chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Injection site erythema, Injection site swelling, Injection site warmth, Respiratory disorder
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 52 years old female patient. Pertinent medical history included history of asthma, diabetes and seasonal allergies. Drug reactions/allergies was reported as none. On 19-SEP-2016, the patient received PNEUMIOVAX 23 0.5 ml, one time, intramuscular in the right deltoid region of the upper arm for diabetes (Lot# M022521 with expiry date: 17-NOV-2017). Concomitant medications included multiple unspecified medications. On an unknown date in September 2016, the patient experienced swelling, redness and warmth to the injection site area of the right deltoid. On 21-SEP-2016, the patient sought medical attention for an unrelated matter of shortness of breath and upper respiratory issue, for which the physician prescribed antibiotics. During the same visit the physician also prescribed treatment for injection site reaction of ADVIL and cool compression application. Lab diagnostics studies were reported as none. Causality of the events swelling, redness and warmth to the injection site and injection site reaction was not reported. The reporter considered the events shortness of breath and upper respiratory issue as not related. Outcome of the events was reported as unknown. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 0.3
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager and refers to a 4 months old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 02-AUG-2016, at the age of 4 months, the patient was inadvertently vaccinated with a dose of GARDASIL 9 injection, intramuscularly (site of administration, dose, lot number and expiration date were unknown). No adverse effect was reported. No further information was provided. Additional information is not expected as no consent for contact was given.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) PROQUAD, 0.5ml, which had lot # M019232 with expiry: 17-OCT-2017, lot# M004892 with expiry date: 25-JUL-2017 and lot # M021427 with expiry 29-OCT-2017. The vaccines were exposed to a temperature of 26.6 Celsius Fahrenheit for 1 hour 36 minutes. The call was because of data logger. No adverse effect reported. No further information provided. This is one of two cases received from the same reporter. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse event.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Oedema, Tenderness
Clinical narrative: LLR following PREVNAR 13 - adult, 10 x 13 cm edema and tenderness.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Constipation, Fatigue, Headache, Malaise
Clinical narrative: Severe, fatigue, headache, sore arm, upset stomach and nausea, constipation. Began 2hrs after shot and is still sick 3 days after.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain in extremity
Clinical narrative: Severe, fatigue, headache, sore arm, upset stomach and nausea, constipation. Began 2hrs after shot and is still sick 3 days after.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pain
Clinical narrative: Deltoid remains sore for 5 weeks following vaccine - hurts with motion.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia oral
Clinical narrative: As of June 23, 2016 (L) arm pain starting in area of injection progressive pain to reach shoulder, elbow (L) arm (L) hand and (R) too, paresthesia lips on and off no change by stopping meloxicam.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives-Cetirizine, BENADRYL
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash erythematous, Swelling
Clinical narrative: Pt received ZOSTAVAX shot on 9-13-16. Reported sore red bump and 2 in red rash on 9-17-16 to RPh.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Metabolic function test, Pain, Pyrexia
Clinical narrative: Patient presents to the clinic with erythematous patch on left arm just below injection site, left upper arm noticed to be longer than the right and c/o low grade fever for 6 days, body aches.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received BOOSTRIX (batch number 9Y57K, expiry date 25th August 2017). On 4th August 2016, the patient received BOOSTRIX 0.5 ml. On 4th August 2016, less than a day after receiving BOOSTRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BOOSTRIX. Additional details were provided as follows: The patient experienced soreness at injection site. The reported batch number (9457K) of BOOSTRIX did not exist and was updated to 9Y57K as per sales database. No other detailed information was provided.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of syncope in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, several minutes after receiving BEXSERO, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. The reporter considered the syncope to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was previously reported to a doctor. The age at vaccination as not reported. The patient did not receive any concomitant medication. At an event booth, the nurse practitioner reported to the sales representative that she had a patient who received BEXSERO in the office and within minutes experienced syncope. All questions were asked to the sales representative, but he had minimal information.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 08-SEP-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L019835, expiration date 23-MAR-2016; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist referring a 60 years old male patient. The patient's concurrent conditions, medical history and concomitant medication were not reported. The patient had no drug allergies. On 17-SEP-2016, the patient was vaccinated with ZOSTAVAX (dose and route were unknown, lot# L044530, expiration date 09-FEB-2017. On the same date after receiving the ZOSTAVAX, the patient experienced redness around the injection site. The patient did not seek medical attention and no treatment was given for the event. No lab diagnostics studies were performed. The patient did not recover from the event. The reporter considered the event to be related to ZOSTAVAX. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of hives in a female patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX and BENADRYL, the patient experienced hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the hives was recovered/resolved. It was unknown if the reporter considered the hives to be related to BOOSTRIX. Additional details were provided as follows: This case was previously not reported to food and drug association. This case was reported by a registered pharmacist. The age at vaccination was not reported. The patient experienced hives after receiving the whooping cough vaccine or BOOSTRIX. The patient recovered fully from adverse reactions. No additional information was provided. This case has been linked with the case US2016GSK141283, reported by the same reporter for the same patient.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown demographics. Information regarding the patients' concurrent conditions and medical history was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, which had a lot number of L007560 and expiration date on 15-JUN-2017 (dose, route of administration and anatomical location were not reported. There were no concomitant medications reported. The details of the temperature excursion noted a temperature of 32.3 degrees Fahrenheit (F) for 11 hours. No adverse effects reported. There was no product quality issue involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant referring to an unknown number of patients of unknown age and gender. Pertinent medical histories, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with incorrectly stored doses of RECOMBIVAX HB (Lot#L018501. Expiration date 22-JUN-2017). Dose, route and anatomical location were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 45-year-old female patient who received BOOSTRIX (batch number K2D2T, expiry date 8th December 2018). On 25th August 2016, the patient received BOOSTRIX (intramuscular). On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced injection site muscle pain and joint pain. On an unknown date, the outcome of the injection site muscle pain was unchanged and the outcome of the joint pain was unknown. The reporter considered the injection site muscle pain and joint pain to be probably related to BOOSTRIX. Additional details were provided as follows: On 25th August 2016, at 13:59 hours, the patient received a dose of BOOSTRIX (in left deltoid) and experienced muscle soreness in her left arm and the pain was getting worse. The reporter also described that there was soreness all around the upper part of her left arm and was experiencing joint pain in her left shoulder. The call was transferred to Medical information.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of leg pain in a 4-year-old male patient who received KINRIX (batch number MH9T7, expiry date unknown). Previously administered products included DTAP vaccine with an associated reaction of adverse reaction (received in 2013 at an age of 6 months, refer case US2016GSK143537). On 21st September 2016, the patient received KINRIX. On 22nd September 2016, 1 days after receiving KINRIX, the patient experienced leg pain and walking difficulty. On an unknown date, the outcome of the leg pain and walking difficulty were unknown. It was unknown if the reporter considered the leg pain and walking difficulty to be related to KINRIX. Additional details were provided as follows: This case was reported by the patient's mother. The patient's mother was trying to get him caught up on vaccines for school. A day before reporting, they went to the doctor and the patient was vaccinated with KINRIX in his left thigh. The patient had left leg pain and difficulty in walking because of the leg pain. The mother provided MH9TZ as the lot number, but it was not found in JDE. The specific number of batch was confirmed a couple of times with the reporter to make the right letters and numbers were heard, but reporter said that was the information which was written in the chart she was provided. The lot number was updated to MH9T7 as per sales database. A product representative would contact the patient because the patient wanted to know additional dosing and schedule information and what they need to do to get him caught up on vaccines.
Age: 66.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site bruising
Clinical narrative: Right deltoid post injection bruising (healing) TDAP on 9/21/16 visit for S/S 9/29/16. No angioedema, respiratory distress or other noted immunological S/S. No problem with past vaccine.
Age: 4.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Slight redness minimal warmth at site.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Nerve injury, Pain
Clinical narrative: After shingles shot it damaged the nerve around my stomach and back. My doc. sent me to a pain specialist. I've had shots and medicine. I still have pain.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Rash developed on patient's face and had begun spreading downward with fever up to 101 no other complaints. Rash described as erythematous maculopapular. No intervention recommended at this time.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dyskinesia, Lip injury, Loss of consciousness, Muscle rigidity
Clinical narrative: Vasovagal response - patient passed out - began to flail - rigid body - bit lip - pale - weak - monitored patient until escorted to spouse's vehicle at 1420.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Pallor, Presyncope
Clinical narrative: Vasovagal response - patient passed out - began to flail - rigid body - bit lip - pale - weak - monitored patient until escorted to spouse's vehicle at 1420.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Discomfort, Pain, Peripheral swelling
Clinical narrative: Patient stating that his arm was swollen and burning sensation and he was in bed for five days after the shots due to pain and discomfort.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness. Swelling. Hot warmth on arm.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Induration, Local swelling
Clinical narrative: Local swelling/induration (R) deltoid.
Age: 77.0
Sex: F
Vaccine: FLU3, PNC13, FLUX
Symptoms: Musculoskeletal pain
Clinical narrative: Severe Shoulder pain all night long followed by lasting pain even now a full year later.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Flank pain, Limb discomfort, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse. A 84-year-old female patient of unknown race received PREVNAR 13, (lot L77777, exp.date 31Jan2017, NDC number: 0005-1971-02) via intramuscular route on the right deltoid at single dose for immunization on 05Aug2015. Medical history included breast cancer, since 2012, bilateral vasectomy, hyperlipidaemia, GERD, hypertension, hypothyroidism, endocrine deficiency and gout. Concomitant medicines included CRESTOR, 10 mg, tablets, once in a day, orally for hyperlipidaemia, omeprazole 20mg, tablets, once daily, orally for gastrooesophageal reflux disease, metoprolol at 50 mg, tablet, one and a half twice daily, orally for hypertension, levothyroxine 88 micrograms, tablets, once daily, orally for hypothyroidism, furosemide 20 mg, tablets, once daily, orally for hypertension and endocrine deficiency and allopurinol at 300 mg, 1x/day for gout. On the same date of the vaccination the patient experienced pain in the injection site and weakness. The events required the doctor visit. The outcome of the events was reported as not recovered.
Age: 84.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse. A 84-year-old female patient of unknown race received PREVNAR 13, (lot L77777, exp.date 31Jan2017, NDC number: 0005-1971-02) via intramuscular route on the right deltoid at single dose for immunization on 05Aug2015. Medical history included breast cancer, since 2012, bilateral vasectomy, hyperlipidaemia, GERD, hypertension, hypothyroidism, endocrine deficiency and gout. Concomitant medicines included CRESTOR, 10 mg, tablets, once in a day, orally for hyperlipidaemia, omeprazole 20mg, tablets, once daily, orally for gastrooesophageal reflux disease, metoprolol at 50 mg, tablet, one and a half twice daily, orally for hypertension, levothyroxine 88 micrograms, tablets, once daily, orally for hypothyroidism, furosemide 20 mg, tablets, once daily, orally for hypertension and endocrine deficiency and allopurinol at 300 mg, 1x/day for gout. On the same date of the vaccination the patient experienced pain in the injection site and weakness. The events required the doctor visit. The outcome of the events was reported as not recovered.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Head injury, Hypoaesthesia, Loss of consciousness, Neck pain
Clinical narrative: Patient got dizzy, numbness through body, blurry vision, passed out from a standing position, hit head, had mild seizure like symptoms, unconscious for 30 seconds, hard to come to, extreme pain in arm and neck for hours following. Vomited about 90 mins later. She was given ibuprofen shortly after incident, then other various treatments at home.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Seizure like phenomena, Vision blurred, Vomiting
Clinical narrative: Patient got dizzy, numbness through body, blurry vision, passed out from a standing position, hit head, had mild seizure like symptoms, unconscious for 30 seconds, hard to come to, extreme pain in arm and neck for hours following. Vomited about 90 mins later. She was given ibuprofen shortly after incident, then other various treatments at home.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm, swollen, can't raise arm.
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Paraesthesia oral, Throat tightness
Clinical narrative: Initial unsolicited report received from a registered nurse on 20 Sep 2016. This case involves two female patient's (age not reported) who were vaccinated with a dose of Fluzone QIV (Batch number- UT5627KA, expiration date: 30 Jun 2017, route of administration was not reported) intramuscularly on 20 Sep 2016. Illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On 20 Sep 2016, one hour following the vaccination, the patient had facial flushing, tingling in tongue and cheek and throat tightness. The patient's were sent for evaluation to the hospital. Relevant diagnostic tests/laboratory data were not reported. Patient's were treated with Benadryl and Zyrtec. The outcome of the events were unknown. Upon internal review, the company decided to consider the case serious because of important medical event cheek tightness, throat tightness, tingling in tongue and facial flushing. List of documents held by sender: none. Sender's Comments: As with other vaccines, anaphylactic reaction is listed following INFLUENZA QUADRIVAL A-B VACCINE. Reported symptoms and time to onset are consistent with the diagnosis of anaphylactic reaction. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), information regarding any drug or food intake during the period between vaccination and reaction and allergy testing to identify the culprit allergen are needed to further assess this case. Based on the available information, a role of the vaccine cannot be ruled out.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited misuse report received from a nurse on 21-Sep-2016. This case involves a five-year-old male patient who was vaccinated with first dose of FLUZONE QIV (batch number: U5309AA, expiry date: 30-Jun-2016, dose, dose in series was not reported) via intramuscular route in the right deltoid on 16-Sep-2016. Previously the patient had no known allergy and had medical history of asthma and ectopic dermatitis. Previous medications included albuterol inhaler and topical hydrocortisone. Illness at the time of vaccination was reported as none. Patient's concomitant medication was not reported. On 19 September 2016, three days following the vaccination the patient's right arm became swollen all the way down arm, sore to touch, and warm to touch. The patient was seen in emergency room. It was a case of expired product administered. Lab data was not reported. Patient received benadryl and oral steroids as corrective treatment. The outcome for the events was reported as not recovered. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Intensive care, Malaise, Pneumonia, Pyrexia
Clinical narrative: Initial unsolicited report received from a Physician on 22 September 2016. This case involves a female patient (age not reported) who was vaccinated with dose of Fluzone Hd High Dose (batch number: UI662AA, dose, expiration date, site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date following vaccination, patient feeling cold and unwell and experienced fever 103-104 (unit not reported). On an unspecified date patient was hospitalized (ICU) for pneumonia. It was reported that patient did not have pneumonia. Lab data and corrective treatment were not reported. Outcome of the events were not reported. On an unspecified date, (reported as next day) patient was discharged from hospital. List of documents held by sender: none. Sender's Comments: This is a poorly documented case concern a 70 year old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and developed fever, feeling cold and unwell. Time to onset of event is not provided. Patients medical history, concurrent conditions, concomitant medication, reaction to previous vaccination and etiological work up will be needed for complete assessment of the case. Based on the data provided, the role of vaccine cannot be assessed.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Hypersensitivity
Clinical narrative: Initial unsolicited report received from a consumer on 21 September 2016. This case involves a female patient (age not reported) who was vaccinated with dose of Fluzone Hd (dose, batch number, expiration date, site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination, patient experienced allergic reaction and had severe difficulty breathing. On an unspecified date patient was hospitalized for three days. Lab data and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none. Sender's Comments: Allergic reaction and severe difficulty breathing are reported after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is unknown. Complementary information regarding any drug or food intake during the period between vaccination and reaction as well as allergic testing to identify the culprit antigen, time to onset and patient's history of reaction after previous vaccinations is needed for complete assessment of the case. Based on the available information role of the vaccine can not be assessed.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Body temperature increased, Drug administered at inappropriate site, Injection site discomfort, Injection site pain, Pain
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional on 23-SEP-2016. This case involves a four-year-old male patient who was vaccinated with a first dose of ADACEL (batch number: U5476AA) (expiry date, dose, dose in series, route of administration were not reported) in right thigh, a dose of FLUZONE QIV (batch number, expiry date, dose, dose in series, route of administration were not reported) in thigh, a dose of PROQUAD (manufacturer: MSD, batch number, expiry date, dose, dose in series, route and site of administration were not reported) both on 19-SEP-2016 and a dose of POLIOMYELITIS VACCINE (INACTIVATED) (batch number, expiry date, dose, dose in series, route of administration were not reported) in arm on 20-SEP-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. Concomitant medications were not reported. On 20-SEP-2016, one day following the vaccination of Adacel, Fluzone QIV, Proquad and same day following vaccination of Polio, the patient began to complain of right leg discomfort, patient stated it "hurt to walk", patient's temperature was noted to be 99 (unit not reported). On 21-SEP-2016, two days following the vaccination of Adacel, Fluzone QIV, Proquad and one day following vaccination of polio, the patient temperature was 99 (unit not reported) and complained of leg pain but did not complain of pain when walking. On 23-SEP-2016, four days following the vaccination of Adacel, Fluzone QIV, Proquad and three days following vaccination of Polio, the patient temperature was 100.6 (unit not reported). It was a case of drug administered at inappropriate site. Other lab data was reported as none and corrective treatment was reported as Ibuprofen. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Initial unsolicited report received from a nurse on 23 Sep 2016. This case involves 4-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE QIV (Batch number-UI658AA, expiration date and route were not reported) in arm on 21 Sep 2016. Medical history and concomitant medications were not reported. On 22 Sep 2016 evening, one day following the vaccination, the patient had rash under armpit same side as vaccine, fever and red swollen sore hot arm. Relevant laboratory data and corrective treatment were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Initial unsolicited report received from a nurse on 23 Sep 2016. This case involves 4-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE QIV (Batch number-UI658AA, expiration date and route were not reported) in arm on 21 Sep 2016. Medical history and concomitant medications were not reported. On 22 Sep 2016 evening, one day following the vaccination, the patient had rash under armpit same side as vaccine, fever and red swollen sore hot arm. Relevant laboratory data and corrective treatment were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Initial unsolicited report received from nurse on 23 September 2016. This case involves 13-year-old female patient who was vaccinated with a 0.5 ml dose of FLUZONE QIV (batch number: UI658AA, expiration date, dose and dose in series, route of administration were not reported) on 21 September 2016. The patient's Medical history and Concomitant medication were not reported. On 22 September 2016, in night, one day following the vaccination the patient had symptoms (unspecified). On 23 September 2016, two days following vaccination, the patient had developed 101 (unit not reported) fever, red swollen sore hot arm. Lab data and corrective treatment were not reported. The outcome of events was not reported. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Rash papular
Clinical narrative: Papular pruritic gloves & feet syndrome, fever x4 days.
Age: 12.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Crying, Dizziness, Eye movement disorder, Fear, Hypotonia
Clinical narrative: After receiving 3rd injection patient reported feeling light headed and nauseous. Cool towel applied to patients neck and this nurse began to fan patient. Within a couple minutes patients eyes rolled backwards and she went limp and made a snoring noise. Patients left arm was extended straight and her legs stiffened. This nurse and mom assisted patient to the floor. Within less than a minutes patient opened her eyes and began to cry and state she was scared. Patients arm and legs relaxed. Patient remained on floor for an additional five minutes and then was assisted to chair for an additional period without any further complications. Mom states the patient has a doctors appointment in a few days and she would discuss incident with him.
Age: 12.0
Sex: F
Vaccine: FLU4, HEPA, HPV9
Symptoms: Musculoskeletal stiffness, Nausea, Snoring
Clinical narrative: After receiving 3rd injection patient reported feeling light headed and nauseous. Cool towel applied to patients neck and this nurse began to fan patient. Within a couple minutes patients eyes rolled backwards and she went limp and made a snoring noise. Patients left arm was extended straight and her legs stiffened. This nurse and mom assisted patient to the floor. Within less than a minutes patient opened her eyes and began to cry and state she was scared. Patients arm and legs relaxed. Patient remained on floor for an additional five minutes and then was assisted to chair for an additional period without any further complications. Mom states the patient has a doctors appointment in a few days and she would discuss incident with him.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Joint swelling, Malaise, Peripheral swelling
Clinical narrative: Fatigue, malaise, jt. pain and swelling hands and ankles. Fatigue and malaise lasted approximately 72 hours. Pain and swelling lasted approximately 15 hours. Took Ibuprofen x 2-3 doses.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Mobility decreased, Pain, Rash
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 68 year old female patient. It was reported that the patient did not have any pertinent medical history and drug reactions or allergies. On 27-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M005286), (route: intramuscular). The patient was not taking any medications concomitantly. On an unknown date in September 2016, the patient developed pain, redness, swelling and skin warm to touch. On 28-SEP-2016 (also reported as the next day), the patient said that in addition to the other symptoms, that she couldn't move her arm and that it was immobile. On 29-SEP-2016, the patient had a rash which was not there previously. On an unknown date approximately in September 2016 the patient was diagnosed as having cellulitis. It was reported that cellulitis is not related to the adverse event reported from the vaccine. The patient sought medical attention and received treatment for the events. The patient was able to move the arm then hence the outcome of the event she couldn't move her arm was considered to be recovered. The outcome of the events pain, redness, swelling, skin warm to touch and cellulitis was unknown. The causality of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 68 year old female patient. It was reported that the patient did not have any pertinent medical history and drug reactions or allergies. On 27-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # M005286), (route: intramuscular). The patient was not taking any medications concomitantly. On an unknown date in September 2016, the patient developed pain, redness, swelling and skin warm to touch. On 28-SEP-2016 (also reported as the next day), the patient said that in addition to the other symptoms, that she couldn't move her arm and that it was immobile. On 29-SEP-2016, the patient had a rash which was not there previously. On an unknown date approximately in September 2016 the patient was diagnosed as having cellulitis. It was reported that cellulitis is not related to the adverse event reported from the vaccine. The patient sought medical attention and received treatment for the events. The patient was able to move the arm then hence the outcome of the event she couldn't move her arm was considered to be recovered. The outcome of the events pain, redness, swelling, skin warm to touch and cellulitis was unknown. The causality of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: REDNESS, RING EFFECT AROUND INJECTION SITE, SWELLING, SORENESS OF ARM.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Dizziness, Injected limb mobility decreased, Limb discomfort
Clinical narrative: Patient felt dizzy and her left arm, shoulder an part of her neck felt heavy and could not move it.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Arm became red, swollen, warm to touch, painful, and itchy.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient felt very dizzy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash, Rash pruritic
Clinical narrative: A RASH, BOTH PAINFUL (FELT AS THOUGH IT WERE IN THE MUSCLE) AND ITCHY, 5 INCHES IN DIAMETER, AT THE SITE AND SPREADING INWARD TOWARD THE ARMPIT (LEFT ARM)LASTED 3 DAYS; USED CORTISONE CREAM (OF MINIMAL BENEFIT) AND ANTIHISTAMINES ORALLY.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Patient felt dizzy, lightheaded and felt pain in her left arm.
Age: 22.0
Sex: M
Vaccine: FLU3, HPV9, PNC13
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain, Pyrexia
Clinical narrative: Body aches, pain at injection site, swelling at injection site, low grade fever, malaise. Pt took APAP. BENADRYL, NSAIDS/APAP and ice pack to area was recommended by PA.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Throat tightness
Clinical narrative: Symptoms: Diarrhea and throat constriction. Treatment: Diphenhydramine 25 mg once.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Vomiting
Clinical narrative: Asymptomatic for approximately 1 hour following immunization administration, TS vomited and reported that she felt her throat was closing. Nurse assessed, delivered .3cc Epinephrine and called 911.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Urticaria
Clinical narrative: PT. REPORTED HIVES ALL OVER BODY (EXCEPT FACE AND TORSO)THAT STARTED OFF WITH AN ITCH AROUND 6:30PM AND SPREAD QUICKLY. SHE WENT TO THE ER AT ABOUT 5AM WHEN THE HIVES BECAME UNBEARABLE AND WAS GIVEN BENADRYL AND PREDNISONE, SHE WAS DISCHARGED AT 6:30A.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Blood urine present, Haemorrhage urinary tract, Pollakiuria, Urethral pain, Urinary retention
Clinical narrative: Sudden onset Acute UTI- (I have only EVER had a UTI once before 25 year ago and unsure if it was immediately after flu vaccine)- First symptom feeling like I had to urinate frequently following shortly by pain to urethra area, constant feeling of having to urinate but passing very little urine each time -then by 9:00 pm, had pinkish blood stains when wiping- noticeable bloody urine and passing blood clots in urine by 10 pm.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Urinary tract infection, Urine output decreased
Clinical narrative: Sudden onset Acute UTI- (I have only EVER had a UTI once before 25 year ago and unsure if it was immediately after flu vaccine)- First symptom feeling like I had to urinate frequently following shortly by pain to urethra area, constant feeling of having to urinate but passing very little urine each time -then by 9:00 pm, had pinkish blood stains when wiping- noticeable bloody urine and passing blood clots in urine by 10 pm.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: Patient indicated soreness and bruising around injection site and uncomfortable to raise arm above head.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: The patient's arm was very sore for four days after receiving the flu shot. She went to her primary care physician due to the arm pain and fever she was experiencing.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Flushing, Hyperhidrosis, Palpitations, Paraesthesia, Tachycardia
Clinical narrative: Palpitations, diaphoresis, tachycardia, flushing, facial paresthesias. Decadron, diphenhydramine, ranitidine, IV fluids hydration, observation.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate increased, Injection site pruritus, Pruritus generalised
Clinical narrative: Shortly after the shot my heart rate increased and I began to have sever itch. It started in the ARM were I received the shot and spread to my whole body. It stop only after taken antihistamines.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Angioedema, Lip swelling, Urticaria
Clinical narrative: 2hrs post flu shot developed swollen lips. Taken to ER given DECADRON + 4hrs observation administered BENADRYL then admitted to Peds floor for overnight observation with continued angioedema, hives to face. No respiratory distress noted. Discharged home next day. Educated on EPIPEN use, f/u with PCP for referral for allergy testing. Previous hx of eating eggs, previous hx of flu vaccine.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Rash covering entire body.
Age: 15.0
Sex: M
Vaccine: DTAP, HPV9
Symptoms: Wrong drug administered
Clinical narrative: Gave a DTaP when patient needed just a TD.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Skin warm
Clinical narrative: Pt's arm was red, warm and had spread similarly (not ciruclar) to cellulitis. Pt's arm remained red, less warm into the next day, however was totally cleared up on day 3.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Pyrexia, Tenderness
Clinical narrative: Late night after vaccine the right arm became tender. The next afternoon a fever of 101.7 started along with a large inflamed circle at the site of shot.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: Child noted to have redness, swelling, induration extending from top of shoulder down to elbow and around half of circumference of arm.  Had not previously complained of pain/decreased range of motion. Upon identification was treated w/ oral Motrin, topical corticosteroid and ice pack.  Symptoms resolved over next 24-48 hrs.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal, Stereotypy, Vertigo
Clinical narrative: Slight case of dizziness, vertigo, fuzzy, more rocking back and forth 3-4 days after shot.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Deafness neurosensory
Clinical narrative: Patient developed sudden onset right sided sensorineural hearing loss two days after receiving routine vaccines at well visit.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Chills, Diarrhoea, Erythema, Hyperhidrosis, Mobility decreased
Clinical narrative: SORE WITHIN FEW HOURS. FEVER. CHILLS. SWEATING. CHILLS. DIARRHEA. ARM IMMOBILE. SEVERE UPPER ARM SWELLING. ERYTHEMA. HOT. GOT STEROID INJECTION IN ER. PT STARTED ON CLINDAMYCIN, IBUPROFEN & ONDANSETRON BY MOUTH.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: SORE WITHIN FEW HOURS. FEVER. CHILLS. SWEATING. CHILLS. DIARRHEA. ARM IMMOBILE. SEVERE UPPER ARM SWELLING. ERYTHEMA. HOT. GOT STEROID INJECTION IN ER. PT STARTED ON CLINDAMYCIN, IBUPROFEN & ONDANSETRON BY MOUTH.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, warm area around the injection site. Area measures 1 inch by 3.5 inches. Soreness around and above the injection site extending into the upper shoulder. No pain or soreness below the injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dizziness postural
Clinical narrative: PATIENT EXPLAINS THAT SHE REMAINED "ALMOST CONTINUALLY DIZZY" AFTER RECEIVING VACCINE FOR ABOUT 2 WEEKS AFTER A FOLLOW-UP THE PATIENT STATES THAT DIZZY SPELLS ARE NOW MORE SPORADIC-USUALLY OCCURING AFTER SHE WAKES IN THE MORNING OR WHEN SHE STANDS UP AFTER SITTING FOR A LONG TIME-EFFECT SOUNDS ORTHOSTATIC IN NATURE. OF NOTE: PATIENT EXPLAINS THAT SHE DID HAVE DIZZY SPELLS IN HER 20'S THAT WE DUE TO LOW BLOOD PRESSURE.
Age: 1.25
Sex: M
Vaccine: DTAP, PNC
Symptoms: Blood test abnormal, Pollakiuria, Thirst, Type 1 diabetes mellitus, Urine analysis abnormal
Clinical narrative: Thirsty at night and wetting alot of diapers.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Inflammation, Peripheral swelling, Pruritus
Clinical narrative: Arm turned red, swelled up to size of lemon. Became inflammed and very itchy.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Immune thrombocytopenic purpura, Immunoglobulin therapy, Petechiae, Platelet count decreased
Clinical narrative: After 2nd GARDASIL 5/7/2016 developed petechiae. It became pronounced 7/4/2016 so mom took him to Urgent Care. Diagnosed w/low platelets (decreased 22). Saw Hematologist 7/10/2016. Received IVIG has been in the 50's, weekly platelet rechecks.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Autopsy, Cardiac arrest, Death, Enterovirus test positive, Human rhinovirus test positive
Clinical narrative: No adverse events at time of immunizations. 7 days late passed with unexplained cardiac arrest. Autopsy being completed.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Emotional distress, Incorrect dose administered, Nausea, Needle issue
Clinical narrative: On 9/27/16 patient received 5 vaccines listed in 13. Two doses of MMR were administered due to the needle separating from syringe and complete dose clearly not given. Patient had some urticaria - felt to be due to emotional upset, (6 needles). Later urticaria persisted and she developed nausea. She proceeded to ED for anaphylaxis treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: On 9/27/16 patient received 5 vaccines listed in 13. Two doses of MMR were administered due to the needle separating from syringe and complete dose clearly not given. Patient had some urticaria - felt to be due to emotional upset, (6 needles). Later urticaria persisted and she developed nausea. She proceeded to ED for anaphylaxis treatment.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling cold, Pain in extremity, Pruritus, Pyrexia, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself via a sales representative. This 83 years old female consumer received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. Medical history included rheumatoid arthritis, thyroid disorder, seizure and allergy to latex. Ongoing concomitant medications included KEPPRA from 2013, for seizure, methotrexate, for rheumatoid arthritis, levothyroxine sodium for thyroid. The patient experienced pain in arm on 31May2015, fever on 31May2015, chills on 31May2015, itching on 04Jun2015, peeling on 04Jun2015. No admission to hospital was required. No treatment was received for pain in arm. Pain in arm had not yet resolved (still experiencing some). The outcome of the other events was unknown. Follow-up (19Sep2016): New information from the same contactable consumer includes: patient age, additional medical history, concomitant drugs details, events onset date, additional events itching and peeling, events outcome.
Age: 68.0
Sex: F
Vaccine: FLUX, PNC, FLUX, PNC13
Symptoms: Ex-tobacco user, Pneumococcal infection
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A 68-year-old female contactable consumer (the patient) of unspecified ethnicity received PREVNAR 13 at 0.5 ml single and influenza vaccine, both via an unspecified route of administration on an unknown date in Dec2009 for immunization. The patient was a smoker. Concomitant medications were not reported. The patient received the vaccine and she got pneumococcal infection in Dec2009 (2 to 3 weeks after vaccination). The event required hospitalization in Dec2009 for 10 days. Therapeutic measures, breathing treatments, were taken in response to the event which resolved on an unknown date. The patient stated that the only good thing that came from this was that she quit smoking and had not had a cigarette since Dec2009. She also had not had a flu shot or pneumonia shot since that time and has been relatedly health. The consumer didn't know whether the suspect product was actually Prevnar and not Prevnar 13 (considering that administration date was reported as Dec2009, while Prevnar 13 was launched only on 31Mar2010). Follow-up (08Aug2016): New information from the same contactable consumer includes: medical history, suspect vaccination partial date, concomitant vaccine, updated event outcome, seriousness criterion of hospitalization provided, treatment received information. Follow-up (27Sep2016): New information reported from a contactable consumer included: SAE onset date; hospitalization date; course of events; unknown if Prevnar or Prevnar 13.