chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB, MNQ, MENB
Symptoms: Headache, Heart rate increased, Injection site pain, Ocular hyperaemia, Pyrexia
Clinical narrative: At 2030 last night (7/26/16) he felt dizzy, nausea, fever 103, increased heart rate, face was red, and she had bloodshot eyes and pain in her arm. Today (7/27/16) temp is 99, but she is still having pain in her left arm.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Photophobia, Pyrexia, Urticaria, Vertigo
Clinical narrative: 5/3/16- Nausea, vertigo, photophobia, urticaria, low grade fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The Patients medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VAIRVAX (Dosage, dose number, route of administration, lot # and expiration date were not reported). No other concomitants therapies were reported. No adverse effects were reported. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to 2 patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 20-JUL-2016, the patients were vaccinated with improperly stored ROTATEQ lot # L035510 with expiry date: 13-MAY-2017 (dosing details were not reported). It was reported that the vaccines were exposed to the temperature of 0.0 C during a time frame of 13 hours and 45 minutes. There was no previous temperature excursion. No adverse were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a multiple unspecified patients of unknown age and gender. No concurrent conditions, allergy/drug reactions, medical history and concomitant medications were reported. On an unknown date, multiple unspecified patients were vaccinated with either ROTATEQ lot#M004542 with expiry date:08-OCT-2017, lot#L039141 with expiry date: 16-AUG-2017 or GARDASIL 9 lot#M007764 with expiry date:30-JAN-2018 (dosing details were not reported) that was improperly stored. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Skin warm
Clinical narrative: This spontaneous report was received from a 62 year old female patient regarding herself. The patient's current conditions included high blood pressure, cholesterol abnormal, asthma, drug allergies to penicillin, sulfa and codeine or codeine derivatives, and also sensitive to medications in general. On an unknown date in 2006, the patient was vaccinated with ZOSTAVAX. Concomitant medications included unspecified medications for high blood pressure, cholesterol and asthma. On an unknown date in 2006, the patient developed shingles. The shingles lasted 90 days. The patient although  had mostly recovered, she still had symptoms such as seeing bumps under the  skin and her back feeling very hot, especially when the weather gets warm. The patient sought medical attention and spike with doctor. The patient was given treatment for the event with LYRICA and with other unspecified treatment. Product quality complaint (PQC) was not involved. The event was resolving. The reporter did not provide causal relationship between the event and suspect therapy. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site pain, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Pain first, no pain at injection site, pain upper arm all over. Then about one hour later I looked at arm and it had like a pancake shaped raised about 3/4in and round dark red spot upper bicep. Lots of pain and got worse as the night went on did not sleep from pain took a BENADRYL 25mg over the counter and two aspirin to see if I could sleep to no avail. In the morning at 9:00 called to see who would be able to see me at my doctor's office my doc was busy so I saw someone else in that group. He gave me prednisone 10mgs 4 one day 3 the next and so forth. Not enough it is moving around. The huge red spot. Yes I do not have so much pain that I cannot move my arm so it is getting better very slow. It also gave me pain upper arm and right side shoulder close to my neck and really hot to the touch.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: Pain first, no pain at injection site, pain upper arm all over. Then about one hour later I looked at arm and it had like a pancake shaped raised about 3/4in and round dark red spot upper bicep. Lots of pain and got worse as the night went on did not sleep from pain took a BENADRYL 25mg over the counter and two aspirin to see if I could sleep to no avail. In the morning at 9:00 called to see who would be able to see me at my doctor's office my doc was busy so I saw someone else in that group. He gave me prednisone 10mgs 4 one day 3 the next and so forth. Not enough it is moving around. The huge red spot. Yes I do not have so much pain that I cannot move my arm so it is getting better very slow. It also gave me pain upper arm and right side shoulder close to my neck and really hot to the touch.
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Musculoskeletal discomfort, Stridor
Clinical narrative: 5 minutes after administration, patient became short of breath, had audible stridor and was grabbing at neck. Patient was given IM epinephrine, IV normal saline, IV SOLU-MEDROL, IV BENADRYL, IV famotidine, and albuterol via nebulizer. O2 2L also applied to patient.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Proquad and Varivax given to 12 month old, no adverse reactions at this time.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: Swelling, redness, itching at vaccine site.
Age: 68.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Dull headache.
Age: 17.0
Sex: M
Vaccine: HEPA, HPVX, MEN
Symptoms: Confusional state, Crying, Dizziness, Dyskinesia, Eye movement disorder
Clinical narrative: Patient received Hep A, HPV, Meningitis and TB test. After administered he stood up and walked over to me maybe four feet and then passed out on me and before I could stand and catch completely fell to the floor. Myself and the nurse assisted him back to the chair where he started to perspire profusely and while nurse went to get a fan he started to make convulsing movements and jerk in the chair. At one point his eyes rolled. I kept yelling his name and after a few seconds he looked at me and started crying (and said Mama) he stayed in a state of confusion for maybe three to four minutes and then seemed okay. I asked the nurse to get some water and maybe some crackers and she did so. After that he started to get his color back and said he was freezing to turn off the fan. We stayed in the office for another 15 to 20 minutes and then we had him walk around to make sure he wasn't dizzy anymore. I asked the nurse if this was normal and she said the it's not unusual for patients to pass out but I think this was a little much. He did have an empty stomach as it was first thing in the morning but I was told that he needed another round 1 to 2 months and then the third round in 6 months. I would like someone to advise if this is necessary as I'm scared that this may have future affect on him. Please advise...thanks.
Age: 17.0
Sex: M
Vaccine: HEPA, HPVX, MEN
Symptoms: Fall, Feeling cold, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient received Hep A, HPV, Meningitis and TB test. After administered he stood up and walked over to me maybe four feet and then passed out on me and before I could stand and catch completely fell to the floor. Myself and the nurse assisted him back to the chair where he started to perspire profusely and while nurse went to get a fan he started to make convulsing movements and jerk in the chair. At one point his eyes rolled. I kept yelling his name and after a few seconds he looked at me and started crying (and said Mama) he stayed in a state of confusion for maybe three to four minutes and then seemed okay. I asked the nurse to get some water and maybe some crackers and she did so. After that he started to get his color back and said he was freezing to turn off the fan. We stayed in the office for another 15 to 20 minutes and then we had him walk around to make sure he wasn't dizzy anymore. I asked the nurse if this was normal and she said the it's not unusual for patients to pass out but I think this was a little much. He did have an empty stomach as it was first thing in the morning but I was told that he needed another round 1 to 2 months and then the third round in 6 months. I would like someone to advise if this is necessary as I'm scared that this may have future affect on him. Please advise...thanks.
Age: 17.0
Sex: M
Vaccine: HEPA, HPVX, MEN
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: Patient received Hep A, HPV, Meningitis and TB test. After administered he stood up and walked over to me maybe four feet and then passed out on me and before I could stand and catch completely fell to the floor. Myself and the nurse assisted him back to the chair where he started to perspire profusely and while nurse went to get a fan he started to make convulsing movements and jerk in the chair. At one point his eyes rolled. I kept yelling his name and after a few seconds he looked at me and started crying (and said Mama) he stayed in a state of confusion for maybe three to four minutes and then seemed okay. I asked the nurse to get some water and maybe some crackers and she did so. After that he started to get his color back and said he was freezing to turn off the fan. We stayed in the office for another 15 to 20 minutes and then we had him walk around to make sure he wasn't dizzy anymore. I asked the nurse if this was normal and she said the it's not unusual for patients to pass out but I think this was a little much. He did have an empty stomach as it was first thing in the morning but I was told that he needed another round 1 to 2 months and then the third round in 6 months. I would like someone to advise if this is necessary as I'm scared that this may have future affect on him. Please advise...thanks.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Mild rash around injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Developed insidious onset erythema, induration, and rash maximum diameter 5 cm around vaccine injection site.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Drug hypersensitivity, Influenza
Clinical narrative: Initial unsolicited report received from a consumer on 24 September 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of Influenza vaccine (manufacturer: unknown, batch number, dose, dose in series, expiry date were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was reported that the patient was not allergic to eggs, latex. On an unknown date, following the vaccination, the patient showed sensitivity to the ingredients and also the patient get the flu each time she takes a shot. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza, Reaction to preservatives
Clinical narrative: Initial unsolicited report received from a consumer on 24 September 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of Influenza vaccine (manufacturer: unknown, batch number, dose, dose in series, expiry date were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was reported that the patient was not allergic to eggs, latex. On an unknown date, following the vaccination, the patient showed sensitivity to the ingredients and also the patient get the flu each time she takes a shot. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Exfoliative rash, Rash, Skin plaque
Clinical narrative: Initial unsolicited report received from a pharmacist on 28-Sep-2015. This case involves a female patient of approximately 73 years of age who was vaccinated with a first dose of FLUZONE HD (batch number and expiry date was not provided) via intramuscular route in the left deltoid on 17-Sep-2015. The patient had a history of penicillin allergy. There was no illness at the time of vaccination. Concomitant medications were not reported. On 20-Sep-2015, 3 days post vaccination; the patient developed rash which was described as "12 x 4" plaque scaly on leg, scaly rash developed on armpits, groin, chest. The rash was scaly and was not like hives or bumps. The patient was advised to see a physician. Laboratory data and corrective treatment were not provided. The patient had not recovered from the above mentioned events. List of documents held by sender: none.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Hypoaesthesia, Peripheral swelling, Skin warm
Clinical narrative: Arm redness, warmth, swelling, numbness.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia, Vomiting
Clinical narrative: Mother reported intermittent fever (at 1550 on 7/27/16 fever was 99.2 degrees F) and states that he generally runs low fevers. Vomiting x1 episode.
Age: 52.0
Sex: M
Vaccine: HEPA
Symptoms: Blister, Scar, Swelling face
Clinical narrative: Developed swelling and blisters under both eyes.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Injection site became red, hot, hard and itchy....patient reports area feeling bumpy.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Gait disturbance, Induration, Injection site swelling, Pain
Clinical narrative: Red hard area approximately 1.5 x 1.5 inches. Itching. Significant pain- child limping. Swelling of site.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Pruritus
Clinical narrative: Red hard area approximately 1.5 x 1.5 inches. Itching. Significant pain- child limping. Swelling of site.
Age: 18.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site discomfort, Pain, Syncope
Clinical narrative: Patient stood up, was noticing discomfort in arms where he received two vaccines today- MenACWY in the right arm and Men B in the left arm.  The left arm hurt badly as her raised it above the shoulder level and he fainted.  Came to within seconds of hitting carpeted floor.  No injury.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Patient got a rash on abdomen which appeared 4 days after receiving the ZOSTAVAX immunization and was resolved after 7 days. Patient describes rash as rash with blisters and not painful.
Age: 1.67
Sex: F
Vaccine: HEP, PNC13, HEP, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Rash developed on face and resolved. Hives developed on full body at 1300 and pt. came to clinic for evaluation.
Age: 1.67
Sex: F
Vaccine: HEP, PNC13, HEP, PNC13
Symptoms: Urticaria
Clinical narrative: Rash developed on face and resolved. Hives developed on full body at 1300 and pt. came to clinic for evaluation.
Age: 1.7
Sex: F
Vaccine: HEP, PNC13, HEP, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Hives.
Age: 1.7
Sex: F
Vaccine: HEP, PNC13, HEP, PNC13
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at left deltoid region with no tenderness and no history of fever, area of erythema approximately 4 to 5 inches in diam.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Pt immediately noticed some dizziness, HA, and tingling in both her hands. On 7/22 she noticed swelling and redness (8x7 inch) of her R deltoid around the injection site, fever, weakness. No pus drainage. Pain is worse with movement. No more hand tingling. Redness resolved w/ KEFLEX.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain, Paraesthesia, Pyrexia
Clinical narrative: Pt immediately noticed some dizziness, HA, and tingling in both her hands. On 7/22 she noticed swelling and redness (8x7 inch) of her R deltoid around the injection site, fever, weakness. No pus drainage. Pain is worse with movement. No more hand tingling. Redness resolved w/ KEFLEX.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient reported having significant swelling, soreness, and arm felt hot to touch and hard. Swelling decreased the next day but she still describes soreness below the injection site.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site nodule
Clinical narrative: PATIENT STATES SHE HAS A "KNOT" WHERE THE SHOT WAS ADMINISTERED, WHICH IS REDUCING IN SIZE DAILY. THE INJECTION SITE IS NOT HEATED/FEVERISH, WEEPING, RED, AND HAS NOT WORSENED SINCE ONSET.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Injection site erythema, Nausea, Vaccination site pain
Clinical narrative: The site of the vaccine became red, hot, tender, and swollen.  The swelling was more than expected for a localized site reaction. She later developed nausea, dizziness and a headache which had not resolved by 7/27/16.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: The site of the vaccine became red, hot, tender, and swollen.  The swelling was more than expected for a localized site reaction. She later developed nausea, dizziness and a headache which had not resolved by 7/27/16.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Hypersensitivity, Lip oedema, Tongue oedema
Clinical narrative: Patient was vaccine on July 22 2016 at 10:10am. At the time mother referred patient did not suffer from any allegies nor illnesses. At 2:00pm mother calls our facilities to notify that her son was presenting edema in lips and tongue. Patient receives medical assistance at 4:00pm that sameday. After he is evaluated he is diagnosed with an allergic reaction due to vaccine administration. He was given Benadryl and Solumedrol intravanously.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Severe swelling, redness. Pain, itching at injection site.
Age: 11.0
Sex: M
Vaccine: HPVX, MEN, TDAP
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling/pain/heat in arm.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 02-FEB-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (strength and dose were not reported). The lot number and expiration date were unspecified (K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Age: 0.38
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 26-OCT-2015, the patient was vaccinated with a dose of ROTATEQ orally (strength and dose were not reported). The lot number and expiration date were unspecified (K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies were reported. Then, on 09-NOV-2015, the patient was vaccinated with a second dose of ROTATEQ, orally (strength and dose were not reported)(K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016 with the same improperly aforementioned characteristics of storage. No adverse events were reported. This is one of several cases form the same reporter. Additional information has been requested.
Age: 0.66
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 7 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 02-FEB-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (strength and dose were not reported). The lot number and expiration date were unspecified (K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases form the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report concerning 19 patients of an unknown gender and age was received from a nurse. The patient's concurrent conditions and medical history were not provided. The reporter stated that multiple unspecified patients were vaccinated with improperly stored doses of PROQUAD (lot # L031603, expiration date 18-FEB-2016) on 16-FEB-2016, 22-FEB-2016, 11-MAR-2016, 17-MAR-2016, 24-MAR-2016, 01-APR-2016, 19-APR-2016, 06-MAY-2016 and 29-JUN-2016; (lot # M006104, expiration date 01-AUG-2017) on 23-MAY-2016, 25-MAY-2016, 06-JUN-2016, 22-JUN-2016 and 30-JUN-2016; (lot # K010319, expiration date 22-JUL-2016) on 10-MAY-2016 and 19-MAY-2016; (lot # L050909, expiration date 14-JUN-2017) on 08-JUN-2016; (lot # L040411, expiration date 13-APR-2017) on 16-JUL-2016 (strength, dose, route and frequency were not provided). There were no concomitant medications and adverse events reported. No product quality complain was involved. Additional information has been requested.
Age: 0.45
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 25-APR-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (strength and dose were not reported). The lot number and expiration date were unspecified (K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to two patients of unknown ages and genders. The patient's medical history and concurrent conditions were not reported. On 08-JUL-2016 the patients were vaccinated with improperly stored doses of GARDASIL lot # K009482 expiration date 06-MAR-2017. Dose, route and anatomical location were not provided. No other suspect or concomitant medications were reported. Excursion details: cumulative time frame for two excursions between 07-JUL-2016 and 08-JUL-2016, 30.3 Fahrenheit degrees for 7 hours. Digital data logger was involved. No adverse effects were reported. This is one of two reports received from the same reporter. (1607USA006901) Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Nausea
Clinical narrative: Left arm redness, 80mm x 80mm, soreness, nausea, loss of appetite, joint pain and chills.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Left arm redness, 80mm x 80mm, soreness, nausea, loss of appetite, joint pain and chills.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Papule, Rash
Clinical narrative: Varicella vaccine place in (R) thigh 7/18/16. No other vaccines placed in (R) thigh. Redness/erythema started night of 7/26/16. Presented to office 7/27. Started as 4" bumps - dime size. Erythema now confluent, with some papules, 2.5 cm diameter.
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 1 cm. localized area of redness at site of VARIVIX, 10-11 days after vaccine.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse events obs or reported. Patient received # 2 dose BEXSERO was given on 07-14-16. #1 dose given 06-27-16.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Injection given on 7/25/16 -Called and reported area at site was hard, red, warm to touch and painful.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt was given 2 injections on left upper Delt. Pt noticed swelling the AM on left arm lower interior part of arm- Swollen hot to touch about 3 inches.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site inflammation, Skin irritation
Clinical narrative: Skin irritation, inflammation on site of vaccination administration earlier today when she woke up (7/27). Recommended BENADRYL OTC and MD visit if unresolved.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Induration, Injection site cellulitis
Clinical narrative: Cellulitis at injection site. Induration pt was seen at PCP office 2 days post injection stated on AUGMENTIN. Vomited AUGMENTIN and Rx changed to BACTRIN on 7/23/16.
Age: 13.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema
Clinical narrative: Pt with 7 cm x 5 cm erythematous, edematous nodule at injection site that starting the morning after the injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Oedema, Pain, Skin warm
Clinical narrative: Pain, edema, warm to touch, cold compress, Ibuprofen, BENADRYL prn itching.
Age: 48.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Rash
Clinical narrative: -redness at area of injection, MD determined cellulitis, treated with antibiotics. -rash
Age: 1.78
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Grandmother reports that the child has a rash over his entire body and a low grade fever. Instructed to give TYLENOL for fever. Use CALAMINE lotion if itching. BENADRYL liquid after consulting with his doctor. Instructed to seek immediate medical attention if symptoms become worse or breathing difficulties occur.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Blood immunoglobulin G, Dizziness, Erythema, Eye swelling, Injection site irritation
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Local swelling, Palpitations, Respiratory tract congestion, Rhinorrhoea, Tachycardia
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Throat irritation, Tremor, Urticaria, Wheezing
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Erythema, Eye swelling, Peripheral swelling, Rhinorrhoea, Throat irritation
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Urticaria
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Erythema, Hepatitis B antibody positive, Injection site erythema, Injection site irritation, Measles antibody positive
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Morbillivirus test positive, Mumps antibody test positive, Peripheral swelling, Rubella antibody positive, Rubivirus test positive
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.
Age: 32.0
Sex: F
Vaccine: FLUX, FLUX, FLUX, FLUX
Symptoms: Rubulavirus test positive
Clinical narrative: Case number PHHY2016US090592, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 633303) website on 20 Jun 2016. This report refers to a 32 years old female patient. Past medical history included as hypothyroidism, actinic keratosis, lumbago, dermatitis, varicose veins and osteoarthritis (OA). Concomitant medications was not reported. It was reported that, the patient concurrently received other vaccines from 2000 to 2015 to include MENVEO vaccine, MMR vaccine, Typhoid vaccine, Tetanus Diphtheria Pertussis (Td/Tdap) vaccine, Yellow fever vaccine (YF) and Anthrax vaccine adsorbed (AVA) without adverse reactions. The patient vaccinated with first dose of seasonal influenza vaccine (manufacturer and batch number: not reported) intramuscularly on 07 Nov 1999. The patient had a large red bump to her arm about size of an orange that extended up to her shoulder that lasted about 03 to 05 days. The patient experienced same thing occurring in 2000 (no vaccine documented) with addition of hives extending to her face/neck and upper chest region (above bra line), had sniffles, her throat itched, and her right eye was swollen. It was stated that, the patient did not receive another flu vaccine for the next several years. The patient visited the emergency room. The outcome of the events was reported as complete recovery on an unknown date. The seriousness of the events was reported as non serious. The causality of the events was not reported. Seriousness assessment of eye swelling, throat irritation, erythema and hives was upgraded to serious (medically significant) based on the information available in the source document. This case is also linked with case IDs: PHHY2016US089968, PHHY2016US090638, PHHY2016US090708 and PHHY2016US090669 as the same patient. Following minute finding on 20 Jun 2016, the following significant was done. Amended as per minute findings.