chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Activities of daily living impaired, Discomfort, Dyspnoea, Grip strength decreased, Injected limb mobility decreased
Clinical narrative: This 44 year old reported she experienced onset of pain to injection site 24 hours following 2015 and 2016 influenza vaccinations. On 16 Oct 2015, she received FLUARIX (quad preservative free influenza) to left deltoid. She advised this discomfort persisted for one month despite use of TYLENOL or ALEVE prn. She sought medical care 11/2/2015 with 8/10 left shoulder pain and difficulty moving/lifting her arm overhead and was having problems putting on clothes, and some SOB/feeling winded after exercises-difficulty catching her breath (symptoms resolving as of Jan 2016 using asthma meds). She denied any chest pain, fever, n/v, arthralgia (to other joints), headaches, or rash following the flu vaccine. HCP documented left shoulder was TTP and pain elicited on movement with no swelling, erythema, or instability or weakness- had normal ROM. X-ray was normal. Patient advised in Dec 2015 pain to left shoulder had improved. In May 2016 she received PPV23 vaccine to left arm with no documented complaints. She advised her arm pain would come and go 1-2 x/week and she just lived with it. On 27 Oct 2016 she received annual flu vaccine FLUARIX to left arm lot# T44G9 (per note); however pt advised vaccine given in right arm due to past problems with left. She advised 24 hours later her right arm was now painful similar to left. She sought medical care on 12/7/2016 (upon return from family medical leave/holiday season) stating that she had right arm 8/10 sharp shooting pain with occasional loss of grip and could not raise her arm. She was treating with MOTRIN. Providers exam was unremarkable documenting TTP anteriorly to both shoulders - treated with Meloxicam and physical therapy. Patient advised she was not going to physical therapy because "If MD didn't know what was wrong, why go to them". Patient advised since first week of Jan 2017 while on Meloxicam, her pain has almost resolved and she has been pain free for about 1 week. She advised she can dress herself normally, can lift arm over head, and continues with her normal exercise routines. She denies any grip weakness, paresthesia, or pain to bilateral upper extremities. She has no SOB/difficulty breathing/feeling winded or chest pain.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain, Pain in extremity, Tenderness, X-ray limb normal
Clinical narrative: This 44 year old reported she experienced onset of pain to injection site 24 hours following 2015 and 2016 influenza vaccinations. On 16 Oct 2015, she received FLUARIX (quad preservative free influenza) to left deltoid. She advised this discomfort persisted for one month despite use of TYLENOL or ALEVE prn. She sought medical care 11/2/2015 with 8/10 left shoulder pain and difficulty moving/lifting her arm overhead and was having problems putting on clothes, and some SOB/feeling winded after exercises-difficulty catching her breath (symptoms resolving as of Jan 2016 using asthma meds). She denied any chest pain, fever, n/v, arthralgia (to other joints), headaches, or rash following the flu vaccine. HCP documented left shoulder was TTP and pain elicited on movement with no swelling, erythema, or instability or weakness- had normal ROM. X-ray was normal. Patient advised in Dec 2015 pain to left shoulder had improved. In May 2016 she received PPV23 vaccine to left arm with no documented complaints. She advised her arm pain would come and go 1-2 x/week and she just lived with it. On 27 Oct 2016 she received annual flu vaccine FLUARIX to left arm lot# T44G9 (per note); however pt advised vaccine given in right arm due to past problems with left. She advised 24 hours later her right arm was now painful similar to left. She sought medical care on 12/7/2016 (upon return from family medical leave/holiday season) stating that she had right arm 8/10 sharp shooting pain with occasional loss of grip and could not raise her arm. She was treating with MOTRIN. Providers exam was unremarkable documenting TTP anteriorly to both shoulders - treated with Meloxicam and physical therapy. Patient advised she was not going to physical therapy because "If MD didn't know what was wrong, why go to them". Patient advised since first week of Jan 2017 while on Meloxicam, her pain has almost resolved and she has been pain free for about 1 week. She advised she can dress herself normally, can lift arm over head, and continues with her normal exercise routines. She denies any grip weakness, paresthesia, or pain to bilateral upper extremities. She has no SOB/difficulty breathing/feeling winded or chest pain.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US023335, is an initial spontaneous report from a consumer received on 12 Sep 2016. This report refers to a 33 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of expired FLUVIRIN (batch number: 157104) intramuscularly at a dose of 0.5 ml on 12 Sep 2016. It was stated that, the 2015/2016 expired vaccine was administered to 05 patients on 12 Sep 2016. No adverse event was reported following this medication error. The case was assessed as non serious by the consumer.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Muscular weakness, Syncope
Clinical narrative: Mother was standing at the window to pay vaccine and child was by her side. She claims his legs buckled and he leaned on the counter and she helped him to the floor. Nurses were called. B/P 119/81 - Pulse 73 at 8:55AM - Pt was alert and oriented. B/P at 9am 116/72 P=68 C/O lightheadedness only monitored for 45 minutes. Advised mother to F/U with MD due to epilepsy DX.
Sex: U
Vaccine: FLU3
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: Case number PHEH2015US023915 is an initial spontaneous report from a health care professional received on 12 Nov 2015. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that while receiving the vaccine, little amount of it squinted on the face of the patient. No adverse event reported following this medication error.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: Case number PHEH2016US023279 is an initial spontaneous report received from nurse on 09 Sep 2016. This report refers to 60 year old female patient. Past medical history and concomitant medications was not reported. The patient was vaccinated with single dose FLUVIRIN (batch number: 168705) at a dose of 0.5 ml intramuscular on 06 Sep 2016. It was reported that, patient received FLUVIRIN in the gluteal muscle and patient had no any problem. Not any adverse event was followed after (wrong route of administration).
Age: 1.8
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US001328, is an initial spontaneous report from a health care professional received on 15 Jan 2016. This report refers to a 21 months female old female infant. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml on an unknown date. No adverse event was reported following this medication error.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US001422, is an initial spontaneous report from health care professional received on 13 Jan 2016. This report refers to a 33 years old male patient. Medical history and concomitant medications were not reported. The patient was administered FLUVIRIN PFS (batch number: 15722P) that was out of temperature range of 31.1 Fahrenheit for 1 hour and 30 minutes on 12 Jan 2016. No adverse event was reported.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Removal of foreign body
Clinical narrative: Case number PHEH2016US001828, is a combined initial and follow up spontaneous report initially received from a nurse on 21 Jan 2016 and from Quality Assurance department (QA reference number: 1011434) on 26 Jan 2016. This report refers to a 21 year old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1518101) into the deltoid on 08 Oct 2015. After vaccination, she noticed pain in left shoulder, went to employee health and they found a thin piece of glass in her deltoid. Glass was removed from her deltoid. This piece of glass was thin enough to go through the syringe. The outcome of the event pain in left shoulder was reported as complete recovery on an unknown date. The events seriousness and causality were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Case number PHEH2016US002103 is a combined initial spontaneous report received from consumer on 25 Jan 2016. This report refers to a female patient of unknown age. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514961) on unknown date. After vaccination, the patient experienced acute pain. Outcome of the event was reported as condition unchanged. Seriousness and causality of the event were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site nodule
Clinical narrative: Case number PHEH2016US002216, is an initial spontaneous report received from a pharmacist on 26 Jan 2016. This report refers to a 50-year-old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516501) intramuscularly on an unknown date. After vaccination from 02 Nov 2015 (almost 03 months), the patient was experiencing a knot at the vaccination site. The outcome of the event was reported as condition unchanged. Seriousness and causality of the event was not reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US022005, is an initial spontaneous case received from a physician on 25 Aug 2016. This report to a 51 years old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 25 Aug 2016. No adverse event was reported following this administration error.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US022698 is an initial spontaneous report received from healthcare professional on 23 Aug 2016. This report refers to a 30 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619901) 0.5 ml intramuscular on 12 Aug 2016 which was temperature excursion of 30 Fahrenheit for unknown amount of time. It was reported that, the vaccine was not frozen. No adverse event was reported following this medication error (incorrect storage of drug).
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2106US022942, is an initial spontaneous report received form a pharmacist on 07 Sep 2016. This report refers to a 64 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618701) at a dose of 0.5 ml, intramuscularly on 06 Sep 2016. The pharmacist stated that a patient received a dose from the FLUVIRIN multi dose vial (MDV) that had been part of the temperature excursion (60F for up to 37.5 hours) (reported as yesterday). No adverse event was reported following this medication error (incorrect storage of drug).
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: Case PHEH2016US023015, is a spontaneous report initially received from a pharmacist on 08 Sep 2016. This is also a quality complaint report (QA reference number: 1016686). This report refers to a 52 years old female patient. Past vaccination history included administration of Pneumo-poly vaccine on 26 Dec 2001 and diphtheria tetanus pertussis vaccine received on 23 Sep 2015. Current condition of the patient included unspecified allergies and metabolic disorders and smoking. She was vaccinated with FLUVIRIN (batch number: 168805, expiry date: 30 Apr 2017) at an unknown dose on 08 Sep 2016 at 11:30 hours. The pharmacist stated that at the time of administration, part of the vaccine squirted out. The needle was all the way in and the syringe luer lock, appeared to be connected correctly. She received an incomplete dose. The luer was checked and the needle was screwed tight to the syringe. The needle was also pushed into her arm as far as it would go. No adverse event was reported following this administration error (underdose and syringe issue). Follow up information received from a pharmacist on 22 Sep 2016: Added patient demographics, vaccination history, current condition, vaccination time and reporter's comment regarding vaccination.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US021870, is an initial spontaneous report received from a physician on 25 Aug 216. This report refers to a 36-year-old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517501, expiration date: Jun 2016) at 0.5 ml intramuscularly on 25 Aug 2016. It was reported that FLUVIRN was expired on Jun 2016. No adverse event was reported following this administration error (expired vaccine administered).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2016US021873, is an initial spontaneous case received from a physician on 25 Aug 2016. The report refers to a 69 years old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 25 Aug 2016. No adverse event was reported following this administration error.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case PHEH2016US022002, is an initial spontaneous case received from a physician on 25 Aug 2016. This report refers to an 80 years old male patient. Medical history and concomitant medications was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: 1517501, expiry date: Jun 2016) at a dose of 0.5 ml intramuscularly on 25 Aug 2016. No adverse event was reported following this administration error (expired product administered).
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US023868, is an initial spontaneous report from a pharmacy technician received on 12 Nov 2015. This report refers to a 28 years old female patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN (batch number: 1515301) intradermal on 11 Nov 2015. No adverse event was reported.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Local reaction
Clinical narrative: Case number PHEH2015US023887 is an initial spontaneous report received from a health care professional on 13 Nov 2015. This report refers to a patient whose identifiers were not reported. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517701) subcutaneously on 09 Nov 2015. It was reported that on the same day after vaccination, the patient had a localized reaction. The outcome of the event was reported as complete recovery on the same date. The seriousness and causality were not reported.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Peripheral swelling
Clinical narrative: Case PHEH2015026643, is an initial spontaneous report received from a physician on 17 Dec 2015. This report refers to an female patient of an unknown age. Historical condition was not reported. Current condition included sensitivity to preservatives. Concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: not reported) intramuscularly on an unknown date (last year). After vaccination, the patient experienced reaction to FLUVIRIN, she had swelling in arm. The outcome of the event was reported as complete recovery. The seriousness and causality of the event were not reported.
Sex: F
Vaccine: HEP
Symptoms: Drug hypersensitivity
Clinical narrative: This case was reported by a other health professional via other manufacturer and described the occurrence of drug allergy in a 68-year-old female patient who received Hepatitis B vaccine. Co-suspect products included DYAZIDE unknown for product used for unknown indication and LAMICTAL tablet for product used for unknown indication. The patient's past medical history included hyperlipidemia, hypothyroidism, partial seizures, benign monoclonal hypergammaglobulinemia, neuropathy peripheral, esophageal stenosis, gastroesophageal reflux, pancreas cyst, hiatal hernia, coronary artery disease, myopathy, gait disturbance, anemia, irritable bowel syndrome, bronchiectasis, atrial fibrillation, cataract and drug allergy. Concurrent medical conditions included pain. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose, DYAZIDE at an unknown dose and frequency and LAMICTAL at an unknown dose and frequency. On an unknown date, an unknown time after receiving Hepatitis B vaccine, DYAZIDE and LAMICTAL, the patient experienced drug allergy. The action taken with DYAZIDE was unknown (Dechallenge was unknown). Rechallenge with DYAZIDE was unknown. The action taken with LAMICTAL was unknown (Dechallenge was unknown). Rechallenge with LAMICTAL was unknown. On an unknown date, the outcome of the drug allergy was unknown. It was unknown if the reporter considered the drug allergy to be related to Hepatitis B vaccine, DYAZIDE and LAMICTAL. Additional details were reported as follows: The age at vaccination was not reported. The patient's medical history included allergies to PLAQUENIL, LASIX, methotrexate, potassium, sulfosalicylic acid, tramadol, ACTIFED, ampicillin, ARAVA, ciprofloxacin, colchicine, COMPAZINE, contrast dye IV, Cyclosporine, DIAMOX,  DILAUDID, doxycycline, erythromycin, GEODON, iron, and KEFLEX. The patient also received various medications including Vitamin D2, BACTROBAN, TYLENOL, SINGULAIR, SYNTHROID, ZOLOFT, MVI, RESTASIS, Folic acid, NASOCORT, ADVAIR, PREVACID, FLEXERIL, VICODIN, REFRESH, FOSAMAX, PHENERGAN, TAZACT, Vitamin D, SYSTANE, ISOPTO tears, MOBIC, DIAMODE, NEXIUM, Calcium, ZANAFLEX, Retin, Vitamin D3, NORCO, Hydrocortisone, Zinc, ZADITOR, RUBRAMIN, ZANTAC, DELTASONE, Vitamin B12 and PROTOPIC. No other information was provided.
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Case number PHEH2015US024143 is an initial spontaneous report received form a pharmacist on 14 Nov 2015. This report refers to a female patient possibly around 40 years of age. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. After 3 weeks, the patient experienced consistent pain at injection site. It was reported that further the pain worsened and spread down to right arm and up towards neck. The outcome of the events was not reported. Seriousness and causality of the events were unknown.
Age: 0.17
Sex: F
Vaccine: DTAPIPV, RVX
Symptoms: Crying, Drug administered to patient of inappropriate age, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of crying in a 2-month-old female patient who received KINRIX. Co-suspect products included Rotavirus vaccine. On 5th January 2017, the patient received KINRIX and Rotavirus vaccine (oral). On 5th January 2017, less than a day after receiving KINRIX and Rotavirus vaccine, the patient experienced crying, fever, wrong vaccine administered and inappropriate age at vaccine administration. In January 2017, the outcome of the crying and fever were recovered/resolved. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the crying and fever to be related to KINRIX and Rotavirus vaccine. Additional details were provided as follows: The patient's birth weight was 6lbs 4ozs and sibling number was 3. The patient received KINRIX (on thigh) by mistakenly instead of INFANRIX at an age of 2 months, which led to an administration of wrong vaccine and an inappropriate age at vaccine administration. The patient also received 2 other immunization injection vaccines and the oral rotavirus vaccine at the same appointment. The names of those vaccines were not known. The patient cried for hours after vaccination and developed a low grade fever that resolved with fever reducer medication.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Immediate shock like pain to left shoulder upper arm with redness and swelling pain radiated to entire arm. Days (2) tenderness and decrease mobility to (L) arm. Ice initially followed by TYLENOL, Physical therapy started with no effect.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Immediate shock like pain to left shoulder upper arm with redness and swelling pain radiated to entire arm. Days (2) tenderness and decrease mobility to (L) arm. Ice initially followed by TYLENOL, Physical therapy started with no effect.
Age: 40.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: Immediate shock like pain to left shoulder upper arm with redness and swelling pain radiated to entire arm. Days (2) tenderness and decrease mobility to (L) arm. Ice initially followed by TYLENOL, Physical therapy started with no effect.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US024219, is an initial spontaneous report from a pharmacist received on 17 Nov 2015. This report refers to a 3 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN PFS (batch number: 158201) intramuscularly on 13 Nov 2015. No adverse event was reported.
Sex: U
Vaccine: MENB
Symptoms: Fatigue
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of tiredness in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a year after receiving BEXSERO, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional only provided limited information. No product or patient information provided. The healthcare professional stated BEXSERO was administered to the patient a few months back from the date of reporting and complained of feeling tired or exhausted for one week.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US024306 is an initial spontaneous report from a nurse received on 17 Nov 2015. This report refers to a 03-year-old female patient. The patient was inadvertently vaccinated with FLUVIRIN (batch number: 1511601) intramuscularly on 21 Oct 2015. No adverse event reported following this medication error (inappropriate age at vaccine administration).
Age: 1.5
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2015US024344 is an initial spontaneous report from a nurse received on 19 Nov 2015 and follow up received on 5 Jan 216. This report refers to a 18-months-old female patient. The patient was inadvertently vaccinated with FLUVIRIN (batch number: 1514701) at a dose of 0.25 ml intramuscularly from multidose vial on 18 Nov 2015. It was reported that the patient did not experience any adverse drug reaction following this medication error (inappropriate age at vaccine administration). Significant FU report received on 05 Jan 2016: Updated reporter's statement (patient did not experience adverse event from vaccine.).
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine and Hepatitis B vaccine. On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 3rd dose of Hepatitis B vaccine. On an unknown date, several years after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that years ago, she received the standard series of Hepatitis B vaccine (manufacturer was unknown). The titer was recently measured and the patient did not display immunity to Hepatitis B leading the patient to be a therapy non-responder. Hence, she required a booster dose. No further details were reported.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Case number PHEH2015US025346 is an initial spontaneous report received from a nurse on 02 Dec 2015. This report refers to a 9 year old female patient. Past medical history and concomitant medications were unknown. She was vaccinated with FLUVIRIN (batch number: 1516401) via intradermal route by mistake at a dose of 0.5 ml on 30 Nov 2015. She experienced redness, swelling and itching at the vaccination site on an unknown date. She was given lidocaine/hydrocortisone cream. The events outcome was unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Injection site swelling, Wrong drug administered
Clinical narrative: Case number PHEH2015US025338, is a spontaneous report initially received from a nurse on 02 Dec 2015. This report refers to a 32-year-old female patient. Past medical history and concomitant medications were unknown. The patient was a smoker. Vaccination history included administration of FLUVIRIN and it was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 1516401) via intradermal route at a dose of 0.5 ml on 30 Nov 2015 at 4 pm. On the same day after vaccination the patient experienced redness, swelling and itching at the injection site. The patient experienced 3 centimeter redden raised area where flu vaccine was given intradermally that was to be a Tine test (TB) given by mistake. The patient was given lidocaine/hydrocortisone cream. The outcome of the events was reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported. Follow up information received from a Nurse on 12 Jan 2016: Vaccination history, patient's history and events description was updated.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US025413, is an initial spontaneous report received from a healthcare professional on 03 Dec 2015. This report refers to a 36-year-old male patient. Past medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157603) subcutaneously at a dose of 0.5 ml, on 02 Dec 2015 at 18:15 pm. No adverse events were reported following the medication error. Follow up report received from a healthcare professional on 21 Jan 2016: Added suspect drug information (dose and vaccination time).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024820, is an initial spontaneous report received from a health care professional on 23 Nov 2015. This report refers to a 57-year-old female patient. Medical history was not reported. Concomitant medication was not reported. Vaccination history included administration of FLUVIRIN in the past and it was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) intramuscularly in the left deltoid at a dose of 0.5 ml on 23 Nov 2015 at 08.48 a.m. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse events were reported following the maladministration. Follow up information received from a health care professional on 21 Jan 2015: Vaccination history, batch number and site of vaccination.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024819 is a spontaneous report initially received from a health care professional on 23 Nov 2015. This report refers to a 59 year old female patient. Past vaccination history included an unknown vaccine was tolerated in the past. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) intramuscularly at a dose of 0.5 ml on 23 Nov 2015 at 09:08 hours. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non serious. No adverse events were reported following the maladministration. Follow up information received from a healthcare professional on 21 Jan 2016: Added batch number, vaccination site and vaccination time.
Age: 28.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US0228892 is a spontaneous report initially received from a nurse on 02 Nov 2015. This report refers to a 28 years old male patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) intramuscularly into left deltoid on 05-Oct 2015. It was reported that FLUVIRIN administered had a temperature excursion of 34F overnight. No adverse event was reported. Follow-up received from a nurse on 22 Dec 2015: Patient details (date of birth) and vaccine details (Batch number, site and date) were updated. Report type was changed to "spontaneous report" from other".
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US025191, is an initial spontaneous report received from a medical assistant on 01 Dec 2015. This report refers to a 35-year-old female patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 173538) at a dose of 0.5 ml intramuscularly on 16 Oct 2015 which was stored out of temperature range first time at 32 Fahrenheit and second time at 48.7 Fahrenheit. No adverse event was reported. Following this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Case number PHEH2015US025437 is an initial spontaneous report received from a nurse on 04 Dec 2015. This report refers to an adult female patient. Past medical history and concomitant medications were not reported. She was vaccinated with 1 ml of FLUVIRIN (batch number: 1411302) intramuscularly on an unknown date. No adverse event was reported following the maladministration. Case was lost to additional follow up.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Case number PHEH2015US023692, is an initial spontaneous report received from a nurse on 11 Nov 2015. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: not reported) subcutaneously on 11 Nov 2015. No adverse event was reported.
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Case number PHEH2015US023396 is an initial spontaneous report received from a pharmacist on 09 Nov 2015. This report refers to a male patient whose age was not reported. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: not reported) multi dose vial (MRD) two times this flu season via intramuscular route on 05 Nov 2015. No adverse events following the inadvertent administration.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Back pain, Neck pain
Clinical narrative: Case number PHEH2015US023444, is an initial and follow up spontaneous report received from a consumer (also healthcare professional) on 10 Nov 2015 (combined report). This report refers to a 72-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: not reported) intramuscularly on 08 Oct 2015. On 12 Oct 2015, four days after vaccination, the patient began to experience severe lower back and neck pain. They got progressively worse over time and with exercise. The events lower back and neck pain had subsided on 12 Oct 2015. Further, the patient experienced severe abdominal pain on an unknown date and the patient was currently experiencing abdominal pain. The outcome of the event abdominal pain was not recovered. Seriousness and causality was not reported.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Case number PHEH2015US024996 is an initial spontaneous report received from a pharmacist on 25 Nov 2015. This report refers to a 60 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 151001) intramuscularly on an unknown date. On 23 Nov 2015, the patient experienced blurred vision after being vaccinated. The outcome of the event was reported as unknown. The seriousness and causality of the event was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain
Clinical narrative: Case number PHEH2015US023222 is a spontaneous report initially received from a pharmacist on 09 Nov 2015. This report refers to a 28 year old female patient. Past medical history was not reported. The pharmacist was unsure of the vaccination status of the patient but in 2014 the patient received FLUARIX (other manufacturer) and tolerated the vaccination. Concomitant medications were none in patient profile. She was vaccinated with FLUVIRIN (batch number: 1514701) multi dose vial (MDV) intramuscularly at a dose of 0.5 ml into the left arm on 09 Nov 2015 at 11:00 AM. On 09 Nov 2015, a few hours after vaccination, the patient experienced pain in both ears. The event outcome was recovered. The seriousness and causality of the event was not reported. Follow up received from pharmacist on 29 Dec 2015: updated vaccination history, dose and anatomical location of FLUVIRIN, outcome of the event and other clinically relevant information in the narrative.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024823, is an initial spontaneous report received from a health care professional on 23 Nov 2015. This report refers to a 56-year-old male patient. Past medical history included metabolic disorders. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) at a dose of 0.5 ml intramuscularly in left deltoid on 23 Nov 2015 at 10:34 AM. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse events were reported following the maladministration. Follow up report received from healthcare professional on 21 Jan 2016: Updated medical history (metabolic disorder) and suspect drug information (batch number, anatomical position of vaccination and time of vaccination).
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Pharyngeal oedema, Pyrexia, Vomiting
Clinical narrative: Mom called 1/13/17 states pt. woke at 2AM C/O throat feeling swollen-low grade fever per mom-vomited-given shower and Ibuprofen. Pt went back to sleep- fine in AM. Throat felt fine next day no vomiting. Never had difficulty breathing. Mom stated same thing happened after last dose of DTaP.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Redness, swelling around injection site, and pain in arm for one week after administration of vaccine.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Culture, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: Received PREVNAR 13 1/18/17 AM. Last night started with moderate arm pain, fever, chills, no cough, mild congestion, rhinorrhea. No N/V/D. Seen at noon with temp 99.9. Other vitals stable.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Rhinorrhoea
Clinical narrative: Received PREVNAR 13 1/18/17 AM. Last night started with moderate arm pain, fever, chills, no cough, mild congestion, rhinorrhea. No N/V/D. Seen at noon with temp 99.9. Other vitals stable.
Age: 63.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pruritus, Injection site urticaria, Injection site vesicles, Injection site warmth
Clinical narrative: Raised hive with two small blisters the size of a grapefruit on right upper arm at site of the injection. Itching at site with heat on site lasting about a week.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Father said at midnight was itching and woke up with rash/hives on legs and arms. Taken to urgent care clinic and given BENADRYL. He did not have difficulty breathing or swallowing. He received vaccines at 1015am. He also had a smoothie with berries that day.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site papule
Clinical narrative: Small fine papular lesions all over lateral aspect of both thigh.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Depression, Fatigue, Feeling hot, Headache
Clinical narrative: 1/9/2017 Rec'd 2nd meningococcal vaccine approximately 4:30 pm. Hot on Tuesday then high fever to 102.8 measured, nausea, HA, fatigue, depression, insomnia, chills W/sweats, neck lymph nodes inflamed and swollen.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Insomnia, Lymphadenitis, Lymphadenopathy, Nausea
Clinical narrative: 1/9/2017 Rec'd 2nd meningococcal vaccine approximately 4:30 pm. Hot on Tuesday then high fever to 102.8 measured, nausea, HA, fatigue, depression, insomnia, chills W/sweats, neck lymph nodes inflamed and swollen.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: 1/9/2017 Rec'd 2nd meningococcal vaccine approximately 4:30 pm. Hot on Tuesday then high fever to 102.8 measured, nausea, HA, fatigue, depression, insomnia, chills W/sweats, neck lymph nodes inflamed and swollen.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Rash and mild swelling over (L) deltoid (urticarial rash) upper 1/3 of arm. Treated w/BENADRYL.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Localized skin rash (4cm round). Recommended ice pack/hydrocortisone cr.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US023067, is an initial spontaneous report received from a health care professional on 06 Nov 2015. This report refers to a 39-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was administered expired FLUVIRIN (batch number: 1414101) intramuscularly at a dose of 0.5 ml on 26 Oct 2015. The case was reported as non-serious. No adverse event was reported.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US023066, is an initial spontaneous report received from a health care professional on 06 Nov 2015. This report refers to a 36-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was administered expired FLUVIRIN (batch number: 1414101) intramuscularly at a dose of 0.5 ml on 28 Oct 2015. The case was reported as non-serious. No adverse event was reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHEH2015US023064, is an initial spontaneous report received from a health care professional on 06 Nov 2015. This report refers to a 62-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was administered expired FLUVIRIN (batch number: 1414101) intramuscularly at a dose of 0.5 ml on 04 Nov 2015. The case was reported as non-serious. No adverse event was reported.
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US022703, is an initial incomplete spontaneous report received from medical assistant on 30 Oct 2015. This report refers to a 38-years-old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with first multidose FLUVIRIN (batch number: 1516201) at a dose of 0.5 ml intramuscularly on an unknown date, which was exposed to temperature of 55.6 F for under 8 hours (reported as between 7:50 AM to 3:50 PM). No adverse event was reported. Follow up report received from a healthcare professional (medical assistant) on 24 Dec 2015: Updated patient details (age and gender_ and vaccine information (dose, lot number and route of administration).
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024868 is an initial spontaneous report received from a physician assistant on 25 Nov 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that FLUVIRIN prefilled syringe was kept at 47 F for 10 min. No adverse event was reported following this maladministration. No further information was provided.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024824 is a spontaneous report initially received from a health care professional on 23 Nov 2015. This report refers to a 44 year old male patient. Medical history was not reported. The patient was vaccinated with unknown vaccine and it was tolerated. Concomitant medications was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) intramuscularly into left deltoid at a dose of 0.5 ml on 23 Nov 2015 at 11:55 am. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse reaction was reported following this maladministration. Follow up report received from other health care professional on 21 Jan 2016: Added batch number, vaccination site and vaccination time.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2015US024821, is an initial spontaneous report received from a health care professional on 23 Nov 2015. This report refers to a 54-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) multi dose vial (MDV) into right deltoid intramuscularly at a dose of 0.5 ml on 23 Nov 2015 at 11:05 am. It was reported that the vaccine administered was out of temperature range at 46.8 degree Fahrenheit for 24 hours. The case was reported as non-serious. No adverse events were reported following the maladministration. Follow up information was received from a health care professional on 21 Jan 2016. Added batch number and patient weight and time of vaccination and site of vaccination and vaccine tolerated in past.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 23-year-old female patient who received BOOSTRIX (batch number 3457Y, expiry date 20th May 2019). Concurrent medical conditions included drug allergy (CIPRO and Sulfa). On 12th January 2017, the patient received BOOSTRIX (intramuscular) .5 ml. On 13th January 2017, 1 days after receiving BOOSTRIX, the patient experienced injection site erythema, injection site warmth and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site lump were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site lump to be related to BOOSTRIX. Additional details were provided as follows: The patient received a dose of BOOSTRIX in her right deltoid and experienced redness, lump and skin which was hot to touch at the injection site.