chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 59 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # M046373 and expiration date 04-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning RECOMBIVAX HB with lot # M046373. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009240 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009240 is being deleted from our files and the case is consolidated into case # 1711USA004093 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Developmental delay, Developmental regression
Clinical narrative: Regression and delay.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: Reaction is local to injection site, with no systemic reaction. A circular rash at the site of injection measuring 3.6 mm, Site is swollen & erythematous. Injection was given on 11/8/17. On 11/9/17 the patient noticed the rash. On 11/10/17 at time of my observation the rash is still present with the same symptoms listed above. The patient also complains to significant pain at site. Patient will apply ICE intermittently for the next several days & the rash will be monitored. FLUARIX was placed into patients chart as an allergy/adverse reaction & she was advised not to receive FLUARIX brand flu shots. Patient received a FLUZONE QUADRIVALENT during last years immunization, which she did not have any adverse reaction to.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Reaction is local to injection site, with no systemic reaction. A circular rash at the site of injection measuring 3.6 mm, Site is swollen & erythematous. Injection was given on 11/8/17. On 11/9/17 the patient noticed the rash. On 11/10/17 at time of my observation the rash is still present with the same symptoms listed above. The patient also complains to significant pain at site. Patient will apply ICE intermittently for the next several days & the rash will be monitored. FLUARIX was placed into patients chart as an allergy/adverse reaction & she was advised not to receive FLUARIX brand flu shots. Patient received a FLUZONE QUADRIVALENT during last years immunization, which she did not have any adverse reaction to.
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Cold sweat, Feeling hot, Flushing, Swelling face
Clinical narrative: Complaint of feeling hot and having back pain. Skin was flushed and face was puffy. Skin felt clammy. Tremor noted to upper extremities. Provider is located in clinic attached to nursing home and NP immediately arrived to assess resident. She was given diphenhydramine 25 mg IM. Symptoms resolved by 5:00 pm the same day.
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Complaint of feeling hot and having back pain. Skin was flushed and face was puffy. Skin felt clammy. Tremor noted to upper extremities. Provider is located in clinic attached to nursing home and NP immediately arrived to assess resident. She was given diphenhydramine 25 mg IM. Symptoms resolved by 5:00 pm the same day.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, UNK
Symptoms: Fatigue, Injection site warmth, Lethargy, Pain, Pyrexia
Clinical narrative: Broke out in a rash, burning hot in both legs and head about 102 fever, jolting out of her sleep at night screaming in pain as of 11/09/2017 starting approx. 10pm lasting until about 6am. Brought her to office to tell them what has been going on and was told the rash and fever would probably worsen. Treated with MOTRIN around 2pm after she seemed a little lethargic and exhausted. On 11/10/2017 at around 1am, was awoken with another high fever of 103. Was treated with MOTRIN at around 1:30am and cold cloth on her head fever finally went down around 2:30 am but legs were still hot. Still has rash on her body.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, UNK
Symptoms: Rash, Screaming
Clinical narrative: Broke out in a rash, burning hot in both legs and head about 102 fever, jolting out of her sleep at night screaming in pain as of 11/09/2017 starting approx. 10pm lasting until about 6am. Brought her to office to tell them what has been going on and was told the rash and fever would probably worsen. Treated with MOTRIN around 2pm after she seemed a little lethargic and exhausted. On 11/10/2017 at around 1am, was awoken with another high fever of 103. Was treated with MOTRIN at around 1:30am and cold cloth on her head fever finally went down around 2:30 am but legs were still hot. Still has rash on her body.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza, Malabsorption, Malaise, Oropharyngeal pain
Clinical narrative: About a week after receiving the flu shot, got sick with the flu. It lasted about 4 days. Fever, malaise, severe sore throat. Now I am sick again about a month later. Bad cough, fever, malaise. Taking lots of vitamins and tylenol, which seem to help some. For year when I was not forced to take the flu shot, and did not take it, I never got these symptoms. I am a very active, healthy person in general. I was forced to take the shot because of my work. Please do not force health care workers to take this ineffective, miserable shot. It should be against our rights to demand this.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: About a week after receiving the flu shot, got sick with the flu. It lasted about 4 days. Fever, malaise, severe sore throat. Now I am sick again about a month later. Bad cough, fever, malaise. Taking lots of vitamins and tylenol, which seem to help some. For year when I was not forced to take the flu shot, and did not take it, I never got these symptoms. I am a very active, healthy person in general. I was forced to take the shot because of my work. Please do not force health care workers to take this ineffective, miserable shot. It should be against our rights to demand this.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Rash, Skin warm, Sluggishness, Swelling
Clinical narrative: Rash/swelling/redness/hot to touch/sluggish for 2 days. Taken to urgent care for observation on 11/8 and was given Predisone and bendryl and facility and Rx for Cethalexin (if needed).
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Venous injury
Clinical narrative: Pain in upper right arm. Patient went to doctor and was told that a vein was hit.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction
Clinical narrative: 10/06/2017 - Charted by NP Local reaction to influenza vaccine, initial encounter It is interesting that with the timing, I would expect that this reaction would be closer to the injection site. However, the localized erythema noted is more distal to the injection site.  I am not 100% convinced that this is truly a reaction to the influenza vaccine and something much more coincidental, but just in case, when she obtains her influenza vaccine next year, she should stay in the clinic for 15-20 minutes post vaccine to make sure she does not have any kind of reaction. If she has a more severe reaction next year, then he we may have to list influenza vaccine as an allergy. In the meantime, patient is to ice the area for 10-15 minutes every 2-3 hours regularly for the next 24-48 hours. She should continue taking acetaminophen and should also take meclizine a bit more regularly if she is able. If she is not needing meclizine for dizziness, then she may take over-the-counter loratadine 1 daily as an antihistamine to help curb any type of reaction. Reviewed signs and symptoms of worsening conditions such as swelling, worsening pain, or worsening redness. The redness may get worse before it gets better, but it should improve or resolve within the next week. Patient verbalized understanding of instructions and plan.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Feeling hot, Paraesthesia
Clinical narrative: 20 minutes after receiving immunization, patient returned to nurses station stating that she felt warm and had a tingly sensation in her hands. VS were taken, all were within normal limits. Within 7 minutes patient began to complain of chest tightness. VS and lung sounds rechecked all within normal limits. Patient continued to complain of chest tightness. After physician evaluation, epinephrine 0.3mL was given intramuscular route. Patient symptoms improved slowly and were gone within 15 minutes after injection and oral fluids.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On an unknown date, the patient was vaccinated with M-M-R II (albumin status not provided) via the intramuscular route instead of the subcutaneous route for prophylaxis (dose, lot# and expiration date were no reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received on 24-JUL-2017 from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 08-MAY-2012, the patient was inoculated at a medical center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-SEP-2013, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages. and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses. and pain and suffering, and other damages. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, X-ray
Clinical narrative: Employee reports having pain in (R) arm. Called MD 2 wks. - used ice. Advised to call staff if still having pain - pain continued saw MD on 11/10/17 - xray ordered.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, FLU3, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Rash maculo-papular, Rash vesicular
Clinical narrative: Maculopapular vesicular rash to trunk. Fussy, low grade fever.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: Patient was administered a flu shot on Friday afternoon, October 13, 2017. Patient reported that he noticed a bruise on his arm about 3 inches below the injection site on Monday 10/16/17. He said the bruise started from the outside muscle to the inside muscle of his arm. He said he had seen his dermatologist, during a follow up appointment for another matter and the dermatologist said the bruise was caused by the flu shot. There was no pain and no tenderness. He stated that he did have some soreness a day or so after the vaccination.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Hypoaesthesia, Injection site warmth, Joint stiffness, Muscle tightness
Clinical narrative: States nothing happened immediately after receiving vaccination "just hurt like a normal shot". Reports that one week later her muscle and shoulder joint felt "tight", states "felt like a pulled muscle." Reported that after about 3 more weeks it got worse and "felt really tight" and "as if someone was putting a knife in my shoulder joint."  She reports still having pain. Has been taking ibuprofen 800 and using a heating pad. Reports "there was a yellowish bruise (sic) on the back of my shoulder". States pain is unbearable at times, feeling tingling and numbness and "hot to touch in the spot the shot was given" as of 11/9/2017. Has not been seen or evaluated by a physician.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia
Clinical narrative: States nothing happened immediately after receiving vaccination "just hurt like a normal shot". Reports that one week later her muscle and shoulder joint felt "tight", states "felt like a pulled muscle." Reported that after about 3 more weeks it got worse and "felt really tight" and "as if someone was putting a knife in my shoulder joint."  She reports still having pain. Has been taking ibuprofen 800 and using a heating pad. Reports "there was a yellowish bruise (sic) on the back of my shoulder". States pain is unbearable at times, feeling tingling and numbness and "hot to touch in the spot the shot was given" as of 11/9/2017. Has not been seen or evaluated by a physician.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Cellulitis in left bicep at 24 hours; extreme redness, swelling at 48 hours. Intravenous antibiotic administered at Hospital 11/3, followed up with 10 days of AUGMENTIN (125 MG 2x daily). Redness lightened w/in 24 hours, swelling and pain persisted through 11/8/2017. Very faint redness and soreness a/o 11/10/2017.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Injection site swelling, Joint range of motion decreased
Clinical narrative: PAIN, LIMITED RANGE OF MOTION, SWELLING AT INJECTION SITE AND ENTIRE UPPER ARM.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Mother reports that evening she put the child to bed and later noted on her video baby monitor it appeared the child was "gasping for air". She picked her up and her breathing returned to normal. She laid the child back down and shortly after it began again. This time she noticed wheezing so she took the child to the ER where they gave her "steroid" breathing treatments and monitored her overnight. Told her the child may have asthma. No further episodes. The child did not have any rash, hives, fever, or obvious lip/tongue swelling.
Age: 46.0
Sex: F
Vaccine: FLUR3
Symptoms: Flank pain, Injection site pain, Oral cavity fistula, Pain in extremity
Clinical narrative: After obtaining flu shot my arm radiating up to my left side was hurting and a hole formed on side of mouth which has to be closed on 11/6/17.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Ear discomfort, Eating disorder, Injection site rash, Insomnia, Pyrexia
Clinical narrative: Patient developed fever of 102 degrees F the day after vaccine administration. Also developed runny nose, ear pulling, trouble eating and sleeping, and brownish rash on right leg, upper back, and face. The fever continued for 4 days and then developed a rash all over the body.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rhinorrhoea
Clinical narrative: Patient developed fever of 102 degrees F the day after vaccine administration. Also developed runny nose, ear pulling, trouble eating and sleeping, and brownish rash on right leg, upper back, and face. The fever continued for 4 days and then developed a rash all over the body.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Loss of consciousness, Tension, Tremor, Unresponsive to stimuli
Clinical narrative: On October 24th, 2017, at approximately 9:45am, I met with patient, a student, to administer a flu vaccine. The parental consent form was present and verified. Patient states he had received the vaccine in the past and was "nervous" to receive another one. The flu vaccine was administered as ordered in the patient's right deltoid. Immediately following the injection, patient tensed his whole body, lost consciousness, had tremors and was unresponsive. I placed patient on the floor and checked that he was breathing and had a pulse - bother were present. This lasted for approximately 30 seconds and patient opened his eyes, tried to sit up and he lost consciousness again. Employee was present and went to retrieve the school nurse. Vital signs were checked by the school nurse and were stable. EMS was also activated. Police and Fire, along with paramedics responded. Patient's mom was called and present at the school. Patient was alert and oriented and transported via ambulance to emergency room per his mother's request.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of hives in a 11-year-old female patient who received BOOSTRIX (batch number 7Y29Z, expiry date 17th August 2019). Concomitant products included MENACTRA. On 4th August 2017, the patient received BOOSTRIX. On 5th August 2017, 1 days after receiving BOOSTRIX, the patient experienced hives. On 6th August 2017, the outcome of the hives was recovered/resolved. The reporter considered the hives to be possibly related to BOOSTRIX. Additional details were reported as follows: The patient received BOOSTRIX in the left deltoid. On the same day, the patient received MENACTRA concomitantly. The patient came a day before reporting on 1st November 2017, for a doctor visit and the patient's mother stated that, the patient experienced hives on her abdominal wall after 24 hours receiving the vaccines. The patient recovered from hives after 24 hours. No additional information was provided.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Axillary pain, Cellulitis, Erythema, Musculoskeletal pain, Peripheral swelling
Clinical narrative: Patient states that she was given both shots in the upper right arm. Both were given through the same inject safe barrier bandage. Next morning patient's arm was red, hot and swollen, area of swelling and erythema continued to expand over the next 24 hours with pain extending up into shoulder and axilla, today a new area of erythema on shoulder and fever of 101. Being tx with clindamycin for cellulitis. Patient is allergic to cephalosporins. Concern that injection given through a bandage and both injections given in same arm it will be impossible to determine cause of the cellulitis. Patient had injections at pharmacy. Pharmacist there was called, very rude and we were not given the lot numbers and expiration dates. This is the second case of cellulitis I have seen in urgent care in less than a week. Both cases have had quadrivalent flu and PNEUMOVAX 23 given the same day. Both done by pharmacies.
Age: 49.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient states that she was given both shots in the upper right arm. Both were given through the same inject safe barrier bandage. Next morning patient's arm was red, hot and swollen, area of swelling and erythema continued to expand over the next 24 hours with pain extending up into shoulder and axilla, today a new area of erythema on shoulder and fever of 101. Being tx with clindamycin for cellulitis. Patient is allergic to cephalosporins. Concern that injection given through a bandage and both injections given in same arm it will be impossible to determine cause of the cellulitis. Patient had injections at pharmacy. Pharmacist there was called, very rude and we were not given the lot numbers and expiration dates. This is the second case of cellulitis I have seen in urgent care in less than a week. Both cases have had quadrivalent flu and PNEUMOVAX 23 given the same day. Both done by pharmacies.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cold sweat, Feeling abnormal, Feeling cold, Hypoaesthesia oral
Clinical narrative: Employee received the flu vaccine at flu clinic being held for employees at the Medical Center by the Employee Health Team. She did report some localized itching at injection site last year after receiving the vaccine, so she was asked to stay and be observed by an RN after today's injection for at least 10 minutes. While under observation following  her vaccine on 11/8/17, employee reported some localized "itching" at the injection and arm feeling :heavy and weird" site within 10 minutes of getting injection. Area was inspected by Employee Health RN and found to be normal, with no redness or erythema noted. VS were taken by RN at that time and were as follows: 122/82, AP 80 and regular, RR 20. Pale color, hands clammy. Denied shortness of breath and was not diaphoretic. Benadryl 25 mg administered by RN per protocol, which did cease itching within 20 minutes, however, employee began to describe additional symptoms such as: being cold, pins and needle sensation in affected arm and feet bilaterally and numbness in mouth. She also began to describe c/o "tightness" in chest area at which time she was transported to ED at Medical Center for further evaluation and treatment.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site reaction, Limb discomfort, Pallor, Paraesthesia
Clinical narrative: Employee received the flu vaccine at flu clinic being held for employees at the Medical Center by the Employee Health Team. She did report some localized itching at injection site last year after receiving the vaccine, so she was asked to stay and be observed by an RN after today's injection for at least 10 minutes. While under observation following  her vaccine on 11/8/17, employee reported some localized "itching" at the injection and arm feeling :heavy and weird" site within 10 minutes of getting injection. Area was inspected by Employee Health RN and found to be normal, with no redness or erythema noted. VS were taken by RN at that time and were as follows: 122/82, AP 80 and regular, RR 20. Pale color, hands clammy. Denied shortness of breath and was not diaphoretic. Benadryl 25 mg administered by RN per protocol, which did cease itching within 20 minutes, however, employee began to describe additional symptoms such as: being cold, pins and needle sensation in affected arm and feet bilaterally and numbness in mouth. She also began to describe c/o "tightness" in chest area at which time she was transported to ED at Medical Center for further evaluation and treatment.
Age: 70.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pt states no pain at time of injection for the PNEUMOVAX but that later at night he developed severe pain in bicep/shoulder/neck and head 9-10 on pain scale. He used ice and ibuprofen and in the morning the pain went down to 6-7.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Patient reported intern gave her the vaccine "higher than previous vaccines" and that she was still experiencing pain in her arm. Patient is waiting to see if it resolves on its own in a few days, may seek medical treatment.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Extrapyramidal disorder, Febrile convulsion, Headache, Pyrexia, Unresponsive to stimuli
Clinical narrative: 4 year old boy had classic febrile seizure consisting of one minute of shuddering  and unresponsiveness followed by 15 minutes being subdued (per mother, it was midnight) which occurred 30 minutes after she called about a high fever (Tmax 105 degrees per mom) and child complained of headache,  and administered 5 mL = 100 mg ibuprofen on my instructions. Child's weight is 14.8 kg (very small four year old). Spoke to mom in follow up the next morning, child did well the rest of the night. Complained once of headache after he woke up (this is not a normal complaint for him), Temp was 99 degrees F with no further antipyretic. Completely back to baseline at 10 AM on 11/10.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: ARMS SWOLLEN AND PAIN RADIATES FROM MUSCLE TO FOREARM.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain
Clinical narrative: Patient states that starting on 11/9/17 at 3pm ish she started to feel aches and significant pain in her core area, she took an aspirin and TYLENOL powder at 3:15ish it helped but did not take her pain away completely. She contacted me at 9:15 am on 11/10, and said she has been taking the aspirin/TYLENOL powder every 4 - 6 hours but still having some pain.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Itching on the site of injection then spread to anterior chest wall and one welt of the body.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 16-month-old patient, who on 28-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 476 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA007325.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 6-month-old patient, who on 31-JUL-2017, received a dose of improperly stored LIQUID PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 476 hours. This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1709USA012770: US-009507513-1709USA012767.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 17 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 05-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a physician refers to an 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 05-JUL-2017, the patient was vaccinated with an improperly stored GARDASIL 9 lot # M043731, expiry date 22-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 06-NOV-2017 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration unknown), subcutaneous on or about 09-OCT-2012 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-APR-2016, the patient was treated by a nurse practitioner at a medical center, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gabapentin (NEURONTIN) and valacyclovir hydrochloride (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 16-MAR-2012, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-JUN-2015, she was treated by a physician at a healthcare facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The female patient has been prescribed valacyclovir (VALTREX) for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX.   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 18-JUN-2012, the patient was inoculated at a medical center with ZOSTAVA) (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2015, the patient was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her continued painful symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages. and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses. and pain and suffering, and other damages. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: On 11/10/2017 the patient reported the following reactions. She stated on the morning after receiving her vaccination, she experienced significant swelling in her right arm, hand and fingers. She reported the swelling was severe enough for her not to wear her rings. She did not seek medical attention, and the reaction subsided after a few days. She also detailed severe redness at the injection site.
Age: 0.75
Sex: F
Vaccine: FLU4
Symptoms: Injection site abscess, Injection site discharge, Injection site erythema, Injection site swelling, Staphylococcus test positive
Clinical narrative: Abscess on right thigh. Received Flu shot on 10/20/17 and as per mom there was redness and swelling at the site, she called and was told to apply Mupirocin, it improved and there was no pus discharge, but it started draining again yesterday when she called and was started on oral antibiotic.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Redness, swelling, warmth to arm.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Mother reported the next day, child had fever body aches. Also, had warm red swelling around injection site.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Headache, Hyperhidrosis, Presyncope
Clinical narrative: Near syncopal episode, diaphoretic and headache a bit sat down and then recovered quickly.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort, Pyrexia
Clinical narrative: Fever to 101 during the evening of flu imm. No headache. C/O back discomfort.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash generalised
Clinical narrative: 11-7-17 10:30 pm itching, rash, all over body.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Redness, swelling, circled at 16 cm (by Mom) per Mom's report.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Blood pressure increased, Chills, Dyspnoea, Eye pruritus
Clinical narrative: I had trouble breathing -- ASTHMATIC reaction to injection. I also had lesser symptoms which apparently are "normally expected":  increased blood pressure, increased heart rate, fever, chills, itchy runny eyes, severe headache. Asthma lasted for 2 hours; other reactions lasted much longer -- 2 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Heart rate increased, Lacrimation increased, Pyrexia
Clinical narrative: I had trouble breathing -- ASTHMATIC reaction to injection. I also had lesser symptoms which apparently are "normally expected":  increased blood pressure, increased heart rate, fever, chills, itchy runny eyes, severe headache. Asthma lasted for 2 hours; other reactions lasted much longer -- 2 days.
Age: 39.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Axillary pain, Breast pain, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Employee recieved Flu and vzv in Right arm and Hep B, MMR and PPD on left arm. On evening of injection date 10/24/17 ee began to feel sore, injection site on right arm was red, warm and swollen to touch. Employee also experienced pain into her right axialla and right breast. I spoke with employee Friday 10/26/17 who reported sx's mostly subsided. No more pain into axilla or breast, injection site still was slightly red and swollen.
Age: 39.0
Sex: F
Vaccine: FLU4, HEP, MMR, VARCEL
Symptoms: Pain
Clinical narrative: Employee recieved Flu and vzv in Right arm and Hep B, MMR and PPD on left arm. On evening of injection date 10/24/17 ee began to feel sore, injection site on right arm was red, warm and swollen to touch. Employee also experienced pain into her right axialla and right breast. I spoke with employee Friday 10/26/17 who reported sx's mostly subsided. No more pain into axilla or breast, injection site still was slightly red and swollen.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Cellulitis
Clinical narrative: Patient's mother claims that he now has cellulitis due to vaccine.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Starting 11/3/17 (one day after vaccine administration), patient had significant swelling on her vaccinated arm from shoulder down to the wrist. All symptoms have recovered as of 11/5/17.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Developed erythema and induration and warmth and tenderness and edema R lateral arm - started about 24h after imz but worsened significantly between 24-48h.  diagnosis: cellulitis.  treated with clindamycin.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site warmth
Clinical narrative: Developed erythema and induration and warmth and tenderness and edema R lateral arm - started about 24h after imz but worsened significantly between 24-48h.  diagnosis: cellulitis.  treated with clindamycin.
Age: 70.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: Patient reports pain in arm starting the day he received the vaccine. Describes it as sore to touch and when not being touched a persistent ache like a minor toothache.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Blood test normal, Computerised tomogram normal, Gait inability
Clinical narrative: I had the shot at 8:00 am at work. By 12:00 pm I started feeling a pain in my back. By the following morning I was unable to walk upright. Had severe pain on my right side front to back. Went to Dr. office who ordered blood work and a CAT Scan thinking appendicitis or kidney stone. Both came up negative. The pain became more centric to the lower back to hip. The pain persisted and Dr. had me admitted to the hospital where I stayed for 4 days. The pain slightly improved but was still unable to walk upright. Three weeks later I have improved to the point where I can stand upright and walk short distances. It is important to note that I am a very healthy 66 year old who went to the gym 3-4 times a week with virtually no symptoms prior to the shot.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal abnormal, Spinal column stenosis, X-ray normal
Clinical narrative: I had the shot at 8:00 am at work. By 12:00 pm I started feeling a pain in my back. By the following morning I was unable to walk upright. Had severe pain on my right side front to back. Went to Dr. office who ordered blood work and a CAT Scan thinking appendicitis or kidney stone. Both came up negative. The pain became more centric to the lower back to hip. The pain persisted and Dr. had me admitted to the hospital where I stayed for 4 days. The pain slightly improved but was still unable to walk upright. Three weeks later I have improved to the point where I can stand upright and walk short distances. It is important to note that I am a very healthy 66 year old who went to the gym 3-4 times a week with virtually no symptoms prior to the shot.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 6-month-old patient, who on 05-AUG-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 492 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA007325.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 4-month-old patient, who on 09-AUG-2017, received a dose of improperly stored LIQUID PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent a temperature excursion of 32-49 degrees Fahrenheit for 492 hours. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012767: US-009507513-1709USA012768: