chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse via Poison and Drug Center (PDC) (MFR# US15-036295) referring to a patient of unknown gender, between the age of 6 years and 12 years old. There was no medical history, drug reaction or concomitant medication reported. The reporter stated the single-dose vial of PROQUAD (Merck) underwent temperature excursion as follows: on 26-MAY-2015, 5.3 degrees Celsius for 2 hours and 8 minutes. On 23-JUN-2015 the patient was vaccinated with the PROQUAD (Merck) lot # K014798, expiration date: 12-MAR-2016 (dose, strength, frequency, route and indication were not reported). No adverse event was reported. This is one of several reprots received from the same source: US15-036288, US15-036289, US15-035294, US15-036293, US15-036292, US15-036291, US15-036290. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician via a company representative referring to 5 patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with second doses of PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). Concomitant drug was not reported. On unknown dates the 5 patients all experienced local injection site reaction. It was unknown whether the patients sought medical attention. The outcome of the causality were unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient 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 a dose of PNEUMOVAX23 (dose, route of administration, lot # and expiration date were not reported). On an unkonwn date, the patient experienced hives after administration of PNEUMOVAX23. The patient sought an unspecified type of medical attention. The outcome of hives was reported as recovered on an unknown date. The relatedness between the hives and the vaccination with PNEUMOVAX32 was not reported. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician via a company representative referring to a 80 years old female patient. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and lot# were not reported) to prevent shingles. On 08-AUG-2015 the patient experienced an "outbreak of varicella". The patient went to an unspecified urgent care facility for medical attention. The patient was treated with prednisone and sent home. The outcome of the event was unknown. Causality was not reported. Additional information is not expected because the physician would not like to be contacted.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 13 year old female patient. Patient's medical history, concurrent conditions and concomitant therapy were not reported. On approximately July 2015 (reported as sometime last week), the patient was vaccinated with a first dose of GARDASIL (lot number, Expiry date, dose and route were not reported). It was reported that the patient fainted after receiving GARDASIL. No other vaccines were administered. The patient was given apple juice and was fine. The relatedness between the event and GARDASIL was not reported. Additional information is not expected due to no consent for follow up.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006960, expiration date 19-FEB-2017, strength, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: This spontaneous report as received from a registered nurse via company representative refers to a 12 year old non-pregnant female patient. The patient's medical history was not reported. In approximately June 2015 (reported as 2 months ago), the patient was vaccinated with her first dose of GARDASIL (route, site of administration, lot # and expiration date were not reported). In approximately 2015 (reported as after receiving GARDASIL), the patient experienced vaccination site erythema and vaccination site was swollen. On an unknown date, a phone call from the patient was placed to the nurse. The patient was advised to treat the injection site with ice and to take ibuprofen as needed. The outcome of events was reported as resolved in approximately 2015. The relatedness between the events and GARDASIL was not reported. Additional information is not expected, because there was no consent to contact the reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K003422 with expiration date 06-MAR-2016; does, route of administration 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age. There was no information about the patients' medical history and concurrent condition. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # K020216, expiration date: 17-SEP-2016; lot # L007558, expiration date: 10-NOV-2016)(strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of the reports received from the same reporter. 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 licensed vocational nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot # K003422 with expiration date 06-MAR-2016; dose, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a physician referring to a 69 year old male patient. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot#, strength and route were unknown). The patient developed a case of shingles and unspecified lesions on his legs an unspecified amount of time after receiving the vaccine. It was unspecified whether the unspecified lesions on the patient's legs were related to the case of shingles. The patient sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant, refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant therapies were not reported. The patient received the first and the second dose of VAQTA (batch #, Lot #, an expiration date, dose and route of administration were not provided) on an unspecified date in 2006 and on an unspecified date in 2013, respectively. Subsequently, on 03-AUG-2015 the patient was inadvertently vaccinated with the third dose of VAQTA (batch #, Lot #, an expiration date, dose and route of administration were not provided). No adverse experience was reported. Additional information has been requested.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a 51 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX, (dose 1, lot# K003604 with expiry date 20-MAR-2015; dose and route were not reported). On 03-AUG-2015 the patient was inadvertently vaccinated with a second dose ZOSTAVAX, (lot # L006379 with expiry date 25-MAY-2015; dose and route were not reported (extra dose administered). No adverse experience had been observed or reported. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Arthralgia, Blood pressure fluctuation, Dizziness, Headache
Clinical narrative: This case was reported by a consumer and described the occurrence of abdominal pain in a female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). Concurrent medical conditions included multiple allergies (allergic to shellfish; iodine; latex; all sulfa drugs; and SEPTRA), factor v deficiency and Grave's Disease. Concomitant products included FARXIGA, levothyroxine, Loratadine, metformin, methocarbamol, nabumetone, ATIVAN and BENADRYL (nos). On 1st August 2015 15:00, the patient received BOOSTRIX. On 4th August 2015, 3 days after receiving BOOSTRIX, the patient experienced abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain. The patient was treated with BENADRYL (nos) and ADVAIR. On an unknown date, the outcome of the abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain were not recovered/not resolved. It was unknown if the reporter considered the abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain to be related to BOOSTRIX. Additional information provided: Husband reporting wife received a tetanus vaccine and started experiencing unusual symptoms about 4 days later. The issues seem to be getting worse. She went to ER last night, but was not hospitalized. She was told she was having a potential allergic reaction, and given a dose of BENADRYL and ADVAIR. Husband does not know if issues are related to vaccine, but he says they are wondering if it may have set off her Factor 5 issues or her Graves Disease. Wife received tetanus shot because she cut herself with a hunting knife. She is scheduled to see a specialist on Monday 10-Aug-2015.
Sex: F
Vaccine: TDAP
Symptoms: Hyperhidrosis, Myalgia, Tremor
Clinical narrative: This case was reported by a consumer and described the occurrence of abdominal pain in a female patient who received BOOSTRIX (batch number NL7K3, expiry date 15th September 2017). Concurrent medical conditions included multiple allergies (allergic to shellfish; iodine; latex; all sulfa drugs; and SEPTRA), factor v deficiency and Grave's Disease. Concomitant products included FARXIGA, levothyroxine, Loratadine, metformin, methocarbamol, nabumetone, ATIVAN and BENADRYL (nos). On 1st August 2015 15:00, the patient received BOOSTRIX. On 4th August 2015, 3 days after receiving BOOSTRIX, the patient experienced abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain. The patient was treated with BENADRYL (nos) and ADVAIR. On an unknown date, the outcome of the abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain were not recovered/not resolved. It was unknown if the reporter considered the abdominal pain, headache, sweating, change in blood pressure, muscle pain, shakiness, dizziness and joint pain to be related to BOOSTRIX. Additional information provided: Husband reporting wife received a tetanus vaccine and started experiencing unusual symptoms about 4 days later. The issues seem to be getting worse. She went to ER last night, but was not hospitalized. She was told she was having a potential allergic reaction, and given a dose of BENADRYL and ADVAIR. Husband does not know if issues are related to vaccine, but he says they are wondering if it may have set off her Factor 5 issues or her Graves Disease. Wife received tetanus shot because she cut herself with a hunting knife. She is scheduled to see a specialist on Monday 10-Aug-2015.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker/clinical medical assistant and refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, route of administration, lot numbers and expiry dates were not reported). No adverse effect was reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse referring to an 11 year old female patient. There was no medical history or concurrent condition reported. On an unknown date, when the patient was a child, she was vaccinated with the first dose of M-M-R II (dosage, strength, route and indication were not reported). The patient had not been revaccinated prior to elementary school entry. On 06-AUG-2015 the patient went to office to vaccinated with M-M-R II dose 2 (dosage, strength, route and indication were not reported)(Inappropriate schedule of drug administration). At the time of the report, no adverse effect was reported. The outcome of the event was unknown. Additional information is not expected because the reporter was not consented to be contacted.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB (strength, dose, frequency and route were unknown, lot # L002866, expiration date 10-NOV-2017) (Incorrect product storage). No symptoms were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter asked not to be contacted.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 25-JUN-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23, lot # K018528, expiration date 14-APR-2016 (dose and route not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified numbers of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On an unknown date the patients were vaccinated with improperly stored GARDASIL (lot# K011562, expire date 08-APR-2017) (dose, strength and route unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age. There was no information about the patients' medical history and concurrent condition. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX23 (SDV)(strength, dose and route unknown) (Lot #: K008927, expiration date: 17-MAR-2016; lot # K016294, expiration date: 28-APR-2016) and PNEUMOVAX23 (syringes) (strength, dose and route unknown) (Lot #: L007720, expiration date: 08-JUL-2016; lot # K010466, expiration date: 23-MAR-2016). There was no information about concomitant therapy. No adverse effects were reported. This is one of the reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Type 1 diabetes mellitus
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to a 17 year old non-pregnant female patient. The patient's pertinent medical history and concurrent condition were not reported. On unknown dates the patients was vaccinated with the first and second doses of GARDASIL (dose and strength unknown) intramuscularly in the arm. In 2010 the patient completed all the 3 doses of the vaccine. Concomitant medication was not reported. In 2012, the patient was diagnosed with type 1 diabetes mellitus. The patient sought medical attention. At the time of reporting, the outcome of the event was unknown. The patient's mother thought it was the GARDASIL that caused her daughter's adverse event. The causality from the reporter was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age. There was no information about the patients' medical history and concurrent condition. On unknown dates the patients were vaccinated with improperly stored GARDASIL (lot # K001500, expiration date: 05-MAY-2017; lot # K008213, expiration date: 17-DEC-2016; lot # K001500, expiration date: 06-NOV-2016) (strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified numbers of patients of unknown age. There was no information about the patients' medical history and concurrent condition. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (lot # K019372, expiration date: 16-JUL-2016) (strength and dose unknown, oral). Lot# K089901 (expiration date: 08-MAY-2016) was not a valid lot number for ROTATEQ. There was no information about concomitant therapy. No adverse effects were reported. This is one of the reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about medical history and concurrent condition was not reported. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot# L002041 with expiration date of 27-JUL-2016 and lot# L013188 with expiration date of 02-NOV-2016; strength, dosage, frequency and route unspecified) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Carpal tunnel syndrome, Electromyogram abnormal, Muscular weakness, Neuralgia, Paraesthesia
Clinical narrative: Diffuse paresthesias with neuralgia in hands and (R) calf paresthesia with diffuse weakness post DTap vaccination on 11-5-2012. Ongoing symptoms.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site blisters in a 4-year-old female patient who received KINRIX (batch number NS74P, expiry date 20th March 2017). On 1st July 2015, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On 1st July 2015, less than a day after receiving KINRIX, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown. It was unknown if the reporter considered the injection site blisters to be related to KINRIX. Additional details were provided as follows: The patient experienced several quarter sized blisters at the injection site (right thigh).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, DTAPIPV
Symptoms: Injection site vesicles
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site blisters in a 4-year-old female patient who received KINRIX (batch number NS74P, expiry date 20th March 2017). On 1st July 2015, the patient received the 1st dose of KINRIX (intramuscular) .5 ml. On 1st July 2015, less than a day after receiving KINRIX, the patient experienced injection site blisters. On an unknown date, the outcome of the injection site blisters was unknown. It was unknown if the reporter considered the injection site blisters to be related to KINRIX. Additional details were provided as follows: The patient experienced several quarter sized blisters at the injection site (right thigh).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unkonwn age with hypertension and hypercholesterolaemia. The patient had no drug reactions/allergies. On 07-AUG-2015, the patient was vaccinated with ZOSTAVAX (dose, route not provided, batch number reported as L011536, expiration date 03-JUL-2016). Concomitant therapies included atorvastatin and losartan potassium (manufacturer unknown). On 09-AUG-2015, the patient developed a "baseball-sized', red, raised, warm knot at the injection site. The patient came to pharmacy but no lab diagnostics studies done nor treatment was given for the events. The outcome of injection site warmth, injection site mass and injection site erythema was reported as not recovered/not resolved. Additional information is not expected because the reporter was not consented to be contacted.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist referring to a male patient of unkonwn age with hypertension and hypercholesterolaemia. The patient had no drug reactions/allergies. On 07-AUG-2015, the patient was vaccinated with ZOSTAVAX (dose, route not provided, batch number reported as L011536, expiration date 03-JUL-2016). Concomitant therapies included atorvastatin and losartan potassium (manufacturer unknown). On 09-AUG-2015, the patient developed a "baseball-sized', red, raised, warm knot at the injection site. The patient came to pharmacy but no lab diagnostics studies done nor treatment was given for the events. The outcome of injection site warmth, injection site mass and injection site erythema was reported as not recovered/not resolved. Additional information is not expected because the reporter was not consented to be contacted.
Age: 15.0
Sex: F
Vaccine: MEN
Symptoms: Headache, Vomiting
Clinical narrative: Severe headache, caused vomiting, lasting 4 days.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Nausea, Vomiting
Clinical narrative: Progressive severe right shoulder and upper arm pain followed by nausea and vomiting. Treated symptomatically with IV fluids, antiemetics and pain meds.
Age: 15.0
Sex: M
Vaccine: HPVX
Symptoms: Body temperature increased, Chills, Dizziness, Fatigue, Injection site pain
Clinical narrative: Pain at injection site, general body aches, fatigue, dizziness, chills, temp 100 degrees F.
Age: 15.0
Sex: M
Vaccine: HPVX
Symptoms: Pain
Clinical narrative: Pain at injection site, general body aches, fatigue, dizziness, chills, temp 100 degrees F.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Redness at injection site; the following day swelling and heat at site, then itching set in hours later and has continued (today is Friday, 8/15).
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Mass, Pain, Pyrexia
Clinical narrative: Soreness, lump, redness, heat, and low grade fever to 100F.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: "Felt like a bee sting exactly 24 hours after I got the vaccine."  A 3 centimeter raised red circumference was noted on the left arm tricep area.  It has a dark center (slighly purple in color). It is painful.  Is taking Benadryl at night to help with the reaction.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Asthenia, Burning sensation, Chest discomfort, Dyspnoea, Musculoskeletal stiffness
Clinical narrative: Pt started with complaints of arms hurting badly, stiff neck, weakness, paleness and heaviness in his chest. He was given NSAIDS as needed. He was checked by nurse at Health Center. He had intermittent fever and complaints over three days, but then had one day of improvement. However on 07/12/15 he woke up with hives and difficulty breathing. He was taken to urgent care and prescribed prednisone and Benadryl use every 4 hours. The next day, he developed worsening of hives into welts with sensation of "burning up inside". His tongue became hot, red and swollen. He was taken to ER and given epinephrine shot and monitored. He was able to be released, but symptoms worsened again later in the day. The doctor was contacted and prescribed Allegra in addition to Benadryl and prednisone as well as increased fluids. Symptoms came intermittently over next few days with hives appearing to move around his body, but he had no further difficulty with his breathing.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Oral discomfort, Pain in extremity, Pallor, Pyrexia, Swollen tongue
Clinical narrative: Pt started with complaints of arms hurting badly, stiff neck, weakness, paleness and heaviness in his chest. He was given NSAIDS as needed. He was checked by nurse at Health Center. He had intermittent fever and complaints over three days, but then had one day of improvement. However on 07/12/15 he woke up with hives and difficulty breathing. He was taken to urgent care and prescribed prednisone and Benadryl use every 4 hours. The next day, he developed worsening of hives into welts with sensation of "burning up inside". His tongue became hot, red and swollen. He was taken to ER and given epinephrine shot and monitored. He was able to be released, but symptoms worsened again later in the day. The doctor was contacted and prescribed Allegra in addition to Benadryl and prednisone as well as increased fluids. Symptoms came intermittently over next few days with hives appearing to move around his body, but he had no further difficulty with his breathing.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Tongue discolouration, Urticaria
Clinical narrative: Pt started with complaints of arms hurting badly, stiff neck, weakness, paleness and heaviness in his chest. He was given NSAIDS as needed. He was checked by nurse at Health Center. He had intermittent fever and complaints over three days, but then had one day of improvement. However on 07/12/15 he woke up with hives and difficulty breathing. He was taken to urgent care and prescribed prednisone and Benadryl use every 4 hours. The next day, he developed worsening of hives into welts with sensation of "burning up inside". His tongue became hot, red and swollen. He was taken to ER and given epinephrine shot and monitored. He was able to be released, but symptoms worsened again later in the day. The doctor was contacted and prescribed Allegra in addition to Benadryl and prednisone as well as increased fluids. Symptoms came intermittently over next few days with hives appearing to move around his body, but he had no further difficulty with his breathing.
Age: 17.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Blood pressure systolic decreased, Syncope
Clinical narrative: Patient fainted 10 minutes after injection of Gardasil and Varivax. Blood pressure low at SBP of 88.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Patient woke up this morning with red bumps all over her body.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Reports 2 hours after vaccination breaking out in welts and having difficulty breathing. Resolved after administration of Benadryl.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Confusional state, Delusion, Dizziness, Fatigue
Clinical narrative: Pain in arm, staggered walking, spinal tap, dizzy, delusions, headaches, weakness, high fever-103.9, frequent urination, confused, 2 grand mal seizures, incoherent speech, ventilator-3 days, tiredness.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Gait disturbance, Generalised tonic-clonic seizure, Headache, Incoherent, Lumbar puncture
Clinical narrative: Pain in arm, staggered walking, spinal tap, dizzy, delusions, headaches, weakness, high fever-103.9, frequent urination, confused, 2 grand mal seizures, incoherent speech, ventilator-3 days, tiredness.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Mechanical ventilation, Pain in extremity, Pollakiuria, Pyrexia
Clinical narrative: Pain in arm, staggered walking, spinal tap, dizzy, delusions, headaches, weakness, high fever-103.9, frequent urination, confused, 2 grand mal seizures, incoherent speech, ventilator-3 days, tiredness.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Pruritus, Rash erythematous, Rash vesicular
Clinical narrative: Multiple red vesicular lesions on arms, back, legs and chin. Very itchy, beginning 2 days after IMZ administration. Returned to clinic on 8/12/15 for treatment, given instructions for Calamine/Caladryl OTC lotions.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red spot around the injection site.  Gradually increased over the next 2 days. Now the area is 6cm of erythema, slightly swollen, no induration, no pain, no fever.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, raised area at injection site with itching.  Area approximately 3 inches in diameter.  Ice pack given by pharmacist to apply to area on 8-14-15. Pt took Benadryl hour later. Gave her another ice pack at 1:45pm and a box of diphenhydramine at no cost.
Age: 43.0
Sex: M
Vaccine: TDAP
Symptoms: Disturbance in attention, Dizziness, Malaise, Pain in extremity
Clinical narrative: Lightheadedness, Malaise, Arm pain (improving), decrease concentration.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Hyperhidrosis, Somnolence
Clinical narrative: During 15 minute wait period past shots (vaccines), parent reported child was sweaty and sleepy. Noted child's palm moist but child responsive. Provided cool fan air and cool compress. Parent provided drink. Condition improved. Respirations 18, and heart rate 92 initially and past. The parent declined 911. Will monitor for problems at home. No past history of syncope after shots.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Crying, Dizziness, Feeling hot, Headache
Clinical narrative: AT APPROXIMATELY 6:00PM, CHILD STARTED CRYING STATING HIS ARM HURT, HAD A HEADACHE, FELT LIGHTHEADED, NAUSEOUS. FELT "HOT". TYLENOL GIVEN PER MOM. CHILD STARTED TO FEEL BETTER. WENT TO SLEEP. APPROXIMATELY 3:30 AM, ARM HURT AGAIN, NAUSEOUS, LIGHTHEADED, TEMP 100.3. TYLENOL GIVEN. VOMITED A FEW MINUTES LATER. BACK TO SLEEP. AT 9:00AM, PATIENT C/O PAIN AND HEAD HURTS. LEGS ALSO HURT. MOTRIN GIVEN BY MOM AT 10:30AM. MOM SPOKE WITH PRIMARY CARE PROVIDER WHO ASSURED HER THIS WAS A NORMAL REACTION TO THE VACCINE. AT 2:30PM 8-14-15 MOM CONTACTED HD TO NOTIFY STAFF OF REACTION. CHILD FEELS OKAY.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: AT APPROXIMATELY 6:00PM, CHILD STARTED CRYING STATING HIS ARM HURT, HAD A HEADACHE, FELT LIGHTHEADED, NAUSEOUS. FELT "HOT". TYLENOL GIVEN PER MOM. CHILD STARTED TO FEEL BETTER. WENT TO SLEEP. APPROXIMATELY 3:30 AM, ARM HURT AGAIN, NAUSEOUS, LIGHTHEADED, TEMP 100.3. TYLENOL GIVEN. VOMITED A FEW MINUTES LATER. BACK TO SLEEP. AT 9:00AM, PATIENT C/O PAIN AND HEAD HURTS. LEGS ALSO HURT. MOTRIN GIVEN BY MOM AT 10:30AM. MOM SPOKE WITH PRIMARY CARE PROVIDER WHO ASSURED HER THIS WAS A NORMAL REACTION TO THE VACCINE. AT 2:30PM 8-14-15 MOM CONTACTED HD TO NOTIFY STAFF OF REACTION. CHILD FEELS OKAY.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient seen 8/14 for left arm pain after recieving Pneumovax 23 vaccine 8/13/2015.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Soreness in Right arm/deltoid.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Asthma, Condition aggravated, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Woke up with an asthma attack, has not had one in two years. She was sweating, hot, and nauseated. She threw up and felt dizzy and the symptoms last for about an hour. She laid down to relieve any symptoms and took Albuterol for her asthma.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Vomiting
Clinical narrative: Woke up with an asthma attack, has not had one in two years. She was sweating, hot, and nauseated. She threw up and felt dizzy and the symptoms last for about an hour. She laid down to relieve any symptoms and took Albuterol for her asthma.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Lethargy, Muscular weakness, Speech disorder
Clinical narrative: Weakness, Lethargy, difficulty speaking, difficulty with speech, muscle weakness in lower extremeties.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth
Clinical narrative: Developed induration, hard, warm at site. Redness was the size of a tennis ball. Next day, redness covered most of upper arm, warm/hot to touch, blister formation on the hard induration that would be center of injection site.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Herpes zoster, Pain, Rash
Clinical narrative: Shingles outbreak (rash) on upper left chest wrapping around to upper left back. Rash is still present, however, in the last stages of healing. Patient also reported localized pain and heat during first week of outbreak.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Mass
Clinical narrative: 8/4/15-SORE NECK ON THE LEFT (CONTINUES), 8/5/15-A LUMP ON THE LEFT SIDE NEAR COLLAR BONE WAS FELT AND THERE FOR ALMOST 2 WEEKS. 8/5/15-ARM HAD RED PATCH AND WAS RAISED AND HARD ABOUT 2-3 INCHES BELOW WHERE THE SHOT WAS GIVEN (RESOLVED BY 8/12). 8/12/15- LEFT SIDE OF NECK AND SHOULDER STILL SORE AND NOW HAVE TINGLING IN ARM.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Paraesthesia
Clinical narrative: 8/4/15-SORE NECK ON THE LEFT (CONTINUES), 8/5/15-A LUMP ON THE LEFT SIDE NEAR COLLAR BONE WAS FELT AND THERE FOR ALMOST 2 WEEKS. 8/5/15-ARM HAD RED PATCH AND WAS RAISED AND HARD ABOUT 2-3 INCHES BELOW WHERE THE SHOT WAS GIVEN (RESOLVED BY 8/12). 8/12/15- LEFT SIDE OF NECK AND SHOULDER STILL SORE AND NOW HAVE TINGLING IN ARM.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site rash, Insomnia, Pyrexia, Rash
Clinical narrative: Here with mom who reports that about a day after the shots, he broke out in spots (first on L arm, and then spread arms, legs, face) and low-grade temp about the day after his shots (which included MMRV). Overnight, the fever got up to 103.8 and again up to 103 last night. During the day, low-grade tactile temp. Mom appied calamine lotion, thinks maybe it has been making him less miserable. No scratching, but she worries that "he has an itch he doesn't know to itch" Has been giving him Tylenol, which helps a bit, but both haven't slept the last couple days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site hypoaesthesia
Clinical narrative: Patient states he experienced some numbness around injection site. A strip of area about 3-4 inches long and about an inch wide laterally across injection site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Rash erythematous, Skin warm, Vaccination complication
Clinical narrative: One day after the vaccination, I felt all the problems in the pamphlet the nurse gave to me but after the 5th day, a red rash shows up and my arm feels hot but the rash dissappeared after 3 days.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, MMRV
Symptoms: Gait disturbance, Injection site swelling
Clinical narrative: Swelling of left thigh around shot area Measuring 16.5cm X 11cm with an area close to inner thigh measuring 13cm X 6.5 cm started the morning after shots and increased in size, he limps on that leg.  No fever.  Treated with warm compresses, ibuprofen and Benadryl.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Nausea, Pain, Pyrexia
Clinical narrative: Fever of 101 degrees F, body aches, weakness, nausea.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Altered state of consciousness, Apparent life threatening event, Decreased activity, Decreased appetite, Eye movement disorder
Clinical narrative: After nap woke up and was very pale with duskiness around lips, awake but not active - lasted 10 min. 911 called. Had resolved by arrival at ER. This is a 10-week-old previously healthy male presents to the emergency department after a witnessed apparent life-threatening event at home. His parents are both physicians and report that today the child received his 2 month vaccinations. After they came home the child naps and mom attempted to breast-feed the child. He fed well but did not complete atypical feeding. After this she handed the child to dad. While dad was holding the child he noted that the child lost all color from head to toe. His lips turned a dusky gray and the child's eyes appeared to be placed over though he did not appear did lose consciousness completely. He had no seizure activity. Dad thought his tone decreased slightly. He had no signs of respiratory distress. EMS was called immediately and they came to the emergency department. About 5 min before arrival in the ER, the parents report resolution of the symptoms. At the time of my evaluation in the ER, the child seems to be back to his baseline. This has never happened before.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypotonia, Lip discolouration, Pallor
Clinical narrative: After nap woke up and was very pale with duskiness around lips, awake but not active - lasted 10 min. 911 called. Had resolved by arrival at ER. This is a 10-week-old previously healthy male presents to the emergency department after a witnessed apparent life-threatening event at home. His parents are both physicians and report that today the child received his 2 month vaccinations. After they came home the child naps and mom attempted to breast-feed the child. He fed well but did not complete atypical feeding. After this she handed the child to dad. While dad was holding the child he noted that the child lost all color from head to toe. His lips turned a dusky gray and the child's eyes appeared to be placed over though he did not appear did lose consciousness completely. He had no seizure activity. Dad thought his tone decreased slightly. He had no signs of respiratory distress. EMS was called immediately and they came to the emergency department. About 5 min before arrival in the ER, the parents report resolution of the symptoms. At the time of my evaluation in the ER, the child seems to be back to his baseline. This has never happened before.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site pruritus, Injection site reaction, Pruritus, Rash erythematous
Clinical narrative: Patient received PREVNAR 13 vaccination on 8/6/15. Patient came into pharmacy on 8/12/15, complaining of itching left arm at injection site. Arm was red rash front deltoid to mid upper arm. Arm was hot to touch, red, blotchy and itchy.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Rash macular, Skin warm
Clinical narrative: Patient received PREVNAR 13 vaccination on 8/6/15. Patient came into pharmacy on 8/12/15, complaining of itching left arm at injection site. Arm was red rash front deltoid to mid upper arm. Arm was hot to touch, red, blotchy and itchy.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness in right thigh-baby crying  in pain-afebrile (98.4 axil).
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: 7-29-15 received PREVNAR. 8-5-15 swelling and itching at site. Some swelling down arm into (L) index finger. 8-12-15 swelling resolved + (L) finger resolved swelling.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Left deltoid area 3 inches x 3/5 inches=of induration, warmth, and erythema itchy, warm.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pain, Swelling
Clinical narrative: 7-12-15 immunizations given. 7-13-15 pain and swelling (Mother reports swelling increased tennis ball size). Went to ER. They recommended "ZYRTEC" and vaccine Tdap avoidance. 7/14 swelling reduced per mother swelling measured at approx 50 mm/diameter both directions.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Induration, Nodule, Skin discolouration, Swelling
Clinical narrative: I examined patient 15 days post vaccination. Mom reported a hard knot and swelling the following day. Returned to our office at 2 weeks because the area is still discolored. Doesn't bother patient. She acts normal with full range of motion. Appears to me that subcutaneous tissue is gone resulting in dermis adhering to muscle of left thigh.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient had vaccines 8/12/15 now had red and swollen right arm. Seemed worse 8/13/15 evening, has been itchy. No fever. Good use of arm, no oozing or drainage. Area seems less inflamed now than yesterday. Got ibuprofen. Area is red, oval 3x5 cm mildly tender macular on (R) upper arm at site of MMRV injection.
Age: 94.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Headache, cough and red ring about 14 cm diameter at injection site. Area reddened and warm and itchy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Abasia, Arthralgia, Joint effusion, X-ray of pelvis and hip abnormal
Clinical narrative: 15 hours after vaccination, patient awoke unable to walk due to pain in left knee. X ray demonstrates small effusion in left hip. to see orthopedics.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature increased, Flushing, Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Vaccine given 8/11/15, mom noticed 8/13/15 at 8:30 am pt had red rash around the injection site, right thigh lesion about 2" c 2" in diameter that is red with some induration noted, temp 99.4, vomited once, fussy, flushed.
Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Irritability, Rash erythematous, Skin lesion, Vomiting
Clinical narrative: Vaccine given 8/11/15, mom noticed 8/13/15 at 8:30 am pt had red rash around the injection site, right thigh lesion about 2" c 2" in diameter that is red with some induration noted, temp 99.4, vomited once, fussy, flushed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Area where injected became very sore. Area is warm to touch and red. This occurred around 4 hours post vaccination. Iced area - did help reduce redness.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site lasting longer than 2 weeks.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Redness/itching rash around injection site. Approximately 4 inches in diameter. Presented within 24 hrs of injection-pt reported to pharmacy 3 days post-injection. Hydrocortisone cream used. Currently ongoing; not worsening.
Age: 19.0
Sex: F
Vaccine: YF
Symptoms: Pruritus, Rash
Clinical narrative: Pt got the shot and called the pharmacy about an hour later to report of rash and itching symptoms. Pt was advised to seek a medical care as soon as possible. Pt went to urgent care and got treated and recovered.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 16-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: L003855 and Expiry: 05-FEB-2015) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On 05-AUG-2015 the patient was vaccinated with a dose of (Oka-Merck) PROQUAD (lot # K010210 with expired date 17-JAN-2016, dose and route were unspecified) and a dose of (Oka/Merck) VARIVAX (lot# K021487 with expired date 03-NOV-2016, dose and route were unspecified). No concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L007558, Exp. 10-NOV-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports received from the same reporter. Additional information has been requested.