chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Decreased appetite, Fatigue, Head discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received PREVNAR 13 on 05Dec2017 via an unknown route of administration in the right arm at single dose for Immunisation. Relevant medical history included spleen removed, in 1998 or 1999. The patient a history of being immunocompromised as chronic condition. Concomitant Products included regular vitamins. In the past after the spleen removed the patient had received PNEUMOVAX. On 05Dec2017 the patient experienced low grade fever, then a high grade fever 102-103 Fahrenheit, injection site was red, itchy, tender, painful, and hard, she had muscle aches, joint aches, headache, on 11Dec2017 lack of appetite, nausea, throwing up, and on unknown date feeling sick like a dog, Fatigue, Weak and pressure inside her head. Doctor had given her an antibiotic because concerned injection site may be injected. She is taking BENADRYL for the injection site reaction like itchiness. She is taking TYLENOL for fever and Ibuprofen for the aches: muscle and joint aches. The outcome of the events was reported as recovering except for pyrexia with outcome of recovered, decreased appetite, nausea, malaise, fatigue, Asthenia with outcome of not recovered and vomiting and Head discomfort with outcome of unknown. She went to urgent care and they checked her for the flu and it came back negative. No virus. Negative for any type of viral infection. Information on the batch number has been requested.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Influenza virus test negative, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received PREVNAR 13 on 05Dec2017 via an unknown route of administration in the right arm at single dose for Immunisation. Relevant medical history included spleen removed, in 1998 or 1999. The patient a history of being immunocompromised as chronic condition. Concomitant Products included regular vitamins. In the past after the spleen removed the patient had received PNEUMOVAX. On 05Dec2017 the patient experienced low grade fever, then a high grade fever 102-103 Fahrenheit, injection site was red, itchy, tender, painful, and hard, she had muscle aches, joint aches, headache, on 11Dec2017 lack of appetite, nausea, throwing up, and on unknown date feeling sick like a dog, Fatigue, Weak and pressure inside her head. Doctor had given her an antibiotic because concerned injection site may be injected. She is taking BENADRYL for the injection site reaction like itchiness. She is taking TYLENOL for fever and Ibuprofen for the aches: muscle and joint aches. The outcome of the events was reported as recovering except for pyrexia with outcome of recovered, decreased appetite, nausea, malaise, fatigue, Asthenia with outcome of not recovered and vomiting and Head discomfort with outcome of unknown. She went to urgent care and they checked her for the flu and it came back negative. No virus. Negative for any type of viral infection. Information on the batch number has been requested.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received PREVNAR 13 on 05Dec2017 via an unknown route of administration in the right arm at single dose for Immunisation. Relevant medical history included spleen removed, in 1998 or 1999. The patient a history of being immunocompromised as chronic condition. Concomitant Products included regular vitamins. In the past after the spleen removed the patient had received PNEUMOVAX. On 05Dec2017 the patient experienced low grade fever, then a high grade fever 102-103 Fahrenheit, injection site was red, itchy, tender, painful, and hard, she had muscle aches, joint aches, headache, on 11Dec2017 lack of appetite, nausea, throwing up, and on unknown date feeling sick like a dog, Fatigue, Weak and pressure inside her head. Doctor had given her an antibiotic because concerned injection site may be injected. She is taking BENADRYL for the injection site reaction like itchiness. She is taking TYLENOL for fever and Ibuprofen for the aches: muscle and joint aches. The outcome of the events was reported as recovering except for pyrexia with outcome of recovered, decreased appetite, nausea, malaise, fatigue, Asthenia with outcome of not recovered and vomiting and Head discomfort with outcome of unknown. She went to urgent care and they checked her for the flu and it came back negative. No virus. Negative for any type of viral infection. Information on the batch number has been requested.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Viral test negative, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 58-year-old female patient received PREVNAR 13 on 05Dec2017 via an unknown route of administration in the right arm at single dose for Immunisation. Relevant medical history included spleen removed, in 1998 or 1999. The patient a history of being immunocompromised as chronic condition. Concomitant Products included regular vitamins. In the past after the spleen removed the patient had received PNEUMOVAX. On 05Dec2017 the patient experienced low grade fever, then a high grade fever 102-103 Fahrenheit, injection site was red, itchy, tender, painful, and hard, she had muscle aches, joint aches, headache, on 11Dec2017 lack of appetite, nausea, throwing up, and on unknown date feeling sick like a dog, Fatigue, Weak and pressure inside her head. Doctor had given her an antibiotic because concerned injection site may be injected. She is taking BENADRYL for the injection site reaction like itchiness. She is taking TYLENOL for fever and Ibuprofen for the aches: muscle and joint aches. The outcome of the events was reported as recovering except for pyrexia with outcome of recovered, decreased appetite, nausea, malaise, fatigue, Asthenia with outcome of not recovered and vomiting and Head discomfort with outcome of unknown. She went to urgent care and they checked her for the flu and it came back negative. No virus. Negative for any type of viral infection. Information on the batch number has been requested.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Limb mass, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable Physician (Internal medicine via a Pfizer sales representative). A 73-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot # S5T635, Expiry Date 30Oct2018, NDC # unknown) intramuscular at 0.5 ml, single into left arm on 07Nov2017 for immunisation for prevention of pneumococcal pneumonia. The patient medical history and concomitant medications were not reported. The patient came back into the office complaining of swelling and a lump on her left arm on 11Nov2017. She was treated with BENADRYL and CLOBETASOL on 11Nov2017.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Infectious mononucleosis
Clinical narrative: This is a spontaneous report from a contactable pharmacist who reported for his son,via Pfizer-sponsored program. A 19-year-old male patient received the second dose of TRUMENBA at single dose for immunization in Aug2017 at the age of 18 years. The patient medical history and concomitant medications were not reported. Patient previously received the first dose of meningococcal group b rlp2086 in Jun2017 as immunization. Patient was diagnosed with "mono" in Nov2017. Outcome of the event was unknown.Patient was scheduled to have his 3rd injection in Dec2017 and pharmacist wanted to know if it was ok for his son to get it or if it should be delayed.Pharmacist did not see any relation taking the vaccine and developing mono.Information on the batch number has been requested.; Sender's Comments: The company  and reasonably does not attribute the event to meningococcal group b rlp2086 based on the information currently available and the pathophysiology of the event.
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Rash generalised, Throat tightness, Urticaria
Clinical narrative: Initial unsolicited report received from nurse on 20-Oct-2017. This case is linked with 2017SA207217 and 2017SA207221 (Same reporter). This case involves female patient (Age not reported) who was vaccinated with 0.5 ml dose of FLUZONE QIV (Frequency: once, batch number, expiry date and site of administration were not reported) intramuscularly on 04 Oct 2017 at Flu clinic. The patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination, patient had developed hives and shortness of breath. Laboratory investigation was not reported. Patient required BENADRYL in the ER. On an unspecified date, patient was recovered from events. Follow-up report received from nurse on 05-Dec-2017. It was reported that 52-year-old patient was vaccinated with FLUZONE QIV (Batch number: UI839AA) at left deltoid. Patient had a medical history of penicillin allergy. Patient was previously vaccinated flu vaccines without any adverse events. It was also reported that no other vaccine was administered within 4 weeks prior to vaccination date. On 04-Oct-2017, same day following vaccination, the patient had experienced generalized rash and throat closure. It was reported that patient felt as though throat closing. As corrective treatment, patient received Dexamethasone injection at a dose of 10mg, BENADRYL at a dose of 25 mg and PEPCID tablet at a dose of 20 mg. Lab test were none. Event outcome were resolved on 04-Oct-2017. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Influenza, Injection site mass, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (herself) on 28-Nov-2017. This case involves a 63-year-old female patient, who was vaccinated with 0.5 ml dose of ADACEL injection once (batch number, expiry date, dose in series were not reported) via intramuscular route in the left deltoid on 01-Sep-2017. Patient medical history and concomitant medications were not reported. On an unknown date, the day after the vaccination, the patient was tired, had flu symptoms, fever, headache, drowsiness and pain in left arm down to hand. She felt a lump in the shoulder at injection site. Also reported that no other vaccines were given on that day. Lab data and corrective treatment were not reported. Outcome of all the events was not recovered at the time of reporting. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Somnolence
Clinical narrative: Initial unsolicited report received from a consumer (herself) on 28-Nov-2017. This case involves a 63-year-old female patient, who was vaccinated with 0.5 ml dose of ADACEL injection once (batch number, expiry date, dose in series were not reported) via intramuscular route in the left deltoid on 01-Sep-2017. Patient medical history and concomitant medications were not reported. On an unknown date, the day after the vaccination, the patient was tired, had flu symptoms, fever, headache, drowsiness and pain in left arm down to hand. She felt a lump in the shoulder at injection site. Also reported that no other vaccines were given on that day. Lab data and corrective treatment were not reported. Outcome of all the events was not recovered at the time of reporting. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Initial unsolicited report received from other non-healthcare professional on 27-Oct-2017. This case was linked with 2017SA211778, 2017SA244729, 2017SA244847, 2017SA244854, 2017SA244856. This case involves an male patient of unknown age who was vaccinated with a 0.5 ml single dose of FLUZONE injection (Lot number: UI856AB, expiry date, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed a severe localized reaction, injection site swelled to baseball size, was very red and painful. The patient's laboratory data and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Bedridden, Erythema, Fatigue, Flushing
Clinical narrative: Initial unsolicited report received from consumer (patient herself) on 04-Dec-2017. This case involves 68 year old female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (frequency once, batch number, expiration date, dose was not reported) via intramuscular route in left arm on 02 Nov 2017. Stated had received flu vaccines for several years and never had reaction. The patient's medical history and concomitant medications were not reported. On 03 Nov 2017 (reported as by the next day of vaccination), one day following the vaccination, the patient experienced red, hard, hot to touch, swollen area of her left arm. On an unspecified date, post vaccination, the patient also experienced nausea, tiredness, weakness. It was reported that, on an unspecified date, post vaccination, the patient had nausea and weakness and were so severe that she could not "get out of bed" for next 10 days. Then symptoms became intermittent and she was able to be out of bed for some of the time. On an unspecified date, post vaccination, the patient intermittently has felt nauseous, weak, and sweaty to the degree the hair on back of her head is wet, feels flushed but no fever, and has rosy checks. Lab data and corrective treatment were not reported. The patient was not recovered of events. Stated still has symptoms to today, 04 Dec 2017. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from consumer (patient herself) on 04-Dec-2017. This case involves 68 year old female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (frequency once, batch number, expiration date, dose was not reported) via intramuscular route in left arm on 02 Nov 2017. Stated had received flu vaccines for several years and never had reaction. The patient's medical history and concomitant medications were not reported. On 03 Nov 2017 (reported as by the next day of vaccination), one day following the vaccination, the patient experienced red, hard, hot to touch, swollen area of her left arm. On an unspecified date, post vaccination, the patient also experienced nausea, tiredness, weakness. It was reported that, on an unspecified date, post vaccination, the patient had nausea and weakness and were so severe that she could not "get out of bed" for next 10 days. Then symptoms became intermittent and she was able to be out of bed for some of the time. On an unspecified date, post vaccination, the patient intermittently has felt nauseous, weak, and sweaty to the degree the hair on back of her head is wet, feels flushed but no fever, and has rosy checks. Lab data and corrective treatment were not reported. The patient was not recovered of events. Stated still has symptoms to today, 04 Dec 2017. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Initial unsolicited report received from consumer (patient herself) on 04-Dec-2017. This case involves 68 year old female patient who was vaccinated with 0.5 ml dose of FLUZONE HD (frequency once, batch number, expiration date, dose was not reported) via intramuscular route in left arm on 02 Nov 2017. Stated had received flu vaccines for several years and never had reaction. The patient's medical history and concomitant medications were not reported. On 03 Nov 2017 (reported as by the next day of vaccination), one day following the vaccination, the patient experienced red, hard, hot to touch, swollen area of her left arm. On an unspecified date, post vaccination, the patient also experienced nausea, tiredness, weakness. It was reported that, on an unspecified date, post vaccination, the patient had nausea and weakness and were so severe that she could not "get out of bed" for next 10 days. Then symptoms became intermittent and she was able to be out of bed for some of the time. On an unspecified date, post vaccination, the patient intermittently has felt nauseous, weak, and sweaty to the degree the hair on back of her head is wet, feels flushed but no fever, and has rosy checks. Lab data and corrective treatment were not reported. The patient was not recovered of events. Stated still has symptoms to today, 04 Dec 2017. List of documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness
Clinical narrative: Patient experienced flu like symptoms after vaccine.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Contusion, Dizziness, Dysgeusia, Erythema, Fatigue
Clinical narrative: Left arm had swelling approx size of a baseball, redness and now a bruise per the client. Client stated she is also experiencing vertigo symptoms such as light headed, dizziness, nausea, poor taste in mouth and fever. Fatigue for 2 days.
Age: 46.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Nausea, Peripheral swelling, Vertigo
Clinical narrative: Left arm had swelling approx size of a baseball, redness and now a bruise per the client. Client stated she is also experiencing vertigo symptoms such as light headed, dizziness, nausea, poor taste in mouth and fever. Fatigue for 2 days.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Activated partial thromboplastin time normal, Blood thyroid stimulating hormone normal, Chest X-ray normal, Computerised tomogram head normal, Feeling cold
Clinical narrative: Employee c/o tingling, numbness and cold sensation in right arm, right side of neck and Right ear, shortly after receiving the Hepatitis B Vaccine. Also pain in Right hand, fingers and all of her right arm. Also had 50 cent size rash on injection site. Seen in ER and admitted to hospital. Diagnostic tests done and CVA was ruled out. Symptoms resolved except for some tingling and swelling in right hand and elbow. Released the following day and followed up 2 days later with Occupational Health physician.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Full blood count normal, Hypersensitivity, Hypoaesthesia, Injection site rash, International normalised ratio normal
Clinical narrative: Employee c/o tingling, numbness and cold sensation in right arm, right side of neck and Right ear, shortly after receiving the Hepatitis B Vaccine. Also pain in Right hand, fingers and all of her right arm. Also had 50 cent size rash on injection site. Seen in ER and admitted to hospital. Diagnostic tests done and CVA was ruled out. Symptoms resolved except for some tingling and swelling in right hand and elbow. Released the following day and followed up 2 days later with Occupational Health physician.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Joint swelling, Metabolic function test normal, Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: Employee c/o tingling, numbness and cold sensation in right arm, right side of neck and Right ear, shortly after receiving the Hepatitis B Vaccine. Also pain in Right hand, fingers and all of her right arm. Also had 50 cent size rash on injection site. Seen in ER and admitted to hospital. Diagnostic tests done and CVA was ruled out. Symptoms resolved except for some tingling and swelling in right hand and elbow. Released the following day and followed up 2 days later with Occupational Health physician.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Peripheral swelling, Prothrombin time normal, Troponin T normal, Ultrasound Doppler normal, Vitamin B12 normal
Clinical narrative: Employee c/o tingling, numbness and cold sensation in right arm, right side of neck and Right ear, shortly after receiving the Hepatitis B Vaccine. Also pain in Right hand, fingers and all of her right arm. Also had 50 cent size rash on injection site. Seen in ER and admitted to hospital. Diagnostic tests done and CVA was ruled out. Symptoms resolved except for some tingling and swelling in right hand and elbow. Released the following day and followed up 2 days later with Occupational Health physician.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Red/Edema at site of injection x 5 days later.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Feeling abnormal, Headache, Laboratory test, Visual impairment
Clinical narrative: Returned to hosp. that day w/chest pain, vision problems, head pains and feeling like worms were crawling around in my veins! They put me on prednisone steroids.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Next day after shot leg was swollen, tender, red, splotchy and felt hard. Swelled area was whole thigh.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: Next day after shot leg was swollen, tender, red, splotchy and felt hard. Swelled area was whole thigh.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Baseball size red, itchy, bump.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Resolved completely within 24 hours and injection site become swollen to about the size of small egg 6.5 cm from 3 to 9 O'clock x 3.0 cm from 12 to 6Oclock. Pt denies shortness of breath, Pt states I fee fine.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site warmth, Localised infection
Clinical narrative: Patient assessed due to complaint of redness to right upper arm at site of PPSV23 vaccine which was administered in the clinic yesterday. Right upper arm is indurated, red, and warm at deltoid in area approximately 3x3 cm; with another 3 x 1 cm linear area which is also indurated and warm, extending around arm toward axilla. Patient reports overnight pain in arm and headache. Denies fever, cough, or respiratory difficulty. No other symptoms. Will give KEFLEX 250 mg QID for apparent localized infection. Patient may apply cool compresses for comfort.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient assessed due to complaint of redness to right upper arm at site of PPSV23 vaccine which was administered in the clinic yesterday. Right upper arm is indurated, red, and warm at deltoid in area approximately 3x3 cm; with another 3 x 1 cm linear area which is also indurated and warm, extending around arm toward axilla. Patient reports overnight pain in arm and headache. Denies fever, cough, or respiratory difficulty. No other symptoms. Will give KEFLEX 250 mg QID for apparent localized infection. Patient may apply cool compresses for comfort.
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Injection site irritation, Peripheral swelling, Skin warm
Clinical narrative: Pt received PNEUMOVAX on 9/23/17 and reported continued symptoms of irritated injection site on 9/26/17. Headache and left arm is swollen, red and hot.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were inadvertently administered VARIVAX, subcutaneous for prophylaxis (doses, lot numbers and expiration dates were not reported) that had been reconstituted with sterile water, rather than Merck sterile water diluent. No adverse effects were reported. Additional information is not expected, as the reporter did not wish to be contacted. This is an amended report, as corrected: the suspect therapy sterile water has been deleted from the case.
Age: 1.5
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an 18-month-old male patient. The patient did not have any pertinent medical history, concomitant therapies and drug reactions or allergies. On an unknown date before 06-NOV-2017, the patient was vaccinated concomitantly with doses of M-M-R II, VARIVAX and unspecified influenza virus vaccine (manufacturer unknown) reconstituted with sterile diluent (for all of them doses, dose numbers, route of administration, lot# and expiration dates were not reported) as routine vaccinations. On an unknown date 2 hours later, the patient started having hives on an unspecified location on the body. It was unknown which vaccine caused the hives. There were no treatment given for the event and no lab diagnostics were performed. The patient saw pediatrician and went to allergist's office. On an unknown date, the patient recovered from the event. The relatedness between the suspect therapies and the event was not reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse practitioner concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # N022703 and expiration date of 27-FEB-2019, intramuscularly (anatomical location was not reported) for prophylaxis, which was stored in the range of 32 Fahrenheit degrees to 35 Fahrenheit degrees for 3 hours and 15 minutes. No previous temperature excursion was reported.  No adverse effects were reported. Digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patient was vaccinated with VARIVAX lot # N020015 and expiration date of 17-JUL-2019, (anatomical location was not reported) for prophylaxis, which was stored in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees for 1 hour and 33 minutes. Previous temperature excursion was reported as 15 Fahrenheit degrees to 46 Fahrenheit degrees for 1 hour and 9 minutes. The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported. Digital data logger was not involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, drug reactions or allergies and concomitant therapies provided. n 14-NOV-2017, the patient was vaccinated with improperly stored dose of PROQUAD (therapy type of recombinant human albumin (rHA)) (exact dose, dose number, route of administration was not reported; lot# M037011 with the expiration date of 21-FEB-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# L019488 with the expiration date of 11-FEB-2018). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion between minus 14 and minus 10 Celsius degrees for 10 hours and 33 minutes, and minus 9 to 8 Celsius degrees for 28 hours, 20 minutes. Digital data logger was involved to capture the temperature excursion. There were no previous temperature excursions reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Electrocardiogram normal, Nausea
Clinical narrative: Patient received ZOSTAVAX at approximately 10:30am and was monitored for 30 minutes with no sign of reaction. At approximately 2:45pm, patient was trying to have a BM when she felt faint and nauseated while still at facility. She called for help. Temperature, heart rate, pulse, respiratory rate, and BP were all within normal limits. Patient was given ZOFRAN 2mg IM in left hip. EKG was performed and was normal.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Petechiae, Rash papular, Rhinorrhoea
Clinical narrative: Pt rec'd. 12 mo. vaccines on 12-01-17 in office. Returned 12/14/17 for S/S = small, raised papulovesicular area (less than 1 cm) with surrounding petechiae (RT) arm. Afebrile (plus) redness at site (plus) runny nose. (Pt teething). TX - monitor and return if S/S worsen.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Teething
Clinical narrative: Pt rec'd. 12 mo. vaccines on 12-01-17 in office. Returned 12/14/17 for S/S = small, raised papulovesicular area (less than 1 cm) with surrounding petechiae (RT) arm. Afebrile (plus) redness at site (plus) runny nose. (Pt teething). TX - monitor and return if S/S worsen.
Age: 19.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: 2.5 inch wheal with pruritus localized to injection site of varicella within 24 hours after administering vaccine. No other s/sx of adverse reactions. TYLENOL prescribed, symptoms reduced 24 hours after administered.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Per Nursing Phone Note: Pt stated she was here on 11/20 and seen by NP then received a flu vaccine. The next day the pt stated, she woke with a very stiff neck, affecting her ability to lift her head up or down or turn side to side. Pt has no other symptoms of a flu vaccine reaction. She did voice having a flu vaccine in the past w/ no adverse affect. She stated she has been using ice/heat, volteran cream with relief. pt stated the discomfort lasted about 3-4 days, now she still has a little " annoying discomfort." but it is tolerable, taking tramadol if needed for pain. The pt was instructed by 2 other Doctors to call and inform us of her issue. Pt was given a Script for outpt  PT for exercise and message. Pt had denied lifting any heavy objects and denied fall. She did report use of a new pillow which she thought may have caused the issue. Instructed pt to call back should any further symptoms appear. Pt v/u.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: No adverse reaction.
Age: 51.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Contusion, Erythema, Peripheral swelling, Pruritus
Clinical narrative: Right arm itching, swollen redness and bruising.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swelling down 1/3 of arm, red, hot, itching.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Swelling down 1/3 arm, hot, red and itching.
Age: 19.0
Sex: F
Vaccine: TYP
Symptoms: Urticaria
Clinical narrative: Within 12 hrs of taking 2nd oral dose of oral typhoid vacc, awoke with ankle, hand hives. Resolved within hours, has been recurring nightly since (10 nights +). Completed course of vaccine.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Swelling, pain, heat, redness at injection site, shaking and nausea (lasted about 15 mins).
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Swelling, pain, heat, redness at injection site, shaking and nausea (lasted about 15 mins).
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Day 1 - Body aches/fatigue. Day 2-3 - Fatigue. Day 4-5 - sore throat; sinus congestion; fever 100; H/A. Seen by PCP and treated with 10 days of ABx.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Sinus congestion
Clinical narrative: Day 1 - Body aches/fatigue. Day 2-3 - Fatigue. Day 4-5 - sore throat; sinus congestion; fever 100; H/A. Seen by PCP and treated with 10 days of ABx.
Age: 35.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 35 year old female patient. The patient's concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On an unknown date, the patient was vaccinated with a one dose of GARDASIL 9 (concentration, route of administration, lot # and expiry date were not reported). No adverse effects was reported.
Age: 25.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pallor, Syncope
Clinical narrative: After receiving a flu shot and Tdap the pt fainted while signing out for the vaccines. After checking on the pt he stated he hadn't eaten, was given juice and monitored for 15 mins pallor diminished and was alert/oriented, declined offer to call 911 and wanted to leave.
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness at injection site (about 2" x 2"). A little warm to touch but no real irritation or itching. Patient had iced the area.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Contusion, Discomfort, Fatigue, Injection site erythema
Clinical narrative: Pt. experienced soreness and discomfort about 24-30 HRS following 2 vaccinations on 11-17-17. Pt. also noted fatigue and some temperature elevation along with redness and itching at injection site. Pt. took BENADRYL over 11-19 and 11-20 but symptoms did not improve. Pt. saw her physician on 11-21 due to symptoms - was give prednisone 20 mg (one BID x 5d). Pt. improved as of this date - still some soreness and bruising.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pruritus, Pain
Clinical narrative: Pt. experienced soreness and discomfort about 24-30 HRS following 2 vaccinations on 11-17-17. Pt. also noted fatigue and some temperature elevation along with redness and itching at injection site. Pt. took BENADRYL over 11-19 and 11-20 but symptoms did not improve. Pt. saw her physician on 11-21 due to symptoms - was give prednisone 20 mg (one BID x 5d). Pt. improved as of this date - still some soreness and bruising.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Local reaction at vaccine site, left deltoid. Redness and swelling of about 2.5cm, some warmth at site.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given a flu vaccine on 08/24/17 and a second on 10/2/17.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid function disorder, Hypoaesthesia oral, Muscle twitching, Nuclear magnetic resonance imaging brain
Clinical narrative: Delayed blinking of left eye. Twitching on right side of mouth. Arching of right eye brows. Middle of tongue is numb.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Flu vaccine administered 12/7/17. Presented to doctor's office 12/8/17 - pain (L) shoulder (history of left shoulder rotator cuff tendonitis).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Started to swell and turn red within 1 hr. Became bruised and remained swollen slightly x 1 week. Is still bruised about the size of a "silver dollar" 12/8/17.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Pruritus, Skin warm, Swelling
Clinical narrative: Itching, red, swollen, hard center, warm to touch, sensitive to touch. TYLENOL and ice.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Itching, red, swollen, hard center, warm to touch, sensitive to touch. TYLENOL and ice.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Area tender and puffy surrounding injection site.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea, Dizziness, Feeling abnormal, Lethargy, Nausea
Clinical narrative: THE EVENING OF THE VACCINE BEING GIVEN PATIENT FELT DIZZY, NAUSEOUS (NO VOMITING), VERY THIRSTY, AND DIARRHEA; FIRST NIGHT. DAY 2: SLEPT WELL, SAME SYMPTOMS ALL THROUGH THE DAY AND FOR THE NEXT FOUR DAYS. REPORTED THESE SYMPTOMS TODAY AS HE IS BACK AT WORK STATUS AND WANTED THE MEDICAL DEPARTMENT TO KNOW THAT HE FELT HORRIBLE AFTER RECEIVING THE INFLUENZA VACCINE WHERE HE HAD FELT NORMAL/HEALTHY PRIOR TO GETTING IT AT THE UNIT.
Age: 24.0
Sex: M
Vaccine: FLUC4
Symptoms: Thirst
Clinical narrative: THE EVENING OF THE VACCINE BEING GIVEN PATIENT FELT DIZZY, NAUSEOUS (NO VOMITING), VERY THIRSTY, AND DIARRHEA; FIRST NIGHT. DAY 2: SLEPT WELL, SAME SYMPTOMS ALL THROUGH THE DAY AND FOR THE NEXT FOUR DAYS. REPORTED THESE SYMPTOMS TODAY AS HE IS BACK AT WORK STATUS AND WANTED THE MEDICAL DEPARTMENT TO KNOW THAT HE FELT HORRIBLE AFTER RECEIVING THE INFLUENZA VACCINE WHERE HE HAD FELT NORMAL/HEALTHY PRIOR TO GETTING IT AT THE UNIT.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Injection site pruritus, Injection site rash, Laboratory test
Clinical narrative: CLIENT STATED 2 DAYS AFTER RECIEVING VACCINES SHE NOTICED A RASH WITH ITCHING TO LEFT ARM DELTOID WHERE SHE RECIVED A VACCINE. CLIENT STATED THE RASH WITH ICHING SPREAD TO HER ARMS, TORSO, AND BOTH LEGS. CLIENT STATED SHE WENT TO PCP AND RECEIVED ANTIBIOTIC CREAM TRIAMACOLONE AND NYASTATIN. CLIENT STATED SHE RETURNED  CLINIC BECAUSE THERE WAS NO IMPROVEMENT. ADVISED CLIENT TO RETURN TO PCP FOR FOLLOW UP.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient called and reported that about 4 weeks ago (around 11/20/2017) that her left upper arm and shoulder has become very painful. She says that it hurts without movement but pain increases with movement and touch, very painful to put on shirt. She says there is no bruising, redness, or any skin changes. She says that when she got vaccine that she did not have any pain except for a little burning with injection and waited in office for 20 min without any problems. She also complains of pain in anticubital of right arm. She said prior to vaccine, she did not have any problems.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient developed a rash on his arm.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pain, swelling and redness in large area of upper arm began several hours after vaccination. Next day, pain made it difficult to move or use right arm, particularly difficult to raise arm. Headache. Now almost 48 hours since vaccination, swelling, redness and pain have subsided. Headache better with aspirin.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Injection site pain, Injection site reaction, Nasopharyngitis, Skin warm
Clinical narrative: 45 y/o female coming in for c/o reaction to flu shot x 3 days ago in the right upper arm/shoulder. Pt shows signs of redness and tender to palpation as well as warm to touch. Pt states was also experiencing cold like sx prior to receiving it and has a hx of intense muscle aches as she described in the area of where the flu shot was administered.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Tenderness
Clinical narrative: 45 y/o female coming in for c/o reaction to flu shot x 3 days ago in the right upper arm/shoulder. Pt shows signs of redness and tender to palpation as well as warm to touch. Pt states was also experiencing cold like sx prior to receiving it and has a hx of intense muscle aches as she described in the area of where the flu shot was administered.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Muscular weakness, Pyrexia
Clinical narrative: Patient described muscle weakness, fever, chest tightening. Patient was about to visit a Dr. to see what illness she contracted. The symptoms have lasted 10 days.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Joint range of motion decreased, Paraesthesia
Clinical narrative: NUMBNESS, TINGLING, LIMITED RANGE OF MOTION. TREATMENT: MEDROL AS PRESCRIBED, TYLENOL AS NEEDED.
Age: 11.0
Sex: F
Vaccine: TYP, YF
Symptoms: Fatigue, Rash
Clinical narrative: Pt. dad called today stating that patient had vaccines 12/14/17. 12/17/17 rash to face and neck with some fatigue, no other symptoms. I recommended that he take her to be seen by her physician. He was thankful for the call.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a License Vocational Nurse referring to an unspecified amount of unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. From 05-NOV-2017 to 27-NOV-2017, the patients were vaccinated with improperly stored VARIVAX lot # M046924, expiration date on 28-NOV-2018, for prophylaxis (strength, dose and route were not reported); which were diluted, concomitantly, with a properly stored sterile diluent (MERCK). The reporter did not know the details about temperature and/or time frame at which vaccines were improperly stored. There were previous temperature excursions but the reporter, also, did not know the details. The call was because of a data logger and no adverse effects were reported.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Immunology test, Laboratory test, Musculoskeletal stiffness
Clinical narrative: On 12/11/17, start having chills, body aches, and stiffness that night after flu vaccine. These symptoms has persists to the present. On 12/15/17 started having diarrhea, nausea, vomiting and aches. Went to Urgent Care for treatment today. - 12/18/17.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain, Vomiting, White blood cell count
Clinical narrative: On 12/11/17, start having chills, body aches, and stiffness that night after flu vaccine. These symptoms has persists to the present. On 12/15/17 started having diarrhea, nausea, vomiting and aches. Went to Urgent Care for treatment today. - 12/18/17.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Diarrhoea, Urine output decreased, Vomiting projectile
Clinical narrative: Patient received the Hep A (not sure which one of the Hep A) vaccine Friday afternoon. Friday night he started projectile vomiting and has had diarrhea. On Saturday he was still vomiting a lot and not having wet diapers so I called the on-call nurse who told me to take him to the emergency room. We took him to hospital where they gave him IV fluids and ZOFRAN. He puked again Sunday and has had a lot of diarrhea Sunday and today (Monday).
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Child was given a HEP A vaccine. Vaccine was not needed; child had completed the HEP A vaccine series 10 years ago. Nurse discussed with parent what had done and parent understood. Child had no reaction to the vaccine.
Age: 7.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Blister, Erythema, Peripheral swelling, Scratch, Skin warm
Clinical narrative: Mother stated child's arm was swollen 2-3 X its normal size, red and hot to touch. She took child to  hospital to ER, was told it was normal reaction to vaccines. Child later developed blisters on the arm so she took her to ER, again was told it looked like a common reaction to vaccines and to bring the child to the clinic. The child's arm was looked at by myself and another RN, arm was slightly swollen, red and warm to touch with 2 broken areas on it that looked to have been scratched open by the child. Instructed mother to put antibiotic ointment on broken areas and cool cloth to help redness and swelling.
Age: 73.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: At immediate injection the injection site began to bleed and welt up to the size of a quarter. I appeared to have bruised. Patient was contacted 24 hours later to attest the swelling had decreased without any medication and a bruise (with soreness to the touch) remained. IBU was suggested for any discomfort.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Patient reported pain at site of injection (thigh), and started limping a few hours after injection. On the day after injection, patient had substantial swelling and hives/redness throughout site of injection (thigh, through to knee), and the site of injection was tender and warm to the touch.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Patient reported pain at site of injection (thigh), and started limping a few hours after injection. On the day after injection, patient had substantial swelling and hives/redness throughout site of injection (thigh, through to knee), and the site of injection was tender and warm to the touch.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and mild swelling on R arm.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Hyperthermia, Pain, Rash macular
Clinical narrative: RT ARM WITH 10 CM ERYTHEMATOUS MACULAR CIRCULAR AREA WITH HYPERTHERMIA AND MINIMAL PAIN TO PALPATION. TREATMENT WILL BE TO F/U AS NEEDED.
Age: 11.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: On 12/15/2017 patient was given a third vaccination of MMR. He had already completed the 2 of 2 series. Prior MMR was given on 01/24/2011. No adverse reaction had.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Pyrexia, Rash generalised
Clinical narrative: The symptoms occur. Rash started on the left thigh 2 days after immunizations (Immunizations given 11/29/17). Large indurated area without pain or itch (per mom). Rash started to spread all over the body covering the legs torso chest back and now on the face. Temperature of 102.0 started 12/7/17. Seen at the ER on 12/8/17 and Dx with reaction to the immunizations. Rx for Cephalexin started.  Fever resolved after starting the antibiotics and has not returned. A reddened area on the right thigh also appeared about 1 week after the immunizations were given. Patient still has the rash, although it is starting to improve. Eating and drinking well. Appears in no distress.
Age: 1.08
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Vaccination complication
Clinical narrative: The symptoms occur. Rash started on the left thigh 2 days after immunizations (Immunizations given 11/29/17). Large indurated area without pain or itch (per mom). Rash started to spread all over the body covering the legs torso chest back and now on the face. Temperature of 102.0 started 12/7/17. Seen at the ER on 12/8/17 and Dx with reaction to the immunizations. Rx for Cephalexin started.  Fever resolved after starting the antibiotics and has not returned. A reddened area on the right thigh also appeared about 1 week after the immunizations were given. Patient still has the rash, although it is starting to improve. Eating and drinking well. Appears in no distress.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Asthenia, Discomfort, Electromyogram, Musculoskeletal stiffness, Nerve conduction studies
Clinical narrative: Initially complained of pain and stiffness in arm. On 10/17/17 called to report continued discomfort, weakness, loss of strength in that extremity.
Age: 72.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Initially complained of pain and stiffness in arm. On 10/17/17 called to report continued discomfort, weakness, loss of strength in that extremity.
Age: 42.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Expired product administered
Clinical narrative: Hepatitis B Vaccine that was administered was expired. Vaccine was given on 12/8/2017, which the vaccine's expiration date is 15SEP2017. No treatment needed.