chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-JAN-2017, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # L037790, expiration date: 30-DEC-2016) (dose, route of administration and injection site were not provided). No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Oxygen saturation decreased, Panic attack
Clinical narrative: This spontaneous report was received from a currently 64 year old female patient, who was also a veterinarian reporting on herself. The patient's concurrent conditions included high blood pressure and heart problems. The patient's known allergies included sulfa allergy. Furthermore, the patient's medical history included brain surgery prior vaccination with PNEUMOVAX 23. The patient's concomitant therapies included an unspecified blood pressure medicine, ADVAIR, influenza virus vaccine and DECADRON. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. On an unknown date, after vaccination with PNEUMOVAX 23, the patient experienced a panic attack, trouble breathing and low oxygen levels (units not provided). Due to it, on an unknown date, the patient was hospitalized for 6 days, in which she received respiration therapy. Computed tomography (CT) scan, x rays and blood work were performed, however results were not provided. The patient also reported, she was not supposed to receive vaccines while on therapy with DECADRON. Furthermore, no product quality issue was involved. At the time of the report, the outcome of panic attack, oxygen saturation decreased and dyspnoea was reported as not recovered. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with PNEUMOVAX 23. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: X-ray
Clinical narrative: This spontaneous report was received from a currently 64 year old female patient, who was also a veterinarian reporting on herself. The patient's concurrent conditions included high blood pressure and heart problems. The patient's known allergies included sulfa allergy. Furthermore, the patient's medical history included brain surgery prior vaccination with PNEUMOVAX 23. The patient's concomitant therapies included an unspecified blood pressure medicine, ADVAIR, influenza virus vaccine and DECADRON. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly (anatomical route of vaccination, lot number and expiration date were not provided) for prophylaxis. On an unknown date, after vaccination with PNEUMOVAX 23, the patient experienced a panic attack, trouble breathing and low oxygen levels (units not provided). Due to it, on an unknown date, the patient was hospitalized for 6 days, in which she received respiration therapy. Computed tomography (CT) scan, x rays and blood work were performed, however results were not provided. The patient also reported, she was not supposed to receive vaccines while on therapy with DECADRON. Furthermore, no product quality issue was involved. At the time of the report, the outcome of panic attack, oxygen saturation decreased and dyspnoea was reported as not recovered. Additionally, the reporter did not provide for a causality between the adverse events and vaccination with PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/ allergies were reported. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (which had a lot # reported as M036616 with an expiration date of 19-NOV-2017; however, the dose, dosage number, route of administration, and anatomical location were unknown) for prophylaxis. No concomitant therapies were reported. Reportedly, the vaccine had experienced a temperature of 36 F to 46 F for a time frame of 2 hours. The call was made due to a data logger. Lot # M036616 was determined to not be valid lot number for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported  On 04-JAN-2017, the patient was vaccinated with expired a dose of ZOSTAVAX 0.65 ml, subcutaneously, lot number L037797, expiration date 30-DEC-2016. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown date in 2015 (reported as "2 years ago"), the patient received a dose of PNEUMOVAX 23 intramuscularly, for prophylaxis (the dose, anatomical location, lot # and expiration date were unknown). Subsequently, on 05-JAN-2017, the patient received another dose of PNEUMOVAX 23 (which had a lot # of M041686 with an expiration date of 20-MAY-2018; however, the dose, and anatomical location were not reported), intramuscularly, for prophylaxis as well. No concomitant therapies were reported as well. Despite this schedule of vaccinations, no adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength, dose number, lot number and expiration date were not provided) for prophylaxis. No adverse events reported. No product quality complaint was involved. The vaccines were improperly stored with a temperature of excursion of: >46°F (fahrenheit degrees) but < 77°F (fahrenheit degrees) during 16 hours. There were no previous temperature excursion. This is one of two reports received from the same reporter. Additional information is not expected, since no consent to contact the reporter was provided.; Sender's Comments: US-009507513-1701USA002524:
Age: 41.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site streaking, Tremor
Clinical narrative: Approximately 24 hours after vaccine had chills and shaking, also bad headache. Right arm/vaccine site was swollen with red streaks from it. To ER and was admitted for ABX and control of HA per pt.
Age: 41.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Vaccination site swelling
Clinical narrative: Approximately 24 hours after vaccine had chills and shaking, also bad headache. Right arm/vaccine site was swollen with red streaks from it. To ER and was admitted for ABX and control of HA per pt.
Age: 1.25
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Pt given 0.5ml dose of flu vaccine.
Age: 48.0
Sex: M
Vaccine: FLU4, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Feeling hot, Nausea, Pain, Pain of skin, Pyrexia
Clinical narrative: Pt. states that his skin is hurting like crazy. He states that he feels like his body is on fire. It is affecting his back, stomach, and legs. Per pt. he has no rash. Per pt. the pain is not at the site of the injections. Pt. states that he had a fever, nausea and vomiting, 3 or 4 days ago. Does not have these symptoms at the time of report, just the all over pain.
Age: 48.0
Sex: M
Vaccine: FLU4, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Pt. states that his skin is hurting like crazy. He states that he feels like his body is on fire. It is affecting his back, stomach, and legs. Per pt. he has no rash. Per pt. the pain is not at the site of the injections. Pt. states that he had a fever, nausea and vomiting, 3 or 4 days ago. Does not have these symptoms at the time of report, just the all over pain.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, VARCEL
Symptoms: Blister, Pyrexia, Scab
Clinical narrative: Vesicles on trunk and extremities that crusted, then cleared; assoc. with fever. Symptomatic care: Resolved without complication in about 1 week.
Age: 28.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: PATIENT SPIKED FEVER OF 102.2
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Skin rash very itchy.
Age: 1.58
Sex: F
Vaccine: MMR, MMR
Symptoms: Food intolerance, Urticaria, Vomiting projectile
Clinical narrative: Projectile vomiting immediately upon leaving clinic (while in parking lot), continued an additional 4-5x that day followed by the development of urticaria on and off for the next 3 days.
Age: 1.58
Sex: F
Vaccine: MMR, MMR
Symptoms: Allergy test, Urticaria, Vomiting projectile
Clinical narrative: Projectile vomiting immediately upon leaving clinic (while in parking lot), continued an additional 4-5x that day followed by the development of urticaria on and off for the next 3 days.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP, FLU4, HPV9, MNQ, TDAP
Symptoms: Full blood count, Rash, Rash generalised
Clinical narrative: MOTHER REFERS THAT PATIENT STARTED TWO DAYS AFTER VACCINATION WITH RASH ON FACE (1/03/2017). THE NEXT DAY SHE HAD RASH ALL OVER BODY AND MOTHER GAVE HER ZYRTEC. MOTHER REFERS THAT ON SUNDAY (1/8/2017) THE RASH WAS TOO MUCH FOR PATIENT AND TOOK HER TO A NEARBY HEALTH CLINIC, THE ATTENDING DOCTOR TOOK A CBC AND EXPLAINS TO MOTHER THAT THEY UNDERSTAND SHE HAD A REACTION TO THE VACCINES ADMINISTERED.
Age: 0.5
Sex: F
Vaccine: DTAP, FLUX, HEP, IPV, PPV, DTAP, FLUX, HEP, PPV
Symptoms: Abdominal discomfort, Abdominal pain, Constipation, Discomfort, Erythema
Clinical narrative: Hives, redness under eyes, abdominal pain, constipation for 5 days (no BM), followed by BMs with large globs of mucus, green BMs. Abdominal distress continued for a week. She was up hourly at night with discomfort.
Age: 0.5
Sex: F
Vaccine: DTAP, FLUX, HEP, IPV, PPV, DTAP, FLUX, HEP, PPV
Symptoms: Faeces discoloured, Middle insomnia, Mucous stools, Urticaria
Clinical narrative: Hives, redness under eyes, abdominal pain, constipation for 5 days (no BM), followed by BMs with large globs of mucus, green BMs. Abdominal distress continued for a week. She was up hourly at night with discomfort.
Age: 65.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a medical practice. This medical assistant reported similar events for 3 patients. This is the 1st of 3 reports.  A 65-year-old male patient received PREVNAR 13) Lot # N34935, Expiry Date Oct2017) via an unspecified route of administration at 0.5 ml, single at left deltoid on 09Dec2016 for immunization, at physician office. Relevant medical history (including any illness at time of vaccination) were none. The reporter did not wish to share his concomitant medications or other medical conditions. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the suspect. Prior Vaccinations (within 4 weeks) were none. No AEs were reported as following prior vaccinations. In Dec2016, about 2 days after the injection, he began to experience redness, swelling, heat and pain at the injection site.  He went back into the office and was treated for cellulitis. His side effects lasted about 2 weeks, and he has completely recovered in Dec2016. He had no relevant investigations done.; Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2017005458 Same reporter/product/events, different patients;US-PFIZER INC-2017005460 Same reporter/product/events, different patients.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a medical practice. This medical assistant reported similar events for 3 patients. This is the second of 3 reports.  A 65-year-old female patient received PREVNAR 13) Lot. N34935, Expiry Date Oct2017) via an unspecified route of administration, at 0.5 ml, single in the left arm on 06Dec2016 for immunization, at physician office. Relevant medical history was none. Concomitant medications were not reported. No additional vaccines were administered on same date or within 4 weeks. In Dec2016, the weekend after receiving the vaccine, the patient experienced redness, swelling, heat and pain at the injection site.  She went back into the office, on 13Dec2016, and was treated for cellulitis. The patient recovered on an unspecified date.; Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2017005456 Same repoter/product/events, different patients;US-PFIZER INC-2017005460 Same repoter/product/events, different patients.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of a medical practice. This medical assistant reported similar events for 3 patients. This is the third of 3 reports. A 83-year-old female patient received PREVNAR 13) Lot # R45377, Expiry Date Dec2017) via an unspecified route of administration at 0.5 ml, single in the right arm on 22Dec2016 for immunization, at physician office. Relevant medical history was none. Concomitant medications were not reported. No additional vaccines were administered on same date or within 4 weeks. In Dec2016, about 2 days after receiving the vaccine, the patient experienced redness, swelling, heat and pain at the injection site.  He went back into the office, one week after vaccination and was treated for cellulitis. The patient recovered on an unspecified date.; Sender's Comments: A causal relationship between the administration of PREVNAR 13 and the occurrence of the reported events cannot be excluded based on the temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2017005456 Same reporter/product/events, different patients;US-PFIZER INC-2017005458 Same repoter/product/events, different patients.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Injection site erythema, Pruritus
Clinical narrative: More than 30 minutes after administration warm flush feeling, diaphoretic, rash arms, chest back - resolved. Today mild itching upper back. Redness at site. (took PEPCID and ADVIL then BENADRYL later on).
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash
Clinical narrative: More than 30 minutes after administration warm flush feeling, diaphoretic, rash arms, chest back - resolved. Today mild itching upper back. Redness at site. (took PEPCID and ADVIL then BENADRYL later on).
Age: 0.33
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX (DTaP/IPV) administered to 4 month old.
Age: 1.17
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on large area 2 days after vaccine covering his entire left shoulder. Mom advised to give BENADRLY and stated it greatly helped reduce swelling/redness.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site pain, Injection site warmth, Ultrasound scan
Clinical narrative: Presented to ER on 1/16/17 with (R) leg pain and warmth to upper thigh. Sitter had child transported to ER, by EMS due to crying/? unable to move leg.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Seizure, Staring
Clinical narrative: Mom claimed child had what appeared to be a seizure. She was starring into space. No fever, jerking, or eye-rolling.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Pallor, Rash generalised, Rash maculo-papular
Clinical narrative: Whole body maculopapular blanching rash no pruritic rash starting 3 hrs after vaccine.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Pt received shot, stayed 10 minutes, felt well and went home. After getting home her arm was red and swollen from shoulder site down to elbow. Could not lift arm due to significant pain and felt throbbing in her arm with heartbeats. Patient treated herself with ibuprofen and ice since she could not contact her doctor over the holiday. As of 1/6/17 her arm is only slight red, swollen and sore.
Age: 52.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Received shot 10/3/15 next day pain (L)arm continued to get worse went back to MD. then Ortho. then Chirop. then and still doing PT.
Age: 30.0
Sex: M
Vaccine: TD
Symptoms: Blindness transient, Hyperhidrosis, Pallor
Clinical narrative: Pale, diaphoretic and temporary loss of vision for approximately 5-7 minutes.
Age: 73.0
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: As per patient, the injection site got little red and itchy after few days.  - then she got an infection at the injection site and had to get an antibiotics from the dr. Now patient is feeling better with the antibiotics.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Swelling face
Clinical narrative: Patient says redness at injection site and face swelled, she also received the PNEUMOVAX at a different location that day so not sure which vaccine caused the reaction.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV
Symptoms: Rash maculo-papular
Clinical narrative: Maculopapular rash on face, trunk, arms.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Blindness, Eye pain, Nuclear magnetic resonance imaging brain, Optic neuritis
Clinical narrative: Eye pain, progressive vision loss Oct 30 '16 later diagnosed as optic neuritis (11-6-16). Was placed on high dose steroids and has slowly seen reduction of the optic neuritis and improvement in her vision.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 79 year old female patient via a company representative referring to herself. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, in 2011 (reported as "5 years ago") the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route, lot # and expiration date were not reported) to treat shingles. On 12-DEC-2016,  the patient reported that her physician, confirmed she had developed shingles and the patient was given therapy to treat the rash that had, "developed quite well on the side of her torso".  The outcome of the patient's shingles was reported as recovering. The relationship between the aforementioned event and ZOSTAVAX was not reported. No product quality complaint (PQC) was involved in this report. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Contusion, Pain, Paraesthesia, Skin warm
Clinical narrative: Large bruise on mid-lower left arm. Burns and tingles. Painful. Warm to touch.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Fever, chills, headache, nausea.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Crying, Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Child had inconsolable screaming, crying for over 9 hours. Child had rash, redness, swelling, and warmth on legs bilaterally for over 24 hours. Child had fever of 100 F for the duration of inconsolable crying/screaming. Tylenol and ice pack for legs given upon arrival home. No seizures or loss of consciousness noted. Child did have lethargy and drowsiness.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Lethargy, Pyrexia, Screaming, Somnolence
Clinical narrative: Child had inconsolable screaming, crying for over 9 hours. Child had rash, redness, swelling, and warmth on legs bilaterally for over 24 hours. Child had fever of 100 F for the duration of inconsolable crying/screaming. Tylenol and ice pack for legs given upon arrival home. No seizures or loss of consciousness noted. Child did have lethargy and drowsiness.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Rash, Rash pruritic
Clinical narrative: Per telephone call, Mom reported pt had developed an itchy rash on her leg. I advised her to FU in Urgent Care or ER. FU call later, pt had applied cream and rash improved.  Did not FU with MD.
Age: 45.0
Sex: F
Vaccine: MEN
Symptoms: Cerebrovascular accident, Emotional distress, Epistaxis, Fear, Headache
Clinical narrative: I was having pain all over my arm. I was talking slow and acting like I had a stroke....nose bloods and headaches bad. I was embarrassed and scared ....people were noticing something was wrong.
Age: 45.0
Sex: F
Vaccine: MEN
Symptoms: Pain in extremity, Slow speech
Clinical narrative: I was having pain all over my arm. I was talking slow and acting like I had a stroke....nose bloods and headaches bad. I was embarrassed and scared ....people were noticing something was wrong.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: DONOR STATES APPROXIMATELY TWO HOURS FOLLOWING ADMINISTRATION OF VACCINE HE DEVELOPED A FEVER, BODY ACHES, CHILLS, AND A SORE THROAT. DONOR STATES SYMPTOMS LASTED APPROXIMATELY THREE DAYS.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Rash, Rash papular, Rash pruritic, Streptococcus test negative
Clinical narrative: Fine, papular red pruritic rash on hands, arms and trunk.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: Eczema, Injection site swelling, Rash, Urticaria
Clinical narrative: She only got the HIB shot because she's had bad reactions in the past. She broke out in hives on her face. Had a bad rash severe eczema and swelling of the injection site. I gave her BENADRYL for the next 24 hours and the hives and rash went away. Still has bad eczema. We are not giving any more vaccine until we see an allergist.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Dyskinesia, Facial paralysis, Retching, Tremor
Clinical narrative: Her whole body started shaking. She wanted to go to the grocery store  BP elevated, 151/115  and "could barely get out of the store." She really does not know what happened. "Husband (she says) did not know if she was having a heart attack or seizing" he states "she was twisted to the left and heaving. Left side of mouth drooping legs were kicking mild then pounding the bed." This lasted  for 90 minutes. Hospitalized 2 days.
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Local swelling, Skin warm
Clinical narrative: Pt exhibited redness and swelling on left arm (slightly towards back of arm) measuring 3 1/8 inches by 1 1/2 inches. Area was warm to touch, slightly hard and raised. Pt had not applied ice to area, nor had she taken any OTC medication (ex Ibuprofen).
Age: 1.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Pain
Clinical narrative: First aid and cold compress. Teaching and pain MGT.
Age: 74.0
Sex: M
Vaccine: FLUA3, PNC13, FLUA3
Symptoms: Cellulitis, Injection site pruritus
Clinical narrative: Pt had itching at site of infection and scratched repeatedly starting 1 day after injection. 2 days later Pt developed cellulitis and was prescribed ABX and steroids in Left arm.
Age: 8.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was given MMR vaccine intramuscularly. This vaccine is supposed to be given subcutaneously.
Age: 15.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Blindness, Nausea, Vomiting
Clinical narrative: Pt. was given Flu and HPV vaccine. Several minutes later pt C/O partial vision loss and nausea. Pt then had vomit x1, reports S/S resolved.
Age: 80.0
Sex: M
Vaccine: TDAP
Symptoms: Blood pressure increased, Bradycardia, Dizziness, Heart rate decreased, Hypertension
Clinical narrative: Patient experienced dizziness, nausea, elevated blood pressure and low heart rate following vaccine, required ER visit to outside hospital on 7/10/16. Dizziness, Nausea Vomiting, Hypertension and Bradycardia.
Age: 80.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Patient experienced dizziness, nausea, elevated blood pressure and low heart rate following vaccine, required ER visit to outside hospital on 7/10/16. Dizziness, Nausea Vomiting, Hypertension and Bradycardia.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash after 10-11 days after nurse varicella vaccine.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site rash, Rash
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to a 82 year old female patient. Concurrent conditions included coronary artery disease, hypertension and osteoporosis. . She did not have known drug allergies. The patient's pertinent medical history and concomitant therapies were not reported. On 04-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, intramuscular (product use issue), lot # M033335 and expiration date 11-OCT-2017 (strength was not reported) for prophylaxis. On 04-DEC-2016, the patient experienced a localized rash at injection site, which spread to arms, upper back, bilateral lower extremities and a scant amount on her upper back and face (rash generalized and rash at the injection site). The reporter stated that patient  was given prednisone (manufacturer unknown) and it seemed to be responding, but rash had not completely resolved. The outcome of rash generalised and injection site rash was reported as recovering. The relationship between the aforementioned events and ZOSTAVAX was not established by the reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unknown patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unknown dates, the multiple unknown patients received improperly stored GARDASIL 9(lot #, expiration date, dose and route were not reported) for prophylaxis. Previous temperature excursion was reported as  greater than 10 excursions. No details were provided regarding temperature or time frame for the excursions. No adverse effects was noted. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014514: US-009507513-1612USA014512: US-009507513-1612USA014513:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unknown patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unknown dates, the multiple unknown patients received improperly stored PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported) for prophylaxis. Previous temperature excursion was reported as greater than 10 excursions. No details were provided regarding temperature or time frame for the excursions. No adverse effects was noted. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014513: US-009507513-1612USA014514: US-009507513-1612USA014298.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unknown patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unknown dates, the multiple unknown patients received improperly stored ROTATEQ (lot #, expiration date and dose were not reported), orally for prophylaxis. Previous temperature excursion was reported as greater than 10 excursions. No details were provided regarding temperature or time frame for the excursions. No adverse effects was noted. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014298: US-009507513-1612USA014514: US-009507513-1612USA014512:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning multiple unknown patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unknown dates, the multiple unknown patients received improperly stored M-M-R II (lot #, expiration date, dose and route were not reported) for prophylaxis. Previous temperature excursion was reported as greater than 10 excursions. No details were provided regarding temperature or time frame for the excursions. No adverse effects was noted. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014513: US-009507513-1612USA014298: US-009507513-1612USA014512:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 19-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Headache, Injection site haematoma, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from a consumer (the patient's mother) who posted the information on social media via a company representative and refers to a 13 year old female patient. No information about the patient's medical history, concomitant medications and drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with GARDASIL 9 injection (dose, route of administration, anatomical location, lot # and expiry date were not specified) as a vaccination against Human Papilloma Virus (HPV). On an unknown date, the patient experienced hematoma in the muscle of the arm where she received the GARDASIL 9 injection. The patient also experienced headaches, nausea, vomiting and severe fatigue on an unknown dates. The patient sought medical attention by contacting a physician. The outcome of the events was unknown. The reporter did not provide the causality assessment between the events and GARDASIL 9. Upon internal review, the event of hematoma in the muscle was considered to be medically significant. Additional information is not expected as there was no consent for further contact given.
Age: 34.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Neck Pain, Stiffness in neck when turning or looking up or down; Pain and stiffness in left foot toes.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Nasal congestion, Peripheral swelling
Clinical narrative: Redness and swelling of the arm, swelling of nasal passages.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Patient experienced eye swelling in the afternoon after receiving a flu vaccine.  She went to her primary care provider and was given a steroid injection.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Pyrexia, Swelling
Clinical narrative: Pain at area of inj. swelling and fever.
Age: 67.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Pt came to pharmacy w/redness on arm and itching (on 1/10/17). Recommended BENADRYL to pt.
Age: 67.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Contusion, Erythema, Pain, Pruritus, Rhinorrhoea
Clinical narrative: Pt came to pharmacy w/redness on arm and itching (on 1/10/17). Recommended BENADRYL to pt.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Rash, Rhinorrhoea
Clinical narrative: Myalgia, rash and runny nose.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a respiratory therapist referring to an patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 19-DEC-2016, the patient was vaccinated once with an expired dose of RECOMBIVAX HB intramuscular injection (dose reported as: 1 ml intramuscularly, lot number L001456, expiration date 22-OCT-2016) for prophylaxis. (Strength was not provided). No adverse effects were noted.  Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse (immunization official) concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates (from 01-MAR-2016 to an unspecified date), the patients were vaccinated with improperly stored doses (incorrect product storage ) of ROTATEQ orally, lot L020859 and lot L023870, (the expiration dates and dose were not reported) for prophylaxis. No adverse events reported at this time. The call was made by the data logger with a registered temperature of 10.3 °C during 107 hours and 30 minutes and there was no previous temperature excursion registered. This is one of three reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA004691: US-009507513-1701USA004692:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 30-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 22-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 22-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 19-SEP-2016, the patient received improperly stored doses of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 16-SEP-2016, the patient received improperly stored doses of PROQUAD (lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. ; Sender's Comments: US-009507513-1610USA011245:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 15-SEP-2016, the patient received improperly stored doses of PROQUAD lot# M015695 with expiration date 26-SEP-2017, therapy type rHA; (dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments: US-009507513-1610USA011245:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 30-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245:
Sex: M
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This spontaneous report received from a consumer (patient's mother) via social media regarding her son of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with unspecified HPV Vaccine (manufacturer unknown), (dose, route, lot# not reported) for prophylaxis. On an unknown date, the patient died. She reported that her son died after vaccination. No PQC has been filed. Causality assessment was not provided. Upon internal review the event of death was determined to be medically significant. Additional information is expected.
Sex: M
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This solicited report was received from a 67-year-old male patient, who refers to himself. He was enrolled in a market research program. The patient's concurrent condition included service. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, route of administration, lot# and expiration date were not reported). The patient reported that he recalled how sick the shot made him when he got it (date unspecified). The outcome of the event was not reported. The reported considered the event to be related to PNEUMOVAX 23. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to follow-up. Sender's Comments: US-009507513-1701USA003984.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to multiple patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug allergies were reported. On an unknown date the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L051123, expiry date : 13-OCT-2018 (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported and no additional information was provided. There was no product quality complaint reported. Temperature of 30.2 F for 56.47 hours. There was no previous excursion. Data logger was reported as yes. This is 1 of 3 reports from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1701USA003860: US-009507513-1701USA003863: US-009507513-1701USA003860.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse referring to multiple patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug allergies were reported. On an unknown date the patient was vaccinated with improperly stored doses of GARDASIL 9 lot # M005714, expiry date : 03-OCT-2017 (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported and no additional information was provided. There was no product quality complaint reported. Temperature of 30.2F for 56.47 hours. There was no previous excursions. Data logger was reported as yes. This is 1 of 3 reports from the same reporter source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA003747: US-009507513-1701USA003863: US-009507513-1701USA003747:
Sex: U
Vaccine: PPV
Symptoms: Malaise
Clinical narrative: This spontaneous report was received from a consumer who refers to unspecified number of patients of unknown age and gender. The patients' concurrent condition included service. The patients' medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 injections (dose, route of administration, lot# and expiration date were not reported). The reported stated that he recalled how sick the shot made all of them when they got them (date unspecified). The outcome of the event was not reported. The reported considered the event to be related to PNEUMOVAX 23. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to follow-up. Sender's Comments: US-009507513-1701USA003557.