chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. The patient did not have any medical history or concurrent conditions. On 02-SEP-2015 the patient was vaccinated with M-M-R II (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication and (Oka/Merck) VARIVAX (lot number and expiry date unknown) (dose regiment and frequency unknown) for an unknown indication. It was reported that the patient was not taking any  medications concomitantly. On 28-SEP-2015 the patient reported that she was pregnant (maternal exposure before pregnancy). On an unknown date approximately in 2015 the patient became pregnant. The Last Menstrual Period and Estimated Date of Delivery was not known. There were no lab diagnostics study performed. It was reported that the patient sought medical attention and visited the office (details unspecified). There was no treatment given for the adverse event. The pregnancy outcome was outcome pending. The outcome of maternal exposure before pregnancy was unknown. The action taken with the suspect drug therapy was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to an 11 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant to a 16 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported. No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a company representative refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 15-OCT-2015, the patient was vaccinated earlier than recommended (unspecified amount of time) with a dose of GARDASIL 9 (lot number, expiration date, dose and route were not provided). Concomitant medication was not reported. No adverse reactions have been reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown demographics. The nurse reported that an unspecified number of improperly stored doses of ZOSTAVAX (lot # L002424, expiry date: 23-APR-2016) were inadvertently administered to the patients (incorrect product storage) on unspecified dates. No adverse events were reported. Outcome was unknown. No product quality complaint was involved. The case is also related to MARRS#1510USA007930 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female patient of unknown age with drug hypersensitivity to sulfa drugs. Pertinent medical history was not reported. On 08-OCT-2015, the patient was vaccinated with ZOSTAVAX, (lot number, dose and strength were not reported), subcutaneous in the left arm. There was no concomitant medication reported. On an unspecified date in October 2015, the patient developed swelling at the injection site and redness at the injection site (injection site erythema) (injection site reaction). The patient visited an unspecified emergency room on 11-OCT-2015, and was diagnosed with cellulitis. She was treated with unspecified intravenous antibiotics and KEFLEX, and the patient was not admitted to the unspecified hospital. On 12-OCT-2015, the patient visited a new physician and it was reported that she developed approximately 6 vesicles around the injection site (injection site vesicles). The injection site erythema had dissipated, however "the vesicles were painful to touch" according to the patient. They physician prescribed VALTREX for treatment of the chicken pox-like rash around the injection site (injection site rash). At the reporting time, the outcome of cellulitis, injection site rash, injection site swelling, injection site reaction and injection site vesicles was reported as not recovered and the outcome of injection site erythema was reported as recovered on an unspecified date in October 2015. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles, Rash vesicular
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a female patient of unknown age with drug hypersensitivity to sulfa drugs. Pertinent medical history was not reported. On 08-OCT-2015, the patient was vaccinated with ZOSTAVAX, (lot number, dose and strength were not reported), subcutaneous in the left arm. There was no concomitant medication reported. On an unspecified date in October 2015, the patient developed swelling at the injection site and redness at the injection site (injection site erythema) (injection site reaction). The patient visited an unspecified emergency room on 11-OCT-2015, and was diagnosed with cellulitis. She was treated with unspecified intravenous antibiotics and KEFLEX, and the patient was not admitted to the unspecified hospital. On 12-OCT-2015, the patient visited a new physician and it was reported that she developed approximately 6 vesicles around the injection site (injection site vesicles). The injection site erythema had dissipated, however "the vesicles were painful to touch" according to the patient. They physician prescribed VALTREX for treatment of the chicken pox-like rash around the injection site (injection site rash). At the reporting time, the outcome of cellulitis, injection site rash, injection site swelling, injection site reaction and injection site vesicles was reported as not recovered and the outcome of injection site erythema was reported as recovered on an unspecified date in October 2015. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The pharmacist informed that on 08-OCT-2015, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose, route and strength were not reported) lot # J012660, expiration date: 10-JAN-2015. No adverse effects reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a office manager referring to a currently 59 year old female patient. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a single dose of PNEUMOVAX 23, (lot # L008664, expiry date 03-NOV-2016). On an unknown date the patient experienced pain in the arm of injection of PNEUMOVAX 23. The outcome of injection site pain was unknown. This is one of several reports from the same reporter source (MARRS # linked case 1510USA006195). Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a office manager referring to the currently 70 year old female patient. Patient's Medical History and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a single dose vial of PNEUMOVAX23, (lot # L008664, expiry date 03-NOV-2016). On an unknown date the patient experienced pain in the arm of injection of PNEUMOVAX23. The outcome of injection site pain was unknown. This is one of several reports from the same reporter sources (MARRS# linked case 1510USA006230). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 2 patients of unspecified demographics. The patient's concurrent conditions or medical history were not reported. On 12-OCT-2015, two doses of improperly stored ZOSTAVAX were administered to the unspecified patients, lot L021612, expiration date 10-SEP-2016 (dose, route and anatomical location not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown demographics. The patient's concomitant conditions or medical history were not reported. On 12-OCT-2015, the patient was vaccinated with a dose of Liquid PEDVAXHIB with expiration date on 06-AUG-2015 (dose, route, anatomical location and lot were not provided). No adverse effect was reported. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Crying, Injection site reaction, Irritability, Malaise, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 2-month-old male patient who received PEDIARIX (batch number 2P79K, expiry date 27th MARCH 2017). On 7th OCTOBER 2015, the patient received PEDIARIX. On 7th OCTOBER 2015, less than a day after receiving PEDIARIX, the patient experienced malaise, injection site reaction and irritability. On an unknown date, the patient experienced fever and crying. On an unknown date, the outcome of the fever, malaise, injection site reaction, irritability and crying to be related to PEDIARIX. Additional details were provided as follows: This case was previously reported to a manufacturer (Sanofi-Pasteur). So, the reporter felt she did not need to report it again. This case was reported by the patient's mother. On the same day, the patient experienced injection site reaction, malaise and fussiness (irritability). In October 2015, less than a week after receiving PEDIARIX, the patient experienced fever and crying. The reporter did not have time to give a complete report as the patient needed her attention and she did not have time to report. The reporter was very concerned about the patient. She contacted the doctor, who advised her that this was normal.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown demographics. The nurse reported that an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX (unspecified lot and expiration date) were inadvertently administered to the patients (incorrect product storage) on unspecified dates. No adverse events were reported. Outcome was unknown. No product quality complaint was involved. This case is also related to MARRS#1510USA006810 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Information was received from manufacturer (manufacturing control number 2015342700) on 13-OCT-2015. This spontaneous report as received from a nurse 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 PNEUMOVAX23 (unknowns strength, route and dose). On an unknown date the patient experienced localized reaction of redness and bruising at the injection site after receiving PNEUMOVAX23. The reporter further enquired if they can get PREVNAR13. The outcome of the events was unknown. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown demographics. The patients's concurrent conditions or medical history were not reported. On unspecified dates, unspecified number of improperly stored (Oka/Merck) VARIVAX doses, lot numbers K005426 with expiration date 15-APR-2016 and L004649 with expiration date 11-FEB-2017, were administered to an unspecified number orf patients. No adverse effects reported. No additional information provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. The patient had an unspecified heart condition (cardiac disorder). On an unknown date, the patient was vaccinated with ZOSTAVAX, one dose once to prevent shingles (dose, route and anatomical location of administration were not reported). Concomitant therapies included unspecified medications reported as "a lot of different med's". On an unknown date, the patient developed shingles (herpes zoster). No Product Quality Complaint (PQC) was involved. The outcome of herpes zoster was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning a female patient of unknown age. No concurrent conditions or medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX one dose once (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. On an unknown date, the patient developed shingles (herpes zoster). No Product Quality Complaint (PQC) was involved. The outcome of herpes zoster was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a pharmacist via manufacturer (manufacturer control # 2015339993) concerning 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 PNEUMOVAX23 (dose, lot/batch#, ,expiration date, route and anatomical location were not reported). Co-suspect therapies or concomitant medications were not provided. On an unknown date, the patient was allergic to PNEUMOVAX23 (allergy to vaccine). The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of GARDASIL lot # K005083, expiration date 04-NOV-2016 (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored does of GARDASIL 9 lot # L007560, expiration date 15-JUN-2017 (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # K013861, expiration date 18-MAY-2016; lot # K0201811, expiration date 24-JUN-2016; dose was not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions of the patients were reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored does of M-M-R II (lot # K024824, expiration date 02-DEC-2016; lot # L001336, expiration date 13-JAN-2017; lot # K016153, expiration date 24-SEP-2016) (dose and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: This report was received from the manufacturer and assigned manufacturer report number 2015321532 for PREVNAR regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23, (dose, route, anatomical location, lot number and expiration date were not reported). There was no concomitant medication reported. On an unknown date, the patient experienced severe swelling, redness (erythema) and pain after receiving a dose of PNEUMOVAX23. At the time of the report, the outcome of severe swelling, redness and pain was unknown. The relatedness between the events and therapy with PNEUMOVAX23 was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: This spontaneous report was received from the office manager referring to a currently 88 year old female patient. The patient's medical history and concurrent condition were not reported. On an unknown date, the patient was vaccinated with a single dose of PNEUMOVAX23 (lot # L008664; expiration date 03-MOV-2016) in the arm (dose was not reported). Concomitant medication was not reported. On an unknown date, the patient complained of pain and swelling. The patient was seen on 12-OCT-2015. The outcome and causality of pain and swelling was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: This spontaneous report as received from a pharmacist refers to an approximately 72 year old female patient with allergy to sulfa drugs. The patient had no pertinent medical history. On 08-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX injection (lot# reported as L012039, expiry date 07-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies. In approximately October 2015, reported as "soon after" the vaccination, the patient developed a bruise at the injection site. The patient sought medical attention-she came into the pharmacy to show the bruise to the pharmacist and reported that she did not experience any pain or other symptoms since receiving the ZOSTAVAX. No treatment was given for the event and no diagnostic lab studies were performed. The outcome of the event was reported as recovering. The relatedness between ZOSTAVAX and the event was not provided. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a 15 year old patient of unknown gender. On 14-OCT-2015 the patient, who had already received two doses of M-M-R II, received a third dose of M-M-R II in error (extra dose administered). The patient was not experiencing any adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unspecified dates starting on or after 19-FEB-2015, the patients were vaccinated with an unspecified number of improperly stored doses of (Oka/Merck) VARIVAX, lot # K016127, expiration date 23-SEP-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a physician refers to a 32 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-OCT-2015, the patient was vaccinated with her first dose of VARIVAX 1350 U (lot # L017997, expiration date 19-MAY-2015) dose 0.5 ml, subcutaneously in the left arm. On 02-OCT-2015, the patient developed a low-grade fever, body aches, and lethargy. On 02-OCT-2015, the patient also developed redness, swelling, warmth, and pain at the injection site on her left arm and two small vesicles on her left shoulder. The patient was evaluated at an unspecified emergency room on 02-OCT-2015 and was prescribed TYLENOL and ice compresses to the injection site. The patient was evaluated in the office on 05-OCT-2015. At that time, the vesicles were crusted and the other symptoms were resolving. The relationship between the events and VARIVAX and action taken were not reported. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Lethargy, Pain, Pyrexia, Scab
Clinical narrative: This spontaneous report as received from a physician refers to a 32 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 01-OCT-2015, the patient was vaccinated with her first dose of VARIVAX 1350 U (lot # L017997, expiration date 19-MAY-2015) dose 0.5 ml, subcutaneously in the left arm. On 02-OCT-2015, the patient developed a low-grade fever, body aches, and lethargy. On 02-OCT-2015, the patient also developed redness, swelling, warmth, and pain at the injection site on her left arm and two small vesicles on her left shoulder. The patient was evaluated at an unspecified emergency room on 02-OCT-2015 and was prescribed TYLENOL and ice compresses to the injection site. The patient was evaluated in the office on 05-OCT-2015. At that time, the vesicles were crusted and the other symptoms were resolving. The relationship between the events and VARIVAX and action taken were not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (route, dose and lot# were unknown). On an unknown date the patient experienced an unspecified reaction. The outcome of the unspecified reaction was unknown. The causality was not reported. Additional information is not expected as no reporter's contact information.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Staphylococcal infection
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route of administration, lot number were not reported). After being vaccinated, the patient developed injection site swelling and redness. The patient visited the physician, who concluded that the patient had Staphylococcus infection that was caused by PNEUMOVAX23. It was also reported that the patient had received PNEUMOVAX23 less than one year before receiving another one. The patient sought medical attention. The outcome of the events and action taken was not reported. The reporting pharmacist considered Staphylococcus infection to be related to PNEUMOVAX23. The relatedness for injection site swelling and redness was not provided. 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 medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unspecified dates starting on or after 23-MAR-2015, the patients were vaccinated with an unspecified number of improperly stored doses of PROQUAD (Merck), lot # K025766, expiration date 08-JUN-2016 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Fatigue, Feeling abnormal, Feeling of body temperature change, Nausea
Clinical narrative: Nausea, stomach cramps, fatigue, hot/cold, feeling "floaty" - feeling a little better today (10/17/2015) but still not 100%.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Body temperature increased, Diarrhoea, Headache, Injection site pain
Clinical narrative: Nausea, vomiting, abdominal discomfort, diarrhea, headache, elevated temperature, muscle soreness at site, general malaise. Symptoms abated by next morning. Treated with antacids and fluids and Tylenol.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, abdominal discomfort, diarrhea, headache, elevated temperature, muscle soreness at site, general malaise. Symptoms abated by next morning. Treated with antacids and fluids and Tylenol.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Fatigue, Lacrimation increased, Lethargy, Ocular hyperaemia
Clinical narrative: Lump in throat making it difficult to swallow.  Breathing ok.  Felt like something stuck in throat. Extremely bloodshot, watery eyes.  Slight fever. Exhaustion and lethargy.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sensation of foreign body
Clinical narrative: Lump in throat making it difficult to swallow.  Breathing ok.  Felt like something stuck in throat. Extremely bloodshot, watery eyes.  Slight fever. Exhaustion and lethargy.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Lacrimation increased, Ocular hyperaemia, Pain
Clinical narrative: Scratchy throat with cough, blood shot eyes that were tearing, extreme headache, feverish and body ache.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Throat irritation
Clinical narrative: Scratchy throat with cough, blood shot eyes that were tearing, extreme headache, feverish and body ache.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Dry skin, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Patient presented to provider on 10/15/2015 with round, red, raised, rough, warm to touch rash approximately 4 inches in diameter at the injection site.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Feeling fatigued, dizziness; approximately 2 hours later started having severe chills, shaking alternately with fever 103 degrees...went to sleep and woke up at 11:00 pm with 165/ 107 BP; took BP meds and aspirin and went back to sleep....4:00 am woke up with severe headache, took Hydroco/apap 5-325M Tab Amne went back to sleep. Woke up at 7:30 am (10/17/2015) feeling weak but much better.  At 11:54 am I am improving.  When this event got to the fever/chills/high BP stage, I considered going to the ER but was too sick to go. I do not know if this event was life threatening but I felt like it was at the time.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Malaise, Pyrexia, Tremor
Clinical narrative: Feeling fatigued, dizziness; approximately 2 hours later started having severe chills, shaking alternately with fever 103 degrees...went to sleep and woke up at 11:00 pm with 165/ 107 BP; took BP meds and aspirin and went back to sleep....4:00 am woke up with severe headache, took Hydroco/apap 5-325M Tab Amne went back to sleep. Woke up at 7:30 am (10/17/2015) feeling weak but much better.  At 11:54 am I am improving.  When this event got to the fever/chills/high BP stage, I considered going to the ER but was too sick to go. I do not know if this event was life threatening but I felt like it was at the time.
Age: 53.0
Sex: F
Vaccine: FLU3, HEPAB, PPV
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Red blotchy areas on arm not at immunization site; possibly hardened area.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Swelling, redness, pain where shot was given. Redness, swelling rash on face. Redness and soreness at site and itching on face still present 5 days later.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Swelling
Clinical narrative: Swelling, redness, pain where shot was given. Redness, swelling rash on face. Redness and soreness at site and itching on face still present 5 days later.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal mass, Axillary mass, Discomfort, Injection site bruising, Injection site swelling
Clinical narrative: Felt "goose egg" size lump under left armpit.  States lump soft.  Lump migrated down to abdomen over the week.  Also had significant bruising and swelling upper Left arm deltoid region.  No fever or pain.  Just discomfort.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Migraine
Clinical narrative: Severe migraine headache.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Severe pain in shoulder and entire upper arm on the day of the injection (9/28), worsened through 10/1. Unable to touch upper arm or lift it, required assistance showering and getting dressed. Morning of 9/30 a large rash appeared on my upper arm, not at the site of the injection but about 5 inches below. Swollen, bright red, extremely tender to the touch, about the size of the palm of my hand. Evening of 9/30 the rash had doubled in size on my arm, still below the injection site. Notified my doctor so we could monitor over a digital platform, sent him pictures and descriptions. Morning of 10/1 the rash had again doubled in size covering half of my upper arm, now a darker red, still extremely swollen and very tender. Evening of 10/1 the rash had increased in size, covering over half of my arm. Pain and swelling the same. Evening of 10/2 the rash covered about 3/4 of my upper arm, but the swelling, red color and pain was not as intense as previous days. Morning of 10/3 the rash and pain appeared to be fading, continued to do so over the next couple of days until it ceased entirely on 10/7.
Age: 21.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity, Tenderness
Clinical narrative: Severe pain in shoulder and entire upper arm on the day of the injection (9/28), worsened through 10/1. Unable to touch upper arm or lift it, required assistance showering and getting dressed. Morning of 9/30 a large rash appeared on my upper arm, not at the site of the injection but about 5 inches below. Swollen, bright red, extremely tender to the touch, about the size of the palm of my hand. Evening of 9/30 the rash had doubled in size on my arm, still below the injection site. Notified my doctor so we could monitor over a digital platform, sent him pictures and descriptions. Morning of 10/1 the rash had again doubled in size covering half of my upper arm, now a darker red, still extremely swollen and very tender. Evening of 10/1 the rash had increased in size, covering over half of my arm. Pain and swelling the same. Evening of 10/2 the rash covered about 3/4 of my upper arm, but the swelling, red color and pain was not as intense as previous days. Morning of 10/3 the rash and pain appeared to be fading, continued to do so over the next couple of days until it ceased entirely on 10/7.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: Injection site induration and erythema measuring 10.5 x 7 cm. Small blister at center.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain, Vaccination site pain
Clinical narrative: Pain in vaccinated arm which radiates into neck, can't move arm without pain, pain has not improved since onset (in 5 days), patient called MD and they said to ice arm and use ibuprofen, did not need to come in for appointment.
Age: 47.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Headache, Muscle tightness, Pityriasis rosea, Rash erythematous, Rash generalised
Clinical narrative: Headache, muscle tension in neck and back lasting for 72 hours. 10/14/2015 in afternoon red, patchy rash develops on legs and torso. Rash continued to spread for approximately 24 hours, to arms and neck.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary tract infection
Clinical narrative: Pt woke up with a UTI around 3am that went away in the morning.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Nasopharyngitis, Pruritus generalised
Clinical narrative: Cold/Flu like symptoms.  Itchy feeling all over her face and body.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Cold sweat, Feeling hot, Headache, Heart rate increased
Clinical narrative: Patient reported headache, clamminess, feeling of being "hot inside" but no fever, increased pulse and heart rate.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Haemolytic anaemia, Laboratory test
Clinical narrative: Patient admitted with acute hemolytic anemia, unclear cause.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Injection site erythema, Pulse abnormal
Clinical narrative: After administering vaccine, patient immediately grew faint, a red bump appeared where the vaccine was administered, patient started shaking uncontrollably, pulse light and thready, had patient put her head between her legs, watched injection site for increasing size, color, etc. and asked patient if she was having trouble breathing, her throat felt like it was closing and her lips or any part of her face felt numb, she denied all, said everything was blurry and that I seemed miles away.  Could not hold her head up and shook as she laid her head upon her arms on the table.  Called 911 and EMT's arrived, pt was feeling better and refused to go to the hospital.  Advised patient to buy Benadryl and keep an eye on the injection site and in the event of any rash, trouble breathing, etc, to call 911 or go to the emergency room right away.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vaccination site swelling, Vision blurred
Clinical narrative: After administering vaccine, patient immediately grew faint, a red bump appeared where the vaccine was administered, patient started shaking uncontrollably, pulse light and thready, had patient put her head between her legs, watched injection site for increasing size, color, etc. and asked patient if she was having trouble breathing, her throat felt like it was closing and her lips or any part of her face felt numb, she denied all, said everything was blurry and that I seemed miles away.  Could not hold her head up and shook as she laid her head upon her arms on the table.  Called 911 and EMT's arrived, pt was feeling better and refused to go to the hospital.  Advised patient to buy Benadryl and keep an eye on the injection site and in the event of any rash, trouble breathing, etc, to call 911 or go to the emergency room right away.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site coldness
Clinical narrative: Patient described feeling cold to the touch on her arm from the shoulder to the elbow on the arm receiving the vaccination ever since getting the Fluzone-HD vaccine last year and has continued even today and feels the same after being vaccinated this year.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Axillary pain, Breast pain, Skin warm, Sleep disorder
Clinical narrative: SORENESS UNDER ARM AND LEFT BREAST. AREA UNDER ARM FELT KIND OF WARM. COULDN'T SLEEP ON THE LEFT SIDE.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Injected limb mobility decreased
Clinical narrative: Pt had a flu shot and felt bone pain upon the administration of vaccine. Patient went home and waited for a few days and the pain still persisted. Patient returned to the store 2 weeks later with complaints of pain and some limited mobility in the left arm.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pyrexia
Clinical narrative: Patient stated his face turned red and he ran 102 degree fever the evening after getting the flu shot.  States he wasn't sure if it was the shot or something else he may have gotten into that caused the reaction.  Stated the reaction was gone by the next day.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Muscle twitching, Sensory disturbance
Clinical narrative: 10/17/15 Patient came in and stated about an hour after receiving the flu shot (Fluzone High-Dose), her arms kept twitching in a "palms facing up then palms facing down manner", shooting sensation up and down the spine, and difficulty breathing. Patient was unable to call for help due to the twitching. The symptoms ended about an hour after they started. She had a consultation with a physician (for an unrelated reason) and mentioned these symptoms. The MD thought it could be Guillain-Barre. The patient is following up with her Primary Care Physician this week. When asked if the patient was "feeling sick" or had an infection she stated that she thought she may have had a UTI the Monday before and that the MD was awaiting culture results.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient developed acute pain at injection site (of Prevnar injection) that radiated down the arm and worsened over several days.  She presented to the pharmacy where immunization had been administered on 10/16/15 and mentioned the reaction to me.  By that time she had developed a red area covering most of her upper arm that was painful and warm to the touch. I recommended that she call her PCP.  She was examined by PCP that day and diagnosed with cellulitis and was started on a course of antibiotics.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Hyperhidrosis, Muscle spasms, Nausea
Clinical narrative: Patient experienced cramps, nausea, vomiting, chills, sweating and an all over tired feeling.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient experienced cramps, nausea, vomiting, chills, sweating and an all over tired feeling.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphagia, Dyspnoea, Eye pruritus, Lacrimation increased
Clinical narrative: Watery/itchy eyes, wheezing, difficulty breathing, difficulty swallowing, excessive coughing, severe sore/swelling throat, like it is closing up.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Throat tightness, Wheezing
Clinical narrative: Watery/itchy eyes, wheezing, difficulty breathing, difficulty swallowing, excessive coughing, severe sore/swelling throat, like it is closing up.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: Patient came in 1 week later to show me a large brusing area (4x4ish) where the shot was given. Must have been a reaction as the area too large for trauma from needle. Was healing never bothered patient but he noticed it. Never itched or hurt per patient.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia, Rash erythematous
Clinical narrative: Patient had a red rash the size of a baseball surronding the injection site. Patient reported no swelling and no pain except some muscle soreness right where the needle entered her arm.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Local reaction, Skin discolouration, Tenderness
Clinical narrative: Local reaction with bruising "green color" on arm.  On 10/17/2015, patient returns with resolved bruising but tenderness remains.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Anaphylactic shock, Chest X-ray, Dyspnoea, Eye discharge, Eye pruritus
Clinical narrative: Runny nose, sore throat, red, itchy eyes with profuse mattering, couldn't catch his breath.  I called the drug store, talked to the pharmacist.  She recommended treatment at facility.  They saw him and called the ambulance to transport him to the ER.  They administered oxygen to the ambulance arrived.  His oxygen level there was 80.  He was going into anaphylactic shock.  I don't know which drugs they gave him at the hospital.  Call them. He was there until around 2:00 PM 10/17/2015.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose, sore throat, red, itchy eyes with profuse mattering, couldn't catch his breath.  I called the drug store, talked to the pharmacist.  She recommended treatment at facility.  They saw him and called the ambulance to transport him to the ER.  They administered oxygen to the ambulance arrived.  His oxygen level there was 80.  He was going into anaphylactic shock.  I don't know which drugs they gave him at the hospital.  Call them. He was there until around 2:00 PM 10/17/2015.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Decreased appetite, Discomfort, Eye discharge, Eye pruritus, Ocular hyperaemia
Clinical narrative: Runny nose, sore throat, red, itchy eyes with profuse mattering, couldn't catch his breath.  I called the drug store, talked to the pharmacist.  She recommended treatment at facility.  They saw him and called the ambulance to transport him to the ER.  They administered oxygen to the ambulance arrived.  His oxygen level there was 80.  He was going into anaphylactic shock.  I don't know which drugs they gave him at the hospital.  Call them. He was there until around 2:00 PM 10/17/2015.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose, sore throat, red, itchy eyes with profuse mattering, couldn't catch his breath.  I called the drug store, talked to the pharmacist.  She recommended treatment at facility.  They saw him and called the ambulance to transport him to the ER.  They administered oxygen to the ambulance arrived.  His oxygen level there was 80.  He was going into anaphylactic shock.  I don't know which drugs they gave him at the hospital.  Call them. He was there until around 2:00 PM 10/17/2015.
Age: 85.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Abdominal pain upper, Back pain, Chest discomfort, Choking
Clinical narrative: 10/01/15: Day 1; Weight: 184 lbs; 3:00pm Received vaccine; 8:00pm Reactions began: 102F fever, Choking, Unable to swallow (except liquids); 11:00pm Went to bed. Unable to sleep, pain in stomach; unable to lay on side or on my stomach pain persisted through the night, no sleep. 10/02/15: Day 2; Unable to eat, attempted to eat 1/2 banana, but no success. Unable to eat anything for the rest of the day. Persistent abdominal pain and dizziness lasting all day. 10/03/15: Day 3; Fried 2 eggs in morning, but barely managed to eat one. Throat feels as though it is swollen shut. Able to drink liquids with some difficulty. 10/04/15: Day 4; Made a bland smoothie, less constriction on my throat, however, the smoothie felt as though it wasn't passing into my stomach. It felt like there was no peristalsis. 10/05/15: Day 5; First bowel movement since vaccine date. Stools were black, tarry and loose. Diarrhea quickly developed. 10/06/15: Day 6; Weight: 175 lbs; Continuing black, tarry diarrhea. 10/07/15: Day 7; Woke up quite hungry and cooked 4 eggs over easy. Painful swallowing so I only was able to eat 2 of the 4 eggs.  I bought protein powder to make a smoothie, which I was able to drink successfully. 10/08/15: Day 8; Woke up and noticed a thick, heavy, white coating on my tongue, which prompted me to go purchase probiotic capsules called Culterelle, of which I took 2. No change in my stools, still black, tarry and loose. 10/09/15: Day 9; Fried up 3 eggs and boiled white rice in the morning. I was able to eat this meal, but it was the only meal I was able to have that day. 10/10/15: Day 10; Stools return to normal. However, noticing pain in my kidneys and lower back developing. 10/11/15-10/13/15 Days 11-13; Weight: 177 lbs; Stools remain normal, 2 pounds gained. 10/17/15: Day 17; Experiencing afternoon headache and noticeable discomfort in left side of chest and what feels to be heart minor heart palpitations.