chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Anxiety, Blood pressure decreased, Blood pressure increased, Condition aggravated, Dizziness
Clinical narrative: Had Pneumovac 23 vaccine on 6/01/2020. Within three hours arm became very sore. Could not sleep on that side for two nights. Felt lethargic the next day. Injection site became red, swollen and feverish within one day and red "ridge" about one inch wide and two inches long appeared below inject site after two days. On third day got severe headache and extreme hypertension. Went to doctors office. Received toradol injection for pain. Sent to ER. After two hours BP even more elevated. Began Hydrozaline to "drive BP down". Admitted to hospital and BP still elevated and severe headache for three days. Still getting Hydrozaline and Valsartan and HCTZ and Amlodipine for BP. Xanax for anxiety. Began throwing up on third day. Then dry heaves. BP began to drop. Sent home. Next day BP bottomed out and almost fainted. Now not on BP meds at all. I attribute all of this to the Pneumovac 23 because I have never had a reaction or headache of that nature before.
Sex: F
Vaccine: PPV
Symptoms: Headache, Hypertension, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Had Pneumovac 23 vaccine on 6/01/2020. Within three hours arm became very sore. Could not sleep on that side for two nights. Felt lethargic the next day. Injection site became red, swollen and feverish within one day and red "ridge" about one inch wide and two inches long appeared below inject site after two days. On third day got severe headache and extreme hypertension. Went to doctors office. Received toradol injection for pain. Sent to ER. After two hours BP even more elevated. Began Hydrozaline to "drive BP down". Admitted to hospital and BP still elevated and severe headache for three days. Still getting Hydrozaline and Valsartan and HCTZ and Amlodipine for BP. Xanax for anxiety. Began throwing up on third day. Then dry heaves. BP began to drop. Sent home. Next day BP bottomed out and almost fainted. Now not on BP meds at all. I attribute all of this to the Pneumovac 23 because I have never had a reaction or headache of that nature before.
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Pain in extremity, Retching, Sleep disorder, Vomiting
Clinical narrative: Had Pneumovac 23 vaccine on 6/01/2020. Within three hours arm became very sore. Could not sleep on that side for two nights. Felt lethargic the next day. Injection site became red, swollen and feverish within one day and red "ridge" about one inch wide and two inches long appeared below inject site after two days. On third day got severe headache and extreme hypertension. Went to doctors office. Received toradol injection for pain. Sent to ER. After two hours BP even more elevated. Began Hydrozaline to "drive BP down". Admitted to hospital and BP still elevated and severe headache for three days. Still getting Hydrozaline and Valsartan and HCTZ and Amlodipine for BP. Xanax for anxiety. Began throwing up on third day. Then dry heaves. BP began to drop. Sent home. Next day BP bottomed out and almost fainted. Now not on BP meds at all. I attribute all of this to the Pneumovac 23 because I have never had a reaction or headache of that nature before.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, Underdose
Clinical narrative: Flulaval Quadrivalent (Influenza Vaccine) Product Malfunction in a one-week period beginning on October 4, 2020, our facility received approximately five reports of Flulaval Quadrivalent leaking drug at the at the hub of the syringe. Most cases were noted to have been caught prior to reaching patients. However, in one specific occurrence, the needle was inserted into the patient's deltoid and the syringe plunger was depressed. However, the entire dose escaped from the hub resulting in an insufficient administration. Upon further investigation, it was determined that the needle was indeed appropriately secured to the syringe. Note that the lot # provided only pertains to one associated incident. The products in the other incidents were not isolated. Further, the drug manufacturer representative has been contacted and scheduled to meet with pharmacy leadership in the coming weak.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: I received a dose of shingrix 50 MCG INJ (!M) sngdse vl10pk administered .5 ML in the muscle of left arm. My arm is red swellen and hot at the point of injection.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pneumonia vaccine and arm swollen and red at the site , warm to the touch and distant red spots by the site as well. Soreness at site I have pics of my arm , this site will not let me upload them
Sex: M
Vaccine: FLUR4
Symptoms: Erythema, Injection site bruising, Injection site swelling, Peripheral swelling
Clinical narrative: swelling of the underarms along with redness, swelling and purple Injection site
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: After receiving a flu shot and Pneumovax-23 vaccine injection the same visit my arm/shoulder were very sore, a day later my bicep was red swollen and it still very painful. I receive a flu shot annually and never had this happen.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Hypoaesthesia, Peripheral swelling
Clinical narrative: Went to pharmacy to get a flu shot and pneumonia short, I'm 66 other than high blood pressure no major health issues. The pharmacist asked if I had a pneumonia shot before I said yes Prevnar 13 last year They gave me a pneumovax 23 shot. Bad reaction redness swelling from my elbow to the back of my shoulder blade and right front chest. Fingers going numb wrist hurt to much to pick things or do much .Went to my Drs walk in clinic 2 days later as it wasn't getting any better they have me a prescription of predisone to try to counter the reaction. Will see if that helps any they said if the swelling and redness didn't go away in a couple of days to come back.
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging abnormal, Optic neuritis, Relapsing-remitting multiple sclerosis
Clinical narrative: Retrobulbar neuritis, Left; h/o RRMS, stable since 2008, on Glatiramer; given Shingrix 10 days before onset of retrobulbar neuritis, and Hep B vaccine 11 days prior.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Myalgia, Pyrexia
Clinical narrative: I received a flu vaccine at my local pharmacy. It was the recommended double dose as I am 65 years old. The next day I had a 99.4 degree fever, muscle aches, and cough. I have never previously had a reaction to a flu shot. A nap in the middle of the day made it better. The following day I'm feeling fine.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING and redness oF Right arm, initially at The injection site with progression to Below Elbow. Not Streaking, Doubt cellulitis Not a systemic allergic reaction
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: severe myalgia developed after Shingrix injection
Age: 68.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Fatigue, Hyperhidrosis, Mobility decreased, Pain in extremity
Clinical narrative: I received injections of Fluzone HD PF 20-21 and also Pneumovax 23 25 in the same arm. By the evening my arm was extremely sore so that I could not lift it above shoulder level. I am 68 years old, an endurance cyclist, and very fit so this is not just being a wimp. I went to bed at my normal time and awoke in the middle of the night with chills and also sweating profusely. I got up and took Acetaminophen and went back to bed. I did not measure my temperature. Chills and sweating remained into the night. I usually get up by 7:00am but I felt so fatigued that I slept until 10:00. When I awoke the chills and sweating were gone. My arm is still a bit sore but I have full range of motion.
Age: 68.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Sleep disorder
Clinical narrative: I received injections of Fluzone HD PF 20-21 and also Pneumovax 23 25 in the same arm. By the evening my arm was extremely sore so that I could not lift it above shoulder level. I am 68 years old, an endurance cyclist, and very fit so this is not just being a wimp. I went to bed at my normal time and awoke in the middle of the night with chills and also sweating profusely. I got up and took Acetaminophen and went back to bed. I did not measure my temperature. Chills and sweating remained into the night. I usually get up by 7:00am but I felt so fatigued that I slept until 10:00. When I awoke the chills and sweating were gone. My arm is still a bit sore but I have full range of motion.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Urticaria
Clinical narrative: After first dose of Shingrix NDC: 58160-0823-11. At 2:30AM following day (8/11) Developed hives on Right thigh. Lasted for 1 1/2 hours. Took Benadryl. Next night, at 11PM developed hives on Left thigh. Lasted under two hours. Third night, hives on right arm, and behind both knees, PLUS severe nerve pain (burning and stinging) up and down both legs. Called my physician and was prescribed prednisone 20 mg/da for five days. No further problems.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Unevaluable event
Clinical narrative: 65+ Flu vaccine; Fluad PFS 2020-21 INJ 0.5 ml
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching, Hives
Sex: M
Vaccine: HPVX
Symptoms: Wrong product administered
Clinical narrative: My 16 year old son was given the wrong vaccine-HPV instead of meningitis booster
Age: 91.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia
Clinical narrative: weakness
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: area red, warm + swollen 1 1/2 - 2" diameter
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: Patient received High Dose Flu vaccine and within 3 hours she experienced myalgia, malaise and fever. Several hours later, she developed a fever of 102F, was nauseous and weak. She continued to experience these symptoms over the next several days.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: I got my flu shot on October 14, the next day the dizziness started and got worse on Friday (Oct, 16). Now, I have some dizziness periods during the day, specially when I do some fast moving.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthma, Chronic kidney disease, Feeling abnormal, Laboratory test, Muscle spasms
Clinical narrative: pneumonia; pneumonia; This spontaneous report was received from a 67-year-old female patient via Pfizer regarding herself. The patient's current conditions included rheumatoid arthritis, Stage 4 renal failure (diagnosed at age of 53 years) and diabetes mellitus (diagnosed in 2008). Also, the patient was Immunocompromised (immunodeficiency). Since at the age of 50 years (unknown date), the patient started to receive influenza virus vaccine inactivated (unspecified) (FLU SHOT) and got sick always after receiving it.  On an unknown date in 2003, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, lot number, strength, route was not provided) for prophylaxis. Other suspect therapies included abatacept(ORENCIA) and influenza virus vaccine inactivated (unspecified)(INFLUENZA VIRUS VACCINE INACTIVATED (UNSPECIFIED)). The patient was vaccinated again with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in 2008. On an unknown date in 2015, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR). Since an unknown date, the patient started abatacept(ORENCIA) infusion at unknown dose, once in a month via intravenous route (strength, lot number, expiry date not provided) for Rheumatoid arthritis. It was reported that since August 2017, the dose of abatacept(ORENCIA) was increased (unspecified). The patient took abatacept(ORENCIA) for around 1-2 years and received it at clinic.The patient received flu shots at doctor's office. On an unknown date in the mid of September 2017, the patient experienced pneumonia for the first time and then hospitalized for two days (unknown dates in September 2017). The patient had severe chest spasm and they did not sure what was it. It turned out to be pneumonia, but the pain was excruciating. So that for the first time at hospital, patient was performed with bunch of tests for pneumonia.   On a Friday (reported as in late October 2017), patient received abatacept(ORENCIA) infusion and on the followed Wednesday, she received influenza virus vaccine inactivated (unspecified) (FLU SHOT). She felt bad after 24 hours of influenza virus vaccine inactivated (unspecified) (FLU SHOT) and then diagnosed with pneumonia that Monday. The patient was not hospitalized for pneumonia but visited the physician's office and received antibiotics, which she was on for quite a while. The patient had fever for 2-3 weeks. The patient had more asthma type problems since the start of pneumonia and got wheezy faster. The patient had recovered from pneumonia with some lasted effects in late 2017 (November or might be even early December 2017). The outcome of pneumonia was considered to be recovered with sequelae. No causality assessment was provided.  Upon internal review, the event pneumonia was determined to be medically significant.
Age: 52.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pneumonia, Pyrexia, Renal failure, Wheezing
Clinical narrative: pneumonia; pneumonia; This spontaneous report was received from a 67-year-old female patient via Pfizer regarding herself. The patient's current conditions included rheumatoid arthritis, Stage 4 renal failure (diagnosed at age of 53 years) and diabetes mellitus (diagnosed in 2008). Also, the patient was Immunocompromised (immunodeficiency). Since at the age of 50 years (unknown date), the patient started to receive influenza virus vaccine inactivated (unspecified) (FLU SHOT) and got sick always after receiving it.  On an unknown date in 2003, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, lot number, strength, route was not provided) for prophylaxis. Other suspect therapies included abatacept(ORENCIA) and influenza virus vaccine inactivated (unspecified)(INFLUENZA VIRUS VACCINE INACTIVATED (UNSPECIFIED)). The patient was vaccinated again with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in 2008. On an unknown date in 2015, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVENAR). Since an unknown date, the patient started abatacept(ORENCIA) infusion at unknown dose, once in a month via intravenous route (strength, lot number, expiry date not provided) for Rheumatoid arthritis. It was reported that since August 2017, the dose of abatacept(ORENCIA) was increased (unspecified). The patient took abatacept(ORENCIA) for around 1-2 years and received it at clinic.The patient received flu shots at doctor's office. On an unknown date in the mid of September 2017, the patient experienced pneumonia for the first time and then hospitalized for two days (unknown dates in September 2017). The patient had severe chest spasm and they did not sure what was it. It turned out to be pneumonia, but the pain was excruciating. So that for the first time at hospital, patient was performed with bunch of tests for pneumonia.   On a Friday (reported as in late October 2017), patient received abatacept(ORENCIA) infusion and on the followed Wednesday, she received influenza virus vaccine inactivated (unspecified) (FLU SHOT). She felt bad after 24 hours of influenza virus vaccine inactivated (unspecified) (FLU SHOT) and then diagnosed with pneumonia that Monday. The patient was not hospitalized for pneumonia but visited the physician's office and received antibiotics, which she was on for quite a while. The patient had fever for 2-3 weeks. The patient had more asthma type problems since the start of pneumonia and got wheezy faster. The patient had recovered from pneumonia with some lasted effects in late 2017 (November or might be even early December 2017). The outcome of pneumonia was considered to be recovered with sequelae. No causality assessment was provided.  Upon internal review, the event pneumonia was determined to be medically significant.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Cardiac stress test, Chest discomfort, Chest pain, Dizziness
Clinical narrative: On Friday October 5th around 8:30 am I completed my health screen assessment which included a flu vaccination. A few hours later I started to feel a bit wheezy and light headed. Around 2pm that day I had a feeling of shortness of breath which  continued off and on into the evening. I continued on with my daily activities and assume it was typical fatigue. Later that evening at around approximately 6pm, I couldn't breathe, my chest tightened up, I felt a sharp throbbing pain in my chest area, which intensified. I felt pressure in my entire upper midchest area, I couldn't breathe and my heart was pounding and beating rapidly, felt like I was having a mini heartattack. I moved from the chair onto the ground to remove my toddler from my hands, laid on my left side and called out for my husband. The pain, shortness of breathe and tightening of chest lasted for a few minutes. I remained on the ground until the pain subsided and breathing patterns returned to normal , then remained seated for the next 20 to 30 minutes. Shortly after my breathing returned to normal however my chest still felt tight, and abnormal. During the day I carried out typically daily activities which included sitting at my desk, while operating a computer. During the incident I waiting for the feeling of wheeziness to pass. Around 2pm I again waited for the shortness of breathe to pass, I remained seated, about 5 to 10 minutes after, then once it passed I stretched, and drank some water. That afternoon I was sitting down on the couch watching tv nursing my infant, when the incident occurred, I laid on the ground on my left side, and there after rested on the couch. In the coming days I made several doctors appointment to assess the issue.  In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Electrocardiogram, Feeling abnormal, Heart rate increased, Palpitations
Clinical narrative: On Friday October 5th around 8:30 am I completed my health screen assessment which included a flu vaccination. A few hours later I started to feel a bit wheezy and light headed. Around 2pm that day I had a feeling of shortness of breath which  continued off and on into the evening. I continued on with my daily activities and assume it was typical fatigue. Later that evening at around approximately 6pm, I couldn't breathe, my chest tightened up, I felt a sharp throbbing pain in my chest area, which intensified. I felt pressure in my entire upper midchest area, I couldn't breathe and my heart was pounding and beating rapidly, felt like I was having a mini heartattack. I moved from the chair onto the ground to remove my toddler from my hands, laid on my left side and called out for my husband. The pain, shortness of breathe and tightening of chest lasted for a few minutes. I remained on the ground until the pain subsided and breathing patterns returned to normal , then remained seated for the next 20 to 30 minutes. Shortly after my breathing returned to normal however my chest still felt tight, and abnormal. During the day I carried out typically daily activities which included sitting at my desk, while operating a computer. During the incident I waiting for the feeling of wheeziness to pass. Around 2pm I again waited for the shortness of breathe to pass, I remained seated, about 5 to 10 minutes after, then once it passed I stretched, and drank some water. That afternoon I was sitting down on the couch watching tv nursing my infant, when the incident occurred, I laid on the ground on my left side, and there after rested on the couch. In the coming days I made several doctors appointment to assess the issue.  In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Wheezing
Clinical narrative: On Friday October 5th around 8:30 am I completed my health screen assessment which included a flu vaccination. A few hours later I started to feel a bit wheezy and light headed. Around 2pm that day I had a feeling of shortness of breath which  continued off and on into the evening. I continued on with my daily activities and assume it was typical fatigue. Later that evening at around approximately 6pm, I couldn't breathe, my chest tightened up, I felt a sharp throbbing pain in my chest area, which intensified. I felt pressure in my entire upper midchest area, I couldn't breathe and my heart was pounding and beating rapidly, felt like I was having a mini heartattack. I moved from the chair onto the ground to remove my toddler from my hands, laid on my left side and called out for my husband. The pain, shortness of breathe and tightening of chest lasted for a few minutes. I remained on the ground until the pain subsided and breathing patterns returned to normal , then remained seated for the next 20 to 30 minutes. Shortly after my breathing returned to normal however my chest still felt tight, and abnormal. During the day I carried out typically daily activities which included sitting at my desk, while operating a computer. During the incident I waiting for the feeling of wheeziness to pass. Around 2pm I again waited for the shortness of breathe to pass, I remained seated, about 5 to 10 minutes after, then once it passed I stretched, and drank some water. That afternoon I was sitting down on the couch watching tv nursing my infant, when the incident occurred, I laid on the ground on my left side, and there after rested on the couch. In the coming days I made several doctors appointment to assess the issue.  In the months that followed I continue to have unexplained frequently occurring chest pains, shortness of breath and heart palpitations.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dry skin, Injection site erythema, Injection site swelling, Paraesthesia, Scar
Clinical narrative: My arm at the injection site swelled to 1/2 the size of a softball.  A few days later. Just below the injection site my arm turned a color of red the size of a silver dollar.  I felt the sensation of a needle poking me under the skin.  The redness did not look like a blister, it was wrinkly and did not look or feel like skin.  I showed it to the pharmacist who knew it was a bad reaction and instructed me to go to my Doc.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Sensory disturbance
Clinical narrative: My arm at the injection site swelled to 1/2 the size of a softball.  A few days later. Just below the injection site my arm turned a color of red the size of a silver dollar.  I felt the sensation of a needle poking me under the skin.  The redness did not look like a blister, it was wrinkly and did not look or feel like skin.  I showed it to the pharmacist who knew it was a bad reaction and instructed me to go to my Doc.
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: patient received a Flublok vaccine on Monday and that evening she developed hives all over her body; injection site looks fine other than a red mark where the patient received the injection; Initial information and regarding this unsolicited valid non-serious case from other health care professional transmitted on 14-Oct-2020.  This case involved a 57 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on Monday and that evening she developed hives all over her body (Urticaria) and injection site looks fine other than a red mark where the patient received the injection (Vaccination site erythema).  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 12-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2043, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was reported that the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE on Monday and that evening following the administration of  the vaccine, she developed hives all over her body (Urticaria). It was also reported that injection site looked fine other than a red mark where the patient received the injection (Vaccination site erythema), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Final diagnosis was injection site looks fine other than a red mark where the patient received the injection and patient received a Flublok vaccine on Monday and that evening she developed hives all over her body.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for the reported events.
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Injection site erythema, Urticaria
Clinical narrative: patient received a Flublok vaccine on Monday and that evening she developed hives all over her body; injection site looks fine other than a red mark where the patient received the injection; Initial information and regarding this unsolicited valid non-serious case from other health care professional transmitted on 14-Oct-2020.  This case involved a 57 years old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on Monday and that evening she developed hives all over her body (Urticaria) and injection site looks fine other than a red mark where the patient received the injection (Vaccination site erythema).  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 12-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2043, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  It was reported that the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE on Monday and that evening following the administration of  the vaccine, she developed hives all over her body (Urticaria). It was also reported that injection site looked fine other than a red mark where the patient received the injection (Vaccination site erythema), unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Final diagnosis was injection site looks fine other than a red mark where the patient received the injection and patient received a Flublok vaccine on Monday and that evening she developed hives all over her body.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for the reported events.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Oral mucosal eruption, Rash, Streptococcus test negative, Tonsillar hypertrophy
Clinical narrative: Rash on side of right neck, perioral rash, bilateral tender cervical LAD, Tonsils 3+
Age: 14.0
Sex: F
Vaccine: FLUA3
Symptoms: Dyspnoea, Eye swelling, Headache, Lip swelling, Oropharyngeal pain
Clinical narrative: Epi and Benadryl, soar throat difficulty breathing, swollen eyes, lips, and throat area, itching, headache, tachycardia
Age: 14.0
Sex: F
Vaccine: FLUA3
Symptoms: Pharyngeal swelling, Pruritus, Tachycardia
Clinical narrative: Epi and Benadryl, soar throat difficulty breathing, swollen eyes, lips, and throat area, itching, headache, tachycardia
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: soreness in arm and fever of 100.5.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope immediately after vaccination-Vital signs stable throughout at 2 min intervals (BP L arm sitting 108/58, pulse 82 regular, 102/60, 84 regular, standing: 104/60, pulse 84 regular).  Recovered on his own within 15 minutes
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Syncope immediately following vaccine administration-Vital signs remained stable and patient was alert/oriented and talking within seconds and fully recovered (no dizziness, etc.) within 20 minutes.  BP L arm lying: 110/60, pulse 82 regular, Sitting: 104/60, pulse-84 regular.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Drooling, Hypersensitivity, Respiratory tract congestion, Speech disorder
Clinical narrative: sounds as if he had marbles in his mouth; Acute congestion; Drooling; he seemed spaced out for a brief time period.; Allergic reaction; This spontaneous report was received from a nurse concerning a 4 years old male patient on 24-SEP-2020. No concurrent condition, medical history or concomitant therapy was reported.      On 10-SEP-2020 at around 16:30, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) once (lot # T013536, expiry date: 17-OCT-2021; dose was not reported) subcutaneously in the right arm for prophylaxis. On the same day, he also received diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (KINRIX) intramuscularly in the left arm (dose, frequency and indication were not reported).   On that day, he had allergic reaction. At around 18:00 at the dinner table before he ate anything, he became acutely congested, drooling, and he sounded as if he had marbles in his mouth. The mother gave the boy diphenhydramine hydrochloride (BENADRYL), and about 10 minutes after he seemed spaced out for a brief time period. On an unspecified date in September 2020, the patient's symptoms resolved with no residual effects, and he has not had any prior vaccine reactions. Action taken with suspect therapies was not applicable.   The causality between the events and suspect therapies was not reported.
Sex: F
Vaccine: PPV
Symptoms: Atrial fibrillation, Pneumonia
Clinical narrative: PNEUMONIA; Afib heart condition; This spontaneous report has been received from a currently 98-year-old female consumer concerning herself. Her current conditions included asthma, hypersensitivity, allergy to vaccine, iodine allergy, drug hypersensitivity, food allergy and seasonal allergy. Her historical medication included penicillin.   On an unknown date in 2002, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), 1 dosage form ( reported as 1 vaccination), via intramuscular as prophylaxis (reported as for pneumococcal disease) (lot number and expiry date were unknown by the reporter).         On an unknown date in 2018, the patient experienced a light case of pneumonia (also reported as a small case of pneumonia) which cause her to be taken to the hospital for precaution, however, the small case of pneumonia turned into an atrial fibrillation heart condition.   The outcome of pneumonia and atrial fibrillation was reported as recovered but the recovery date was unknown by the reporter.     The causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and the occurrence of pneumonia and atrial fibrillation was considered related.   Upon internal review, pneumonia and atrial fibrillation were considered medically significant events.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster; Information has been received from a lawyer and a patient of unknown gender (currently about 81 year old) regarding a case in litigation on 12-OCT-2020. On or about 12-JUL-2012, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (strength, dose, route, lot# and expiration date note reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. The outcome of the events was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Age: 11.0
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Administered improperly stored MMR II.; This spontaneous report was received from a registered nurse, referring to a 11-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 13-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 0.5 milliliter (ml) (lot number S029454 which has been verified to be valid, expiration date reported and validated as 19-SEP-2021) (vaccination scheme, route of administration and anatomical site of injection were not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of -50 degrees Celsius (C) to +8 C (14.58 C), during a time frame of 11 hours and 45 minutes, as recorded by a digital data logger. There was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA004754: US-009507513-2010USA005233:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion; This spontaneous report was received from a practice manager 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 27-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 11-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 14-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 15-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager 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 15-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Visual impairment
Clinical narrative: permanent vision loss; deteriorating vision; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information about current condition, historical condition and concomitant medication was provided. On or about 26-FEB-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: herpes zoster, deteriorating vision and permanent vision loss. The outcome of permanent vision loss was considered as not recovered. The outcome of the other events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Permanent vision loss was considered as disabled. Upon internal review, permanent vision loss was considered to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; ROTATEQ was improperly stored and administered; This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 14-OCT-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered (lot number S040076 which has been verified to be valid, expiration date reported and validated as 15-JUN-2021) (dose and frequency were unknown by the reporter; vaccination scheme was not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 11.35 degrees Celsius (C), during a time frame of 40 hours, as recorded by a digital data logger. There were previous temperature excursions on 07-OCT-2020: 9.45 C, during a time frame of 1 hour and 30 minutes; on 09-OCT-2020: 11.86 C, during a time frame of 11 hours and 15 minutes; and on 10-OCT-2020: 10.23 C, during a time frame of 1 hour and 45 minutes. No additional adverse events were reported in the patient.
Age: 20.0
Sex: M
Vaccine: FLUN4
Symptoms: Product administration error, Rhinorrhoea
Clinical narrative: ADMINISTERING MORE THAN PRESCRIBED/DRUG OVERDOSE; NOSE DRIPPAGE OUT OF NOSTRIL THAT RECEIVED FULL DOSE; FULL DOSE ADMINISTERED IN ONE NOSTRIL; NOT FOLLOWING IFU; ADMINISTERED ANOTHER HALF DOSE INTO THE OTHER NOSTRIL; A spontaneous report has been received from a pharmacist. The report concerns a male patient (age 18 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza virus vaccine live, intranasal) (batch number MH2024) 0.2 ml once/single administration, via nasal route, for vaccine for influenza on 03-OCT-2020.     The report described a medication error for Flumist Quadrivalent. The reported term was "full dose administered in one nostril" (Preferred term: Product administration error). The reported term was "not following ifu" (Preferred term: Wrong technique in product usage process). The report described an overdose for Flumist Quadrivalent. The reported term was "administering more than prescribed/drug overdose" (Preferred term: Overdose) and administered another half dose into the other nostril (Preferred term: Intentional product misuse).    On 03-OCT-2020, the patient experienced nose drippage out of nostril that received full dose (preferred term: Rhinorrhoea).     The outcome of the event(s) of administering more than prescribed/drug overdose, nose drippage out of nostril that received full dose, full dose administered in one nostril, not following ifu and administered another half dose into the other nostril was unknown.     The events were considered non-serious.     The reporter considered the following event(s) related to treatment with Flumist Quadrivalent (influenza virus vaccine live, intranasal): not following ifu.    Summary of follow-up information received by AstraZeneca/MedImmune 13-Oct-2020 received from Pharmacist via spontaneous: Reporter causality added for event not following IFU. Lot number updated for suspect FluMist. Start date of vaccine FluMist updated to 03-Oct-2020 from 04-Oct-2020. Event onset date updated to 03-Oct-2020 for event not following IFU and event onset date 03-Oct-2020 updated for rest of events. Reporter case ID added. Reporter middle name and address updated for Pharmacist. The patient demographic details added. Form completed date updated as follow up. Narrative updated. Corrected report on 16-Oct-2020: Reporter type corrected to patient from patient assistance program for second reporter Valid null flavors added to Reporter 6 (Reference). Overdose ticked on product add info. Order of events and association corrected. Form completed by, Have you reported this adverse event previously (Vaccines only) and Relation to patient ticked for Pharmacist on reporter tab.    Minor corrrection on 19-Oct-2020: Null flavour added in reporter tab.