chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Tenderness, Vomiting
Clinical narrative: Case number PHHY2015US062095, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568661) website on 12 May 2015. This report refers to a 32 years old polymedicated male patient. Medical history was not reported. He was vaccinated with FLUVIRIN (batch number: 145021) into left arm on 02 Mar 2015. On the same day, he was also vaccinated with ADACEL (batch number: U4971AA) into right arm and PNEUMOVAX (K009874, other manufacturer) into left arm. On 03 Mar 2015, the patient experienced rash, swelling, redness, tenderness, fever, nausea and vomiting. Outcome of the events was unknown. Case was assessed as non-serious. Causality of the events was not reported.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nodule, Pruritus, Swelling
Clinical narrative: Case number PHHY2015US062097, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568673) website on 12 May 2015. This report refers to a 17 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 146304) intramuscularly into left arm on 09 Oct 2014. On 23 Oct 2014, the patient presented with red, raised, knot that was itching. Outcome of the events was reported as not recovered. Case was assessed as non-serious. Causality of the events was not reported.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Underdose
Clinical narrative: Case number PHHY2015US062222, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 569745) website on 12 May 2015. This report refers to a 68 years old patient of an unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with low dose of FLUVIRIN (batch number: unknown) on 17 Nov 2012. Case was assessed as non-serious. No adverse event was reported.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Scar
Clinical narrative: Case number PHHY2015US070591, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 571126) website on 09 Jun 2015. This report refers to a 48-year-old male patient. The patient's concurrent conditions included rash outbreak/bumps and pneumonia. Concomitant medications were none. On 17 Sep 2014, the patient was vaccinated with PNEUMOVAX 23 (batch number: not reported). The patient was vaccinated with FLUVIRIN (batch number: 66521011710) on 16 Oct 2014. On 17 Oct 2014, the patient had a break out on face and neck small bumps and scars and left arm. Further the patient had pneumonia. The patient was given three medications (no details provided) and antibiotic for one day. The outcome of the events was condition unchanged. The events were reported as non-serious. Causality was not reported.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Case number PHHY2015US070551 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 571493) received on 09 Jun 2015. This report refers to a 69-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number 145002) in his right arm intramuscularly on 22 Oct 2015. On 10 Nov 2014 about 2 weeks after receiving the vaccine he began feeling pain and stiffness in his right arm. He saw his physician in Dec 2014, and reported the problem, but the doctor did not address the issue. The patient stated that his arm began getting weaker and had more stiffness after this time, but with some increase in exercise of the muscles, seem to get somewhat better. The arm showed no outward signs of swelling or infection, but the patient stated that the pain was persisting. Following the events he visited the emergency room. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 62.0
Sex: F
Vaccine: FLU3, PNC13, FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Case number PHHY2015US070471, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 572954) website on 09 Jun 2015. This report refers to a 62 years old female patient. The patient's concurrent condition included rheumatoid arthritis. Concomitant medication included BACTRIM, citalopram, cyclobenzaprine, hydroxyzine, leflunomide and levothyroxine. The patient was vaccinated with FLUVIRIN (batch number: 145405) into right arm and PREVNAR 13 (batch number: H86652, other manufacturer) into left arm; both vaccines administered intramuscularly on 07 Apr 2015. It was reported that the patient received vaccines which were expired in Mar 2015. Case was assessed as non-serious. No adverse event was reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Feeling cold, Hyperhidrosis, Injection site erythema, Tremor
Clinical narrative: Case number PHHY2015US070720, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 573248) website on 09 Jun 2015. This report refers to a 65-year-old male patient. He was vaccinated with FLUVIRIN (batch number: 1205901) along with PNEUMOVAX (batch number: 0709AE, other manufacturer), both in the right arm on 18 Sep 2012. On the same date night, after vaccination he was cold, shaking like a leaf, sweating but cold. On 19 Sep 2012, he felt bad, but did not have the shakes. On an unknown date, he felt better but noticed redness at injection site without pain and swelling, just a bug red at site about the size of a saucer. He had no fever. The outcome of the events reported as recovered. The events as non-serious. The causality of the events was not reported.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Case number PHHY2015US077285, is an initial spontaneous report received from the vaccine adverse events reporting system (VAERS reference number: 574266) on 15 Jun 2015. This report refers to a 29 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: not reported) instead of TDAP (batch number: not reported) on 09 Feb 2015. No adverse events reported after the maladministration.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bone disorder
Clinical narrative: Case number PHHY2015US088056, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 574330) website on 07 Jul 2015. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date after vaccination the patient experienced left radius distortion. Final outcome, seriousness and causality was not reported.
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, X-ray limb normal
Clinical narrative: Case number PHHY2015US088056, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 574330) website on 07 Jul 2015. This report refers to female patient of unknown age. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on an unknown date. On an unknown date after vaccination the patient experienced left radius distortion. Final outcome, seriousness and causality was not reported.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Case number PHHY2015US081037 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 574342) received on 15 Jun 2015. This report refers to a 70-year-old patient of unspecified gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: unknown)) on 24 Sep 2014. It was reported that the patient was administered the wrong seasonal influenza vaccine. No adverse event was reported following this administration error.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Case number PHHY2015US085557, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS ID: 575095) received on 07 Jul 2015. This report refers to a 58 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413701) into left arm along with PNEUMOVAX (batch number: K009809, other manufacturer) into right arm on 08 Jan 2015. On 10 Jan 2015 the patient presented with painful arms and shoulders. Further the patient stated that it hurts to raise arms over head. Outcome of the events was condition unchanged as of 22 Apr 2015. Seriousness and causality of the events were not reported.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Case number PHHY2015US085586, is an initial spontaneous report from the Vaccine Adverse Event Reporting System (VAERS ID: 575719) received on 07 Jul 2015. This report refers to a 62 years old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1413701) intramuscularly into left arm on 25 Nov 2014. On the same day after vaccination the patient's arm became sore which continued to be sore 5 months later. Further the patient could not lift her arm at 90 degrees as it was constantly aching. The patient was treated with APAP and Ibuprofen with no improvement. Final outcome of the events was condition unchanged. Seriousness and causality of the events was not reported.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Muscular weakness, Pain in extremity, Sleep disorder
Clinical narrative: Case number PHHY2015US088722, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 575807) website on 07 Jul 2015. This report refers to a 73-year-old female patient. Concurrent conditions included thyroid. Concomitant medications included levothyroxine. The patient received FLUVIRIN (batch number: not reported) into the right arm on 22 Oct 2014. On 27 Oct 2014, the patient experienced pain in right arm and was unable to life above the shoulder level. Further the patient had weakness in the arm when holding an object heavier than a glass and was sleepless at nights because of the pain. Final outcome was condition unchanged. The events were reported as non-serious. Causality was not reported.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Amenorrhoea, Menorrhagia, Muscle spasms
Clinical narrative: Case number PHHY2015US123552 is an initial spontaneous report received via vaccine adverse events reporting system (VAERS reference number: 578696) on 05 Oct 2015. This report refers to a 12 year old female patient. She had no medical history, current conditions or concomitant medications. She was vaccinated with FLUVIRIN (batch number: not reported) on 05 Jun 2011. It was reported that her menstruation began not long after the vaccination and she had heavy bleeding with cramps which were very painful on 01 Aug 2011. This went for over a year. Her periods then stopped completely. She went to emergency room and had now to take hormones for her period to begin. The reporter stated that the patient would have problems conceiving when she decides so and it would be something that would affect her for the rest of her life. The final outcome of the event period stopped completely was reported as condition unchanged and that of other events were reported as complete recovery. The events were reported as non-serious. The causality of the events was not reported.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Case number PHHY2015US124517, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 579630) on 05 Oct 2015. This report refers to a 68 year old male patient. Medical history and current illness was none. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: 1413901) into the left arm and PNEUMOVAX (other manufacturer, batch number: K005797) into the right arm, both intramuscularly on 15 Oct 2014. On 16 Oct 2014, the patient developed muscle pain and arm weakness. He was referred to neurology on 26 May 2015. These events were reported as non-serious. The patient did not recover from the event at the time of reporting. Causality of the event was not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chest pain, Electrocardiogram normal
Clinical narrative: Case number PHHY2015US120474, is an initial spontaneous report received from the Vaccines Adverse Event Reporting System (VAERS, reference number: 580091) on 05 Oct 2015. This report refers to a 63 year old female patient. Medical history was not reported. Current condition included sulfonamide and tetracycline allergy. Concomitant medication included levothyroxine. The patient was vaccinated with FLUVIRIN (batch number: NDC665210111710) intramuscularly into the right arm on 17 Oct 2014. On 09 Dec 2014, the developed severe joint pain all over body and chest pain. The patient was taken to an emergency room. Electrocardiogram was reported as normal. The patient was given TAMIFLU. Outcome of these events was reported as not recovered. Events were reported as non-serious. Causality was not reported.
Sex: M
Vaccine: FLU3, HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHHY2015US125103, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 581185) on 05 Oct 2015. This report refers to male neonate. Medical history and current illness was none. Concomitant medications included erythromycin and AQUAMEPHYTON. The patient received FLUVIRIN (batch number: 14624P) intramuscularly into the right leg on 10 Jun 2015. On the same day, the patient was concomitantly vaccinated with ENGERIX B (other manufacturer, batch number: A9XX7) intramuscularly into the left leg. No adverse event was reported following this maladministration (inappropriate age at vaccine administration).
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint crepitation, Joint range of motion decreased, Musculoskeletal stiffness, Pain
Clinical narrative: Case number PHHY2015US124733, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 581397) website on 05 Oct 2015. This report refers to a 34 year old female patient. Historical condition and concurrent illness were reported as none. Concomitant medications was reported as none. The patient was vaccinated with FLUVIRIN (batch number: 14512P) intramuscular into the left arm on 11 Sep 204. On 13 Sep 2014 the patient experienced slight pain in left shoulder. The patient was told it was normal and was going to subside after a week or so. As time passed, about a month to two months, the pain grew and her shoulder got stiff with limited range of motion. The patient could hear cracks when moved and stated that it was very painful to move in certain places. It got worse while sleeping and waking up. The patient  consulted doctor after three months and he didn't think anything of it and brushed it off. The patient did not get checked out again as she was managing it with ibuprofen and "joint vitamins". The patient still takes vitamins and ibuprofen for the pain when its discomforting. On 11 Jun 2015 the patient felt lot better but not healed all the way. Final outcome of the events was not recovered. The case was assessed as non-serious. Causality of the events was not reported.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Case number PHEH2015US017499 is an initial spontaneous report received from a health care professional on 04 Sep 2015 and a follow up report from the health care professional received on 16 Oct 2015. This report refers to a 40 year old female patient. Past medical history and concomitant medications were not reported. It was reported that the patient who was expecting was vaccinated with FLUVIRIN (batch number: 1514701) intramuscularly on 01 Sep 2015. No adverse events were reported following the maladministration. Follow up report from the health care professional received on 16 Oct 2015: Patient's physician details were updated.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Arthritis, Asthenia, Breast swelling, Computerised tomogram
Clinical narrative: This spontaneous report was received from a 69 year old female patient reporting on herself. Patient's concurrent conditions included codeine allergy. The patient had an unspecified medical history. On 10-AUG-2015, the patient was vaccinated with PNEUMOVAX 23 single 0.5 ml dose, intramuscular. The patient was on unspecified concomitant medications. On 14-AUG-2015, reported as 4 weeks ago, the patient experienced peripheral swelling as her armpit swelled, pain in her right shoulder, muscle spasms, elbow pain, swelling of her breast and injection site pain. The patient received treatment with FLEXERIL. On an unspecified date, the patient was treated at the emergency room but she was not admitted. The patient had scheduled an appointment for medical attention. Laboratory tests included a computed tomography (CAT scan) and X-rays but no results were provided. The patient also stated that the therapy with PNEUMOVAX 23 was continued. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling was reported as not recovered. The reporter did not assess the relatedness of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling with PNEUMOVAX 23. Follow up information has been received from the patient's husband on 05-OCT-2015. The reporter stated that his wife was still having injection site pain and swelling after receiving PNEUMOVAX 23. He also reported that the patient's body still ached, she had inflammation in her joints and swelling under her right breast. The patient's physician also gave her tramadol for her pain. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms, breast swelling, pain and arthritis was reported as not recovered. The reporter did not assess the relatedness of pain and arthritis with PNEUMOVAX 23. Follow up information has been received from a nurse on 05-FEB-2016. The patient was vaccinated with PNEUMOVAX 23 lot # was reported as "24119" (illegible number) at the private doctor's office/hospital on 10-AUG-2015 at 10:45. At that time, the patient did not presented any illness. The nurse stated that the patient experienced severe shoulder pain upper her right extremity and swelling. It was also reported that on an unknown date, the strength in the patient's right arm decreased "decreased power due to pain". At the time of this report the outcome of asthenia was unknown. The reporting nurse considered the events of peripheral swelling, musculoskeletal pain and asthenia to be serious due to disability. Additional information has been requested. Event and narrative were updated.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Muscle spasms, Musculoskeletal pain, Pain, Peripheral swelling
Clinical narrative: This spontaneous report was received from a 69 year old female patient reporting on herself. Patient's concurrent conditions included codeine allergy. The patient had an unspecified medical history. On 10-AUG-2015, the patient was vaccinated with PNEUMOVAX 23 single 0.5 ml dose, intramuscular. The patient was on unspecified concomitant medications. On 14-AUG-2015, reported as 4 weeks ago, the patient experienced peripheral swelling as her armpit swelled, pain in her right shoulder, muscle spasms, elbow pain, swelling of her breast and injection site pain. The patient received treatment with FLEXERIL. On an unspecified date, the patient was treated at the emergency room but she was not admitted. The patient had scheduled an appointment for medical attention. Laboratory tests included a computed tomography (CAT scan) and X-rays but no results were provided. The patient also stated that the therapy with PNEUMOVAX 23 was continued. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling was reported as not recovered. The reporter did not assess the relatedness of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling with PNEUMOVAX 23. Follow up information has been received from the patient's husband on 05-OCT-2015. The reporter stated that his wife was still having injection site pain and swelling after receiving PNEUMOVAX 23. He also reported that the patient's body still ached, she had inflammation in her joints and swelling under her right breast. The patient's physician also gave her tramadol for her pain. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms, breast swelling, pain and arthritis was reported as not recovered. The reporter did not assess the relatedness of pain and arthritis with PNEUMOVAX 23. Follow up information has been received from a nurse on 05-FEB-2016. The patient was vaccinated with PNEUMOVAX 23 lot # was reported as "24119" (illegible number) at the private doctor's office/hospital on 10-AUG-2015 at 10:45. At that time, the patient did not presented any illness. The nurse stated that the patient experienced severe shoulder pain upper her right extremity and swelling. It was also reported that on an unknown date, the strength in the patient's right arm decreased "decreased power due to pain". At the time of this report the outcome of asthenia was unknown. The reporting nurse considered the events of peripheral swelling, musculoskeletal pain and asthenia to be serious due to disability. Additional information has been requested. Event and narrative were updated.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: This spontaneous report was received from a 69 year old female patient reporting on herself. Patient's concurrent conditions included codeine allergy. The patient had an unspecified medical history. On 10-AUG-2015, the patient was vaccinated with PNEUMOVAX 23 single 0.5 ml dose, intramuscular. The patient was on unspecified concomitant medications. On 14-AUG-2015, reported as 4 weeks ago, the patient experienced peripheral swelling as her armpit swelled, pain in her right shoulder, muscle spasms, elbow pain, swelling of her breast and injection site pain. The patient received treatment with FLEXERIL. On an unspecified date, the patient was treated at the emergency room but she was not admitted. The patient had scheduled an appointment for medical attention. Laboratory tests included a computed tomography (CAT scan) and X-rays but no results were provided. The patient also stated that the therapy with PNEUMOVAX 23 was continued. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling was reported as not recovered. The reporter did not assess the relatedness of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms and breast swelling with PNEUMOVAX 23. Follow up information has been received from the patient's husband on 05-OCT-2015. The reporter stated that his wife was still having injection site pain and swelling after receiving PNEUMOVAX 23. He also reported that the patient's body still ached, she had inflammation in her joints and swelling under her right breast. The patient's physician also gave her tramadol for her pain. At the time of this report, the outcome of musculoskeletal pain, arthralgia, injection site pain, peripheral swelling, muscle spasms, breast swelling, pain and arthritis was reported as not recovered. The reporter did not assess the relatedness of pain and arthritis with PNEUMOVAX 23. Follow up information has been received from a nurse on 05-FEB-2016. The patient was vaccinated with PNEUMOVAX 23 lot # was reported as "24119" (illegible number) at the private doctor's office/hospital on 10-AUG-2015 at 10:45. At that time, the patient did not presented any illness. The nurse stated that the patient experienced severe shoulder pain upper her right extremity and swelling. It was also reported that on an unknown date, the strength in the patient's right arm decreased "decreased power due to pain". At the time of this report the outcome of asthenia was unknown. The reporting nurse considered the events of peripheral swelling, musculoskeletal pain and asthenia to be serious due to disability. Additional information has been requested. Event and narrative were updated.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Case number PHEH2015US022215, is an initial spontaneous report from a nurse received on 28 Oct 2015. This report refers to a 68 years old male patient. Medical history and concomitant medications were not reported. The patient was administered with FLUVIRIN (batch number:U146AA) on 22 Oct 2015. Post vaccination the patient developed fever, chills, headache, nausea, lightheadedness, flu like symptoms and redness at the injection site. The outcome, seriousness and causality of the events were not reported.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pyrexia
Clinical narrative: Case number PHEH2015US022215, is an initial spontaneous report from a nurse received on 28 Oct 2015. This report refers to a 68 years old male patient. Medical history and concomitant medications were not reported. The patient was administered with FLUVIRIN (batch number:U146AA) on 22 Oct 2015. Post vaccination the patient developed fever, chills, headache, nausea, lightheadedness, flu like symptoms and redness at the injection site. The outcome, seriousness and causality of the events were not reported.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Influenza, Pain
Clinical narrative: Case number PHEH2015US022545, is an initial spontaneous report received from a consumer on 02 Nov 2015. This report refers to a 63 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 58201) intramuscularly on 27 Oct 2015. On 29 Oct 2015, the patient experienced flu symptoms of cough, body aches and fatigue. The outcome of the events was reported as unknown. Seriousness and causality of the events were not reported.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Case number PHEH2015US022684, is an initial spontaneous report received from a pharmacist on 02 Nov 2015. This report refers to a 64-year-old female patient. Medical history was not reported. Concomitant medication was not reported. The patient received FLUVIRIN (batch number: not reported) intramuscularly on 28 Sep 2015. On the same day after vaccination, the patient experienced soreness and rash in the arm at the injection site. Final outcome of the events was condition unchanged at the time of reporting. Seriousness and causality was not reported.
Age: 15.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash generalised
Clinical narrative: Case number PHEH2015US022009, is an initial spontaneous report received from a health care professional on 26 Oct 2015. This report refers to a 15 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157105) intramuscularly in Oct 2015. Next day the patient came and reported that the night before he developed localized rash on trunk, extremities, face and neck on 22 Oct 2015. The patient was treated with BENADRYL for rash. The outcome of the event was reported as condition improving. Seriousness of the event was unknown. Causality was not reported.
Age: 15.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash
Clinical narrative: Case number PHEH2015US022009, is an initial spontaneous report received from a health care professional on 26 Oct 2015. This report refers to a 15 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157105) intramuscularly in Oct 2015. Next day the patient came and reported that the night before he developed localized rash on trunk, extremities, face and neck on 22 Oct 2015. The patient was treated with BENADRYL for rash. The outcome of the event was reported as condition improving. Seriousness of the event was unknown. Causality was not reported.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Crying, Injection site pain, Pain, Pain in extremity
Clinical narrative: My son was sitting in a chair eating. He out of no where began grabbing his leg at 8:30 PM and saying "owwww" repeatedly. I picked him up and he started crying when his leg moved. After I calmed him about five minutes later I put him down to walk and he started crying and was not willing to walk on his leg that received the vaccine. It hurts to move his leg at all.
Sex: U
Vaccine: FLUX, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial unsolicited report received from a Physician via Partner Company (Pfizer) on 03 February 2016. This case involves a patient (age and gender not reported) who was vaccinated with a dose of Flu shot (batch number, route and site of administration not reported) last year on an unspecified date. The patient's medical history concomitant medications concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced Guillain-Barre Syndrome. Laboratory data and corrective treatment were not reported. The outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event Guillain-Barre Syndrome. List of documents held by sender: none. Sender's Comments: The manufacturer of the INFLUENZA VACCINE involved in this report is not known. Guillain-Barre Syndrome is reported following administration of INFLUENZA VACCINE. This case is very poorly documented consumer case to assess the role of the vaccine. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Shoulder was sore the day after injection. Instead of getting better shoulder became progressively more sore. It has now been 4 months since injection and shoulder is stiff and painful to the touch. Range of motion is decreased, particularly when attempting to reach upward with the arm.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes zoster diagnosis at ED. She was previously vaccinated with 2 doses of varicella vaccine. Painful rash in one dermatome. She also reported a history of varicella in 2009.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN4, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Herpes zoster diagnosis in two-dose varicella vaccine recipient. Painful unilateral rash in one dermatome, left arm. Lasted less than four weeks. No antiviral prescribed.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Herpes zoster, Loss of consciousness, Rash
Clinical narrative: Herpes zoster diagnosis in herpes zoster vaccine recipient. Diagnosed at ED. Painful rash in one dermatome, on right side of face. Also had an upset stomach and passed out. Prescribed antiviral medication.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Nausea, Rash, Rash pruritic, Urticaria
Clinical narrative: Nausea, welts on right upper arm with pruritic rash that spreads down to right wrist.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Vaccination site cellulitis, Vaccination site pain
Clinical narrative: Cellulitis at the site of vaccination, pain and redness. No fever. Admitted to Emergency department at hospital an was treated with antibiotic.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pt reports that site was sore and started itching. A short time after it started itching, the pt noted that the injection site was swollen, red, hot to the touch, and was "hard as a rock". Pt treated symptoms with Benadryl PO, Benadryl topical, and hydrocortisone topical at home. Pt reports that site is less swollen today and that it is bruised, but no longer reddened.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt reports that site was sore and started itching. A short time after it started itching, the pt noted that the injection site was swollen, red, hot to the touch, and was "hard as a rock". Pt treated symptoms with Benadryl PO, Benadryl topical, and hydrocortisone topical at home. Pt reports that site is less swollen today and that it is bruised, but no longer reddened.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Patient has contracted shingles after receiving Zostavax Vaccine. He has rash and pain. Patient was prescribed Valacyclovir to treat the shingles out break.
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site sore to touch, warm, redness extending from 2 in below shoulder to 2 in above elbow in the arm injection was given.
Age: 63.0
Sex: M
Vaccine: HEPAB, MNQ, TDAP, TYP, YF
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Meningococcal (MCV4) vaccine was administered to 63 year old patient for overseas travel.  After patient left clinic, error was recognized and reported.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Dizziness, Dysstasia, Headache, Pain
Clinical narrative: Headache, acute pain and dizziness. Have difficulty to remain standing up.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Eyelid function disorder, Hypoaesthesia
Clinical narrative: Presented at hospital at 12:03 with complaints of Rt side facial numbness, unable to smile on Rt side, unable to close Rt eye completely.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Fatigue, Headache, Injection site erythema
Clinical narrative: Fever 99.8. Baseball size red lump at site of injection. Dizziness. Very bad headache. My shortness of breath increase and I had to use my inhaler multiple times. Very tired for 3 days after the injection. Symptoms are still present but are decreasing each day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Fever 99.8. Baseball size red lump at site of injection. Dizziness. Very bad headache. My shortness of breath increase and I had to use my inhaler multiple times. Very tired for 3 days after the injection. Symptoms are still present but are decreasing each day.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Pain
Clinical narrative: Muscle pain and weakness in both arms and legs. Unable to move. Very sore.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Rash generalised
Clinical narrative: Systemic rash treated with Benadryl.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Red spot at injection site.
Age: 61.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Severe arm pain, headache, fatigue.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Arthralgia, Back pain, Decreased appetite, Ear pain
Clinical narrative: Body aches, fever, headache, abdominal cramping, nausea. Around 10am I started not feeling well. At about 1:50pm bought a thermometer temperature 100.3, pain was escalating to a 10. Got home around 2:30pm. Took 1 tb 800mg ibuprofen because in severe pain. By 4pm. Tempeture went to 101.8 then took 2 tbs acetaminophen 500mg. Pain subsided an hour after the last dose. Within 2 hrs pain again. All cramping. Muscle and joint pain, headache, jaw, ear pain. Lower back. Pretty much everything. Loss of appetite. In the am on Wednesday 2/10/2016 reported to facility and nurse line stated she didnt think it was the vaccinne but if pain is severe to go to urgent care. I told her I can't lack of transportation. I ride a bicycle or bus and my body ached too much I need to call someone for transportation. I've been laying in bed since 2:30pm the day before.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain
Clinical narrative: Body aches, fever, headache, abdominal cramping, nausea. Around 10am I started not feeling well. At about 1:50pm bought a thermometer temperature 100.3, pain was escalating to a 10. Got home around 2:30pm. Took 1 tb 800mg ibuprofen because in severe pain. By 4pm. Tempeture went to 101.8 then took 2 tbs acetaminophen 500mg. Pain subsided an hour after the last dose. Within 2 hrs pain again. All cramping. Muscle and joint pain, headache, jaw, ear pain. Lower back. Pretty much everything. Loss of appetite. In the am on Wednesday 2/10/2016 reported to facility and nurse line stated she didnt think it was the vaccinne but if pain is severe to go to urgent care. I told her I can't lack of transportation. I ride a bicycle or bus and my body ached too much I need to call someone for transportation. I've been laying in bed since 2:30pm the day before.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in jaw, Pyrexia
Clinical narrative: Body aches, fever, headache, abdominal cramping, nausea. Around 10am I started not feeling well. At about 1:50pm bought a thermometer temperature 100.3, pain was escalating to a 10. Got home around 2:30pm. Took 1 tb 800mg ibuprofen because in severe pain. By 4pm. Tempeture went to 101.8 then took 2 tbs acetaminophen 500mg. Pain subsided an hour after the last dose. Within 2 hrs pain again. All cramping. Muscle and joint pain, headache, jaw, ear pain. Lower back. Pretty much everything. Loss of appetite. In the am on Wednesday 2/10/2016 reported to facility and nurse line stated she didnt think it was the vaccinne but if pain is severe to go to urgent care. I told her I can't lack of transportation. I ride a bicycle or bus and my body ached too much I need to call someone for transportation. I've been laying in bed since 2:30pm the day before.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Rash
Clinical narrative: Rash on her arm, hand and abdomen.
Age: 62.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Chills, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Upon second medical examination of the case during internal review, a significant correction was performed on 9 February 2016 to change the company causality from "Unclassified" to "Possible". Upon second medical examination of the case during internal review, a significant correction was performed on 9 February 2016 to add modifier for the company drug 'Praluent' and to add the labelling for this product in event to product assessment screen. Initial unsolicited report received from a healthcare professional on 10 November 2015. This case involves a 62-year-old female patient who was vaccinated with a dose of Flu vaccine (batch number, expiration date, dose number, dose, site and route were not reported) on or around 15 October 2015. The patient also received a dose of Praluent 75mg for treatment of cholesterol on or around 15 October 2015. On 29 October 2015 (fourteen days later) the patient received her second Praluent dose 75mg. The treating physician discontinued Praluent on 29 November 2015. The patient's medical history and Concomitant medications were not reported. On unspecified date following the vaccination the patient experienced flu like symptoms, nausea, fever, chills and body aches. After second dose of Praluent, the patient again experienced the same flu like symptoms, nausea, fever, chills and body ache. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. The treating physician was uncertain if the symptoms could be attributed to Praluent, the flu vaccine or illness. List of documents held by sender: none. Addendum on 9 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 9 February 2016 to add modifier for the company drug 'Praluent' and to add the labelling for this product in event to product assessment screen. Addendum on 9 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 9 February 2016 to change the company causality from "Unclassified" to "Possible".
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site urticaria, Injection site vesicles, Rash pruritic
Clinical narrative: Spreading itchy rash, including sizable wheel and vesicles at site of injection.  No respiratory, cardiac, or throat symptoms.  Placed on prednisone with good effect -- less itching, rash nearly resolved.  Also placed on antibiotics as precaution, however more likely hypersensitivity reaction based on appearance.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site mass, Injection site pain, Joint range of motion decreased, Pain in extremity, X-ray
Clinical narrative: Very painful on administration, continued to be sore at injection site, developed a large lump at injection site. Lump remained for about a week, area stayed painful. A month or 2 later experienced a very sudden shooting pain down that (right) arm, extremely sharp. Shoulder was affected, movement and range was affected. Saw an orthopedic doctor a few months later (maybe Jan. 2015), no help. Pain and movement restriction continued. In June 2015 saw another Orthopedic nurse practitioner, received cortisone shot in right shoulder and went to physical therapists, continued exercises through summer and received a good bit of relief. In Fall of 2015 saw same NP and went back to PT (new PT practitioner), received more help/exercises. There has been a marked improvement, about 95% better.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site mass, Injection site pain, Pain
Clinical narrative: Very painful on administration, continued to be sore at injection site, developed a large lump at injection site. Lump remained for about a week, area stayed painful. A month or 2 later experienced a very sudden shooting pain down that (right) arm, extremely sharp. Shoulder was affected, movement and range was affected. Saw an orthopedic doctor a few months later (maybe Jan. 2015), no help. Pain and movement restriction continued. In June 2015 saw another Orthopedic nurse practitioner, received cortisone shot in right shoulder and went to physical therapists, continued exercises through summer and received a good bit of relief. In Fall of 2015 saw same NP and went back to PT (new PT practitioner), received more help/exercises. There has been a marked improvement, about 95% better.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Pain, Pyrexia
Clinical narrative: Fever, body aches, injection site redness, cellulitis down the arm to the elbow.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Swelling
Clinical narrative: Patient first complains of muscle pain at site of injection on right arm, where the Prevnar 13 was injected. Later on, the muscle pain progressed until she noticed swelling on 02/09/2016. Patient's daughter gave the patient Aleve and topical arnical gel to try and relieve pain/swelling. Still swollen. No reaction on the left arm.
Age: 7.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria, Injection site warmth
Clinical narrative: Hives and bumps around injection site in left arm, redness, itchy, and area warm too touch.  Grandmother administered Zyrtec OTC.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Muscle twitching, Self-injurious ideation, Tremor
Clinical narrative: Shaky arm twitching, anxious feeling, she was picked up from school Tuesday Feb the 9th for shaking and thoughts of hurting herself was taken to ER and then admitted to psychiatric ward.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthritis, Chills, Eye swelling, Headache
Clinical narrative: Could smell and taste vaccine then headache and chills began.  Rash on face started 02/07/16 at 08:00 AM. Face swelling, eyes swollen, BP 176/100 at 10:00 AM 02/08/16. Arthritis Arthralgias in shoulders, arms, elbows.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rubella antibody negative, Swelling face
Clinical narrative: Could smell and taste vaccine then headache and chills began.  Rash on face started 02/07/16 at 08:00 AM. Face swelling, eyes swollen, BP 176/100 at 10:00 AM 02/08/16. Arthritis Arthralgias in shoulders, arms, elbows.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 01Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant via Pfizer Sales Representative and from a contactable nurse. This medical assistant reported similar events on five patients. This is the second of five reports. A 81 year-old female patient of unspecified ethnicity received PREVNAR 13 (lot number M06898, NDC number: 0005-1971-02) on 28Oct2015, at 0.5 ml single, in deltoid. Relevant medical history and concomitant medications were not reported. The patient experienced cellulitis on 28Oct2015. No admission to hospital was involved. She received KEFLEX to treat the event and she recovered on an unknown date.