chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ, lot number was either M014753 with expiration date of 11-OCT-2017 or M004542 with expiration date 18-OCT-2017, orally (strength and dose were not reported). There were no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored RECOMBIVAX, lot number was M006708 and expiration date of 02-JUN-2018 (strength, route of administration and dose were not reported). There were no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, at a dose of 65 ml, administered via subcutaneous, the frequency was reported as "one time" (anatomical location, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On an unknown date, the patient developed a rash that resembled "five red bumps with white heads" in between her legs that were red and sore following the administration of ZOSTAVAX. On an unknown date, the patient sought unspecified medical attention and was seen at the pharmacy, no laboratory studies were performed and no treatment was given for the adverse events. No product quality complaint was involved. At the time of reporting, the outcome of the rash papular and rash was unknown. The relatedness between the events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose and route unknown, lot# L038917, expiration date: 20-FEB-2018). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Red rash-circular-lasting over 1 week. Pt states is getting better and does not want to take any medication such as BENADRYL or Hydrocortisone cream. Pt will call to let them know.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Gaze palsy, Tension, Unresponsive to stimuli
Clinical narrative: Patient did not sit after GARDASIL 9 injection. Patient fell to the floor approx. 3-5 minutes after injection eyes rolled to back of head, pt unresponsive, legs and arms tensed. pt recovered approx. 2 minutes.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site nodule
Clinical narrative: Red hard knot in arm at vaccination site.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Injection site oedema, Pyrexia, Vomiting
Clinical narrative: Vomiting, edema noted to area of injection, feeling weak. Fever. Gave prednisone 5 mg po to take x 7 days.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever of 101 degrees, arm red and swollen at injection site, 14cm x 7cm. Steroids sent to pharmacy. TYLENOL and MOTRIN, cold compresses.
Age: 15.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Pain in extremity, Paraesthesia
Clinical narrative: Presented with fever, SOB, rash and pain in left arm. Treated with BENADRYL 25mg-IM and Decadron 4mg IM. Placed on O2/2L. Also had tingling in hands and feet. Fever.
Age: 15.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Pyrexia, Rash
Clinical narrative: Presented with fever, SOB, rash and pain in left arm. Treated with BENADRYL 25mg-IM and Decadron 4mg IM. Placed on O2/2L. Also had tingling in hands and feet. Fever.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Red, swollen/tender area about the size of an apple. Sore to touch.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema
Clinical narrative: AUGMENTIN (600/S) 8ml PO BID for ten days area of erythema 4"x3".
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Antibody test positive, Erythema, Nodule, Pain, Rash
Clinical narrative: Varicella=large red raised nodule w/"rash" sore, "bug bite like" approx 5 cm.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella=large red raised nodule w/"rash" sore, "bug bite like" approx 5 cm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral mucosal blistering, Rash
Clinical narrative: Blistering rash.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at injection site. She said it will be ok.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: TDaP ADACEL administered on 9/15/16 at 2:50pm. Pt woke up morning of 9/16/16 with diffuse rash on both arms, armpits and back, welts near injection site (left arm) itching, all resolved by 9/17/16. No other symptoms reported. Still has some pain in left arm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Activities of daily living impaired, Dizziness, Incomplete course of vaccination, Muscular weakness
Clinical narrative: Pt in clinic 10/4/16 for Flu. Mother related incident after 1st HPV9 given 1/26/16 so declines HPV9 dose 2 at this time. Mother states patient became weak in legs and dizzy after leaving clinic on 1/26/16. Sx remained until 1/28/16 when she was allowed to rtn to school. Mother did not report sx until this visit.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: 3 cm area of erythema and induration with TTP at injection site.  Painful with any ROM of biceps or triceps. Given antihistamine and ibuprofen.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. was very itchy, swelling and redness at site, some soreness. Applied cold compress and took BENADRYL and ADVIL.
Age: 31.0
Sex: F
Vaccine: HEPA, MNQ, TD
Symptoms: Local reaction, Peripheral swelling, Skin warm
Clinical narrative: Pt is under conservatorship of step mother. Step mother called the clinic to inform us pt had localized reaction 1 day after injection of vaccine, pt R arm swollen, raised and warm to touch and was 3 in in diameter. Step mom gave BENADRYL symptoms went away after 5 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site movement impairment, Pyrexia
Clinical narrative: Unable to walk on right leg. High fever.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dry skin, Urticaria
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old (also reported as 12 years old) female patient. The patient was vaccinated with her first dose of GARDASIL) (dose, frequency, lot # and expiration date were not reported). No adverse events were reported at that time. On 11-APR-2016 at 4pm, the patient was vaccinated with a second dose GARDASIL intramuscularly in the right deltoid (lot # L040460, expiration date: 27-MAY-2016; dose was not reported). On the same day at 6:15pm, the patient returned to the office with unspecified rash on both arms that developed within an hour after vaccination. No treatment was given for the rash. No laboratory diagnostics studies were performed. It was reported that the patient would be seen by allergy associates on an unspecified date. The outcome of rash was unknown. The relatedness between adverse event and the GARDASIL was unknown. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 11 year old (also reported as 12 years old) female patient. The patient was vaccinated with her first dose of GARDASIL) (dose, frequency, lot # and expiration date were not reported). No adverse events were reported at that time. On 11-APR-2016 at 4pm, the patient was vaccinated with a second dose GARDASIL intramuscularly in the right deltoid (lot # L040460, expiration date: 27-MAY-2016; dose was not reported). On the same day at 6:15pm, the patient returned to the office with unspecified rash on both arms that developed within an hour after vaccination. No treatment was given for the rash. No laboratory diagnostics studies were performed. It was reported that the patient would be seen by allergy associates on an unspecified date. The outcome of rash was unknown. The relatedness between adverse event and the GARDASIL was unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS, VARZOS
Symptoms: Back pain, Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66-year-old female patient with high blood pressure, depression, obesity and morphine allergy. On 20-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # M020071, expiration date 18-JUL-2017, subcutaneous in the left arm. Concomitant therapies included hydrochlorothiazide (manufacturer unknown), CELEXA and atenolol. On 21-SEP-2016, the patient was seen in the pharmacy and 1 inch diameter area of redness around the injection site was noted. On 22-SEP-2016, the redness and swelling increased in size to the full area of the back of her left arm. The outcome of injection site swelling and injection site erythema was reported as not recovered/not resolved. No laboratory diagnostics studies were performed and no treatment was given for the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66-year-old female patient with high blood pressure, depression, obesity and morphine allergy. On 20-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX lot # M020071, expiration date 18-JUL-2017, subcutaneous in the left arm. Concomitant therapies included hydrochlorothiazide (manufacturer unknown), CELEXA and atenolol. On 21-SEP-2016, the patient was seen in the pharmacy and 1 inch diameter area of redness around the injection site was noted. On 22-SEP-2016, the redness and swelling increased in size to the full area of the back of her left arm. The outcome of injection site swelling and injection site erythema was reported as not recovered/not resolved. No laboratory diagnostics studies were performed and no treatment was given for the events. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Injected limb mobility decreased
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received first (PREVNAR 13; lot N16515, expiration date Oct2017), in the right arm on 29Sep2016 (at approximately 1330-1400), as single dose for pneumonia vaccination and (FLUZONE (manufacturer: Sanofi); lot number UI697AA, expiration date 06May2017), intramuscularly in left arm on 29Sep2016, as single dose for immunisation.  Patient had no illnesses at time of vaccination(s).  Medical history included diabetes mellitus from an unknown date and unknown if ongoing.  No family medical history relevant to adverse event(s) were reported. The patient's concomitant medications were not reported. The patient previously took influenza vaccine (unknown if FLUZONE) for immunisation and experienced no adverse event. The patient experienced severe right shoulder pain and could not move his right arm in the evening (time unspecified) on 29Sep2016. No emergency room or physician office visit was required. No investigations were conducted. The patient reported he was feeling well and had no allergies to food or medications. The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine was not applicable. The outcome of severe right shoulder pain and could not move his right arm was not recovered as of the reporting on 30Sep2016.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13, FLU4, PNC13
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 69-year-old male patient received first (PREVNAR 13; lot N16515, expiration date Oct2017), in the right arm on 29Sep2016 (at approximately 1330-1400), as single dose for pneumonia vaccination and (FLUZONE (manufacturer: Sanofi); lot number UI697AA, expiration date 06May2017), intramuscularly in left arm on 29Sep2016, as single dose for immunisation.  Patient had no illnesses at time of vaccination(s).  Medical history included diabetes mellitus from an unknown date and unknown if ongoing.  No family medical history relevant to adverse event(s) were reported. The patient's concomitant medications were not reported. The patient previously took influenza vaccine (unknown if FLUZONE) for immunisation and experienced no adverse event. The patient experienced severe right shoulder pain and could not move his right arm in the evening (time unspecified) on 29Sep2016. No emergency room or physician office visit was required. No investigations were conducted. The patient reported he was feeling well and had no allergies to food or medications. The action taken with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and influenza vaccine was not applicable. The outcome of severe right shoulder pain and could not move his right arm was not recovered as of the reporting on 30Sep2016.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue
Clinical narrative: Customer came in and spoke to technician several days after receiving the vaccine. She claim that she felt more tired.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Inflammation, Malaise, Muscular weakness, Nausea
Clinical narrative: Patient complained of redness and inflammation around injection site.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient complained of redness and inflammation around injection site.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis treatment sulfa/trim 800-160 bid x 5 days.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Nausea, Oropharyngeal pain
Clinical narrative: Immediate severe headache, nausea, vision issue, sore throat, fatigue.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Visual impairment
Clinical narrative: Immediate severe headache, nausea, vision issue, sore throat, fatigue.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Dizziness, Headache, Nausea, Oropharyngeal pain, Streptococcus test positive
Clinical narrative: Immediate severe headache, nausea, vision issue, sore throat, fatigue.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, C-reactive protein normal, Complement factor C3, Complement factor C4
Clinical narrative: Immediate severe headache, nausea, vision issue, sore throat, fatigue.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Complement factor normal, Full blood count normal, Headache, Liver function test normal, Metabolic function test normal
Clinical narrative: Immediate severe headache, nausea, vision issue, sore throat, fatigue.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Myalgia, Oropharyngeal pain, Pain, Paraesthesia, Red blood cell sedimentation rate normal
Clinical narrative: Immediate severe headache, nausea, vision issue, sore throat, fatigue.
Age: 12.0
Sex: F
Vaccine: FLUX, HPV9, FLU4, HPV9, FLU4, HPV9
Symptoms: Thyroid function test normal, Tic
Clinical narrative: Immediate severe headache, nausea, vision issue, sore throat, fatigue.
Age: 1.25
Sex: M
Vaccine: DTAP, FLUX, HIBV
Symptoms: Injection site mass, Injection site reaction
Clinical narrative: Lumps at injection sites on both thighs. Children Motrin given and warm clothes applied to lumps for 7 days.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Vertigo, Vomiting
Clinical narrative: Severe vertigo. Vomiting.
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a physician via a company representative referring to a 75 years old female patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date not reported). On an unknown date (reported as after receiving ZOSTAVAX), the patient had a "near stroke like event". The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Upon internal review, the event of "near stroke like event" was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Initial unsolicited report received from a nurse on 27-SEP-2016. This case involves 60 patients (gender not reported) who were vaccinated with a dose of FLUZONE ID (batch number: UT5570AA, expiration date: 27-MAR-2017) intradermally in deltoid on 26-SEP-2016. Reporter denied patients Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. Concomitant medications were not reported. On 27-SEP-2016, one day following the vaccination, the patients had redness and swelling at the site and some claimed knot formation. Patients did not require physician evaluation as per reporter. Lab data was not reported and patients were advised to take Benadryl as corrective treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Oxygen saturation decreased, Pyrexia, Urticaria
Clinical narrative: Initial unsolicited case received from a health care professional (Medical assistant) on 28 Sep 2016. This case involves a 6 year old male patient who was vaccinated with a dose of FLUZONE QIV (Batch number: U5630AA, expiry date: 30 Jun 2017) intramuscularly in right deltoid on 26 Sep 2016. The patient illness at the time of vaccination was reported as none. And Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no know allergies and any other vaccinations within 4 weeks of vaccinations were not reported. Concomitant medications were not reported. On 26 Sep 2016, one hour after vaccination the patient developed full body hives. The patient was taken to Emergency Room (facility unknown). On same day the patient had fever and low oxygen at ER. The patient's lab tests were not reported. The patient had corrective treatment with Benadryl. The outcome of the events was reported as unknown. List of documents held by the sender: none.
Age: 54.0
Sex: F
Vaccine: ANTH, FLU4, PPV
Symptoms: Inflammation, Swelling
Clinical narrative: Localized inflammation, swelling.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Inflammation, Swelling
Clinical narrative: Localized inflammation, swelling.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Dysarthria, Erythema, Eye swelling, Fatigue
Clinical narrative: Sharp headache over right eye, blurred vision, split vision in left eye, red swollen face and eyes, extreme fatigue, slurred speech, increased blood pressure.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Ocular hyperaemia, Swelling face, Vision blurred, Visual impairment
Clinical narrative: Sharp headache over right eye, blurred vision, split vision in left eye, red swollen face and eyes, extreme fatigue, slurred speech, increased blood pressure.
Age: 50.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Inflammation, Swelling
Clinical narrative: Localized inflammation, swelling.
Age: 61.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Gait disturbance, Malaise, Paraesthesia, Pyrexia
Clinical narrative: Ran fever. Couldn't walk up and down stairs. Tingling in hands and feet.
Age: 53.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Inflammation, Swelling
Clinical narrative: Localized inflammation, swelling.
Age: 51.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Inflammation, Swelling
Clinical narrative: Localized inflammation, swelling.
Age: 50.0
Sex: M
Vaccine: HEPA
Symptoms: Injected limb mobility decreased, Muscular weakness, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis
Clinical narrative: Severe shoulder pain began: restricted movement of left arm and weakness. Pain did not subside after reducing exercise, NSAID. Saw physical therapist 8/29/16 who though it was frozen shoulder. Saw orthopedic surgeon 9/29 who ordered MRI to r/o rotator cuff issue. Followed up with MD 10/5 and diagnosed with frozen shoulder (adhesive capsulitis) Received cortisone shot, EMG ordered, and will be starting physical therapy.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Sore arm following vaccination; tiredness in evening of 10/5; 100.4 degree F fever at 0400 on 10/6, aches, chills, weakness, sore arm.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Sore arm following vaccination; tiredness in evening of 10/5; 100.4 degree F fever at 0400 on 10/6, aches, chills, weakness, sore arm.
Age: 52.0
Sex: F
Vaccine: ANTH, FLU4, PPV
Symptoms: Inflammation, Swelling
Clinical narrative: Localized inflammation, swelling.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Inflammation, Swelling
Clinical narrative: Localized inflammation, swelling.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Flushing
Clinical narrative: Face flushed bright red.  Bright red for 24 hours.  Today, Thursday, 10/6/2016 still red but not as much.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient received FLUVIRIN vaccine on 9/23/2016. Patient reported that she woke up the next morning with a rash on her face. Pt has been using BENADRYL and hydrocortisone cream for the rash.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Very sore at injection site with reduced range of motion, only to 90 degree position of left arm, with alot of pain.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthropathy, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: Arm Pain, Shoulder Pain; Shoulder Dysfunction. Limited Range of Motion Shoulder. Tendonitis. I seeked med attn. 10-1 Prednisone.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Tendonitis, X-ray
Clinical narrative: Arm Pain, Shoulder Pain; Shoulder Dysfunction. Limited Range of Motion Shoulder. Tendonitis. I seeked med attn. 10-1 Prednisone.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm Pain, Shoulder Pain; Shoulder Dysfunction. Limited Range of Motion Shoulder. Tendonitis. I seeked med attn. 10-1 Prednisone.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Feeling abnormal, Injection site pain, Viral infection
Clinical narrative: This is a spontaneous report from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASP2016132248), license partner for ENBREL. Initial Receipt Date = 26-SEP-2016. This spontaneous report (USASP2016132248) was reported to Amgen on 26/SEP/2016 by a consumer and involves a 63 years old female patient who took Prevnar 13 about a year ago and felt like crap, she moved both medications doses to Sunday this week, coughed all winter, last winter, she had infections, mostly all viral, and SureClick Autoinjectors, but they became very painful and unbearable/7 or 8 seconds of pure agony while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included ongoing Rheumatoid Arthritis. Concomitant medication included methotrexate. Co-suspect medication included Prevnar 13. The patient began Enbrel on an unknown date. The patient used to use Sureclick autoinjectors but they became very painful and unbearable. It was seven or eight seconds of pure agony. On an unknown date, the patient switched to a prefilled syringe. In 2015, the patient took Prevnar 13 and felt like crap. Last winter in 2015, the patient had infections, mostly all viral, all winter long. Subsequently, the patient had to be off of Enbrel for three months from November until spring. On an unknown date, the patient stated that she coughed all winter, could not isolate herself anymore and stated that she stayed home mostly. On an unknown date in SEP/2016, the patient stated that she moved both medications doses (methotrexate and Enbrel) to Sunday this week and was planning on adjusting next week's dose of these medications if she goes through with the Pneumovax 23 on Thursday. No treatment information was provided. The outcome of the events feeling abnormal, intentional product misuse, cough, viral infection and injection site pain were reported as unknown. Action taken with Enbrel was reported as unknown for the events feeling abnormal, intentional product misuse, cough and injection site pain. Action taken with Enbrel was temporarily withheld for the event viral infection. The causal relationship between the events feeling abnormal, intentional product misuse, cough, viral infection and injection site pain and the product Enbrel was not provided by the consumer. Amgen's assessment: The events were considered to be non-serious.
Sex: F
Vaccine: PNC
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: rash which was red, itchy and was on right side of the arm; rash which was red, itchy and was on right side of the arm; rash which was red, itchy and was on right side of the arm; This is a spontaneous report from a Non-Contactable pharmacist.  A female patient of an unspecified age and ethnicity received pneumococcal 7-val conj vac (dipht crm197 protein) (PREVNAR) , via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash like the size of a hand  which was red, itchy and was on right side of the arm on an unspecified date with outcome of unknown.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: MENB
Symptoms: Pruritus, Skin warm, Swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. A patient of unspecified age ethnicity and gender received TRUMENBA lot: M15167, via an unspecified route of administration on 26Sep2016 at 0.5 ml, single for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced hives on 28Sep2016 with outcome of unknown, itching warm and 'bigger the pm' on an unspecified date with outcome of unknown. There were no difficulty breathing, no other systemic symptoms, Treatment includes BENADRYL by mouth as needed, hydrocortisone 1% twice a day as needed and warm compresses.
Age: 44.0
Sex: M
Vaccine: FLU4
Symptoms: Dysgeusia, Dysphonia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Lip numbness, hoarseness, metallic taste, left arm numbness.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Productive cough, Pyrexia, Respiratory tract congestion, Sinus congestion
Clinical narrative: 9/29 not feeling well, getting chest congestion, phlegm, fever continuously, congested sinus. Took 2 ADVIL and over the counter medicine. Symptoms are getting worse. Called doctor 3x.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Received flu shot in LD on  10-3-16 at 2:20PM. Received call from grandma that left upper arm is swollen and twice its size.
Age: 58.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Red, warm, and inflammation where shots were given. Patient will go to urgent card to be seen.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Seizure
Clinical narrative: Pt. had convulsions on 9/27/16 and was admitted.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling abnormal, Nausea
Clinical narrative: 2 hours after influenza vaccine developed nausea and dizziness and not feeling right.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Left Deltoid Myalgia.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema, extreme itching, warmth at injection site. Patient did present with a cough, but after discussion had been seen by doctor approximately 3-4 weeks prior with a virus and still had a lingering cough. Patient given 50mg IM Benadryl and monitored. Discharged without any distress noted.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Vaccine was administered in right deltoid. Approximately 30 minutes later patient experienced hand and arm swelling, redness, and local pain. Treated with ice pack to area. Symptoms alleviated within one hour and resolved within 24 hours.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Redness and pain at injection site, generalized muscle and joint pains, chills.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site bruising, Injection site pain, Pain in extremity
Clinical narrative: Pain and bruising at site, pain down left arm and wrist.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness, called doctor. Just got up more slowly and walked slowly. Lasted about 1 hour or so, better today.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Dyspnoea, Erythema, Wheezing
Clinical narrative: Started with chest tightness, wheezing, SOB, facial redness, cough, treated with BENADRYL, steroids, inhaler, ZPAK.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient came it with redness and a bruising like rash at the joint of her left elbow. When the rash first appeared with was itchy and the redness was larger than when she came in on 10/6/16. On 10/6/16 the rash was circular about the size of a baseball. It was light red to dark red in color and about a foot from the administration site. The rash was noticed on 10/5 in the morning, which was 2 days after the immunization. When the patient came in on 10/6 the rash was no longer itchy and the size was subsiding. We advised her to get Benadryl and keep an eye on it to make sure it continues to go away.
Age: 17.0
Sex: U
Vaccine: FLU4, MENB
Symptoms: Induration, Injection site erythema, Injection site pain, Pain, Skin discolouration
Clinical narrative: Redness and pain at site of injection with residual subcutaneous induration (knot) painful; and cutaneous post infl; discoloration (resolving).
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pyrexia, Tremor
Clinical narrative: 101 degree fever chills shaking redness.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: Pt became diaphoretic and dizzy about 5 minutes after vaccines were given.
Age: 0.42
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Nausea, Pain in extremity, Skin reaction, Skin warm
Clinical narrative: Rt arm became red, hard hot and really sore-The redness soreness The size of a salad plate - Also felt nauseous for two days, took about six days to recede completely.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: After receiving FLUZONE HD, patient states she can't raise her shoulder. Pharmacist recommended icing and TYLENOL x 24hr period and follow up w/MD if no relief.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling cold, Mobility decreased, Peripheral swelling
Clinical narrative: On 9-26-2016, patient got 2 shots, PNEUMOVAX 23 and FLUZONE HD. Patient got "ice cold" night of shot. Swelling was noted in arm where she received pneumonia shot. She could not move her arm that night to brush teeth. On Friday 9:30, swelling has started to subside.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient received both the FLUZONE QUAD and PNEUMOVAX in the same arm on the same day. Patient had a local reaction of redness, swelling, and warmth at injection site and also a low grade fever. MD prescribed AUGMENTIN 875 po BID x 10 days.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Got flu shot 9/26 at 10:37 AM-Developed serious case of hives later in the day- still with me today, 9/30.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness in my R arm (same arm where the flu shot was administered) all the way down the arm to the hand, mainly on my pinky and ring finger.  Symptoms lasted approximately 12 hours.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing, Headache, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient reported (today - 10/6/16) that after receiving the vaccine on 9/30/16 she had flushing, swelling at the injection site (pretty large). Rash, itchiness, and headache. She self medicated with Benadryl and Hydrocortisone topically (OTC). She asked that we report the reaction.
Age: 56.0
Sex: M
Vaccine: FLU4, MMRV, TDAP, TYP
Symptoms: Wrong drug administered
Clinical narrative: Nurse administered MMRV instead of MMR to client.
Age: 56.0
Sex: F
Vaccine: MMRV, TYP
Symptoms: Wrong drug administered
Clinical narrative: Nurse administered MMRV verses MMR to client.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Eczema, Haemorrhage, Pyrexia, Regressive behaviour
Clinical narrative: Inconsolable crying for 12 hours. High Temperatures. Regression of communication and eye contact. Aggresive eczema developed to the point of bleeding. Treated with infant probiotics, infant DHA supplement and organic detoxifying diet.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness and warmth below injection site, accompanied by soreness, 3 days post injection, symptoms were resolving, still minor redness and warmth present.
Age: 12.0
Sex: F
Vaccine: DTAP, HPVX, MEN
Symptoms: Abdominal discomfort, Headache, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: Fever, stiff neck, tingling and pain in arm, upset stomach, rash, headache.
Age: 12.0
Sex: F
Vaccine: DTAP, HPVX, MEN
Symptoms: Pyrexia, Rash
Clinical narrative: Fever, stiff neck, tingling and pain in arm, upset stomach, rash, headache.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Menorrhagia, Syncope
Clinical narrative: I passed out approximately 14 hours after receiving the vaccine.  I am experiencing a particularly heavy menstrual period simultaneously.  I do not know what caused the syncope, but wanted to report what happened.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Dizziness, Nausea, Fatigue, Muscle aches and Headache symptoms severe for 1 day and mild on day 2. Advil and anti-nausea medication.
Age: 70.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Asthenia, Decreased appetite, Feeling cold, Malaise
Clinical narrative: Alarm went off, I couldn't get up and fell back asleep (on a work-day, I always jump out of bed and get started as soon as the alarm goes off) I woke up 1/2 hour later, realized the time, forced myself to get up and call in sick to my employer. I am chilly, very weak, feel slightly nauseated and lack an appetite. I'm definitely feeling too ill to carry out my normal daily activities.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Nausea
Clinical narrative: Alarm went off, I couldn't get up and fell back asleep (on a work-day, I always jump out of bed and get started as soon as the alarm goes off) I woke up 1/2 hour later, realized the time, forced myself to get up and call in sick to my employer. I am chilly, very weak, feel slightly nauseated and lack an appetite. I'm definitely feeling too ill to carry out my normal daily activities.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Injection site pain, Neck pain, Pain of skin
Clinical narrative: On my appt date Sept 2016 - had flu shot before due date of last one of Nov-Dec 2015. Flu shot given in upper left shoulder by staff who suggested shot. Next AM woke up with severe pain in left shoulder - pain kept migrating through back - shoulders and eventually settled in lower-upper neck and scalp. Painful.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, Swelling, Warm to touch, and pain around injection site.
Age: 61.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction. There was a sore red raised area where injection was given, and it was itchy.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, Swelling, Pain, and heat at the injection site.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain, Pyrexia, Skin discolouration, Throat irritation
Clinical narrative: Fever, scratchy throat, bruising and soreness at injection site.
Age: 87.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Swelling from elbow to top of shoulder with warmth and low grade fever high of 100F. Patient states that it lasted 36 hours and swelling has since dissipated. Patient also complains on her arm being sore.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warm to touch at injection site.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient's left arm from shoulder to elbow is swollen, red, and hot to touch. Patient also states it is sore.
Age: 61.0
Sex: M
Vaccine: MENB
Symptoms: Impaired work ability, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Health Care Professional via a Pfizer sales representative. A 61-year-old male patient of an unspecified ethnicity received TRUMENBA, (lot M95612, expiry date Jul2017) 0.5 ml single, intramuscular in the left deltoid on 26May2016 09:30 for immunization.  At the time of vaccination patient had malignant paragangliom. The patient was immunocompromised.  Concomitant medication included MENACTRA administered on unknown date intramuscular in the right deltoid (lot U517AA) for immunization. On an unspecified date in Jun2016 the site where meningococcal group b rlp2086 was administered became enlarged, swollen, red and it hurt a lot and the patient (an electrician) had difficulty in working. The patient recovered from the reported events on an unspecified date in 2016. The reporter considered that the vaccine had a causal effect to the adverse event. Follow-up (16Sep2016): New information received from a  contactable Health Care Professional  includes vaccine administration information (date, route, site), outcome of the events, causality assessment. Follow up attempts completed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported information: Legacy paper report 2016364116 added as linked report number. Sender's Comments: Linked Report(s): 2016364116 Legacy paper report number.
Age: 20.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult given pediatric dose of Hep A vaccine.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain, Pyrexia
Clinical narrative: Fever (100.6), achiness. Altered administering Ibuprofen and Tylenol every 3 hours. Symptons lasted 36 hours.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site haemorrhage, Injection site hypoaesthesia
Clinical narrative: Patient experienced bleeding upon extraction of the needle. Immediately notice a small "bubble" formed at the injection site. Within minutes, patient experience swelling (approx 1.5" diameter) at injection site, and her entire right arm turned rosy-red. She stated she felt tingling down the length of the arm, and numbness at the site of the injection (radiating out 4-5"). I observed patient for approximately 20 minutes after injection, during which time we applied ice to the injection site. After approximately 10 minutes, the redness in the arm had virtually disappeared, but the swelling at the injection site was still present (approximately 2" diameter), and patient stated the tingling was still there and some numbness was still present. After approximately 20 minutes patient returned to her office and kept ice applied to the injection site. I checked on her again before leaving the building approximately 10 minutes later and she seemed to doing fine, although there was some swelling present.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site paraesthesia, Injection site swelling, Injection site vesicles, Paraesthesia
Clinical narrative: Patient experienced bleeding upon extraction of the needle. Immediately notice a small "bubble" formed at the injection site. Within minutes, patient experience swelling (approx 1.5" diameter) at injection site, and her entire right arm turned rosy-red. She stated she felt tingling down the length of the arm, and numbness at the site of the injection (radiating out 4-5"). I observed patient for approximately 20 minutes after injection, during which time we applied ice to the injection site. After approximately 10 minutes, the redness in the arm had virtually disappeared, but the swelling at the injection site was still present (approximately 2" diameter), and patient stated the tingling was still there and some numbness was still present. After approximately 20 minutes patient returned to her office and kept ice applied to the injection site. I checked on her again before leaving the building approximately 10 minutes later and she seemed to doing fine, although there was some swelling present.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Hypotension, Injection site swelling
Clinical narrative: Swelling of arm about injection site, pain. Benadryl taken. Transient hypotension (87/56) the following morning, resolved by afternoon, with improvement in swelling.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Night sweats, Pyrexia
Clinical narrative: Injection point very sore.  Cannot lift arm.  Upper arm (shoulder to elbow) red in color and sensitive to touch.  High temperature, 101.8 F.  Night sweats.  Following day temperature subsides to low grade, 99.3 F.
Age: 1.08
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Vaccination complication, Vomiting
Clinical narrative: Infant given Influenza Vaccine 0.25mL in right thigh.  No distress noted and injection tolerated well.  The Grandmother and infant left the Health Department and the Grandmother returned at 11:15 AM and said the infant vomited. So the infant was brought back in the hospital and the RN did a respiratory, cardiovascular and integumentary assessment.  Respirations 28/minute; Pulse 120/minute and the skin had red patches on the torso.  No rash or Hives.  The Infant appeared to not be in distress and no other occurrence happened.  The infant's pediatrician was contacted, and after hearing of the vomiting and skin redness.  The MD called in Zofran for the infant just in case he continued to vomit.  The MD said that this does sound like a reaction to the influenza vaccine and to not get another influenza injection for a couple of years. The MD instructed the grandmother to take infant to ER if any changes occur, any hives or respiratory distress.  The parent verbalized understanding.  The Grandmother and infant stayed in the clinic 30 minutes longer with no occurrences. At 1:45pm, RN called the Grandmother and asked how the infant was doing.  She said he is doing well, he vomited once more and has had no other occurrences.  She said they are at another MD appointment and he is playing and doing well.  RN instructed the Grandmother to take the infant to ER for any changes or occurrences as MD stated.  The Grandmother verbalized understanding.
Age: 17.0
Sex: F
Vaccine: HEPA, HPVX, MEN
Symptoms: Altered state of consciousness, Syncope
Clinical narrative: Patient was being walked to the restroom when she said she felt like she was going to pass out. Healthcare professional was able to get her to the nearest exam room and the patient collapsed in their arms.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Patient had a rash ~2inches by 2inches underneath the injection site. It was raised, red, hot, and painful. Patient said it hadn't gotten any worse, but it just hurt and was hot. I told her to monitor it make sure if didn't get any worse, and use appropriate otc measures.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU4, HIBV
Symptoms: Urticaria
Clinical narrative: Developed diffuse hives within 15 minutes of receiving vaccines.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Back pain, Chills, Dizziness, Erythema, Headache
Clinical narrative: Fever, chills/sweats, pain in the back and legs, a red strip down my shoulder to my arm pit, very light headed, head ache.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Hyperhidrosis, Influenza, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills/sweats, pain in the back and legs, a red strip down my shoulder to my arm pit, very light headed, head ache.