chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Feeling hot, Headache, Injection site rash
Clinical narrative: Pt received 2nd dose of SHINGRIX immunization on Saturday, 11/10/18. Afterwards, she started feeling weak and suffered from a headache. On Sunday, she discovered a quarter-sized rash approx. 2 inches below the injection site. Pt also described feeling warmth in her left arm and pain in joints through yesterday (11/13/18). Pt felt that rash may be spreading/"getting worse." Pharmacist recommended getting the rash checked out by a doctor. The pt, being a nurse, agreed that this was the best course of action. Pt also mentioned that she did not experience these side effects with the first injection.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient came stating that her left arm hurt, and felt warm to touch. The arm appeared red and swollen as well. I advised to go to urgent care. Patient listened to the recommendation and received KELFEX 500 mg qty 40, 1 QID for 10 day. She states she was diagnosed with cellulitis.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Pain in arm started within hours of vaccine. Fever, severe arm pain, erythema, induration, swelling at site occurred 24 hours later. Fever lasted approximately 24 hours, Pain, erythema, edema & induration improved 4 days after vaccine given. On visit 11/14 still had faint erythema, tenderness, induration & heat in area of left deltoid.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Pain in arm started within hours of vaccine. Fever, severe arm pain, erythema, induration, swelling at site occurred 24 hours later. Fever lasted approximately 24 hours, Pain, erythema, edema & induration improved 4 days after vaccine given. On visit 11/14 still had faint erythema, tenderness, induration & heat in area of left deltoid.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Metabolic function test, Pain, Swelling, Urticaria
Clinical narrative: Single large urticarial hive extending around deltoid and to medial part of upper extremity. Diffuse swelling. 10/10 pain.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling
Clinical narrative: GOT THE SHOT AT 9:20AM. CALLED PHARMACY BACK AT AROUND 3:30PM REPORTING OF BASEBALL SIZE SWELLING AT THE INJECTION SITE. PT CONFIRMED NO DIFFICULTY BREATHING. I ADVISED PT TO USE COLD COMPRESS TO SEE IF THAT HELPS AND MONITOR THE SWELLING. PT CALLED BACK 30 MINUTES LATER REPORTING THE SWELLING IS GETTING WORST. I ADVISED PT TO SEEK MEDICAL ATTENTION BY CALL 911 OR GO TO THE EMERGENCY ROOM.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Impaired work ability, Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Right arm swelled and turned red covering 3/4 of arm. Affected range of motion and ability to work on computer.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Right arm swelled and turned red covering 3/4 of arm. Affected range of motion and ability to work on computer.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Joint swelling, Oedema peripheral, Peripheral swelling
Clinical narrative: Patient stated vaccine may caused his hand and wrist to swell/edema.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal pain, Cardiac stress test normal, Chest discomfort, Chest pain
Clinical narrative: Dizziness, cold sweat, abdominal/chest discomfort and pain, very high blood pressure.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Computerised tomogram abdomen abnormal, Dizziness, Endoscopy abnormal, Gastritis
Clinical narrative: Dizziness, cold sweat, abdominal/chest discomfort and pain, very high blood pressure.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Gastrointestinal wall thickening, Gastrooesophageal reflux disease, Hypertension, Panic attack
Clinical narrative: Dizziness, cold sweat, abdominal/chest discomfort and pain, very high blood pressure.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Herpes simplex, Large for dates baby, Polycystic ovaries
Clinical narrative: This is a serious observational study case, initially received on 31-Oct-2018, concerning a 27-year-old, pregnant female, subject. This was the subject's second pregnancy. The subject had a previous pregnancy and no birth defect was reported. The father did not receive any medications prior to conception. The subject did not have any paternal or maternal history with major congenital malformation. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 08-Feb-2018. The gestational age of the subject was 34 weeks. On 04-Apr-2018, 07-May-2018, 27-Aug-2018 and 24-Sep-2018, the subject underwent ultrasound test and no major congenital malformation was noted. On 07-May-2018, the subject underwent first trimester screening test and no major congenital malformation was noted. On 08-Oct-2018, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, anatomical location and expiry date: not reported) (explicitly considered as exposure during pregnancy). On an unknown date, after administration of suspect vaccine, the subject's pregnancy status was collected, which suggested large for gestational age, polycystic ovarian syndrome and herpes simplex virus. The subject's estimated date of delivery was reported as 15-Nov-2018. At the time of this report, the outcome of the events was not reported. This case was linked to the original case: 201805222.
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain
Clinical narrative: Pain, redness.
Age: 79.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm, Swelling
Clinical narrative: 21/2-3 hours after injections, Patient experienced extreme swelling, itching, redness and her arm felt hot. Swelling continued into the next day and she had swelling past her elbow. She applied hydrocortisone and ice. Injection was on 11/10/2018. She went to her Doctor on 11/12/18 and received a prednisone taper prescription over 8 days. She saw her Doctor again on 11/14/18 and told her to stop prednisone on 11/15 rather than 11/20 since her condition had improved back to normal. On 11/12 she was also instructed by Doctor to take aspirin.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Herpes simplex test, Rash vesicular, Rhinorrhoea, Varicella virus test
Clinical narrative: Vesicular rash of lower abdomen and diaper area. Mild runny nose. HSV/VZV collected and pending.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Same day swelling, pain, redness at injection site, still painful 14 days after receiving BEXSERO injection.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Neck pain on the side, both sides of neck. Starting at 6 am after immunization. 72 hours pain was going. IBU did not help.
Age: 17.0
Sex: M
Vaccine: DTAP, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: MD ordered flu vaccination to be given. INFANRIX was given accidentally. Within 5 minutes, patient and guardian pulled back to room and informed of error. S/S given to patient to look out for. Flu vaccination then given in other arm. MD made aware. No adverse reactions noted.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain
Clinical narrative: Patient described throbbing pain from injection site that lasted over 2 months and is spreading to her neck.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Asthenia, Back pain, Chest X-ray, Chest pain, Computerised tomogram head
Clinical narrative: Chest xray, CT head; Lumbar puncture; urinalysis, drug screen, EKG, thyroid test, CBC; Presented to ED 11/12/18 about 23:31 with arm pain; weakness; headache and back pain per ED notes; then described having paresthesias to hands and feet; c/o chest pain; nausea; lightheaded and dizzy.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Dizziness, Drug screen, Electrocardiogram, Full blood count, Headache
Clinical narrative: Chest xray, CT head; Lumbar puncture; urinalysis, drug screen, EKG, thyroid test, CBC; Presented to ED 11/12/18 about 23:31 with arm pain; weakness; headache and back pain per ED notes; then described having paresthesias to hands and feet; c/o chest pain; nausea; lightheaded and dizzy.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Lumbar puncture, Nausea, Pain in extremity, Paraesthesia, Thyroid function test
Clinical narrative: Chest xray, CT head; Lumbar puncture; urinalysis, drug screen, EKG, thyroid test, CBC; Presented to ED 11/12/18 about 23:31 with arm pain; weakness; headache and back pain per ED notes; then described having paresthesias to hands and feet; c/o chest pain; nausea; lightheaded and dizzy.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Urine analysis
Clinical narrative: Chest xray, CT head; Lumbar puncture; urinalysis, drug screen, EKG, thyroid test, CBC; Presented to ED 11/12/18 about 23:31 with arm pain; weakness; headache and back pain per ED notes; then described having paresthesias to hands and feet; c/o chest pain; nausea; lightheaded and dizzy.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen, warm to touch
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Eye movement disorder
Clinical narrative: About 1-2 minutes after injection, pt eyes rolling backward. No other symptoms.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Presyncope
Clinical narrative: Vasovagal Rx to needle and drop of blood after vaccination. Pt felt faint after seeing a drop of blood on his arm. He and his wife sat in the immunization room with his feet elevated. We took BP and he said it was at his baseline. He left, felt nauseous.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: On the 2nd of July 2018, the patient received the 1st dose of SHINGRIX intramuscular 0.5 ml. Immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site bleeding. The bleeding stopped right away. The swelling was about 2cm with raised circle.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: On the 2nd of July 2018, the patient received the 1st dose of SHINGRIX intramuscular 0.5 ml. Immediately after receiving SHINGRIX, the patient experienced injection site swelling and injection site bleeding. The bleeding stopped right away. The swelling was about 2cm with raised circle.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Contusion, Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: This spontaneous report has been received from a 64-year-old female consumer referring to herself with diabetes mellitus. Concomitant medications included CELEBREX, CRESTOR, CYMBALTA, gabapentin, tramadol hydrochloride, levothyroxine sodium, metformin and ZENPEP. The patient's pertinent medical history included half of a thyroid and low white blood cell count. The patient received a pneumonia shot in 1990 and experienced arm swelling up like a football. Drug reactions/allergies included neomycin, NEOSPORIN AF, morphine and codeine. The patient was also allergic to eucalyptus and cats. On 10-OCT-2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23 for pneumonia prevention (strength, frequency, route of administration, lot # and expiration date were not reported). On 10-OCT-2018, the patient's arm was hot, red and bumpy, and she experienced hives, bruising of the injection site, arm stiffness and swallowing problems. The patient had sought medical attention. Treatment was given for the events. No lab diagnostics/studies were performed. At the time of the report, the outcome of the events was reported as not recovered. No causality assessment was provided.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report has been received from a 64-year-old female consumer referring to herself with diabetes mellitus. Concomitant medications included CELEBREX, CRESTOR, CYMBALTA, gabapentin, tramadol hydrochloride, levothyroxine sodium, metformin and ZENPEP. The patient's pertinent medical history included half of a thyroid and low white blood cell count. The patient received a pneumonia shot in 1990 and experienced arm swelling up like a football. Drug reactions/allergies included neomycin, NEOSPORIN AF, morphine and codeine. The patient was also allergic to eucalyptus and cats. On 10-OCT-2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23 for pneumonia prevention (strength, frequency, route of administration, lot # and expiration date were not reported). On 10-OCT-2018, the patient's arm was hot, red and bumpy, and she experienced hives, bruising of the injection site, arm stiffness and swallowing problems. The patient had sought medical attention. Treatment was given for the events. No lab diagnostics/studies were performed. At the time of the report, the outcome of the events was reported as not recovered. No causality assessment was provided.
Age: 64.0
Sex: F
Vaccine: FLUC4, PPV, PPV
Symptoms: Dysphagia, Erythema, Injection site bruising, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report has been received from a 64-year-old female consumer referring to herself with diabetes mellitus. Concomitant medications included CELEBREX, CRESTOR, CYMBALTA, gabapentin, tramadol hydrochloride, levothyroxine sodium, metformin and ZENPEP. The patient's pertinent medical history included half of a thyroid and low white blood cell count. The patient received a pneumonia shot in 1990 and experienced arm swelling up like a football. Drug reactions/allergies included neomycin, NEOSPORIN AF, morphine and codeine. The patient was also allergic to eucalyptus and cats. On 10-OCT-2018, the patient was vaccinated with 1 dose of PNEUMOVAX 23 for pneumonia prevention (strength, frequency, route of administration, lot # and expiration date were not reported). On 10-OCT-2018, the patient's arm was hot, red and bumpy, and she experienced hives, bruising of the injection site, arm stiffness and swallowing problems. The patient had sought medical attention. Treatment was given for the events. No lab diagnostics/studies were performed. At the time of the report, the outcome of the events was reported as not recovered. No causality assessment was provided.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: I have had extreme nerve pain throughout my entire body immediately following the flu shot. I was completely healthy when I walked in to get my flu shot, and walked out with sharp nerve pain in my feet, legs, hands, fingers, etc. My body is completely messed up after I received the flu vaccine. I have had two visits to my PCP since the flu shot as a result of my extreme nerve pain. My PCP conducted some blood tests and has referred me to a neurologist. I do not understand why the flu shot has caused me so much pain to my body. I was completely healthy and pain free before I got the flu vaccine. Now I am in constant pain. Please warn people that the flu shot can ruin your life. I am in so much pain!!!!
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Full blood count, Immediate post-injection reaction, Immunology test, Neuralgia, Pain
Clinical narrative: I have had extreme nerve pain throughout my entire body immediately following the flu shot. I was completely healthy when I walked in to get my flu shot, and walked out with sharp nerve pain in my feet, legs, hands, fingers, etc. My body is completely messed up after I received the flu vaccine. I have had two visits to my PCP since the flu shot as a result of my extreme nerve pain. My PCP conducted some blood tests and has referred me to a neurologist. I do not understand why the flu shot has caused me so much pain to my body. I was completely healthy and pain free before I got the flu vaccine. Now I am in constant pain. Please warn people that the flu shot can ruin your life. I am in so much pain!!!!
Age: 2.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from an assistant and refers to a 2-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 01-NOV-2018, the patient was vaccinated with PROQUAD (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. Administrator reported that when the nurse was gathering the vaccines for which the patient was due, the nurse inadvertently gathered 2 doses of PROQUAD without realizing it and administered both doses. The PROQUAD, was reconstituted with sterile diluent. No adverse effect was reported.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Pyrexia, Skin warm
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 42 years old female patient who experienced edema, fever and a very swollen lymph node under my left arm, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid. On 07-Nov-2018 the patient experienced a non-serious a very swollen lymph node under my left arm and fever, two days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient experienced a non-serious edema (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included blood work, chest x-ray, mammogram, and ultrasound due to the edema was performed. Final diagnosis was a very swollen lymph node under my left arm and fever. The patient received antibiotics and steroids. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Blood test, Chest X-ray, Lymphadenopathy, Mammogram, Oedema
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 42 years old female patient who experienced edema, fever and a very swollen lymph node under my left arm, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid. On 07-Nov-2018 the patient experienced a non-serious a very swollen lymph node under my left arm and fever, two days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient experienced a non-serious edema (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included blood work, chest x-ray, mammogram, and ultrasound due to the edema was performed. Final diagnosis was a very swollen lymph node under my left arm and fever. The patient received antibiotics and steroids. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pyrexia, Ultrasound scan
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 42 years old female patient who experienced edema, fever and a very swollen lymph node under my left arm, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Nov-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left deltoid. On 07-Nov-2018 the patient experienced a non-serious a very swollen lymph node under my left arm and fever, two days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient experienced a non-serious edema (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included blood work, chest x-ray, mammogram, and ultrasound due to the edema was performed. Final diagnosis was a very swollen lymph node under my left arm and fever. The patient received antibiotics and steroids. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Lethargy, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Pain in head, hands. Stiff neck, fever chills, lethargy.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Woke up at 1 AM with shivers and high fever, 102°F. Fever drop to about 100° by 8 AM. Fever remain between 99°F and 99.7°F until approximately 2 PM, and fever returned to normal at approximately 3 PM in the afternoon or so. This was my second dose of the SHINGRIX vaccine. I had no reaction like this to the first dose which was administered six months prior.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Have swollen and painfulhand sized axillary lymph node under L arm on same side of flu immunization none as of yet.
Age: 59.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Antinuclear antibody positive, Lymph node pain, Lymphadenopathy
Clinical narrative: Have swollen and painfulhand sized axillary lymph node under L arm on same side of flu immunization none as of yet.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On unknown date in June 2018 (reported as unspecified date four months ago), the patient was vaccinated with first dose of VAQTA (route of administration, lot number and expiration date were not reported) for prophylaxis. On 17-OCT-2018, the patient was vaccinated with second dose VAQTA lot number R018775, expiration date 09-AUG-2019 (route of administration was not reported) for prophylaxis. No adverse event reported.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-OCT-2018, the patient was vaccinated with a dose of M-M-R II intramuscularly (dose not provided, lot # R000554, expiration date 08-JAN-2020) via an incorrect route of administration. No adverse effect reported.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Information has been received from an X-ray technician referring to a 4.5 years old male patient. The patient's pertinent medical history, concomitant therapy and drug reactions/allergies was not reported. On 26-OCT-2018, the patient came into clinic to receive his second dose of VAQTA (50/1.0 U/ml, batch/lot # and expiration date were not reported ) intramuscularly for prophylaxis, but accidentally received the "adult VAQTA dose instead of the pediatric VAQTA dose (incorrect dose administered; adult product administered to child). On 27-OCT-2018, the patient was seen in the office and no adverse events were reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a female patient "in her 20's". The patient's historical condition, concomitant medications and drug reactions or allergies were not reported. On an unknown date in 2018, reported as "a couple months ago", the patient was vaccinated with PNEUMOVAX 23, for prophylaxis (dosage schedule, anatomical location, lot number and expiration date were not reported). On an unknown date in 2018, after administration, the patient had "an injection site reaction" that was described as "swelling down to the elbow" (injection site joint swelling). The patient sought medical attention and received unspecified treatment for the event. At the time of the report, the patient had recovered from injection site joint swelling. The causality between injection site joint swelling and PNEUMOVAX 23 was unknown.
Sex: F
Vaccine: DTAP, HEP, PNC13, RV5
Symptoms: Blood glucose normal, Dyspnoea, Dystonia, Electroencephalogram normal, Foaming at mouth
Clinical narrative: This spontaneous report as received from an other unspecified reporter refers to a female patient of unknown age. The patient's concurrent conditions included gastrooesophageal reflux disease, gas and peripheral pulmonic stenosis (PPS) murmur. The patient had no known drug allergies (NKDA) Concomitant therapies included ZANTAC and INFANTS MYLICON DROPS. On an unknown date the patient was vaccinated with ROTATEQ (lot # R000331, expiry date: 28-FEB-2019) (dose and frequency were not reported) intramuscularly (thigh) (incorrect route of product administration) for prophylaxis. Other suspect therapies included PREVNAR 13 (lot # T94428), HEPATITIS B VIRUS VACCINE (UNSPECIFIED) at birth (lot # 2372K) and DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID (lot # CS389AA) (dose, frequency and expiry date were not reported) intramuscularly (thigh) for prophylaxis. It was reported that, while taking a nap, the patient became dystonic and had trouble catching breath and started foaming at the mouth. The patient's electroencephalogram (EEG) and fingerstick Blood Sugar (FSBS) showed normal, at the hospital. The events lasted approximately 30 seconds to 1 minute. The patient was alert after event, but sleepy. The outcome of events, dystonia, foaming at mouth and dyspnoea was reported as recovered, on an unknown date. The outcome of event, somnolence was unknown. The relationship between the events and suspect drugs was not provided. No digital data logger was involved.
Sex: F
Vaccine: DTAP, HEP, PNC13, RV5
Symptoms: Incorrect route of product administration, Somnolence
Clinical narrative: This spontaneous report as received from an other unspecified reporter refers to a female patient of unknown age. The patient's concurrent conditions included gastrooesophageal reflux disease, gas and peripheral pulmonic stenosis (PPS) murmur. The patient had no known drug allergies (NKDA) Concomitant therapies included ZANTAC and INFANTS MYLICON DROPS. On an unknown date the patient was vaccinated with ROTATEQ (lot # R000331, expiry date: 28-FEB-2019) (dose and frequency were not reported) intramuscularly (thigh) (incorrect route of product administration) for prophylaxis. Other suspect therapies included PREVNAR 13 (lot # T94428), HEPATITIS B VIRUS VACCINE (UNSPECIFIED) at birth (lot # 2372K) and DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TETANUS TOXOID (lot # CS389AA) (dose, frequency and expiry date were not reported) intramuscularly (thigh) for prophylaxis. It was reported that, while taking a nap, the patient became dystonic and had trouble catching breath and started foaming at the mouth. The patient's electroencephalogram (EEG) and fingerstick Blood Sugar (FSBS) showed normal, at the hospital. The events lasted approximately 30 seconds to 1 minute. The patient was alert after event, but sleepy. The outcome of events, dystonia, foaming at mouth and dyspnoea was reported as recovered, on an unknown date. The outcome of event, somnolence was unknown. The relationship between the events and suspect drugs was not provided. No digital data logger was involved.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse prescriber, referring to an adult patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not disclosed. In September 2017 the patient was vaccinated with the first dose of GARDASIL 9, for prophylaxis, lot # N004799, expiration date 15-NOV-2019 (dose, route of administration, and anatomical location were not reported). The nurse prescriber informed that the patient would return on 02-NOV-2018 to receive the second dose of the vaccine (inappropriate schedule of drug administration). At the time of this report, the second dose had not been administered yet and no adverse event was noted.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, frequency, route of administration were not reported) lot # N021571 with an expiration date on 29-APR-2020 for prophylaxis. No adverse effects were reported. The vaccines underwent temperature excursion of 32 to 35 degrees Fahrenheit (F) (34F) for 102 hours and 47 to 77 degrees Fahrenheit (F) (47F) for 18 hours. No previous temperature excursion was reported. A digital data logger was involved. This is one from a several reports from the same reporter. Sender's Comments: US-009507513-1811USA005707: US-009507513-1811USA005706:US-009507513-1811USA005709: US-009507513-1811USA005705: US-009507513-1811USA005708.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-NOV-2018, the patient was vaccinated with a dose of VAQTA (lot # N023953, dose and route of administration were not provided) for prophylaxis which expired on 05-NOV-2018. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medications was not provided. In or around 23-JUL-2013, the patient was inoculated (by an unspecified person) with ZOSTAVAX (dose, route of administration, and lot # were not reported) for routine health maintenance and for its intended purpose: prevention of shingles. Shortly after receiving ZOSTAVAX, the patient has suffered from numerous, reoccurring instances of pneumonia requiring several hospitalizations. As a direct and proximate result of the vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The outcome of the event was unknown.  Causality assessment was considered to be related. Upon internal review, the event of pneumonia recurrent was determined to be medically significant. The event of pneumonia recurrent was considered to be disabling. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Electroencephalogram, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Information has been received from a consumer (the patient's father) referring to a 14 year old female patient. There was no concurrent condition, concomitant medication or drug reactions/allergies. On 03-MAY-2017, at age 13 years old, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot# and expiration date were not reported) for prophylaxis. On 03-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 (strength, route, lot# and expiration date were not reported) for prophylaxis. On an unspecified date in August 2018, the patient experienced a seizure. On an unspecified date in 2018, the patient had an electroencephalogram (EEG) and a magnetic resonance imaging (MRI) without results and KEPPRA prescribed by an unspecified neurologist. The outcome of the event was unknown. The causality between the event and GARDASIL 9 was not reported. Upon internal review, seizure was determined to be medically significant.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Electroencephalogram, Juvenile myoclonic epilepsy, Nuclear magnetic resonance imaging, Seizure
Clinical narrative: Information has been received from a consumer (the patient's father) referring to a 14 year old female patient. There was no concurrent condition, concomitant medication or drug reactions/allergies. On 03-MAY-2017, at age 13 years old, the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot# and expiration date were not reported) for prophylaxis. On 03-NOV-2017, the patient was vaccinated with the second dose of GARDASIL 9 (strength, route, lot# and expiration date were not reported) for prophylaxis. On an unspecified date in August 2018, the patient experienced a seizure. On an unspecified date in 2018, the patient had an electroencephalogram (EEG) and a magnetic resonance imaging (MRI) without results and KEPPRA prescribed by an unspecified neurologist. The outcome of the event was unknown. The causality between the event and GARDASIL 9 was not reported. Upon internal review, seizure was determined to be medically significant.
Age: 65.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative referring to a 65 year old female patient. Information about medical history, concurrent conditions and concomitant therapies was unknown. On 22-OCT-2018, the patient received a dose of PNEUMOVAX 23 (dose detail, route, lot # and expiration date were not reported) and a dose of FLUAD (dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unspecified date in 2018, the patient experienced cellulitis with arm swelling, therefore she went to see her primary care physician and was prescribed steroids with antibiotics (dosage and formulation were unknown). The outcome of cellulitis with swollen arm was unknown at the time of report. The causality assessment were not reported. Upon internal review, cellulitis was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, frequency, route of administration were not reported) lot # N021571 with an expiration date on 29-APR-2020 for prophylaxis. No adverse effects were reported. The vaccines underwent temperature excursion of 32 to 35 degrees Fahrenheit (F) (34F) for 102 hours and 47 to 77 degrees Fahrenheit (F) (47F) for 18 hours. No previous temperature excursion was reported. A digital data logger was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1811USA001803.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored doses of GARDASIL 9 (strength, dose, frequency, route of administration were not reported) lot # N021571 with an expiration date on 29-APR-2020 for prophylaxis. No adverse effects were reported.  The vaccines underwent temperature excursion of 32 to 35 degrees Fahrenheit (F) (34F) for 102 hours and 47 to 77 degrees Fahrenheit (F) (47F) for 18 hours. No previous temperature excursion was reported. A digital data logger was involved. This is one of the several reports from the same reporter.; Sender's Comments: US-009507513-1811USA001803:
Sex: U
Vaccine: FLU4
Symptoms: Reaction to preservatives
Clinical narrative: This case was reported by a physician and described the occurrence of reaction to sulfites in a patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced reaction to sulfites. On an unknown date, the outcome of the reaction to sulfites was unknown. It was unknown if the reporter considered the reaction to sulfites to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: This case was reported by the patient himself who was a neonatologist. The age at vaccination was not reported. After receiving flu shot, the patient developed a reaction which was recognized as a sulfite sensitivity. The patient asked whether they produce a Flu shot that was free of sulfites, sulfates and any sulfa derivatives.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284510, 2018SA284495 (same reporter). Case was considered as non-case as no event was reported. Additional information was received on 02-Nov-2018 from Nurse. This case involves an patient of unknown demographics who received vaccine PENTACEL (batch number, expiry date, dose in series, route and site of administration not reported) which was inactive due to temparature stability on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to incorrect product storage and Deteriorated drug administered. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Initial information received on 30-Oct-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case is linked with case 2018SA302120 (same reporter). This case involves a four-year-old female patient who was vaccinated with a 0.5 ml dose of vaccine IPOL (lot P1A251M, expiration date 02-May-2020) via intramuscular route in the right thigh on 27-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included FLUZONE QIV for Immunisation on 27-Oct-2018; DTAP for Immunisation on 27-Oct-2018; MMR for Immunisation on 27-Oct-2018; and VARICELLA VACCINE for Immunisation on 27-Oct-2018. It was a case of actual medication error due to deteriorated drug administered and incorrect product storage. It was reported that the vaccines exposed to a temperature excursion twice on 22-sep-2018 with temp up to 8.29 C for 1 hour and on 19-Oct-2018, at 8.33 C for 1 hour (opened vial). It was reported that they had an open vial of IPOL and 4 patients received it after it should of been discarded. The patient didn't experience any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up report received from other health care professional on 31-Oct-2018. The reporter has information about the other 3 patients. No information has been reported about the patient in this case. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Flushing, Local reaction, Pain in extremity
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 67 years old female patient who experienced localized reaction, flushing and redness in her face, felt warm but no fever, feels sluggish and achiness in her legs, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Herpes zoster (shingles twice this year in on unspecified date at May and July). The patient's past medical treatment included Acyclovir for shingles, BENADRYL and Prednisone for 4 days for another problem but is not sure which year she took the medication. The patient's past vaccination(s) included FLUZONE QUADRIVALENT past every year. The patient's past family history was not provided. On an unknown date at 05:00 PM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious localized reaction, four hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date (reported as next AM), the patient developed a non-serious flushing in her face, redness in her face and felt warm but no fever following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious feels sluggish and achiness in her legs, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was achiness in her legs, feels sluggish, felt warm but no fever, flushing and redness in her face and localized reaction. The patient received BENADRYL but did not help her. The outcome of the events was not reported. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Sluggishness
Clinical narrative: Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 67 years old female patient who experienced localized reaction, flushing and redness in her face, felt warm but no fever, feels sluggish and achiness in her legs, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Herpes zoster (shingles twice this year in on unspecified date at May and July). The patient's past medical treatment included Acyclovir for shingles, BENADRYL and Prednisone for 4 days for another problem but is not sure which year she took the medication. The patient's past vaccination(s) included FLUZONE QUADRIVALENT past every year. The patient's past family history was not provided. On an unknown date at 05:00 PM, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious localized reaction, four hours following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date (reported as next AM), the patient developed a non-serious flushing in her face, redness in her face and felt warm but no fever following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious feels sluggish and achiness in her legs, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. No lab data reported. Final diagnosis was achiness in her legs, feels sluggish, felt warm but no fever, flushing and redness in her face and localized reaction. The patient received BENADRYL but did not help her. The outcome of the events was not reported. Documents held by sender: none.
Age: 62.0
Sex: U
Vaccine: TYP
Symptoms: Syringe issue
Clinical narrative: Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. PTC was generated on 06-Nov-2018 under PTC number 100002726. This case involves a 62 years old patient who received vaccine TYPHIM VI lot N1K811M via intramuscular route in the left arm on 01-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to syringe issue. It was reported that administering TYPHIM VI to a patient and the liquid started spraying out of the syringe in the space between where the needle attaches (luer lock) and the syringe.He had to administer the vaccine to the patient using a different prefilled syringe because it was obvious the patient wasn't getting any of the dose. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none. Additional information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. PTC was initiated ant the PTC number was updated. Documents held by sender: none.