chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (immunization official) concerning to an unspecified patients of unknown age and gender.  Medical history and concurrent conditions were not provided. On an unknown dates (from 01-MAR-2016 to an unspecified date), the patients were vaccinated with improperly stored doses (incorrect product storage ) of RECOMBIVAX HB lot # L025738, (the expiration date, dose and route were not reported) for prophylaxis. No adverse events reported at this time. The call was made by the data logger with a registered temperature of 10.3 °C during 107 hours and 30 minutes and there was no previous temperature excursion registered. This is one of three reports form the same reporter.   Additional information has been requested.; Sender's Comments:  US-009507513-1701USA004692: US-009507513-1612USA011665:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (immunization official) concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates (from 01-MAR-2016 to an unspecified date), the patients were vaccinated with improperly stored doses (incorrect product storage ) of GARDASIL 9 lot # L043213, (the expiration date, dose and route were not reported) for prophylaxis.. No adverse events reported at this time. The call was made by the data logger with a registered temperature of 10.3 °C during 107 hours and 30 minutes and there was no previous temperature excursion registered. This is one of three reports from the same reporter. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A 79-year-old female patient received PREVNAR 13 (Lot # Q02071, Expiry Date Jan2018, NDC # 00005197102) via an unspecified route of administration at 0.5 ml single on her right deltoid muscle on 28Dec2016 for immunization, not prescribed by a physician. She had never received it before this vaccine. Medical history was none.  There were no concomitant medications. At the very end of Dec2016, 2 to 3 days after injection, she had an injection site reaction: a red spot that appeared and she said that it itched at the beginning and then the redness had gone down but it was not as red as it used to be but now its spreading, it was getting bigger and there is a lump. It has been about a week so, the Pharmacist was just wondering how long does the reaction usually take place and when should it go away. The outcome was not recovered.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Injection site erythema
Clinical narrative: This is a spontaneous report from a non-contactable nurse practitioner (reporting on behalf of her son) via a Pfizer sales representative.  A 19-year-old male patient received TRUMENBA (lot R45077) at single dose for immunization on unknown date. Medical history and concomitant medications were unknown. On unknown date the patient experienced redness by injection site that travel down his arm. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Ageusia, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Initial unsolicited report received from a health care professional (pharmacist) on 04-Jan-2017. This case involves a 75 year old male patient who was vaccinated with a dose of FLUZONE HD Batch number- U4764AA (expiration date, dose, dose in series and route of administration were not reported) right deltoid on 29-Sep-2016. Pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination was none. Any other vaccinations within four weeks of vaccinations were also none. On 29-Sep-2016, within hours of receiving the vaccine patient developed runny nose, red eyes, no taste to anything. It was reported that pharmacist advised to seek care and patient went on to an urgent care as advised. Relevant diagnostic tests/laboratory data were none Corrective treatment were not reported.The outcome of events were reported as not recovered. List of documents held by the sender: None
Sex: F
Vaccine: TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: Initial unsolicited report received from a non-healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016590759) on 05-Jan-2017. This case involves adult female patient (age unknown) who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient experienced fever and headache. Laboratory investigations and corrective treatment were not reported. The outcome of the events were not reported. List of documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Alopecia
Clinical narrative: Initial unsolicited report received from a consumer (Patient herself) on 05 January 2017. This case involves a 50-year-old female patient who was vaccinated with doses of FLUZONE QIV (batch number, expiry date, dose were not reported) intramuscularly on an unknown dates since last 2 years (reported as 2015-2016 and 2016-2017 Flu). Patient's pre-existing physician diagnosed allergies, birth defects, illness at the time of vaccination were reported as none and patient had medical history of High blood pressure. Concomitant medications were not reported. On an unknown date, within 3-4 weeks after each vaccination, patient's hair began to fall out. Last year they were unsure of the cause and took time to investigate causes and she became completely bald on her head and face. Now patient had only lost 1/3 of her hair on her head and had not lost facial hair. Patient visited dermatologist but had not concluded a cause. The patient had previous five doses of FLUZONE QIV. Laboratory investigations was not reported. The patient received shots to preserve hair. The outcome of event was reported as not recovered. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient experienced redness and swelling at the injection site about the size of a small ball (in between a grape and a golf ball). The swelling is reduced and only some bruising remains about three weeks later.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Mobility decreased, Nausea, Peripheral swelling, Renal pain
Clinical narrative: Head ache, nausea, arm swelling, arm pain, couldn't lift arm, kidney pain, face swelling, uti.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling face, Urinary tract infection
Clinical narrative: Head ache, nausea, arm swelling, arm pain, couldn't lift arm, kidney pain, face swelling, uti.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Generalised tonic-clonic seizure, Laboratory test, Lumbar puncture, Resuscitation
Clinical narrative: Child had been awake and alert. Feeding well. Witnessed tonic clonic seizure with apnea.  EMS called; CPR started and pt transferred to local hospital with eventual transfer to another hospital.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13
Symptoms: X-ray
Clinical narrative: Child had been awake and alert. Feeding well. Witnessed tonic clonic seizure with apnea.  EMS called; CPR started and pt transferred to local hospital with eventual transfer to another hospital.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1, DTAPHEPBIP, HIBV, PNC13
Symptoms: Generalised tonic-clonic seizure, Pyrexia
Clinical narrative: Child had been awake and alert. Feeding well. Witnessed tonic clonic seizure with apnea.  EMS called; CPR started and pt transferred to local hospital with eventual transfer to another hospital.
Age: 21.0
Sex: F
Vaccine: FLU3, HEPAB, MMR, VARCEL
Symptoms: Injection site induration, Injection site irritation, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Pt has rash and irritation on sites where live vaccines were administered. Pt states that sites were warm, hard and painful.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies were not informed. On 16-DEC-2016, the patient was inadvertently vaccinated with a expired dose of ZOSTAVAX, expiration date 15-DEC-2016, (lot #, dosage and therapy route were not provided), for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 23-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 20-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 19-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the  PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. ; Sender's Comments: US-009507513-610USA011245:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 16-SEP-2016, the patient received improperly stored doses of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site vesicles, Wrong technique in product usage process
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 03-JAN-2017, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose number, anatomical location, lot number and expiration date were not provided) for prophylaxis. The reporter stated that on 03-JAN-2017, when administering the ZOSTAVAX to the patient, a small bubble formed at injection site ( injection site vesicles). It was reported that the pharmacist then withdrew needle from patient "after about a third of the dose had been given", and re-stuck the patient in a different spot and finished the dose. The outcome of injection site vesicles was not reported. The reporter did not assess the relatedness between the event and ZOSTAVAX.  Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a physician referring to a 24 year old male patient. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB dose 1 (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. On an unspecified date, nine years after the original vaccination was given, the patient tested negative for any antibody titers (hepatitis b surface antibody negative). Additionally, a second dose of RECOMBIVAX HB (anatomical route of vaccination, lot number and expiration date were not provided) was administered to the patient on an unknown date. Subsequently, on an unspecified date, one month after the final immunization was given, the patient was again tested for titers, and again tested negative for any antibody titers (hepatitis b surface antibody negative). Furthermore, no product quality issue was involved. At the time of the report, the outcome of hepatitis b surface antibody negative was unknown. Additionally, the reporter did not provide for causality between the adverse event and vaccination with RECOMBIVAX HB. Additional information is not expected as consent to contact the physician was not provided.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test normal, Gastrointestinal disorder, Pain, Respiratory disorder
Clinical narrative: My wife and I are both experiencing excruciating pain on the sides of our bodies where our flu shots were administered (and, in my case, this includes the specific area of the upper arm where I received the shot).  These symptoms commenced AFTER we each got sick with separate flu bugs a month or two after we received the shots - as if something latent in the vaccine was triggered by the illnesses we contracted.  I've had these symptoms for 12 days, commencing 2-3 days after I recovered from an intestinal illness.  My wife's symptoms also commenced 2-3 days after she got over a throat/respiratory illness.  Her symptoms were severe for 2 weeks, but have lingered to a lesser degree now for 7 weeks and counting.  I'm wondering if you've received any other complaints like this and if you have any recommendations for dealing with/curing these symptoms.  Thank you.
Age: 53.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Blood test normal, Gastrointestinal disorder, Injection site pain
Clinical narrative: My wife and I are both experiencing excruciating pain on the sides of our bodies where our flu shots were administered (and, in my case, this includes the specific area of the upper arm where I received the shot).  These symptoms commenced AFTER we each got sick with separate flu bugs a month or two after we received the shots - as if something latent in the vaccine was triggered by the illnesses we contracted.  I've had these symptoms for 12 days, commencing 2-3 days after I recovered from an intestinal illness.  My wife's symptoms also commenced 2-3 days after she got over a throat/respiratory illness.  Her symptoms were severe for 2 weeks, but have lingered to a lesser degree now for 7 weeks and counting.  I'm wondering if you've received any other complaints like this and if you have any recommendations for dealing with/curing these symptoms.  Thank you.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Breast pain, Breast swelling, Epistaxis, Erythema
Clinical narrative: Patient reported the reaction to our pharmacy on 1/5/2017. We tried to contact patient's physician on the same day of 1/5/2017.  Patient stated the day after vaccine, she developed itchiness, feeling of "skin crawling", itchy and swollen, painful breasts. She took Benadryl for 1 day and symptoms got better, but she stopped taking the Benadryl. Two days after vaccine, she says she developed accumulation in her nose with blood, plus throat irritation with phlegm. On 1/7/2017, patient stated her hands were still swollen and back still itchy. The doctor's followed up with patient on 1/10/17 and the nurse informed patient to keep taking Benadryl. Patient stated around 4pm on 1/10/17 she noticed the feeling of pricking on her skin (bottom, sides, and stomach.  She stated her legs were fine.  Today on 1/11/7, patient reports itching on back and breasts and skin is still sensitive.  She stated she went to the gym today and her hands became red and itchy when she grabbed her weights. She also stated her blood pressure increasing but feels it is due to the Benadryl.  Informed patient to contact MD regarding her raise in blood pressure and her persisting symptoms.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Formication, Paraesthesia, Peripheral swelling, Pruritus, Throat irritation
Clinical narrative: Patient reported the reaction to our pharmacy on 1/5/2017. We tried to contact patient's physician on the same day of 1/5/2017.  Patient stated the day after vaccine, she developed itchiness, feeling of "skin crawling", itchy and swollen, painful breasts. She took Benadryl for 1 day and symptoms got better, but she stopped taking the Benadryl. Two days after vaccine, she says she developed accumulation in her nose with blood, plus throat irritation with phlegm. On 1/7/2017, patient stated her hands were still swollen and back still itchy. The doctor's followed up with patient on 1/10/17 and the nurse informed patient to keep taking Benadryl. Patient stated around 4pm on 1/10/17 she noticed the feeling of pricking on her skin (bottom, sides, and stomach.  She stated her legs were fine.  Today on 1/11/7, patient reports itching on back and breasts and skin is still sensitive.  She stated she went to the gym today and her hands became red and itchy when she grabbed her weights. She also stated her blood pressure increasing but feels it is due to the Benadryl.  Informed patient to contact MD regarding her raise in blood pressure and her persisting symptoms.
Age: 51.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Burning sensation, CD4 lymphocytes normal, Chest X-ray normal, Herpes zoster, Hypoaesthesia
Clinical narrative: Patient woke with painful shoulder, burning, itching, numbness. Seen by orthopedist, no steroid injection given. Called oncologist office 1/10/17 to report symptoms and asked to come in for assessment. Seen in clinic 1/10/17, and exam clinically consistent with herpes zoster, involving C5 dermatome, not crossing midline. Rash with vesicles noted on exam, some involuted. Treated with famvir and gabapentin, 1st dose of famvir to start 1/10/17.
Age: 51.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Laboratory test normal, Musculoskeletal pain, Pruritus, Pyrexia, Rash vesicular
Clinical narrative: Patient woke with painful shoulder, burning, itching, numbness. Seen by orthopedist, no steroid injection given. Called oncologist office 1/10/17 to report symptoms and asked to come in for assessment. Seen in clinic 1/10/17, and exam clinically consistent with herpes zoster, involving C5 dermatome, not crossing midline. Rash with vesicles noted on exam, some involuted. Treated with famvir and gabapentin, 1st dose of famvir to start 1/10/17.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Hyperhidrosis, Nausea, Tremor
Clinical narrative: PATIENT REPORTED FEELING SWEATTY,NAUSEATED AND NON RUNNY DIARRHEA AND SHAKEY.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Headache, Neck pain, Pruritus
Clinical narrative: Itching to back of neck, aching to nech, extreme headach, and lower back ach.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: About 9 hours after vaccination, patient reports he felt pain, inflammation, and redness at injection site on right deltoid.
Age: 46.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Associate noticed that the top of his feet were itching.  Associate woke up later that morning and realized he had hives on his feet, arms, and hands.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling, redness of entire thigh accompanied with fever.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Crying, Cyanosis, Hypotonia, Musculoskeletal stiffness, Pallor
Clinical narrative: Immediately after vaccines administered, mom pick child up and was holding her in her arms. Mom and child still in treatment room. Heard mom cry out for help and handed child to corpsman. Entered room to find child unresponsive and limp. Mild circumoro cyanosis. Stiffened extremities briefly then relaxed. Unresponsive for about 20 seconds. Breathing and strong heart rate palpated. Able to talk to RN about recent birthday and the cake she ate. Skin color pale and is crying looking for her mother. Mother at bedside talking to her and reassuring her. Discussed with child's PCM who will see in pediatrics. Walked with child and mother to pediatric clinic.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Unresponsive to stimuli
Clinical narrative: Immediately after vaccines administered, mom pick child up and was holding her in her arms. Mom and child still in treatment room. Heard mom cry out for help and handed child to corpsman. Entered room to find child unresponsive and limp. Mild circumoro cyanosis. Stiffened extremities briefly then relaxed. Unresponsive for about 20 seconds. Breathing and strong heart rate palpated. Able to talk to RN about recent birthday and the cake she ate. Skin color pale and is crying looking for her mother. Mother at bedside talking to her and reassuring her. Discussed with child's PCM who will see in pediatrics. Walked with child and mother to pediatric clinic.
Sex: M
Vaccine: FLUN4
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: A report has been received from consumer. The report concerns , Male patient, Height: 75.0 Inches; Weight: 230.0 Pounds, who had been received Nasal FLUMIST (INTRANASAL) for SO WE DONT GET THE FLU  and Nasal FLUMIST QUADRIVALENT (INTRANASAL) for SO WE DON'T GET THE FLU. The patient's medical history included WOULD GET SICK 3 TIMES A YEAR DURING WINTER, SPRING, SUMMER. It was reported that the patient had been prescribed FLUMIST in 2011 and 2012 and FLUMIST QUADRIVALENT 2013, 2014 and 2015 for flu prevention. The reporter stated that since taking the FLUMIST, her husband would get a cold (Preferred Term: Nasopharyngitis) once a year instead of three times a year prior to starting the FLUMIST. She also stated that after the FLUMIST was administered, sniffing would occur because otherwise the vaccine would run out of from the nose after administration) (Preferred Term: Circumstance or information capable of leading to medication error). The outcome of the event of COLD and AFTER FLUMIST WAS ADMINISTERED SNIFFING WOULD OCCUR BECAUSE OTHERWISE THE VACCINE WOULD RUN OUT FROM THE NOSE  AFTER ADMINISTRATION (MEDICATION ERROR) is unknown. The reporter's description of the event(s) was as follows: would get sick 3 times a year during Winter, Spring,  Summer. Additional JASPERs will be submitted for additional AE mentioned for other people. The report was considered to be non-serious. Corrected report  08-Nov-2016: Suspect product  FLUMIST QUADRIVALENT was added. Dosing regimen was corrected. Associated case id was added. Narrative updated.
Sex: F
Vaccine: FLUN4
Symptoms: Medication error, Nasopharyngitis, Rhinorrhoea
Clinical narrative: A spontaneous report was received from consumer concerning a female patient (height: 71.0 inches; weight: 150.0 pounds). Patient would get sick 3 times a year during Winter, Spring, Summer. Patient received FLUMIST (intranasal) in 2011 and 2012 and FLUMIST QUADRIVALENT (intranasal) in 2013, 2014 and 2015 so patient do not get the flu. The reporter stated that since taking the FLUMIST, her daughter would get a cold once a year instead of three times a year prior to starting the FLUMIST. She also stated that after the FLUMIST was administered, sniffing would occur because otherwise the vaccine would run out of from the nose after administration. The outcome of the events of cold and after FLUMIST was administered sniffing would occur because otherwise the vaccine would run out from the nose after administration was unknown. The company physician assessed the events of cold and after FLUMIST was administered sniffing would occur because otherwise the vaccine would run out from the nose after administration to be non serious. Corrected report on 08-Nov-2016: Suspect product FLUMIST was added. Dosing regimen was corrected. Associated case id was added. Narrative updated.
Sex: M
Vaccine: FLUN4
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: A spontaneous report was received from consumer concerning a male patient (height: 72.0 inches; weight: 160.0 pounds). Patient received nasal FLUMIST (intranasal in 2011 and 2012) and nasal FLUMIST QUADRIVALENT (intranasal) in 2013, 2014 and 2015 so patient would not get the flu. The dose was unknown. Patient stated that since taking the FLUMIST, her son got a cold once a year instead of three times a year prior to starting the FLUMIST. She also stated that after the FLUMIST was administered, sniffing would occur because otherwise the vaccine would run out of from the nose after administration). The outcome of cold and after FLUMIST was administered sniffing would occur because otherwise the vaccine would run out from the nose after administration was unknown. The company physician assessed cold and after FLUMIST was administered sniffing would occur because otherwise the vaccine would run out from the nose after administration to be non serious.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported similar event for 3 patients. This is the first of three reports. A patient of an unspecified age, gender and ethnicity received PREVENAR 13, via an unspecified route of administration, on an unspecified date, single dose, for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced pain redness and swelling at the site of injection. The patient recovered from the events at time of this report. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017006206 Same reporter/drug/AE, different patients;US-PFIZER INC-2017006205 Same reporter/drug/AE, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. This nurse reported similar event for 3 patients. This is the second of three reports. A patient of an unspecified age, gender and ethnicity received PREVENAR 13, via an unspecified route of administration, on an unspecified date, single dose, for immunization. The patient medical history and the patient's concomitant medications were not reported. The patient experienced pain redness and swelling at the site of injection. The patient recovered from the events at time of this report. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017006187 Same reporter/drug/AE, different patients.;US-PFIZER INC-2017006206 Same reporter/drug/AE, different patients.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced local reaction at injection site. The patient was seen at the doctor's office for the reaction. Therapeutic measures were taken as a result of local reaction at injection site and included treatment with applied ice and with unspecified over-the-counter medications. The outcome for the event was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  An adult patient of an unspecified race and gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling on an unspecified date with outcome of unknown.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Hypoaesthesia, Paraesthesia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. A 18-year-old female patient received on 30Jun2016 in the morning (between 9:30AM and 10:30AM) first dose of TRUMENBA, lot number M37314, expiration date 30Apr2017) at 0.5 ml single dose intramuscular in the left arm for immunization. Medical history and concomitant medications were not reported. On 30Jun2016 the patient experienced numbness and tingling in both hands, headache and vomiting 20 minutes after receiving the vaccine. The patient's mother called the office later that day, on 30Jun2016, around 1:30 PM and said that the patient vomited when she tried to drink water (caller stated the mother called back because the patient possibly had gotten worse, but it is unknown exactly). The doctor recommended fluid intake and to return to the office or go to the Emergency Room if the symptoms got worse. The patient did not return to the office or go to the Emergency Room and never called back. The patient did return to the office on 05Jul2016 for a Man2 skin test and even thus the reporter was assuming the patient was fine at that point, the final outcome was unknown.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Allergy to vaccine, Anal incontinence, Asthenia, Body temperature increased
Clinical narrative: Reported eye swelling on 11/1/16. Noted fluid pockets above and below both eyes. No relief with Zyrtec. On 11/8/16, temp was 99.1 with c/o diarrhea. On 11/29/16, she had a fall, and was noted to have confusion and weakness. This progressed into bilateral weakness with some bladder and bowel incontinence. Was unable to walk or transfer by herself. Confusion and weakness continued. Was seen in 2 emergency depts., and by primary MD. Symptoms started to resolve on 12/22. MD office called on 12/26 to report flu vaccine is listed as allergy now d/t weakness and cognitive decline.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cognitive disorder, Confusional state, Diarrhoea, Eye swelling, Fall
Clinical narrative: Reported eye swelling on 11/1/16. Noted fluid pockets above and below both eyes. No relief with Zyrtec. On 11/8/16, temp was 99.1 with c/o diarrhea. On 11/29/16, she had a fall, and was noted to have confusion and weakness. This progressed into bilateral weakness with some bladder and bowel incontinence. Was unable to walk or transfer by herself. Confusion and weakness continued. Was seen in 2 emergency depts., and by primary MD. Symptoms started to resolve on 12/22. MD office called on 12/26 to report flu vaccine is listed as allergy now d/t weakness and cognitive decline.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary incontinence
Clinical narrative: Reported eye swelling on 11/1/16. Noted fluid pockets above and below both eyes. No relief with Zyrtec. On 11/8/16, temp was 99.1 with c/o diarrhea. On 11/29/16, she had a fall, and was noted to have confusion and weakness. This progressed into bilateral weakness with some bladder and bowel incontinence. Was unable to walk or transfer by herself. Confusion and weakness continued. Was seen in 2 emergency depts., and by primary MD. Symptoms started to resolve on 12/22. MD office called on 12/26 to report flu vaccine is listed as allergy now d/t weakness and cognitive decline.
Age: 12.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, MNQ, TDAP, HEP, HPV9, IPV, MMR, MNQ, TDAP
Symptoms: Hyperhidrosis, Somnolence
Clinical narrative: CLIENT BECAME DIAPHORETIC AND SLEEPY AFTER VACCINES.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Anosmia, Endoscopy, Hyposmia, Laboratory test
Clinical narrative: Hyposmia (limited smell)  or Anosmia (absence of smell) began approximately during the first two weeks of October 2016.
Age: 9.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, TDAP, VARCEL, FLU4, HEPA, HPV9, TDAP, VARCEL
Symptoms: Fatigue, Pruritus, Urticaria
Clinical narrative: Client broke out in generalized hives across torso, back, arms and legs, itching 1 minute after vaccines administered. Client was given 25 mg liquid Diphenhydramine orally, hives subsided and client tired 15 minutes later. No respiratory changes noted. Client examined by physician on site, no further treatment.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque-forming unit (PFU), 0.65 ml once, subcutaneously (anatomical place of vaccination, dose number, lot# and expiration date were not provided), for prophylaxis. Information regarding concomitant therapies was not reported. Therefore, the patient seek for an unspecified medical attention. On an unknown date, following the ZOSTAVAX administration, the patient experienced redness (injection site erythema)and swelling at the injection site. At the time of reporting, the outcome of injection site swelling and injection site erythema was unknown. The reporter did not provide a causality assessment between ZOSTAVAX, injection site swelling and injection site erythema. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via company representative referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (anatomical route of vaccination, dose number, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patients developed pain at the injection site (injection site pain). Furthermore, no product quality issue was involved. At the time of the report, the outcome of injection site pain was unknown. Additionally, the reporter did not provide for causality between the adverse event and vaccination with PNEUMOVAX 23. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This solicited report was received from a physician concerning a female patient of unknown age enrolled in a patient support program. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided. On 07-DEC-2016, the subject was vaccinated by an unspecified physician with ZOSTAVAX (lot# and expiration date were unknown) subcutaneously for shingles prevention (prophylaxis). On an unknown date, the patient experienced rash generalised. At the reporting time, the outcome of rash generalised was unknown. The causality between ZOSTAVAX and rash generalised was not assessed. The reporter stated that the event was not life threatening. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site reaction, Muscle swelling, Myosclerosis
Clinical narrative: Approximately 24 hours after vaccine administration, patient noticed localized swelling within the muscle at the site of injection. There was notable absence of pain, redness, warmth, or fever. Palpable firmness deep within the muscle without tenderness, weakness, or pain. Took Ibuprofen at home and iced area. Presented to office on 1/11/17 for routine well check and had area assessed by Physician's Assistant.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Pain, Rash erythematous, Vaccination site reaction
Clinical narrative: Reddened non-raised rash to upper arm where vaccine was administered. Some warmth. Soreness per patient.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: RIGHT ARM SORENESS AT SHOULDER BLADE NEAR ARMPIT. HAD TO VISIT DOCTOR FOR SHOULDER PAIN AND WAS TOLD PAIN WAS RELATED TO ROTATOR BONE, REFERRED TO ORTHOPEDIC SPECIALIST. PATIENT WILL FOLLOW-UP. PATIENT USES HEAT-PAD AND SYMPTOMS ARE IMPROVING SINCE 1/10/2017.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Rash, Skin warm
Clinical narrative: WARMTH, RASHING FORMING LOWER ON ARM...CELLULITIS DIAGNOSED.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pain, X-ray limb
Clinical narrative: Morning after vaccine awoke with severe left shoulder pain both at rest and with attempted movement.
Age: 10.0
Sex: M
Vaccine: FLU4, HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Rash, Rash papular
Clinical narrative: Patch of pink skin raised directly over vaccine administration sites. The following day the rash spread as smaller papular rash over trunk adn extremities.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder
Clinical narrative: Sore upper left arm, Reduction in motuion, has gotten progressively worse, awake with pain if i turn on left side problem/pain raising left arm.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hostility, Pain
Clinical narrative: Complained at first about pain. Then became exceedingly beligerant.  This lasted nearly 1 hour.  Then she became tired.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Rash, Vaccination site bruising, Vaccination site swelling
Clinical narrative: 3 inch swelling of vaccine site and a bruise. A rash started the next day. It appeared to be hives down my arm front and back of my left arm where I received the shot. I used baking soda paste on them. It took 5 days for them to go away.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: SWELLING REDNESS.
Age: 76.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Activities of daily living impaired, Impaired driving ability, Injection site joint pain, Injection site pain
Clinical narrative: Pain in left upper arm and shoulder, includes joint, increasing over several days.  I still have it and it has not decreased.  It hampers everything I do. This is not the normal pain from flu shot I've always had for a few days. This is severe and limits my ability to take care of myself and my home. I have trouble driving and I require help with some activities.
Age: 52.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pyrexia, Rash, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: On the same day that the flu and Tdap vaccines were received, the patient developed a erythematous, maculopapular, pruritic rash to her upper chest and felt feverish. Symptoms lasted for 3 days before the patient returned to the clinic. Denied history of reactions after vaccines, anaphylaxis, dyspnea, wheezing, difficulty breathing. Patient had taken Tylenol on the day of vaccination and each day after before returning to the clinic. Symptoms did not change since onset. Oral temperature when the patient returned to the clinic was 100.4F. Patient was advised to continue to take Tylenol as needed for fever, apply hydrocortisone 1% cream 2-3 times daily to the affected area, Claritin 10 mg by mouth once daily, and Benadryl 25 mg by mouth at night as needed for itchiness. Advised to return to the clinic in 1 week or sooner for non-improving or worsening symptoms.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Dizziness, Flushing
Clinical narrative: Patient felt dizzy, flush and was about to faint. She complained of a lower back pain.
Age: 60.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Mobility decreased
Clinical narrative: Hard to lift arm. Hard to rotate Arm. Hard to lift arm over her head.
Age: 60.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder
Clinical narrative: Hard to lift arm. Hard to rotate Arm. Hard to lift arm over her head.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Abasia, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Gait disturbance, Injection site pain, Migraine, Mobility decreased, Muscle spasms
Clinical narrative: I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.
Age: 43.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Musculoskeletal stiffness, Pain, Pain in extremity, Pyrexia, Rash
Clinical narrative: I was feeling very lightheaded and "floaty" in the early evening while I was watching TV.  Got up to get to the kitchen and remembered that I had my vaccinations--influenza and pneumonia (in Left Thigh)--thigh was sore.  About 8:30 realized I was maybe having a slight reaction to the vaccine, typical, so took a shower and readied for bed.  While in shower, back muscles started spasming and cramping.  Almost immediately got chills and realized I actually had a fever.  Went to bed.  Pain in leg was immense, moving or covers touching it woke me up.  Fever, cramping, and chills continued through the night and continued the next day, continuing to get worse as Saturday progressed.  Saturday afternoon, got off work and got home.  Overwhelmed by exhaustion.  Took 800mg ibuprofin and went to sleep.  Woke 2 hours later, had to crawl down stairs pain in leg was incapacitating.  Could not walk without hanging on to walls.  Fever, chills, body aches continued to the next day.  Sunday the fever was mostly gone and I felt much more myself, but could not move leg normally.  I could not stand even brushing anywhere on my entire thigh muscle, and a rash appeared right above my inner knee.  Ibuprofin useless.  My pain scale is such: 10, migraine.  9: this pain in my leg 8: childbirth.  As of today, wednesday the 11th, my leg is still very tender, but I"m able to both gently touch it and move my foot normally while walking.  I still walk with a limp, and my thigh feels extremely stiff and tight.  After the tenderness dissipates a little, I will start doing some light stretches as I honestly worry I may lose some range of motion if I don't.  This was very unpleasant.  But I guess if I don't get pneumonia again--maybe don't get pneumonia TWICE again--it will be worth it.