chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: I saw patient's wife in the store and ask how he was doing. She said he is doing fine. She mentioned that he had a bit of redness at the site and swelling but he is doing good now.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Underarm red, warm, swollen.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Bedridden, Chills, Erythema, Pain, Peripheral swelling
Clinical narrative: Today (Tuesday, December 5th) the patient's wife reported to me that roughly a day after receiving the vaccinations her husband's arm became very red and swollen and he felt chills and very achy. He was bed ridden for the past two days.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt had severe local site injection reaction. Was deep red and warm to touch. Pt did not report any systemic fever as of 12/5/17.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient did not report to us until 2 days later... but experienced itching and redness at the site of injection... warm skin and swelling.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The patient described and showed swelling in the left arm starting in the bicep area (odd, but that's where it started) and it wrapped around and covered the entire upper arm. It had redness, was hot to the touch, and was painful. The patient took ibuprofen scheduled and iced the area. The reaction responded well to these treatments and the swelling began to subside by Sunday morning (3 days later). The patient said she would have seen a doctor if it had not started to get better or if it had gotten any worse, but she did not seek medical help.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Redness and itching along entire arm. Recommended taking Benadryl or other antihistamine. Outcome unknown.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, RV1
Symptoms: Vomiting
Clinical narrative: Patient vomited a massive amount while sleeping on her back. When I lifted her out of her bed, she continued to vomit a massive amount. Definitely was not spit up. Patient does not frequently spit up. And this was far in excessive and more watery than anything she's previously spit up.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Hypersensitivity, Respiratory tract congestion
Clinical narrative: From the time the patient received the PREVNAR 13, the patient is experiencing allergy and congestion. The congestion and allergy never goes away and it  got worse and having shortness of breath.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site inflammation, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Severe swelling, inflammation, hardness and warmth to arm at injection site and surrounding tissue up to a 10 cm circumference. Painful and itching, requiring medical treatment within 24 hours.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Severe swelling, inflammation, hardness and warmth to arm at injection site and surrounding tissue up to a 10 cm circumference. Painful and itching, requiring medical treatment within 24 hours.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Pain and tenderness at injection site x3 weeks.
Age: 13.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal pain upper, Haematochezia
Clinical narrative: This serious initial spontaneous case was received on 23-Nov-2017 from a Pharmacist, concerns a 13-year-old, male patient. It was reported that, the patient had no relevant medical history and had not received any relevant concomitant medications. On 09-Nov-2017, the patient was administered with INN Flu vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number, trade name, manufacturer and expiry date: not reported). On 10-Nov-2017, one day after vaccination, the patient experienced bloody stools and his stomach hurted for 2 days. It was reported that, the patient was not given any treatment medications. On 12-Nov-2017, the patient recovered from the events. The reporter assessed the case as non-serious.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest X-ray normal, Chest pain, Eye pruritus, Lacrimation increased, Musculoskeletal pain
Clinical narrative: This serious initial spontaneous case, was received from Other Non-Health Professional on 27-Nov-2017, concerning a 59-year-old, adult female patient. The patient had received in past flu vaccine and had sharp pain in right shoulder into chest, watery itchy eyes and pleurisy. It was reported that the patient broke her left shoulder in the last July (year unknown). Concomitant medications included: Baby aspirin, Multivitamin and Calcium for unknown indication. On 08-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195781, expiry date: not reported). On 10-Nov-2017, after 2 days of vaccination, the patient woke up in middle of the night with sharp pain in right shoulder into chest and was diagnosed with pleurisy that lasted for 2 weeks. The patient also had watery and itchy eyes. The patient visited urgent care. The chest x-ray and oxygen saturation was found to be normal. It was reported that the patient did not have treatment measures associated with the events. The outcome of the events (watery and itchy eyes) was recovered on 15-Nov-2017 and the event pleurisy was recovered on 27-Nov-2017.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Pleurisy, Sleep disorder
Clinical narrative: This serious initial spontaneous case, was received from Other Non-Health Professional on 27-Nov-2017, concerning a 59-year-old, adult female patient. The patient had received in past flu vaccine and had sharp pain in right shoulder into chest, watery itchy eyes and pleurisy. It was reported that the patient broke her left shoulder in the last July (year unknown). Concomitant medications included: Baby aspirin, Multivitamin and Calcium for unknown indication. On 08-Nov-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195781, expiry date: not reported). On 10-Nov-2017, after 2 days of vaccination, the patient woke up in middle of the night with sharp pain in right shoulder into chest and was diagnosed with pleurisy that lasted for 2 weeks. The patient also had watery and itchy eyes. The patient visited urgent care. The chest x-ray and oxygen saturation was found to be normal. It was reported that the patient did not have treatment measures associated with the events. The outcome of the events (watery and itchy eyes) was recovered on 15-Nov-2017 and the event pleurisy was recovered on 27-Nov-2017.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into pharmacy 12-5-17 stating redness, itchy, and heat around injection site. Also, some swelling around the red area.
Age: 97.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count normal, Syncope, Urine analysis normal
Clinical narrative: Daughter came to pharmacy 12/4/17 and told us that her mom is  fainted and admitted to ER 10/26/17. MD at hospital did blood work as well as urine test result are negative. Discharged home the next day and again fainted episode again.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site infection, Skin reaction
Clinical narrative: Per patient's spouse, patient had a skin reaction to the vaccines administered including a skin infection at site or nearby site - vague description.
Sex: M
Vaccine: YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Initial unsolicited report received from the literature, on 23-Oct-2017. This case is linked with 2017SA207244, 2017SA207248, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207280 and 2017SA207282 and 2017SA205665 (Same reporter). The following is the abstract from the article: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. This case involves 23 years old male patient who was vaccinated with dose of YF-VAX (batch number, expiry date, route and site of administration were not reported) on 01 Jun 2006. The patient's medical history and concomitant medication were not reported. On 16 Jun 2006, 15 days post vaccination, patient had multiple vesicles at inoculation site, slight swelling that progresses to a large area of redness with blisters, swelling and itching on upper arm. Patient denied fever, SOB, chest or joint pain, nausea vomiting or headaches. Laboratory investigation was not reported. He was treated with prednisone 10mg a day for 7 days, fexofenadine 180 mg a day and diphenhydramine 50mg PO at bedtime. Patient was not recovered from events. List of documents held by sender: none.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a 76 year old female patient referring to herself. The patient had no concomitant medication and pertinent medical history. The patient's drug allergy included MACROBID. On an unknown date (reported as when the patient was 64 or 65 year old), the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose and route unknown, 1 time vaccine) to prevent shingles. On 22-NOV-2017 (also reported as the day before Thanksgiving), the patient had an outbreak. She thought the outbreak was pre-shingles. The patient had bumps in the bottom left arm close to her elbow and into her hand. After 3 days the bump cleared up. "This" past Saturday the patient had a second outbreak in the same area. The patient sought medical attention and treatment was given for the adverse event (AE). The patient believed she needed a new vaccine. The outcome of the event and the causality assessment were unknown.
Sex: F
Vaccine: FLU3, MNQ, TYP, YF
Symptoms: Injection site urticaria, Injection site vesicles, Pruritus, Skin irritation, Swelling
Clinical narrative: Initial unsolicited report received from the literature on 23-Oct-2017. This case is linked with linked with 2017SA207244, 2017SA207248, 2017SA207251, 2017SA207267, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207280, 2017SA207282 and 2017SA205665 (Same reporter). The following is the abstract from the article: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. This case involves 57 years old female patient who was vaccinated with first dose of FLUZONE (batch number: U2462AA) intramuscularly in right arm, first dose of YF-VAX (batch number: UF139AA) subcutaneously in left arm, first dose of MENACTRA (batch number: U2278AA) intramuscularly in left arm and first dose of VIVOTIF (batch number: 3001291) orally (expiry date was not reported for all) on 21 Feb 2008. Patient had allergy to acetylsalicylic acid, penicillin and sulpha. Patient did not have any current Illness other medication and concomitant medication were not reported. On 25 Feb 2008 four days post vaccination patient had complained of swelling Lt severe enough she has to go to ER to get ring cut off on 23 Feb 2008. Also had hive like blister at/near injection site of YFVAX (multiple vesicles occurring at the yellow fever inoculation site), itching and irritation all on Left arm. Laboratory investigation was reported as none. Corrective treatment was not reported. Patient was not recovered from events. List of documents held by sender: none.
Sex: F
Vaccine: YF
Symptoms: Blister, Pruritus, Rash vesicular, Skin hyperpigmentation
Clinical narrative: Initial unsolicited report received from the literature on 23-Oct-2017. This case is linked with: 2017SA207244, 2017SA207248, 2017SA207251, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207279, 2017SA207275, 2017SA207277, 2017SA207282, 2017SA207280 and 2017SA207244. (Same literature). Abstract: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. Keywords: yellow fever vaccine; adverse reaction; blisters; rash; hyperpigmentation. This case involves a 20-year-old female patient, who was vaccinated with a dose of YELLOW FEVER VACCINE (batch number, expiry date, dose, dose in series and route of administration were not reported) in left arm on 20-Apr-2011. Patient had no current illness and no preexisting conditions. Concomitant medications were not reported. On 24-Apr-2011, four days after the vaccination, patient developed scratchy patches and blisters on her inner arm next to the injection site. On an unknown date, following the vaccination, patient also developed vesicles and pruritus. It was reported as the patient did not visit any doctor or ER visit and was not hospitalized. Relevant lab tests and corrective treatment were not reported. The outcome of the events scratchy patches and blisters next to the injection site had not recovered and the outcome of all the other events were not reported. Documents held by sender: none.
Sex: M
Vaccine: YF
Symptoms: Dermatitis bullous, Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site irritation
Clinical narrative: Initial unsolicited report received from the literature on 23-Oct-2017. This case is linked with: 2017SA207244, 2017SA207248, 2017SA207251, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207280 and 2017SA205665. Abstract: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. This case involves a 27-year-old male patient, who was vaccinated with a syringe first dose of YF-VAX (batch number: UH350AA, expiry date, route and dose not reported) in left arm on 12-Oct-2012. Patient's medical history was not reported. Patient had no current illness and preexisting conditions. Patient's concomitant medication included Multivitamin and fish oil. On an unknown date, after the vaccination, patient experienced coalescing bullous lesion at the inoculation site associated with surrounding hyperpigmentation. On 17-Oct-2012, five days following the vaccination, patient experienced at first the area surrounding the vaccination site was very puffy, itchy, and red. On an unknown date, few days after the vaccination, later the surface of the skin in the area was covered with small blisters, similar in appearance to sunburn blisters. On an unknown date, after the vaccination, the blisters were gone, but the skin was very irritated, and the inflamed area had increased in size significantly (about the size of a silver dollar right now). Additionally, there was some discoloration that looks similar to bruising, but patient could not think of a reason that patient would had a bruise there. It does not itch anymore, but it was still very painful when touched. It was also reported that patient consulted a medic a few days before the blisters developed and was told to report the reaction, and get to a treatment facility immediately if patient started to have issues with fever, nausea, vomiting, headaches, etc. Patient's other laboratory and corrective treatment was not reported. On an unspecified date, patient was recovered from events injection site vesicles and injection site pruritus. The patient was not yet recovered from other events. Documents held by sender: none.
Sex: M
Vaccine: YF
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site vesicles
Clinical narrative: Initial unsolicited report received from the literature on 23-Oct-2017. This case is linked with: 2017SA207244, 2017SA207248, 2017SA207251, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207273, 2017SA207275, 2017SA207277, 2017SA207279, 2017SA207280 and 2017SA205665. Abstract: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. This case involves a 27-year-old male patient, who was vaccinated with a syringe first dose of YF-VAX (batch number: UH350AA, expiry date, route and dose not reported) in left arm on 12-Oct-2012. Patient's medical history was not reported. Patient had no current illness and preexisting conditions. Patient's concomitant medication included Multivitamin and fish oil. On an unknown date, after the vaccination, patient experienced coalescing bullous lesion at the inoculation site associated with surrounding hyperpigmentation. On 17-Oct-2012, five days following the vaccination, patient experienced at first the area surrounding the vaccination site was very puffy, itchy, and red. On an unknown date, few days after the vaccination, later the surface of the skin in the area was covered with small blisters, similar in appearance to sunburn blisters. On an unknown date, after the vaccination, the blisters were gone, but the skin was very irritated, and the inflamed area had increased in size significantly (about the size of a silver dollar right now). Additionally, there was some discoloration that looks similar to bruising, but patient could not think of a reason that patient would had a bruise there. It does not itch anymore, but it was still very painful when touched. It was also reported that patient consulted a medic a few days before the blisters developed and was told to report the reaction, and get to a treatment facility immediately if patient started to have issues with fever, nausea, vomiting, headaches, etc. Patient's other laboratory and corrective treatment was not reported. On an unspecified date, patient was recovered from events injection site vesicles and injection site pruritus. The patient was not yet recovered from other events. Documents held by sender: none.
Sex: F
Vaccine: YF
Symptoms: Blister, Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from the literature on 23-Oct-2017. This case is linked with: 2017SA207244, 2017SA207248, 2017SA207251, 2017SA207263, 2017SA207267, 2017SA207271, 2017SA207279, 2017SA207273, 2017SA207275, 2017SA207282, 2017SA207280 and 2017SA207244. (Same literature). Abstract: Yellow fever vaccine is a live attenuated viral inoculation indicated for patients traveling to endemic areas. The vaccine is generally well tolerated with minimal adverse effects. Typical side effects include malaise, pain at the injection site, and, albeit rarely, immediate hypersensitivity reactions. We present a case of a rare adverse reaction to yellow fever vaccine in which a patient developed vesicular lesions resulting in bullae and circumferential hyperpigmentation. Keywords: yellow fever vaccine; adverse reaction; blisters; rash; hyperpigmentation. This case involves a 49-year-old female patient, who was vaccinated with a dose one of YF-VAX (Batch number: UI121AA, expiry date and dose was not reported) subcutaneously in left arm on 03-Dec-2014. Patient had no current illness and no Preexisting Conditions. Patient previous vaccinations were not reported. Concomitant medications were reported as Thyroid and estrogen medication. On 03-Dec-2014, same day following the vaccination, patient arm swelled to size of watermelon, she developed bubbles and blisters/vesicles, hard and hot (induration). On an unknown date, following the vaccination, patient also developed erythema. It was reported as patient required ER visit and patient was not hospitalized. Relevant lab tests and corrective treatment were not reported. The outcome of the events peripheral swelling, Vesicles/ Bubbles and blisters, Induration and Skin warm were reported as not recovered and the outcome of erythema was not reported. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hyperhidrosis, Malaise, Posture abnormal, Syncope
Clinical narrative: Initial unsolicited report received from a pharmacist on 20 Oct 2017. This case involves a 17-year-old male patient who was vaccinated with 0.5 ml one dose of MENACTRA (Batch number: UI5766AE and Expiry date: 02-Dec-2018, dose in series not reported) intramuscularly in left deltoid on 16-Oct-2017. Patient medical history was not reported. Concomitant medications were not reported. (It was reported as no other vaccines were given to the patient). On 16-Oct-2017, 10 minutes after the vaccination, patient fainted and on the same day after the vaccination, patient was taken to ER with heart rate of 50. Other lab tests were not reported. No corrective treatment was given to the patient. On an unknown date, patient recovered from the events. List of documents held by sender: none.
Age: 17.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Syncope
Clinical narrative: Initial unsolicited report received from a pharmacist on 20 Oct 2017. This case involves a 17-year-old male patient who was vaccinated with 0.5 ml one dose of MENACTRA (Batch number: UI5766AE and Expiry date: 02-Dec-2018, dose in series not reported) intramuscularly in left deltoid on 16-Oct-2017. Patient medical history was not reported. Concomitant medications were not reported. (It was reported as no other vaccines were given to the patient). On 16-Oct-2017, 10 minutes after the vaccination, patient fainted and on the same day after the vaccination, patient was taken to ER with heart rate of 50. Other lab tests were not reported. No corrective treatment was given to the patient. On an unknown date, patient recovered from the events. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Impaired driving ability, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Initial unsolicited report received from a Consumer on 07-Nov-2017. This case involves a 68 years old female patient who was vaccinated with 0.5 ml one dosage FLUZONE HIGH-DOSE via intramuscular route on right deltoid (batch number, expiry date, dose in series not reported) on 29-Sep-2017. The patient also vaccinated with 0.5 ml one dosage PNEUMOVAX via intramuscular route on left arm (batch number, expiry date, dose in series not reported) on 29-Sep-2017. Patient medical history not reported. It was also reported that patient had no known drug allergy and chronic illness. Patient's thyroid removed and had increased cholesterol. Concomitant medications were not reported. On an unknown date, immediately after vaccination, began having pain in the upper arm. Pain has been ongoing, she has limited ROM in the right arm, has difficulty dressing herself due to the arm pain. Pain is only in the upper arm. Seen by her PCP for the pain. Seen by a chiropractor received physical therapy with no improvement. Lab data and corrective treatment were not reported. Outcome of the events were not recovered. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Initial unsolicited report received from a Consumer on 07-Nov-2017. This case involves a 68 years old female patient who was vaccinated with 0.5 ml one dosage FLUZONE HIGH-DOSE via intramuscular route on right deltoid (batch number, expiry date, dose in series not reported) on 29-Sep-2017. The patient also vaccinated with 0.5 ml one dosage PNEUMOVAX via intramuscular route on left arm (batch number, expiry date, dose in series not reported) on 29-Sep-2017. Patient medical history not reported. It was also reported that patient had no known drug allergy and chronic illness. Patient's thyroid removed and had increased cholesterol. Concomitant medications were not reported. On an unknown date, immediately after vaccination, began having pain in the upper arm. Pain has been ongoing, she has limited ROM in the right arm, has difficulty dressing herself due to the arm pain. Pain is only in the upper arm. Seen by her PCP for the pain. Seen by a chiropractor received physical therapy with no improvement. Lab data and corrective treatment were not reported. Outcome of the events were not recovered. List of documents held by sender: none.
Age: 94.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 14-Nov-2017 and additional information received from the same reporter on 14-Nov-2017. This case involves a 94-year-old female patient who was vaccinated with a 0.5 ml single injection of FLUZONE HIGH-DOSE (Batch number: UI890AB, expiration date and dose in series were not reported) intramuscularly in the left arm on 19-Oct-2017. Patient was not aware of her medical history at this time. Concomitant medications were not reported. On an unknown date, after the vaccination, the patient had bruising and swelling without pain and during the week it extended to her wrist, she had no pain at the injection site at any point although she was embarrassed by the look of the arm. The patient lived in an assisted living so Medical Assistants monitored her arm and the reporter isn't aware if the doctor was contacted at any point. It was also reported that she had a doctor's appointment on 30-Nov-2017 and felt comfortable to wait until that appointment for further evaluation, also she was aware if anything happened that concerns her she should see the doctor at once. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as recovering (also reported as today the site was mostly resolved although there might be a small mark at the injection site). List of documents held by sender: none.
Age: 94.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Injection site discolouration, Swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 14-Nov-2017 and additional information received from the same reporter on 14-Nov-2017. This case involves a 94-year-old female patient who was vaccinated with a 0.5 ml single injection of FLUZONE HIGH-DOSE (Batch number: UI890AB, expiration date and dose in series were not reported) intramuscularly in the left arm on 19-Oct-2017. Patient was not aware of her medical history at this time. Concomitant medications were not reported. On an unknown date, after the vaccination, the patient had bruising and swelling without pain and during the week it extended to her wrist, she had no pain at the injection site at any point although she was embarrassed by the look of the arm. The patient lived in an assisted living so Medical Assistants monitored her arm and the reporter isn't aware if the doctor was contacted at any point. It was also reported that she had a doctor's appointment on 30-Nov-2017 and felt comfortable to wait until that appointment for further evaluation, also she was aware if anything happened that concerns her she should see the doctor at once. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as recovering (also reported as today the site was mostly resolved although there might be a small mark at the injection site). List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Mobility decreased
Clinical narrative: This spontaneous report has been received from a physician and refers to a 18 year old female patient. The patient's concomitant medications included thyroid medication and Hashimoto's disease was reported as concurrent condition. No information was provided regarding the patient's medical history. On an unspecified date in September 2017, the patient was vaccinated with a dose of GARDASIL 9 for human papillomavirus (HPV) prevention (dose, route of administration, lot number and expiration date were not reported). Immediately after vaccination, the patient experienced fatigue, vitamin D deficiency and elevated thyroid peroxidase levels. On an unknown date, before vaccination with GARDASIL 9 thyroid peroxidase levels were in 200 and then after the vaccination were in 1300. On an unknown date, the patient sought medical attention and vitamin D levels were evaluated but results were not reported. The outcome for fatigue, vitamin D deficiency and thyroid disorder was not recovered. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the events. There was not product quality complaint involved.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Anti-thyroid antibody positive, Fatigue, Immediate post-injection reaction, Thyroid disorder, Vitamin D deficiency
Clinical narrative: This spontaneous report has been received from a physician and refers to a 18 year old female patient. The patient's concomitant medications included thyroid medication and Hashimoto's disease was reported as concurrent condition. No information was provided regarding the patient's medical history. On an unspecified date in September 2017, the patient was vaccinated with a dose of GARDASIL 9 for human papillomavirus (HPV) prevention (dose, route of administration, lot number and expiration date were not reported). Immediately after vaccination, the patient experienced fatigue, vitamin D deficiency and elevated thyroid peroxidase levels. On an unknown date, before vaccination with GARDASIL 9 thyroid peroxidase levels were in 200 and then after the vaccination were in 1300. On an unknown date, the patient sought medical attention and vitamin D levels were evaluated but results were not reported. The outcome for fatigue, vitamin D deficiency and thyroid disorder was not recovered. The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the events. There was not product quality complaint involved.
Age: 60.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Injection site pain, Radiculopathy
Clinical narrative: I received the injection on October 7, 2017. My husband also got an injection at the same time, by the same pharmacist. I expected a bit of discomfort for the next few days. After a week, my arm was still feeling sore. My husband said that he was fine. Two weeks later, it was still sore. If anything, it seemed to be getting worse. The pain turned into constant burning, heaviness, and throbbing, exactly at the injection site. I was not able to sleep on the side that I always sleep on due to the pain and burning. I have continued to have complete freedom of movement in my shoulder. I kept waiting for it to subside, but as yet it has not. On November 28, I went to see an orthopedic surgeon, whose specialty is shoulders. I had x-rays taken. As soon as the doctor walked into the examining room, his first words were, "I've been waiting to see when I would get my first case of pain from flu injection. I get them every year." He examined the x-rays, had me do some shoulder tests, and said that the injection irritated the nerves in my arm. It will take awhile to calm down and the pain to subside. I would need 4-6 weeks of physical therapy. I am currently getting physical therapy twice a week.
Age: 60.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Burning sensation, Discomfort, Injection site pain, Injection site reaction, Pain
Clinical narrative: I received the injection on October 7, 2017. My husband also got an injection at the same time, by the same pharmacist. I expected a bit of discomfort for the next few days. After a week, my arm was still feeling sore. My husband said that he was fine. Two weeks later, it was still sore. If anything, it seemed to be getting worse. The pain turned into constant burning, heaviness, and throbbing, exactly at the injection site. I was not able to sleep on the side that I always sleep on due to the pain and burning. I have continued to have complete freedom of movement in my shoulder. I kept waiting for it to subside, but as yet it has not. On November 28, I went to see an orthopedic surgeon, whose specialty is shoulders. I had x-rays taken. As soon as the doctor walked into the examining room, his first words were, "I've been waiting to see when I would get my first case of pain from flu injection. I get them every year." He examined the x-rays, had me do some shoulder tests, and said that the injection irritated the nerves in my arm. It will take awhile to calm down and the pain to subside. I would need 4-6 weeks of physical therapy. I am currently getting physical therapy twice a week.
Age: 60.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Pain in extremity, Sleep disorder, X-ray limb normal
Clinical narrative: I received the injection on October 7, 2017. My husband also got an injection at the same time, by the same pharmacist. I expected a bit of discomfort for the next few days. After a week, my arm was still feeling sore. My husband said that he was fine. Two weeks later, it was still sore. If anything, it seemed to be getting worse. The pain turned into constant burning, heaviness, and throbbing, exactly at the injection site. I was not able to sleep on the side that I always sleep on due to the pain and burning. I have continued to have complete freedom of movement in my shoulder. I kept waiting for it to subside, but as yet it has not. On November 28, I went to see an orthopedic surgeon, whose specialty is shoulders. I had x-rays taken. As soon as the doctor walked into the examining room, his first words were, "I've been waiting to see when I would get my first case of pain from flu injection. I get them every year." He examined the x-rays, had me do some shoulder tests, and said that the injection irritated the nerves in my arm. It will take awhile to calm down and the pain to subside. I would need 4-6 weeks of physical therapy. I am currently getting physical therapy twice a week.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Patient c/o 2 days expanding redness to upper extremity, itchiness, warm to touch at the site, and firmness to the area. Evaluated on 6 Dec in clinic patient was given Topical BENADRYL and MOTRIN for symptom control.
Age: 4.0
Sex: F
Vaccine: HEP
Symptoms: Abnormal behaviour, Aggression, Anger, Disturbance in attention, Tic
Clinical narrative: Vaccine at 12:00 pm, by 4:30 pm she had developed a tic of pulling at her shirt sleeves, one side then the other. This has been going on for six days now, it has not lessened. When she has to pull at her shirt sleeves she loses concentration on whatever she was doing and is fully engrossed in adjusting her sleeves. When asked if she has an itch, or why, she replied with my brain is telling me my body is uncomfortable. The same night she received her vaccine she had the biggest tantrum I have ever seen. The next day at school her teacher pulled me aside after class and told me today she was unlike she had ever been, was angry and mean to other kids.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Ear discomfort, Ear pain, Hot flush, Myalgia
Clinical narrative: Muscle soreness in shoulders, upper back, and neck. Intermittent hot flashes in face and upper body. Earaches and pressure. No rash. Member presented on 6 Dec 2017 which is 10 days after the Anthrax vaccination on 27 Nov 2017 with above symptoms resolved, except for continued intermittent hot flashes in face and upper body. Physical exam normal. No treatment given.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 22 yo female presented on 26 Nov 2017 c/o some swelling and redness over left shoulder after anthrax shot 2 days ago on 24 Nov 2017. Pt is otherwise doing well, and denies F/C, systemic sxs, significant pain, or restricted arm ROM. Exam of left shoulder with 4 cm x 6 cm elliptical area of mild erythema and mild swelling, with minimal tenderness but no warmth or streaking. No treatment other than observation and Motrin prn.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse concerning to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 14-NOV-2017, the patient received an improperly stored dose of PNEUMOVAX 23 (lot # N023651, expiration date 20-MAY-2019) (dosage schedule, dose number and route not reported) for prophylaxis. No adverse effects reported. The time frame of the temperature excursion ranged between 47F to 77F (70F) for 72 hours, which was recorded by a data logger. No previous temperature excursion was reported.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a registered nurse reporting on a 4 year old female patient. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 16-NOV-2017, the patient received inadvertently a partial dose of VARIVAX, subcutaneous, in an unspecified arm for prophylaxis (dose, lot number and expiration date were not reported) with sterile diluent; the reporter indicated that the patient did not receive a complete dose, as the patient's arm moved during the administration. No adverse effects reported.
Age: 27.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 27-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 07-NOV-2017, the patient was vaccinated with the third dose of GARDASIL 9, (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Initial unsolicited report received from a nurse on 20-Oct-2017. This case involves a teen patient (age and gender not reported) who was vaccinated with 0.5 ml prefilled syringes dose of FLUZONE QUADRIVALENT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced swelling, redness, hot area. The patient had no fever or difficulty breathing. Lab data and Corrective treatment were not reported. The event outcome was not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Injection site laceration, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Initial unsolicited report received from a nurse on 20-Oct-2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE ID (batch number: U15904AA, expiry date, dose in series, dose, route and site of administration were not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe laceration and blistering at and around injection site, which was warm to touch, pain and swelling radiating to left hand. Laboratory data and corrective treatment were not reported. Outcome of all the events were not reported. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a nurse on 20-Oct-2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE ID (batch number: U15904AA, expiry date, dose in series, dose, route and site of administration were not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe laceration and blistering at and around injection site, which was warm to touch, pain and swelling radiating to left hand. Laboratory data and corrective treatment were not reported. Outcome of all the events were not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Initial unsolicited report received from a nurse on 20-Oct-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE ID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient couldn't able to lift her arm. Lab data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle atrophy, Myalgia
Clinical narrative: Initial unsolicited report received from a consumer (patient) on 19-OCT-2017. This case involves a 56-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (batch number, expiry date and site of administration was not reported) via intramuscular route on 01-NOV-2015. The patient's medical history was not reported. No other vaccines were taken. On an unknown date, after vaccination, it was stated that patient had muscle pain and aches for one week after vaccine and two weeks later she had muscle atrophy in bilateral quadraceps and now it has spread to her arms. Patient was going to have muscle testing done as lab tests. Corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Fatigue, Malaise, Palpitations
Clinical narrative: Initial unsolicited report received from a other non-health care professional on 21 October 2017. This case involves a 12-year-old female patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (frequency once, batch number and expiration date was not reported) intramuscularly in left deltoid on 21-Oct-2017 at 12:00 PM. Patients medical history and concomitant medication were not reported. On 21-0ct-2017, approximately one-hour post vaccination, the patient began complaining of dizziness and general malaise. On the same day by 3:00 PM, three hours post vaccination, patient had spiked a fever of 104 F, heart rate was 148 and visibly pounding through her chest, had chills, was very dizzy and tired. Other relevant lab tests were not reported. The corrective treatment included tylenol and ibuprofen every 2 hours and placing ice packs on her. It was reported that fever remained for over 24 hours despite corrective treatment (not recovered) and her heart rate continues to race when standing and she continues to complain of dizziness (not recovered). Outcome for other events was reported as unknown. Documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a other non-health care professional on 21 October 2017. This case involves a 12-year-old female patient who was vaccinated with a dose of FLUZONE QUADRIVALENT (frequency once, batch number and expiration date was not reported) intramuscularly in left deltoid on 21-Oct-2017 at 12:00 PM. Patients medical history and concomitant medication were not reported. On 21-0ct-2017, approximately one-hour post vaccination, the patient began complaining of dizziness and general malaise. On the same day by 3:00 PM, three hours post vaccination, patient had spiked a fever of 104 F, heart rate was 148 and visibly pounding through her chest, had chills, was very dizzy and tired. Other relevant lab tests were not reported. The corrective treatment included tylenol and ibuprofen every 2 hours and placing ice packs on her. It was reported that fever remained for over 24 hours despite corrective treatment (not recovered) and her heart rate continues to race when standing and she continues to complain of dizziness (not recovered). Outcome for other events was reported as unknown. Documents held by sender: none.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Initial unsolicited report received from a consumer on 23-Oct-2017. This case involves 9-year-old male patient who was vaccinated with dose of 0.5 ml FLUZONE QIV once via intramuscular route (batch number: U5319AA, expiry date, dose in series, site were not reported) on 14-Dec-2015. Patient's medical history and concomitant medications were not reported. On 15 Dec 2015, one day following the vaccination, patient experienced red, hot itchy parts all over his body. Lab data were not reported. Corrective treatment was reported as Benadryl with some relief. The outcome of the event was not reported. List of documents held by sender: none.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Burning sensation, Feeling hot
Clinical narrative: Burning arm, warm sensation all over body, got weak and sat down. Taken to the ED and put on observation and later released.
Age: 1.08
Sex: M
Vaccine: FLUX
Symptoms: Body temperature increased, Decreased appetite, Vomiting
Clinical narrative: Within an hour of receiving flu shot, patient was throwing up. This is unusual behavior as he does not spit up or throw up. He could not keep anything down until 2am, 11 hours after receiving the shot. This morning, he does not have an appetite but has not thrown up. Took his temperature around 7:15am and he had a temperature of 100.2 degree Fahrenheit. Called doctor around 4:05 pm on 12.05.2017 and was told there was no link between patient throwing up and the flu shot.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Rash-raised over trunk, urticaria took Benadryl-resolved.
Age: 25.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Pt. given flu vaccine instead of TDaP vaccine. Pt. does not have allergies and no reaction to vaccines given. Pt. had flu vaccine 11/17.