chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Case number PHHY2013US140224, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 507447) website on 03 Dec 2013. This report refers to a 65-year-old male patient. His medical history included drug allergy to naproxen, PERCOCET and VICODIN. He was vaccinated with a dose of FLUVRIN (batch number: 1307601) intramuscularly into his left arm on 07 Sep 2013. On 10 Sep 2013 three days after vaccination, he developed severe ache/pain from his knees to his feet, back pain (back also now is in pain) and overall body stiffness. It was also reported that his body felt like poisoned and was being attacked from the inside out. He was unsure about fever. He was taken to Emergency Room (ER) for medical support. He went to an MD and tested for gout which gave a negative test result. The outcome of the events was reported as condition unchanged (still having symptoms) as of 01 Oct 2013. The causality and seriousness of the event were not reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mass
Clinical narrative: Case number PHHY2013US140285, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507816) website on 03 Dec 2013. This report refers to a 70-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN, (batch number: 1309201) intramuscularly into the left arm on 07 Oct 2013. On the same day after vaccination, she developed a lump which was one and half inches in diameter. The lump was not warm/hot or hard to touch and it was not associated with bleeding. It was reported that she never had a problem with the flu shot before. The outcome of the event was reported as condition unchanged as of 12 Oct 2013. The seriousness and causality of the event was not reported. No additional information was available.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea, Skin discolouration
Clinical narrative: Case number PHHY2013US140297, is an initial report from the Vaccine Adverse Event Reporting System (VAERS reference number: 507619) website on 03 Dec 2013. This report refers to a 70-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309201) intramuscularly on 07 Oct 2013. On 08 Oct 2013, he experienced cold, cough, runny nose and developed black/blue spot, oblong in shape. He did not have fever, bleeding and hard to touch. It was reported that he never had a problem with the vaccine. The outcome of the events was reported as condition unchanged as of 12 Oct 2013. The seriousness and causality of the events was not reported. No additional information was available.
Age: 54.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Erythema, Pain, Swelling
Clinical narrative: Case number PHHY2013US140316, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507628) website on 03 Dec 2013. This report refers to a 54-year-old patient of unknown gender. Concomitant drugs included NORCO, KLONOPIN, NEURONTIN, SPIRIVA and SYMBICORT. The patient was vaccinated with FLUVIRIN (batch number: 143421P) intramuscularly and PNEUMOVAX (batch number: J005067) subcutaneously, both in the left arm on 09 Oct 2013. On 10 Oct 2013, the patient experienced redness, burning sensation, swelling and body aches from head to toe. The outcome of the events reported as not recovered. The seriousness and causality of the events were not reported.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Case number PHHY2014US000764 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (reference number: 507658) website on 06 Jan 2014: This report refers to an 88-year-old female patient. Her medical history included allergy to Nabumetone, cervical arthritis, chronic renal disease (stage III), colon adenocarcinoma, hypercholesterolemia, hypertension, hyperuricemia, menopause syndrome and myalgia, osteoarthritis of right knee, pemphigoid, S/P TAH-BSO (Total Abdominal Hysterectomy and Bilateral Salpingo-Oophorectomy) and tubular adenoma of colon. This polymedicated patient was vaccinated with FLUVIRIN (batch number: 13443P) intramuscularly on 12 Oct 2013. Within four hours after vaccination, she experienced left hand swelling, pain and redness. Final outcome of the events was reported as condition unchanged as on 15 Oct 2013. No further information about seriousness and causality was provided.
Age: 68.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Case number PHHY2013US140339, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 507700) website on 03 Dec 2013. This report refers to a 68-year-old male patient. His medical history included hypertension. He was vaccinated with FLUVIRIN (batch number: 1309601) intramuscularly and ZOSTAVAX (batch number: J001005) subcutaneously, both on 01 Oct 2013. On 07 Oct 2013, the patient experienced shingles due to ZOSTAVAX. The patient visited the emergency room. The outcome of the event reported as not recovered as on 12 Oct 2013. The seriousness and causality of the event were not reported.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Case number PHHY2013US140345 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 507702) on 03 Dec 2013. This report refers to a 70-year-old male patient. He was vaccinated with FLUVIRIN (Batch number: 1308501; expiry date: not reported) to left arm on an unspecified date. On an unspecified date after FLUVIRIN shot he developed stiff neck that required care by chiropractor. Outcome of the event was reported as condition unchanged as of 12 Oct 2013. Seriousness and causality were not reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Vertigo
Clinical narrative: Case number PHHY2014US000827 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 507750) website on 06 Jan 2014. This case refers to a 51-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 66521) in his left arm on 08 Oct 2013. On 09 Oct 2013 after vaccination he developed extreme vertigo and nausea. He went to urgent care given anti-nausea medication and steroid. Prescribed steroid and motion sickness pills. On 17 Oct 2013 went to ear nose and throat doctor and ear checks out clear but still suffering from extreme vertigo and nausea. The outcome of the events was reported as condition unchanged as of 17 Oct 2013. The seriousness and causality assessment of the events was not reported.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Feeling hot, Pallor
Clinical narrative: Case number PHHY2014US000842 is an initial spontaneous report from a health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 507785) website on 06 Jan 2014. This case refers to a 66-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number 13415P) in her right arm on 17 Oct 2013. On the same date after vaccination she developed pale color, cold sweats but hot. The outcome of the events was reported as complete recovery as of 17 Oct 2013. The seriousness and causality assessment of the events was not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Malaise, Pruritus, Respiratory tract infection
Clinical narrative: Case number PHHY2014US000860 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 507837) on 06 Jan 2014. This report refers to a 50-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in the left arm on 13 Oct 2013. On an unspecified date after vaccination she presented with a big hard red spot in left arm, which was hot to touch and itchy. Patient felt very fatigued and felt like she had respiratory and sinus infection all at the same time. The patient felt sniffy and was starting to get sick. Outcome of the event was reported complete recovery. Seriousness and causality were not reported.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Sinusitis, Skin warm
Clinical narrative: Case number PHHY2014US000860 is an initial report received from vaccine adverse event reporting system (VAERS reference number: 507837) on 06 Jan 2014. This report refers to a 50-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in the left arm on 13 Oct 2013. On an unspecified date after vaccination she presented with a big hard red spot in left arm, which was hot to touch and itchy. Patient felt very fatigued and felt like she had respiratory and sinus infection all at the same time. The patient felt sniffy and was starting to get sick. Outcome of the event was reported complete recovery. Seriousness and causality were not reported.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Hyperhidrosis, Lymph node pain, Pyrexia, Rash
Clinical narrative: Case number PHHY2014US000887 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 507905) website on 06 Jan 2014. This case refers to 60-year-old male patient. The patient was vaccinated with FLUVIRIN (batch number: 1308501) intramuscularly in right arm, ZOSTAVAX (other manufacturer, batch number: J003723) subcutaneously and PNEUMOVAX (other manufacturer, batch number: J004332) all on 09 Oct 2013. On 10 Oct 2013, the patient developed rash, sweats, fever and sore lymph nodes. He was sent to local walk in clinic for evaluation. The outcome of events was reported as condition unchanged. The seriousness and causality of events was not reported.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Erythema, Feeling abnormal, Local swelling
Clinical narrative: Case number PHHY2014US000893 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 507911) website on 06 Jan 2014. This case refers to 76-year-old female patient. Concomitant medications included NORVASC and MOTRIN. The patient was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in left arm and PNEUMOVAX (other manufacturer, batch number: J004332) intramuscularly in left arm on 14 Oct 2013. On 14 Oct 2013, the patient complained of redness, swelling, bumpy/lumpy and hot to touch an unspecified area. Her back and chest also hurt. No fever but she just felt really bad. She went to emergency room and was given KEFLEX 500 mg and methocarbamol 150 mg. The outcome of events was reported as condition unchanged. The seriousness and causality of events was not reported.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mass, Skin warm
Clinical narrative: Case number PHHY2014US000893 is an initial spontaneous report received from health care professional via Vaccine Adverse Event Reporting System (VAERS reference number: 507911) website on 06 Jan 2014. This case refers to 76-year-old female patient. Concomitant medications included NORVASC and MOTRIN. The patient was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in left arm and PNEUMOVAX (other manufacturer, batch number: J004332) intramuscularly in left arm on 14 Oct 2013. On 14 Oct 2013, the patient complained of redness, swelling, bumpy/lumpy and hot to touch an unspecified area. Her back and chest also hurt. No fever but she just felt really bad. She went to emergency room and was given KEFLEX 500 mg and methocarbamol 150 mg. The outcome of events was reported as condition unchanged. The seriousness and causality of events was not reported.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Case number PHHY2014US000868, is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Report System (VAERS reference number: 509021) website on 06 Jan 2014. This report refers to a 72-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN, (batch number: 1307601) intramuscularly in the right arm on 23 Sep 2013. On 17 Oct 2013, he experienced painful right forearm starting at elbow. He stated that, shot was given in elbow. The outcome of the event was reported as condition unchanged as of 17 Oct 2013. The seriousness and causality of the event were not reported. No additional information was available.
Age: 12.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Wrong drug administered
Clinical narrative: Case number PHHY2013US147861, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 509623) website on 16 Dec 2013. This report refers to a 12 years old female patient. Her medical history and concomitant medication were not reported. She was requested for FLUVIRIN (batch number: 1307601) but in error she received PNEUMOVAX (other manufacturer and batch number: H018944) intramuscularly in the left arm 12 Oct 2013. No more information was available.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia, Vomiting
Clinical narrative: Case number PHHY2013US147756 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 509774) website on 16 Dec 2013. This report refers to a 52-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1308601) intramuscularly on 11 Oct 2013. On an unknown date, post vaccination, she experienced severe illness stating vomiting and fever, etc.; flu-like symptoms. She went to emergency room due to these events. Outcome of the events was reported as condition unchanged as of 15 Oct 2013. Seriousness and causality of the events was not reported.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Upper respiratory tract infection, Vaccination site reaction
Clinical narrative: Case number PHHY2014US000717 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 509974) website on 06 Jan 2014. This case refers to 28-year-old female patient. Concomitant medications included VENTOLIN, FIORICET and LO-OVRAL-28. She was vaccinated with FLUVIRIN (batch number: 1309101) intramuscularly in left arm on 14 Oct 2013. On 15 Oct 2013, the patient developed myalgia at deltoid at vaccination site that initially improved, but patient developed upper respiratory tract infection (URI). It was stated that, at that time pain had increased. The patient was currently on unspecified pain and anti-inflammatory medications. The outcome of events was reported as condition unchanged as of 28 Oct 2013. The seriousness and causality of events were not reported.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Colitis microscopic, Diarrhoea, Flatulence
Clinical narrative: Case number PHHY2014US000725 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 509983) web site on 06 Jan 2014. This report refers to a 55-years-old female patient. Her medical history included allergy to penicillin, ciprofloxacin, latex and thimerosal. Her current conditions included collagenous colitis without diarrhea. Her concomitant medications included liothyronine. She was vaccinated with FLUVIRIN, (batch number: 0044021A) intramuscularly in the right arm on 14 Oct 2013. On 14 Oct 2013, she had abdominal cramping which started in the morning and later diarrhea in the evening. She also had severe gas. It was reported that the diarrhea and abdominal cramping did not stop even at the time of reporting. The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Case number PHHY2013US147874, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 509984) website on 16 Dec 2013. This report refers to a 55 years old male patient. His medical history was not reported and concomitant medication included Montelukast, Gabapentin and SUBOXONE. He was vaccinated with FLUVIRIN, (batch number: not reported) intramuscularly in the left arm on 28 Sep 2013 by the pharmacist. During the vaccination he heard a snapping sound and felt severe pain  in the left arm and shoulder since the date and time of the vaccination. He also reported the pain to his primary physician and he had scheduled an MRI for range of motion. The final outcome of the events was reported das condition unchanged as of 28 Oct 2013. The seriousness and causality of the events were not reported. No more information was available.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Influenza, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Case number PHHY2014US000761 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 509997) website on 06 Jan 2014. This case refers to 58-year-old female patient. Concomitant medications included LIPITOR. She was vaccinated with FLUVIRIN, (batch number: 665210116-0) intramuscularly in left arm on 03 Oct 2013. On 05 Oct 2013, the patient developed full blown flu complete with sore throat, respiratory congestion (nasal and bronchial) three-plus degree fever, aches, chills and vomiting. The outcome of events was reported as condition unchanged as of 28 Oct 2013. The seriousness and causality of events were not reported.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Vomiting
Clinical narrative: Case number PHHY2014US000761 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 509997) website on 06 Jan 2014. This case refers to 58-year-old female patient. Concomitant medications included LIPITOR. She was vaccinated with FLUVIRIN, (batch number: 665210116-0) intramuscularly in left arm on 03 Oct 2013. On 05 Oct 2013, the patient developed full blown flu complete with sore throat, respiratory congestion (nasal and bronchial) three-plus degree fever, aches, chills and vomiting. The outcome of events was reported as condition unchanged as of 28 Oct 2013. The seriousness and causality of events were not reported.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dizziness, Erythema, Fall, Limb discomfort
Clinical narrative: Case number PHHY2014US000802 is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 510066) website on 06 Jan 2014. This case refers to 75-year-old female patient. Her medical history included thiazide diuretic allergy. The patient was vaccinated with FLUVIRIN, (batch number: not reported) in right arm and PNEUMOVAX 23, (batch number: H022280, expiry date: 16 Jul 2014) intramuscularly in right deltoid both on 08 Oct 2013. On the same date, shortly after the vaccinations, her arm felt hot to the touch and the top of her arm was whiter than normal and the underside of her arm was very red. The patient reported that her arm was painful when she tried to lift it, and that it "felt full". The patient also reproted fever and chills and dizziness and on 13 Oct 2013, she had a fall. The patient's injuries were unspecified, but the patient reported to the pharmacist that she was seen by her physician and that she did go for a Magnetic Resonance Imaging (MRI), but no result provided. No treatment was given for these events. She went to emergency room for the events. The outcome of the events was reported as not recovered/not resolved as of 29 Oct 2013. The seriousness and causality of events were not reported.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging, Pain, Pain in extremity, Pallor, Pyrexia
Clinical narrative: Case number PHHY2014US000802 is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 510066) website on 06 Jan 2014. This case refers to 75-year-old female patient. Her medical history included thiazide diuretic allergy. The patient was vaccinated with FLUVIRIN, (batch number: not reported) in right arm and PNEUMOVAX 23, (batch number: H022280, expiry date: 16 Jul 2014) intramuscularly in right deltoid both on 08 Oct 2013. On the same date, shortly after the vaccinations, her arm felt hot to the touch and the top of her arm was whiter than normal and the underside of her arm was very red. The patient reported that her arm was painful when she tried to lift it, and that it "felt full". The patient also reproted fever and chills and dizziness and on 13 Oct 2013, she had a fall. The patient's injuries were unspecified, but the patient reported to the pharmacist that she was seen by her physician and that she did go for a Magnetic Resonance Imaging (MRI), but no result provided. No treatment was given for these events. She went to emergency room for the events. The outcome of the events was reported as not recovered/not resolved as of 29 Oct 2013. The seriousness and causality of events were not reported.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Case number PHHY2014US000802 is an initial spontaneous report received from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 510066) website on 06 Jan 2014. This case refers to 75-year-old female patient. Her medical history included thiazide diuretic allergy. The patient was vaccinated with FLUVIRIN, (batch number: not reported) in right arm and PNEUMOVAX 23, (batch number: H022280, expiry date: 16 Jul 2014) intramuscularly in right deltoid both on 08 Oct 2013. On the same date, shortly after the vaccinations, her arm felt hot to the touch and the top of her arm was whiter than normal and the underside of her arm was very red. The patient reported that her arm was painful when she tried to lift it, and that it "felt full". The patient also reproted fever and chills and dizziness and on 13 Oct 2013, she had a fall. The patient's injuries were unspecified, but the patient reported to the pharmacist that she was seen by her physician and that she did go for a Magnetic Resonance Imaging (MRI), but no result provided. No treatment was given for these events. She went to emergency room for the events. The outcome of the events was reported as not recovered/not resolved as of 29 Oct 2013. The seriousness and causality of events were not reported.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Sensation of foreign body
Clinical narrative: Case number PHHY2013US147765 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 511333) website on 16 Dec 2013: This report refers to a 50-year-old male patient. His medical history concomitant medications were not reported. He was anxious to receive the vaccine and was reassured by the pharmacy. It was verified that he did not have any allergies. He was vaccinated with FLUVIRIN (batch number: 1309401) intramuscularly in the right arm on 04 Nov 2013. He was fine 15 minutes after flu vaccine. 30 minutes later he stated he had lump in throat. He visited the emergency room (ER) following this event. Electrocardiogram was performed but no results were reported. Final outcome of the event was reported as condition unchanged as on 04 Nov 2013. No further information about seriousness and causality was reported.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2014US000763 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 511340) web site on 06 Jan 2014. This report refers to a 51-years-old male patient. His medical history and concomitant medication was not reported. It was reported that he requested FLUARIX QUADRIVALENT (other manufacturer, batch number: not reported), but was vaccinated inadvertently with FLUVIRIN (batch number: 1309701) intramuscularly in the left arm on 24 Oct 2013. No adverse event was reported following the maladministration.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site injury, Injection site pain, Pain, Pain in extremity
Clinical narrative: Case number PHHY2014US000824, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 511488) website on 06 Jan 2014. This report refers to a 59-year-old male patient. His medical history included allergies to iodine, environmental dust, mold, pollen, fur, feathers and grass. Concomitant drugs included MULTAQ, TRICOR, low-dose aspirin, ibuprofen, multi-vitamin, vitamin D and fish oil. He was vaccinated with FLUVIRIN, (batch number: not reported) intramuscularly in the left arm. On the same date, after vaccination the patient experienced pain in left shoulder and arm. It was not sore to the touch, but painful to lay on, especially on the night of vaccination. On an unknown date, 4 weeks later, he still had some pain when laying on it and sharp pain when he was trying to reach behind his back. It was reported that there was a shoulder injury related to vaccine administration. The final outcome of the events reported as not recovered.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dizziness, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Case number PHHY2014US000831 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 511542) web site on 06 Jan 2014. This report refers to a 63-years-old female patient. Her medical history included seasonal allergy, depression and insomnia. Her concomitant medications were trazodone, zolpidem and fluticasone nasal spray. She was vaccinated with FLUVIRIN (batch number: 13424P) intramuscularly on 24 Oct 2013. On 25 Oct 2013, she had very sore arm, shoulder and elbow and the pain radiated down to forearm and hand. It was reported that she was unable to move arm. She also had drowsiness and dizziness which got worsened as the day went on. She had different set of aches daily. She went to emergency room. The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Case number PHHY2014US000831 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 511542) web site on 06 Jan 2014. This report refers to a 63-years-old female patient. Her medical history included seasonal allergy, depression and insomnia. Her concomitant medications were trazodone, zolpidem and fluticasone nasal spray. She was vaccinated with FLUVIRIN (batch number: 13424P) intramuscularly on 24 Oct 2013. On 25 Oct 2013, she had very sore arm, shoulder and elbow and the pain radiated down to forearm and hand. It was reported that she was unable to move arm. She also had drowsiness and dizziness which got worsened as the day went on. She had different set of aches daily. She went to emergency room. The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Peripheral swelling
Clinical narrative: Case number PHHY2014US000891, is an initial spontaneous report received from the consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 511817) website on 06 Jan 2014. This report refers to a 46-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 1309001) intramuscularly in the left arm on 05 Nov 2013. On 06 Nov 2013, she had swelling, redness and bruising at almost her entire top arm. The final outcome of the events reported as recovered.
Age: 19.0
Sex: M
Vaccine: ANTH, HEPAB, JEV1, SMALL, TYP
Symptoms: Post vaccination autoinoculation, Vaccinia virus infection
Clinical narrative: This initial unsolicited case was received on 05 January 2015 via a third party query tool search on the VAERS database, under reference number 540713. A 19-year-old male patient received on 12 August 2014 the following vaccinations: a right arm ACAM2000 (lot number VV004003A); TYPHIM VI(lot number J1631); TWINRIX (GlaxoSmithKline, lot number 3EX72); BIOTHRAX (Emergent, lot number FAV371); IXIARO (Intercell, lot number JEV12B08E). The patient had no current illness or relevant medical history, and was not taking any concomitant medications. Three days post-vaccination, on 15 August 2014, the patient experienced a spread of vaccinia from the original site, with autoinoculation from the site of the spread described as a few inches inferior to the original inoculation site. The patient presented to the emergency room, and the event subsequently recovered on an unspecified date. Documents held by sender: None.
Age: 20.0
Sex: M
Vaccine: ANTH, FLU3, SMALL, TYP, ANTH, FLU3, SMALL, TYP
Symptoms: Blood bilirubin increased, Pruritus, Rash generalised
Clinical narrative: Initial case received on 05 January 2015 via a third party query tool search on the VAERS database, under reference number 551068. A 20-year-old male patient had received an injection of ACAM2000 (lot number VVD4-003A, site of administration not reported), concomitantly with TYPHIM VI (lot number J1629, route and site of administration unknown), BIOTHRAX (other manufacturer, lot number FAV387A, route and site of administration unknown), and Influenza vaccine (other manufacturer, lot number T58B05, route and site of administration not reported) on 26 September 2014. On 09 October 2014, approximately 13 days post vaccination, the patient developed generalized rash which began in legs and then spread to the rest of the body including face and hands. Pruritus was also experienced. The patient was found to be afebrile. There was a mild bilirubin increase noted (1.4). The patient was given BENADRYL. The patient was hospitalized (dates not reported). Outcome was reported as recovered. Note: To date, the only ACAM2000 lot released to the SNS from the bulk lot VV04-003 is VV04-003-A. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of pain in arm in a 61-year-old female patient who received BOOSTRIX (batch number 3P9CL, expiry date 15th April 2016). Previously administered products included PNEUMOVAX (given as 1 dose in series). On 28th September 2014, the patient received BOOSTRIX .5 ml. On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced pain in arm, pain in arm and difficulty sleeping. On an unknown date, the outcome of the pain in arm, pain in arm and difficulty sleeping were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, pain in arm and difficulty sleeping to be related to BOOSTRIX. Additional information: The pharmacist wants the patient to call and file the adverse event report herself since she has more details.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: I got the shot on Nov 3, the next morning I could not move my shoulder or right arm. I went to my PCP and she sent me to ortho. They said they see this happen 4-5 times a year when flu shots are given to high. I received a cortisone injection.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain
Clinical narrative: This spontaneous report was received from a consumer and refers to herself, a 66 year old female patient with sulfa allergy. On 12-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous in the left arm. On an unknown date the patient experienced pain and discomfort in her left arm where she received the ZOSTAVAX. Her physician told her to put a warm compress on her arm. The patient was still experiencing the discomfort at the time of the report. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: The patient's arm began hurting at 10 am following the inject at 9:30 am on 12-16-14. Some redness. Fever 101.7 (normal temp = 97) by 2 pm that day patient stated that her arm hurt from injection site down below her elbow (excruciating pain). Her arm is still sore as of 12-29-14. Range of motion cause patient pain.
Age: 45.0
Sex: M
Vaccine: MMR
Symptoms: Mumps antibody test, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 45 year old male patient who was a physician. The patient's pertinent medical history included seasonal allergies. Concomitant therapies included CLARITIN. It was reported that the patient had received MMR monovalents as a child in 1970 with no type of side effects. The nurse stated that the patient had to be re-vaccinated with M-M-R II because his titer was equivocal for mumps. On 17-DEC-2014 the patient was vaccinated with M-M-R II, dose 0.5ml, lot nr: K002528, expiry date: 18-FEB-2016 subcutaneously, in left arm. Approximately 2 hours after vaccination, the patient's left hand had swelling, itching, and faint red rash. There was no other adverse events. The patient received oral BENADRYL, which helped a bit, but it did not resolve the swelling as it returned. On 21-DEC-2014 the patient sought a medical attention and went to the emergency room. There was no lab tests performed. He was treated with an unspecified anti-inflammatory and released. The patient was not hospitalized. The anti-inflammatory medication was not helpful therefore the physician increased the dose of antihistamine medication, but there was no improvement. The patient still had tissue swelling of the left hand. The nurse stated that she vaccinated others with the same lot number of M-M-R II and they had not experienced any adverse effects. The outcomes of the events: swelling, itching and faint red rash were not recovered/not resolved. The relatedness between the events and the M-M-R II was not reported. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Chest discomfort, Chest pain, Painful respiration, Pharyngeal oedema
Clinical narrative: Swelling in throat, chest tighness/pain, hurting while breathing.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Pruritus generalised, Rash
Clinical narrative: Severe Itching and Rash on Back and Lower Abdomen...also feel itchy on other parts of body.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Influenza like illness, Injection site rash
Clinical narrative: Rash around injection site. Flu like Sx.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chapped lips, Cheilitis, Lip swelling, Pharyngeal oedema
Clinical narrative: Initial unsolicited report was received from a consumer, who is also the patient, on 05 January 2015. A 65 year-old female with a history of hypothyroidism had received on 24 November 2014 FLUZONE HD (lot number and administration details not reported) and PNEUMOVAX (lot number and administration details not reported) and six days later on 30 November 2014 (also reported as 01 December 2014), experienced swelling of her lips and throat and her lips became all red and chapped. Patient was evaluated by a nurse practitioner who did not tell the patient that this was or could have  been caused by the vaccines. Treatment included BENADRYL, steroids and amoxicillin. No further information was available at the time of the report. Outcome was unknown. Documents held by sender: none.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle spasms, Peroneal nerve palsy
Clinical narrative: Right foot developed 'drop foot'. Noticed when leaving vaccine location but did not taken seriously. Cannot raise front of right foot at heel (dorsiflexion) as before vaccine and when comparing to other foot. Front of right foot drops when trying to stand on right heel only. Cramps in the right exterior ? muscle about twice a week.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Chills, Fatigue, Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: Began as aches in legs on the 4th. Night time extreme chills, nasal congestion and fever. This continued for three nights. Turned into extreme chest congestion. At time of report still has effects. Tired and drained overall feeling.
Age: 60.0
Sex: F
Vaccine: FLUC3
Symptoms: Respiratory tract congestion
Clinical narrative: Began as aches in legs on the 4th. Night time extreme chills, nasal congestion and fever. This continued for three nights. Turned into extreme chest congestion. At time of report still has effects. Tired and drained overall feeling.
Age: 21.0
Sex: F
Vaccine: FLUC3
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Up to 102 Temp, tired, achy - lasted 4 days. Fever finally leaving.
Sex: U
Vaccine: FLUX
Symptoms: Death, Oesophageal carcinoma
Clinical narrative: This medically confirmed spontaneous report (initial receipt-29-Dec-2014) concerns a patient of unknown demography. The patient had a concurrent condition of human immunodeficiency virus which was contributing to death but not resulting in the underlying cause of death. On 12-May-2014, the patient received influenza virus vaccine (manufacturer and batch number not reported). On 30-Nov-2014, the patient died due to metastatic esophageal carcinoma. The Medical Examiner or Coroner was contacted. The outcome was reported as fatal. Reporter comments: It was unknown if tobacco contributed to death. The manner of death was natural.
Sex: M
Vaccine: FLU3
Symptoms: Joint contracture, Peripheral swelling
Clinical narrative: Case number PHEH2015US000764 is an initial spontaneous report from a nurse received on 07 Jan 2015. This report refers to an adult male patient (in his 50's). He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly in the arm on an unknown date. On an unknown date, after vaccination he experienced unilateral hand contracture in the arm where vaccine was given as well as had bilateral upper extremity swelling. The outcome of the events was unknown. The seriousness and causality of the events was not reported. Seriousness assessment of the events (unilateral hand contracture and bilateral upper extremity swelling) was upgraded based on the available information in the source document.
Sex: U
Vaccine: RAB, RAB
Symptoms: Anaphylactic reaction
Clinical narrative: Case number PHEH2015US000589 is a combined initial and follow up spontaneous reports received from a pharmacist via another pharmaceutical company on 06 Jan 2015 and from the Quality Assurance department (QA reference number: 345284) on 07 Jan 2015. This report refers to a patient of an unspecified age and gender. Past medical history and concomitant medications of the patient were not reported. On an unspecified date, the patient was vaccinated with RABAVERT (batch number: not reported) and with IMOVAX (other manufacturer, batch number: not reported). On an unspecified date, several years prior to this report, the patient developed an anaphylactic reaction to either to RABAVERT or to IMOVAX. The outcome of the events was not reported. The seriousness of the event was not reported but the seriousness of anaphylactic reaction was upgraded based on the NVS-IME list. The causality of event was not reported.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 6 month old female patient. Patient's medical history included vaccination on 21-APR-2014 with the first dose of ROTATEQ (2 ml, orally, lot # J002785), first dose of DTAPHBIP (default manufacturer GlaxoSmithKline reported as "GSK") (0.5 ml, left right thigh, lot # UH969AA) and with first dose of PCV 13 (default manufacturer: Pfizer reported as "PFI") (0.5 ml, right thigh, lot # G77643), and on 02-JUL-2014 with second dose of ROTATEQ (2 ml, orally, lot # J004875), second dose of DTAPHBIP (GSK) (0.5 ml, left thigh, lot # 2EB97), second dose of HIB (AVP) (0.5 ml, right thigh, lot # UH969AA) and second dose of PCV 13 (0.5 ml, right thigh, lot # H17300). Patient had no history of chickenpox. On 03-SEP-2014, the patient was vaccinated with incorrectly stored dose of ROTATEQ (third dose, lot # J004875, 2 ml, orally). Concomitant therapies included third dose of DTAPHBIP, HIB and PCV 13. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 6 month old female patient. Patient's medical history included vaccination on 21-APR-2014 with the first dose of ROTATEQ (2 ml, orally, lot # J002785), first dose of DTAPHBIP (default manufacturer GlaxoSmithKline reported as "GSK") (0.5 ml, left right thigh, lot # UH969AA) and with first dose of PCV 13 (default manufacturer: Pfizer reported as "PFI") (0.5 ml, right thigh, lot # G77643), and on 02-JUL-2014 with second dose of ROTATEQ (2 ml, orally, lot # J004875), second dose of DTAPHBIP (GSK) (0.5 ml, left thigh, lot # 2EB97), second dose of HIB (AVP) (0.5 ml, right thigh, lot # UH969AA) and second dose of PCV 13 (0.5 ml, right thigh, lot # H17300). Patient had no history of chickenpox. On 03-SEP-2014, the patient was vaccinated with incorrectly stored dose of ROTATEQ (third dose, lot # J004875, 2 ml, orally). Concomitant therapies included third dose of DTAPHBIP, HIB and PCV 13. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Convulsion neonatal
Clinical narrative: This case was reported by a consumer (subject's mother) via a sales representative and described the occurrence of seizure in a neonate female subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of ENGERIX B pediatric (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with ENGERIX B pediatric, the subject experienced seizure. The physician was informed or consulted regarding the reported event. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 17 April 2014: The newborn subject, experienced seizures after each administration and that she received them at/from Hospital. Follow-up information received on 29 April 2014: A week or so after the 1st vaccination week after the 1st vaccination with ENGERIX B pediatric, the subject started having seizures and was still experienced then, as she was 3 years old at the time of reporting. The subject's mother contacted the hospital in order to obtain the lot numbers of the vaccines as three different types of Hepatitis B vaccines were administered. At the time of reporting the information was not available. The subject's mother contacted her physicians and they were not sure if the seizures were caused by the vaccine. She wondered if her child was the "10% of kids that are sensitive to vaccines and can't get them". At the time of reporting the event was unresolved. The consumer was unsure if she wanted to pursue this any further and declined to provide her address for authorization to contact healthcare professional.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 4 month old male patient. Patient had no history of chickenpox. On 30-OCT-2014, the patient was vaccinated with first dose of ROTATEQ (dose: 2 ml, orally) (lot # J013589, expiration date: 06-JUN-2015) which was incorrectly stored. Concomitant therapies included DTAPHBIP (default manufacturer GlaxoSmithKline reported as "GSK"), HIB (default manufacturer: Sanofi reported as "AVP") and PCV 13 (default manufacturer: Pfizer reported as "PFI"). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 4 month old male patient. Patient had no history of chickenpox. On 30-OCT-2014, the patient was vaccinated with first dose of ROTATEQ (dose: 2 ml, orally) (lot # J013589, expiration date: 06-JUN-2015) which was incorrectly stored. Concomitant therapies included DTAPHBIP (default manufacturer GlaxoSmithKline reported as "GSK"), HIB (default manufacturer: Sanofi reported as "AVP") and PCV 13 (default manufacturer: Pfizer reported as "PFI"). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.