chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 15-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 360 hours, the lowest recorded temperature was 20F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from a female physician via a company representative of unknown age refers to herself. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX, subcutaneously (dose, lot# and expiration date were not reported) in arm. On an unknown date, the patient's arm got red and swollen from the injection site to the elbow. The outcome of events was reported as recovered on an unspecified date. The causality was not reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 30-AUG-2016, the patient was vaccinated with ZOSTAVAX (lot # L046893, expiry date: 23-FEB-2017), administered per subcutaneous route. Concomitant therapies were not informed. It was reported that the patient did not receive the full dose of ZOSTAVAX due to leakage around the needle. No adverse effects reported. Follow up information has been received from a pharmacist on 18-OCT-2016. It was informed that the report was concerning a 67 years old male patient. Regarding the vaccination, it was stated that the patient was vaccinated in the right deltoid and that the vaccine was purchased with private funds. Finally, it was reported that the syringe leaked minimally and that the vaccine was injected. Additional information is not expected as the follow up information required was received.
Age: 67.0
Sex: U
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 67 years old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not informed. On 14-OCT-2016 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # M032360, expiration date 18-AUG-2017, 0.65 ml administered once per subcutaneous route due a patient request. On the same date, the patient was vaccinated with a dose of pneumococcal vaccine (manufacturer unknown), lot # reported as N34936, expiration date October of 2017, (dosage was not provided), administered per intramuscular route. Concomitant therapies were not informed. It was reported that on unspecified date in October of 2016, reported as "unspecified onset", the patient experienced an injection site reaction described as: "redness, pain and swelling" (injection site erythema, injection site pain and injection site swelling). It was also informed that the patient sought medical attention by contacting the pharmacist and he states that the patient was prescribed treatment of "take TYLENOL and apply Hydrocortisone cream to reduce swelling at the injection site". The outcome of the adverse events was reported as not recovered at the time of the report. The causality relationship between ZOSTAVAX, pneumococcal (manufacturer unknown) and the adverse events was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Insomnia, Mobility decreased, Pain
Clinical narrative: Worsening soreness (R) shoulder. Difficulty moving shoulder/sleeping secondary to pain.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: 1 day after vaccine arm was swollen hard, red, painful and hot from shoulder to elbow.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Induration, Limb discomfort
Clinical narrative: Pt reported left arm feeling heavy, itchy, hard hot. Pt also reported having chest pain, and shortness of breath. (Late evening day after vaccine 10/21/16). Pt. called 911 a EKG was done. Pt was given aspirin. Pt was taken to ER. Pt. followed up with PCP 10/28/16 and reported ER visit.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Skin warm
Clinical narrative: Pt reported left arm feeling heavy, itchy, hard hot. Pt also reported having chest pain, and shortness of breath. (Late evening day after vaccine 10/21/16). Pt. called 911 a EKG was done. Pt was given aspirin. Pt was taken to ER. Pt. followed up with PCP 10/28/16 and reported ER visit.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Mom reports non stop crying x increased 8 degrees after vaccines. TYLENOL not effective. Went to ER but was not seen as had calmed by the time they arrived.
Age: 88.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Daughter called said mom had Rxn to shot at the site -swollen, red, elevated, hot to touch and painful. M.D. prescribed antibiotic, oral steroid and antihistamine. (If gets worse MD told pt to go to hospital. Pt. Daughter called 10/27/16 9pm).
Age: 1.0
Sex: U
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-JUN-2016, the patient was vaccinated with improperly stored VAQTA (lot # L048456, expiration date: 25-MAY-2017; dose and route of administration were not provided). On the same day, the patient was also vaccinated with M-M-R II, VARIVAX and PREVNAR. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 82 year old male patient. The medical history, concurrent conditions and concomitant medications were none. On 22-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M020521, 17-NOV-2017, 0.5 ml, intramuscular. On 23-OCT-2016, the patient developed a bump 2 inches below the PNEUMOVAX 23 site. No treatment was rendered for the event. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Local swelling
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 82 year old male patient. The medical history, concurrent conditions and concomitant medications were none. On 22-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M020521, 17-NOV-2017, 0.5 ml, intramuscular. On 23-OCT-2016, the patient developed a bump 2 inches below the PNEUMOVAX 23 site. No treatment was rendered for the event. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: 6VAX-F
Symptoms: Decreased appetite, Irritability, Pyrexia, Seizure
Clinical narrative: Seizures ×3+, admission to hospital, fever, anorexia, irritability.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Hot flush, Insomnia, Sleep disorder
Clinical narrative: Hot flashes keeping me awake all night, insomnia, sleep medication works very little.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Arthralgia, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: Slight fever, difficult catching breath, projectile vomiting, whole body aches, joint pain, headache.
Age: 11.0
Sex: M
Vaccine: IPV
Symptoms: Vomiting projectile
Clinical narrative: Slight fever, difficult catching breath, projectile vomiting, whole body aches, joint pain, headache.
Age: 69.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Abnormal behaviour, Feeling drunk, Pain in extremity, Pyrexia
Clinical narrative: Patient reports being delirious the day after receiving the immunizations. She had a fever, was driving like she was drunk, pulled into her neighbors driveway instead of own, and tore apart her house looking for a "piece for her internet." This included removing the dishwasher from the wall. These symptoms lasted less than 24 hours. However, she reports her right arm is still having pain with movement.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Headache, Injection site erythema
Clinical narrative: Light headed, dizzy, briefly lost consciousness, bad headache, stomach ache, weakness, at site of injection and 4 inches below she had inflamed, red, hot skin that was hard.
Age: 7.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Injection site inflammation, Injection site warmth, Loss of consciousness
Clinical narrative: Light headed, dizzy, briefly lost consciousness, bad headache, stomach ache, weakness, at site of injection and 4 inches below she had inflamed, red, hot skin that was hard.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, hardness, and warm to the touch at injection site 1 week after injection. Has not tried to self treat yet.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Severe soreness about an inch below the injection site.  Then redness about the size of a lemon that spread around the arm down to the elbow over the next 2 days.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain and inability to lift arm. Pain resolved in 3 days.
Age: 68.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Erythema, Inflammation, Pain, Pruritus
Clinical narrative: Large red, inflamed area. Itching and painful area.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Started out as quarter sized red spot at vaccine spot (Shingles vaccine.). It got bigger and by Friday, 10/28, it was red, swollen, and I could feel a lump. It started itching 10/29. And it's sore to the touch.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site erythema, Injection site urticaria
Clinical narrative: Large welt 1 and a half incest at injection site discomfort and then redness 3 inches round.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Rash, Rash erythematous
Clinical narrative: Patient started to feel muscle pain at the upper part of the injected arm and it was getting worse till today (10/29) when she contacted the pharmacy. No treatment was done. She also noticed red raised rash on both sides of her neck about 10 days after the shot and the rash is getting better now.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Sore arm muscle at injection site, still, 19 days later.  It's limiting the motion of my left arm.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT HAD SWELLING OF SHOT AREA WITH REDNESS AND SOME WARMTH. PT APPLIED ICEPAK AND SOME BENADRYL ALSO SUGGESTED SOME IBUPROFEN.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Myositis, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Developed left calf pain morning of 10/21 which continued to worsen. Swelling started slightly later that day and worsened. Low grade fever started 10/24. Admitted 10/25 when she could not bear weight at all. Was seen in ED 10/23 with nl CBC and ESR, slightly high CRP, nl CK, nl Doppler ultrasound of calf and sent home.  Was seen in office 10/24, refused ED return.  Seen again in office again 10/25, had xray (nl bone, +soft tissue swelling) and admitted to hosp.  STat MRI showed myositis (ESR up to 35). IV clindamycin started and responded well with discharge 24 hours later.  generalized hives on day 3 prompted antibiotic change to Bactrim and cefdinir.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Soft tissue swelling, Swelling, Ultrasound Doppler normal
Clinical narrative: Developed left calf pain morning of 10/21 which continued to worsen. Swelling started slightly later that day and worsened. Low grade fever started 10/24. Admitted 10/25 when she could not bear weight at all. Was seen in ED 10/23 with nl CBC and ESR, slightly high CRP, nl CK, nl Doppler ultrasound of calf and sent home.  Was seen in office 10/24, refused ED return.  Seen again in office again 10/25, had xray (nl bone, +soft tissue swelling) and admitted to hosp.  STat MRI showed myositis (ESR up to 35). IV clindamycin started and responded well with discharge 24 hours later.  generalized hives on day 3 prompted antibiotic change to Bactrim and cefdinir.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria, Weight bearing difficulty, X-ray normal
Clinical narrative: Developed left calf pain morning of 10/21 which continued to worsen. Swelling started slightly later that day and worsened. Low grade fever started 10/24. Admitted 10/25 when she could not bear weight at all. Was seen in ED 10/23 with nl CBC and ESR, slightly high CRP, nl CK, nl Doppler ultrasound of calf and sent home.  Was seen in office 10/24, refused ED return.  Seen again in office again 10/25, had xray (nl bone, +soft tissue swelling) and admitted to hosp.  STat MRI showed myositis (ESR up to 35). IV clindamycin started and responded well with discharge 24 hours later.  generalized hives on day 3 prompted antibiotic change to Bactrim and cefdinir.
Age: 10.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, fever to 101, headache, myalgias--treated with ibuprofen.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Feeling abnormal, Immune system disorder, Injection site pain, Pain
Clinical narrative: My entire body hurt especially my right arm where the flu and pneu shots were given. The pain is excruciating and I sleep very little. I am writing this on the 3rd day of the vaccine. I have gotten no relief despite the heavy painkillers (Aleve) I am taking. I called my geriatic physician on Friday but their phone system was messed up. It is Saturday now one fifteen in the afternoon. Not only do I hurt physically but it feels like my entire immune system has deteriorated. No energy and just feeling horrible.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Sleep disorder
Clinical narrative: My entire body hurt especially my right arm where the flu and pneu shots were given. The pain is excruciating and I sleep very little. I am writing this on the 3rd day of the vaccine. I have gotten no relief despite the heavy painkillers (Aleve) I am taking. I called my geriatic physician on Friday but their phone system was messed up. It is Saturday now one fifteen in the afternoon. Not only do I hurt physically but it feels like my entire immune system has deteriorated. No energy and just feeling horrible.
Age: 1.25
Sex: M
Vaccine: DTAP, FLUX, VARCEL
Symptoms: Myositis
Clinical narrative: Benign acute childhood myocitis, onset 10/25 afternoon, worsened through 10/27, gradually improved starting AM 10/28, no further symptoms by AM 10/29.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Marked swelling, redness, and itching of left arm from shoulder to elbow (injection was in left deltoid). Some pain, but mostly itching.  No fever, no trouble breathing, no vomiting.  Otherwise acting well.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Red, raised ring around injection site along with fever.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling cold, Influenza like illness, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Flu like symptoms including fever, runny nose, aches, chills.
Age: 35.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Anosmia, Nasopharyngitis, Nerve injury, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Cold like symptoms: congestion, runny nose followed by long term (continuous) inability to smell (nerve damage).
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Paraesthesia, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: She stated that her arm got swollen and warm and tingled all down her arm with a huge itchy red area.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Flushing, Muscle spasms, Urticaria
Clinical narrative: Patient's face was flushed, had red hives on arms and legs and complained of back spasms.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Pyrexia, Skin warm, Swelling
Clinical narrative: Patient states swelling/redness/warmth began appearing on her left arm a few days ago, almost a week after receiving her vaccination.   Patient states that it is warm to the touch.  I drew a margin around the red area and instructed her to take ibuprofen 800 mg po q6h wf for the pain and inflammation.  At this time the patient was not running a fever; I instructed her to see a physician if the margin extended outside the sharpie line or if she began running a fever.  I told her I was concerned that she may have a secondary infection from the vaccination despite following sanitary protocol.  Later in the day I received a prescription for cephalexin 500 mg q6h x 10d.  The patient returned to the pharmacy for her prescription same day and stated she had begun to run a fever >100.  I instructed her to take one tablet now (4pm) to get the medication started and one before bed with food.  I will follow up with the patient; patient is in good spirits despite the complication.
Age: 70.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Arm pain, soreness, weakness and diminished arm use.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: VET RECEIVED PNEUMONIA SHOT 8/2/16 AND HER ARM WAS SWOLLEN, HOT, SORE TO TOUCH.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pain/soreness in injection site area lasting around 4 weeks. Patient didn't report till 10/29/16.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Tunnel vision
Clinical narrative: Patient felt faint (saw tunnel vision)  patient immediately returned to pharmacy and sat for 15-20 min patient was offered water and cookies.  After the resting time, patient felt fine. Advised patient to come back to pharmacy if he felt faint again.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: SIGNS AND SYMPTOMS: RASH, HIVES, REDNESS ON FACE. TIME COURSE: 10/27/16 UPTO 10/29/16.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Bronchiolitis, Oxygen saturation decreased, Pneumonia, Respiratory syncytial virus infection
Clinical narrative: My child's oxygen regressed to 86 percent on his stats, his temperature went up to 104.0, he was screaming without stopping for 4 hours straight, and this all started within a few hours of him getting a full dose of vaccines.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Respiratory syncytial virus test, Screaming
Clinical narrative: My child's oxygen regressed to 86 percent on his stats, his temperature went up to 104.0, he was screaming without stopping for 4 hours straight, and this all started within a few hours of him getting a full dose of vaccines.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal discomfort, Musculoskeletal stiffness, Myalgia
Clinical narrative: PATIENT REPORTS SORNESS & MUSCLE STIFFNESS.  WHEN ASKED STATES DID NOT LOSE RANGE OF MOTION, BUT MOTION WAS UNCOMFORTABLE IN LEFT ARM/SHOULDER.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient reports redness and swelling at injection site.  Patient also reports injection site is hot to the touch.  Patient also reports fever.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Asthenia, Balance disorder, Dizziness, Hypoaesthesia
Clinical narrative: I am an RN and have been vaccinated for influenza for the past 20+ years.  I've never had a reaction to a vaccine.  Forty five minutes after receiving this vaccine I walked out to my car and noticed that my vision was blurred and I felt like I was off balance.  I had numbness to my face and down my arms.  I then began to feel dizzy, nauseated & weak with a strange "impending doom" feeling.  I sat down in my car and considered going back into the emergency room where I work.  But I thought, could this all be in my head?  So I started driving home but had to pull over twice on the way because I almost passed out.  The symptoms lasted another 6 hours after I returned home.  I did not see a doctor for these symptoms, and they eventually resolved.  It was definitely an unpleasant experience.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vision blurred
Clinical narrative: I am an RN and have been vaccinated for influenza for the past 20+ years.  I've never had a reaction to a vaccine.  Forty five minutes after receiving this vaccine I walked out to my car and noticed that my vision was blurred and I felt like I was off balance.  I had numbness to my face and down my arms.  I then began to feel dizzy, nauseated & weak with a strange "impending doom" feeling.  I sat down in my car and considered going back into the emergency room where I work.  But I thought, could this all be in my head?  So I started driving home but had to pull over twice on the way because I almost passed out.  The symptoms lasted another 6 hours after I returned home.  I did not see a doctor for these symptoms, and they eventually resolved.  It was definitely an unpleasant experience.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Began with severe arm pain, redness, swelling, warmth around injection site about 2 hours after receiving vaccine. Symptoms diminished slightly over the next few days but redness and warmth spread around arm and down to elbow. Over a week after receiving the vaccine arm is still quite painful and shoulder is hurting quite a bit. Painkillers do not seem to help. Been getting vaccines my whole life and never had a reaction like this. If I react at all, symptoms have always been gone within two days.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Erythema multiforme, Pyrexia
Clinical narrative: Fever, Erythema multiforme.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Pallor, Visual impairment
Clinical narrative: The patient was faint, light headed, and extremely pale. She complained of vision changes and excessive sweating.  She did not have seem to have any difficulty breathing. This event lasted about 5 minutes in duration.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient reported lightheadedness and nausea directly following administration of AFLURIA PF. Patient appeared nervous and tense before and during administration of the shot. Water was offered to the patient, which he accepted, and after resting for 5-10 minutes, the patient said he felt better and left.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blister, Cellulitis, Erythema
Clinical narrative: A few days after receiving vaccines, her left arm began to turn red. It slowly blistered and she went to the hospital. Hospitalist diagnosed her with cellulitis.
Age: 49.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Arthralgia, Bone pain, Headache, Sleep disorder
Clinical narrative: Severe bone and joint pain, headache,woke me up. Treated with 800mg ibuprofen -pain went from 8 on 1-10 scale to 5.
Age: 59.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Injection site ulcer, Ulcer
Clinical narrative: Day after vaccine administration, patient noticed sores at ZOSTAVAX injection site and upper chest, near neck. Used cold compresses and BENADRYL cream. Came into pharmacy two weeks later and sores crusted over, no pain.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Pt. received PREVNAR 13 on 10/23/16. He presented on 10/29/16 with redness on his Rt arm from just below shoulder to about two inches above his elbow. He reported itching. No swelling and no broken skin. Pt. was advised to take BENADRYL and follow up with MD on 10-31, or go to urgent care if it gets worse.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Skin warm
Clinical narrative: Patient's right arm was "red" and described as being "hot"; patient saw her physician and was prescribed an antibiotic.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Fall, Hypotension
Clinical narrative: Patient received a flu vaccine and fell while moving from the immunization room to the blood pressure machine. Blood pressure was low and had to go see the doctor. Blood pressure went up to 200 the night the vaccine was received.
Age: 42.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt's arm was swollen, red, hot to touch w/mild pain - mostly a few inches below injection site around elbow area.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: 3 inches x 3 inches very inflamed red, hot and painful. 2 days after vaccines. Advised OTC products and if gets worse patient is going to urgent care of ER.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt stated "uncomfortable at first, by 4 pm pain was worse, used heating pad around 11:30 pm on 10-27-16 to help with pain" described pain as "excruciating". By date of notification (10-29-16) pt states she can still do daily activities (i.e. play bridge, etc) and move - no discomfort but "feels abnormal". I examined (R) arm and it was definitely red around upper arm, slightly swollen, and warm to touch. Redness appeared 10-28-16 but states "getting better". Pt has not sought treatment but I encouraged follow up with MD on Monday.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-JUL-2014, the patient was vaccinated with a single dose of improperly stored PNEUMOVAX 23 and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 336 hours and then at 33 Fahrenheit (F) Degrees (0.555555556 Celsius) for a total of 1000 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 17-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 408 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 09-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medications provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 216 hours, the lowest recorded temperature was 20 F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1236 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, or concomitant medications were not reported. On 24-MAR-2014, the patient was vaccinated with a dose of PNEUMOVAX 23 2.5 ml, five dose vial, (lot number J004332, with an expiration date of 26-SEP-2014) (route and anatomical location of administration were not reported) that was improperly stored. The lowest temperature excursion was of 32 Fahrenheit (F) (0 Celsius) for a total of 72 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA "25U/0.5ml-SD LLok wCap Ped" which had a lot number L02259 and expiration date on 06-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an  unspecified date, the VAQTA vaccine had had two temperature excursions: one of 96 hours and other one of 360 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 18-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS-LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 32 F for 48 hours (lowest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 22-MAR-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 24 degrees C and 168 hours with 33 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 01-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5mL SD-PFS-LLok wTip" which had the lot # K009874 with expiration date on 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius)for 40 hours (highest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 20-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius) for 40 hours (highest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a patient (Encounter key # 106174) of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-JUL-2016, the patient was vaccinated with a dose of RECOMBIVAX HB, "10Pk 5 mcg/0.5 mL SDLLokCap Ped", lot # L016959, expiration date: 12-MAR-2018, (dose number and route of administration were unknown), which was improperly stored. On unspecified dates, the RECOMBIVAX HB vaccine had three temperature excursions of 0.55 Celsius Degrees (33 Fahrenheit) for 96 hours, 1.11 Celsius Degrees (34 Fahrenheit) for 528 hours and -0.55 Celsius Degrees (31 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as in excursion and the type of excursion and storage criteria were reported as refrigerator (R). No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 24-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 576 hours, the lowest recorded temperature was 20 F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 27-JUL-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had multiple excursions varying from 28.9 degrees Fahrenheit (-1.72 degrees Celsius) (lowest recorded temperature) for 48 hours to 64.8 degrees Fahrenheit (18.22 degrees Celsius) (highest recorded temperature) for 24 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 02-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 64 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter through a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 15-OCT-2014, the patient was vaccinated with VAQTA "25U/.5ML 10x1(ped), lot # J000985 with expiration date 20-AUG-2015 (route of administration unknown), which was stored at 1 Celsius Degrees for 48 hours. The storage criteria and the type of excursion was refrigerator (R) and the vaccine status was reported as "in excursion". There were no concomitant therapies and adverse effects reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 20-APR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10 PK SD-PFS LLok w Tip", lot # L007720 with expiration date 08-JUL-2016 (strength, dose and route of administration were not reported). No concomitant medications were not reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 192 hours with a lowest recorded temperature of 1 F (1 Celsius degree). There were also another excursions on unknown dates which lasted 100, 96, 24 and 24 hours with the lowest recorded temperatures of 34 F (1.111111111 Celsius degrees), -1 F (also reported as -1 Celsius degree), 0 F (also reported as 0 Celsius degrees) and 32 F (0 Celsius degrees), respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-OCT-2014, the patient was vaccinated with an unspecified stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 5520 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported and nor product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 01-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced two temperature excursions one of 48 hours and other of 40 hours. The lowest recorded temperature was 34 F (1.111111111 Celsius) and the highest recorded temperature was 47 F (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 15-DEC-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 11-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS-LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 504 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.