chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Varicella virus test positive, Varicella zoster virus infection, Weight bearing difficulty
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient with attention deficit/hyperactivity disorder (ADHD). The patient had no drug reactions or allergies. On an unknown date (at the age of 1 year old), the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route of administration, lot number and expiration date were not reported). On an unknown date (at the age of 5 year old), the patient received a second dose of VARIVAX (Merck) (dose, route of administration, lot number and expiration date were not reported). It was stated that the patient had no exposure to anyone else. Concomitant therapy included unspecified ADHD medications. On an unknown date, the patient presented to unspecified urgent care/emergency room with knee and hip pain with difficulty weight bearing. The physician stated that there were some diagnostic tests (unspecified) completed (results were not provided) and the patient was treated with gabapentin for severe pain. Later, on an unknown date, the patient developed a rash and shingles on left lower leg and back. The patient was placed on valacyclovir hydrochloride and was doing better a couple of days later and lesions started to crust. The polymerase chain reaction (PCR) testing was completed and showed positive for varicella zoster virus (VZV). The sample was sent to another doctor for genotyping but it leaked in transit so a second attempt was being made. The outcome of weight bearing difficulty, knee and hip pain and severe pain was unknown. The outcome of varicella zoster virus infection was recovering/resolving. The relatedness between the events and VARIVAX (Merck) was not reported. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: HEP
Symptoms: Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: No appetite 4/3, 4/4 began diarrhea and fevers.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Vaccination complication
Clinical narrative: On 04/01/16, pt started to notice redness and swelling at the injection site. +itching and burning to site.  Over the next two days, redness and swelling spread across the whole upper arm and down to the elbow with reports of increased "burning and itching."  DENIES fever, wheezing, SOB, swelling to lips/tongue/throat.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium double contrast, Intussusception
Clinical narrative: Intussusception requiring air enema and hospitalization.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 49 unspecified patients of unknown age and gender. On unknown dates the patients received doses of improperly stored VARIVAX (Merck) (lot # L041207 with expiration date of 20-OCT_2017; strength, dosage, frequency and route unspecified). No adverse effects were reported. There was no previously temperature excursion. Temperature was 30.6 F  and time frame was 676.9 total cumulative hours. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. On 09-MAR-2016 the patient was vaccinated with an expired dose of VAQTA (lot # K001296, expiration date 15-JAN-2016) (dose and route were not reported). No adverse effects were reported. Additional information is not expected since the reporter does not wish to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # L019128 with expiration date of 27-MAY-2017; strength, dosage, frequency and route unspecified). No adverse effects were reported. There was no previously temperature excursion. Temperature was 42 F and time frame was 48 hours. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On an unspecified date in 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, dosage, frequency and route unspecified). On 17-MAR-2016 the patient was vaccinated with another dose of ZOSTAVAX (lot#, strength, dosage and frequency unspecified; subcutaneous). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report was received from a pharmacist regarding her 18 year old daughter. Patient did not have any pertinent medical history and drug allergies. Concomitant therapies included ORTH-NOVUM 1/35. On 14-MAR-2016, the patient was vaccinated with her third dose of GARDASIL 9, lot # L038917, expiry: 20-FEB-2018, intramuscularly. The reporter stated that there was a funny, squishing sound when the vaccine was administered. On 14-MAR-2016, reported as immediately after administration and for several hours later, the patient experienced burning pain. On next day, 15-MAR-2016, the patient developed a red, raised area, 3 inches in diameter and quarter inch high, that was firm in the middle and very painful at the injection site. Pharmacist also describes the area as having "irregular lobes, resembling the shape of a dinosaur". Treatment included ice and ibuprofen. The patient sought medical attention at physician's office on 15-MAR-2016. On 17-MAR-2016, the patient visited the office again and it was reported that the area was larger, diffusing and still firm in the area of the injection site, but the pain improving. No lab test were performed. The outcome of pain and injection site was reported as recovering. The outcome of injection site erythema and injection site mass was not recovered. The reporter did not assess the relatedness between the events with GARDASIL 9. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a pharmacist regarding her 18 year old daughter. Patient did not have any pertinent medical history and drug allergies. Concomitant therapies included ORTH-NOVUM 1/35. On 14-MAR-2016, the patient was vaccinated with her third dose of GARDASIL 9, lot # L038917, expiry: 20-FEB-2018, intramuscularly. The reporter stated that there was a funny, squishing sound when the vaccine was administered. On 14-MAR-2016, reported as immediately after administration and for several hours later, the patient experienced burning pain. On next day, 15-MAR-2016, the patient developed a red, raised area, 3 inches in diameter and quarter inch high, that was firm in the middle and very painful at the injection site. Pharmacist also describes the area as having "irregular lobes, resembling the shape of a dinosaur". Treatment included ice and ibuprofen. The patient sought medical attention at physician's office on 15-MAR-2016. On 17-MAR-2016, the patient visited the office again and it was reported that the area was larger, diffusing and still firm in the area of the injection site, but the pain improving. No lab test were performed. The outcome of pain and injection site was reported as recovering. The outcome of injection site erythema and injection site mass was not recovered. The reporter did not assess the relatedness between the events with GARDASIL 9. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Urticaria, Vaccination site pain
Clinical narrative: The day the vaccine was given, in the area where it was given was sore. Red whelps that look like a handprint near armpit area that's very sore and heated.
Age: 32.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Fall, Loss of consciousness
Clinical narrative: Patient receive 2 vaccines (BOOSTRIX and ENGERIX-B) and passed out/fell. She was taken to the ER but was fine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Local reaction, Pruritus
Clinical narrative: Large local reaction with pruritis developed approximately 24 hours after vaccination. Treatment with prn BENADRYL.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers 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 30-MAR-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # L025598, expiration date 13-JAN-2017 (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 hours. This is one of several reports received from the same reporter. Additional information has ben requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Hyperhidrosis, Injection site hypoaesthesia, Injection site pain, Nausea, Pyrexia
Clinical narrative: Increasing pain at injection site beginning 4 hours after injection. Pt then developed swelling, nausea, diaphoresis, fever to 102 degrees F, and transient numbness at injection site.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Swelling
Clinical narrative: Increasing pain at injection site beginning 4 hours after injection. Pt then developed swelling, nausea, diaphoresis, fever to 102 degrees F, and transient numbness at injection site.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Shoulder to elbow swollen to 3 times size of arm to elbow. Took steroid shots next day. Went down in 2 days. Elbow to lower arm swollen 2 times bigger than arm had cellulitis in arm from shot.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Redness, swelling, hot to the touch, raised whelp about 6 inches by 3 inches. Hard and moderately painful.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Redness, swelling, hot to the touch, raised whelp about 6 inches by 3 inches. Hard and moderately painful.
Age: 57.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity, Sleep disorder
Clinical narrative: I had a flu shot on October 26, 2015 at my local public health department. I am a county employee and the county was offering a free shot through our health insurance. The shot was given to me in my upper arm; however, the prick/insert was rather high on my upper arm. Ever since that day, my right upper arm has been sore. It is now almost April, 2016, and my arm is still sore. I can't raise it high and I feel a discomfort when I'm changing shirts. I also can't sleep on my right side, due to discomfort in my upper arm.
Age: 57.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Discomfort, Drug administered at inappropriate site, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: I had a flu shot on October 26, 2015 at my local public health department. I am a county employee and the county was offering a free shot through our health insurance. The shot was given to me in my upper arm; however, the prick/insert was rather high on my upper arm. Ever since that day, my right upper arm has been sore. It is now almost April, 2016, and my arm is still sore. I can't raise it high and I feel a discomfort when I'm changing shirts. I also can't sleep on my right side, due to discomfort in my upper arm.
Age: 57.0
Sex: F
Vaccine: FLU4, FLUX
Symptoms: Sleep disorder
Clinical narrative: I had a flu shot on October 26, 2015 at my local public health department. I am a county employee and the county was offering a free shot through our health insurance. The shot was given to me in my upper arm; however, the prick/insert was rather high on my upper arm. Ever since that day, my right upper arm has been sore. It is now almost April, 2016, and my arm is still sore. I can't raise it high and I feel a discomfort when I'm changing shirts. I also can't sleep on my right side, due to discomfort in my upper arm.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Personality change
Clinical narrative: He had a complete personality change. The very obvious changes lasted 1 1/2 weeks. No smiles, very fussy! He was very smiley and happy prior to vaccinations.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: High fever followed by febrile seizure 30 hours after.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding to an unspecified patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 18-MAR-2016, the patient was inadvertently vaccinated with a dose of expired GARDASIL (lot # J009788, expiry date 17-MAR-2016) dosage regimen and route unknown and it was supported. Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Age: 0.06
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right tricep area warm, red, swollen 8 x 9 cm redness. Cool compress. BENADRYL 1/2 - 1 tsp every 6-8 hrs PRN.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. From 09-MAR-2016 to 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot # K007979 with expiration date 03-JUN-2016, lot # K015970 with expiration date 23-SEP-2016 and lot # L017144 with expiration date 13-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 7.4 degrees Fahrenheit for 12 hours and 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Has not received vax in last 10 years. Felt strange and fatigue after lunch. Tuesday woke up with flu-like symptoms, chills, aches which remained all week. Bicep (LA) was hot, red, hard. Took MOTRIN which helped somewhat. Went to doctor on Friday. Diagnosed with cellulitis and prescribed amoxicillin. Today, already finished antibiotics, and feels fine.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: Has not received vax in last 10 years. Felt strange and fatigue after lunch. Tuesday woke up with flu-like symptoms, chills, aches which remained all week. Bicep (LA) was hot, red, hard. Took MOTRIN which helped somewhat. Went to doctor on Friday. Diagnosed with cellulitis and prescribed amoxicillin. Today, already finished antibiotics, and feels fine.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers 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 30-MAR-2016, the patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. On 16-FEB-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route of administration were not reported, lot # L041627 with expiration date: 20-APR-2017, therapy type rHA). The temperature excursion (-14 Celsius degrees) lasted 56 hours. There was also a previous temperature excursion which lasted 2 hours and 48 minutes (captured in MARRS# 1602USA006365). No adverse effects were reported. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: FLUX, HEP, HEPA, FLUX, FLUX
Symptoms: Injection site pain
Clinical narrative: Soreness at site of injection and surrounding area for some days no treatment.
Age: 40.0
Sex: F
Vaccine: FLUX, HEP, HEPA, FLUX, FLUX
Symptoms: Hepatitis A, Hepatitis B, Injection site pain
Clinical narrative: Soreness at site of injection and surrounding area for some days no treatment.
Age: 40.0
Sex: F
Vaccine: FLUX, HEP, HEPA, FLUX, FLUX
Symptoms: Pain
Clinical narrative: Soreness at site of injection and surrounding area for some days no treatment.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Face injury, Syncope
Clinical narrative: Patient received second dose of GARDASIL 9 today. No current illness or contraindication to immunization. Patient fainted while walking to the door after vaccine and hit face on floor. Responsive after about one minute, no abnormal movements. Alert and oriented and pink within another minute.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers 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. From 09-MAR-2016 to 01-APR-2016, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L008354, expiration date 11-SEP-2016, lot # L040412, expiration date 13-APR-2017 and lot # L030587, expiration date 10-FEB-2017 (albumin status, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 7.4 degrees Fahrenheit for 12 hours and 40 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus generalised
Clinical narrative: 3/30/16 at 11:23AM pt was given PREVNAR 13 0.5 ml intramuscular (L) arm. Called office 3/31/16 10:12AM states she is so itchy all over no rash, just itching Lot #M51194 Exp: 5-30-17.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of entire left thigh where vaccine was given.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 23 month old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions and concomitant medications was reported. On 26-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L044475, expiry date 12-MAY-2017 (dose, frequency, route of administration and anatomical location were not specified). It was not reported it if was first, second or third dose of GARDASIL 9. The administered dose underwent temperature excursion at 1.5 Celsius degrees for 15 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chest X-ray normal, Pyrexia, Respiration abnormal
Clinical narrative: High temp, mother gave Tylenol 1.25mg po, abnormal breathing pattern.  Was seen in ER, CXR normal, infant stable.  No treatment, resolved.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Headache, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Patient specifies that she felt fever, headaches, body aches and edema on right arm.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Blood test normal, Injection site pain, Screaming, Urine analysis normal
Clinical narrative: Progressively worsening pain at and around the site of the injection.  Pain progressed to the point of uncontrolled screaming.  Went to the ER, they sedated me for 7 hours.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 13 year old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions and concomitant medications was reported. On 24-MAR-2016, the patient was vaccinated with an improperly with an improperly stored dose of GARDASIL 9 lot # L044475, expiry date 12-MAY-2017 (dose, frequency, route of administration and anatomical location were not specified). It was not reported if it was first, second or third dose of GARDASIL 9. The administered dose underwent temperature excursion at 1.5 Celsius degrees for 15 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neurological symptom, Rash
Clinical narrative: This spontaneous report was received from physician assistant (who was also the stepdaughter of the patient) via field representative regarding a male patient of unknown age. The patient's medical history included urinary blockage. The patient was immunocompromised. On an unknown date the patient was vaccinated with ZOSTAVAX lot details, dosage regimen and route unknown. Concomitant medications were not reported. On an unknown date the patient developed unilateral chest rash that was indicative of shingles outbreak and the patient also developed unspecified neurological side effect during unspecified time after receiving a dose of ZOSTAVAX. The patient sought medical attention and visited physician. No treatment was given for the events. The outcome of events was unknown. Product quality complaint (PQC) was not filed. Causality assessment was not provided. Additional information has been provided. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Injection site induration, Injection site pain, Injection site swelling, Tearfulness
Clinical narrative: Pt's left thigh is swollen - measured in circumference 34 cm. Right thigh (unaffected) is 31.5 cm - Area surrounding injection measures 8 cm W x 7 cm long. Area is indurated and painful to touch. Temp on admit 100.3. MOTRIN given. temp on D/C 99.5. Vaccine area is warm to touch. Very tearful. Unable to bear weight at this time due to pain.
Age: 3.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Vaccination site warmth, Weight bearing difficulty
Clinical narrative: Pt's left thigh is swollen - measured in circumference 34 cm. Right thigh (unaffected) is 31.5 cm - Area surrounding injection measures 8 cm W x 7 cm long. Area is indurated and painful to touch. Temp on admit 100.3. MOTRIN given. temp on D/C 99.5. Vaccine area is warm to touch. Very tearful. Unable to bear weight at this time due to pain.
Age: 3.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Adverse event
Clinical narrative: Pt's left thigh is swollen - measured in circumference 34 cm. Right thigh (unaffected) is 31.5 cm - Area surrounding injection measures 8 cm W x 7 cm long. Area is indurated and painful to touch. Temp on admit 100.3. MOTRIN given. temp on D/C 99.5. Vaccine area is warm to touch. Very tearful. Unable to bear weight at this time due to pain.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hyperhidrosis, Pallor, Presyncope
Clinical narrative: After receiving vaccine pt became pale and sweaty. Nurse took vitals 100% on RA. Most likely vagal response.
Age: 68.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Asthenia, CSF test abnormal, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Onset of tingling and numbness about 10 days, post flu shot, then start in his feet/toes and then progressed to the fingers and hands. Progressed up the left arm and shoulder. Legs became weak and seem unable to have the strength to walk up down stairs. No fever, chills. No SOB, dysphagia.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist technician and refers to 2 unspecified patients of unknown patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, improperly stored doses of ZOSTAVAX (lot # L031272, expiration date: 19-NOV-2016, dose, route of administration and injection site were not reported) were administered to two unspecified patients. Administered doses of ZOSTAVAX underwent temperature excursions at 36 Fahrenheit degrees for 12 hours. The previous temperature excursions were at 26 Fahrenheit degrees for 21 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Chills, Feeling cold, Formication, Osteopenia
Clinical narrative: Heart palpitations, shivering, crawling feeling, burning sensation, cold, extreme pain at vaccination site and upper arm.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Osteoporosis, Palpitations, Vaccination site pain
Clinical narrative: Heart palpitations, shivering, crawling feeling, burning sensation, cold, extreme pain at vaccination site and upper arm.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to 3 unspecified patients in their sixties (adult patients). No information regarding their concurrent conditions and medical history was provided. On an unknown dates, the patients were vaccinated with ZOSTAVAX refrigerated vial 19400 PFU, subcutaneously (lot # not reported). Concomitant medication was not mentioned. On an unknown dates, all the three patients developed shingles post vaccination with ZOSTAVAX. The patients sought medical attention by visiting the physician's office. The physician reported that the patients were all doing well now, but did not provide a specific time when the patients recovered. Causality assessment was not provided by the reporter. No product quality complaint was reported. It was also reported that the therapy with ZOSTAVAX was not discontinued. Additional information is not expected as the reporter did not wish further contact.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Had pain in arm for several days. Never had any prior problems. Always had the shots. Doctor's office sent me this form. Seem to be OK now.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route of administration were not reported, lot # L041627 with expiration date: 20-APR-2017, therapy type rHA). The temperature excursion (-14 Celsius degrees) lasted 56 hours. There was also a previous temperature excursion which lasted 2 hours and 48 minutes (captured in MARRS# 1602USA006365). No adverse effects were reported. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to patient of unknown age and gender. On 04-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (dose, frequency and route of administration were not reported, lot # L041627 with expiration date: 20-APR-2017, therapy type (HA). The temperature excursion (-14 Celsius degrees) lasted 56 hours. There was also a previous temperature excursion which lasted 2 hours and 48 minutes (captured in MARRS # 1602USA006365). No adverse effects were reported. This is one of several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Hepatic enzyme increased, Hepatitis, Pyrexia
Clinical narrative: Fever 104, took him to ER and was admitted for liver enzymes being in the 300'S.
Age: 79.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain on left arm. He said still have pain on his left arm.
Age: 56.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Pyrexia, Urticaria
Clinical narrative: Patient noticed large red mark and felt hot spot and golf ball sized welt at injection site. Had low grade fever.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Balance disorder, Blood pressure decreased, Computerised tomogram abdomen normal, Computerised tomogram head normal, Culture negative
Clinical narrative: By night arm was achy and body aches started Thursday morning body aches all over and did not feel well, nausea. By 2:30pm felt cold, temp was about 100.8 degrees. Layed down to let it pass and couldn't move much. At night temp was 102.6 degrees F, took cold and flu pill since it has ibuprofen to see if it helped with fever. Friday was awake on and off, couldn't move much, temp at 12:30pm was about 103 degrees F. Called clinic but had long wait time. Called urgent care who recommended to go to ER. Went to ER, felt like health was going downhill. Blood work specified white blood cell count was elevated. At night blood pressure dropped, body was going into shock. Got lumbar puncture test because neck was too stiff. Moved to ICU on Saturday. They have performed cultures, CT scan of abdomen and head and all results negative. The doctors mentioned symptoms/reaction may have worsened because pt was dehydrated. Today still feels unsteady on feet and has headaches. Patient was moved from ICU to general bed and still in monitoring.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Dehydration, Feeling cold, Headache, Intensive care, Lumbar puncture
Clinical narrative: By night arm was achy and body aches started Thursday morning body aches all over and did not feel well, nausea. By 2:30pm felt cold, temp was about 100.8 degrees. Layed down to let it pass and couldn't move much. At night temp was 102.6 degrees F, took cold and flu pill since it has ibuprofen to see if it helped with fever. Friday was awake on and off, couldn't move much, temp at 12:30pm was about 103 degrees F. Called clinic but had long wait time. Called urgent care who recommended to go to ER. Went to ER, felt like health was going downhill. Blood work specified white blood cell count was elevated. At night blood pressure dropped, body was going into shock. Got lumbar puncture test because neck was too stiff. Moved to ICU on Saturday. They have performed cultures, CT scan of abdomen and head and all results negative. The doctors mentioned symptoms/reaction may have worsened because pt was dehydrated. Today still feels unsteady on feet and has headaches. Patient was moved from ICU to general bed and still in monitoring.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Mobility decreased, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: By night arm was achy and body aches started Thursday morning body aches all over and did not feel well, nausea. By 2:30pm felt cold, temp was about 100.8 degrees. Layed down to let it pass and couldn't move much. At night temp was 102.6 degrees F, took cold and flu pill since it has ibuprofen to see if it helped with fever. Friday was awake on and off, couldn't move much, temp at 12:30pm was about 103 degrees F. Called clinic but had long wait time. Called urgent care who recommended to go to ER. Went to ER, felt like health was going downhill. Blood work specified white blood cell count was elevated. At night blood pressure dropped, body was going into shock. Got lumbar puncture test because neck was too stiff. Moved to ICU on Saturday. They have performed cultures, CT scan of abdomen and head and all results negative. The doctors mentioned symptoms/reaction may have worsened because pt was dehydrated. Today still feels unsteady on feet and has headaches. Patient was moved from ICU to general bed and still in monitoring.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Shock, White blood cell count increased
Clinical narrative: By night arm was achy and body aches started Thursday morning body aches all over and did not feel well, nausea. By 2:30pm felt cold, temp was about 100.8 degrees. Layed down to let it pass and couldn't move much. At night temp was 102.6 degrees F, took cold and flu pill since it has ibuprofen to see if it helped with fever. Friday was awake on and off, couldn't move much, temp at 12:30pm was about 103 degrees F. Called clinic but had long wait time. Called urgent care who recommended to go to ER. Went to ER, felt like health was going downhill. Blood work specified white blood cell count was elevated. At night blood pressure dropped, body was going into shock. Got lumbar puncture test because neck was too stiff. Moved to ICU on Saturday. They have performed cultures, CT scan of abdomen and head and all results negative. The doctors mentioned symptoms/reaction may have worsened because pt was dehydrated. Today still feels unsteady on feet and has headaches. Patient was moved from ICU to general bed and still in monitoring.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness that spreads, itching, warmth upon touch, swelling.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness that spreads, itching, warmth upon touch, swelling.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal discomfort, Blood thyroid stimulating hormone normal, Epstein-Barr virus antibody negative, Fatigue, Full blood count normal
Clinical narrative: Patient began complaining of a headache, sore throat, and fatigue on 4/1/16. On 4/2/16, patient also began complaining of an upset stomach and sweating a lot.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Human chorionic gonadotropin negative, Hyperhidrosis, Influenza virus test negative, Metabolic function test normal
Clinical narrative: Patient began complaining of a headache, sore throat, and fatigue on 4/1/16. On 4/2/16, patient also began complaining of an upset stomach and sweating a lot.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Mononucleosis heterophile test negative, Oropharyngeal pain, Respiratory syncytial virus test negative, Streptococcus test negative, Urine analysis normal
Clinical narrative: Patient began complaining of a headache, sore throat, and fatigue on 4/1/16. On 4/2/16, patient also began complaining of an upset stomach and sweating a lot.
Age: 15.0
Sex: F
Vaccine: HEP, HEPA, HPV4, IPV, MMR, VARCEL
Symptoms: Dizziness, Feeling abnormal, Head discomfort, Pyrexia
Clinical narrative: Patient presented to this clinic with her younger brother to complete his shots.  It started the evening after she got her shots and she felt pressure in her head for 5 days. She just wasn't hungry just didn't feel good. She denies any nausea or vomiting, just pressure in her head and some dizziness.  No weakness or numbness of any extremity and no problems with her speech.  Mom relates that she may have ran a low grade fever but didn't check it with a thermometer just to her touch. Mom relates that she has had other shots in Saudi Arabia but unable to get any shot record.  Shots have been started in September 21st 2015. with most of the same shots given then.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Vomiting
Clinical narrative: After patient receive meningococcal vaccine, she became pale, dizzy, diaphoretic, and nauseous.  She was placed in a recliner with her feet elevated and then proceeded to vomit up clear fluid.  Cool compress was applied to nape of neck and patient remained in recliner for 15 minutes.  Patient was placed in sitting position for several minutes without symptoms and then was able to stand without symptoms and ambulate out of the clinic area without further complications.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Erythema > 3in on 3/5/16 grew to include lower part of upper arm from elbow to axilla by 3/12/16.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anger, Irritability, Malaise, Pyrexia
Clinical narrative: Several hours after receiving the MMR Vaccine, he got fever, malaise, and irritability. The fever lasted about one day. The malaise lasted two days. For the next 10-14 days he was very irritable, it was difficult for him to cooperate, and he was angry. Usually, he is an enthusiastic, cooperative kid.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Mild fever, chills, and shaking for 30 minutes.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling hot, Injection site erythema, Injection site warmth, Pain, Rash
Clinical narrative: Started to feel warmth/rash same day of vaccine. just waited to see if it would resolve. Has gotten worse, traveled down outer arm to elbow. No fever no pain, just feels sore and warm to touch. No weakness of arm or restriction in movement. Skin:  right upper outer arm with erythema, no induration, warmth to touch nontender from lower deltoid to just above lateral epicondylar area.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Started to feel warmth/rash same day of vaccine. just waited to see if it would resolve. Has gotten worse, traveled down outer arm to elbow. No fever no pain, just feels sore and warm to touch. No weakness of arm or restriction in movement. Skin:  right upper outer arm with erythema, no induration, warmth to touch nontender from lower deltoid to just above lateral epicondylar area.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Oropharyngeal pain
Clinical narrative: Sore throat, headache, soreness at sight of injection.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on the arm of injection, covered lateral portion of upper arm from shoulder to elbow. Patient applied OTC hydrocortisone cream to the area and used oral loratadine 10mg for 15 days. Currently symptoms are improving but not completely resolved (4/5/2016).
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Pyrexia, Swelling face
Clinical narrative: Difficulty breathing, fast heartbeat, dizziness, high fever, swollen face.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Insomnia
Clinical narrative: Patient reported rash, severe pain, and swelling at injection site. She said that she was unable to sleep and missed appointments due to the severity of the pain.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt received PCV 13 injection yesterday from HC, redness/pain started 4 hours after visit on R deltoid injection site. No redness is noted, however, tender to touch 7/10 pain with localized swelling. Afebrile, temp 97.2F, no shortness of breath, no rash/hives, no other symptoms or complaints. Consulted POD, dispensed Ibuprofen 200mg 1-2 tabs q 4-6 hours, to take with food to reduce GI upset. Instructed pt to ice injection area for 20mins/hr until swelling/pain improves, icebag provided in clinic. Pt v/u, return precaution given if symptoms worsen.
Age: 17.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Seizure, Syncope
Clinical narrative: Patient fainted and seized for around 10-15 seconds following vaccinations.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Patient returned to pharmacy 12 days later for a prescription refill.  Through casual conversation, discovered patient incurred swelling of injection arm requiring emergency room visit.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Seizure, Tremor
Clinical narrative: 4 weeks ago my son present a symptoms like a fell down, temblors and dizzy. Now he have 2 seizures in one week. He never present this in the past and none family history with that.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Arthralgia, Burning sensation, Cough, Culture negative, Joint swelling
Clinical narrative: 10/26/15 tinnitus - referred to ENT. Burning in feet - started gabapentin 100mg. Joint pain. Patient words: coughing x 1 week ringing in ears and irritates me feet burn at night-visit 1 month ago was for blood in the urine. Note finished CIPRO-culture was neg-has not seen anymore blood. The patient is a 66 year old female who presents for a recheck of Diabetes. The patient was most recently seen 1 month ago. The patient checks their glucose never. Patient words: She went out to shovel some snow-moved get in firewood Sat-Sun with pain. Took ADVIL. The patient is a 66 year old female who presents with joint pain. Symptoms include joint pain and joint swelling. Symptoms are located in the neck, lower back, right knee and right foot. The patient describes the pain as aching. The patient describes this as worsening. Associated symptoms include muscle weakness. Current treatment includes non steroidal anti-inflammatory drugs.
Age: 66.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Tinnitus
Clinical narrative: 10/26/15 tinnitus - referred to ENT. Burning in feet - started gabapentin 100mg. Joint pain. Patient words: coughing x 1 week ringing in ears and irritates me feet burn at night-visit 1 month ago was for blood in the urine. Note finished CIPRO-culture was neg-has not seen anymore blood. The patient is a 66 year old female who presents for a recheck of Diabetes. The patient was most recently seen 1 month ago. The patient checks their glucose never. Patient words: She went out to shovel some snow-moved get in firewood Sat-Sun with pain. Took ADVIL. The patient is a 66 year old female who presents with joint pain. Symptoms include joint pain and joint swelling. Symptoms are located in the neck, lower back, right knee and right foot. The patient describes the pain as aching. The patient describes this as worsening. Associated symptoms include muscle weakness. Current treatment includes non steroidal anti-inflammatory drugs.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Full blood count normal, Herpes zoster
Clinical narrative: Developed shingles on 1/21/16.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Hyperhidrosis
Clinical narrative: Pt stated symptoms started 2 hours after PREVNAR injection. Patient drove himself home where patient had coughing episode and was sweating. Symptoms subsided on their own. Patient also had difficulty breathing. Patient is a smoker.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Information about their medical history, concurrent condition and concomitant medication were unspecified. On unknown dates, the patients were vaccinated with two of the improperly stored doses VARIVAX (Merck) (which had a lot # of L002871 and an expiration date of 27-JAN-2017; dose, dosage number, anatomical location and route of administration were unknown. The temperature excursion for the vaccine was 33 F for a time frame of 2 hours. It was also reported that there had been a previous excursion of 12 F for a time frame of 1 hour and the excursions were reported due to a data logger. However, no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Blood test normal, Gait disturbance, Injection site swelling, X-ray normal
Clinical narrative: Left thigh where received HepA vaccine swollen causing child to limp. On 4/1/16 vaccine site not identifiable - swelling from knee to groin. No warm, redness, tenderness or discharge.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swollen, pain w/ moving at injection site.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse, referring to a 12 year old, female patient. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On unknown dates the patient was vaccinated with the three dose series of GARDASIL (dose, route, lot # and expiration date were not reported). Then, on 01-SEP-2015, the patient was vaccinated with an additional dose of GARDASIL 9 by intramuscular route in the left arm (reported as LD), lot # K026247 (expiration date was not reported), because a company representative mistakenly told that it was the Centers for Disease Control and Prevention (CDC) recommendation. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information has been received.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Local reaction at injection site, including redness, swelling, tenderness, warmness, induration. No systemic symptoms.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Local reaction
Clinical narrative: Local reaction at injection site, including redness, swelling, tenderness, warmness, induration. No systemic symptoms.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Pain proximal deltoid/apex of shoulder x2 weeks thus far.