chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 31-JAN-2017, the patient was vaccinated with an expired dose of PNEUMOVAX23 with lot number L024129 and expiration date of 21-JAN-2017, intramuscularly (strength, dose and anatomical location were unknown) for prophylaxis. The patient had not experienced an adverse effect. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: PNC
Symptoms: Inappropriate schedule of drug administration, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date as single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received PNEUMOVAX and PREVNAR 13 for immunization. The patient received 2 Prevnar doses in a 10 month period of time and experienced pain and the swelling at the site on an unspecified date. Details were as follows:  patient had received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) about 10 months ago and then received pneumococcal vaccine at a pharmacy and then a month later went back to the pharmacy and got pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein). The patient went to the hospital and was discharged with therapeutic measures for pain and the swelling at the site in form of BENADRYL; but patient said it was getting worse. The outcome of patient received 2 Prevnar doses in a 10 month period of time was unknown and the outcome of experienced pain and the swelling at the site was not recovered.
Age: 39.0
Sex: F
Vaccine: HEPA
Symptoms: Gastrointestinal disorder
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of gastrointestinal disorder in a 39-year-old female patient who received HAVRIX adult (batch number 5D952, expiry date 20th April 2018). Concurrent medical conditions included milk allergy. On 9th August 2016, the patient received the 1st dose of HAVRIX adult .5 ml. On 9th August 2016, 20 min after receiving HAVRIX adult, the patient experienced gastrointestinal disorder. On an unknown date, the outcome of the gastrointestinal disorder was recovered/resolved. It was unknown if the reporter considered the gastrointestinal disorder to be related to HAVRIX adult. Additional details were provided as follows: The healthcare professional reported that the patient stated she had gastrointestinal issues about 20 minutes after receiving HAVRIX. The patient experience same reaction like gastrointestinal issues when she eats or consumes dairy. No other information was provided.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: Swelling. Diphenhydramine 25 mg tid.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 16-year-old male patient  who received BEXSERO. In July 2016, the patient received the 1st dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The healthcare professional who was the patient's mother stated her son had pain in arm following administration of BEXSERO. The healthcare professional did not have vaccine information and did not recall any details of the pain such as duration as the vaccination was back in July. This did not result in any doctor's visits. The healthcare professional stated  that the patient was hesitant to get 2nd dose due to arm pain.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Injection site pain, Pain
Clinical narrative: Mild tenderness present at the left deltoid area measuring 3x2 inches, pain 2/10, T degrees 98. Child taken to ED 2 days after flu vaccine for above sx. Discharged home on meds: Ranitidine 75 mg 1q12 hours. Diphenhydramine 12.5 mg 1 q 8 degrees. Prednisone 10 mg 2 BID.
Age: 7.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 3" x 3" red itchy area at site of flu vaccine.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Severe redness was noted, the morning after injection, in the left deltoid region eventually spreading with redness, edema, warmth and tenderness involved entire upper arm extending from top of shoulder to elbow. TX was ZYRTEC and BENADRYL round the clock for three days.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Dehydration, Diarrhoea, Gastroenteritis, Intussusception, Pyrexia
Clinical narrative: Shortly after receiving vaccines, the infant began having fever and diarrhea she was seen and admitted to hospital on 1-27-17 and discharged on 1-30-17. Dx. with gastroenteritis and intussusception with dehydration secondary to rotavirus vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMRV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling and redness approx 10cm round. Tender to touch. Ice and TYLENOL treatment, (L) anterior thigh.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune hypothyroidism, Autoimmune thyroiditis, Rheumatoid arthritis, Scleritis
Clinical narrative: Developed recurrent scleritis after vaccination that went on for years without explanation only to discover my body is now in a state of autoimmunity and have since been diagnosed with autoimmune hypothyroidism (Hashimoto's) and rheumatoid arthritis.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Dizziness, Flushing, Somnolence
Clinical narrative: The patient received the Hepatitis B Vaccine at about 1:00 PM. at about 1:40 PM she became, dizzy, drowsy, flushed and confused. Initially she did not report these symptoms to any staff member. At about 2:00 PM she reported these symptoms to a staff member. Only the confusion had resolved. She stated all her symptoms were minor. Her vitals were obtained (BP 116/72 & pulse 78) At about 2:35 EMS was requested as her symptoms (except for her confusion continued.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: Severe pain at injection site at time of injection, tingling in fingers, unable to use left arm because of pain, difficult to find a position to rest left arm that doesn't cause pain.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling, Swelling
Clinical narrative: ARM SWOLLEN AND SPREADING DOWN SIDE. WAS PRESCRIBED ORAL STEROID (PREDNISONE)FOR SWELLING.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling starting last evening at site of PNEUMOVA 23 injection received yesterday 2/1/17. She reports the pain was initially worse , however the red area has spread to the whole upper arm. No trouble breathing, swallowing, rash/hives elsewhere. No hx prior similar reaction.  Apply ice , Benadryl 25-50 q 6-8 hours. If any extension rash, redness, worsening pain, or otherwise worse, to f/u. Will forward note for Dr.'s review.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, erythema, itchiness, pain around injection site.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registerd nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M022924 with expiration date of 24-JAN-2018 and lot # M047658 with expiration date of 28-OCT-2017) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter stated that the doses of the vaccine (lot # M022924) experienced a temperature excursion between >8 degrees Celsius but <25 degrees Celsius for 40 Hours 25 minutes and the doses of the vaccine (lot # M022924 and lot # M047658) also experienced a temperature excursion between 0 degrees Celsius to 2 degrees Celsius for 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000930: US-009507513-1702USA000929: US-009507513-1702USA000927: US-009507513-1702USA000928.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registerd nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M031574 with expiration date of 11-NOV-2018; lot # M037771 with expiration date of 21-FEB-2019 and lot# M039642 with expiration date of 03-JUL-2018) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter stated that the doses of the vaccine experienced a temperature excursion between 0 degrees Celsius to 2 degrees Celsius for 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000930: US-009507513-1702USA000929: US-009507513-1702USA000364: US-009507513-1702USA000364.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registerd nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # M017983 with expiration date of 30-MAY-2018; lot # M033583 with expiration date of 14-APR-2019 and lot # M041212 with expiration date of 21-JUN-2019) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter stated that the doses of the vaccine (lot # M017983) experienced a temperature excursion between >8 degrees Celsius but <25 degrees Celsius for 40 Hours 25 minutes and the doses of the vaccine (lot # M033583 and lot # M041212) experienced a temperature excursion between 0 degrees Celsius to 2 degrees Celsius for 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000930: US-009507513-1702USA000929: US-009507513-1702USA000927: US-009507513-1702USA000364.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registerd nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ(lot # M031650 with expiration date of 16-MAR-2018; lot # M038717 with expiration date of 24-APR-2018 and lot # M042171 with expiration date 07-JUN-2018) (strength, dosage schedule and anatomical location were not reported) orally for prophylaxis. No adverse effects were reported. The reporter stated that the doses of the vaccine experienced a temperature excursion between 0 degrees Celsius to 2 degrees Celsius for 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000930: US-009507513-1702USA000364: US-009507513-1702USA000927: US-009507513-1702USA000928.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registerd nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # M015931 with expiration date of 30-MAR-2018; lot # M035935 with expiration date of 09-AUG-2018 and lot # M002419 with expiration date 12-JAN-2018) (strength, dosage schedule, route of administration and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The reporter stated that the dose of the vaccine (lot # M002419) experienced a temperature excursion between >8 degrees Celsius but <25 degrees Celsius for 40 hours 25 minutes and the dose of the vaccine (lot # M015931) experienced a temperature excursion between >8 degrees Celsius but <25 degrees Celsius for 40 hours 25 minutes and between 0 degrees Celsius to 2 degrees Celsiusfor 4.5 hours. There were no previous excursions reported. The aforementioned temperature was identified due to a data logger. There were no previous excursions. Furthermore, no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000364: US-009507513-1702USA000929: US-009507513-1702USA000927: US-009507513-1702USA000928.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered nurse refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On 01-FEB-2017, the patients were vaccinated with a dose of improperly stored GARDASIL 9 with lot number M030380 and expiration date of 01-FEB-2019 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1 Celsius degree for 24 hours. There was no previous temperature excursion. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Swelling
Clinical narrative: Redness at injection site, warm to the touch, no itching, no pain.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Vomiting
Clinical narrative: Arm red, painful, swollen and hot at site of injection. Patient also stated that she vomited.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Endometrial thickening, Fatigue, Fungal infection, Ovarian cyst
Clinical narrative: Abdominal pain, fatigue, persistant UTI's & yeast infections.
Age: 16.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Urinary tract infection
Clinical narrative: Abdominal pain, fatigue, persistant UTI's & yeast infections.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Staring
Clinical narrative: Eyes wide open, vacant look in eyes, not blinking for the rest of the day.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Strabismus
Clinical narrative: Crossed eyed for the day.
Age: 39.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Injection site erythema, Rash
Clinical narrative: Patient having shortness of breath, then co-worker noted silver dollar size localized red circle at injection site. Shortness of breath worsened, went to ER, treated with zantac, prednisone and albuterol. Discharged home. Next day reports redness on arm diminishing, but now has rash to face.
Age: 51.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Activities of daily living impaired, Grip strength decreased, Injection site pain, Paraesthesia, Sleep disorder
Clinical narrative: Shoulder pain in arm vaccinated, have not been able to wear a handbag on that shoulder since. Occasional tingling in fingers of same arm. Grasp & strength of hand significantly & surprisingly weakened. Difficult to sleep on that side.
Age: 51.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Loss of personal independence in daily activities, Paraesthesia, Sleep disorder
Clinical narrative: Shoulder pain in arm vaccinated, have not been able to wear a handbag on that shoulder since. Occasional tingling in fingers of same arm. Grasp & strength of hand significantly & surprisingly weakened. Difficult to sleep on that side.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Blood culture, Chest X-ray normal, Culture urine, Full blood count normal, Influenza virus test negative
Clinical narrative: Mother states hive like reaction at site of vaccination "since vaccinated" (left thigh only) On 1/31/17 baby had fever of 103 and 2 30 second seizures. Seen in ER, sepsis work up done. Rocephin given in ER. Azithromycin x 5 days. No further fevers or seizures.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Injection site urticaria, Pyrexia, Respiratory syncytial virus test negative, Seizure, Streptococcus test negative
Clinical narrative: Mother states hive like reaction at site of vaccination "since vaccinated" (left thigh only) On 1/31/17 baby had fever of 103 and 2 30 second seizures. Seen in ER, sepsis work up done. Rocephin given in ER. Azithromycin x 5 days. No further fevers or seizures.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Culture urine, Diarrhoea
Clinical narrative: Mother states hive like reaction at site of vaccination "since vaccinated" (left thigh only) On 1/31/17 baby had fever of 103 and 2 30 second seizures. Seen in ER, sepsis work up done. Rocephin given in ER. Azithromycin x 5 days. No further fevers or seizures.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Ear infection, Full blood count, Influenza virus test, Injection site reaction, Injection site urticaria
Clinical narrative: Mother states hive like reaction at site of vaccination "since vaccinated" (left thigh only) On 1/31/17 baby had fever of 103 and 2 30 second seizures. Seen in ER, sepsis work up done. Rocephin given in ER. Azithromycin x 5 days. No further fevers or seizures.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Irritability, Pyrexia, Respiratory syncytial virus test, Seizure, Urticaria
Clinical narrative: Mother states hive like reaction at site of vaccination "since vaccinated" (left thigh only) On 1/31/17 baby had fever of 103 and 2 30 second seizures. Seen in ER, sepsis work up done. Rocephin given in ER. Azithromycin x 5 days. No further fevers or seizures.
Age: 1.5
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Rash, Rash erythematous, Stomatitis
Clinical narrative: On January 31, 2017 He began running a high fever (102.8) that persisted even with alternating Motrin and Tylenol. February 1, 2017 Fever returned around 2:00 PM along with a few red sores around his mouth. February 2, 2017 He woke up with a severe rash on his face and left ear. He also had the red bumps beginning to appear behind his legs and on his arms.
Age: 71.0
Sex: M
Vaccine: MEN
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Pain at injection site that failed to resolve spontaneous in two weeks.
Age: 0.08
Sex: F
Vaccine: DTAP
Symptoms: Crying, Diarrhoea, Pyrexia, Rash generalised, Strabismus
Clinical narrative: Same day PM her Body rash, persistent crying for hours, crossing of eyes, diarrhea, 105F fever.
Age: 38.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Fatigue, Myalgia, Pyrexia, Rash
Clinical narrative: Multiple round, dime-sized rashes. Patient also reported fever of 101, fatigue and aching muscles.
Age: 40.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever 101.6, aching and pain in legs.
Age: 40.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever 101.6, aching and pain in legs.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Fall, Gait disturbance
Clinical narrative: Immediate sign was a headache dizziness and high fever at 10:55 AM at around 11:10 AM severe dizziness complaint of head hurting badly and inability to walk straight (i.e. walking like a drunk person) only taking about 3 steps this was about 11:15ish he blacked out and went down luckily I caught him before he hit anything and I put him in a chair when I put him in the chair he went into full convulsions and had a seizure of which he has never had before. I took him to hospital ER they did a CT scan and blood work both of which came back Normal. Then we got transferred to another Hospital where Dr. saw him I believe we arrived at 5:40ish and did not leave until around 1:00 AM.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Loss of consciousness, Pyrexia, Seizure
Clinical narrative: Immediate sign was a headache dizziness and high fever at 10:55 AM at around 11:10 AM severe dizziness complaint of head hurting badly and inability to walk straight (i.e. walking like a drunk person) only taking about 3 steps this was about 11:15ish he blacked out and went down luckily I caught him before he hit anything and I put him in a chair when I put him in the chair he went into full convulsions and had a seizure of which he has never had before. I took him to hospital ER they did a CT scan and blood work both of which came back Normal. Then we got transferred to another Hospital where Dr. saw him I believe we arrived at 5:40ish and did not leave until around 1:00 AM.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 70-year-old female patient who received Seasonal Influenza vaccine. Concomitant products included clindamycin and MEPRON. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and cough. The patient was treated with Amoxicillin. On an unknown date, the outcome of the vaccination failure, influenza and cough were unknown. It was unknown if the reporter considered the vaccination failure, influenza and cough to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. During the follow up reporting of case US2015GSK103853 (same patient for adverse events following administration of MEPRON), the caller stated that she was taking MEPRON one tsp twice daily to treat Babesiosis, which was causing the chills and sweats from previous reports. She had been taking MEPRON together with clindamycin and she was getting better since starting that combination. She no longer experience the chills and sweats, which she had been experiencing since she was 22 years old. Recently the patient got the flu, even though she had received the flu vaccine, which had been causing her to cough. She had been taking amoxicillin and the flu was getting better. This case was considered as suspected vaccination failure since the time to onset of the events and the confirmatory lab test details were unknown.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Axillary pain, Feeling hot, Headache, Local swelling
Clinical narrative: After 1st RABAVERT pt c/o HA q d but has increased since 8p last night. Armpit pain (when arm down only) started at 8pm last night-has elevated-ice only increased pain. Pt. feels hot but has not taken temp.-face not red. Under arm has sharp pain and sl. swelling. Recommend PCP FU today.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: SX started about 8:00 PM 2-1-17 consisting of redness and slight swelling in the thigh from diaper area to knee and persistent shrieking crying from about 8:00-10:00 PM.  TX w/TYLENOL-crying subsided about 10:00-redness gone by 2-2-17.
Age: 23.0
Sex: U
Vaccine: FLUR3
Symptoms: Cold sweat, Diarrhoea, Dizziness, Feeling jittery, Nausea
Clinical narrative: Afternoon after receiving vaccination, developed diarrhea and nausea, feeling faint and lightheaded, jittery, clammy. Symptoms have stayed the same since receiving vaccine.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Influenza like illness, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site, weakness, and flu like symptoms.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Skin lesion
Clinical narrative: C/o (R) arm lesion x 1-2 days. Mom states lesions started right after vaccine was administered. Mom admits pt was fighting when vaccine was administered.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Pt complained of significant swelling the size of a fist, lasting greater than 1 week.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Pt. received high dose flu vaccine 1 0.5 ml Lot# UI728AB exp. 6/30/17 in left deltoid 1/31/17. He then went to pharmacy to get PREVNAR 13 and was given Pneumo 23 in same arm same day. Now has reaction. Patient states he had reaction at 11:30 AM swelling redness left arm.
Sex: F
Vaccine: HEPA
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received HAVRIX (batch number 5D952, expiry date 20th April 2018). Concurrent medical conditions included milk allergy. On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced hives and allergic reaction. On an unknown date, the outcome of the hives and allergic reaction were unknown. It was unknown if the reporter considered the hives and allergic reaction to be related to HAVRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced hives, described as an allergic reaction, after receiving a dose of HAVRIX. The reaction was further described as similar to the reaction the patient had after consuming milk. The reporter had limited information but consented to follow up by email.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness and stiffness within 4 hours of injection, swollen and redness from a 2"-6" band around circumference of arm. A lot of stiffness, pain and general malaise. Patient called on 2/2/2017 to say swollen arm has cleared up.
Age: 0.25
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Pt stated vomiting-4-5 hours after Roto- vomited 5x each at 5 minutes apart. Then was fine.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Injection site rash
Clinical narrative: Rash on right deltoid.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Localized erythema 7.5 cm x 18 cm-warm to touch-no resp involvement-no fever. Rx: antihistamines.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Pain in extremity, Tenderness
Clinical narrative: Case number PHHY2016US054620, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 624756) website on 18 Apr 2016. This report refers to a female patient of an unknown age. Medical history and concurrent conditions were not reported. The patient had no concomitant medications. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) and PNEUMOVAX 23 (batch number: not reported, other manufacturer) on an unknown date. On an unknown date after vaccinations, the patient  experienced headache. Further the patient's arm felt sore and tender. The patient did not reported if the vaccines were given at the same time or on different dates. Outcome of the events was condition unchanged. Seriousness and causality of the events was not reported.
Age: 36.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Case number PHHY2016US092997, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 631725) on 06 Jul 2016. This report refers to a 36 years old female patient. Past medical history included diarrhea. Current condition included hypertension. Concomitant medication was not reported. She was vaccinated with FLUCELVAX (batch number: 174084) on an unknown date. After vaccination, she experienced shoulders ache and pain in joints. The outcome of the events was reported as condition unchanged. The events were assessed as non serious and causality was not reported.
Age: 69.0
Sex: M
Vaccine: FLUC3, PNC13
Symptoms: Arthralgia, Body temperature increased, Rash
Clinical narrative: Case number PHHY2016US093252 is an initial spontaneous report received from healthcare professional via Vaccine Adverse Event Reporting System (VAERS reference number: 634274) on 06 Jul 2016. This report refers to 69 year old male patient. Historical condition included coronary artery disease, status post CABG (coronary artery bypass graft); depression; hyperlipidemia; glaucoma; olecranon bursitis; impotence; allergies. Current condition include atrial fibrillation; hypertension; osteoarthritis. Past drugs included simvastatin, morphine, niacin. The patient was vaccinated with first  dose of FLUCELVAX (batch number 174277) into right arm and first dose of PREVENAR 13 (other manufacturer, batch number L99275) into left arm on 01 Feb 2016. On 07 Feb 2016, the patient had rash around his waist, forearms and chest. He had temperature last night was 101.2, and today it was 99. Patient stated his joints are achy, pain 2/10. The patient visited to emergency room on an unknown date. The patient received ibuprofen 800 mg BID as treatment. The outcome of events was completely recovered. The seriousness of the events was reported as non serious and causality was not reported. Following an internal review for the data received on 06 Jul 2016, significant case correction was performed: Suspect drug coding was changed.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation, Knee arthroplasty
Clinical narrative: Pt. had reaction to PREVNAR - 13 inject given 8-12-16 (Form submitted). Pt. had knee replacement approximately 12-20-16 and developed A. Fib - requested this form be submitted to determine if PREVNAR related to A Fib.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash generalised, Urticaria
Clinical narrative: Case number PHEH2017US002629, is an initial spontaneous report received from a consumer on 23 Jan 2017. This report refers to a 79 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 30 Sep 2016. On 01 Oct 2016, the patient experienced rash on her legs the following day and rash spread over her body. On 24 Dec 2016, the patient suffered with flu. It was reported that, patient visited 03 different physicians with prescriptions for creams and pills with no improvement. The patient received the flu shot for 21 years and never had a reaction before. The outcome of the event rash all over was reported as condition unchanged and event flu was reported as complete recovery on 02 Jan 2017. The seriousness of the events was  reported  as  non  serious.  The  causality  of  the  events  was  not  reported.  The  seriousness  assessment  of  events  rash generalized, influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Influenza, Rash generalised, Vaccination failure
Clinical narrative: Case number PHEH2017US002629, is an initial spontaneous report received from a consumer on 23 Jan 2017. This report refers to a 79 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml, intramuscularly on 30 Sep 2016. On 01 Oct 2016, the patient experienced rash on her legs the following day and rash spread over her body. On 24 Dec 2016, the patient suffered with flu. It was reported that, patient visited 03 different physicians with prescriptions for creams and pills with no improvement. The patient received the flu shot for 21 years and never had a reaction before. The outcome of the event rash all over was reported as condition unchanged and event flu was reported as complete recovery on 02 Jan 2017. The seriousness of the events was  reported  as  non  serious.  The  causality  of  the  events  was  not  reported.  The  seriousness  assessment  of  events  rash generalized, influenza and vaccination failure was upgraded to serious (medically significant) based on the information available in the source document.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Weakness, dizziness, swelling of arm above elbow. Tired, slight headache, throat feels funny but not closing.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Weakness, dizziness, swelling of arm above elbow. Tired, slight headache, throat feels funny but not closing.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Peripheral swelling
Clinical narrative: Weakness, dizziness, swelling of arm above elbow. Tired, slight headache, throat feels funny but not closing.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Throat irritation
Clinical narrative: Weakness, dizziness, swelling of arm above elbow. Tired, slight headache, throat feels funny but not closing.
Age: 24.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Rash, Rash papular, Vaccination site rash
Clinical narrative: Patient presented with a rash on the left bicep near vaccination site and papular rash upper chest.
Age: 22.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Dizziness, Fatigue, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, dizziness, fatigue with some tenderness the first night. The second day, the site started to swell and be extremely tender, coupled with more fatigue and higher fever.
Age: 22.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Tenderness
Clinical narrative: Fever, dizziness, fatigue with some tenderness the first night. The second day, the site started to swell and be extremely tender, coupled with more fatigue and higher fever.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical Assistant refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX injection, lot # M024680, expiration date 18-MAY-2018, lot # M028546, expiration date 07-JUN-2018 and lot# M028552, expiration date 07-JUN-2018 (dose, site and route of administration were not reported). No adverse effects were reported. The vaccines experienced a temperature excursion of between -10 and 8 Celsius degrees (C) for 2 hours and 21 minutes, which was detected by a digital data logger. There was previous temperature excursion: for vaccine with lot # M024680 between -10 and 8 Celsius degrees (C) for 21 hours and 7 minutes; for all other lots # between -10 and 8 Celsius degrees (C) for 18 hours. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013571:
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On an unknown date, (reported as "some time ago"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (dose, strength, anatomical location, lot#, and expiry dates were not reported) to prevent shingles. On an unknown date, (reported as "very short time, a couple of days of being administered ZOSTAVAX"), the patient developed symptoms of Bell's Palsy, without the rash. She did not experience shingles. The patient sought medical attention by seeing the physician. On an unknown date, the patient totally recovered. The relatedness between the event and ZOSTAVAX was not reported. Upon internal review, the event of facial paralysis was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with PROQUAD (lot #: M011664 with expiration date: 08-SEP-2017) (dose, dosage schedule and anatomical location were not reported), subcutaneously, for prophylaxis. The vaccine had been stored at a temperature excursion of 5-14 °F for 19 hours (digital data logger) with no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a pediatric patient of unknown age. The patient had no pertinent medical history, drug allergies/reactions or concomitant therapies reported. The nurse reported that on an unknown date, the pediatric patient was administered with an adult dose of RECOMBIVAX HB (lot #M018645, expiration date: 31-MAY-2018) (dose, frequency, and anatomical location were not reported) for prophylaxis. No adverse effects or additional information were reported. No product quality complaint was involved (PQC). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 19-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot number M033906, expiration date 20-JUL-2018 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius (C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013092: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical Assistant refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On an unknown dates, the patients were vaccinated with improperly stored PROQUAD (rHA) injection, lot# M032496, expiration date 02-JAN-2018 and lot# M034692, expiration date 24-JAN-2018 (dose, site and route of administration were not reported). No adverse effects were reported. The vaccines experienced a temperature excursion of between -10 and 8 Celsius degrees (C) for 2 hours and 21 minutes, which was detected by a digital data logger. There was no previous temperature excursion. No product quality complaint was involved. This is one of two reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007743:
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. It was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored RECOMBIVAX HB injection (lot # reported as  M036156, expiration date 23-FE-2019) for prophylaxis (strength, dose and route were unknown). On an unknown date, the vaccine was stored to a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call as made because of a digital data logger. No adverse effects reported. This is one of several reports from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013818: US-009507513-1701USA013819: US-009507513-1701USA013820: US-009507513-1701USA013821:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. It was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored VAQTA injection (lot # reported as M039202, expiration date 11-MAR-2018) for prophylaxis (strength, dose and route were unknown). On an unknown date, the vaccine was stored a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call was made because of a Digital Data Logger. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013631: US-009507513-1701USA013819: US-009507513-1701USA013820: US-009507513-1701USA013821:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. It was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored ROTATEQ Oral liquid (orally, lot # reported as M039744, expiration date 26-APR-2018) for prophylaxis (strength and dose were unknown). On an unknown date, the vaccine was reported to a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call was made because if a digital data logger. No adverse effects reported. This is one of several reports from the source. Additional information has been requested. Sender's Comments: US-009507513-1701USA013818: US-009507513-1701USA013631: US-009507513-1701USA013820: US-009507513-1701USA013821.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. It was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored PNEUMOVAX23 injection (lot # M040004, expiration date 20-MAY-2018) for prophylaxis (strength, dose and route were unknown). On an unknown date, the vaccine was stored to a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call was made because of a digital data logger. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013818: US-009507513-1701USA013819: US-009507513-1701USA013631: US-009507513-1701USA013821: