chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative. A 17 year-old patient of unspecified gender and ethnicity received the first dose of TRUMENBA intramuscular on the arm on unknown date in 2015 (probably two months before this report) at 0.5 ml single dose. Relevant medical history and concomitant medications were not reported. After receiving the vaccine, the patient went home and immediately went to bed. The patient experienced fever of 101 degrees F and extreme fatigue that began right after the vaccine, on an unspecified date in 2015. The patient was recovering from fever while the outcome of fatigue was unknown. The physician thought that the patient experience was related to the vaccine.
Sex: F
Vaccine: MENB
Symptoms: Injection site rash, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received second dose of TRUMENBA, via an unspecified route of administration, on an unspecified date. The patient medical history and the patient's concomitant medications were not reported. The patient experienced rash at the injection site, fever and body aches on an unspecified date with outcome of unknown. Follow-up (02OCT2015): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Injection site reaction, Local reaction, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the second dose of TRUMENBA at single dose on an unknown date. Concomitant medications and medical history were not reported. The patient had a local reaction, also had like fever and like body ache on an unknown date. The pharmacist believed that these reactions were related to TRUMENBA as those were injection site reactions, and they were on the area around that injected. Outcome was not reported. Follow-up (02OCT2015): Follow-up attempts are completed.  No further information is expected.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Feeling cold, Injection site pain, Malaise, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (Pfizer employee) for his 15 years son. A 15-year-old male patient received, on 06Aug2015 at 04:00 pm, second dose of TRUMENBA (Lot. J29203, Expiration date: Jun2016), via an unspecified route of administration in the right upper arm, at 0.5 ml single. Relevant medical history included allergies (he took medication for seasonal allergies). Concomitant medications included SINGULAIR (tablet) 10 mg once daily (every day at night) for allergies, NASONEX once at night for allergies, Ibuprofen as needed (occasionally) for soccer accidents and XYZAL 5 mg as needed (occasionally) for antihistamines. Previously the patient received first dose of TRUMENBA, on an unspecified date. On 06Aug2015, the patient experienced sore at injection site, the patient had little bit of soreness but nothing really bad. On 07Aug2015, the patient experienced chills, fever, joints achy, body ache and he was not feeling well. Relevant laboratory data included body temperature at 102.2 Fahrenheit on 07Aug2015 and at 103 Fahrenheit on an unspecified date, in Aug2015. Patient's clinical course was the following: the patient received TRUMENBA, 06Aug2015, at 2:00 pm. The patient came home and was doing fine except his arm was sore. Reporter does not know which arm the vaccine was given in. He went to soccer, he came back from soccer and took a shower. He was not feeling well, feeling chilled and his joints were achy. At 6:00 pm, reporter took the patient's temperature which was 102.2 Fahrenheit (orally). He gave the patient ibuprofen 200 mg two tablets at 6:00 pm. Reporter then called the pediatrician who said the temperature may be elevated for 72 hours and maybe due to the vaccine. The Paediatrician recommended to give him TYLENOL/MOTRIN and if the fever was high be sure that he was hydrated; if fever continues and get worse to go to emergency room. On 08Aug2015, the patient recovered from the events (patient had no chills, no feeling achy and no fever. He did not complain anymore). The reporting health professional assessed that TRUMENBA did not have a causal effect to the adverse events. The patient received again, on 17Oct2015, TRUMENBA (Lot. J29203, Expiration date: Jun2016), via an unspecified route of administration, at 0.5 ml single. Follow-up (10Aug2015): New information reported from the same contactable consumer includes: reaction data (body ache added as additional adverse event). Follow-up (09Sep2015): New information received from a contactable health professional includes: reporter's causality assessment, treatment for fever updated, TRUMENBA details, past vaccination. Follow up (21Oct2015): New information received includes: patient's clinical course. Follow up attempts completed. No further information expected.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (Pfizer employee) for his 15 years son. A 15-year-old male patient received, on 06Aug2015 at 04:00 pm, second dose of TRUMENBA (Lot. J29203, Expiration date: Jun2016), via an unspecified route of administration in the right upper arm, at 0.5 ml single. Relevant medical history included allergies (he took medication for seasonal allergies). Concomitant medications included SINGULAIR (tablet) 10 mg once daily (every day at night) for allergies, NASONEX once at night for allergies, Ibuprofen as needed (occasionally) for soccer accidents and XYZAL 5 mg as needed (occasionally) for antihistamines. Previously the patient received first dose of TRUMENBA, on an unspecified date. On 06Aug2015, the patient experienced sore at injection site, the patient had little bit of soreness but nothing really bad. On 07Aug2015, the patient experienced chills, fever, joints achy, body ache and he was not feeling well. Relevant laboratory data included body temperature at 102.2 Fahrenheit on 07Aug2015 and at 103 Fahrenheit on an unspecified date, in Aug2015. Patient's clinical course was the following: the patient received TRUMENBA, 06Aug2015, at 2:00 pm. The patient came home and was doing fine except his arm was sore. Reporter does not know which arm the vaccine was given in. He went to soccer, he came back from soccer and took a shower. He was not feeling well, feeling chilled and his joints were achy. At 6:00 pm, reporter took the patient's temperature which was 102.2 Fahrenheit (orally). He gave the patient ibuprofen 200 mg two tablets at 6:00 pm. Reporter then called the pediatrician who said the temperature may be elevated for 72 hours and maybe due to the vaccine. The Paediatrician recommended to give him TYLENOL/MOTRIN and if the fever was high be sure that he was hydrated; if fever continues and get worse to go to emergency room. On 08Aug2015, the patient recovered from the events (patient had no chills, no feeling achy and no fever. He did not complain anymore). The reporting health professional assessed that TRUMENBA did not have a causal effect to the adverse events. The patient received again, on 17Oct2015, TRUMENBA (Lot. J29203, Expiration date: Jun2016), via an unspecified route of administration, at 0.5 ml single. Follow-up (10Aug2015): New information reported from the same contactable consumer includes: reaction data (body ache added as additional adverse event). Follow-up (09Sep2015): New information received from a contactable health professional includes: reporter's causality assessment, treatment for fever updated, TRUMENBA details, past vaccination. Follow up (21Oct2015): New information received includes: patient's clinical course. Follow up attempts completed. No further information expected.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Blood creatine phosphokinase increased
Clinical narrative: This is a spontaneous report from a non-contactable consumer that reported for the son. A 21-years-old male patient received the first vaccination of TRUMENBA, single dose on unknown date. The patient experienced that he had elevated CPK levels. Outcome of the event was not reported. No follow up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Erythema, Headache, Joint swelling, Myalgia
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A female patient of an unspecified age (from 16 to 18 years old) received on 07Aug2015 TRUMENBA (lot number J28923, expiry date Jun2016) at 0.5 ml single, intramuscular, in left upper arm. No antipyretic was given prior to vaccine. No other vaccines were given on the same day or within four weeks prior to date of vaccination. Relevant medical history and concomitant medications were unknown. On 07Aug2015, the patient experienced swelling (swelling of arm pain), redness, pain, muscle aches, feeling hot touch, fever at 101 degrees F, chills and headache. Clinical outcome of the events was unknown. The events did not require an emergency room of physician visit. The reporter considered there was a reasonable possibility that the events were related to the suspect vaccine. Follow-up (25Sep2015): New information from the same contactable physician includes: vaccine lot number, expiry date, route of administration, posology, additional events 'chills' and 'headache', causality assessment.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Pyrexia, Skin warm
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A female patient of an unspecified age (from 16 to 18 years old) received on 07Aug2015 TRUMENBA (lot number J28923, expiry date Jun2016) at 0.5 ml single, intramuscular, in left upper arm. No antipyretic was given prior to vaccine. No other vaccines were given on the same day or within four weeks prior to date of vaccination. Relevant medical history and concomitant medications were unknown. On 07Aug2015, the patient experienced swelling (swelling of arm pain), redness, pain, muscle aches, feeling hot touch, fever at 101 degrees F, chills and headache. Clinical outcome of the events was unknown. The events did not require an emergency room of physician visit. The reporter considered there was a reasonable possibility that the events were related to the suspect vaccine. Follow-up (25Sep2015): New information from the same contactable physician includes: vaccine lot number, expiry date, route of administration, posology, additional events 'chills' and 'headache', causality assessment.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pruritus, Pain, Pruritus, Rash erythematous
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative and from a contactable nurse. A 17-year-old female patient of an unspecified ethnicity received, on 06Aug2015 11:30, TRUMENBA (Lot# J29203, expiration date Jun2016), intramuscular at 0.5 ml single dose in the left deltoid. Relevant medical history and concomitant medications were unknown. On an unspecified date, in Aug2015, the patient experienced itchy at the site of injection, big rash red, sore and itchy. Treatment received included BENADRYL, ALLEGRA and ZYRTEC. The patient did not recover from the event, rash erythematous; while clinical outcome of the other events was unknown. There was a reasonable possibility that the events was related to TRUMENBA. Follow up (01Sep2015): 06 Aug 2015 New information obtained from a contactable nurse includes: lot# and expiration date, route of administration, dose, anatomical location and start date (updated) for TRUMENBA; patient's date of birth. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Lip blister
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date, single dose. The patient medical history and the patient's concomitant medications were not reported. The patient experienced flu like symptoms and blister around his lips after taking this vaccine on an unspecified date with outcome of unknown. Follow-up (08SEP2015): Follow-up attempts completed. No further information expected.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Neck pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 18-year-old female patient (reporter friend's daughter) received a single dose of TRUMENBA on 09Aug2015. Concomitant medications and medical history were not reported. In Aug2015 (unknown if 09Aug2015 or 10Aug2015) the patient was having headache and neck pain. Subsequently, the family contacted the physician who advised them to give her TYLENOL to manage the symptoms. Outcome was unknown. Follow-up (09Oct2015): Follow-up attempts completed. No further information expected. Follow-up (16Oct2015): New information from the same contactable consumer includes: reporter type detail. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: MENB
Symptoms: Pain, Swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer who reported for her daughter. A female patient of an unspecified age and ethnicity received, on an unspecified date, TRUMENBA, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced some pain and little bit of swelling. Clinical outcome of the events was unknown at the time of this report. Follow-up (10OCT2015): Follow-up attempts completed. No further information expected.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is the second of 2 reports for patient 1. A 20-year-old female patient received on 04Aug2015 at 3:30 pm a single dose of TRUMENBA. The patient had ongoing asthma chronic and allergy for entire life. Concomitant medications included birth control pills and inhaler as needed for asthma. The patient received the first dose on 05Jun2015 intramuscular and experienced minimal pain at the injection site. No other vaccines were administered on the same date or within 4 weeks. Immediately after second vaccination, the patient felt tingling throughout the body like someone was sticking needles in it. The event lasted for 2 hours then went away on 04Aug2015. No treatment was provided. Laboratory tests were not performed. The same reactions occurred to her sister after first and second vaccination with TRUMENDA performed respectively on 05Jun2015 and 04Aug2015. Follow-up (24Aug2015): Follow-up attempts completed. No further information expected.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site. Symptoms lessened after 6-7 days but still remain on 11/25.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Large rash on arm.
Age: 88.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt stated that itching, redness, and swelling started approximated 3 to 4 days after receiving her vaccinations. Pt stated that the spot started small and has spread to wrap around her arm.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal pain upper, Cyanosis, Dizziness postural, Fall, Headache
Clinical narrative: She stated she felt dizzy while standing waiting to check out, then she passed out and slid herself along the wall while I caught her before she fell. Her face was pale and her lips were blue tinged and she was not responsive for about 10 seconds. Feet were elevated and shortly after she came too, kind of groggy though. Juice was given, she drank it without difficulty and stated she felt better, but had a bad headache and nauseous and stomachache. Did come home shortly after, no complaints of dizziness or feeling of passing out, but a lot of pain and lots of swelling at the injection site.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Injection site pain, Injection site swelling, Loss of consciousness, Nausea, Pallor
Clinical narrative: She stated she felt dizzy while standing waiting to check out, then she passed out and slid herself along the wall while I caught her before she fell. Her face was pale and her lips were blue tinged and she was not responsive for about 10 seconds. Feet were elevated and shortly after she came too, kind of groggy though. Juice was given, she drank it without difficulty and stated she felt better, but had a bad headache and nauseous and stomachache. Did come home shortly after, no complaints of dizziness or feeling of passing out, but a lot of pain and lots of swelling at the injection site.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Somnolence, Unresponsive to stimuli
Clinical narrative: She stated she felt dizzy while standing waiting to check out, then she passed out and slid herself along the wall while I caught her before she fell. Her face was pale and her lips were blue tinged and she was not responsive for about 10 seconds. Feet were elevated and shortly after she came too, kind of groggy though. Juice was given, she drank it without difficulty and stated she felt better, but had a bad headache and nauseous and stomachache. Did come home shortly after, no complaints of dizziness or feeling of passing out, but a lot of pain and lots of swelling at the injection site.
Age: 0.78
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Immediately after receiving the vaccine, acquired hives on his face. The hives spread to both arms and the right side of his chest. Monitored in clinic for about 45 minutes.  Dr told mom it is ok to give OTC Benadryl.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Fatigue, Foetal death, Infection, Malaise
Clinical narrative: I didn't feel well few days after the vaccination. On 11/24/2014 I continued to feel even more fatigued and not well. When I saw my doctor, she states my water broke and I was rushed to ER at hospital. The infant in-utero did not survive.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Premature rupture of membranes
Clinical narrative: I didn't feel well few days after the vaccination. On 11/24/2014 I continued to feel even more fatigued and not well. When I saw my doctor, she states my water broke and I was rushed to ER at hospital. The infant in-utero did not survive.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Ovarian failure
Clinical narrative: Primary ovarian insufficiency.
Age: 0.87
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: The immunization was given at 10:30 am.  The frist hive was seen by his left eye around 11:30 am, which progressed to left ear and below mouth. He was seen at 4pm in clinic, there were multiple hives on his back, torso and extremities.  Dr sent in a prescription for oral children's Benadryl.
Age: 25.0
Sex: F
Vaccine: TYP
Symptoms: Haemoglobin normal, Immune thrombocytopenic purpura, Petechiae, Platelet count decreased, White blood cell count normal
Clinical narrative: Patient developed petechiae starting the morning after her typhoid vaccination.  Had a CBC done on 11/24 which showed a platelet count of 6,000 and has been presumptively diagnosed with ITP.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Back pain, Blood test normal, Influenza like illness, Injection site rash
Clinical narrative: Minor back pain on the morning of the 18th. Rash at injection site and abdominal pain on the afternoon of the 19th.   By midnight on the 19th a severe migraine that necessitated 2 ER trips as pain meds given AFTER 2 hours in the ER with fluids, anti nausea and IV Dilaudid worked until the drug wore off.   Oxycontin for pain control after was ineffective.   After the migraine passed (three days later) I am still left with minor flu like symptoms and remaining back pain.  It has been 8 days since the vaccine and I am still suffering ill effects.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Minor back pain on the morning of the 18th. Rash at injection site and abdominal pain on the afternoon of the 19th.   By midnight on the 19th a severe migraine that necessitated 2 ER trips as pain meds given AFTER 2 hours in the ER with fluids, anti nausea and IV Dilaudid worked until the drug wore off.   Oxycontin for pain control after was ineffective.   After the migraine passed (three days later) I am still left with minor flu like symptoms and remaining back pain.  It has been 8 days since the vaccine and I am still suffering ill effects.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Allergy test, Headache, Laboratory test, Nuclear magnetic resonance imaging, Skin test
Clinical narrative: Headache developed, has not resolved since (15 months).
Age: 1.74
Sex: M
Vaccine: DTAP, IPV, MMRV, UNK
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Immediately swelling at injection site. The next day swelling was still present just bigger and more red. The third day, it was even bigger. Almost hard and bruised. Followed by a rash a few days later. Rash that's started on neck, the spread to face, shoulders, stomach, back, groin and legs. Still has a bruise at injection site.
Age: 1.74
Sex: M
Vaccine: DTAP, IPV, MMRV, UNK
Symptoms: Rash
Clinical narrative: Immediately swelling at injection site. The next day swelling was still present just bigger and more red. The third day, it was even bigger. Almost hard and bruised. Followed by a rash a few days later. Rash that's started on neck, the spread to face, shoulders, stomach, back, groin and legs. Still has a bruise at injection site.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site erythema, Injection site rash, Mobility decreased, Pain
Clinical narrative: Extreme soreness which prevents the movement of my arm in all directions without causing sharp pain. I also got bruising in the area with redness (small bumps) around injection site.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Extreme soreness which prevents the movement of my arm in all directions without causing sharp pain. I also got bruising in the area with redness (small bumps) around injection site.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Streptococcus test, Streptococcus test negative, Tic
Clinical narrative: Dad reports tics 12 hours after flu vaccine, progressed in frequency and severity went to ER on 11.20.15 admit and d/c same day, saw neurologist.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no concomitant medications, concurrent conditions and medical history reported. On 24-NOV-2015, the patient received an expired dose of ZOSTAVAX (dose, route of administration were not reported) lot # K010628 exp. 30-OCT-2015. There was no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 19-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # K006681, expiration date: 21-OCT-2015) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (also reported as practice manager) refers to an approximately 12 year old patient of unknown gender. No medical history and concurrent conditions were reported. On 17-APR-2015 the patient was vaccinated with GARDASIL 9 (lot number K004204, expiry date 12-JAN-2017) (dose unknown). On 29-JUL-2015 the patient was vaccinated with GARDASIL 9 (lot number K004204, expiry date 12-JAN-2017) and on 09-NOV-2015 the patient was vaccinated with GARDASIL 9 (lot number L023230, expiry date 28-JUL-2017) (inappropriate schedule of drug administration). No adverse effects were reported. There was no product quality complaint reported. The action taken and outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 28-SEP-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 31.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 31 year old patient of unknown age and gender. On 23-NOV-2015, 31 year old patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (lot# L027321 and expiry date: 21-OCT-2016). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report has been received from a healthcare worker referring to a male patient of unknown age. On 16-NOV-2015 the patient was inadvertently vaccinated with (Merck) VARIVAX (dose, route and lot# not reported) instead of ZOSTAVAX (wrong vaccine administered). No adverse effects reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician's assistant refers to a 14 year old female patient. No concurrent condition or medical history was reported. On 15-JUN-2012, the patient was vaccinated with first dose of VAQTA. On 18-NOV-2015 the patient was vaccinated with second dose of expired VAQTA (lot # K008254, exp. 12-NOV-2015) (25/0.5, intramuscularly) (Incorrect product storage). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL (lot number-L013429, expiry date-21-JUL-2017 and lot number-K010215, expiry date-05-MAY-2017, Lot number-K011562, expiry date-08-APR-2017, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to GARDASIL. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of ROTATEQ (lot # K009181, expiry date 24-APR-2016), which were improperly stored. No adverse effects were reported. This is one  of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 24-NOV-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (strength reported as 25/0.5 (units not provided), lot number K004483 and expiration date 16-AUG-2015, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 20 unspecified patients of unknown age and demography. No concurrent conditions and medical history were reported. On an unknown date approximately in 2015 (also reported as between 29-APR-2015 and 29-JUN-2015) the patient was vaccinated with (Merck) VARIVAX (lot: K007784; expiration date 28-MAY-2016 and lot: K010439; expiration: 22-JUL-2016) subcutaneously which was improperly exposed to minus 12.3 degrees centigrade for a cumulative of 17 hours (incorrect product storage). On unspecified dates from 05-MAY-2015 to 29-JUN-2015, 20 patients each received one of the improperly exposed vaccines listed above. It was unspecified which patient received which lot. It was also unspecified exactly how long each lot was actually improperly stored before being administered to each patient. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint reported. The action taken and outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L007560 and expiry date of 15-JUN-2017, after the temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot lumber-L018501, expiry date-22-JUN-2017 and lot number-L004754, expiry date-10-NOV-2016, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to RECOMBIVAX HB. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care worker refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot number-K023159, expiry date-26-JUL-2016, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered to be not related to ROTATEQ. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No medical history or concomitant medications were reported. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA (lot number-L007559, expiry date-01-JUN-2017 and lot number-L028666, expiry date-04-NOV-2016, dosing regimen unknown). No adverse events were reported. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter considered events to be not related to VAQTA. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 20 unspecified patients of unknown age and demography. No concurrent conditions and medical history were reported. On an unknown date approximately in 2015 (also reported as between 29-APR-2015 and 29-JUN-2015) the patient was vaccinated with PROQUAD (Merck) (lot: K011967; expiration: 21-FEB-2016) subcutaneously which was improperly exposed to minus 12.3 degrees Centigrade for a cumulative of 17 hours. On unspecified dates from 05-MAY-2015 to 29-JUN-2015, 20 patients each received the improperly exposed vaccine. It was also unspecified exactly how long the lot was actually improperly stored before being administered to each patient. No concurrent medications were reported. No adverse effects were reported. There was no product quality complaint reported. The action taken and outcome of the events was unknown. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 12-NOV-2015, the patient was vaccinated with a dose of improperly stored (Merck) VARIVAX (lot number L019126 and expiration date 27-MAY-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified dates, an unknown number of patients were inadvertently administered improperly stored PROQUAD (Merck) (lot #L033692, expiration date 28-FEB-2017, therapy type: rHA) (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 11 patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. From 01-OCT-2015, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # L020000 with expiry date 02-JUN-2017; dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K005881 with expiry date 04-JAN-2017; dose and route were not reported). No adverse effects were reported. This is one of two 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 as received from a nurse practitioner refers to a patient of unknown age and gender. On 07-AUG-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. 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: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as between 27-OCT-2015 and 18-NOV-2015) the patients were vaccinated with unspecified doses in the series of GARDASIL 9 (unknown route and strength) (lot # 007560 with expiry date of 15-JUN-2017 or lot #L016428 with expiry date of 30-JUL-2017 or lot # L020015 with expiry date of 16-AUG-2017) which were improperly stored. No adverse effects were reported. There was no product quality complaint involved. This is one of the three 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 as received from a nurse practitioner refers to a patient of unknown age and gender. On 25-SEP-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, MENB
Symptoms: Blood glucose normal, Drug administered to patient of inappropriate age, Haemoglobin normal
Clinical narrative: None stated.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site arthralgia multiple sites including left 3rd finger - PIP joint.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: Muscle soreness lasting more than 2 weeks and difficulty with range of motion when lifting arm.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: Several hours post vaccines patient felt slight pain in arm around site of injections. Returned 1 week later with similar complaints. 2nd complaints 2 weeks later.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash erythematous
Clinical narrative: Very painful to move arm and red bumps developed 1 week later that have gone away with BENADRYL.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient had red swollen area around the injection site on her left deltoid. It was warm to touch 48 hours after vaccination. Pt stated itstarted to get sore and red around 8-10 hours after injection.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as between 27-OCT-2015 and 18-NOV-2015) the patients were vaccinated with unspecified doses in the series of ROTATEQ (lot # L004466 with expiry date of 02-AUG-2016 or lot # L008059 with expiry date of 18-DEC-2016 or lot # L009119 with expiry date of 17-DEC-2016) (oral, unknown strength) which were improperly stored. No adverse effects were reported. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 20-NOV-2015, the patient was inadvertently administered a pediatric dose of RECOMBIVAX HB (strength 5mcg/0.5 ml, dose, route, lot # and expiration date were not reported). This was the first dose the patient was administered. At the time of the report, the patient had no known adverse effect. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 15-SEP-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Injection site erythema, Injection site pain, Pleural effusion, Respiratory tract infection
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of approximately 79 years old. The patient doesn't have any pertinent medical history. Patient is allergic to penicillin. On 02-NOV-2015 the patient was vaccinated with ZOSTAVAX 0.65 mL once lot # L013546 expiry date not reported subcutaneously. Concomitant therapies included LIPITOR. On an unknown date in November 2015 (also reported a couple of days later) the patient developed injection site reaction, described as redness and soreness of the skin surrounding the injection site with a radius of "about the size of a quarter." Also the reporter stated on an unknown date in November 2015, (a couple of days ago (from 13-NOV-2015) patient developed shortness of breath and visited her physician, who determined the patient has fluid in lungs and was diagnosed with a respiratory infection. Patient received treatment, she was prescribed with azithromycin and prednisone. The outcome of the events injection site erythema and injection site pain was reported as recovered/resolved. The outcome of respiratory tract infection was unknown. The reporter did not provide the causality between the events and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Approximately in 2015 (reported as between 27-OCT-2015 and 18-NOV-2015) the patients were vaccinated with unspecified doses in the series of GARDASIL Lot # K011562 with expiry date of 08-APR-2017 (unknown route and strength) which were improperly used. No adverse effects were reported. There was no product quality complaint involved. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site reaction, Injection site swelling, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No patient's concurrent conditions, medical history or concomitant medications were reported. On 17-NOV-2015, the patient was vaccinated with ZOSTAVAX subcutaneous injection, Lot# L031274, expiry date 19-NOV-2016 (strength, dose, injection site were not reported). The patient had an immediate reaction once the vaccine was being administered. The patient developed an immediate "red rise" in her skin at the site of injection. The pharmacist stated that she stopped the administration of the ZOSTAVAX as a result of the immediate reaction to the vaccine upon administration. The patient had a red raised welt at injection site. Consequently, the patient was not administered the full dose of the ZOSTAVAX. There were no labs tests performed and no treatment given for the adverse event. It was reported that the patient had not recovered from the adverse events. The causality between the events and suspect drug was considered to be related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No patient's concurrent conditions, medical history or concomitant medications were reported. On 17-NOV-2015, the patient was vaccinated with ZOSTAVAX subcutaneous injection, Lot# L031274, expiry date 19-NOV-2016 (strength, dose, injection site were not reported). The patient had an immediate reaction once the vaccine was being administered. The patient developed an immediate "red rise" in her skin at the site of injection. The pharmacist stated that she stopped the administration of the ZOSTAVAX as a result of the immediate reaction to the vaccine upon administration. The patient had a red raised welt at injection site. Consequently, the patient was not administered the full dose of the ZOSTAVAX. There were no labs tests performed and no treatment given for the adverse event. It was reported that the patient had not recovered from the adverse events. The causality between the events and suspect drug was considered to be related. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 10 cm x 5 cm leg swelling surrounding the injection site - appearing within 12 hrs of vaccination. Erythema also present. No tenderness to palpation.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site discolouration, Injection site erythema, Injection site pruritus
Clinical narrative: Initially, redness and itching at injection site (half-dollar size) reported 10/29 (2 days after 10/27/15 injection). Patient refused biopsy offered by Merck. PCP treated patient w/valacyclovir and acyclovir. Injection site still discolored 11/25/15 and patient has seen PCP 4 or 5x since vaccine. Complains of joint pain and "internal shingles".
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Initially, redness and itching at injection site (half-dollar size) reported 10/29 (2 days after 10/27/15 injection). Patient refused biopsy offered by Merck. PCP treated patient w/valacyclovir and acyclovir. Injection site still discolored 11/25/15 and patient has seen PCP 4 or 5x since vaccine. Complains of joint pain and "internal shingles".