chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: Patient reported 2 areas that were red and sore 24-48 hours after the immunization. The 1st area was at injection site and was about 1.5"x 1.5" and the 2nd area was on the bicep area of same arm near the elbow which the painful rash was about 3" x 5" in size. Patient also reported that her skin on the back of her neck and shoulder was sore to touch and hot. Patient reported a fever about 24 hours after immunization and malaise for 48 hours. Patient stated she felt like she was getting shingles. Patient stated that after 5 days she started feeling better.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Patient presented to pharmacy 11/20/18 complaining of muscle soreness in deltoid muscle and experiencing pain rotating and/or lifting arm. She stated her arm was sore after the injection and the pain did not resolve after a couple of days. She has been taking NSAIDs to help alleviate the pain.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Pt presented with fever, nausea and vomiting 12 hours after the shot. Advised pt to contact MD.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Lingering shoulder pain, unable to lift my arm without severe pain that has been getting progressively worse.
Age: 78.0
Sex: M
Vaccine: FLUA3
Symptoms: Abdominal pain, Abdominal rigidity, Heart rate increased, Panic attack
Clinical narrative: Patient received FLUAD vaccine and 5 minutes later began having symptoms consistent with panic attack. He reported having a rapid heart rate and had abdominal spasm/cramping. His abdominal symptoms were both visible and palpable on examination. I did vitals only (BP 225/90, Heart Rate 155, RR 19) and had pharmacy technician call EMS. Within 2 to 3 minutes his symptoms subsided and he stated that he felt much better. Vitals on recheck were as follows: BP 160/85, HR 80, RR 15. Patient had no respiratory distress and showed no signs of anaphylaxis. EMS came and checked him out and said everything was normal (ECG and vitals). EMS suspected that it may have been a panic attack, though the patient felt it might be a reaction to the FLUAD vaccine.
Age: 46.0
Sex: F
Vaccine: MMR
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came in 5 days after her vaccination complaining of slight itching and a small bump at the injection site. Upon examination the injection site had slight induration but did not look red, swollen or warm to the touch. Instructed the patient to follow-up with her PCP for further testing.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: Severe itching, burning sensation and warmth at the injection site, redness, sharp stabbing pain,  formation of lump/welt at injection site.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Erythema and swelling around the injection site with some induration. About 4 cm in diameter.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site, body aches, chills, fatigue (flu like symptoms).
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain and swelling at injection site, body aches, chills, fatigue (flu like symptoms).
Age: 1.75
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Urticaria chronic
Clinical narrative: Recurrent/chronic (daily) urticaria beginning 2 weeks after vaccinations continuing through the present (11/20/2018).
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Nasal congestion, Pyrexia
Clinical narrative: STUFFY NOSE; FEVER 102.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain in extremity, Tenderness
Clinical narrative: Patient stated left arm was sore after getting vaccine. She said that night it got swollen and when she woke up it was swollen down to her elbow. Has taken NSAIDS and iced the area and the swelling has gone down but it is still sore to the touch.
Age: 50.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain
Clinical narrative: Per patient, since the day patient received the flu vaccine in his left arm, he has been experiencing pain. (it has been about 3 weeks since the time of the vaccination). He stated he has pain when lifting his arm as well. He has not visited MD for his symptoms yet.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose normal, Chills, Electrocardiogram normal, Head discomfort, Nausea
Clinical narrative: Patient received SHINGRIX vaccine on 11/15/2018. The next morning she awoke with chills and nausea and feeling her head was heavy. She then had a syncopal episode. No cardiac or neurologic symptoms, no other new meds. Pt was found by housekeeper and EMS was called. They evaluated her and told her glucose and EKG was fine- they advised ER visit which she declined. I evaluated her in office but by this time was completely asymptomatic. She has never had a prior syncopal episode.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Patient received SHINGRIX vaccine on 11/15/2018. The next morning she awoke with chills and nausea and feeling her head was heavy. She then had a syncopal episode. No cardiac or neurologic symptoms, no other new meds. Pt was found by housekeeper and EMS was called. They evaluated her and told her glucose and EKG was fine- they advised ER visit which she declined. I evaluated her in office but by this time was completely asymptomatic. She has never had a prior syncopal episode.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Irritability, Myalgia, Nausea, Vomiting
Clinical narrative: Received the FLULAVAL flu shot. Experiencing severe muscle pain, which is worsening my current injury, nausea, vomiting, headaches, and irritability.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: On 11/08/2018 (Thursday) Employee experienced potential allergic reaction to the Influenza vaccine she received on 11/07/2018 (Wednesday). She sated that Thursday evening she developed rash on the upper extremity Influenza vaccine was given. She reports rash started at the hand and moved upwards, by 11/09/2018 Friday morning she had rash on her cheeks, neck and upper chest. She stated she did not change her cosmetics, soaps, or laundry detergents, she also denies any food allergies or any previous allergy to influenza vaccination. She did see MD at urgent care, was given ALLEGRA and her symptoms went away within 2 days.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient complaining of shoulder pain and having to frequent physicians office
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient came in stating arm was still sore and had limited range of motion.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Bradycardia, Dysphagia, Dysphonia, Dyspnoea, Electrocardiogram abnormal
Clinical narrative: Left arm pain on movement, nauseous, trouble breathing and swallowing water, swollen lips, hoarse voice, tongue feeling thick. Administration of EPI 0.3 mg IM, TORADAL 15 mg IV; ZOFRAN 4mg IV; DECADRON 10 mg IV; BENADRYL 25 mg IV
Age: 16.0
Sex: M
Vaccine: FLU4, MENB
Symptoms: Lip swelling, Nausea, Pain, Sinus arrhythmia, Tongue disorder
Clinical narrative: Left arm pain on movement, nauseous, trouble breathing and swallowing water, swollen lips, hoarse voice, tongue feeling thick. Administration of EPI 0.3 mg IM, TORADAL 15 mg IV; ZOFRAN 4mg IV; DECADRON 10 mg IV; BENADRYL 25 mg IV
Age: 27.0
Sex: M
Vaccine: PNC13
Symptoms: Haemoptysis
Clinical narrative: Pt came in on 11/20/2018 saying that primary care doctor/pulmonary physician recommended getting PREVNAR 13 after receiving PNEUMOVAX a year prior due to his preexisting condition with bronchiolitis and prior surgery for a collapsed lung about 10 years ago. Patient was administered the vaccination and was observed for around 10 minutes before leaving with no symptoms. No allergies were noted. Around 3:00 pm patient's mother called back stating that patient had been coughing up a little blood. Contacted patient and noted that patient was not having any angioedema/allergic symptoms or trouble breathing or hived. Only notable symptom was the coughing up of blood. Advised patient to get checked out by emergency room due to coughing up blood. Advised doctor of the situation, which he said it could be due to his condition and not necessarily the vaccination. Patient at this time is getting check out at ER. Otherwise no notable other cardinal symptoms.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Severe localized reaction red, warm to touch painful right upper arm.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: 9.5 x 9.5 cm erythema (R) thigh at injection site.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: During administration of flu shot, device malfunctioned and RPh had to get another needle tip and reinject patient. Upon 2nd injection, pt felt pain at injection site. She has had persistent pain at injection site and down arm since immunization. This pain has been relieved some with steroids. But comes back when steroids are discontinued.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: See additional page(s) for complete text.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash erythematous
Clinical narrative: Raised erythematous rash. Total of 5 areas identified. No evidence of increased work of breathing, tachycardia or lethargy.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Rash erythematous, Rash maculo-papular
Clinical narrative: Patient with mild erythematous. Maculopapular rash just medial to injection site next day. No fever. No difficulty breathing. Injection site ok.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received varicella vaccine on Friday, 11/16/18. Adverse symptoms presented on Saturday evening, 11/17/18 and continued to worsen. Right arm where it was administered was red, hot, swollen, itchy, and tender to touch. Went to ER on 11/18/18 and received a prescription for Naproxen and was evaluated and released.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Computerised tomogram head normal, Dizziness, Headache, Lumbar puncture normal, Nausea
Clinical narrative: This spontaneous report was received from an office manager and the patient's mother and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On an unknown date following the vaccination, the patient experienced severe headache and weakness. It was unknown if any treatment was provided. The outcome of headache and weakness was unknown. The relatedness between the events and GARDASIL 9 was not reported.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Pain
Clinical narrative: This spontaneous report was received from an office manager and the patient's mother and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On an unknown date following the vaccination, the patient experienced severe headache and weakness. It was unknown if any treatment was provided. The outcome of headache and weakness was unknown. The relatedness between the events and GARDASIL 9 was not reported.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9
Symptoms: Asthenia, Headache
Clinical narrative: This spontaneous report was received from an office manager and the patient's mother and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On an unknown date following the vaccination, the patient experienced severe headache and weakness. It was unknown if any treatment was provided. The outcome of headache and weakness was unknown. The relatedness between the events and GARDASIL 9 was not reported.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Body temperature increased, Dizziness, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 17 years old female patient who experienced temperature, body aches, headache, stiff neck, vomiting and dizziness, while she received vaccines TRUMENBA and MENACTRA. The patient's past medical history, medical treatment(s), and family history were reported as none. Patient received MENACTRA previously on 12 July 2012. On 24-Sep-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6016AA) via intramuscular route in the left deltoid. On 24-Sep-2018, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur (lot number: T52806) via intramuscular route in the right deltoid at 8:30 am. On 24-Sep-2018, the patient developed a serious temperature of 102.1 degrees Fahrenheit, body aches, headache, stiff neck and vomiting 2 hours following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. On 24-Sep-2018, the patient developed a serious dizziness 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. (Other relevant tests included No lab data.) Final diagnosis was vomiting, stiff neck, headache, body aches, temperature and dizziness. The patient received a corrective treatment Ondansetron for nausea and vomiting. She was instructed to take TYLENOL or ibuprofen. On an unknown date in Oct 2018, the patient was recovered from all the events. The reporter assessed the events to be related with TRUMENBA. List of documents held by sender: None. Sender's Comments: This case involves a 17 years old patient who experienced fever, body aches, headache, stiff neck, vomiting and dizziness same day post vaccination with TRUMENBA and MENACTRA. Time to onset is compatible. However, more details regarding patient's medical history, condition at the time of vaccination, etiological workup and investigation reports to identify alternative infectious etiology are needed for complete assessment of the case. Moreover, concomitant administration of two vaccines preceded the events. Based upon the reported information, the role of the vaccines cannot be individually assessed.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Pain, Vomiting
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 17 years old female patient who experienced temperature, body aches, headache, stiff neck, vomiting and dizziness, while she received vaccines TRUMENBA and MENACTRA. The patient's past medical history, medical treatment(s), and family history were reported as none. Patient received MENACTRA previously on 12 July 2012. On 24-Sep-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6016AA) via intramuscular route in the left deltoid. On 24-Sep-2018, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur (lot number: T52806) via intramuscular route in the right deltoid at 8:30 am. On 24-Sep-2018, the patient developed a serious temperature of 102.1 degrees Fahrenheit, body aches, headache, stiff neck and vomiting 2 hours following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. On 24-Sep-2018, the patient developed a serious dizziness 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. (Other relevant tests included No lab data.) Final diagnosis was vomiting, stiff neck, headache, body aches, temperature and dizziness. The patient received a corrective treatment Ondansetron for nausea and vomiting. She was instructed to take TYLENOL or ibuprofen. On an unknown date in Oct 2018, the patient was recovered from all the events. The reporter assessed the events to be related with TRUMENBA. List of documents held by sender: None. Sender's Comments: This case involves a 17 years old patient who experienced fever, body aches, headache, stiff neck, vomiting and dizziness same day post vaccination with TRUMENBA and MENACTRA. Time to onset is compatible. However, more details regarding patient's medical history, condition at the time of vaccination, etiological workup and investigation reports to identify alternative infectious etiology are needed for complete assessment of the case. Moreover, concomitant administration of two vaccines preceded the events. Based upon the reported information, the role of the vaccines cannot be individually assessed.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 17 years old female patient who experienced temperature, body aches, headache, stiff neck, vomiting and dizziness, while she received vaccines TRUMENBA and MENACTRA. The patient's past medical history, medical treatment(s), and family history were reported as none. Patient received MENACTRA previously on 12 July 2012. On 24-Sep-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6016AA) via intramuscular route in the left deltoid. On 24-Sep-2018, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur (lot number: T52806) via intramuscular route in the right deltoid at 8:30 am. On 24-Sep-2018, the patient developed a serious temperature of 102.1 degrees Fahrenheit, body aches, headache, stiff neck and vomiting 2 hours following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. On 24-Sep-2018, the patient developed a serious dizziness 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. (Other relevant tests included No lab data.) Final diagnosis was vomiting, stiff neck, headache, body aches, temperature and dizziness. The patient received a corrective treatment Ondansetron for nausea and vomiting. She was instructed to take TYLENOL or ibuprofen. On an unknown date in Oct 2018, the patient was recovered from all the events. The reporter assessed the events to be related with TRUMENBA. List of documents held by sender: None. Sender's Comments: This case involves a 17 years old patient who experienced fever, body aches, headache, stiff neck, vomiting and dizziness same day post vaccination with TRUMENBA and MENACTRA. Time to onset is compatible. However, more details regarding patient's medical history, condition at the time of vaccination, etiological workup and investigation reports to identify alternative infectious etiology are needed for complete assessment of the case. Moreover, concomitant administration of two vaccines preceded the events. Based upon the reported information, the role of the vaccines cannot be individually assessed.
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid serious case received from a nurse. This case involves a 17 years old female patient who experienced temperature, body aches, headache, stiff neck, vomiting and dizziness, while she received vaccines TRUMENBA and MENACTRA. The patient's past medical history, medical treatment(s), and family history were reported as none. Patient received MENACTRA previously on 12 July 2012. On 24-Sep-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6016AA) via intramuscular route in the left deltoid. On 24-Sep-2018, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur (lot number: T52806) via intramuscular route in the right deltoid at 8:30 am. On 24-Sep-2018, the patient developed a serious temperature of 102.1 degrees Fahrenheit, body aches, headache, stiff neck and vomiting 2 hours following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. On 24-Sep-2018, the patient developed a serious dizziness 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant. (Other relevant tests included No lab data.) Final diagnosis was vomiting, stiff neck, headache, body aches, temperature and dizziness. The patient received a corrective treatment Ondansetron for nausea and vomiting. She was instructed to take TYLENOL or ibuprofen. On an unknown date in Oct 2018, the patient was recovered from all the events. The reporter assessed the events to be related with TRUMENBA. List of documents held by sender: None. Sender's Comments: This case involves a 17 years old patient who experienced fever, body aches, headache, stiff neck, vomiting and dizziness same day post vaccination with TRUMENBA and MENACTRA. Time to onset is compatible. However, more details regarding patient's medical history, condition at the time of vaccination, etiological workup and investigation reports to identify alternative infectious etiology are needed for complete assessment of the case. Moreover, concomitant administration of two vaccines preceded the events. Based upon the reported information, the role of the vaccines cannot be individually assessed.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Heart rate increased, Hypertension
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 67 years old female patient who experienced a fainting state, could not walk, felt hot, began to feel weak and nauseated, blood pressure high while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HD last year with no adverse reaction. The patient's past medical history, medical treatment(s) and family history were not provided. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and Exp. date not reported via unknown route in the left arm. On an unknown date, the patient developed a serious fainting state following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On an unknown date, the patient could not walk, felt hot, began to feel weak, nauseated and blood pressure high following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included Date: Unk, Test Name: Blood pressure, Result: 185/155, Notes: high; Date: Unk, Test Name: pulse rate, Result: 107. It was reported that, on an unknown date, received IV fluids and did chest X-ray and different blood tests. Also it was reported that, they did a cardiogram and was recommend to go to emergency room and was monitored for about 4 or 5 hours and then discharged the same day. Final diagnosis was nauseated, feeling weak, felt hot, could not walk, fainting and blood pressure high. It was not reported if the patient received a corrective treatment. The patient was not recovered from events. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Asthenia, Blood test, Chest X-ray, Electrocardiogram, Feeling hot
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 67 years old female patient who experienced a fainting state, could not walk, felt hot, began to feel weak and nauseated, blood pressure high while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HD last year with no adverse reaction. The patient's past medical history, medical treatment(s) and family history were not provided. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and Exp. date not reported via unknown route in the left arm. On an unknown date, the patient developed a serious fainting state following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On an unknown date, the patient could not walk, felt hot, began to feel weak, nauseated and blood pressure high following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included Date: Unk, Test Name: Blood pressure, Result: 185/155, Notes: high; Date: Unk, Test Name: pulse rate, Result: 107. It was reported that, on an unknown date, received IV fluids and did chest X-ray and different blood tests. Also it was reported that, they did a cardiogram and was recommend to go to emergency room and was monitored for about 4 or 5 hours and then discharged the same day. Final diagnosis was nauseated, feeling weak, felt hot, could not walk, fainting and blood pressure high. It was not reported if the patient received a corrective treatment. The patient was not recovered from events. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Gait inability, Hypertension, Nausea, Syncope
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 67 years old female patient who experienced a fainting state, could not walk, felt hot, began to feel weak and nauseated, blood pressure high while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HD last year with no adverse reaction. The patient's past medical history, medical treatment(s) and family history were not provided. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and Exp. date not reported via unknown route in the left arm. On an unknown date, the patient developed a serious fainting state following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On an unknown date, the patient could not walk, felt hot, began to feel weak, nauseated and blood pressure high following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included Date: Unk, Test Name: Blood pressure, Result: 185/155, Notes: high; Date: Unk, Test Name: pulse rate, Result: 107. It was reported that, on an unknown date, received IV fluids and did chest X-ray and different blood tests. Also it was reported that, they did a cardiogram and was recommend to go to emergency room and was monitored for about 4 or 5 hours and then discharged the same day. Final diagnosis was nauseated, feeling weak, felt hot, could not walk, fainting and blood pressure high. It was not reported if the patient received a corrective treatment. The patient was not recovered from events. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Blood test normal, Cardiac imaging procedure abnormal, Chest X-ray normal, Hypertension, Immediate post-injection reaction
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 67 years old female patient who experienced a fainting state, could not walk, felt hot, began to feel weak and nauseated, blood pressure high while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HD last year with no adverse reaction. The patient's past medical history, medical treatment(s) and family history were not provided. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and Exp. date not reported via unknown route in the left arm. On an unknown date, the patient developed a serious fainting state following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On an unknown date, the patient could not walk, felt hot, began to feel weak, nauseated and blood pressure high following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included Date: Unk, Test Name: Blood pressure, Result: 185/155, Notes: high; Date: Unk, Test Name: pulse rate, Result: 107. It was reported that, on an unknown date, received IV fluids and did chest X-ray and different blood tests. Also it was reported that, they did a cardiogram and was recommend to go to emergency room and was monitored for about 4 or 5 hours and then discharged the same day. Final diagnosis was nauseated, feeling weak, felt hot, could not walk, fainting and blood pressure high. It was not reported if the patient received a corrective treatment. The patient was not recovered from events. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3, FLU3
Symptoms: Palpitations
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a 67 years old female patient who experienced a fainting state, could not walk, felt hot, began to feel weak and nauseated, blood pressure high while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HD last year with no adverse reaction. The patient's past medical history, medical treatment(s) and family history were not provided. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number and Exp. date not reported via unknown route in the left arm. On an unknown date, the patient developed a serious fainting state following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On an unknown date, the patient could not walk, felt hot, began to feel weak, nauseated and blood pressure high following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included Date: Unk, Test Name: Blood pressure, Result: 185/155, Notes: high; Date: Unk, Test Name: pulse rate, Result: 107. It was reported that, on an unknown date, received IV fluids and did chest X-ray and different blood tests. Also it was reported that, they did a cardiogram and was recommend to go to emergency room and was monitored for about 4 or 5 hours and then discharged the same day. Final diagnosis was nauseated, feeling weak, felt hot, could not walk, fainting and blood pressure high. It was not reported if the patient received a corrective treatment. The patient was not recovered from events. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Cough, Dyspnoea, Hypoaesthesia oral, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: About 2 hrs after flu shot was administered on Oct. 4th, pt started coughing, felt that her throat was closing up, eyes became red and started tearing. Her face became red and swollen with numbness to lips reported as well. The patient then went to a nearby ER. In the ER, pt was treated with IV: BENADRYL, PEPCID, and steroids. Pt was sent home w/ an Rx for all three meds to be taken orally q6h for 3 days. Pt states that while in the ER, they stated that 7 other pts had come in that week for the same response to the FLU shot. Noted that ED noted that this was "the 7th" anaphylaxis this past week per patient. Other Personal allergy history only includes iodine allergy (from MRI) - broke out in hives but no breathing affected (20 yrs ago).
Age: 51.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Swelling
Clinical narrative: About 2 hrs after flu shot was administered on Oct. 4th, pt started coughing, felt that her throat was closing up, eyes became red and started tearing. Her face became red and swollen with numbness to lips reported as well. The patient then went to a nearby ER. In the ER, pt was treated with IV: BENADRYL, PEPCID, and steroids. Pt was sent home w/ an Rx for all three meds to be taken orally q6h for 3 days. Pt states that while in the ER, they stated that 7 other pts had come in that week for the same response to the FLU shot. Noted that ED noted that this was "the 7th" anaphylaxis this past week per patient. Other Personal allergy history only includes iodine allergy (from MRI) - broke out in hives but no breathing affected (20 yrs ago).
Age: 51.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Anaphylactic reaction, Cough, Erythema, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: About 2 hrs after flu shot was administered on Oct. 4th, pt started coughing, felt that her throat was closing up, eyes became red and started tearing. Her face became red and swollen with numbness to lips reported as well. The patient then went to a nearby ER. In the ER, pt was treated with IV: BENADRYL, PEPCID, and steroids. Pt was sent home w/ an Rx for all three meds to be taken orally q6h for 3 days. Pt states that while in the ER, they stated that 7 other pts had come in that week for the same response to the FLU shot. Noted that ED noted that this was "the 7th" anaphylaxis this past week per patient. Other Personal allergy history only includes iodine allergy (from MRI) - broke out in hives but no breathing affected (20 yrs ago).
Age: 51.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Ocular hyperaemia, Swelling face, Throat tightness
Clinical narrative: About 2 hrs after flu shot was administered on Oct. 4th, pt started coughing, felt that her throat was closing up, eyes became red and started tearing. Her face became red and swollen with numbness to lips reported as well. The patient then went to a nearby ER. In the ER, pt was treated with IV: BENADRYL, PEPCID, and steroids. Pt was sent home w/ an Rx for all three meds to be taken orally q6h for 3 days. Pt states that while in the ER, they stated that 7 other pts had come in that week for the same response to the FLU shot. Noted that ED noted that this was "the 7th" anaphylaxis this past week per patient. Other Personal allergy history only includes iodine allergy (from MRI) - broke out in hives but no breathing affected (20 yrs ago).
Age: 51.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Feeling abnormal, Swelling of eyelid
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 07-Nov-2018, concerns a 51-year-old, adult female patient. The patient had intolerance to egg (reported as: diarrhoea after eating eggs) and had egg allergy. The patient was allergic to sulfa drugs, hydrocodone and prednisone caused anxiety. On 07-Nov-2018, at 10:40 am, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019]. On the same day, one minute after vaccination, the patient's eyes started to swell and broke out with a rash on her chest. Additionally, the patient's heartbeats were increased. At 10:43 am, within a minute and a half she received an EPIPEN shot (dose: 0.3 mg, intramuscularly in thigh). After that, within 10 minutes, the patient had another similar reaction with similar effects. The patient went to emergency room and felt better. The same day (07-Nov-2018), the patient had recovered from the events. The reporter assessed the case as serious (medically significant).
Age: 51.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Eye swelling, Heart rate increased, Rash
Clinical narrative: This spontaneous case, initially received from other non-health professional (consumer) on 07-Nov-2018, concerns a 51-year-old, adult female patient. The patient had intolerance to egg (reported as: diarrhoea after eating eggs) and had egg allergy. The patient was allergic to sulfa drugs, hydrocodone and prednisone caused anxiety. On 07-Nov-2018, at 10:40 am, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252668 and expiry date: 30-Jun-2019]. On the same day, one minute after vaccination, the patient's eyes started to swell and broke out with a rash on her chest. Additionally, the patient's heartbeats were increased. At 10:43 am, within a minute and a half she received an EPIPEN shot (dose: 0.3 mg, intramuscularly in thigh). After that, within 10 minutes, the patient had another similar reaction with similar effects. The patient went to emergency room and felt better. The same day (07-Nov-2018), the patient had recovered from the events. The reporter assessed the case as serious (medically significant).
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received SHINGRIX on the right deltoid. The pharmacist stated that the patient had local reaction like redness, soreness, warm to touch and a red line about half inch wide (not a thin red line) coming from the red circle at the injection site. The patient called the pharmacist on the reporting day to provide these details.
Age: 55.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX (batch number 424A7, expiry date 18th April 2021) for prophylaxis. On 9th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient received SHINGRIX on the right deltoid. The pharmacist stated that the patient had local reaction like redness, soreness, warm to touch and a red line about half inch wide (not a thin red line) coming from the red circle at the injection site. The patient called the pharmacist on the reporting day to provide these details.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Burning sensation, Erythema, Fatigue, Injection site erythema
Clinical narrative: Red swollen injection site approx 5hrs post administration. Tender L deltoid to touch & arm moment. Approx 3 days post vaccine L arm > R arm bumpy rash. Overall tired, weak feeling. Arm tenderness continues. Approx 14hrs post arm rash generalized hives over entire torso, neck, face, groom, anterior upper thighs, & L arm. Mild bumpy rash continues in R arm. Hives are prickly, itchy, burning, raised, red and warm. Hives are not responding to BENADRYL. Over all malaise continues with weakness, exhaustion. Afebrile.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Malaise, Pain, Pruritus
Clinical narrative: Red swollen injection site approx 5hrs post administration. Tender L deltoid to touch & arm moment. Approx 3 days post vaccine L arm > R arm bumpy rash. Overall tired, weak feeling. Arm tenderness continues. Approx 14hrs post arm rash generalized hives over entire torso, neck, face, groom, anterior upper thighs, & L arm. Mild bumpy rash continues in R arm. Hives are prickly, itchy, burning, raised, red and warm. Hives are not responding to BENADRYL. Over all malaise continues with weakness, exhaustion. Afebrile.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Red swollen injection site approx 5hrs post administration. Tender L deltoid to touch & arm moment. Approx 3 days post vaccine L arm > R arm bumpy rash. Overall tired, weak feeling. Arm tenderness continues. Approx 14hrs post arm rash generalized hives over entire torso, neck, face, groom, anterior upper thighs, & L arm. Mild bumpy rash continues in R arm. Hives are prickly, itchy, burning, raised, red and warm. Hives are not responding to BENADRYL. Over all malaise continues with weakness, exhaustion. Afebrile.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Gait inability, Injection site pain, Synovitis, X-ray normal
Clinical narrative: Fine afterwards, jumped off a small block at daycare on November 6 and hasn't been able to walk since. The only consistent is that he always grabs the thigh where the shot was given. Xrays and blood work done and nothing came back. He now has full range of motion in his leg and hip but still won't put pressure on left leg to walk. We are now going on week 3. No fevers. Told it was toxic synovitis and to treat with ibuprofen.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Feeling abnormal, Haemorrhage, Head injury, Headache, Injection site pain
Clinical narrative: We left the room after the shot to check out. He said the shot felt weird. While checking out he essesntially fainted but looked like he was paralyzed and having a seizure. I screamed, Drs came. They lifted his legs, grabbed ice, water, crackers. He was out between 1 to 2 minutes. When he came to he did not know why he was on the floor or why his head hurt and all these people were around him. He hit the chair going down and had some knots and one slightly bleeding. He was put in chair and we waited about 15 minutes or more. Drs explained fainting can happen. The nurse nor Drs told us we needed to sit and wait after the shot. Now we know, but it was very scary. So far he just has arm pain where shot was administered.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site reaction, Loss of consciousness, Swelling, Syncope
Clinical narrative: We left the room after the shot to check out. He said the shot felt weird. While checking out he essesntially fainted but looked like he was paralyzed and having a seizure. I screamed, Drs came. They lifted his legs, grabbed ice, water, crackers. He was out between 1 to 2 minutes. When he came to he did not know why he was on the floor or why his head hurt and all these people were around him. He hit the chair going down and had some knots and one slightly bleeding. He was put in chair and we waited about 15 minutes or more. Drs explained fainting can happen. The nurse nor Drs told us we needed to sit and wait after the shot. Now we know, but it was very scary. So far he just has arm pain where shot was administered.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 51 year old female patient. Concomitant medication, pertinent medical history and drug allergies were unknown by the reporter. On 15-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 lot # R017900, expiration date 26-MAR-2020 (strength, dose, frequency and route were not reported) for prophylaxis. On 17-OCT-2018, the patient experienced a fever which had lasted 8 days since the administration of PNEUMOVAX 23 and no treatment was given. The outcome of fever was reported as not recovered. The causality assessment was not provided.
Sex: F
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report has been received from a pharmacist, referring to a female patient under 65 years old. The pharmacist stated that the patient did not have any chronic medical condition. Information about her pertinent medical history, previous drug reactions, allergies and concomitant medication was not provided. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX 23 injection for prophylaxis (frequency, route and anatomical location of vaccination, lot number and expiration date were not provided). The pharmacist reported that the clinic where the patient worked, suggested her to receive the vaccine since she worked with the elderly; therefore, the patient was coming back for a second dose.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal stiffness
Clinical narrative: This spontaneous report has been received from a nurse practitioner referring to a 56 year old female patient with allergy to penicillin as concurrent condition. The patient had no medical history, or concomitant medications to be reported. On 15-NOV-2018,the patient was vaccinated with PNEUMOVAX 23, intramuscular in the left deltoid (strength, dose, frequency, lot# and expiration date were not provided) to prevent pneumonia. It was reported that on the same date (15-NOV-2018) (reported as one hour after the administration of PNEUMOVAX 23, the patient experienced erythema (injection site erythema), tenderness and pain below the injection site (injection site pain) and arm stiffness (musculoskeletal stiffness). The reporter stated that the patient self medicated with BENADRYL, BENGAY (contradicting information as it was also reported that the patient did not received any treatment). Furthermore, the patient visited the doctor's office on 16-NOV-2018. No laboratory studies were performed. The outcome of injection site erythema, musculoskeletal stiffness and injection site pain was reported as not recovered, as it was reported that the patient did not feel relief. At the reporting time, the causality between the aforementioned events and therapy with PNEUMOVAX 23 was not reported.