chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Facial pain, Feeling abnormal, Headache, Herpes zoster
Clinical narrative: Patient received the zoster vaccine on 9/28/15. He presented to his PCP on 10/6/15 with a rash on the left side of his face with pain, a headache, and hearing loss. Physical exam revealed swelling as well and a patch near the left ear. PCP notes patient reports sx started shortly after vaccine was administrated. Diagnosis of facial zoster was made. Patient was dispensed valacyclovir from office stock. Valacyclovir 1000 mg TID.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Patient received the zoster vaccine on 9/28/15. He presented to his PCP on 10/6/15 with a rash on the left side of his face with pain, a headache, and hearing loss. Physical exam revealed swelling as well and a patch near the left ear. PCP notes patient reports sx started shortly after vaccine was administrated. Diagnosis of facial zoster was made. Patient was dispensed valacyclovir from office stock. Valacyclovir 1000 mg TID.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an inadvertently RECOMBIVAX HB, lot number K009953, expiration date 03-APR-2016 which had been improperly stored. There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter (case # 1511USA004005). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Vaccination complication
Clinical narrative: Information has been received from an ID specialist as part of a marketing research program conducted, referring to unknown patients  of unknown age and gender. There was no concurrent condition or medical history reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dosage, strength, route and lot # not reported). There was no concomitant medication reported. The reporter stated that the patients experienced rash type reaction in site area of vaccine, red area/ cellulitis a few days after vaccination (saw it maybe once every few years), fever and achiness. The outcome of the events was unknown. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Abdominal pain upper, Asthenia, Blood pressure increased, Chest pain, Diarrhoea
Clinical narrative: Pt started feeling pain the day after vaccine (01/13/15). Area is red and swollen. Her stated that he was in the ER due to the pain. It radiated across his chest. BP also increased. Stomach pain, feeble, vomit, diarrhea.
Age: 67.0
Sex: U
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling, Pain, Vomiting
Clinical narrative: Pt started feeling pain the day after vaccine (01/13/15). Area is red and swollen. Her stated that he was in the ER due to the pain. It radiated across his chest. BP also increased. Stomach pain, feeble, vomit, diarrhea.
Age: 0.63
Sex: F
Vaccine: FLU4
Symptoms: Cough, Irritability, Pyrexia
Clinical narrative: Flu vaccine #2 given  11-12-15 in office pt seen 11-16-15 for fever (103.6 T Max) x 4 days. Began approx 24 hours after shot. Fussy; occasional cough. Had fever x 1 day after Flu #1 was given. Tx with PRN TYLENOL/ IBP. Return if no improved 2-3 D or worsening.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Mydriasis, Ophthalmological examination normal, Pupil dilation procedure, Pupillary reflex impaired, Vision blurred
Clinical narrative: 12:30 vital signs 118/70-86 and O2 Sats on RA 97%. Child complained of visual disturbances. No respiratory distress noted. Eyes dilated and sluggish blurred vision. EMS called and child taken to ER. ER physician did assessment and noted to have visual disturbances and referred to Optomotrist. Full eye exam done and no specific dx identified.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Visual impairment
Clinical narrative: 12:30 vital signs 118/70-86 and O2 Sats on RA 97%. Child complained of visual disturbances. No respiratory distress noted. Eyes dilated and sluggish blurred vision. EMS called and child taken to ER. ER physician did assessment and noted to have visual disturbances and referred to Optomotrist. Full eye exam done and no specific dx identified.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Dizziness, Headache, Injection site mass, Injection site pain
Clinical narrative: After influenza vaccine injection at about 2:30 pm, pt noticed that (L) upper arm was warm to touch, painful with movement and had developed a lump the size of a golf ball then increased to the size an egg. Also developed mild elevated temp to 99 degrees F, headache, dizziness.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: After influenza vaccine injection at about 2:30 pm, pt noticed that (L) upper arm was warm to touch, painful with movement and had developed a lump the size of a golf ball then increased to the size an egg. Also developed mild elevated temp to 99 degrees F, headache, dizziness.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Dizziness
Clinical narrative: Dizzy, lightheaded, claims drop in blood pressure (actual BP unknown).
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site bruising, Injection site erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported itching after injection. Her arm was sore later that evening. Her arm started to swell and turned red that evening. The red area surrounding the injection site increased in size over a 24 hour period. She developed a bruise from injection. She went to doctor and was prescribed KEFLEX 500 mg twice daily for 1 week. Her arm remains sore 1 week after administration.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: Patient reported itching after injection. Her arm was sore later that evening. Her arm started to swell and turned red that evening. The red area surrounding the injection site increased in size over a 24 hour period. She developed a bruise from injection. She went to doctor and was prescribed KEFLEX 500 mg twice daily for 1 week. Her arm remains sore 1 week after administration.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Oedema peripheral, Pain
Clinical narrative: (L) arm edema/induration 7 cm minimal erythema and ROM secondary pain.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an inadvertently GARDASIL, lot number J010668, expiration date 29-APR-2016 and lot number K009482, expiration date 06-MAR-2017, which had been improperly stored (incorrect product storage). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same reporter (case # 1511USA008404). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient in her 50's. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (route of administration, dose, lot number and expiration date were not reported). On an unknown date, the patient experienced a "very large red swollen area down her arm". The outcome of the events was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of (Merck) PROQUAD L026728; expiry: 15-JAN-2017, L030587; expiry: 10-FEB-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Burning sensation, Muscle spasms, Neck pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a 37 year old male consumer with no pertinent medical history and no drug reactions or allergies reporting on himself. On 02-NOV-2015, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (dose, route and lot # not reported) the left arm. There was no concomitant medication. The consumer reported that on 02-NOV-2015, right after he received the vaccine, he experienced a burning sensation. His shoulder felt like "Charlie horse" or cramp. The consumer reported that he could not sleep through the night because his left arm was aching. His left peck was also in pain and he believed that this would affect his heart. There was a constant cramp in his chest area. TYLENOL was given as treatment for the adverse events. On an unspecified date the patient underwent a blood work for a wellness check (results were not provided). At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: This spontaneous report was received from a 37 year old male consumer with no pertinent medical history and no drug reactions or allergies reporting on himself. On 02-NOV-2015, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX23 (dose, route and lot # not reported) the left arm. There was no concomitant medication. The consumer reported that on 02-NOV-2015, right after he received the vaccine, he experienced a burning sensation. His shoulder felt like "Charlie horse" or cramp. The consumer reported that he could not sleep through the night because his left arm was aching. His left peck was also in pain and he believed that this would affect his heart. There was a constant cramp in his chest area. TYLENOL was given as treatment for the adverse events. On an unspecified date the patient underwent a blood work for a wellness check (results were not provided). At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to two patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck), lot # L023114, expiration date 24-DEC-2016, (dose was not provided). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Immunodeficiency
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date, exact dose and route of administration were not reported) or PREVNAR (lot #, expiration date, exact dose and route of administration were not reported). The patient was a poor historian and could not provide which vaccine he was administered with in the past. On an unknown date, the patient was seeing a rheumatologist for an unknown reason and he became immunocompromised. It was unknown if he became immunocompromised prior to or after possibly getting the vaccine. It was unknown if any relevant tests were done. The pharmacist reported that on an unknown date, the patient was requesting the PNEUMOVAX 23 but the pharmacist did not give it to him since he did not known if he received it previously. The outcome of immunocompromised was unknown. At the time of report, it was also unknown if the patient would receive the PNEUMOVAX 23. The relatedness between the event and both suspect therapies was not reported. Additional information has been requested.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Product name confusion, Wrong drug administered
Clinical narrative: Information has been received from a consumer via Pfizer (manufacturer report number 2015355195), concerning his wife, a female patient of unknown age. No relevant medical history or concurrent conditions were reported. The patient recently requested a PREVNAR 13 vaccine from a pharmacy, but was vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dose, route, lot# and expiration date not reported) instead (Product name confusion) on an unknown date. Concomitant therapy included influenza virus vaccine (unspecified). This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency and route were not reported) (lot# K010215 and expiration date 05-MAY-2017) and confirmed not GARDASIL (quadrivalent). M-M-R II and PNEUMOVAX23 appeared on the product list, because stability questions were asked about these products and no doses of improperly stored M-M-R II and PNEUMOVAX23 were administered. No adverse effects were reported. No Product Quality Product (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 12-NOV-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K005402, expiration date 07-NOV-2015; dose and route not reported). No adverse effects were 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 pharmacist referring to a patient of unknown age. On 11-NOV-2015 the patient was vaccinated with a dose of improperly stored GARDASIL lot # K011562 (expiration date 08-APR-2017) (Incorrect product storage). No adverse effect reported. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. The reporter stated that the patient was vaccinated with 3 doses of GARDASIL injection (exact doses, route of administration, lot# and expiry date were not reported) off the prescribing information schedule: the patient received the first dose on an unknown date in August 2014, the second dose on an unknown date in June 2015 and the third dose on 12-NOV-2015. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patiens were vaccinated with improperly stored multiple unspecified doses of RECOMBIVAX HB L004754; expiry: 10-NOV-2016, L018501; expiry: 22-JUN-2017 (dose, route and frequency unspecified). No concomitant medications were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of GARDASIL lot # K010215; expiry: 05-MAY-2017, K011562; expiry: 08-APR-2017, K016966; expiry: 10-MAY-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Accidental exposure to product, Cough, Throat tightness
Clinical narrative: This spontaneous report was received fro a licensed practical nurse via a company representative concerning herself, a female patient of unknown age who has latex allergy. No concomitant conditions or medical history were reported. On 03-NOV-2015, when the nurse opened the vial of VAQTA to administer the vaccine to the patient, she started coughing and her throat started to close up. The nurse reported that she was still coughing and clearing her throat several hour later. No Product Quality Complaint (PQC) was involved. The outcome of throat tightness and cough was reported as not recovered. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of VAQTA (L018499; expiry: 25-FEB-2017, L028666; 04-NOV-2016 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Product name confusion, Wrong drug administered
Clinical narrative: Information has been received from a male patient of unknown age via Pfizer (manufacturer report number 2015355195), concerning himself. No relevant medical history or concurrent conditions were reported. The patient recently requested a PREVNAR 13 vaccine from his pharmacy, but was vaccinated with Pneumococcal vaccine (manufacturer unknown) (dose, route, lot# and expiration date not reported) instead (Product name confusion) on an unknown date. Concomitant therapy included influenza virus vaccine (unspecified). This is one of two reports received from the same reporter. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, No therapeutic response, Product quality issue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of therapy no-responder in a 57-year-old male patient who received ENGERIX B adult. This case was associated with a product complaint. Co-suspect products included ENGERIX B adult (batch number F3BB3, expiry date 18th April 2017) and ENGERIX B adult (batch number FP393, expiry date 17th August 2015). On 9th June 2014, the patient received the 1st dose of ENGERIX B adult. On 9th March 2015, the patient received the 2nd dose of ENGERIX B adult. On 15th July 2015, the patient received the 3rd dose of ENGERIX B adult. On 15th September 2015, 1 year and 98 days after receiving ENGERIX B adult, 190 days after receiving ENGERIX B adult and 62 days after receiving ENGERIX B adult, the patient experienced therapy non-responder. On an unknown date, the patient experienced drug dose administration interval too long, drug dose administration interval too short and pharmaceutical product complaint. On an unknown date, the outcome of the therapy non-responder, drug dose administration interval too long, drug dose administration interval too short and pharmaceutical product complaint were unknown. The reporter considered the therapy non-responder to be possibly related to ENGERIX B adult and ENGERIX B adult. Additional details provided were as follows: This case was one of the seven reports reported by an occupational nurse for patients tested negative for Hepatitis B titers following vaccination with ENGERIX B (see cases US2015135763, US2015GSK136757, US2015GSK136758, US2015GSK136759, US2015GSK136760 and US2015GSK136762). The caller reported that, they had their laboratory equipment recalibrated and the tests were rerun and results were dame or even lower titres. For 2 different batches involved in this case there were 2 different National Drug Code (NDCs). The patient concerned in this case received 1st dose of ENGERIX B adult vaccine on 9th June 2014 at a different hospital and at the reporter's. Any more details about this 1st dose was not available with the reporter. On 9th March 2015, the patient received the 2nd dose, which led to lengthening of the vaccination schedule. On 15th July 2015, the patient received the 3rd dose, which led to shortening of the vaccination schedule. On 15th September 2015, 463 days after receiving 1st dose of ENGERIX B adult, 190 days after receiving 2nd dose of ENGERIX B adult and 62 days after receding 3rd dose of ENGERIX B adult, the patient underwent test  for Hepatitis B antibodies and it was found to be negative with the value of 3.4, causing the patient to be a non-responder to the therapy.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Fatigue, Injected limb mobility decreased, Injection site induration, Injection site pain
Clinical narrative: This spontaneous report was received from a 54 year old female patient reporting on herself. The patient's concurrent conditions included an allergy to a compound in amoxicillin, AUGMENTIN and doxycycline. On 29-OCT-2015, the patient was vaccinated with PNEUMOVAX 23. Concomitant therapies included atorvastatin (manufacturer unknown) and SYNTHROID. On the date that she received the dose, the patient experienced injection site induration, injection site swelling and injection site pain. The reporter also stated that "I could barely move my arm; my arm was stiff" so she left work early that day. Later, on the same date during the evening, she began to experience fatigue and malaise. During the night of 29-OCT-2015 and 30-OCT-2015, she began to have fever of 99.9F. She sought medical attention at an urgent care clinic on 30-OCT-2015. The healthcare provider at the clinic recommended her to use ice on the injection site and to take BENADRYL. The patient stated she did not like BENADRYL because it made her sleep. The following date, on 31-OCT-2015, she was instructed to use heat on her injection site. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: This spontaneous report was received from a 54 year old female patient reporting on herself. The patient's concurrent conditions included an allergy to a compound in amoxicillin, AUGMENTIN and doxycycline. On 29-OCT-2015, the patient was vaccinated with PNEUMOVAX 23. Concomitant therapies included atorvastatin (manufacturer unknown) and SYNTHROID. On the date that she received the dose, the patient experienced injection site induration, injection site swelling and injection site pain. The reporter also stated that "I could barely move my arm; my arm was stiff" so she left work early that day. Later, on the same date during the evening, she began to experience fatigue and malaise. During the night of 29-OCT-2015 and 30-OCT-2015, she began to have fever of 99.9F. She sought medical attention at an urgent care clinic on 30-OCT-2015. The healthcare provider at the clinic recommended her to use ice on the injection site and to take BENADRYL. The patient stated she did not like BENADRYL because it made her sleep. The following date, on 31-OCT-2015, she was instructed to use heat on her injection site. The outcome of the events was reported as recovering. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hypertension, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 27-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3L7MZ, expiry date 30th June 2016). On 2nd November 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 2nd November 2015, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced tingling of extremity, fever, lightheaded feeling and hypertension. On 3rd November 2015, the patient experienced cold symptoms. On an unknown date, the outcome of the tingling of extremity, fever, lightheaded feeling, hypertension and cold symptoms were recovered/resolved. It was unknown if the reporter considered the tingling of extremity, fever, lightheaded feeling, hypertension and cold symptoms to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: On 2nd November 2015, at 3:00 PM, the patient received a dose of FLUARIX QUADRIVALENT. On 2nd November 2015, at 4:00 PM, 1 hour after receiving FLUARIX QUADRIVALENT, the patient experienced tingling in the left arm, a slight fever, felt lightheaded and hypertension. The patient went to the emergency room for the events but was not admitted to the emergency department and was discharged on the same day (2nd November 2015). On 3rd November 2015, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced cold like symptoms. No further information was available.
Age: 27.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Dizziness, Hypertension, Nasopharyngitis, Paraesthesia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 27-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3L7MZ, expiry date 30th June 2016). On 2nd November 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 2nd November 2015, 1 hr after receiving FLUARIX QUADRIVALENT, the patient experienced tingling of extremity, fever, lightheaded feeling and hypertension. On 3rd November 2015, the patient experienced cold symptoms. On an unknown date, the outcome of the tingling of extremity, fever, lightheaded feeling, hypertension and cold symptoms were recovered/resolved. It was unknown if the reporter considered the tingling of extremity, fever, lightheaded feeling, hypertension and cold symptoms to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: On 2nd November 2015, at 3:00 PM, the patient received a dose of FLUARIX QUADRIVALENT. On 2nd November 2015, at 4:00 PM, 1 hour after receiving FLUARIX QUADRIVALENT, the patient experienced tingling in the left arm, a slight fever, felt lightheaded and hypertension. The patient went to the emergency room for the events but was not admitted to the emergency department and was discharged on the same day (2nd November 2015). On 3rd November 2015, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced cold like symptoms. No further information was available.
Age: 66.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: Injection site bruising
Clinical narrative: PATIENT EXPERIENCED BLACK AND BLUE BRUISE ON HIS UPPER LEFT ARM A FEW DAYS AFTER THE SHOT. Patient was instructed by doctor to take Tylenol and use ice pack for reaction.
Age: 66.0
Sex: M
Vaccine: TDAP, UNK
Symptoms: Contusion
Clinical narrative: PATIENT EXPERIENCED BLACK AND BLUE BRUISE ON HIS UPPER LEFT ARM A FEW DAYS AFTER THE SHOT. Patient was instructed by doctor to take Tylenol and use ice pack for reaction.
Age: 65.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Malaise, Sensation of foreign body
Clinical narrative: Fever, swollen throat, bloodshot weeping mucus eyes, elevated blood pressure, body joint aches, numb fingertips, chills.
Age: 65.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood pressure increased, Chills, Eye discharge, Hypoaesthesia
Clinical narrative: Fever, swollen throat, bloodshot weeping mucus eyes, elevated blood pressure, body joint aches, numb fingertips, chills.
Age: 65.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Ocular hyperaemia, Pharyngeal oedema, Pyrexia
Clinical narrative: Fever, swollen throat, bloodshot weeping mucus eyes, elevated blood pressure, body joint aches, numb fingertips, chills.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chills, Ocular hyperaemia, Pyrexia, Rhinorrhoea
Clinical narrative: Fever, swollen throat, blood shot eyes weeping mucus, elevated blood pressure, body and joint aches chills.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Blood pressure increased, Chills, Eye discharge, Ocular hyperaemia
Clinical narrative: Fever, swollen throat, blood shot eyes weeping mucus, elevated blood pressure, body and joint aches chills.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pharyngeal oedema, Pyrexia
Clinical narrative: Fever, swollen throat, blood shot eyes weeping mucus, elevated blood pressure, body and joint aches chills.
Age: 28.0
Sex: M
Vaccine: DTAP
Symptoms: Hair growth abnormal
Clinical narrative: Started growing backhair.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cold sweat, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: I received the vaccine around 10:45 AM on 11/16/15 at Public Health. Around 7:45 that evening I was struck with a sudden feeling of weakness, dizziness, nausea and I became clammy (sweating around forehead). I laid down immediately and within an hour I developed a body ache from head to toe. The body ache lasted for several hours. The nausea and light headedness seemed to go away after I laid down.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: I received the vaccine around 10:45 AM on 11/16/15 at Public Health. Around 7:45 that evening I was struck with a sudden feeling of weakness, dizziness, nausea and I became clammy (sweating around forehead). I laid down immediately and within an hour I developed a body ache from head to toe. The body ache lasted for several hours. The nausea and light headedness seemed to go away after I laid down.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: RIGHT SHOULDER PAIN, INABILITY TO MOVE ARM ABOVE HEAD. DIFFICULTY WITH FULL RANGE OF MOTION. SHOOTING PAIN FROM DELTOID TO BICEPS.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Mobility decreased, Pain
Clinical narrative: I have had left shoulder pain with certain movements since receiving the flu vaccine.  I am unable to raise my left arm over my head and can not rotate my hand into the supinate position.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Ear pain, Erythema, Headache, Hypoaesthesia, Injection site pain
Clinical narrative: Arm pain from wrist up through Left shoulder, up the neck and into the ear, numbness and tingling on the skin of L leg, enlarged axillary lymph nodes and neck nodes bilaterally, fevers over 101, general malaise, heachache, redness and swelling of site 3 inches in diameter.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Malaise, Neck pain, Pain in extremity, Paraesthesia
Clinical narrative: Arm pain from wrist up through Left shoulder, up the neck and into the ear, numbness and tingling on the skin of L leg, enlarged axillary lymph nodes and neck nodes bilaterally, fevers over 101, general malaise, heachache, redness and swelling of site 3 inches in diameter.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Swelling
Clinical narrative: Arm pain from wrist up through Left shoulder, up the neck and into the ear, numbness and tingling on the skin of L leg, enlarged axillary lymph nodes and neck nodes bilaterally, fevers over 101, general malaise, heachache, redness and swelling of site 3 inches in diameter.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Gait disturbance, Tunnel vision, Vertigo
Clinical narrative: Awakened with vertigo and difficulty walking.  Usual wake-up time is not until 11am, so went back to sleep.  When I re-awakened, I felt a bit better but continued to experience vertigo, dizziness, light-headedness and tunnel vision off and on for the remainder of the day.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient with redness and large area of swelling on the upper arm at the site of the immunization.
Age: 34.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site urticaria
Clinical narrative: Large red, raised hive at injection site.  Hive is itchy and tender; otherwise I feel fine.
Age: 51.0
Sex: F
Vaccine: TTOX
Symptoms: Asthenia, Back pain, Chest pain, Chills, Dizziness
Clinical narrative: Pain radiating from left shoulder to chest, upper back and neck. Lightheadedness, weakness and chills x 3 weeks.
Age: 51.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site pain, Neck pain
Clinical narrative: Pain radiating from left shoulder to chest, upper back and neck. Lightheadedness, weakness and chills x 3 weeks.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Abasia, Encephalitis viral, Immunoglobulin therapy, Influenza B virus test positive, Lumbar puncture normal
Clinical narrative: 10/7 - unable to walk, shaking. Had brain MRI and LP - both normal. Tested positive for influenza B and dx of viral cerebellitis. Given IVIG. Followed by Neuro and PT.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Nuclear magnetic resonance imaging brain normal, Tremor
Clinical narrative: 10/7 - unable to walk, shaking. Had brain MRI and LP - both normal. Tested positive for influenza B and dx of viral cerebellitis. Given IVIG. Followed by Neuro and PT.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Client states she has pain in left arm since receiving IM flu immuinzation.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Approximately 40 after receiving Influenza Vaccine, Participant alerted nurse she was having difficulty breathing.
Age: 1.58
Sex: M
Vaccine: DTAP, PPV
Symptoms: Abasia, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient's entire left leg swelled up, was warm and had red blotches on it. It was tender and sensitive, he was unable to walk on it for a day. He was in pain when he applied pressure or if I touched it. He developed a fever and was vomiting throughout the night.
Age: 1.58
Sex: M
Vaccine: DTAP, PPV
Symptoms: Pyrexia, Rash macular, Vomiting
Clinical narrative: Patient's entire left leg swelled up, was warm and had red blotches on it. It was tender and sensitive, he was unable to walk on it for a day. He was in pain when he applied pressure or if I touched it. He developed a fever and was vomiting throughout the night.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to an adult patient of unknown gender. On 12-NOV-2015 the patient was inadvertently vaccinated with a pediatric dose of RECOMBIVAX HB (5 microgram/0.5 ml). No adverse effect reported. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a 65 years old male patient, who was reporting on himself. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX 1 shot/one time (lot # and route of administration were not provided). On 10-NOV-2015, within 24 hours of vaccination, the patient experienced terrible rash of shingles. The event was treated with unspecified antiviral medication on the same day. The outcome of the event was reported as not recovered. The patient sought unspecified medical attention. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Urticaria
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. No medical history and concurrent conditions were reported. On an unknown date approximately in 2015 (also reported as a few weeks ago) the patient was vaccinated with GARDASIL dose 1, intramuscularly (lot number and expiry date unknown) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. On an unknown date approximately in 2015 (also reported as the day after receiving the vaccine ) the patient experienced nausea and broke out into hives (urticaria). It was reported that the patient sought medical attention and called the physician. The patient was directed to an unspecified dermatologist. It was reported that the therapy with GARDASIL was discontinued and not reintroduced. The outcome of nausea and urticaria was unknown. The relatedness of the events to the therapy with GARDASIL was unknown. There was no product quality complaint reported. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a male patient of unknown age. No patient's concurrent conditions, medical history or concomitant medications were reported. On an unknown date, the patient was vaccinated with GARDASIL the first dose (dose, route and location of administration, LOT# were not reported). On 06-NOV-2015, the patient was in the reporter's office to receive GARDASIL 9 (dose, route and location of administration, LOT# were not reported) as a second dose of the Human Papillomavirus series. No adverse effects were reported. The outcome of the events and causality assessment were not provided. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a female patient of unknown age referring to herself. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date in the mid of August 2015, the patient was vaccinated with the first dose GARDASIL (formulation, strength, dose, frequency, route and lot number were not reported). Other suspect therapies included the second dose of GARDASIL 9 injection (strength, dose, frequency, route and lot number were not reported) (interchange of vaccine products) on an unknown date in October 2015 (reported as a couple of weeks ago). No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. The outcome of the event "patient received first dose of GARDASIL and second dose of GARDASIL 9" was unknown. The reporter did not provide the causal relationship between the event "patient received first dose of GARDASIL and second dose of GARDASIL 9" and suspect therapies. 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 professional concerning an unknown number of unspecified patients. In November 2015, the patients were vaccinated with improperly stored ROTATEQ (lot # K024700, expiry date 30-SEP-2016) and, also in November 2015, with another lot of the vaccine (reported as L022446, expiry date: 14-FEB-2017). Route and dose for both lots was not reported. It was reported that the vaccination took place "since 09-NOV-2015", but since another vaccine was also involved, the exact date of administration is unknown. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Urticaria
Clinical narrative: Vaccine at approximately 1530. Hives, dizzy, lightheaded, intermittent SOB by 1600.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Neck pain, Pyrexia
Clinical narrative: Severe pain base of skull on Rt side, radiating to neck. Then resulting in severe headache. Felt feverish (low grade) no temp taken. 5 days.
Age: 40.0
Sex: F
Vaccine: FLUR3
Symptoms: Lip swelling, Swelling face
Clinical narrative: 15 minutes after vaccine, bottom lip started swelling. The next day-face was swollen.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Pain in extremity, Pruritus
Clinical narrative: Pt presented to office today with redness at injection site of Tdap given 11/12/15. Arm is red, itchy and painful. Area is 6 in x 3 in around injection site. Dr examined pt, no signs of infection. Instructed pt to take BENADRYL and use cold compresses.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Injection site rash, Rash morbilliform
Clinical narrative: Mom states that 7 days post vaccine received, pt. developed rash at injection site. She went on to say that 11-12 days post vaccine received, pt. developed measles like rash on face and torso. On day 13, rash gone. Dr. aware. No further orders.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Allergy to vaccine, Erythema, Pruritus, Urticaria
Clinical narrative: Parents noted red nose on client 11/12/15 next AM client c/o itching and redness of Rt thigh, penis and between Lt fingers. Sx increased to include hives and taken to urgent care 11/15/15 Dx as allergy probable flu vaccine with Rx for BENADRYL and prednisone.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity, Ultrasound scan normal, X-ray normal
Clinical narrative: Patient states she cannot move arm and has severe pain. Saw a doctor initially who saw no problems. Had a massage which helped short term. Had ultrasound and X-ray at hospital which showed nothing. Saw Dr. who recommended PT (physical therapy).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health worker referring to a number of unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated with doses of improperly stored VARIVAX (dose, strength and route unknown, lot # L021215, expiry date: 10-JUN-2017 or lot #: L011085, expiry date: 01-APR-2017) or PROQUAD (dose, strength and route unknown, lot#: L023111, expiry date: 24-DEC-2016, lot # reported as L030589, expiry date: 10-FEB-2017, lot # K020750, expiry date: 30-APR-2016). There was no concomitant therapy reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Arthritis
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient was immunocompetent. No medical history was reported. The nurse reported that the patient received the first, the second and the third dose of PNEMOVAX 23 (lot #, expiration dates and doses were not provided) on the following dates: on 06-NOV-1992, on 01-NOV-2001 and on 27-OCT-2008 respectively. On 08-OCT-2014 the patient also received one dose of PREVNAR 13 (lot #, expiration date and dose were not reported.) On an unknown date the patient experienced arthritis. The patient was being treated by an unspecified rheumatologist for arthritis within an unspecified dose of an unspecified steroid. The outcome of arthritis was unknown. The patient was in the office on 30-OCT-2015 ("today"), for another dose of PNEUMOVAX 23 (Lot#; dose was not reported). The nurse reported that the patient was instructed by the rheumatologist to receive a dose of PNEUMOVAX 23 every year with their flu shot. The relatedness between the arthritis and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse practitioner and refers to a female patient of unknown age. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, strength, vaccination site, dose number, # lot, expiry date unspecified) during her pregnancy (exposure during pregnancy). Product quality complaint was not reported. No further information was provided. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified patients. On an unspecified date in 2015, the patients were vaccinated with improperly stored dose of ROTATEQ (lot # L002042, expiration date 28-JUL-2016; lot# L013188, expiration date 02-NOV-2016; lot# L008578, expiration date 14-DEC-2016). NO adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored doses of oral, ROTATEQ lot # K019370; exp. 10-NOV-2016; L008996, exp: 01-DEC-2016 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects are reported. This is one of two reports received from the same source. Additional information has been requested.