chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2016US026380, is an initial spontaneous report received from a consumer on 10 Oct 2016. This report refers to an adult female patient. Medical history was and concomitant medication was not reported. The patient was vaccinated with one single dose of Influenza virus vaccine unknown Inn on an unknown date two years ago. The patient received unidentified preservative free influenza vaccine both seasons. The patient experienced had soreness at site, then limited movement of the arm two years ago. last year had swelling and soreness at site which turned to bruising. Final outcome of the event was complete recovery. Seriousness of the event was reported as non serious by consumer. Causality was not reported.
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US026941, is an initial spontaneous report received from a pharmacist on 14 Oct 2016. This report refers to a 63 year old male patient (off label use). Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with a single dose of FLUAD (batch number 165801, expiry date: Apr 2017) at a dose of 0.5 ml intramuscular on 14 Oct 2016. No adverse event was reported following this medication error (drug administered to patient of inappropriate age).
Age: 72.0
Sex: F
Vaccine: FLUA3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2016US027765, is an initial spontaneous report received from a pharmacist on 24 Oct 2016. This report refers to a 72 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 166002) at an unknown dose intramuscularly on 21 Oct 2016. The pharmacist stated that, a female patient received a partial dose of FLUAD. No adverse event reported following this administration error (underdose).
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Full blood count, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: 20 mins after shot, tops of hands got very red and faded next morning but the symptoms have come and gone since then it comes and goes, shortly after rash hands grew painful and tender, only on the dorsum of both hands. He also noticed his veins looking very prominent on the tops of his hands since shot. The next day he had trouble getting out of bed due to pain in both feet that was moderate. His feet were also red and he has been experiencing foot pain and tenderness on tops of feet and bottoms of feet. Mom reports both feet were swollen, but no longer are swollen.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Tenderness
Clinical narrative: 20 mins after shot, tops of hands got very red and faded next morning but the symptoms have come and gone since then it comes and goes, shortly after rash hands grew painful and tender, only on the dorsum of both hands. He also noticed his veins looking very prominent on the tops of his hands since shot. The next day he had trouble getting out of bed due to pain in both feet that was moderate. His feet were also red and he has been experiencing foot pain and tenderness on tops of feet and bottoms of feet. Mom reports both feet were swollen, but no longer are swollen.
Age: 66.0
Sex: F
Vaccine: FLUA3
Symptoms: Tinnitus
Clinical narrative: Case number PHEH2106US028838, is an initial spontaneous report received from a pharmacist on 01 Nov 2016. This report refers to a 63 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 165803) at a dose of 0.5 ml intramuscularly on 22 Sep 2016. On 24 Sep 2016, the patient experienced ringing in the ears and tinnitus two days after being administered with FLUAD (reported as on or about 24 Sep 2016). The patient has seen a few physicians for the issue, but was insure of the cause. The patient called into the pharmacy on 28 Oct 2016 to see if FLUAD could be the cause and the pharmacist in turn called the Med Info center. Tinnitus was ongoing and had not resolved. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious. The causality of the event was not reported.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, Swelling throughout arm-PCP gave course of antibiotics for 7 days (drug unknown).
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Nausea
Clinical narrative: Symptoms included flu-like symptoms of headache, nausea, body-aches, fatigue and soreness at injection site.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Symptoms included flu-like symptoms of headache, nausea, body-aches, fatigue and soreness at injection site.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Bladder disorder, Change of bowel habit, Diagnostic procedure, Laboratory test normal, Monoplegia
Clinical narrative: Rapidly progressive neurologic signs, including paralysis of right leg, pain, bladder and bowel changes, eventually dx as transverse myelitis.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Myelitis transverse, Neurological symptom, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Rapidly progressive neurologic signs, including paralysis of right leg, pain, bladder and bowel changes, eventually dx as transverse myelitis.
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Case number PHEH2016US029276, is a combined initial and follow up spontaneous report received from a consumer on 10 Oct 2016. This report refers to a female patient. Past vaccination history included patient vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date 2 years ago and she experienced soreness at site, then limited movement of the arm which lasted 3 month, then resolved (see case: PHEH2016US026380). Concomitant medications were not reported. She was vaccinated with influenza vaccine (Manufacturer and batch number: not reported) on an unknown date last year. After vaccination, she had swelling and soreness at site which turned to bruising and lasted a few days. It was reported that she received unidentified preservative free influenza vaccine both seasons. The outcome, seriousness and causality of the events were not reported.
Age: 8.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US029307 is an initial spontaneous report received from pharmacist on 04 Nov 2016. This report refers to 08 year old male patient (off label use). Medical history and concomitant medication was not reported. The patient was vaccinate with single dose of FLUAD (batch number: 165703) at a dose of 0.5 ml intramuscular on 29 Oct 2016. No adverse event was reported following this medication error.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Dizziness, Lymphadenopathy
Clinical narrative: Case number PHEH2016US029589, is an initial spontaneous report received from a consumer on 08 Nov 2016. This report refers to a 67 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: not reported) at a dose of 0.5 ml, intramuscularly 24 Oct 2016. On 25 Oct 2016 in the next morning when she awoke, she was dizzy also had swelling in lymph nodes in neck and throat. The swelling lasted for a week. She went to ENT (ear, nose and throat) physician. The physician stated that the swelling was from the FLUAD. She was still having dizziness from the FLUAD. The final outcome of events dizzy was condition unchanged and for lymph nodes in neck and throat was complete recovery. The seriousness events dizzy and swelling in lymph nodes in neck and throat was not reported. The causality of event swelling in lymph nodes in neck and throat was assessed as suspected to be related to treatment with FLUAD and causality of event dizzy was not reported.
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2016US029677, is an initial spontaneous report received from a pharmacist on 09 Nov 2016. This case is also associated with quality complaint number(101776). This report refers to a patient of an unknown age and an unknown gender. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUAD (unknown whether seasonal or pandemic, batch number: 166101, Expiry: Apr 2017) on an unknown date. At the time of vaccination, the plunger fell out, it was inserted into the syringe once pressure was applied, vaccine squirted out and a partial dose was administered. It was reported that the package condition was good. The plunger rod was loose and it fell out completely during administration of vaccine. No adverse event was reported following this medication error.
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site extravasation, No adverse event, Underdose
Clinical narrative: Case number PHEH2016US030272, is an initial spontaneous report received from a pharmacist on 15 Nov 2016. This report refers to a 77-years-old female patient. Past medical history and concomitant medications were not reported. This patient was vaccinated with a single dose of FLUAD (batch number: 166003, expiry date: Apr 2017) intramuscularly, on 15 Nov 2016. On the same day after vaccination, vaccine leaked on patient and partial dose administered as some of vaccine trickled down her arm. No adverse event was reported following this administration error. The pharmacist assessed the case as non serious.
Sex: U
Vaccine: FLUA3
Symptoms: Product quality issue, Syringe issue
Clinical narrative: Case number PHEH2016US030408, is an initial spontaneous report received from a pharmacist on 17 Nov 2016. This report refers to a patient of an unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUAD (lot number: 166103, expiration date: Apr 2017) from an unknown start date at a dose of 0.5 ml (frequency: one single dose), intramuscularly. On an unknown date, the plunger did not move when vaccine was tried to be administered. He (the reporter) then put the needle in the patient's arm and started to push and nothing happened and again trued with another prefilled syringe and the same thing happened. It was further reported that a product complaint was also filed. The outcome of the events was reported as unknown. The seriousness and causality for the events were not reported.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2016US030608, is an initial spontaneous report received from a pharmacist on 16 Nov 2016. This report refers to a 65-years-old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUZONE (batch number not reported) at an unspecified dose on 24 Oct 2016. The patient was vaccinated with a single dose of FLUAD (batch number: 165801, expiry date Apr 2017) at a dose of 0.5 ml intramuscularly on 16 Nov 2016. On the same day it was discovered that that in the same season the patient was already vaccinated with FLUZONE (on 24 Oct 2016). No adverse event was reported following this administration error. The case was assessed as non serious by the pharmacist.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9 lot # L026602, expiry date: 19-FEB-2017; lot # L036301, expiry date: 20-DEC-2017 and lot # M026306, expiry date: 30-APR-2018 (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. Information was received on 28-OCT-2016, lot number M026306 is an invalid lot number for GARDASIL 9. Follow up information has been received on 19-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA012627: US-009507513-1610USA012626: US-009507513-1610USA012628: US-009507513-1610USA012625: MERCK 1610USA010371:Mfr number.
Sex: F
Vaccine: PPV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. In approximately 2013 (reported as 3 years ago), the patient was vaccinated with dose of PNEUMOVAX 23 (dose and route were not reported, lot M036812 with expiration date: 04-FEB-2018 ) for prophylaxis. In approximately 2016, the patient came to the facility to receive PREVNAR 13 and inadvertently received another dose of PNEUMOVAX 23. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Activities of daily living impaired, Headache, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician and company representative refers to a 16 year old male patient. The patient's pertinent medical history included attention deficit hyperactivity disorder and Allergic runny nose. It was reported that the patient had drug reaction or allergies to Penicillin (manufacturer unknown). On 10-AUG-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly (lot # M007764, expiry date not reported) for vaccination. Concomitant therapies included VYVANSE. On 05-OCT-2016 the patient was vaccinated with second dose of  GARDASIL 9 (inappropriate schedule of drug administration) intramuscularly (lot # M016193, expiry date not reported) for vaccination. On unknown date in August 2016 and October 2016 (reported as within hours of each dose) the patient experienced severe headache which caused the patient to be unable to perform their activity of daily living for the first day after administration. It was reported that the patient reported these events on an unknown date in 2016 when the patient was seen in the physician's office. The patient did not receive any treatment for the events and no lab diagnostic studies were performed. The action taken with the therapy with GARDASIL 9 was unknown. The patient had recovered from both the episodes of the headaches the day after the day following administrations. The relatedness of the events to the therapy with GARDASIL 9 was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 15 year old female patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 27-APR-2016, the patient was vaccinated with GARDASIL (dose: 0.5 ml, 0, 2,6 months) (lot #, expiration date and route were not reported) for prophylaxis. On 09-AUG-2016, the patient was vaccinated with GARDASIL 9 dose 2 for prophylaxis and on 08-NOV-2016 the patient again was vaccinated with GARDASIL 9 (dose 3) ((lot #, expiration date and route were not reported)) (inappropriate schedule of drug administration and interchange of vaccine products). No adverse effects were reported. There was no product quality complaint involved. 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 registered nurse concerning to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients received doses of improperly stored PROQUAD (dose and route of administration were not reported) for prophylaxis. Data Logger was involved. No adverse effects reported. A product quality complaint was not involved. The following lot numbers and temperature were reported: M014301 expiration date 09/22/17 -13.9C for 15 minutes -14.9C for 15 minutes -14.8C for 15 minutes M022400 expiration date 11/01/17 -14.6C for 15 minutes -14.9C for 15 minutes -14.3C for 05 minutes -14.7C for 05 minutes -14.7C for 05 minutes -14.6C for 05 minutes -14.6C for 05 minutes -14.7C for 15 minutes -14.8C for 15 minutes -14.9C for 15 minutes -14.1C for 15 minutes -14.8C for 15 minutes -10.7C for 10 minutes - 9.4C for 01 minutes Lot number report as M224001 expiration date 11/01/17 -14.8C for 15 minutes -14.9C for 15 minutes -14.1C for 07 minutes -14.5C for 15 minutes -14.8C for 15 minutes -10.7C for 10 minutes - 9.4C for 01 minute -14.5C for 15 minutes - 9.4C for 11 minutes -10.3C for 03 minutes -14.8C for 15 minutes - 9.6C for 01 minute -13.0C for 14 minutes -14.9C for 05 minutes -14.6C for 05 minutes M032496 expiration date 01/02/18 - 9.4C for 01 minute -10.7C for 10 minutes -14.5C for 15 minutes - 9.4C for 11 minutes -10.3C for 03 minutes -14.8C for 15 minutes - 9.6C for 01 minute -13.0C for 14 minutes -14.9C for 05 minutes M035690 (RHA) expiration date 02/06/18 -14.6C for 05 minutes This is one of the two cases reported for the same contact. Additional information has been requested; Sender's Comments:  US-009507513-1612USA005779: Original Case : 1612USA005638
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 78 year old female patient concerning herself. Concurrent medical conditions included high blood pressure and allergy to zinc. Concomitant medications included an unspecified medication. In February 2013, the patient received one dose of ZOSTAVAX for prevention of shingles (route and lot number not provided). On approximately 01-DEC-2016 (reported as three weeks ago), the patient developed shingles. She went to the Emergency Room (ER) and was treated with triamcinolone. The patient's present status was not recovered. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MMR, MNQ, VARCEL
Symptoms: Injection site rash, Injection site reaction, Injection site warmth, Rash, Skin lesion
Clinical narrative: 12/7/2016 Patient received Varicella subcutaneous in right arm and MMR subcutaneous and MENACTRA IM in left arm. Patient woke the next morning with a "hot" rash on forehead, cheeks, bridge of nose and behind her right upper arm. She was seen that day by a medical doctor. The provider also noted one lesion at the injection site. The patient denied any shortness of breath or cough. No itching in the throat or mouth. The provider treated her with Alavert and Benadryl. The patient was instructed to take one Alavert in the AM and 2 Benadrly in the PM.
Age: 19.0
Sex: F
Vaccine: MMR, MNQ, VARCEL
Symptoms: Skin warm, Varicella virus test negative
Clinical narrative: 12/7/2016 Patient received Varicella subcutaneous in right arm and MMR subcutaneous and MENACTRA IM in left arm. Patient woke the next morning with a "hot" rash on forehead, cheeks, bridge of nose and behind her right upper arm. She was seen that day by a medical doctor. The provider also noted one lesion at the injection site. The patient denied any shortness of breath or cough. No itching in the throat or mouth. The provider treated her with Alavert and Benadryl. The patient was instructed to take one Alavert in the AM and 2 Benadrly in the PM.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Activities of daily living impaired, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: Before being discharged from the hospital on 12/07/2016, I was given a pneumonia and influenza injection. Entire left arm is extremely sore. My arm aches constantly at a 5/10 level. I am unable to reach or move arm without very intense sharp pain at 9/10 level. The pain hampers my ability to dress or undress, bathe, do my hair and other normally simple tasks. The pain affects my ability to sleep. Pain medication is not effective for my level of pain. It has been 2+ weeks since the injections and there is no sign of pain resolving or lessening. In fact, it feels like it may be getting worse because I have a constant awareness of the pain. The only change is the intensity of the pain depending upon my activity.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Eye pruritus, Eyelid oedema, Fatigue, Headache
Clinical narrative: Tachycardia, sore/red/itchy eyes, HA, fever, fatigue, eyelid swelling, facial swelling.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia, Pyrexia, Swelling face, Tachycardia
Clinical narrative: Tachycardia, sore/red/itchy eyes, HA, fever, fatigue, eyelid swelling, facial swelling.
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Case number PHEH2016US021231, is an initial spontaneous report received from a pharmacist on 12 Aug 2016. This report refers to a male patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, batch number: not reported) on an unknown date. The patient also vaccinated with ZOSTAVAX Vaccine (other manufacture, batch number: not reported) on an unknown date. The pharmacist stated that, the patient was vaccinated with unspecified flu vaccine years ago and was diagnosed with Guillain Barre syndrome after receiving the vaccine (10 to 20 years ago). Reported that AFLURIA as the vaccine given was not ruled out. The outcome of the event was reported as complete recovery on an unknown date. The seriousness and causality of the event was not reported. The seriousness assessment of the event Guillain Barre syndrome was upgraded to medically significant based on the Novartis Important Medical Event list. Follow up report received from a pharmacist on 17 Oct 2016: Added suspect product (ZOSTAVAX Vaccine) and updated reporter comments.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Impaired work ability, Malaise, Nausea
Clinical narrative: Case number PHEH2016US030049, is an initial spontaneous report received from a consumer on 16 Nov 2016. This report refers to a female patient of an unknown age. Past vaccination history included she received the influenza virus vaccine (unknown manufacturer, batch number not reported) every year and had gotten sick. Concomitant medication was not reported. She was vaccinated with a single dose of seasonal influenza vaccine INN (unknown manufacturer, batch number: not reported) at a dose of 0.5 ml intramuscularly on 05 Nov 2016. After vaccination, on an unknown date, she had gotten sick. On 08 Nov 2016, she experienced sore throat, headache, mild fever along with nausea and dizziness. Reporter stated that this only happened when she got the flu shot. She did not completely recover and had to take off work. She did not know and was unable to retrieve the name of the vaccine. The final outcome of the events was reported as condition improving. The events were assessed as serious (disability) by the consumer. The causality of the events was not reported. This case was lost to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Case number PHEH2016US030049, is an initial spontaneous report received from a consumer on 16 Nov 2016. This report refers to a female patient of an unknown age. Past vaccination history included she received the influenza virus vaccine (unknown manufacturer, batch number not reported) every year and had gotten sick. Concomitant medication was not reported. She was vaccinated with a single dose of seasonal influenza vaccine INN (unknown manufacturer, batch number: not reported) at a dose of 0.5 ml intramuscularly on 05 Nov 2016. After vaccination, on an unknown date, she had gotten sick. On 08 Nov 2016, she experienced sore throat, headache, mild fever along with nausea and dizziness. Reporter stated that this only happened when she got the flu shot. She did not completely recover and had to take off work. She did not know and was unable to retrieve the name of the vaccine. The final outcome of the events was reported as condition improving. The events were assessed as serious (disability) by the consumer. The causality of the events was not reported. This case was lost to follow up.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm red, swollen, achy, hot, and itching. Took BENADRYL without relief. Reported to HD on 12/21/2016 and was referred to PHP. Saw Dr. on 12/22/2016. Received "steroid shot" and prescribed "2 antibiotics".
Sex: U
Vaccine: HEPA, HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown date, the patient may had received an improperly stored dose of either  GARDASIL 9 lot # M023169 with expiration date 13-JUN-2018 (dosage and therapy route were not provided), for prophylaxis; ROTATEQ lot # M006111 with expiration date 18-NOV-2017 (dosage and was not provided) orally, for prophylaxis; or VAQTA lot # M027879 with expiration date 24-JAN-2018 (dosage and therapy route were not provided), for prophylaxis. No adverse effects were reported.  The doses of GARDASIL 9; ROTATEQ and VAQTA were exposed to a temperature of 46.1F and were out of range for 18 hours. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Office Manager referring to 2 unspecified patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On 19-DEC-2016, the patients were vaccinated with a doses of improperly stored VARIVAX, lot # of M024675, expiration date of 18-MAY-2018 (strength, dose number, route and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 26 hours: 52.0 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: This is a spontaneous report from a Pfizer sponsored Program IBCC (Inbound Call Center for HCPs). A contactable physician reported for his wife. A female patient of an unspecified age and race received  PREVNAR 13 (Lot  N34936, Expiry date: 04Nov2017, NDC number: 0005-1971-02) for immunization on 04Dec2016 at single dose. Seven days after the vaccination she experienced redness, pain and swelling around the injection area, restriction of movement, and swelling in the sole of her feet and joint pain. In the morning she noticed severe rash in her low extremities and a "huge bump" above her knee, in her thigh. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Rash
Clinical narrative: This is a spontaneous report from a Pfizer sponsored Program IBCC (Inbound Call Center for HCPs). A contactable physician reported for his wife. A female patient of an unspecified age and race received  PREVNAR 13 (Lot  N34936, Expiry date: 04Nov2017, NDC number: 0005-1971-02) for immunization on 04Dec2016 at single dose. Seven days after the vaccination she experienced redness, pain and swelling around the injection area, restriction of movement, and swelling in the sole of her feet and joint pain. In the morning she noticed severe rash in her low extremities and a "huge bump" above her knee, in her thigh. The outcome of the events was unknown.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Pneumonia pneumococcal
Clinical narrative: This is a spontaneous report from a non-contactable consumer communicated to a Pfizer sales representative. A 60-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient had an allergic reaction to pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date. The patient was in the hospital for pneumococcal pneumonia on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: FLUX
Symptoms: Rash, Urticaria
Clinical narrative: Case number PHEH2016US025909, is a spontaneous report initially received from a consumer (patient's mother) on 03 Oct 2016. This report refers to a male patient. Past medical history was not reported. Current condition included mild egg allergy which was diagnosed after allergy testing. Concomitant medication was not reported. He was vaccinated with influenza vaccine (manufacturer and batch number: not reported) on an unknown date 2 years ago. After vaccination, he experienced hives and rash. The outcome of the events was reported as complete recovery on an unknown date. The reporter assessed the events as non serious. The causality of the events was not reported. Non significant information received from a consumer on 03 Oct 2016: Updated reporter information.
Age: 65.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Pyrexia
Clinical narrative: Case PHEH2016US025988 is an initial spontaneous report received from nurse on 05 Oct 2016. This report refers to a 65 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with single dose of FLUAD (batch number: 166002) at a dose of 0.5 ml into deltoid on 29 Sep 2016. On the same day, the patient experienced fever and hard chills after vaccine at evening (night). On 30 Sep 2016, the events were completely recovered on next morning. The outcome of events was completely recovered on 30 Sep 2016. The seriousness of the events was reported as non serious. The causality of events were not reported. Follow up report received from nurse on 03 Nov 2016: Patient detail updated (age), event details (onset and recovery date, seriousness) updated and updated narrative accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Malaise, Upper-airway cough syndrome
Clinical narrative: Case number# PHEH2016US026223, is an initial report received from a consumer (patient) through phone call via a Patient Oriented Program on 11 Oct 2016. This report refers to a 68-year-old female patient. Historical condition included clostridium difficile infection. Past medication included antibiotics (unspecified). Current condition was not reported. The patient was polymedicated. The patient underwent knee replacement. The patient received COSENTYX injection for the treatment of an unknown indication from an unknown date in Jun 2016 at a dose of 300 mg, QW4 (injection NOS) and she was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unknown date (reported as Friday). The patient had last dose of COSENTYX 2 weeks ago. On 08 Oct 2016 (reported as since Saturday), the patient was not feeling well. The patient was taking care of 2 sick grandchildren last week. On an unknown date, the patient was feeling very tired and a lot of post nasal drip in her throat (upper-airway cough syndrome). The patient stated that she needs to be very careful with what types of antibiotics she takes because of the C Diff. She would be contacting her physician. Action taken with COSENTYX and seasonal influenza vaccine was unknown. The outcome of the event was unknown. The seriousness and causality of the events were not reported. The consent was not given to contact reporter.
Age: 66.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Bronchitis, Influenza, Nasopharyngitis
Clinical narrative: Cold and Flu symptoms about 10 days after shot. Bronchitis symptom about 1 week later. Bronchitis presents to 12-12-16 -  nearly 2 months!
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: Case number PHEH2016US026564, is an initial spontaneous report received from a consumer on 11 Oct 2016. This report refers to a 75 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 166001) at a dose of 0.5 ml intramuscularly in left arm on 06 Sep 2016. On the same day of vaccination, patient experienced sore in upper left arm. It was reported that, patient received FLUAD about 3 weeks ago and her arm still bothered her where the injection was given. Symptoms began since day of administration and continued till the day of report. The outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Adverse drug reaction, Drug hypersensitivity
Clinical narrative: Case number PHEH2016US028828, is an initial spontaneous report received from a consumer on 04 Oct 2016. This report refers to an adult female patient. Past medical history included chronic fatigue syndrome, surgeries for the melanoma, needle biopsy, cold sores and LEEP (loop electrosurgical excision procedure). Current condition included melanoma on chest and legs. Concomitant medications included dexamethasone and VALTREX. The patient was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacturer unknown and batch number: not reported) on an unknown date. On an unknown date, the patient experienced drug allergy/drug reaction. The outcome, seriousness and causality of the event was not reported.
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case PHEH2016US029086 is an initial spontaneous report received from pharmacist on 14 Oct 2016. This report refers to 63 year old female patient (off label use). Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUAD (batch number: 165703) at a dose of 0.5 ml intramuscular on 13 Oct 2016. No adverse event was reported following this medication error.
Sex: F
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Case number PHEH2016US026693, is an initial spontaneous report received from a consumer on 12 Oct 2016. This report refers to an unknown age of female patient. Past medical history was not reported. Current conditions included as immune issues. Concomitant medications was not reported. She was vaccinated with influenza vaccine (unknown whether seasonal or pandemic, manufacturer and batch number: not reported) on an unknown date. On an unspecified date, the patient experienced sick every year. The outcome of the event was reported as unknown. Seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site reaction
Clinical narrative: Case number PHEH2016US028148, is an initial spontaneous report received from a nurse on 24 Oct 2016. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with Influenza Virus Vaccine Unknown INN (manufacturer unknown, batch number: not reported) on an unknown date. The patient experienced vaccination site reaction. The outcome of the event was reported as completely recovery. Seriousness of the event was reported as non serious and causality of the event was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Case number PHEH2016US029205, is an initial spontaneous report received from a nurse on 25 Oct 2016. This report refers to a 68 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of influenza vaccine (manufacturer unknown, batch number not reported) at an unknown dose intramuscularly on 17 Oct 2016. On the same day after vaccination, the patient experienced the pain in her arm that lasted for an unspecified amount of time. Nurse also reported that, the patient vomited after she got out of the shower on the same day after administration. The outcome of the events was reported as complete recovery on 17 Oct 2016. The seriousness of the events was reported as non serious. The causality of the events was not reported.
Age: 48.0
Sex: M
Vaccine: PPV
Symptoms: Immune thrombocytopenic purpura, Pain, Purpura, Pyrexia
Clinical narrative: Fever and body aches started 12/10/16. Continued body aches with purpura over the weekend and he made an appt in our office 12/15/16 and we sent him to the ER. Acute ITP.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain, swelling (L) arm.
Age: 45.0
Sex: F
Vaccine: MNQ, YF
Symptoms: Injection site erythema
Clinical narrative: 5 x 7 cm erythema showed inj. site (L) post. Patient placed on Cephalexin and F/U with PCP recommended.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had vaccine on a Monday. Tuesday started having swelling and redness greater than 1 inch at injection site. Hot to touch. Pt evaled by provider-watching SX for improvement.
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2016US028241, is an initial spontaneous report received from a pharmacist on 24 Oct 2016 (combine report). This is also a quality complaint report (QA reference number: 1017508). This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: 166002, expiry date: Apr 2017) on an unknown date. The pharmacist stated that , while administering the FLUAD vaccine to a patient, she noticed that the vaccine squirted out on the pants of the patient and did not know from where exactly the product leaked. The needle was placed in the sharp containers. It was also reported that, the patient received partial dose. No adverse event was reported following the maladministration (under dose and syringe issue).
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Injection site warmth, Pain in extremity
Clinical narrative: Case number PHEH2016US022997, is a spontaneous report initially received from a consumer on 07 Sep 2016. This report refers to a 55 years old female patient. Past medical history was not reported. Her current condition included common variable immune deficiency (CVID). Concomitant medications included prednisone and RITUXAN. The patient was vaccinated with single dose of FLUAD (batch number: not reported) at a dose of 0.5 ml intramuscularly on 06 Sep 2016. After vaccination, on 07 Sep 2016, she noticed that her arm was very sore (like a bad bruise) and the injection site was warm. It was reported that she was on high doses of prednisone and had a high dose RITUXAN on a day before this report. It was reported that the adverse reaction was not resolved as of 07 Sep 2016. Final outcome of the events was not reported. The seriousness of the event sore arm was reported as non serious by the consumer and for other events was not reported. The causality of the events was not reported. Follow up information received from a consumer on 07 Sep 2016: Updated events outcome.
Age: 63.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US023708, is an initial spontaneous report received from a pharmacist on 14 Sep 2016. This report refers to a 63 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 165803) at a dose of 0.5 ml intramuscularly on 13 Sep 2016. The pharmacist reported that, 2 patients received FLUAD vaccine that were not 65 years or older. No adverse event was reported following this administration error. The case was assessed as non serious by the pharmacist.
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US023793, is an initial spontaneous report received from a pharmacist on 14 Sep 2016. This report refers to a 55 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUAD (batch number: 165803) at a dose of 0.5 ml, intramuscular on 13 Sep 2016. On 13 Sep 2016, 02 patients vaccinated with FLUAD that were not 65 years or older. No adverse event was reported following this medication error. The case was assessed as non-serious by the pharmacist.
Age: 90.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue, Wrong technique in product usage process
Clinical narrative: Case PHEH2016US023986 is a spontaneous report initially received from a pharmacist on 16 Sep 2016. This case is also associated with quality complaint number (1016921). This case refers to a 90 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with a single dose of FLUAD (batch number: 165803) expiry date: not reported) at a dose of 0.5 ml intramuscularly on 15 Sep 2016. It was reported that the pharmacist inserted the needle into the patient arm and noticed that the plunger was not in the barrel. He picked up the plunger and attached it to the barrel while needle in arm and administered the vaccine. No adverse event was reported following this medication error. Combined report of internal review done on 10 Nov 2016 for the information received on 16 Sep 2016, the significant case correction was done and non significant follow up report received from a pharmacist on 16 Sep 2016: Added event wrong doing technique in product usage process, previously coded event vaccine underdose was recoded to syringe issue. Updated reporter information.
Sex: U
Vaccine: FLUA3
Symptoms: Syringe issue
Clinical narrative: Case PHEH2016US024027 is an initial spontaneous report received from pharmacist on 16 Sep 2016. This case refers to unknown demographic patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose FLUAD (batch number: 165803) at a dose of 0.5 ml intramuscular on an unknown date. The pharmacist was reported that, the FLUAD syringe leaked when administering vaccine to a patient. The pharmacist did not know the date of occurrence did not have any patient information or expiration date. No adverse event was reported following this medication error.
Age: 46.0
Sex: F
Vaccine: FLUR3
Symptoms: Cough, Ear congestion, Nasal congestion, Otorrhoea, Productive cough
Clinical narrative: Received eggless flu vac on 11/23/16. Came back to clinic (12/15/2016). The night of receiving flu shot she began experiencing coughing wheezing and congestion. There was increase in phlegm prod by day 3 and lot of nasal congestion on which got worse and was still experiencing 12/15. 12/15 has bi-lateral ear congestion with left ear drainage. No cough.
Age: 46.0
Sex: F
Vaccine: FLUR3
Symptoms: Respiratory tract congestion, Wheezing
Clinical narrative: Received eggless flu vac on 11/23/16. Came back to clinic (12/15/2016). The night of receiving flu shot she began experiencing coughing wheezing and congestion. There was increase in phlegm prod by day 3 and lot of nasal congestion on which got worse and was still experiencing 12/15. 12/15 has bi-lateral ear congestion with left ear drainage. No cough.
Age: 71.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site reaction, redness, swelling, soreness in (L) arm.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pt was vaccinated 11/28/16/ Began having reaction 11/30/16. Site of injection became red/raised, warm to touch, itchy and painful. The site (left deltoid) was large and pain tenderness lingered.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt came in on 12/8/16 saying that he had a redness at the injection site at 8 cm in diameter. RPH on duty recommended BENADRYL. RPH called MD. No response from MD. Called pt to check on him, and he was fine.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Culture urine, Full blood count, Hyperhidrosis
Clinical narrative: Chills and sweats 8 hours after getting vaccine.
Age: 3.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash due to vaccine.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient returned to the store around 6pm the evening she received the shot 12-14-16 and reported significant swelling and pain in the arm she received the shot. Pt stated this reaction has happened in the past and symptoms improved 12/15/16 after using ice/ibuprofen.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain, Administration site reaction, Administration site warmth, Injection site erythema, Injection site pain
Clinical narrative: Pain at admin site, red, war, itchy. Pain and red w/in an hour of admin. Present 3 days later, pink warm tender.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus
Clinical narrative: Pain at admin site, red, war, itchy. Pain and red w/in an hour of admin. Present 3 days later, pink warm tender.
Age: 68.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Injected limb mobility decreased, Peripheral swelling
Clinical narrative: Rt side flu shot no problem. Left side PNEUMONIA shot 11/05/16 AM woke up an my left arm is swollen 2 times its normal size and could hardly move it. I had to lift it up to move lasted 1 day and 1/2 before the swelling went down.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: Warmth and redness approximately 4-4.5 cm in diameter-Patient denies itching but states sited is painful to the touch.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Approximately 30 minutes after injection of TDaP and MCV4 pt's forearms and face started turning red. Took BENADRYL 50mg at 1330.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Blister, Injection site pruritus, Urticaria
Clinical narrative: x 24 hrs post injection - lower back pain/soreness -light colored welt - turned into blisters - face, neck, chest, back of both arms, worse at injection site (itching).
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Upper left thigh swollen around injection site 3x3 inches.