chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Aggression, Anaphylactic reaction, Cough, Eye swelling, Lethargy
Clinical narrative: 10 minutes after receiving the MMR vaccine he walked to the front desk with his mother, he sneezed 5 times with mucus coming out of his nose, he then had a gagging cough and threw up once, he then continued to have dry heaves and he looked puffy around his eyes, he then started to become lethargic alternating with combative, his O2 dropped to 88%, he face became puffier, we give him AUVI-Q 0.15 in the left thigh and called 911, oxygen was started as his O2 was 100%, he was lethargic off and on, but his HR, RR and BP remained stable, he never developed a rash, he was taken by ambulance to the local hospital and given IV SOLU-MEDROL and diphenhydramine, after about 4 hours he became much more active, less swollen and he was drinking, he was discharged home from the ER with a EPIPEN, he will follow up with an allergist; the clinical picture was consistent with anaphylaxis.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Oxygen saturation decreased, Retching, Rhinorrhoea, Sneezing, Swelling face
Clinical narrative: 10 minutes after receiving the MMR vaccine he walked to the front desk with his mother, he sneezed 5 times with mucus coming out of his nose, he then had a gagging cough and threw up once, he then continued to have dry heaves and he looked puffy around his eyes, he then started to become lethargic alternating with combative, his O2 dropped to 88%, he face became puffier, we give him AUVI-Q 0.15 in the left thigh and called 911, oxygen was started as his O2 was 100%, he was lethargic off and on, but his HR, RR and BP remained stable, he never developed a rash, he was taken by ambulance to the local hospital and given IV SOLU-MEDROL and diphenhydramine, after about 4 hours he became much more active, less swollen and he was drinking, he was discharged home from the ER with a EPIPEN, he will follow up with an allergist; the clinical picture was consistent with anaphylaxis.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Vomiting
Clinical narrative: 10 minutes after receiving the MMR vaccine he walked to the front desk with his mother, he sneezed 5 times with mucus coming out of his nose, he then had a gagging cough and threw up once, he then continued to have dry heaves and he looked puffy around his eyes, he then started to become lethargic alternating with combative, his O2 dropped to 88%, he face became puffier, we give him AUVI-Q 0.15 in the left thigh and called 911, oxygen was started as his O2 was 100%, he was lethargic off and on, but his HR, RR and BP remained stable, he never developed a rash, he was taken by ambulance to the local hospital and given IV SOLU-MEDROL and diphenhydramine, after about 4 hours he became much more active, less swollen and he was drinking, he was discharged home from the ER with a EPIPEN, he will follow up with an allergist; the clinical picture was consistent with anaphylaxis.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Cough, Lethargy, Periorbital swelling, Retching, Secretion discharge
Clinical narrative: 10 minutes after receiving the MMR vaccine he walked to the front desk with his mother, he sneezed 5 times with mucus coming out of his nose, he then had a gagging cough and threw up once, he then continued to have dry heaves and he looked puffy around his eyes, he then started to become lethargic alternating with combative, his O2 dropped to 88%, he face became puffier, we give him AUVI-Q 0.15 in the left thigh and called 911, oxygen was started as his O2 was 100%, he was lethargic off and on, but his HR, RR and BP remained stable, he never developed a rash, he was taken by ambulance to the local hospital and given IV SOLU-MEDROL and diphenhydramine, after about 4 hours he became much more active, less swollen and he was drinking, he was discharged home from the ER with a EPIPEN, he will follow up with an allergist; the clinical picture was consistent with anaphylaxis.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Sneezing, Swelling face, Vomiting
Clinical narrative: 10 minutes after receiving the MMR vaccine he walked to the front desk with his mother, he sneezed 5 times with mucus coming out of his nose, he then had a gagging cough and threw up once, he then continued to have dry heaves and he looked puffy around his eyes, he then started to become lethargic alternating with combative, his O2 dropped to 88%, he face became puffier, we give him AUVI-Q 0.15 in the left thigh and called 911, oxygen was started as his O2 was 100%, he was lethargic off and on, but his HR, RR and BP remained stable, he never developed a rash, he was taken by ambulance to the local hospital and given IV SOLU-MEDROL and diphenhydramine, after about 4 hours he became much more active, less swollen and he was drinking, he was discharged home from the ER with a EPIPEN, he will follow up with an allergist; the clinical picture was consistent with anaphylaxis.
Age: 2.0
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Sneezing, Swelling face, Unresponsive to stimuli, Vomiting
Clinical narrative: 10 minutes after receiving the MMR vaccine he walked to the front desk with his mother, he sneezed 5 times with mucus coming out of his nose, he then had a gagging cough and threw up once, he then continued to have dry heaves and he looked puffy around his eyes, he then started to become lethargic alternating with combative, his O2 dropped to 88%, he face became puffier, we give him AUVI-Q 0.15 in the left thigh and called 911, oxygen was started as his O2 was 100%, he was lethargic off and on, but his HR, RR and BP remained stable, he never developed a rash, he was taken by ambulance to the local hospital and given IV SOLU-MEDROL and diphenhydramine, after about 4 hours he became much more active, less swollen and he was drinking, he was discharged home from the ER with a EPIPEN, he will follow up with an allergist; the clinical picture was consistent with anaphylaxis.
Age: 50.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Asthenia, Dizziness, Headache, Influenza like illness, Pain
Clinical narrative: Hight temperature 101.5/ Headach / Body aches / Weakness / dizziness / Symptoms similar to flu but without congestion / Patient took Aleve, Tylenol & Advil but it didn't help with the symptoms ... Patient will go to the clinic today to be check up.
Age: 50.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Pyrexia
Clinical narrative: Hight temperature 101.5/ Headach / Body aches / Weakness / dizziness / Symptoms similar to flu but without congestion / Patient took Aleve, Tylenol & Advil but it didn't help with the symptoms ... Patient will go to the clinic today to be check up.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: PT GOT SWELLING ON LEFT ARM BELOW ELBOW.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: After administration of vaccine patient fainted. 911 was contacted and EMS responded, then transported patient for further care.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Arm pain began and worsened over several hours. The pain was located from the elbow to the mid-upper arm area. Pushing and pulling movement of arm elevated the pain and had difficulty lifting arm. Continued over night. Began to improve the next day with ibuprofen and heating pad and ice. As of this report (3/28/19), it feels nearly back to normal with slight tightness.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Fever of at least 101 degrees F, all over muscle aches, sore all over, chills beginning night of injection, continuing until evening of next day. Has treated with ibuprofen and had some symptomatic relief of fever. Initially took temperature and had reading of 104 degrees F day of injection, but thinks she pushed the wrong button on her thermometer.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Blood test normal, Decreased appetite, Flat affect, Insomnia, Intrusive thoughts
Clinical narrative: The day after the event or son began to have intrusive thoughts, loss of appetite, compulsive behavior such as excessive hand washing excessive double checking that he closed the door or did his homework. Loss of sleep and flat affect in mood and as well as mood swings at times. This has worsened in severity over time. We have seen the pediatrician and three therapists in the past three months.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Mood swings, Obsessive-compulsive disorder
Clinical narrative: The day after the event or son began to have intrusive thoughts, loss of appetite, compulsive behavior such as excessive hand washing excessive double checking that he closed the door or did his homework. Loss of sleep and flat affect in mood and as well as mood swings at times. This has worsened in severity over time. We have seen the pediatrician and three therapists in the past three months.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pain, Rash
Clinical narrative: 3 days after getting got achy, lasted about 3 days, 1 day later got burning sensation to left hip that lasted 24 hours, 3/27/19 noted rash on back that spread quickly to left lateral chest/anterior chest in 12 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Blister, Herpes zoster, Influenza like illness, Injection site pain
Clinical narrative: 3 days after getting got achy, lasted about 3 days, 1 day later got burning sensation to left hip that lasted 24 hours, 3/27/19 noted rash on back that spread quickly to left lateral chest/anterior chest in 12 hours.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Skin burning sensation
Clinical narrative: 3 days after getting got achy, lasted about 3 days, 1 day later got burning sensation to left hip that lasted 24 hours, 3/27/19 noted rash on back that spread quickly to left lateral chest/anterior chest in 12 hours.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered visual depth perception, Arthralgia, Chills, Decreased appetite, Impaired work ability
Clinical narrative: Following morning 3 AM, normal wake up time. From my knees up I was in horrible pain. Every joint felt like a migraine. I thought heading to work and moving around would help. It did not. Fever and chills started in at 4AM and I couldn't maintain it with TYLENOL or ADVIL. I knew I had to leave work when I couldn't do my job anymore because I had no depth perception and must drive for my position. Left work sick at 10:15AM. Stayed home from work for three days total. Fever and chills remained the entire time. Treated it like the flu, but never had a stomach, just no appetite.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Following morning 3 AM, normal wake up time. From my knees up I was in horrible pain. Every joint felt like a migraine. I thought heading to work and moving around would help. It did not. Fever and chills started in at 4AM and I couldn't maintain it with TYLENOL or ADVIL. I knew I had to leave work when I couldn't do my job anymore because I had no depth perception and must drive for my position. Left work sick at 10:15AM. Stayed home from work for three days total. Fever and chills remained the entire time. Treated it like the flu, but never had a stomach, just no appetite.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Pain in extremity, Urticaria, Vaccination site warmth
Clinical narrative: Patient had red welts under arms. Redness and warmth at area where vaccine administered and has spread to elbow area. Both arms sore despite only getting vaccinated in right arm.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Middle insomnia, Mobility decreased, Pain
Clinical narrative: 03/26/2019 PT RECEIVED THE PREVNAR 13 AT ABOUT 7:30PM. SHE STARTED TO FEEL PAIN WHEN SHE WAKE UP IN THE MIDDLE OF THE NIGHT AND THE PAIN CONTINUE UNTIL NOW. SHE STATED THAT SHE COULD NOT MOVE HER NECK WHEN SHE WAS WORKING ON 03/27/19 AND CALLED THE PHARMACY TO REPORT ON 03/28/19. PHARMACIST RECOMMENDED HER TO TAKE IBUPROFEN FOR PAIN AND MONITOR HER NECK AND PAIN. HER PAIN LEVEL IS GOING DOWN SLOWLY AND CONTINUE TO MONITOR.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Eructation, Exposure during pregnancy, Haemoptysis, Oropharyngeal pain
Clinical narrative: Received an injection in right arm. Was feeling exceptionally good in the hours before and immediately after, then awoke with major body aches, sore throat, mild fever and stomach discomfort. This persisted for two days, and on day #2 had bloody mucus (coughed this up). Also had a burping fit that lasted for 1.5 hours, burping every 20-30 seconds. This is very unusual (never had the burping) for me.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Productive cough, Pyrexia
Clinical narrative: Received an injection in right arm. Was feeling exceptionally good in the hours before and immediately after, then awoke with major body aches, sore throat, mild fever and stomach discomfort. This persisted for two days, and on day #2 had bloody mucus (coughed this up). Also had a burping fit that lasted for 1.5 hours, burping every 20-30 seconds. This is very unusual (never had the burping) for me.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: After receiving immunizations, family was waiting their 15 minutes in the lobby area when child's grandmother walked into the clinic and informed PHN and PHN that child had spit-up. PHN assisted child by removing the small amount of clear mucous, < 1 ounce, from the child's face with a paper towel. 10:45 am: PHN completed assessment of child VS: Apical HR 88, RR 36, Temp 97.2, BP 90/70. Lung sounds clear bilaterally, good aeration. No redness, swelling, or hives at or around injection site. No respiratory distress or generalized hives. Child was alert and responded to verbal commands during assessment. Child rested and was reading a book. No further episodes of spitting-up . Reviewed S/S of severe allergic reaction (swelling of the face, mouth or throat; difficulty breathing and generalized hives) and response with parent prior to releasing family at 11:15am. Child left walking with father and grandmother in no apparent distress.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash generalised, Vaccination site rash
Clinical narrative: Rash on the vaccine site. Rash throughout the body and face.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine administered IM instead of sub-q.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms - Muscle ache, fever,  fatigue.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms- Muscle ache, fever, fatigue.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Mother arrived for physical noting that there was redness, heat, swelling, and pain to his right arm where he received the KINRIX vaccine. The redness started to absorb yesterday and today and spread to the entire deltoid area and around to the inner aspect of his arm on both sides. Site of redness and swelling was > 110 mm.
Age: 18.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL
Symptoms: Full blood count, Metabolic function test normal, Pregnancy test negative, Rash pruritic, Rash vesicular
Clinical narrative: Pt has vasicular rash to both hands and going up arms that is itchy and raised. Symptoms started hours after the 8 vaccines were given. Pt was treated with Decadron and sent home with a script for steroids and itch cream. Pt left with the rash still intact.
Age: 18.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL
Symptoms: Urine analysis normal, White blood cell count decreased
Clinical narrative: Pt has vasicular rash to both hands and going up arms that is itchy and raised. Symptoms started hours after the 8 vaccines were given. Pt was treated with Decadron and sent home with a script for steroids and itch cream. Pt left with the rash still intact.
Age: 18.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL
Symptoms: Pruritus generalised, Rash
Clinical narrative: Pt has vasicular rash to both hands and going up arms that is itchy and raised. Symptoms started hours after the 8 vaccines were given. Pt was treated with Decadron and sent home with a script for steroids and itch cream. Pt left with the rash still intact.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Discomfort, Pyrexia
Clinical narrative: Patient contacted Pharmacist (Administrating Person) of going to be night of injection with 102 deg F. fever, chills, and feeling of discomfort and aches in joints. Patient was asked to report any adverse symptoms, as she had experienced many of these same effects from the 1st administration.  Symptoms from 2nd dose were just or more severe than 1st dose, given 01/26/2019. Reason she reported now, was Pharmacist / Administrator of Injection had asked if she had felt any adverse effects from 1st dose. She had and would call back if these adverse affects were present this time. She called 3/28/19 in am to state what occurred and was on 2nd day after administration just now returning to "herself".
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Patient reports Itching and hives at injection site (upper arm) legs, and stomach.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Weakness with muscular and joint pain. Intermittent prickling sensation in upper back and lower limbs. Fatigue and aching persisted throughout the day. Area where the injection occurred on the left shoulder is red, swollen & tender.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pain, Paraesthesia
Clinical narrative: Weakness with muscular and joint pain. Intermittent prickling sensation in upper back and lower limbs. Fatigue and aching persisted throughout the day. Area where the injection occurred on the left shoulder is red, swollen & tender.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Heart rate increased, Mobility decreased, Myalgia
Clinical narrative: Aching in muscle began within an hour; could not raise elbow for about 36 hours. Rapid pulse (120 - 140) began early in the morning after the shot. I did not read the "serious reaction" portion of the "Vaccine Information Statement" until after several days of the rapid pulse. The pulse decreased to 90-100 after two days, and continued to slow down to 80-90, but didn't drop below 80 (my pulse is consistently 60-70). I called the doctor's office on March 5th to report this. The doctor didn't think the event was related to the vaccination.
Age: 21.0
Sex: F
Vaccine: DTAP, HPV9
Symptoms: Chills, Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, moderate fever, chills, full body muscle aches.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Blood test normal, Chest X-ray normal, Computerised tomogram normal, Discomfort
Clinical narrative: 10 minutes after injection patient passed out and had a seizure for 30 sec. Then 5 minutes later it happened again for about 10 sec. Patient felt weak and heavy after both seizures and had nausea and vomited about 5 minutes after 2nd seizure.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Electrocardiogram normal, Loss of consciousness, Nausea, Seizure, Urine analysis normal
Clinical narrative: 10 minutes after injection patient passed out and had a seizure for 30 sec. Then 5 minutes later it happened again for about 10 sec. Patient felt weak and heavy after both seizures and had nausea and vomited about 5 minutes after 2nd seizure.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Chills, Condition aggravated, Immunoglobulin therapy
Clinical narrative: Patient presented today (3-28-19) asking to speak to me who had immunized him on 2-22-19. He reported that he had quite a reaction to the SHINGRIX vaccine that I had given him. He explained that beginning the following day he experienced chills/fever/weakness and vision disturbances that continued to worsen in the following weeks until he was hospitalized with a flare of his myasthenia gravis during the week of March 18 through the 23rd. He reports his neurologist treated him with a 5 day series of IVIG. He was discharged on the 23rd improved but still experiencing vision disturbances, weakness, and balance issues. He is unable to drive.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Impaired driving ability, Myasthenia gravis, Pyrexia, Visual impairment
Clinical narrative: Patient presented today (3-28-19) asking to speak to me who had immunized him on 2-22-19. He reported that he had quite a reaction to the SHINGRIX vaccine that I had given him. He explained that beginning the following day he experienced chills/fever/weakness and vision disturbances that continued to worsen in the following weeks until he was hospitalized with a flare of his myasthenia gravis during the week of March 18 through the 23rd. He reports his neurologist treated him with a 5 day series of IVIG. He was discharged on the 23rd improved but still experiencing vision disturbances, weakness, and balance issues. He is unable to drive.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness, swelling at injection site. Severe all-over body ache, shivering, fatigue, headache, 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Pain, redness, swelling at injection site. Severe all-over body ache, shivering, fatigue, headache, 24 hours.
Age: 79.0
Sex: M
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Angina pectoris
Clinical narrative: Pateint family called at 850pm due to patient complaining of angina on 3/27/19, that started at approx 8pm. Patient had received new routine vaccines at 130pm same day. Patient had history of anigna and stent placements. Instructed to use nitroglycerin tablets SL as directed (1 SL q5min up 3x) and to call 911 if not releived after 3 doses. Followed up with family 3/28/19 and they informed me patient was admitted to hospital that evening and they were waiting for Doctor to make rounds on the patient. No additional information provided or available at that time.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Headache, body stiffness, body aches, fatigue, Pain at injection site.
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Right upper Deltoid starting within 2 days injection site red hot swollen and tender, hard to touch, itchy. 3 1/2" circle. Subsided over 10 days developing fluid filled blister. 1/4" x 1/2 " itchy and sore to touch.
Age: 64.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Right upper Deltoid starting within 2 days injection site red hot swollen and tender, hard to touch, itchy. 3 1/2" circle. Subsided over 10 days developing fluid filled blister. 1/4" x 1/2 " itchy and sore to touch.
Age: 7.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Crying, Cyanosis, Fall, Loss of consciousness, Slow response to stimuli
Clinical narrative: Child cried during vaccinations, then went and sat in waiting room with parent while paperwork was entered and record could be printed, child was standing by our desk, passed out and fell to the floor, unresponsive but breathing, sternal rub, responded, blue around mouth, HR 50-60, resp 6, 911 called, Epi 0.2 administered at 2:40 pm. EMS arrived at 2:50, child was awake, slow to respond, neck was supported, HR 96-100, resp 10, interpreter called and asked mother further questions if this had happened in previous country since they did not have their records, she answered no. EMS left with child to Hospital, mother in ambulance. Hospital called said she was ok, they thought it could have been a vagal response.
Age: 7.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Child cried during vaccinations, then went and sat in waiting room with parent while paperwork was entered and record could be printed, child was standing by our desk, passed out and fell to the floor, unresponsive but breathing, sternal rub, responded, blue around mouth, HR 50-60, resp 6, 911 called, Epi 0.2 administered at 2:40 pm. EMS arrived at 2:50, child was awake, slow to respond, neck was supported, HR 96-100, resp 10, interpreter called and asked mother further questions if this had happened in previous country since they did not have their records, she answered no. EMS left with child to Hospital, mother in ambulance. Hospital called said she was ok, they thought it could have been a vagal response.
Age: 1.25
Sex: F
Vaccine: HEPA, HIBV, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None at this time.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Nausea, Pyrexia, Skin warm
Clinical narrative: Redness/swelling/hot to touch/tender; Fever/chills/nausea.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Redness/swelling/hot to touch/tender; Fever/chills/nausea.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling of body temperature change, Flushing
Clinical narrative: Flushed, hot and cold chills, lasted for about an hour.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count normal, Influenza virus test negative, Pyrexia, Respiratory syncytial virus test negative, X-ray normal
Clinical narrative: Patient was presented to ER with fever of 102 degrees F, was given TYLENOL. Patient left ER AMA and followed up with us at Clinic and fever had come down to 100 degrees F, CBC and Xray were WNL, No signs of distress. Flu and RSV tests were negative.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Local reaction
Clinical narrative: Local reaction with redness, no swelling.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain, Eye contusion, Fall, Loss of consciousness
Clinical narrative: On second day got a very upset stomach, no throwing up, and in minutes blacked out in shower. Woke up about 20 min. later. Got bruised eye and mouth and muscle pain in back after the fall. Was checked out by my doctor and have RX for a CT-scan of the bruise of eye.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral contusion
Clinical narrative: On second day got a very upset stomach, no throwing up, and in minutes blacked out in shower. Woke up about 20 min. later. Got bruised eye and mouth and muscle pain in back after the fall. Was checked out by my doctor and have RX for a CT-scan of the bruise of eye.
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site warmth, Pallor
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from a Health authority under VAERS ID- 338070. This case involves a 58 years old female patient who experienced cellulitis, arthus-type reaction left deltoid 10 x 10 cm, warm tissue than surrounding tissue, pale center and redder surrounding, while she received vaccine ADACEL. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No medical history. Concomitant medications included (other medication)- CRESTOR. On 24-Nov-2008, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On 25-Nov-2008, the patient experienced a serious cellulitis and arthus-type reaction left deltoid 10 x 10 cm (type iii immune complex mediated reaction) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These events was assessed as medically significant. On 25-Nov-2008, the patient experienced a non-serious warm tissue than surrounding tissue, pale center (injection site warmth) and redder surrounding (injection site redness) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On 28-Nov-2008, the patient returned to clinic for an arthus-type reaction left deltoid 10 x 10 cm, warm tissue than surrounding tissue, pale center, redder surrounding. (Other relevant tests included no lab data.) Final diagnosis was redder surrounding, warm tissue than surrounding tissue, pale center, arthus-type reaction left deltoid 10 x 10 cm and cellulitis. The patient recieved antibiotics. The events outcome were not reported. List of documents held by sender: none.; Sender's Comments: This case concerns a 58 years old female patient who presented with cellulitis, arthus-type reaction, injection site warmth and injection site redness one day after vaccination with ADACEL. The time to onset is compatible. Further information including patient's medical history, condition at the time of vaccination, immune status, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case.
Sex: F
Vaccine: TDAP
Symptoms: Skin warm, Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from a Health authority under VAERS ID- 338070. This case involves a 58 years old female patient who experienced cellulitis, arthus-type reaction left deltoid 10 x 10 cm, warm tissue than surrounding tissue, pale center and redder surrounding, while she received vaccine ADACEL. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No medical history. Concomitant medications included (other medication)- CRESTOR. On 24-Nov-2008, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On 25-Nov-2008, the patient experienced a serious cellulitis and arthus-type reaction left deltoid 10 x 10 cm (type iii immune complex mediated reaction) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These events was assessed as medically significant. On 25-Nov-2008, the patient experienced a non-serious warm tissue than surrounding tissue, pale center (injection site warmth) and redder surrounding (injection site redness) one day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On 28-Nov-2008, the patient returned to clinic for an arthus-type reaction left deltoid 10 x 10 cm, warm tissue than surrounding tissue, pale center, redder surrounding. (Other relevant tests included no lab data.) Final diagnosis was redder surrounding, warm tissue than surrounding tissue, pale center, arthus-type reaction left deltoid 10 x 10 cm and cellulitis. The patient recieved antibiotics. The events outcome were not reported. List of documents held by sender: none.; Sender's Comments: This case concerns a 58 years old female patient who presented with cellulitis, arthus-type reaction, injection site warmth and injection site redness one day after vaccination with ADACEL. The time to onset is compatible. Further information including patient's medical history, condition at the time of vaccination, immune status, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In January 2013, at age 60, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her ZOSTAVAX use: Herpes zoster. The outcome of the herpes zoster is unknown. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Condition aggravated, Dyspnoea, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe adverse reaction and was on life support for 5 days. The reporter had contacted both the Centers for Disease Control and Prevention (CDC) or other agency to report the occurrence, but was not sure if anyone had contacted the drug maker.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Headache, Intensive care, Mechanical ventilation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe adverse reaction and was on life support for 5 days. The reporter had contacted both the Centers for Disease Control and Prevention (CDC) or other agency to report the occurrence, but was not sure if anyone had contacted the drug maker.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Respiratory failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe adverse reaction and was on life support for 5 days. The reporter had contacted both the Centers for Disease Control and Prevention (CDC) or other agency to report the occurrence, but was not sure if anyone had contacted the drug maker.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction, Life support
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe adverse reaction and was on life support for 5 days. The reporter had contacted both the Centers for Disease Control and Prevention (CDC) or other agency to report the occurrence, but was not sure if anyone had contacted the drug maker.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Achy, tired, fever, chills, sore arm. Took ALEVE.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of elderly patients (65 years old or older). No information was provided regarding the patients' historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications. The nurse stated that on unknown dates, "possibly back to 1998", the patients inadvertently received a second dose of PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported) based on "oversights in self reporting". It was reported that most of this information was related to historical vaccination records possibly dating back to 1998. The nurse did not have any specific patients information or reactions that may have occurred.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 01-MAR-2019, the patient was vaccinated with improperly stored M-M-R II (lot # R019684, expiry date: 09-JUL-2020 (also reported as 10-JUL-2020) for prophylaxis. Nurse has reported that M-M-R II was reconstituted with properly stored Sterile diluent. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported. The outcome of product storage error and no adverse event was unknown. This was seven of nine reports mentioned in the report. Lot number R019684 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Sender's Comments: US-009507513-1903USA009054: Master case #.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 01-MAR-2019, the patient was vaccinated with improperly stored M-M-R II (lot# R019684, expiry date: 09-JUL-2020 (also reported as 10-JUL-2020) for prophylaxis (product storage error). Nurse has reported that M-M-R II was reconstituted with properly stored Sterile diluent. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was eight of nine reports mentioned in the report. Lot number R019684 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Sender's Comments: US-009507513-1903USA009054:Master#.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 19-FEB-2019, the patient was vaccinated with improperly stored M-M-R II (lot # R019684, expiry date: 09-JUL-2020 also reported as 10-JUL-2020) for prophylaxis. Nurse has reported that M-M-R II was reconstituted with properly stored Sterile diluent. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported. The outcome of product storage error and no adverse event was unknown. This was nine of nine reports mentioned in the report. Lot number R019684 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live. Sender's Comments: US-009507513-1903USA009054: Master case #.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Sepsis
Clinical narrative: This spontaneous report was received from a physician via a company representative referring to a 49 years old female patient. Concurrent condition included adult celiac disease and hypothyroidism. The patient's medical history included acute asthmatic bronchitis. Information about concomitant medication not provided. On 28-FEB-2019 the patient was vaccinated with PNEUMOVAX 23 (lot # R033343 with expiration date 03-AUG-2020; strength, dose and route were not reported) in the left deltoid for prophylaxis. On 01-MAR-2019, the patient experienced redness and swelling at the injection site and all over the upper left arm. The patient went back to the to the physician's office on 01-MAR-2019, where it was noted that the redness and swelling was 6 inches by 6 inches in diameter. The physician recommended applying ice to the area and taking acetaminophen (TYLENOL), but to go to the emergency room if symptoms worsened. The patient did decide to go to the emergency room on 02-MAR-2019 due to the symptoms, where she was admitted to the hospital. The patient was diagnosed with cellulitis and sepsis. During hospitalization, patient received azithromycin as treatment. The patient recovered completely by 06-MAR-2019 and was discharged from the hospital on 06-MAR-2019. The physician was requesting a lot check and was requesting expedited response. The outcome of cellulitis and sepsis was reported as recovered. The causality assessment was not provided. Upon internal review, the events cellulitis and sepsis were determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a pharmacist (the patient's mother) via a company representative referring to a female patient of unknown age. Concurrent condition included postural orthostatic tachycardia syndrome (POTS). Information about the concomitant medication and drug reactions or allergies was unknown by the reporter. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, dose route, lot # and expiration date were not reported) for prophylaxis. On the next day, the patient passed out. It was unknown if the treatment was given and if the lab diagnostics or studies were performed. The outcome of the event was reported as recovered. The causality assessment was not provided. Upon internal review, the event passing out was determined to be medically significant.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 18-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine: PROQUAD, lot # R022568, expiration date 04-FEB-2020, (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. No improperly stored sterile diluent used was reported. The vaccine was exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases. Sender's Comments: US-009507513-1903USA011573; US-009507513-1903USA011572; US-009507513-1903USA011571; US-009507513-1903USA011574; US-009507513-1903USA011570.
Sex: F
Vaccine: PPV
Symptoms: Death
Clinical narrative: Information has been received from a pharmacist and the patient's husband referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as Pneumococcal vaccine) (dose, route, lot # and expiration date unknown) for prophylaxis. On an unknown date, the patient died after getting the vaccine. The cause of death was not reported. It was unknown if the autopsy was done. The causality between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Reported Cause(s) of Death: Cause of Death: Unknown by reporter.
Age: 19.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 19 year old patient, gender unknown. Patient's current conditions, medical history, concomitant medications, drug allergies or reactions were not reported. On 02-AUG-2018, the patient was vaccinated in error with a dose of ZOSTAVAX (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided. The nurse reported that, on 25-MAR-2019, the patient was inadvertently vaccinated with one dose of M-M-R II rHA (dose number, route and anatomical locations of administration were not provided; witch lot number either R008028 or R008031, both with expiration date on 18-MAR-2020) for prophylaxis. On an unspecified date, the dose of M-M-R II was exposed to a temperature excursion of -58 degrees Fahrenheit and +46 degrees Fahrenheit (46.4 degrees Fahrenheit) for a time frame of 6 minutes, which was detected by the Digital Data Logger. On an unspecified date, there was a previous temperature excursion of above 47 degrees Fahrenheit (47.7 degrees Fahrenheit) for 12 minutes. In addition, the nurse stated that M-M-R II was reconstituted with properly stored sterile diluent.  No adverse effects or product quality complaints were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA012691.