chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Case number PHHY2015US167593, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 598292 website 14 Dec 2015. This report refers to a 38-year-old male patient. Historical condition included Crohn's disease and underwent status post remote colectomy. Vaccination history included administration of seasonal influenza vaccine (manufacturer unknown and batch number: not reported) which caused fever. Current conditions included hyperlipidemia and overweight. Concomitant medications included HUMIRA, IMURAN and testosterone. The patient was vaccinated with FLUVIRIN (batch number: 1515801) and PNEUMOVAX (other manufacturer), batch number: K021030) both intramuscularly into left arm on 01 Oct 2015. On 02 Oct 2015 after vaccination, the patient developed fever with body temperature to 101 Fahrenheit and felt achy all over. The outcome of the events was reported as unknown. Seriousness of the events was reported as non serous and causality not reported.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus generalised, Rash
Clinical narrative: Case number PHHY2015US167874, is an initial spontaneous report received form Vaccine Adverse Event Reporting System (VAERS reference number: 598420) website on 14 Dec 2015. This report refers to a 37 years old female patient. Historical condition was not reported. Current conditions included allergic to latex and ibuprofen (manufacturer unknown). Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1517601) intramuscularly into left arm on 02 Oct 2015. On the same day after vaccination, the patient experienced rash and generalized itching. The outcome of  the events was reported as complete recovery. The seriousness of the events was reported as non serious and causality not reported.
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pyrexia, Rash generalised
Clinical narrative: Case number PHHY2015US164735, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598460) website on 14 Dec 2015. This report refers to a 53 years old female patient. Medical history and concurrent illness were none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157602) intramuscularly into left arm on 18 Sep 2015. On 20 Sep 2015 the patient developed body rash, muscle ache and fever. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Case number PHHY2015US167741, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 598637) website on 14 Dec 2015. This report refers to a 23 years old female patient. Medical history was none. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157903) intramuscularly on 01 Oct 2015. On the same day after vaccination the patient experienced soreness and redness at injection site. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Case number PHHY2015US167630 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 600712) on 14 Dec 2015. This report refers to a 47 year old female patient. Her medical history was not reported. She had no current conditions. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 15751P) in the left arm and PREVNAR 13 (batch number: L43700) in the right arm; both vaccines administered intramuscularly on 28 Sep 2015. On 29 Sep 2015, the patient had pain and swelling at injection site and tingling in jaw area. The outcome of the events was reported as unknown. The events were reported as non-serious. The causality of the events was not reported.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Case number PHHY2015US167759, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 600744) website on 14 Dec 2015. This report refers to a 71 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516201) intramuscularly into left arm on 29 Sep 2015. On the same day after vaccination the patient presented with symptoms of feeling faint for a day and half. Outcome of the event was recovered on 01 Oct 2015. The case was assessed as non-serious. Causality of the event was not reported.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2015US167763 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 600757) website on 14 Dec 2015. This report refers to a 61 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1516601) into right arm on 28 Sep 2015. On the same day the patient was also vaccinated with PNEUMOVAX, batch number: L024129, other manufacturer) into left arm and BOOSTRIX (batch number: X4J70, other manufacturer) into right arm. On 29 Sep 2015 the patient experienced pain, redness and swelling at injection site. The patient iced the injection site and took acetaminophen and felt better. Final outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Injection site erythema, Pruritus
Clinical narrative: Case number PHHY2015US165658, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 600955) website on 14 Dec 2015. This report refers to a 64-year-old male patient. Medical history was not reported. The patient had no current illness. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly into the left arm on 23 Sep 2015. On the same day after vaccination, the patient experienced itchy arm, felt like chest was tight and had redness at the site of injection. Final outcome of the events was complete recovery. Events were reported as non-serious. Causality was not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Rash, Vomiting
Clinical narrative: Case number PHHY2015US167821 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 601211) on 14 Dec 2015. This report refers to a 46 year old female patient. Her current conditions included antibiotic allergies. Her concomitant medications were metformin, SYNTHROID and Cetirizine. The patient was vaccinated with FLUVIRIN (batch number: 1515601) intramuscularly in the right arm on 06 Oct 2015. On 07 Oct 2015, the events started with rash and then vomiting. She was very tired. 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.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Case number PHHY2015US167765, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601322) website on 14 Dec 2015. This report refers to a 60 years old female patient. Concurrent conditions included allergic to thimerosal. Concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1576C1) intramuscularly into left arm and ZOSTAVAX (batch number: L011534, other manufacturer) subcutaneously into left arm on 05 Oct 2015. On 06 Oct 2015 the patient experienced itchy, red, and hot at the injection site. Outcome of the events was not recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Decreased appetite, Headache, Nausea
Clinical narrative: Case number PHHY2015US167766, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601404) website on 14 Dec 2015. This report refers to a 31 years old female patient. Concurrent condition included peanut allergy. Concomitant medication included FLONASE. The patient was vaccinated with FLUVIRIN (batch number: 1518101) intramuscularly into right arm on 05 Oct 2015. On the same day after vaccination the patient experienced severe nausea for 48 hours, lack of appetite and low grade headache. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Case number PHHY2015US167538, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 601819) website on 14 Dec 2015. This report refers to a 9-year-old male patient. Historical condition included asthma. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 157604) intramuscularly into the left arm on 10 Oct 2015. On the same day after vaccination, the patient experienced redness (3 into 5 inches) circular around injection site and the injection site was hot to touch. The patient was given BENADRYL and cold compress. Final outcome of the events was unknown. Events were reported as non-serious. Causality was not reported.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash pruritic
Clinical narrative: Case number PHHY2015US164229 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601873) website on 14 Dec 2015. This report refers to a 60 years old female patient. Medical history and concurrent illness were none. Concomitant medications included HCTZ and atorvastatin. The patient was vaccinated with FLUVIRIN (batch number: 1514621) intramuscularly into right arm and ZOSTAVAX (other manufacturer, batch number: L021610) subcutaneously into left arm on 19 Sep 2015. On 26 Sep 2015 the patient developed small itchy spots on trunk, legs, arms and head. Outcome of the events was recovered. The case was assessed as non-serious. Causality of the event was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Dizziness, Fatigue
Clinical narrative: Case number PHHY2015US162676, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 601984) website on 24 Nov 2015. This report refers to a 43 year old female patient. Her medical history was not reported. She had no concurrent condition. The patient's concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) 16 Sep 2015. On 17 Sep 2015, she was feeling weak, tired, drained out and dizzy accompanied by lower back pain. She went to emergency room. The events outcome was reported as complete recovery. The events were reported as non-serious. The causality of the events was reported as possible related to flu vaccine.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Paraesthesia
Clinical narrative: Case number PHHY2015US167097, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602315) website on 14 Dec 2015. This report refers to a 57 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514601) intramuscularly into right arm on 15 Sep 2015. On 17 Sep 2015 the patient's arm began to tingle from the shoulder to the tips of fingers. Further the patient had nerve pain which was not relieved by OTC medication or muscle rubs. The patient went to emergency room due to these events. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain lower, Back pain, Nausea, Vomiting
Clinical narrative: Case number PHHY2015US167117, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602359) website on 14 Dec 2015. This report refers to a 63 years old male patient. Medical history and concomitant medications were not reported. The patient had no current illness. The patient was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly into left arm on 09 Oct 2015. On 10 Oct 2015 the patient experienced extreme pain in lower left back which migrated, over the next 36 hours to the middle lower abdomen. Accompanied by nausea, vomiting and inability to consume even water without vomiting. Outcome of the events was unknown. The case was assessed as non-serious. Causality of the events was not reported.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2015US167631, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 602416) website on 14 Dec 2015. This report refers to a 61 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 157021) intramuscularly into left arm on 26 Sep 2015. It was reported that the injection was painful followed by continued pain in the arm/shoulder for 3 weeks at the current time. The pain was less now but was still ongoing. The case was assessed as non-serious. Causality of the events was not reported.
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2015US167150 is an initial spontaneous report received via Vaccine Adverse Event Reporting System (VAERS reference number: 602548) on 14 Dec 2015. This report refers to a 32 year old male patient. He had medical history or current conditions. His concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) in the left arm and BOOSTRIX (batch number: not reported) in the right arm; both vaccines given intramuscularly on 12 Oct 2015. On 13 Oct 2015 morning, he experienced vomiting, nausea, fever with a body temperature 102.5 and chills. He was given TYLENOL 1000 mg every 6 hours for 2 days. 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.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2015US167157 is an initial spontaneous report received via Vaccine Adverse Events Reporting (VAERS reference number: 602556) on 14 Dec 2015. This report refers to a 58 year old female patient. She had no medical history or current conditions. Her concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) in the left arm intramuscularly on 14 Oct 2015. On 14 Oct 2015 her arm was really sore. She described it as her entire arm being sore and she called the pharmacy around 4:15 pm. No laboratory tests were done. The vaccine administrator recommended the patient to take some over the counter (OTC) pain reliever and to follow up on 15 Oct 2015 if the pain continued. The outcome of the event was unknown. The event was reported as non-serious. The causality of the event was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Joint swelling, X-ray limb
Clinical narrative: Case number PHEH2015US025093, is an initial spontaneous report received from a nurse on 30 Nov 2015. This report refers to a 39-year-old female patient. Medical history was not reported. Concomitant medication was not reported. Patient was vaccinated with FLUVIRIN (batch number: not reported) in past with no adverse effects. The patient received FLUVIRIN (batch number: 157101) intramuscularly on 12 Nov 2015. On 14 Nov 2015, two days following the injection, the patient experienced swelling and pain in the left knee and left arm pain. The patient went to emergency room four days after injection. The patient was given Anti-inflammatories. Final outcome of the events was not recovered. Seriousness and causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Joint swelling, Pain in extremity
Clinical narrative: Case number PHEH2015US025093, is an initial spontaneous report received from a nurse on 30 Nov 2015. This report refers to a 39-year-old female patient. Medical history was not reported. Concomitant medication was not reported. Patient was vaccinated with FLUVIRIN (batch number: not reported) in past with no adverse effects. The patient received FLUVIRIN (batch number: 157101) intramuscularly on 12 Nov 2015. On 14 Nov 2015, two days following the injection, the patient experienced swelling and pain in the left knee and left arm pain. The patient went to emergency room four days after injection. The patient was given Anti-inflammatories. Final outcome of the events was not recovered. Seriousness and causality was not reported.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Antinuclear antibody increased, Arthralgia, Dyspepsia, Eructation, Fatigue
Clinical narrative: Case number PHEH2015US025824 is an initial spontaneous report received from a consumer on 07 Dec 2015. This report refers to a 57 year old female patient. She had no medical history. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly on 10 Nov 2015. The patient had pain in spine that woke her up on an unknown date. On 14 Nov 2015, she had joint pain, overwhelming fatigue and constant indigestion requiring antacids. She also had frequent belching on unspecified date. It was reported that the patient had elevated antinuclear antibody (ANA) and rheumatoid levels (values were not reported). The final outcome of joint pain, overwhelming fatigue and constant indigestion was reported as condition unchanged and that of other events were not reported. The seriousness and causality of the events was not reported. The reporter agreed for follow up contact.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Rheumatoid factor increased, Sleep disorder, Spinal pain
Clinical narrative: Case number PHEH2015US025824 is an initial spontaneous report received from a consumer on 07 Dec 2015. This report refers to a 57 year old female patient. She had no medical history. Her concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly on 10 Nov 2015. The patient had pain in spine that woke her up on an unknown date. On 14 Nov 2015, she had joint pain, overwhelming fatigue and constant indigestion requiring antacids. She also had frequent belching on unspecified date. It was reported that the patient had elevated antinuclear antibody (ANA) and rheumatoid levels (values were not reported). The final outcome of joint pain, overwhelming fatigue and constant indigestion was reported as condition unchanged and that of other events were not reported. The seriousness and causality of the events was not reported. The reporter agreed for follow up contact.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHEH2015US026584, is an initial spontaneous report received from a consumer on 14 Dec 2015. This report refers to a 42-years-old male patient. Past medical history and concomitant medications were not reported. Vaccination history included administration of Flu vaccine (manufacturer unknown) on an unknown date. He was vaccinated with FLUVIRIN (batch number: 1516901 and expiry date: Jun 2016) intramuscularly, in left arm on 05 Dec 2015. He experienced persistent pain and stiffness in left arm on 05 Dec 2015. He stated he did not experience lingering effects before. The outcome of the events was reported as condition unchanged. The seriousness and causality of the events was not reported.
Age: 62.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: Case number PHEH2016US001274, is an initial spontaneous report received from a pharmacist on 13 Jan 2016. This report refers to a 62 year old male patient. This case also contains QA reference number (1011059). Medical history was not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) which was tolerated. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15754P) into right arm and ZOSTAVAX  ((other manufacture), batch number: L028279), subcutaneously both on 13 Jan 2016. It was reported that, syringe was defective. Syringe did not administer dose properly, plunger was fully depressed and when needle removed over half of dose sprayed across the vaccination booth. The reporter stated that another pharmacist was administering a FLUVIRIN and he pushed the plunger all the way down during administration, when pharmacist pulled the needle out of the patient skin a fair amount of vaccine squirted out of the syringe. It was reported that, plunger was fully depressed and tip of the needle (syringe and needle) was intact. The patient had no other issues. The patient was again revaccinated with FLUVIRIN (batch number: not reported) at a dose of 1 ml intramuscularly at 11:15 am on 13 Jan 2016. No adverse event was reported following this maladministration. Seriousness of the maladministration was reported as non serious. Follow up report received from a pharmacist on 02-Feb-2016: FLUVIRIN details (dose and time of administration), new suspect drug (ZOSTER), new event (inappropriate dose of vaccine administered) and reporters comment was updated. Following an internal review done on 18 Mar 2016 it was identified that the case PHHY2016US035442 found to be duplicate of case PHEH2016US001274, hence all the information of PHHY2016US035442 was merged into retained case PHEH2016US001274 and the case PHHY2016US035442 would be deactivated and follow up report received from Vaccine Adverse Event Reporting System (VAERS ID: 618768) website of 15 Mar 2016 was added: Event coding changed from inappropriate dose of vaccine administered to overdose, co-suspect coded with brand name ZOSTAVAX (with correct lot number), event added (syringe issue).
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Case number PHEH2016US001394, is an initial spontaneous report received from a pharmacist via pharmaceutical company (Pfizer In) on 15 Jan 2016. This report refers to a 41 year old female patient. Medical history was not reported. Vaccination history included administration of FLUVIRIN one year before. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15721P, expiry date: 30 May 2016) in the left deltoid intramuscularly on 26 Sep 2015. In Oct 2015, the patient experienced pain in hand an arm still had trouble lifting the arm. The outcome of the event pain in extremity was reported as condition improving and for mobility decreased condition unchanged. Seriousness and causality of the event were not reported. Follow up information was received form other pharmaceuticals company on 08 Feb 2016. Added event mobility decreased.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHEH2016US001394, is an initial spontaneous report received from a pharmacist via pharmaceutical company (Pfizer In) on 15 Jan 2016. This report refers to a 41 year old female patient. Medical history was not reported. Vaccination history included administration of FLUVIRIN one year before. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 15721P, expiry date: 30 May 2016) in the left deltoid intramuscularly on 26 Sep 2015. In Oct 2015, the patient experienced pain in hand an arm still had trouble lifting the arm. The outcome of the event pain in extremity was reported as condition improving and for mobility decreased condition unchanged. Seriousness and causality of the event were not reported. Follow up information was received form other pharmaceuticals company on 08 Feb 2016. Added event mobility decreased.
Sex: F
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a physician via other company, Pfizer (Manufacturer report number- 2014065832) on 10-Jan-2017. This case involves a 68-years-old female patient who was vaccinated with TETANUS TOXOID (Tetanus shot) (lot number, expiration date, route of administration, site of administration, dose and dose in series were not reported) on an unspecified day. The medical history and the concomitant medications were not reported. On an unknown day, following the vaccination, the patients developed allergy to vaccine. The laboratory test and the corrective treatment was not reported. The outcome of the event was not reported. List of the documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2106US022702, is an initial spontaneous report received form a healthcare professional on 23 Aug 2106. This report refers to a 59 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619901) at a dose of 0.5 ml, intramuscularly on 15 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).
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US022705, is an initial spontaneous report received from a healthcare professional on 23 Aug 2016. This report refers to a 58 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619901) at a dose of 0.5 ml, intramuscularly on 17 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.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Case number PHEH2016US022709, is an initial spontaneous report received from a healthcare professional on 23 Aug 2016. This report refers to a 54 years old male patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with singe dose of FLUVIRIN (batch number: 1619901) at a dose of 0.5 ml, intramuscularly on 17 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.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case PHEH2016US022965, is an initial spontaneous report received from a pharmacist on 08 Sep 2016. This report refers to a 52 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 168805) at a dose of 0.5 ml intramuscularly on 08 Sep 2016. The pharmacist stated that, while administering FLUVIRIN the patient received only a partial dose. The needle was secure to the syringe and connected correctly. The needle was inserted all the way  in the arm. The pharmacies thought the syringe leaked. No adverse event was reported following this maladministration (underdose and syringe issue).
Age: 38.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Abdominal pain upper, Chills, Computerised tomogram abdomen, Computerised tomogram pelvis, Computerised tomogram thorax
Clinical narrative: Case number PHEH2016US023875, is an initial spontaneous received from a consumer on 17 Sep 2016. This report refers to a 38 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: NCD: 70461-0119-10) at 0.5 ml intramuscularly on 13 Sep 2016. On the same day after vaccination, the patient experienced horrible head pain hours after vaccination. On 14 Sep 2016 (on second day after injection of FLUVIRIN), the patient experienced horrible stomach pains, nausea and vomiting. The pain level was so extreme that the patient had to visit emergency room. The patient also experienced horrendous body aches, fatigue and low grade fever. Outcome of the events were reported as condition improving. Seriousness and causality of the events were not reported.
Age: 38.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Headache, Laboratory test, Pain, Pyrexia, Vomiting
Clinical narrative: Case number PHEH2016US023875, is an initial spontaneous received from a consumer on 17 Sep 2016. This report refers to a 38 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: NCD: 70461-0119-10) at 0.5 ml intramuscularly on 13 Sep 2016. On the same day after vaccination, the patient experienced horrible head pain hours after vaccination. On 14 Sep 2016 (on second day after injection of FLUVIRIN), the patient experienced horrible stomach pains, nausea and vomiting. The pain level was so extreme that the patient had to visit emergency room. The patient also experienced horrendous body aches, fatigue and low grade fever. Outcome of the events were reported as condition improving. Seriousness and causality of the events were not reported.
Age: 38.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Abdominal pain upper, Fatigue, Headache, Nausea, Pain
Clinical narrative: Case number PHEH2016US023875, is an initial spontaneous received from a consumer on 17 Sep 2016. This report refers to a 38 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: NCD: 70461-0119-10) at 0.5 ml intramuscularly on 13 Sep 2016. On the same day after vaccination, the patient experienced horrible head pain hours after vaccination. On 14 Sep 2016 (on second day after injection of FLUVIRIN), the patient experienced horrible stomach pains, nausea and vomiting. The pain level was so extreme that the patient had to visit emergency room. The patient also experienced horrendous body aches, fatigue and low grade fever. Outcome of the events were reported as condition improving. Seriousness and causality of the events were not reported.
Age: 38.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Case number PHEH2016US023875, is an initial spontaneous received from a consumer on 17 Sep 2016. This report refers to a 38 year old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: NCD: 70461-0119-10) at 0.5 ml intramuscularly on 13 Sep 2016. On the same day after vaccination, the patient experienced horrible head pain hours after vaccination. On 14 Sep 2016 (on second day after injection of FLUVIRIN), the patient experienced horrible stomach pains, nausea and vomiting. The pain level was so extreme that the patient had to visit emergency room. The patient also experienced horrendous body aches, fatigue and low grade fever. Outcome of the events were reported as condition improving. Seriousness and causality of the events were not reported.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Activities of daily living impaired, Grip strength decreased, Injected limb mobility decreased, Mobility decreased, Pain
Clinical narrative: Left arm pain, numbness, tingling, weakness.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain in extremity
Clinical narrative: Left arm pain, numbness, tingling, weakness.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Left arm pain, numbness, tingling, weakness.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Ageusia, Computerised tomogram, Ear pain, Facial paralysis, Pain in jaw
Clinical narrative: On 9/22/11 I began with left sided jaw/ear pain. The following day I had loss of taste in the left side of my mouth. On the third day following the vaccine I had left sided facial drooping. On 09/26/11 I was diagnosed with Bells palsy at the urgent care. On 10/07/11 I informed my primary care doctor of the MMR vaccine, and he suggested it was a possibility there was a correlation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Alopecia, Specialist consultation, Thyroid function test, Vitamin D
Clinical narrative: Diffuse hair loss, alopecia.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Nausea, Pruritus, Pyrexia
Clinical narrative: This spontaneous report was received from a physician referring to a 60 year old female patient. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On 14-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 PUF (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, in December 2016, the patient experienced fever, injection site swelling and injection site erythema. The reporter stated that patient went to emergency on an unspecified date and was treated with KEFLEX 500 mg 3 times daily and prednisone (manufacturer unknown) 50mg orally one time daily. The physician reported that on 18-DEC-2016, due to lack of improvement, KEFLEX was stopped and doxycycline (manufacturer unknown) 100 mg twice daily was started. The physician reported that the patient's arm looks better (injection site swelling and injection site erythema were recovering), however nausea, pyrexia, and itching (pruritus) developed, on an unspecified date in December 2016. The outcome of pruritus, nausea and pyrexia was reported as not recovered. The relationship between the aforementioned events and ZOSTAVAX was not established or mentioned by he reporter. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 months old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 14-SEP-2016, the patients received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 13-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 13 months old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 13-SEP-2016, the patient received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received; Sender's Comments:  US-009507513-1610USA011133:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-DEC-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot number M035690, expiration date 06-FEB-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine was exposed to a temperature excursion of "12 degrees F >5 degrees F but <14 degrees F" for 2 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA007293.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to unknown number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On unknown dates, the patients were inadvertently administered GARDASIL 9 (lot # M016193, expiration date 24-APR-2018, route of administration and dose were not reported) that had been improperly stored. No adverse effects were reported. The vaccine experienced a temperature excursion of 47 Fahrenheit degrees (F) for 5 minutes, which was detected by a digital data logger. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1701USA002060: US-009507513-1701USA002061: US-009507513-1612USA012239.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to unknown number of patients of unknown demographics. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On an unknown date, the patients were inadvertently administered RECOMBIVAX HB injection, lot #M023718, expiration date 09-AUG-2018 (formulation, strength, dose, route of administration were not reported) that had been improperly stored. No adverse effects were reported. The vaccine experienced a temperature excursion of 47 Fahrenheit degrees (F) for 5 minutes, which was detected by a digital data logger. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.; Sender's Comments: US-009507513-1701USA002060: US-009507513-1612USA012239: US-009507513-1701USA002059:
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (Lot# M020521, Expiry date: 17-NOV-2017, 1 dose) for prophylaxis. The pharmacist reported the patient called the pharmacy "the next day complaining of redness, swelling, pain, and inflammation and was ordered KEFLEX by her physician". The pharmacist requested a lot check for this lot of PNEUMOVAX 23. The outcome of the events was reported as recovered/resolved. This case is one of three "Multiple Patient Reports" (MARRS# 1701USA004988 and 1701USA003778). Additional information has been requested. Sender's Comments: US-009507513-1701USA003778: US-009507513-1701USA004988.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 09-JAN-2017, the patient was inadvertently vaccinated subcutaneously with a dose of improperly stored VARIVAX injection, lot # M025870, lot# 24-MAY-2018 (dose and anatomical location were not reported). No adverse effects were reported. Data logger was involved. The VARIVAX was stored in - 13 Celsius degrees for 46 hours 30 minutes. There was no previous excursion. Additional information is not expected as no consent for further contact was given.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Mass, Pyrexia
Clinical narrative: Information had been received on 11-JAN-2017 from a field employee who reported that a female patient (age unknown) who is the consumer reported to her that she experienced "redness, lump, fever, headaches lasting about a week" after receiving a dose of ZOSTAVAX for prevention of shingles at an unspecified pharmacy on an unspecified date. Outcome of events was unknown. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot number L028276, expiration date 28-JUL-2017 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported.  Administered dose of vaccine was exposed to a temperature excursion of "11°F >5°F but <14°F" for 1 hour. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA000973:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with GARDASIL 9 in a many school health care clinics which were dosing GARDASIL 9 according to the Center for Disease Control dosing guidelines, and not the Merck dosing guidelines (strength, dose, frequency, route of administration, lot#, expiry date were not reported). The reporter also believed that he or she was also dosed via the Center for Disease Control guidelines on an unknown date. No adverse effect were reported. Additional information is not expected as no contact details were provided.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness and itching at injection site that lasted for 10 days.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Muscle injury
Clinical narrative: Initial soreness in injection, persisted for over two months, currently participating in physical therapy for muscle injury.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and body aches for 5 hours even after taking Aleeve. Fever peaked at 100.3
Age: 64.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Pain in arm where vaccine was administered that has never gone away.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Rash generalised, Streptococcal infection
Clinical narrative: On day 7 of amoxicillin for a presumed strep infection. Many in daycare positive for it. Rash on buttocks only symptom. Received a PREVNAR and woke up with a whole body rash next day.
Age: 45.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient was diagnosed with Guillain Barre syndrome 11 days after flu vaccine. Presently hospitalized at hospital.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 for prophylaxis, (route, dose, lot and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA012322: US-009507513-1612USA013204: US-009507513-1612USA013205: US-009507513-1612USA013206.
Sex: U
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 4 week old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date, the patient received a dose of PEDVAXHIB (strength, dose, route of administration, lot # and expiration date were not provided) for prophylaxis. No adverse effects were reported in the patient. No product quality complaint was involved. Additional information is not expected because there was no consent to contact the reporter.