no physician or emergency room visit were needed. Follow-up (12AUG2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Arthralgia, Chills, Dizziness, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced lot of body aches, joint pain, nausea, dizziness, chills all on an unspecified date with outcome of not recovered. The patient reported that when they works out, it got worse. Follow-up (18)AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hyperaesthesia, Local reaction, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. The Nurse reported for two patients. This is the 1st of two reports. A 17-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced skin sensitivity, bodyache, nausea and local reaction, assessed as non-serious, non an unspecified date with outcome of unknown. Follow-up (19AUG-2016): Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Hyperaesthesia, Local reaction, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. The Nurse reported for two patients. This is the 2nd of two reports. A 20-year-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5 ml single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced skin sensitivity, bodyache, nausea and local reaction, assesses as non-serious, on an unspecified date with outcome of unknown. Follow-up (19AUG2016): Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Injection site erythema, Injection site swelling, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable Health Care Professional  via Pfizer Sales representative. A 22-year-old female patient of an unspecified ethnicity received, on 11May2016 at 04:56 PM, TRUMENBA, Lot. J28923, Expiration date: 01Jun2016, intramuscular, in the left deltoid, at 0.5 ml, single dose. The vaccine was administered at the private physician's office/hospital. The next administration will be in Nov2016. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, nausea and swelling and redness at injection site all on 11May2016 with outcome of recovered after 1.5 days, on 13May2016. Emergency room, physician visit, treatment and hospitalization were not required. Follow-up (01Aug2016): New information received from a contactable Health Care Professional includes: patient details, suspect drug details, and reaction data.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Health Care Professional  via Pfizer Sales representative. A 22-year-old female patient of an unspecified ethnicity received, on 11May2016 at 04:56 PM, TRUMENBA, Lot. J28923, Expiration date: 01Jun2016, intramuscular, in the left deltoid, at 0.5 ml, single dose. The vaccine was administered at the private physician's office/hospital. The next administration will be in Nov2016. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, nausea and swelling and redness at injection site all on 11May2016 with outcome of recovered after 1.5 days, on 13May2016. Emergency room, physician visit, treatment and hospitalization were not required. Follow-up (01Aug2016): New information received from a contactable Health Care Professional includes: patient details, suspect drug details, and reaction data.
Sex: M
Vaccine: MENB
Symptoms: Chills, Feeling cold, Influenza like illness, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her son. This is the 2nd of 2 reports and regards the 1st vaccination dose. An 18-year-old male patient received the 1st dose of TRUMENBA, via an unspecified route of administration at 1 DF, single on an unspecified date in 2016 3 months before this report (because he was going to college and he would be on campus). The patient medical history was not reported. There were no concomitant medications. On an unspecified date in 2016 the patient experienced chills, low grade fever, it was chills like flu, he was cold. The outcome of the events was recovered in 2016. Therapeutic measures were taken as a result of stiff neck and TYLENOL and ADVIL were received. The patient had undergone lab work for his physical.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable registered nurse via Pfizer sales representative. The nurse reported similar events for 2 patients. This is the first of two reports. A patient of unspecified age (16-17 unit not provided), ethnicity and gender received a single dose of TRUMENBA and MENVEO, both via an unspecified route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced dizziness on an unspecified date and he/she was put in observation for 2 or 3 minutes and the situation was resolved. The patient recovered from the event. Follow-up (19AUG2016): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Dizziness
Clinical narrative: This is a spontaneous report from a contactable registered nurse via Pfizer sales representative. The nurse reported similar events for 2 patients. This is the second of two reports. A patient of unspecified age (16-17 unit not provided), ethnicity and gender received a single dose of TRUMENBA and MENVEO, both via an unspecified route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient experienced dizziness on an unspecified date and he/she was put in observation for 2 or 3 minutes and the situation was resolved. The patient recovered form the event. Follow-up (17AUG02016) Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: C-reactive protein increased, Chills, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter and from a contactable physician. A 17-year-old female patient received TRUMENBA; lot M37316, expiry date 01Apr2017 intramuscular, in left deltoid, on 15Jun2016 at 0.5 ml single. No other vaccines were given on the same day or within 4 weeks prior. Medical history included Crohn's disease (colon) since Nov2004, seasonal allergies and asthma. Concomitant medications included ASACOL HD, 800 mg, tablet since she was 6-7 years old and ongoing at two tablets 3 times a day, orally for Crohn's disease (colon), calcium/vitamin D and unspecified birth control pill (BCP). On 15Jun2016, few hours after injection, the patient experienced fever, chills, arms were extremely swelled for several days, headaches, general feeling of crappiness and left arm throbbing. On an unspecified date in Jun2016 C-reactive protein result high and sedimentation rate increased. Laboratory test on 21Jun2016 showed C- reactive protein and red blood cell sedimentation rate were high than the usual values. Patient was treated for fever, chills and headache with TYLENOL, tablet at 1000 mg once orally. Fever, chills, headache and general feeling of crappiness resolved the day after their occurrence (Jun2016, in the morning), while swollen arm lasted for several days, then resolved (Jun2016). Left arm throbbing resolved on an unspecified date in 2016. The outcome of c-reactive protein increased an sedimentation rate increased was unknown. The events did not require an emergency room or physician visit. High values of C-reactive protein and sedimentation rate could be because of patient gastrointestinal condition, but the reporting consumer was wondering if that could be the cause of getting the vaccine because it takes a few weeks for body to deal with the vaccine. The reporting physician considered the vaccine had a causal effect to the adverse event left arm throbbing. Follow-up (18Jul2016): New information from a contactable physician includes: additional medical history, concomitant drugs, vaccine lot number, expiry date, route and anatomical location of administration, additional event 'left arm throbbing', reporter causality assessment.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her daughter and from a contactable physician. A 17-year-old female patient received TRUMENBA; lot M37316, expiry date 01Apr2017 intramuscular, in left deltoid, on 15Jun2016 at 0.5 ml single. No other vaccines were given on the same day or within 4 weeks prior. Medical history included Crohn's disease (colon) since Nov2004, seasonal allergies and asthma. Concomitant medications included ASACOL HD, 800 mg, tablet since she was 6-7 years old and ongoing at two tablets 3 times a day, orally for Crohn's disease (colon), calcium/vitamin D and unspecified birth control pill (BCP). On 15Jun2016, few hours after injection, the patient experienced fever, chills, arms were extremely swelled for several days, headaches, general feeling of crappiness and left arm throbbing. On an unspecified date in Jun2016 C-reactive protein result high and sedimentation rate increased. Laboratory test on 21Jun2016 showed C- reactive protein and red blood cell sedimentation rate were high than the usual values. Patient was treated for fever, chills and headache with TYLENOL, tablet at 1000 mg once orally. Fever, chills, headache and general feeling of crappiness resolved the day after their occurrence (Jun2016, in the morning), while swollen arm lasted for several days, then resolved (Jun2016). Left arm throbbing resolved on an unspecified date in 2016. The outcome of c-reactive protein increased an sedimentation rate increased was unknown. The events did not require an emergency room or physician visit. High values of C-reactive protein and sedimentation rate could be because of patient gastrointestinal condition, but the reporting consumer was wondering if that could be the cause of getting the vaccine because it takes a few weeks for body to deal with the vaccine. The reporting physician considered the vaccine had a causal effect to the adverse event left arm throbbing. Follow-up (18Jul2016): New information from a contactable physician includes: additional medical history, concomitant drugs, vaccine lot number, expiry date, route and anatomical location of administration, additional event 'left arm throbbing', reporter causality assessment.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer received via a sales representative. A patient of unspecified age, ethnicity and gender received TRUMENDA on 22Jun2016, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced pain in right calf when walking on an unspecified date in Jun2016 with outcome of unknown. No follow up attempts possible. No further information expected.
Age: 20.0
Sex: F
Vaccine: IPV, MENB, TDAP
Symptoms: Abdominal pain, Asthenia, Chest pain, Fatigue, Lumbar puncture normal
Clinical narrative: This is a spontaneous report from a non-contactable physician's assistant and from a contactable physician reported through a Pfizer sales representative. A 20 year-old-female patient of an unspecified ethnicity received the second dose of TRUMENBA, at single dose and TDAP IPV, both via an unspecified route of administration on the same unspecified date. Medical history included diarrhea. Concomitant medication included Z-PAK for diarrhea. Two weeks prior the patient was traveling and she ended up getting diarrhoea episode, so she was ended up taking azithromycin there and then she was also scratched by rusty nail while she was there which caused her to bleed. By the time patient reached doctor office, it was healed up but patient's previous dose of diphtheria vaccine, pertussis vaccine, polio vaccine, tetanus vaccine was nine years before that, so that was why she got it again that day. Seven days after vaccinations, the patient experienced neck pain, jaw was hurting, felt weak, pain, lump in throat, chest pain, abdominal pain, fatigue, all with outcome of unknown. She ended up in ER (Emergency Room) on an unknown date, they did a spinal tap which came back with normal results. All events were assessed as non-serious. The reporting physician did not consider that meningococcal group b rlp2086 has causal effect to the adverse events. Follow-up (08-Aug-2016): New information from a contactable physician includes: reporter causality assessment. Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: F
Vaccine: IPV, MENB, TDAP
Symptoms: Neck pain, Pain, Pain in jaw, Sensation of foreign body
Clinical narrative: This is a spontaneous report from a non-contactable physician's assistant and from a contactable physician reported through a Pfizer sales representative. A 20 year-old-female patient of an unspecified ethnicity received the second dose of TRUMENBA, at single dose and TDAP IPV, both via an unspecified route of administration on the same unspecified date. Medical history included diarrhea. Concomitant medication included Z-PAK for diarrhea. Two weeks prior the patient was traveling and she ended up getting diarrhoea episode, so she was ended up taking azithromycin there and then she was also scratched by rusty nail while she was there which caused her to bleed. By the time patient reached doctor office, it was healed up but patient's previous dose of diphtheria vaccine, pertussis vaccine, polio vaccine, tetanus vaccine was nine years before that, so that was why she got it again that day. Seven days after vaccinations, the patient experienced neck pain, jaw was hurting, felt weak, pain, lump in throat, chest pain, abdominal pain, fatigue, all with outcome of unknown. She ended up in ER (Emergency Room) on an unknown date, they did a spinal tap which came back with normal results. All events were assessed as non-serious. The reporting physician did not consider that meningococcal group b rlp2086 has causal effect to the adverse events. Follow-up (08-Aug-2016): New information from a contactable physician includes: reporter causality assessment. Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative and from a contactable nurse. An 18-year-old female student patient of unspecified age ethnicity and gender received the 1st dose of TRUMENBA (Batch/Lot M95612, exp. date Jul2017) IM at 0.5ml single dose at right deltoid on 22Jun2016 09:30. The 2nd was due on 22Dec2016. Medical history was not reported. There were no concomitant medications. On same date along with suspect vaccine she received: the 1st dose of Hepatitis A (Merck, Lot# L045713) IM at left deltoid. No other vaccinations within 4 weeks prior to date of vaccination was received. The patient stated that it was very tender, it's like a bruise, site was raised a bit of pink and it was warm and it was shape of the triangle with one inch line, and also had lump which lasted 2-3 wks, all on 22Jun2016. No specific tests and/or treatment required and the patient recovered on 29Jun2016. The AEs did not require an emergency room or physician visit. The reporter assessed the events as related to TRUMENBA. The nurse stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was a reasonable possibility that the event is related to suspect product. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow up (09Aug2016): New information reported from a contactable nurse included: patient age and gender; vaccination data; Event onset/recovery date: new event (had a lump); vaccination history; no treatment; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable physician (pediatrician) received via a Pfizer sales representative and from a contactable nurse. An 18-year-old female student patient of unspecified age ethnicity and gender received the 1st dose of TRUMENBA (Batch/Lot M95612, exp. date Jul2017) IM at 0.5ml single dose at right deltoid on 22Jun2016 09:30. The 2nd was due on 22Dec2016. Medical history was not reported. There were no concomitant medications. On same date along with suspect vaccine she received: the 1st dose of Hepatitis A (Merck, Lot# L045713) IM at left deltoid. No other vaccinations within 4 weeks prior to date of vaccination was received. The patient stated that it was very tender, it's like a bruise, site was raised a bit of pink and it was warm and it was shape of the triangle with one inch line, and also had lump which lasted 2-3 wks, all on 22Jun2016. No specific tests and/or treatment required and the patient recovered on 29Jun2016. The AEs did not require an emergency room or physician visit. The reporter assessed the events as related to TRUMENBA. The nurse stated that the patient provided to him/her information regarding the reported adverse events with the use of the suspect. The nurse considered there was a reasonable possibility that the event is related to suspect product. The nurse was willing to be contacted again by Pfizer on the reported adverse events. Follow up (09Aug2016): New information reported from a contactable nurse included: patient age and gender; vaccination data; Event onset/recovery date: new event (had a lump); vaccination history; no treatment; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (HCP) via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA, via an unspecified route of administration, on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced arm pain on an unspecified date after the vaccination. The outcome of the event was unknown at the time of this report. Follow-up (19Aug2016): Follow-up attempts are completed. No further information is expected.
Age: 1.25
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Rash, Swelling
Clinical narrative: Skin rash and swelling. Sulfamethoxazole-Trimethoprim 200-40 mg/5ml 8 mgs BID x 10 days.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (also provided as nurse) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates between 06-AUG-2016 and 09-AUG-2016, the patients were vaccinated with improperly stored doses of VAQTA injection, lot # M011116, expiration date: 17-JUN-2017 and lot # L023936, expiration date: 15-MAR-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 48 degrees Fahrenheit for 1 hour 6 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. 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.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Full blood count normal, Injection site erythema, Irritability
Clinical narrative: Fussiness, redness at injection site.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Fussiness, redness at injection site.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Groin pain, Headache, Laboratory test, Nodule
Clinical narrative: Subject is enrolled in a clinical trial that is evaluating the HPV vaccine in cancer survivors. Pt received Dose 1 of the HPV vaccine on 8/17/2016. On 8/25/16 the patient's mother contacted the study nurse and reported that the patient had been evaluated by her OBGYN physician for a variety of medical issues including arthralgia and painful nodules on bilateral lower extremities. the mother states that the patient's medical issues may be related to HPV vaccine that she received in June, which has prompted this report. The mother also reported that the physician indicated that alternatively, the patient's medical issues may be due to a concomitant medication (birth control pills - Crysalta-28 tab, 0.3 mg/0.03 mg, initiated 6/18/18), which is being discontinued. We have requested medical records and will update this report when we have more information, but we are reporting what is known at this time. Additionally, the patient underwent medical evaluation for similar symptoms, including groin pain, arthralgia, and headache on 8/3/16; no diagnosis was made and no treatment was prescribed at that time. the patient was subsequently seen her oncologist on 8/9/16 for evaluation of continuing symptoms, and the oncologist had indicated at that time that he did not believe her symptoms were related to the HPV vaccine; he initiated an evaluation to determine the etiology of the patient's symptoms. the patient's symptoms did not improve, and the returned to the oncologist on 8/15/16 for further evaluation, including a work-up to rule out leukemia recurrence. Leukemia recurrence was ruled out; the final report of the additional evaluation are pending at this time.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization official, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. Between 11-MAY-2016 and 31-MAY-2016 the patient was vaccinated with a dose of improperly stored VARIVAX lot# K007976 expiration date 03-JUN-2016 (strength, dose and administration route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization official referring to 7 patients of unknown ages and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Between 13-AUG-2015 and 01-JAN-2016 the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # K007976 expiration date 03-JUN-2016 (strength, dose and administration route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an immunization official referring to 68 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, 20 patients were vaccinated with improperly stored PROQUAD lot # L040414 expiration date 13-APR-2017 (strength, dose and administration route were not reported). On an unspecified dates, 20 patients were vaccinated with improperly stored PROQUAD lot # L031600 expiration date 18-FEB-2017 (strength, dose and administration route were not reported). On an unspecified dates, 20 patients were vaccinated with improperly stored PROQUAD lot # L010143 expiration date 24-SEP-2016 (strength, dose, administration route were not reported. On an unspecified dates, 8 patients were vaccinated with improperly stored PROQUAD lot # L006390 expiration date 25-AUG-2016 (strength, dose and administration route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients (ages and genders were not indicated). The pertinent medical history of patients and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of GARDASIL 9 lot # L048237, expiration date 08-MAY-2017 (concentration, dosage and therapy route were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88 F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS # 1608USA010369, 1608USA010370, 1608USA010371, 1608USA010372). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Migraine
Clinical narrative: This solicited report was received from a consumer, as part of a marketing research program. Pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL. Dose, route, lot # and anatomical location were not reported. the reporter stated that the patient had a severe reaction to the GARDASIL that ended up with chronic fatigue and migraines. At the time of reporting the outcome of the events was unknown. the causality assessment between chronic fatigue and migraine and the suspect therapy was not provided. Additional information is not expected due there is not consent for follow-up.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Chest X-ray normal, Irritability, Pyrexia, Screaming, Urine analysis normal
Clinical narrative: Uncontrollable screaming after vaccines. Fever 8/24. Fussy but consolable.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: White blood cell count increased
Clinical narrative: Uncontrollable screaming after vaccines. Fever 8/24. Fussy but consolable.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Erythema, Irritability, Peripheral swelling, Screaming, White blood cell count normal
Clinical narrative: Uncontrollable screaming after vaccines. Fever 8/24. Fussy but consolable.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This report was received from Pfizer and was assigned manufacturer report number 2016342936 and 216343027 for PREVNAR, and refers to a 2 month old patient of unknown gender. Patient's pertinent medical history, drugs reactions/allergies and concomitant medication were not reported. On 06-JUL-2016, the reporter stated that the vaccine stayed in the fridge during all the period between 06-JUL-2016 and 10-JUL-2016. It was specified that on 06-JUL-2016, during a 24 hours period the maximum temperature of the fridge was 19 degrees. On 09-JUL-2016 the patient was vaccinated with an improperly storage ROTATEQ orally (strength, dosage schedule, lot # and expiration date were not reported). The reporter stated that, they would like to received information with evidence base data that showed the stability of the vaccine at room temperature and any information on whether they must kept the stock or dispose it. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Palpitations, Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 with a dose of an unspecified flu vaccine (manufacturer unspecified). On an unknown date, the patient experienced "her heart racing, a fever and a rash". The pharmacist stated the patient fully recovered on an unspecified date. The relatedness between vaccination with a dose of PNEUMOVAX 23 with a dose of an unspecified flu vaccine (manufacturer unspecified) with the heart racing, a fever and a rash was not reported. Additional information is not expected, the reporter refused to provide consent to contact the physician (and did not provide physician's contact details).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 31-JUL-2015, the patient was vaccinated with GARDASIL 9, dose 1 (lot # K026247/ expiration date- 29-JAN-2017), dose 2 (lot # L023230/ expiration date- 28-JUL-2017) on 24-DEC-2015 and dose 3 (lot # L019297/ expiration date- 18-AUG-2017) on 26-FEB-2016 (inappropriate schedule of drug administration). No adverse event was reported. Non concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX M018766 15-OCT-2017. No adverse effects reported. The vaccines reached 15.5 c for 3 hours. Data logger was yes. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister rupture, Cellulitis, Erythema, Pain, Pyrexia
Clinical narrative: Developed erythema and pain about 24 hours after injection. Blister appeared last night and was broke open this morning. Low grade fever last night Tmax 100.2. Mom marked area with a pen and redness is spreading well beyond boundaries this morning. Unable to site on area.
Age: 5.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Tenderness
Clinical narrative: Developed erythema and pain about 24 hours after injection. Blister appeared last night and was broke open this morning. Low grade fever last night Tmax 100.2. Mom marked area with a pen and redness is spreading well beyond boundaries this morning. Unable to site on area.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L044694, expiration date 04-FEB-2018 and M010671, expiration date 02-Jun-2018). Concentration, dose and route of administration were not provided. The patients' concomitant medications were not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a physician concerning an unspecified patient (unknown age and gender). The patient's pertinent medical history and concurrent conditions were not provided. The physician reported that on 27-JUL-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dosage and therapy route were not indicated), and on 08-AUG-2016 the patient received a second dose of ZOSTAVAX (lot #, expiration date, dosage and therapy route were not indicated). Concomitant therapies were not provided. No adverse reactions were reported. No product quality complaint (PQC) was involved at the time of the report. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Inappropriate schedule of drug administration, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her son. This is the 1st of 2 reports and regards the 2nd vaccination dose. An 18-year-old (other ethnic group unknown) male patient received the 2nd dose of TRUMENBA via an unspecified route of administration at 1 DF, single on an unspecified date less than 2 weeks before this report in 2016 (because he was going to college and he would be on campus) and after the first dose received in 2016 only 3 months before this report. The vaccinations were supposed to be three and he would take one more in two or three months. The patient medical history was not reported. There were no concomitant medications. The patient previously took TRUMENBA and experienced chills, pyrexia, influenza like illness, and feeling cold. On an unspecified date in 2016 (around 2 days before this report) the patient experienced stiff neck with outcome of not recovered, he had received the vaccine, the first one 3 months before this report and the second one was given a week before this report on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of stiff neck and TYLENOL and ADVIL were received. The patient had undergone lab work for his physical.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injected limb mobility decreased, Myalgia
Clinical narrative: ~3PM Received Pneumovax-23 in Rt deltoid muscle on previous day. Complaining of severe myalgia preventing patient from using arm. Patient states she is unable to lift arm without assistance.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Body temperature increased, Rash, Tremor, Varicella post vaccine, Varicella virus test positive
Clinical narrative: 105 Temp, shaking broken out in chicken pox rash.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy
Clinical narrative: Patient is having swelling, redness, and warmth at the site of injection. On 8/26 the area was the size of approximately a 50 cent piece per patient. As of 0900 on 8/27 the swelling, redness and warmth has decrease to the size of a quarter per patient. The patient says that her lymph nodes under the right arm (the arm where one injection was given) are swollen and tender to the touch. The pt was advised to seek medical attention if the area is painful or continues to worsen.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: High fever (103.5), chills, head ache.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Oropharyngeal pain
Clinical narrative: Started with sneezing for a couple days then 08/23/16 developed a sore throat in the pm followed with productive yellow sputum and yellow material from nose, severe chills and aching all over for 2 days and low grade fever 99 degrees, headaches and fatigue. Gradually started improving on 08/26/16 without chills and aches, but continue to have productive yellow sputum and sinus yellow drainage, less fatigue some decreased appetite, but better as of 8/27/16.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Paranasal sinus hypersecretion, Productive cough, Pyrexia, Rhinitis
Clinical narrative: Started with sneezing for a couple days then 08/23/16 developed a sore throat in the pm followed with productive yellow sputum and yellow material from nose, severe chills and aching all over for 2 days and low grade fever 99 degrees, headaches and fatigue. Gradually started improving on 08/26/16 without chills and aches, but continue to have productive yellow sputum and sinus yellow drainage, less fatigue some decreased appetite, but better as of 8/27/16.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Sneezing, Sputum discoloured
Clinical narrative: Started with sneezing for a couple days then 08/23/16 developed a sore throat in the pm followed with productive yellow sputum and yellow material from nose, severe chills and aching all over for 2 days and low grade fever 99 degrees, headaches and fatigue. Gradually started improving on 08/26/16 without chills and aches, but continue to have productive yellow sputum and sinus yellow drainage, less fatigue some decreased appetite, but better as of 8/27/16.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion
Clinical narrative: Bruising lasting more than 2 weeks.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Back pain
Clinical narrative: The child is reporting strong lower back pain.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Pain, Poor quality sleep, Pyrexia, Swelling
Clinical narrative: FEVER, WARM, SWOLLEN, TENDER AREA, WITH PAIN SHOOTING DOWN TO WRIST UNRELIEVED BY TYLENOL 8 HOUR TABS.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tenderness
Clinical narrative: FEVER, WARM, SWOLLEN, TENDER AREA, WITH PAIN SHOOTING DOWN TO WRIST UNRELIEVED BY TYLENOL 8 HOUR TABS.
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Back pain, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A severe headache, vomiting, injection site was swollen, red and sore, glands under my left arm were swollen, and pain radiated into my back under my scapula. I still continue to have back pain on that side.
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Lymphadenopathy, Vomiting
Clinical narrative: A severe headache, vomiting, injection site was swollen, red and sore, glands under my left arm were swollen, and pain radiated into my back under my scapula. I still continue to have back pain on that side.
Age: 81.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea and vomiting and diarrhea 8/34-8/27.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Lethargy, Pyrexia, Rash, Rash macular
Clinical narrative: Fever beginning on date listed. 24 hours later a spotty rash appearing on face and trunk. Within 24 hours of rash first appearing on face and trunk, rash spread to arms and legs. Rash remained for another 24 hours before dissipating. During its course, patient continued to exhibit mild fever and the rash appeared to itch based on patient's behavior. Patient also showed lethargy and reduced appetite.