chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 24-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (Lot # L013192, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. 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 healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 16-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (Lot # L013192, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter link. 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 healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 19-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013192, does and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. 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 healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 24-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L013192, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. 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 healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 27-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (Lot # L013192, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a multiple unspecified patient of unknown age and gender. No information on patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored GARDASIL 9 injection, lot# L016428, expiration date 30-JUL-2017 (dose and route of administration were not provided). No adverse effects were reported. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored GARDASIL 9 (lot # L016429 with expiration date 09-AUG-2017 and lot # L016428 with expiration date 30-JUL-2017, strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report was received from a physician, via company representative, refers to a 14 year old male patient. The patient's medical history and concurrent conditions were not reported. The physician stated that the patient received the first dose of GARDASIL (dosage, lot# and expiration date were not reported) on 14-AUG-2013, then received the second dose of GARDASIL (dosage, lot# and expiration date were no reported), on 11-AUG-2014 and finally on 18-NOV-2015, was vaccinated with GARDASIL 9 (dosage, lot# and expiration date were no reported), as third dose. No product quality complain was involved. The physician reported that on 18-NOV-2015, (reported as at the time of the third dose) the patient was experiencing "possible genital warts", but he was not 100% sure if it was HIV. The outcome of genital warts and interchange of vaccine products was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist regarding a female patient who was in her mid fifties. Patient's pertinent medial history was not reported. The patient had no drug reactions or allergies. On 08-DEC-2015 the patient was vaccinated with ZOSTAVA lot # L032397, expiry date: 26-NOV-2016, 0.65 ml, subcutaneously. Concomitant medications were not provided. On an unknown date in December 2015, approximately, the patient experienced redness and warmth at injection site. The patient sought medical attention by visiting the pharmacy. No treatment was provided for the events. No laboratory diagnostics tests were performed. The outcome of redness and warmth at injection site was unknown. Causality assessment was not provided. Product quality complaint was not filled. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 26-NOV-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K012918, Expiry date: 28-FEB-2016 (dose and route not specified). No adverse effects were reported. No further information was provided. This is one of the two reports from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist regarding a male patient who was in his mid fifties. Patient's pertinent medical history was not reported. The patient had no drug reactions or allergies. On 08-DEC-2015 the patient was vaccinated with ZOSTAVAX lot # L032397, expiry date: 26-NOV-2016, 0.65 ml, subcutaneously. Concomitant medications were not provided. On an unknown date in December 2015, approximately, the patient experienced redness and warmth at injection site. The patient sought medical attention by visiting the pharmacy. No treatment was provided for the events. No laboratory diagnostics tests were performed. The outcome of redness and warmth at injection site was unknown. Causality assessment was not provided. Product quality complaint was not filed. This is one of the two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The nurse stated that an improperly stored dose of PROQUAD (Merck) Lot# L031600, an expiry date 18-FEB-2017 (dose and frequency were not reported) was administered to an unspecified patient on an unspecified date. No adverse effects were reported. No further information was provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 4 year old male patient. The patient had no illnesses at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 09-AUG-2015 at 10:38 a.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (Merck) (subcutaneously, in right thigh, lot # L010145; dose and expiration date were not reported) that was improperly stored. On 09-AUG-2015 at 10:38 a.m., the patient was also concomitantly vaccinated with the second dose (reported as #1 given elsewhere) of HAVRIX (intramuscularly, in left thigh, lot # C7392; dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all scheduled correspondence was already received.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a 13 year old male patient. The patient had no illness at time of vaccination. No information on patient's medical history or concomitant medications was provided. On 25-AUg-2015 at 8:54 a.m., the patient was vaccinated with the second dose (reported as #1 given elsewhere) of VARIVAX (Merck) (subcutaneously, in right arm , lot # L010145; dose and expiration date were not reported) that was improperly stored. At the same time, the patient was concomitantly vaccinated with the first dose of MENACTRA (intramuscularly, in right arm, lot # 0502CA; dose and expiration date were not reported) and with the first dose of ADACEL (intramuscularly, in the left arm, lot # 05095AA;dose and expiration date were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information is not expected as all scheduled correspondence was already received.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old female patient. There were no pertinent medical history and drug reactions or allergies. On 06-DEC-2015 the patient was vaccinated with one dose of ZOSTAVAX (lot # L032397, expiration date 26-NOV-2015, 0.65 ml, subcutaneous). Concomitant therapies included SYNTHROID, TOPROL XL, paroxetine, pravastatin, isosorbide dinitrate and XANAX. On 07-DEC-2015, the patient developed redness and itching at the injection site. On 09-DEC-2015, the patient returned to the pharmacy for medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of report, the events had not yet resolved and has been getting steadily worse. The causality between the events and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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. The patient's pertinent medical history and concomitant medications were not reported. The pharmacist reported that the patient had an unspecified allergy to neomycin and, on 09-DEC-2015, received a dose of ZOSTAVAX lot # L031271, expiration date: 19-NOV-2016 (dose and route were not provided), which was outside the recommendations per the prescribing information. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding an unspecified patient of unknown demographics. There was no information about concurrent condition and historical medication. On 12-JUN-2015, of the patient was vaccinated with the first dose in the series of three GARDASIL 9, dose 2 on 14-AUG-2015 and dose 3 on 10-DEC-2015. No adverse event was reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, since 24-SEP-2015, the patients were vaccinated with doses of VARIVAX (Merck) lot # K018961, expiry date: 15-OCT-2016 and lot # L013068, expiry date: 14-APR2017 (strength, dose and route of administration were not reported), which had been exposed to temperatures outside of the recommended range. No adverse events were reported. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Feeling abnormal, Injection site erythema, Pyrexia
Clinical narrative: 1900 hours - started "just feeling bad. I went to bed because I felt terrible". Approx. 2300 hours fever of 104 degrees. Had fever of between 99 degrees and 104 degrees until fever free at approx. 1100 hours on 12/20/15. Red at injection site but no swelling.
Age: 0.6
Sex: U
Vaccine: RV1
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from an approximately 7 months old physician refers to a patient of unknown gender. The patient's relevant medical history and concurrent conditions were not reported. On 03-MAR-2015, the patient was vaccinated orally with a first dose of ROTATEQ, (dose, lot # and expiration date not reported). On 12-AUG-2015, the subject received ROTARIX as a second dose in rotavirus series (dose, route of administration, lot # and expiration date were not reported). On 04-DEC-2015, the patient received a dose of ROTATEQ, lot # K003208, expiration date 15-DEC-2015, orally (dose not reported) and as the third dose in the rotavirus series. No concomitant medications were reported. The patient was 11 months old at the time of vaccination with the third dose in rotavirus series, which was older than the recommended age for last dose of ROTATEQ. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("after 17-NOV-2015"), the patients were vaccinated with doses of improper stored PEDVAXHIB (lot # K026533, expiration date 07-AUG-2017; lot # L012838, expiration date 10-MAR-2018; lot # L012837, expiration date 11-MAR-2018)(dose and  route were not reported). No adverse effects were reported. This is one of 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: Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("after 17-NOV-2015"), the patients were vaccinated with doses of improper stored GARDASIL (lot # K011562, expiration date 08-APR-2017; lot # K016966, expiration date 10-MAY-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patient s with unknown age and gender. On unknown date in 2015 ("after 17-NOV-2015"), the patients were vaccinated with dose of improper stored M-M-R II (lot # K024035, expiration date 26-NOV-2016; lot # L005291, expiration date 17-FEB-2017; lot # K011188 expiration date 12-AUG-2016; lot # L012481, expiration date 10-APR-2017)(dose and route were not reported). 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: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 16-DEC-2015 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (lot # K007262, expiration date 25-NOV-2015; route not reported). No adverse effects were reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, Seizure like phenomena
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure like phenomena in a 18-year-old male patient who received BOOSTRIX (batch number 2729X, expiry date 15th September 2017). Co-suspect products included HAVRIX pediatric (batch number F3J75, expiry date 18th November 2017). HPV vaccine (batch number L014415, expiry date 25th July 2017), MENACTRA (batch number U5179AA, expiry date 19th January 2017) and varicella vaccine (batch number L026412, expiry date 15th July 2017). On 11th December 2015, the patient received BOOSTRIX, HAVRIX pediatric, HPV vaccine, MENACTRA and varicella vaccine. On 11th December 2015, less than a day after receiving BOOSTRIX and HAVRIX pediatric, the patient experienced seizure like phenomena (serious criteria GSK medically significant), gaze palsy (serious criteria GSK medically significant), pallor, confusion and jerky movement nos. On an unknown date, the outcome of the seizure like phenomena, gaze palsy, pallor, confusion and jerky movement nos were recovered/resolved. It was unknown if the reporter considered the seizure like phenomena, gaze palsy, pallor, confusion and jerky movement nos to be related to BOOSTRIX and HAVRIX pediatric. Additional details were provided as follows: The patient received BOOSTRIX, HAVRIX pediatric, HPV 9 vaccine, varicella vaccine and MENACTRA. Then he got up and walked to the waiting area about 1 minute later he experienced seizure-like activity. He had jerking in his upper extremities and arms and his eyes rolled back. The event lasted for about 30 seconds and he was confused and pale. He was fine after 10 minutes, but he was monitored for 3 hours.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV9, MNQ, TDAP
Symptoms: Confusional state, Dyskinesia, Eye movement disorder, Gaze palsy, Pallor
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure like phenomena in a 18-year-old male patient who received BOOSTRIX (batch number 2729X, expiry date 15th September 2017). Co-suspect products included HAVRIX pediatric (batch number F3J75, expiry date 18th November 2017). HPV vaccine (batch number L014415, expiry date 25th July 2017), MENACTRA (batch number U5179AA, expiry date 19th January 2017) and varicella vaccine (batch number L026412, expiry date 15th July 2017). On 11th December 2015, the patient received BOOSTRIX, HAVRIX pediatric, HPV vaccine, MENACTRA and varicella vaccine. On 11th December 2015, less than a day after receiving BOOSTRIX and HAVRIX pediatric, the patient experienced seizure like phenomena (serious criteria GSK medically significant), gaze palsy (serious criteria GSK medically significant), pallor, confusion and jerky movement nos. On an unknown date, the outcome of the seizure like phenomena, gaze palsy, pallor, confusion and jerky movement nos were recovered/resolved. It was unknown if the reporter considered the seizure like phenomena, gaze palsy, pallor, confusion and jerky movement nos to be related to BOOSTRIX and HAVRIX pediatric. Additional details were provided as follows: The patient received BOOSTRIX, HAVRIX pediatric, HPV 9 vaccine, varicella vaccine and MENACTRA. Then he got up and walked to the waiting area about 1 minute later he experienced seizure-like activity. He had jerking in his upper extremities and arms and his eyes rolled back. The event lasted for about 30 seconds and he was confused and pale. He was fine after 10 minutes, but he was monitored for 3 hours.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL, HEPA, HPV9, MNQ, TDAP
Symptoms: Seizure like phenomena
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of seizure like phenomena in a 18-year-old male patient who received BOOSTRIX (batch number 2729X, expiry date 15th September 2017). Co-suspect products included HAVRIX pediatric (batch number F3J75, expiry date 18th November 2017). HPV vaccine (batch number L014415, expiry date 25th July 2017), MENACTRA (batch number U5179AA, expiry date 19th January 2017) and varicella vaccine (batch number L026412, expiry date 15th July 2017). On 11th December 2015, the patient received BOOSTRIX, HAVRIX pediatric, HPV vaccine, MENACTRA and varicella vaccine. On 11th December 2015, less than a day after receiving BOOSTRIX and HAVRIX pediatric, the patient experienced seizure like phenomena (serious criteria GSK medically significant), gaze palsy (serious criteria GSK medically significant), pallor, confusion and jerky movement nos. On an unknown date, the outcome of the seizure like phenomena, gaze palsy, pallor, confusion and jerky movement nos were recovered/resolved. It was unknown if the reporter considered the seizure like phenomena, gaze palsy, pallor, confusion and jerky movement nos to be related to BOOSTRIX and HAVRIX pediatric. Additional details were provided as follows: The patient received BOOSTRIX, HAVRIX pediatric, HPV 9 vaccine, varicella vaccine and MENACTRA. Then he got up and walked to the waiting area about 1 minute later he experienced seizure-like activity. He had jerking in his upper extremities and arms and his eyes rolled back. The event lasted for about 30 seconds and he was confused and pale. He was fine after 10 minutes, but he was monitored for 3 hours.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Had trouble breathing.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt received flu vaccine on 12/03/2015 with no outstanding observations. Pt reported to pharmacy on 12/22 c/o continuing pain in vaccine administered arm. Pt did not report any swelling, redness, or itchiness in arm.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Severe muscle and joint pain.  Treated with Tylenol and Ibuprofen.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to injection site on right arm.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash developed to right arm about 2-3 days after she received the shot. Rash lasted several days. Did not go to MD for this.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Lt arm Redness and hot to touch from shoulder to elbow.  Swollen at injection site an more at the site about the size of silver dollar.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria torso and upper extremities.
Age: 56.0
Sex: F
Vaccine: HEP, MMR, TD
Symptoms: Asthenia, Dizziness, Eye pain, Malaise, Visual impairment
Clinical narrative: 12/10/15 client and daughter walked in to PH office. Daughter was reported changes with vision that she thought was due to LTBI meds. While reporting this, daughter translated that her mother had history of November immunization at public health clinic and felt ill day after vaccination. Lasted two -three days weak, dizziness, pain above and below eyes. No yellowing in eyes. No redness or drainage noted. No secretion in nares. No cough BP 126/84. Daughter had called Dr who did not think it was medicine but advised to hold until 12/14. Consulted by phone. Attempted to make clinic appt as generally unwell and uninsured. No appts today. Daughter works tomorrow but off Monday. PHN will work to get clinic Monday if still unwell. Will enter in VAERS for last immunizations.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain, Muscle twitching, Neck pain, Pain
Clinical narrative: Vaccine given 11-5-2015 11-6-2015 for 5 days had extreme fatigue, body aches, pain left deltoid (site of injection) which radiated to left shoulder and neck. Had intermittent twitching of muscles left arm. Several symptoms lasted 5 days. "Took a few more days to feel normal". No fever no cough.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: I shook uncontrollable for about 30 minutes and felt a chill. I was about to go to ER when the symptoms calmed down.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site nodule
Clinical narrative: Patient was given Tdap intradermally instead of PPD intradermal; developed reddened hard bump or knot at site of Tdap injection.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Amylase increased, Anaemia, Blood alkaline phosphatase increased, Blood calcium increased
Clinical narrative: Patient presented to our ED on 11/05 with complaints of recent nausea, vomiting, diarrhea and abdominal pain. All symptoms started shortly after receiving influenza vaccination. Patient reports no regular use of alcohol, tobacco or recreational medications. Initial lab results are significant for creatinine of 4.07, BUN of 52, calcium of 14.7, alkaline phosphate of 730, lipase of >3,000, amylase of 861, platelet count of 510,000, blood iron of 253 with other labs largely within normal limits. Upon CT scan patient is found to have a diffusely enlarged, edematous pancreas, hepatic cirrhosis, splenomegaly, portal hypertension. Patient is diagnosed with acute pancreatic of unknown origin (possibly related to influenza vaccine, possibly related to underlying sarcoidosis/hypercalcemia). Patient was admitted to intensive care unit. On day two of hospitalization patient displayed altered mental status, a head CT was negative and change was thought to be due to metabolic encephalopathy. Patient was electively intubated evening of day 2 and would remain on the ventilator for 7 days. While in the ICU patient received 7 bags of TPN and 3 dialysis sessions. Also while in ICU patient spiked temperatures and was subsequently started on meropenem. Patient also experienced anemia with her lowest hemoglobin at 6.5 (blood transfusions refused). Gradually patient improved and was downgraded from ICU status on 11/14 and subsequently moved to a medical floor on 11/16 and discharged on 11/18.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatinine increased, Blood iron increased, Blood urea increased, Computerised tomogram abdomen abnormal, Computerised tomogram head normal
Clinical narrative: Patient presented to our ED on 11/05 with complaints of recent nausea, vomiting, diarrhea and abdominal pain. All symptoms started shortly after receiving influenza vaccination. Patient reports no regular use of alcohol, tobacco or recreational medications. Initial lab results are significant for creatinine of 4.07, BUN of 52, calcium of 14.7, alkaline phosphate of 730, lipase of >3,000, amylase of 861, platelet count of 510,000, blood iron of 253 with other labs largely within normal limits. Upon CT scan patient is found to have a diffusely enlarged, edematous pancreas, hepatic cirrhosis, splenomegaly, portal hypertension. Patient is diagnosed with acute pancreatic of unknown origin (possibly related to influenza vaccine, possibly related to underlying sarcoidosis/hypercalcemia). Patient was admitted to intensive care unit. On day two of hospitalization patient displayed altered mental status, a head CT was negative and change was thought to be due to metabolic encephalopathy. Patient was electively intubated evening of day 2 and would remain on the ventilator for 7 days. While in the ICU patient received 7 bags of TPN and 3 dialysis sessions. Also while in ICU patient spiked temperatures and was subsequently started on meropenem. Patient also experienced anemia with her lowest hemoglobin at 6.5 (blood transfusions refused). Gradually patient improved and was downgraded from ICU status on 11/14 and subsequently moved to a medical floor on 11/16 and discharged on 11/18.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Dialysis, Diarrhoea, Endotracheal intubation, Haemoglobin decreased, Hepatic cirrhosis
Clinical narrative: Patient presented to our ED on 11/05 with complaints of recent nausea, vomiting, diarrhea and abdominal pain. All symptoms started shortly after receiving influenza vaccination. Patient reports no regular use of alcohol, tobacco or recreational medications. Initial lab results are significant for creatinine of 4.07, BUN of 52, calcium of 14.7, alkaline phosphate of 730, lipase of >3,000, amylase of 861, platelet count of 510,000, blood iron of 253 with other labs largely within normal limits. Upon CT scan patient is found to have a diffusely enlarged, edematous pancreas, hepatic cirrhosis, splenomegaly, portal hypertension. Patient is diagnosed with acute pancreatic of unknown origin (possibly related to influenza vaccine, possibly related to underlying sarcoidosis/hypercalcemia). Patient was admitted to intensive care unit. On day two of hospitalization patient displayed altered mental status, a head CT was negative and change was thought to be due to metabolic encephalopathy. Patient was electively intubated evening of day 2 and would remain on the ventilator for 7 days. While in the ICU patient received 7 bags of TPN and 3 dialysis sessions. Also while in ICU patient spiked temperatures and was subsequently started on meropenem. Patient also experienced anemia with her lowest hemoglobin at 6.5 (blood transfusions refused). Gradually patient improved and was downgraded from ICU status on 11/14 and subsequently moved to a medical floor on 11/16 and discharged on 11/18.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Hypercalcaemia, Intensive care, Lipase increased, Mechanical ventilation, Mental status changes
Clinical narrative: Patient presented to our ED on 11/05 with complaints of recent nausea, vomiting, diarrhea and abdominal pain. All symptoms started shortly after receiving influenza vaccination. Patient reports no regular use of alcohol, tobacco or recreational medications. Initial lab results are significant for creatinine of 4.07, BUN of 52, calcium of 14.7, alkaline phosphate of 730, lipase of >3,000, amylase of 861, platelet count of 510,000, blood iron of 253 with other labs largely within normal limits. Upon CT scan patient is found to have a diffusely enlarged, edematous pancreas, hepatic cirrhosis, splenomegaly, portal hypertension. Patient is diagnosed with acute pancreatic of unknown origin (possibly related to influenza vaccine, possibly related to underlying sarcoidosis/hypercalcemia). Patient was admitted to intensive care unit. On day two of hospitalization patient displayed altered mental status, a head CT was negative and change was thought to be due to metabolic encephalopathy. Patient was electively intubated evening of day 2 and would remain on the ventilator for 7 days. While in the ICU patient received 7 bags of TPN and 3 dialysis sessions. Also while in ICU patient spiked temperatures and was subsequently started on meropenem. Patient also experienced anemia with her lowest hemoglobin at 6.5 (blood transfusions refused). Gradually patient improved and was downgraded from ICU status on 11/14 and subsequently moved to a medical floor on 11/16 and discharged on 11/18.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Metabolic encephalopathy, Nausea, Oedematous pancreatitis, Pancreatic enlargement, Pancreatitis acute
Clinical narrative: Patient presented to our ED on 11/05 with complaints of recent nausea, vomiting, diarrhea and abdominal pain. All symptoms started shortly after receiving influenza vaccination. Patient reports no regular use of alcohol, tobacco or recreational medications. Initial lab results are significant for creatinine of 4.07, BUN of 52, calcium of 14.7, alkaline phosphate of 730, lipase of >3,000, amylase of 861, platelet count of 510,000, blood iron of 253 with other labs largely within normal limits. Upon CT scan patient is found to have a diffusely enlarged, edematous pancreas, hepatic cirrhosis, splenomegaly, portal hypertension. Patient is diagnosed with acute pancreatic of unknown origin (possibly related to influenza vaccine, possibly related to underlying sarcoidosis/hypercalcemia). Patient was admitted to intensive care unit. On day two of hospitalization patient displayed altered mental status, a head CT was negative and change was thought to be due to metabolic encephalopathy. Patient was electively intubated evening of day 2 and would remain on the ventilator for 7 days. While in the ICU patient received 7 bags of TPN and 3 dialysis sessions. Also while in ICU patient spiked temperatures and was subsequently started on meropenem. Patient also experienced anemia with her lowest hemoglobin at 6.5 (blood transfusions refused). Gradually patient improved and was downgraded from ICU status on 11/14 and subsequently moved to a medical floor on 11/16 and discharged on 11/18.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Parenteral nutrition, Platelet count increased, Portal hypertension, Pyrexia, Sarcoidosis
Clinical narrative: Patient presented to our ED on 11/05 with complaints of recent nausea, vomiting, diarrhea and abdominal pain. All symptoms started shortly after receiving influenza vaccination. Patient reports no regular use of alcohol, tobacco or recreational medications. Initial lab results are significant for creatinine of 4.07, BUN of 52, calcium of 14.7, alkaline phosphate of 730, lipase of >3,000, amylase of 861, platelet count of 510,000, blood iron of 253 with other labs largely within normal limits. Upon CT scan patient is found to have a diffusely enlarged, edematous pancreas, hepatic cirrhosis, splenomegaly, portal hypertension. Patient is diagnosed with acute pancreatic of unknown origin (possibly related to influenza vaccine, possibly related to underlying sarcoidosis/hypercalcemia). Patient was admitted to intensive care unit. On day two of hospitalization patient displayed altered mental status, a head CT was negative and change was thought to be due to metabolic encephalopathy. Patient was electively intubated evening of day 2 and would remain on the ventilator for 7 days. While in the ICU patient received 7 bags of TPN and 3 dialysis sessions. Also while in ICU patient spiked temperatures and was subsequently started on meropenem. Patient also experienced anemia with her lowest hemoglobin at 6.5 (blood transfusions refused). Gradually patient improved and was downgraded from ICU status on 11/14 and subsequently moved to a medical floor on 11/16 and discharged on 11/18.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Splenomegaly, Vomiting
Clinical narrative: Patient presented to our ED on 11/05 with complaints of recent nausea, vomiting, diarrhea and abdominal pain. All symptoms started shortly after receiving influenza vaccination. Patient reports no regular use of alcohol, tobacco or recreational medications. Initial lab results are significant for creatinine of 4.07, BUN of 52, calcium of 14.7, alkaline phosphate of 730, lipase of >3,000, amylase of 861, platelet count of 510,000, blood iron of 253 with other labs largely within normal limits. Upon CT scan patient is found to have a diffusely enlarged, edematous pancreas, hepatic cirrhosis, splenomegaly, portal hypertension. Patient is diagnosed with acute pancreatic of unknown origin (possibly related to influenza vaccine, possibly related to underlying sarcoidosis/hypercalcemia). Patient was admitted to intensive care unit. On day two of hospitalization patient displayed altered mental status, a head CT was negative and change was thought to be due to metabolic encephalopathy. Patient was electively intubated evening of day 2 and would remain on the ventilator for 7 days. While in the ICU patient received 7 bags of TPN and 3 dialysis sessions. Also while in ICU patient spiked temperatures and was subsequently started on meropenem. Patient also experienced anemia with her lowest hemoglobin at 6.5 (blood transfusions refused). Gradually patient improved and was downgraded from ICU status on 11/14 and subsequently moved to a medical floor on 11/16 and discharged on 11/18.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Soreness since injection.  Some limited ROM.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion
Clinical narrative: The patient complained of bruising.  She said the pharmacist required her to rest her arm on the desk. She said the pharmacist's technique was the cause of her bruise.  The shot was administered on the deltoid muscle--the patient pointed to the place where she got the shot.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Confusional state, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of passed out in a 11-year-old male patient who received BOOSTRIX (batch number 2729X, expiry date 15th September 2017). Co-suspect products included HAVRIX pediatric (batch number F3J75, expiry date 18th November 2017), HPV vaccine (batch number L020015, expiry date 16th August 2017) and MENACTRA (batch number U5179AA, expiry date 19th January 2017). On 11th December 2015, the patient received BOOSTRIX, HAVRIX pediatric, HPV vaccine and MENACTRA. On 11th December 2015, less than an hour after receiving BOOSTRIX and HAVRIX pediatric, the patient experienced passed out (serious criteria GSK medically significant), confusion and unresponsive to stimuli (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out and unresponsive to stimuli were recovered/resolved and the outcome of the confusion was unknown. It was unknown if the reporter considered the passed out, confusion and unresponsive to stimuli to be related to BOOSTRIX and HAVRIX pediatric. Additional details were provided as follows: The patient received BOOSTRIX, HAVRIX pediatric, HPV 9 vaccine and MENACTRA and then nurse put on the band aids to the patient. The patient slumped over and did not respond. The event lasted about 5 seconds and the patient opened his eyes, but was looking confused.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The unspecified patients were administered PEDVAXHIB (lot# L012837, expiration date 11-MAR-2018)(dose and frequency not reported), which were exposed to temperatures outside of the recommended range since 05-NOV-2015. No adverse experience had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: At time of injection had shooting pain down arm to below elbow. Since vaccine have had arm pain and cannot move arm in full range of motion.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Cough, Dyspnoea, Eye pruritus, Rash
Clinical narrative: Rash, itchy throat, SOB, itchy eyes, coughing, wheezing, pt felt as if she was burning inside. Started at 3pm 12/16/15. 2 EPI injections 1 BENADRYL injection.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation, Wheezing
Clinical narrative: Rash, itchy throat, SOB, itchy eyes, coughing, wheezing, pt felt as if she was burning inside. Started at 3pm 12/16/15. 2 EPI injections 1 BENADRYL injection.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Received flu shot, pt was experiencing gradual muscle pain where immunization occurred. At night, its hard for pt to lift arm w/o excruciating pain. Pt came in on Monday (12/14/15) to complain Rph wrote up VAERS.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: C/O 2 months of Lt deltoid pain. Pain with sleeping on shoulder and raising arm.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Seizure
Clinical narrative: Patient had seizures for 10 minutes or so roughly 10 minutes following influenza immunization.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Patient called in mid December reporting pain at the injection site.  She also reports shoulder pain unassociated. This has not been ongoing since the time of administration.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abnormal faeces, Culture stool, Diarrhoea, Faeces discoloured
Clinical narrative: Infant developed diarrhea day following vaccination becoming more severe 48 hours.  Stools green and of foul odor.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Soreness in arm of injection
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Rash pruritic
Clinical narrative: On 12/14/15, 78 yo F presented to clinic for a follow up appointment. During visit, pt was ordered to receive pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13). At 1158, pt was administered 0.5 mL in left deltoid (lot #M27554; exp: 4/30/2017). Soon after the injection, pt developed a pruritic rash around the injection site. Pt denied any SOB, fever or other symptoms. Pt reported event to the MD and was instructed to take over the counter diphenhydramine for itching and/or use hydrocortisone cream as needed. On 12/22, pt reported symptom improvement.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Severe pain at site of injection (L) shoulder (upper) increased with slightest movement associate w/severe tenderness to touch, and severe swelling, induration, redness, heat. Resolved w/in approximately 72 hours but blotches remain today 12/18/15.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Rash macular
Clinical narrative: Severe pain at site of injection (L) shoulder (upper) increased with slightest movement associate w/severe tenderness to touch, and severe swelling, induration, redness, heat. Resolved w/in approximately 72 hours but blotches remain today 12/18/15.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Full blood count normal, Pruritus, Red blood cell sedimentation rate normal, Skin warm
Clinical narrative: Redness, warm area, itchiness. Dr. ordered labs (all within range) and a course of antibiotics.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Pain
Clinical narrative: Sore for 3-4 days. Took Band Aid Off and saw blister. Blister - with red liquid.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Blood heavy metal test, CSF glucose normal, CSF lymphocyte count increased, CSF protein increased, CSF virus no organisms observed
Clinical narrative: Patient received High Dose influenza vaccine approximately 2 weeks ago from PCP. Family reports developed dizziness "sometime" after vaccine administration and subsequently seen by ENT provider. Admitted to Medical Center 11/13/15 for possible stroke. On 11/17/15 seen by ID diagnosed with severe encephalitis. Hospital MRI of brain unavailable due to patient's large size. CSF with 24 WBCs, 97% lymphocytes, protein 91, glucose 58 on 11/15/15. CSF HSV PCR negative. Additional tests in process include PPD, heavy metal screen, Arbor virus serologies, serum cryptococcal antigen, HIV test. Prognosis very guarded to poor. Consider possible ADR flu vaccine-report FDA.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: CSF white blood cell count increased, Cryptococcus test, Dizziness, Encephalitis, HIV test
Clinical narrative: Patient received High Dose influenza vaccine approximately 2 weeks ago from PCP. Family reports developed dizziness "sometime" after vaccine administration and subsequently seen by ENT provider. Admitted to Medical Center 11/13/15 for possible stroke. On 11/17/15 seen by ID diagnosed with severe encephalitis. Hospital MRI of brain unavailable due to patient's large size. CSF with 24 WBCs, 97% lymphocytes, protein 91, glucose 58 on 11/15/15. CSF HSV PCR negative. Additional tests in process include PPD, heavy metal screen, Arbor virus serologies, serum cryptococcal antigen, HIV test. Prognosis very guarded to poor. Consider possible ADR flu vaccine-report FDA.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes simplex serology negative, Polymerase chain reaction, Tuberculin test, Viral test
Clinical narrative: Patient received High Dose influenza vaccine approximately 2 weeks ago from PCP. Family reports developed dizziness "sometime" after vaccine administration and subsequently seen by ENT provider. Admitted to Medical Center 11/13/15 for possible stroke. On 11/17/15 seen by ID diagnosed with severe encephalitis. Hospital MRI of brain unavailable due to patient's large size. CSF with 24 WBCs, 97% lymphocytes, protein 91, glucose 58 on 11/15/15. CSF HSV PCR negative. Additional tests in process include PPD, heavy metal screen, Arbor virus serologies, serum cryptococcal antigen, HIV test. Prognosis very guarded to poor. Consider possible ADR flu vaccine-report FDA.
Age: 72.0
Sex: F
Vaccine: FLUC3
Symptoms: Blood culture negative, Chest X-ray normal, Computerised tomogram normal, Hepatobiliary scan, Laboratory test normal
Clinical narrative: Post injection flu vaccine febrile illness (T 100 -> 104 degrees F) x 13 days requiring hospitalization. No response to broad antibiotics.
Age: 72.0
Sex: F
Vaccine: FLUC3
Symptoms: Legionella test, Mycoplasma test, Pyrexia, Typhus rickettsia test, Urine analysis normal
Clinical narrative: Post injection flu vaccine febrile illness (T 100 -> 104 degrees F) x 13 days requiring hospitalization. No response to broad antibiotics.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Drooling, Dysgeusia, Erythema, Eye irritation, Eye patch application
Clinical narrative: Developed Bell's Palsy 3-4 weeks after taking ZOSTAVAX (shingles vaccine). November 20, 2015 had ZOSTAVAX. Left arm very sore and red for two weeks. Dec. 15, 2015 headache and right eye burning. Went to ophthalmologist who said the eye lid doesn't close when you blink. He put lubricating gel in the eye and patched it over night. As the day progressed so did symptoms. Nothing I ate tasted right all day which developed into numbness on right side of my mouth, liquids drooled out, I bit my lip when I chewed and couldn't smile right. December 16, 2015 went back to ophthalmologist who confirmed I had Bell's Palsy. At 1100 I went to neurologist who also confirmed I had Bell's Palsy. He order me drop dose pack and acyclovir. Literature says Bell's often preceded by a virus. I am not diabetic.