chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Eye swelling, Injection site irritation, Injection site mass, Mass, Nausea
Clinical narrative: This case was reported by a physician and described the occurrence of injection site irritation in a adult female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site irritation, injection site mass, mass, eye swelling, nausea, and pruritus. On an unknown date, the outcome of the injection site irritation, injection site mass, mass, eyes swelling, nausea and pruritus were unknown. It was unknown if the reporter considered the injection site irritation, injection site mass, mass, eye swelling, nausea and pruritus to be related to BEXSERO. Additional details were reported as follows: The reporter stated that, the patient was a friend of the family. The patient who was going to college to receive the BEXSERO and was believed that, the patient had an adverse reaction. The patient had an irritant a knot below the injection site also has another knot at a remote location. The events seem like a minor reaction. The reporter stated that, she was not his patient but a family friend. The reporter asked to give him a call.
Sex: F
Vaccine: MENB
Symptoms: Pruritus
Clinical narrative: This case was reported by a physician and described the occurrence of injection site irritation in a adult female patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site irritation, injection site mass, mass, eye swelling, nausea, and pruritus. On an unknown date, the outcome of the injection site irritation, injection site mass, mass, eyes swelling, nausea and pruritus were unknown. It was unknown if the reporter considered the injection site irritation, injection site mass, mass, eye swelling, nausea and pruritus to be related to BEXSERO. Additional details were reported as follows: The reporter stated that, the patient was a friend of the family. The patient who was going to college to receive the BEXSERO and was believed that, the patient had an adverse reaction. The patient had an irritant a knot below the injection site also has another knot at a remote location. The events seem like a minor reaction. The reporter stated that, she was not his patient but a family friend. The reporter asked to give him a call.
Sex: U
Vaccine: TDAP
Symptoms: Enlarged uvula, Oropharyngeal pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of sore throat in a patient who received BOOSTRIX. On 28th August 2017, the patient received BOOSTRIX. On 29th August 2017, 1 days after receiving BOOSTRIX, the patient experienced sore throat and elongated uvula. On an unknown date, the outcome of the sore throat was recovering/resolving and the outcome of the elongated uvula was unknown. It was unknown if the reporter considered the sore throat and elongated uvula to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. The next day after vaccination, the patient woke up and felt like throat was sore and uvula was elongated. The healthcare professional had offered the patient to come into his office to be looked at, but the patient stated it was not necessary.
Sex: F
Vaccine: FLU4
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Injection site swelling
Clinical narrative: This case was reported by pharmacist via call center representative and described the occurrence of injection site numbness in a 22-year-old female patient who received FLUARIX Quadrivalent. On 16th August 2017, the patient received the 1st dose of FLUARIX Quadrivalent (intramuscular) .5 ml. On 25th August 2017, 9 days after receiving FLUARIX Quadrivalent, the patient experienced injection site numbness, injection site tingling and injection site swelling. On an unknown date, the outcome of the injection site numbness, injection site tingling and injection site swelling were recovering/resolving. The reporter considered the injection site numbness, injection site tingling and injection site swelling to be related to FLUARIX Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. The patient received FLUARIX Quadrivalent in left arm and experienced events in her left arm. The patient came back on 29th August 2017. The pharmacist observe little bit of swelling on the left arm in the area of the injection. The pharmacist reporter declined the patient information, pharmacist was transferred to medical Information for further discussion.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Red rash towards armpit about 2-3 in about quarter size.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives located (B) UE and LE distal>proximal, trunk, face.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Mother reported tremors 2-3 hr after receiving vaccines. Patient was seen the next day in office. Tremors were observed but resolved in the course of one week.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Blood pressure increased, Cyanosis, Dizziness, Hyperhidrosis, Immediate post-injection reaction
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 30-year-old female patient who received HAVRIX adult (batch number 7439F, expiry date 20th February 2020). Concomitant products included TYPHIM. On 25th August 2017, the patient received HAVRIX adult. On 25th August 2017, immediately after receiving HAVRIX adult, the patient experienced dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis. On 25th August 2017, the outcome of the dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis were recovered/resolved. The reporter considered the dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis to be related to HAVRIX adult. Additional details were provided as follows: The patient's concomitant products included non-GSK vaccine TYPHIM (batch number N1C1S, expiry date 15th March 2019). The patient received HAVRIX adult vaccine in left deltoid and experienced the side effects immediately following the administration on the HAVRIX in the left deltoid. Her head dropped to the back of the chair and her face was pale and also blue. The patient was sweating, described it as fainting but she was not unconscious that lasted for 5 to 10 minutes. The patient's blood pressure 5 minutes after vaccinating checked that read 129/114. It was checked again after 10 minutes and read as 115/77. The patient was asked to stay for 20 minutes and she was recovered when she left the pharmacy. The patient was again contacted by the reporter in the evening and she was fine. On 28th August 2017, the reporter again contacted the patient and she was fine.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Pallor, Posture abnormal, Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 30-year-old female patient who received HAVRIX adult (batch number 7439F, expiry date 20th February 2020). Concomitant products included TYPHIM. On 25th August 2017, the patient received HAVRIX adult. On 25th August 2017, immediately after receiving HAVRIX adult, the patient experienced dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis. On 25th August 2017, the outcome of the dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis were recovered/resolved. The reporter considered the dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis to be related to HAVRIX adult. Additional details were provided as follows: The patient's concomitant products included non-GSK vaccine TYPHIM (batch number N1C1S, expiry date 15th March 2019). The patient received HAVRIX adult vaccine in left deltoid and experienced the side effects immediately following the administration on the HAVRIX in the left deltoid. Her head dropped to the back of the chair and her face was pale and also blue. The patient was sweating, described it as fainting but she was not unconscious that lasted for 5 to 10 minutes. The patient's blood pressure 5 minutes after vaccinating checked that read 129/114. It was checked again after 10 minutes and read as 115/77. The patient was asked to stay for 20 minutes and she was recovered when she left the pharmacy. The patient was again contacted by the reporter in the evening and she was fine. On 28th August 2017, the reporter again contacted the patient and she was fine.
Age: 30.0
Sex: F
Vaccine: HEPA, TYP, HEPA, TYP
Symptoms: Dizziness, Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 30-year-old female patient who received HAVRIX adult (batch number 7439F, expiry date 20th February 2020). Concomitant products included TYPHIM. On 25th August 2017, the patient received HAVRIX adult. On 25th August 2017, immediately after receiving HAVRIX adult, the patient experienced dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis. On 25th August 2017, the outcome of the dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis were recovered/resolved. The reporter considered the dizziness, fainting, increased blood pressure, sweating, pallor and cyanosis to be related to HAVRIX adult. Additional details were provided as follows: The patient's concomitant products included non-GSK vaccine TYPHIM (batch number N1C1S, expiry date 15th March 2019). The patient received HAVRIX adult vaccine in left deltoid and experienced the side effects immediately following the administration on the HAVRIX in the left deltoid. Her head dropped to the back of the chair and her face was pale and also blue. The patient was sweating, described it as fainting but she was not unconscious that lasted for 5 to 10 minutes. The patient's blood pressure 5 minutes after vaccinating checked that read 129/114. It was checked again after 10 minutes and read as 115/77. The patient was asked to stay for 20 minutes and she was recovered when she left the pharmacy. The patient was again contacted by the reporter in the evening and she was fine. On 28th August 2017, the reporter again contacted the patient and she was fine.
Age: 11.0
Sex: F
Vaccine: HPVX, MNQ
Symptoms: Wrong drug administered
Clinical narrative: Patient came in today 8/16/2017, for WCC. Patient was supposed to receive 1st HPV. Patient had had a well child visit less than 1 year ago. Provider had ordered HPV vaccine but MENACTRA was given instead. There was confusion, as Medical assistant and provider were talk about 2 different patients that need vaccines as well. Provider wanted the visit to be switched to nurse visit for HPV. Medical assist thought the patient was getting MENACTRA and had given it into the R arm at 3:00 PM. Provider notified that wrong vaccine was given and called mother of child. Mother understands that this was done wrong on our terms and understands that this will not hurt patient but does need to start HPV series.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Dry throat, Oral mucosal erythema, Pharyngeal oedema, Pharyngeal paraesthesia, Throat irritation
Clinical narrative: Received RABAVERT at 10:08 am and sent to waiting room for 15 minutes. After 15 minutes elapsed, RN inquired if client had any side effects. She stated no and RN stated she could leave. At 11:10 am, RN went to waiting room and client was sitting in a chair. She stated that she left the clinic, got into her car and drove around 5 minutes when she began to experience a "tingly" dry throat. Contacted place of employment and took 50 mg BENADRYL. Returned to clinic. RN escorted client to lab area and had client sit in a chair. BP 120/76, HR 78. Breath sounds clear, no wheezing, able to talk, no diaphoresis. Mouth area slightly reddened. Physician consultant contacted and recommended that client be observed and it symptoms increase, send to Emergency Room. At 11:20 am, BP 116/78 and HR 72. Client stated throat felt "scratchy", no shortness of breath, able to talk and drink water. Client called her mother to come to the clinic to pick her up. At 11:40 am, BP 110/66, HR 70. Client's mother arrived at the clinic at 11:45 am. Mother instructed on symptoms to watch for and if symptoms worsen, go to Emergency Room. RN contacted client later in the day and she stated that her throat began to swell and mother took her to the Emergency Room.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Livedo reticularis, Pain
Clinical narrative: Child presented to ED fever 101, R thigh with diffuse swelling and mottled redness, not indurated so doubt abscess or cellulitis, gave ibuprofen for pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Child presented to ED fever 101, R thigh with diffuse swelling and mottled redness, not indurated so doubt abscess or cellulitis, gave ibuprofen for pain.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: Red, warm, itchy area developed right below vaccination site. Went to oncologist diagnosed w/possible cellulitis. Given KEFLEX, and is monitoring spread. (No decrease in movement).
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Lethargy, Malaise, Pain, Urticaria
Clinical narrative: Started sore and hot approx 4 hours post vaccination feelings of lethargy and general malaise; now resolving. Hive like rash from deltoid to elbow, now resolving.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Eyelid oedema
Clinical narrative: Swelling under eyes.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Rt deltoid (injection site) slightly swollen, No T.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness around injection about 6 inches around. Itching when it first appeared but now - mainly the redness.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Pt had swollen, red shoulder after IM shingles administration.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Red dots on feet. About 20 total between both feet. Itchy, pink, eraser size. Not pussing. Developed 9 days after vaccine. Antihistamine recommended.
Age: 37.0
Sex: U
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: 2 hours post vaccine, itching and hives on arms. Hives spread throughout entire body.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation
Clinical narrative: Pt experiencing inflamed lymph nodes in armpit region.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Myalgia, Vomiting
Clinical narrative: 8/22: Felt sick (no fever). 8/23: Vomited. 8/24: Muscle pain across shoulders/neck/upper back.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Patient presented day after vaccine with bruising on raised area at injection site. She was recommended to get BENADRYL in case reaction was allergy related and to apply ice as needed to decrease swelling and bruising.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt stated that she had redness, itching and swelling day after influenza administration. She stated that she had it last year (2016-2017) as well despite different mfr. States No Egg Allergy.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Patient stated that she has redness, swelling and discomfort at injection site one day after receiving immunization.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Dyspnoea, Pain, Peripheral swelling, Skin discolouration
Clinical narrative: Soreness as day went on. Noticed arm was swollen and black and blue. Prior to that, patient had difficulty swallowing, breathing all night. Pt used MDI, saline nasal.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dyspnoea, Injection site discolouration, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness as day went on. Noticed arm was swollen and black and blue. Prior to that, patient had difficulty swallowing, breathing all night. Pt used MDI, saline nasal.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Skin discolouration
Clinical narrative: Soreness as day went on. Noticed arm was swollen and black and blue. Prior to that, patient had difficulty swallowing, breathing all night. Pt used MDI, saline nasal.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Pain in (L) deltoid where PNEUMOVAX was administered. Pain travels up to the neck and down to lower arm. Primary Dr contacted and told patient to wait and see if pain alleviates.
Age: 52.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen at injection site 6 1/2" x 5 1/2".
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis (L) upper arm.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Blood gases normal, Culture urine negative, Cyanosis, Diarrhoea, Febrile convulsion
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15 month old female patient. The patient's medical history included multiple ear infections and a fracture of left humerus during birth. The patient had none concurrent conditions, concomitant medications or drug reactions/allergies. On 14-AUG-2017, the patient was vaccinated with M-M-R II 0.5 ml subcutaneously (lot # M048368 and expiration date 08-DEC-2018), VARIVAX (lot # N001528 and expiration date 13-JAN-2019) and with ACTHIB for routine vaccination. On 21-AUG-2017, the patient developed a fever which then led to a febrile seizure. That day, the patient was taken to the emergency room due to this. At the emergency room, a urine sample was taken and showed positive for ketones, glucose and protein which, the attending physician considered were related to the stress response from having the seizure. Additionally, the patient's blood gases were a little off, her blood sugar was elevated and a blood culture was negative. The patient was also tested for hemoglobin A1C and a metabolic panel (results were not provided). The reporter stated that the patient received ibuprofen while in the emergency room and was discharged from the emergency room later that day. The nurse stated that the patient's fever broke on 25-AUG-2017, and had not returned. The outcome of blood glucose increased, blood gases abnormal, glucose urine present, protein urine present and urine ketone body present were unknown. The reporter stated that the attending physician in the emergency room stated that the patient's reaction was consistent with a reaction to M-M-R II vaccine. The reporter did not provide a causality assessment between the events and M-M-R II and VARIVAX.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Hypotonia, Laboratory test, Loss of consciousness, Pyrexia, Respiratory arrest
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15 month old female patient. The patient's medical history included multiple ear infections and a fracture of left humerus during birth. The patient had none concurrent conditions, concomitant medications or drug reactions/allergies. On 14-AUG-2017, the patient was vaccinated with M-M-R II 0.5 ml subcutaneously (lot # M048368 and expiration date 08-DEC-2018), VARIVAX (lot # N001528 and expiration date 13-JAN-2019) and with ACTHIB for routine vaccination. On 21-AUG-2017, the patient developed a fever which then led to a febrile seizure. That day, the patient was taken to the emergency room due to this. At the emergency room, a urine sample was taken and showed positive for ketones, glucose and protein which, the attending physician considered were related to the stress response from having the seizure. Additionally, the patient's blood gases were a little off, her blood sugar was elevated and a blood culture was negative. The patient was also tested for hemoglobin A1C and a metabolic panel (results were not provided). The reporter stated that the patient received ibuprofen while in the emergency room and was discharged from the emergency room later that day. The nurse stated that the patient's fever broke on 25-AUG-2017, and had not returned. The outcome of blood glucose increased, blood gases abnormal, glucose urine present, protein urine present and urine ketone body present were unknown. The reporter stated that the attending physician in the emergency room stated that the patient's reaction was consistent with a reaction to M-M-R II vaccine. The reporter did not provide a causality assessment between the events and M-M-R II and VARIVAX.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Resuscitation, Seizure, Unresponsive to stimuli
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15 month old female patient. The patient's medical history included multiple ear infections and a fracture of left humerus during birth. The patient had none concurrent conditions, concomitant medications or drug reactions/allergies. On 14-AUG-2017, the patient was vaccinated with M-M-R II 0.5 ml subcutaneously (lot # M048368 and expiration date 08-DEC-2018), VARIVAX (lot # N001528 and expiration date 13-JAN-2019) and with ACTHIB for routine vaccination. On 21-AUG-2017, the patient developed a fever which then led to a febrile seizure. That day, the patient was taken to the emergency room due to this. At the emergency room, a urine sample was taken and showed positive for ketones, glucose and protein which, the attending physician considered were related to the stress response from having the seizure. Additionally, the patient's blood gases were a little off, her blood sugar was elevated and a blood culture was negative. The patient was also tested for hemoglobin A1C and a metabolic panel (results were not provided). The reporter stated that the patient received ibuprofen while in the emergency room and was discharged from the emergency room later that day. The nurse stated that the patient's fever broke on 25-AUG-2017, and had not returned. The outcome of blood glucose increased, blood gases abnormal, glucose urine present, protein urine present and urine ketone body present were unknown. The reporter stated that the attending physician in the emergency room stated that the patient's reaction was consistent with a reaction to M-M-R II vaccine. The reporter did not provide a causality assessment between the events and M-M-R II and VARIVAX.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Blood culture negative, Blood gases abnormal, Blood glucose increased, Febrile convulsion, Glucose urine present
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15 month old female patient. The patient's medical history included multiple ear infections and a fracture of left humerus during birth. The patient had none concurrent conditions, concomitant medications or drug reactions/allergies. On 14-AUG-2017, the patient was vaccinated with M-M-R II 0.5 ml subcutaneously (lot # M048368 and expiration date 08-DEC-2018), VARIVAX (lot # N001528 and expiration date 13-JAN-2019) and with ACTHIB for routine vaccination. On 21-AUG-2017, the patient developed a fever which then led to a febrile seizure. That day, the patient was taken to the emergency room due to this. At the emergency room, a urine sample was taken and showed positive for ketones, glucose and protein which, the attending physician considered were related to the stress response from having the seizure. Additionally, the patient's blood gases were a little off, her blood sugar was elevated and a blood culture was negative. The patient was also tested for hemoglobin A1C and a metabolic panel (results were not provided). The reporter stated that the patient received ibuprofen while in the emergency room and was discharged from the emergency room later that day. The nurse stated that the patient's fever broke on 25-AUG-2017, and had not returned. The outcome of blood glucose increased, blood gases abnormal, glucose urine present, protein urine present and urine ketone body present were unknown. The reporter stated that the attending physician in the emergency room stated that the patient's reaction was consistent with a reaction to M-M-R II vaccine. The reporter did not provide a causality assessment between the events and M-M-R II and VARIVAX.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR, VARCEL, HIBV, MMR, VARCEL
Symptoms: Glycosylated haemoglobin, Metabolic function test, Protein urine present, Pyrexia, Urine ketone body present
Clinical narrative: This spontaneous report was received from a nurse and refers to a 15 month old female patient. The patient's medical history included multiple ear infections and a fracture of left humerus during birth. The patient had none concurrent conditions, concomitant medications or drug reactions/allergies. On 14-AUG-2017, the patient was vaccinated with M-M-R II 0.5 ml subcutaneously (lot # M048368 and expiration date 08-DEC-2018), VARIVAX (lot # N001528 and expiration date 13-JAN-2019) and with ACTHIB for routine vaccination. On 21-AUG-2017, the patient developed a fever which then led to a febrile seizure. That day, the patient was taken to the emergency room due to this. At the emergency room, a urine sample was taken and showed positive for ketones, glucose and protein which, the attending physician considered were related to the stress response from having the seizure. Additionally, the patient's blood gases were a little off, her blood sugar was elevated and a blood culture was negative. The patient was also tested for hemoglobin A1C and a metabolic panel (results were not provided). The reporter stated that the patient received ibuprofen while in the emergency room and was discharged from the emergency room later that day. The nurse stated that the patient's fever broke on 25-AUG-2017, and had not returned. The outcome of blood glucose increased, blood gases abnormal, glucose urine present, protein urine present and urine ketone body present were unknown. The reporter stated that the attending physician in the emergency room stated that the patient's reaction was consistent with a reaction to M-M-R II vaccine. The reporter did not provide a causality assessment between the events and M-M-R II and VARIVAX.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Tenderness
Clinical narrative: I put ice on my arm after the shot. By bedtime (9pm) I was achy which I have had before from the flu shot and I took 500mg naproxen. I couldn't sleep after 1.5 hours and took one TYLENOL #3. I woke up around 5am from pain and tenderness in my left armpit, as well as the return of generalized aches. I finally got up at 6:15am and took another 500mg naproxen. My generalized aches are ebbing, but my armpit still hurts. I don't think the lymph node is particularly swollen, but it is tender in addition to just hurting even when I don't touch it.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician referring to a 7 month old patient of unknown gender. On 09-AUG-2017 the patient was vaccinated with a first dose of ROTATEQ (strength, dosage and frequency unspecified) orally for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Product storage error
Clinical narrative: Information has been received from nurse referring to a patient of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date, the patient was vaccinated with an improperly stored dose of one of the following vaccines: PROQUAD (lot # N001488 with expiration date 12-JUL-2018, dose and route unknown) or VARIVAX (lot # M038859 with expiration date 14-SEP-2018 or lot # N008827 with expiration date 16-MAR-2019, dose and route unknown) for prophylaxis (incorrect product storage). The vaccines had been exposed under temperature in the range of -9 degree Celsius to 8 degree Celsius for 2 hours, but did not undergo previous excursion. Data logger was used.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a nurse referring to a 13 year old patient of unknown gender.  The patient's medical history, concurrent medication and drug reactions were not reported. The patient received a dose of GARDASIL (lot # M005714 with expiration date 03-OCT-2017, dose and route not reported) on 05-AUG-2015 and a dose of GARDASIL (lot # K011325 with expiration date 08-APR-2017, dose and route not reported) on 12-AUG-2016 for prophylaxis (inappropriate schedule of vaccine administered). The patient was currently (in approximately August 2017) in the office to receive a dose of GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis (interchange of vaccine products). No adverse effects were reported.
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin irritation, Tenderness
Clinical narrative: This spontaneous report has been received from a pharmacist via a company field representative referring to a 72 year old male patient. Information about pertinent medical history was not reported. The patient had no drug reactions/allergies. The concomitant medication included Blood pressure medication, Vitamin D, Acid Reflux medication, Benign Prostatic Hyperplasia (BPH) medication. On an unknown date (reported as several weeks ago), the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (route, lot # and expiration date were unknown). On an unknown date, shortly after vaccination, the patient experienced swelling, irritation, and tenderness in an unspecified arm and down to the elbow. No lab diagnostics studies were performed. At the time of the report, the outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 was unknown.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Skin discolouration, Skin disorder, Subcutaneous haematoma
Clinical narrative: Information has been received from a physician via a company representative referring to a 15 year old female patient. The patient had not had a bad reaction to other vaccines. The patient's concomitant medication and drug reactions were unknown. About 2 months ago (in approximately June 2017) the patient was administered a dose of GARDASIL 9 (dose, route, lot# and expiration date were unknown) for prophylaxis, then immediately developed a subdermal hematoma, on the front side of the left arm, that was changing in color and texture after the immunization. The patient did seek medical attention. Ultrasound was scheduled for 16-AUG-2017. No treatment was given to the patient. At the reporting time, the patient did not recover from the event. The physician did not believe that the hematoma was associate with GARDASIL 9.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. The patient was administered with first dose of GARDASIL 9 (dose, route, lot#, expiration date not reported) in November 2014, second dose of GARDASIL 9 (dose, route, lot#, expiration date not reported) in June 2016, and third dose of GARDASIL 9 (dose, route, lot#, expiration date not reported) in July 2017 for prophylaxis (Inappropriate schedule of vaccine administered). On 14-AUG-2017, The patient was administered a fourth dose of GARDASIL 9 (dose, route, lot#, expiration date not reported) for prophylaxis (extra dose administered). No adverse effects were reported.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Posture abnormal
Clinical narrative: This spontaneous report has been received from a nurse practitioner via a company representative referring to an 11 year old female patient. There was no pertinent medical history. The patient was allergic to amoxicillin. On 14-AUG-2017, the patient was vaccinated with the first dose of GARDASIL 9, 0.5 ml (lot # and expiration date were not reported) intramuscularly for prevention of Human Papilloma Virus (HPV). The nurse practitioner reported that the patient did concomitantly receive diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) and MENACTRA vaccine during the same office visit but the vaccines were given in a different arm than GARDASIL 9. On the same day, the patient experienced light headed, and the patient's head rolled but she did not lose consciousness. The patient was given "orange juice and cookies for this event". No lab diagnostics were performed. On an unknown date in August 2017, the patient was recovered from the event. The causality between the event and GARDASIL 9 was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number patients of unknown age and gender. On an unknown date, the patients were vaccinated with an unspecified number of doses of VARIVAX lot # N015477 and expiration date: 18-MAY-2019 (dose, frequency, route of administration were not reported) for prophylaxis, reconstituted with sterile diluent. There were no adverse effects reported. Administered doses of vaccine experienced the temperature excursion from 6 to 14 degrees Fahrenheit for 4 hours. There were previous excursions reported, from 6 to 14 degrees Fahrenheit for 6 hours. Data logger was involved. Sterile diluent used for reconstitution did not undergo a temperature excursion. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA011152:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other refers to an unspecified number of patients of unknown ages and genders. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# M046005, lot# N01461 and lot# reported as M031971 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date, the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX.     This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-1708USA012377:
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a 22 year old female patient. The patient had no pertinent medical history, drug reactions/allergies and concomitant medications. On an unknown date "in the beginning of August 2017", the patient was vaccinated with first dose in the series of GARDASIL 9 (strength, route, lot/batch# and expiration date were not reported) for prophylaxis. On an unknown date in August 2017 (reported as"fairly soon after, receiving GARDASIL 9", the patient felt tired, nauseated and achy. It was reported that treatment was provided, however, it was not specifically known what treatment was provided. No lab diagnostics/studies were performed. There was no product quality complaint(PQC) involved. The symptoms of the events lasted for "3-4 days" and were then recovered. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from a consumer refers to a female patient of unknown age (also reported as around 70 years-old). On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced adverse reaction. On an unknown date, the patient went to a hospital searching medical attention. The outcome of adverse reaction was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to a patient of unknown demographics. The patient's medical history was not reported. On 31-AUG-2017, the patient was vaccinated with ZOSTAVAX (Strength, dose, frequency, anatomical location and route were not reported) of lot # M033910 with an expiry date of 17-OCT-2017 for prophylaxis. Co-suspect therapy included sterile diluent. There were no concomitant therapies reported. On 31-AUG-2017, during administration of ZOSTAVAX to the patient, the pharmacist got a small amount of vaccine in her eye. No adverse effects were reported for the patient or the pharmacist who were exposed ZOSTAVAX. No product quality complaint was involved. Lot number M033910, has been verified to be a valid lot number for ZOSTAVAX.
Sex: M
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a male nurse of unknown age concerning himself. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date when he was a child, he was vaccinated with one dose of M-M-R II (lot# and expiration date were not reported) for prophylaxis. On an unknown date in 2013, he got tested for titers and came up negative. On an unknown date in 2013, he got another dose of M-M-R II (lot# and expiration date were not reported) and sterile diluent (strength, dose, frequency, route, lot# and expiration date were not reported) for prophylaxis, and his titers were still coming up negative. The outcome of the events was unknown. The causality between M-M-R II with the events was unknown.
Sex: U
Vaccine: HPVX
Symptoms: Injection site mass
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 11-AUG-2017, the patient was vaccinated with GARDASIL 9, intramuscular for prophylaxis.  Other suspect therapies included GARDASIL. In 2017 the patient experienced vaccination site mass.    The outcome of vaccination site mass was reported as not resolved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of M-M-R II for prophylaxis reconstituted with sterile diluent. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA001915: US-009507513-1709USA001916: US-009507513-1709USA001917: US-009507513-1709USA001918: US-009507513-1709USA001919.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis reconstituted with sterile diluent. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA001903: US-009507513-1709USA001916: US-009507513-1709USA001917: US-009507513-1709USA001918: US-009507513-1709USA001919.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of PROQUAD for prophylaxis reconstituted with sterile diluent (STERILE DILUENT). No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001903: US-009507513-1709USA001915: US-009507513-1709USA001917: US-009507513-1709USA001918: US-009507513-1709USA001919:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis reconstituted with sterile diluent. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA001903: US-009507513-1709USA001915: US-009507513-1709USA001916: US-009507513-1709USA001918: US-009507513-1709USA001919.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 for prophylaxis reconstituted with sterile diluent (STERILE DILUENT). No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA001903: US-009507513-1709USA001915: US-009507513-1709USA001916: US-009507513-1709USA001917: US-009507513-1709USA001919:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an other health professional refers to patients of unknown age and gender. Since June 2016, the patients were vaccinated with improperly stored doses of PEDVAXHIB for prophylaxis reconstituted with sterile diluent. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA001903: US-009507513-1709USA001915: US-009507513-1709USA001916: US-009507513-1709USA001917: US-009507513-1709USA001918.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-AUG-2017 the patient was vaccinated with PROQUAD lot # N010247 (rHA) with expiration date 25-SEP-2018 and N014634 (rHA) with expiration date 07-NOV-2018, for prophylaxis.   Concomitant therapies included sterile diluent (STERILE DILUENT). On 31-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD.; Sender's Comments: US-009507513-1709USA002532:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified patients of unknown ages and genders. On 01-AUG-2017 the patients were vaccinated with PROQUAD lot # N014759. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD.; Sender's Comments: US-009507513-1709USA002543:
Sex: M
Vaccine: MMR
Symptoms: Autism spectrum disorder
Clinical narrative: This spontaneous report was received from a consumer refers to an unspecified male patient of unknown age. Patient's pertinent medical history, drug allergies/reactions and concomitant medications were unknown. The reporter also mentioned that she has heard of "anecdotal" stories from unspecified sources of "young boys" who after getting the combination M-M-R II who potentially developed autism. Other suspect therapy included DILUENT. No PQC involved. No additional AE information was provided. Outcome and causality was not provided by the reporter. Upon internal review, autism was determined to be medically significant. This case was linked to the case#1709USA000577.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # N010866 for prophylaxis. Other suspect therapies included sterile diluent (STERILE DILUENT).  On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD and sterile diluent (STERILE DILUENT).  Sender's Comments:  US-009507513-1709USA002548:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a nurse, refers to 3 unspecified patients. Concomitant therapies included sterile diluent(manufacturer unknown).  On 05-SEP-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # N014949 (rHA albumin status) for prophylaxis. No adverse event were reported. This is one of several reports received from the same source.; Sender's Comments: US-009507513-1709USA002084:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-AUG-2017 the patient was vaccinated with VARIVAX lot # N002204 with expiration date 19-JAN-2019, and N009766 with expiration date 24-MAR-2019, for prophylaxis. Concomitant therapies included sterile diluent. On 31-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Sender's Comments: US-009507513-1709USA002196.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a unspecified patients of unknown ages and genders. On 01-AUG-2017 the patient was vaccinated with VARIVAX lot # N014632 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. Sender's Comments: US-009507513-1709USA002211.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX. Other suspect therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage and no adverse event to be not related to sterile diluent and VARIVAX. Sender's Comments: US-009507513-1709USA002438.