chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates in 2017, the patients received improperly stored doses of sterile diluent lot # M020944, expiration date 24-OCT-2018 (dose and route of administration were not reported) used to reconstitute unknown live vaccines. Administered doses of sterile diluent experienced the temperature excursion of 47.48 degrees Fahrenheit for 45 minutes. There was previous excursion on 11-FEB-2017 reported. As of 28-JUL-2017, it was unknown if patients continued to receive live vaccines reconstituted with diluent that underwent a temperature excursion. Follow-up information was received from the register pharmacist on 22-SEP-017. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot # and expiration date unknown) (dose and route were not reported) and sterile diluent (manufacturer unknown) (dose and route were not provided) for prophylaxis which was improperly stored. The PNEUMOVAX 23 were stored at from 47 to 77 degree Fahrenheit for 1 hour 30 minutes. It had no previous temperature excursion. Data logger was involved. The following lot numbers of sterile diluent (manufacturer unknown) underwent temperature excursion of 47 to 77 degree Fahrenheit (48.3 degree Fahrenheit) for 1 hour 30 minutes: lot# M047667, expiration date 25-JUL-2019; lot# N004190, expiration date 04-JUL-2019; lot# M020944, expiration date 24-OCT-2018; lot# M017521, expiration date 12-OCT-2018. It was previous underwent temperature excursion from 47 to 77 degree Fahrenheit for 45 minutes. Data logger was involved. No adverse effects were reported. This case was previously considered valid but per current process it was determined to be non-valid as no patient identifier, therefore it is being sent to distribution for the last time to notify all recipients.
Sex: U
Vaccine: VARZOS
Symptoms: Blood cholesterol increased, Pain, Post-traumatic pain
Clinical narrative: This spontaneous report was received from a patient of unknown age and gender. The patient's medical history included melanoma from the right thigh, mammogram every year and shingles. The patient's concurrent conditions, drug reaction and allergy history were not reported. In 1992 the patient stated that, she had two of the worst cases of shingles that her doctor had ever seen, when two senior cheerleaders with chickenpox were in his/her home and sit on either side of her. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced post-traumatic pain all across its back especially under the shoulder blades where she/he had shingles. The patient stated that when she/he got upset, tired or overworked the pain got unbearable and the only medicine that helped him/her with the pain was TYLENOL and "Bio=freeze". On an unknown date, the patient asked for help getting ZETIA, because he/she could not afford it and could not take any of the statins for high cholesterol. The outcome of post-traumatic pain, pain and high cholesterol was unknown. The causality assessment between post-traumatic pain, pain and high cholesterol with ZOSTAVAX was unknown.
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to two patients of unknown demographics. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On 15-AUG-2017 the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N011305, expiry date: 20-JAN-2019) for prophylaxis (incorrect product storage). The doses of PNEUMOVAX 23 were stored at a temperature of 47 degree Fahrenheit (F) to 77 F for time frame of 19 days. No adverse effects reported. No Product Quality complaint (PQC) was involved. This case is cross-referenced with 1708USA007541 (Same Reporter link). Follow up information was received from the office manager on 19-SEP-2017. The improperly stored vaccine was administered to three male patients, this case is one of them who vaccinated with the vaccine on 15-AUG-2017. This case is cross-referenced with 1708USA008930 (Same Reporter link).; Sender's Comments:  US-009507513-1708USA007541: US-009507513-1708USA008930:
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Rash macular, Skin warm
Clinical narrative: This spontaneous report has been received from a pharmacist referring to a 71 year old female patient. The did not have pertinent medical history or concomitant medications. The patient's drug reactions or allergies included cephalosporin and hydrocodone, acetaminophen (VICODIN). On 21-SEP-2017, the patient was vaccinated with PNEUMOVAX 23  (strength, dose, route, anatomical and location were not reported) lot # N000508, expiration date 19-OCT-2018, for prophylaxis. On 22-SEP-2017, the patient went to the pharmacy because "her upper arm was swollen, splotchy, red and warm to the touch " (peripheral swelling, pigmentation disorder, skin warm and erythema). No treatment was provided and none laboratory studies were performed.  At the reporting time, The outcome of peripheral swelling, pigmentation disorder, skin warm and erythema was reported as not resolved. The causality assessment between therapy with PNEUMOVAX 23 and the events was not reported.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a vaccine provider referring to a 53 year old female patient. The patient's concurrent condition, medical history and concomitant therapies were reported as none.     On 15-SEP-2017, at the private doctor's office, the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # N011867, expiration date 08-NOV-2018) intramuscularly on left deltoid for prophylaxis. The vaccine was purchased with private funds. It was reported that the additional vaccine shelves were being placed in fridge and the temperature was out of range (incorrect product storage). There was no illness at the time of vaccination. There was no adverse reaction and no treatment was required. It was reported that there was no need to re-vaccinate or destroy the vaccine. The temperature excursion occurrence was not a result of reading from a digital data logger.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Migraine, Muscular weakness, Paraesthesia
Clinical narrative: This spontaneous report as received from registered nurse, via a company representative referring to a 16 year old female patient. The patient's concurrent conditions included migraines and "unstable home situation". Her pertinent medical history was not mentioned. On 23-AUG-2017, the patient was vaccinated with a second dose GARDASIL 9 lot # N004799, 0.5 ml, intramuscular in the left deltoid for prophylaxis. She was also co-administrated medroxyprogesterone acetate (DEPO PROVERA). On 09-SEP-2017, the patient was seen at the Emergency Room for "needle-like" feelings in various parts of her body, and the patient reported that this feeling would "normally go away in 30 minutes" but this time the "needle-like feeling lasted for more than 2 hours in her left arm". On 18-SEP-2017, patient's mother called the physician's office to report that her daughter experienced weakness and numbness in both arms. The patient was seen by an unspecified physician for migraines. The patient received her first dose of GARDASIL 9 on 06-FEB-2017 without any adverse effects. The outcome of the events was not mentioned. The relatedness between vaccination with GARDASIL 9 and the events was unknown.
Sex: U
Vaccine: HPVX
Symptoms: Product use in unapproved indication, Therapeutic response unexpected
Clinical narrative: This spontaneous initial report was received from a physician referring to a patient of unspecified age and gender. Patient's medical history, current conditions and concomitant medications were not reported. The physician reported that on an unknown date an unspecified patient was vaccinated with  GARDASIL 9 (strength, route, frequency and lot number not provided) or GARDASIL (strength, route, frequency and lot number  not provided); it was not specified which of the two vaccines was used; indicated to treat anogenital warts. The physician informed that after receipt of the vaccine, the lesions disappeared.
Age: 0.83
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site mass, Injection site swelling, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 10 months old female patient. The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 27-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # M042599 and expiration date on 17-JUN-2018 (strength and dose were no reported), administered intramuscularly in her left deltoid, to prevent pneumonia. On 28-SEP-2017, the patient developed a bump of 1 inch under the injection site; so on 29-SEP-2017, she returned to the pharmacy and her arm was warm, swollen, reddened and painful to touch with a raised area at the injection site. Then, the patient took diphenhydramine hydrochloride (BENADRYL) without relief but she did not seek medical attention. No laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. At the time of this report, the patient had not recovered yet from the injection site mass, skin warm, peripheral swelling, erythema, and pain in extremity. The causal relationship between the injection site mass, skin warm, peripheral swelling, erythema, and pain in extremity with PNEUMOVAX 23 was not provided.
Age: 0.83
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a 10 months old female patient. The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On 27-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 with lot # M042599 and expiration date on 17-JUN-2018 (strength and dose were no reported), administered intramuscularly in her left deltoid, to prevent pneumonia. On 28-SEP-2017, the patient developed a bump of 1 inch under the injection site; so on 29-SEP-2017, she returned to the pharmacy and her arm was warm, swollen, reddened and painful to touch with a raised area at the injection site. Then, the patient took diphenhydramine hydrochloride (BENADRYL) without relief but she did not seek medical attention. No laboratory diagnostics studies were performed. No product quality complaint (PQC) was involved. At the time of this report, the patient had not recovered yet from the injection site mass, skin warm, peripheral swelling, erythema, and pain in extremity. The causal relationship between the injection site mass, skin warm, peripheral swelling, erythema, and pain in extremity with PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's historical and concurrent conditions, drug reactions and allergies, and concomitant medications were not reported. On 22-SEP-2017, the patient was vaccinated with VARIVAX, subcutaneously, lot # N012487 and expiration date 20-APR-2017 (dose was not reported), and during the same office visit received 1 separate dose of PROQUAD) (albumin status of rHA (recombinant human albumin)) lot # N009775 and expiration date 20-SEP-2018 (dose and route of administration were not reported), both reconstituted with MERCK STERILE DILUENT (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster oticus
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative, and refers to a female patient in her "mid 60's". The patient had no medical history, concomitant medications, concurrent conditions nor drug reactions/allergies. On an unknown date in September 2017 (reported as about a month ago), the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, route, lot number and expiration date were not provided). In approximately September 2017 (reported as the patient came back into the office a few days later), the patient had developed Ramsay-Hunt syndrome. As a result, the patient was prescribed an unspecified steroid, and acyclovir, and was also referred to see an unspecified ear, nose and throat (ENT) provider. No product quality complaint (PQC) was involved. The outcome of herpes zoster oticus was unknown. However, The physician's assistant stated that he believed the patient was doing better, since the patient has not come back to the office for any follow up visits. The causal relationship between ZOSTAVAX and herpes zoster oticus was not provided. Upon internal review, the event herpes zoster oticus was determined to be a medically significant event.
Sex: F
Vaccine: HPV4
Symptoms: Influenza, Pain
Clinical narrative: This spontaneous report was received from a physician via company representative who refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unspecified date in August 2017 (reported as last month), the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. In August 2017 (reported as since the vaccination), the patient has been feeling aches and pains over her body. The patient's mother scheduled a doctor's appointment for the patient. The physician said it was most likely flu. The outcome of the event was not reported. The relationship between the event and GARDASIL was not reported.
Age: 68.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse, referring to a 68 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-OCT-2017, the patient was vaccinated with a dose of VARIVAX lot # N017700, with expiration date on 09-JUN-2019 (strength, anatomical location and administration route were not reported) for prophylaxis instead of ZOSTAVAX. The reporting nurse stated that the reason for giving VARIVAX was a human error. No adverse effect were reported.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a 16 years old female patient. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 17-FEB-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. Later, on 05-OCT-2017, the patient received the second dose of GARDASIL 9 (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis. No symptoms reported. There was no product quality complaint (PQC) involved.
Sex: U
Vaccine: HPVX
Symptoms: Death
Clinical narrative: This spontaneous report has been received from a newspaper article concerning a 10 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date the patient was vaccinated with a human papillomavirus vaccine (manufacturer unknown) (dose, dose number, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis. It was reported that on an unknown date the human papillomavirus vaccine (manufacturer unknown) might have caused the death of the patient. It was unknown if an autopsy was done. The causal relationship between human papillomavirus vaccine (manufacturer unknown) and the event was considered as related. Upon internal review, death was determined to be medically significant.
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Erythema, Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from consumer on 27 Sep 2017. This case involves 85 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HD (Frequency: once, batch number and expiry date was not reported) arm intramuscularly on 23 Sep 2017. The patient's medical history and concomitant medication were not reported. On 23 Sep 2017 in Saturday afternoon same day post vaccination, she started with some pain in her arm at the injection site, by the night few hours post vaccination her arm was red hot and 2 times the size it should have been, had swelling (Gigantic; it hasn't improved by today) and now she was having difficulty moving her arm. On 24 Sep 2017 in the morning few hours post vaccination she also had a temperature of 101 with aches and chills. She describes the site as at her shoulder near the top. She has not seen a provider. She has never had a vaccine reaction like this before in all her years. She is a small woman wears a size 6 dress. Other laboratory investigation and corrective treatment were not reported. On an unspecified date, patient was recovered from aches, fever and chills and patient was not recovered from other events. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Initial unsolicited report received from consumer on 27 Sep 2017. This case involves 85 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HD (Frequency: once, batch number and expiry date was not reported) arm intramuscularly on 23 Sep 2017. The patient's medical history and concomitant medication were not reported. On 23 Sep 2017 in Saturday afternoon same day post vaccination, she started with some pain in her arm at the injection site, by the night few hours post vaccination her arm was red hot and 2 times the size it should have been, had swelling (Gigantic; it hasn't improved by today) and now she was having difficulty moving her arm. On 24 Sep 2017 in the morning few hours post vaccination she also had a temperature of 101 with aches and chills. She describes the site as at her shoulder near the top. She has not seen a provider. She has never had a vaccine reaction like this before in all her years. She is a small woman wears a size 6 dress. Other laboratory investigation and corrective treatment were not reported. On an unspecified date, patient was recovered from aches, fever and chills and patient was not recovered from other events. List of documents held by sender: none.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hallucination, auditory
Clinical narrative: Initial unsolicited case received from a nurse on 28 Sep 2017. This case involves 73-year-old female patient who was vaccinated with 0.5 ml one dose of FLUZONE HD (Batch number: UI835AB, expiry date: 27 Mar 2018, dose in series not reported) intramuscularly in deltoid on 26 Sep 2017. Patient medical history and concomitant medications were not reported. On 26 Sep 2017, same day after the vaccination, the patient went to her car and stated that she felt like jelly and after she began to hear voices in her car. She conversed with the voices until she realized she was alone in the car. This episode lasted 30 minutes, and did not recur. The patient did not report any visual hallucinations and did not receive any other vaccines that day. Relevant lab tests and corrective treatment were not reported. On an unknown date, the patient recovered from the event. (Reported as she has been fine since then). List of documents held by sender: none.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Dizziness
Clinical narrative: Initial unsolicited case received from a nurse on 28 Sep 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number: UI678AA, expiry date, dose in series, dose, route and site of administration were not reported) on an unknwon date. Patient medical history and concomitant medications were not reported. On an unknwon date, following the vaccination, the patient had severe confusion for 7-8 hours and dizziness. It was reported as patient referred to neurology for follow up and Patient now concerned to receive flu shot going forward. Lab tests and corrective treatment were not reported. On an unknwon date, the patient recovered from the events. (Reported as dizziness persisted for about one week) List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Oral mucosal blistering, Pain, Pyrexia
Clinical narrative: Initial unsolicited case received from a consumer on 27 Sep 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE .5 QUADRAVALENT (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed chills, fever, body aches and blister in and around mouth. Relevant lab tests and corrective treatment were not reported. The outcome of all the events were not reported. List of documents held by sender: none.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Sore throat, chest congestion and high fever. Patient went to urgent care. Prescribed antibiotic azithromycin and bought over the counter cold medications.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: SUBJECTIVE: Walk-in office visit. Patient is a 68-year-old woman who complains of pain redness swelling left upper arm. States yesterday he received influenza vaccine and PNEUMOVAX 23 in the same arm. Patient states last evening developed redness itching and swelling in the area of what she thinks was the Pneumovax vaccination. She has no other complaints now hives denies fever chills myalgias or arthralgias. Apply some hydrocortisone with some relief. Has no other complaints. Diagnoses and all orders for this visit: Local reaction to pneumococcal vaccine, initial encounter. Pt was also seen with Dr. Patient Instructions Apply the hydrocortisone cream 2-3 times daily as needed for itching. Can take CLAIRTIN or ZYRTEC as directed for itching. Follow up for any worsening symptoms such as increased pain redness fever.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Dyspnoea, Fatigue, Palpitations, Somnolence
Clinical narrative: Sudden onset fatigue, mildly labored breathing, palpitations. Slept on/off from 12:30 PM on 10/10 to 7 PM. Slept regualar hours that night (10:30 PM to 7 Am). Mildly labored breathing and palpitations persisted throughtout the day. Fatigue still present on 10/11, but less. Slept for 2 hours in the afternoon with generally less energy throughout the day. Breathing normal, palpitations mild. Today, 10/12, mild decreased energy and mild palpitations.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Large local reaction with swelling, redness and warm to touch. Measured 8 cm wide by 8.5 cm long. Symptoms started to resolve 48 hrs after injection. No decrease in function of the affected limb. No breathing issues.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated
Clinical narrative: Asthma attack. Treated with albuterol inhaler, BENADRYL.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: 9 cm wide by 7cm long circular area of redness and slight swelling, normal temperature as surrounding skin, bruise at site of injection (slightly above center of circle). No other symptoms. Already resolving. No anaphylaxis.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth, itching.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Asthma, Chest discomfort, Condition aggravated, Dyspnoea, Eye swelling
Clinical narrative: Son (not sick) went to Pediatrician for "Well-Child" visit and needed vaccines. He received vaccines at approximately 4:45 PM. We left MD office at about 5:00 PM, picked up dinner which he ate on the way home, and got home about 6:00 PM. He was given Ibuprofen 15ml/300mg as recommended by MD. He went upstairs to do homework. He came down about 7:00 PM with complaints of headache, runny nose, chest tightness, wheezing, and I noticed his eye starting to swell. He said he did not feel well and he felt like he feels when he has asthma exacerbations. I gave him BENADRYL 15ml/37.5mg. He sat on couch with box of tissue as his nose was very runny.  Over the next hour, symptoms worsened and he reported feeling even worse with difficulty breathing. His eyes became "bloodshot" red and eyelids almost swollen shut, face puffy. At 8:00 PM, I gave him Albuterol inhaler 2 puffs and FLOVENT inhaler 2 puffs. Also gave him ZYRTEC 10 mg disintegrating tablet. I watched him over the next few hours and he had no additional swelling and he laid down to go to sleep at approx. 9:30 PM. Since I am a nurse and have had to deal with his asthma and allergies in the past, I felt confident that I could manage his symptoms safely. This is why I was up until 1:00 AM monitoring him to make sure that he did not have any additional troubles. The next morning, his facial swelling and eyelids were almost back to normal. He felt better and was able to go to school.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Eyelid oedema, Headache, Malaise, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Son (not sick) went to Pediatrician for "Well-Child" visit and needed vaccines. He received vaccines at approximately 4:45 PM. We left MD office at about 5:00 PM, picked up dinner which he ate on the way home, and got home about 6:00 PM. He was given Ibuprofen 15ml/300mg as recommended by MD. He went upstairs to do homework. He came down about 7:00 PM with complaints of headache, runny nose, chest tightness, wheezing, and I noticed his eye starting to swell. He said he did not feel well and he felt like he feels when he has asthma exacerbations. I gave him BENADRYL 15ml/37.5mg. He sat on couch with box of tissue as his nose was very runny.  Over the next hour, symptoms worsened and he reported feeling even worse with difficulty breathing. His eyes became "bloodshot" red and eyelids almost swollen shut, face puffy. At 8:00 PM, I gave him Albuterol inhaler 2 puffs and FLOVENT inhaler 2 puffs. Also gave him ZYRTEC 10 mg disintegrating tablet. I watched him over the next few hours and he had no additional swelling and he laid down to go to sleep at approx. 9:30 PM. Since I am a nurse and have had to deal with his asthma and allergies in the past, I felt confident that I could manage his symptoms safely. This is why I was up until 1:00 AM monitoring him to make sure that he did not have any additional troubles. The next morning, his facial swelling and eyelids were almost back to normal. He felt better and was able to go to school.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Swelling face, Wheezing
Clinical narrative: Son (not sick) went to Pediatrician for "Well-Child" visit and needed vaccines. He received vaccines at approximately 4:45 PM. We left MD office at about 5:00 PM, picked up dinner which he ate on the way home, and got home about 6:00 PM. He was given Ibuprofen 15ml/300mg as recommended by MD. He went upstairs to do homework. He came down about 7:00 PM with complaints of headache, runny nose, chest tightness, wheezing, and I noticed his eye starting to swell. He said he did not feel well and he felt like he feels when he has asthma exacerbations. I gave him BENADRYL 15ml/37.5mg. He sat on couch with box of tissue as his nose was very runny.  Over the next hour, symptoms worsened and he reported feeling even worse with difficulty breathing. His eyes became "bloodshot" red and eyelids almost swollen shut, face puffy. At 8:00 PM, I gave him Albuterol inhaler 2 puffs and FLOVENT inhaler 2 puffs. Also gave him ZYRTEC 10 mg disintegrating tablet. I watched him over the next few hours and he had no additional swelling and he laid down to go to sleep at approx. 9:30 PM. Since I am a nurse and have had to deal with his asthma and allergies in the past, I felt confident that I could manage his symptoms safely. This is why I was up until 1:00 AM monitoring him to make sure that he did not have any additional troubles. The next morning, his facial swelling and eyelids were almost back to normal. He felt better and was able to go to school.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Urticaria, Wheezing
Clinical narrative: Cough, wheeze, hives
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Next day was red around injection site, then became more raised and continued to spread slowly, on 10/11/17 area became pruritic and painful. Patient advised to apply cold compress, topical steroid cream or calamine, and to give oral BENADRYL.
Age: 18.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 18 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions or allergies provided. On 18-JUL-2017, the patient was vaccinated with ENGERIX (manufactured by GlaxoSithKline) 10 microgram. On 17-SEP-2017, the patient received a second dose of RECOMBIVAX HB, 10 microgram for prophylaxis (route, lot number and expiration date were not reported). No adverse effects were reported. No product quality complaint was involved.
Age: 36.0
Sex: M
Vaccine: HPV4
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, who referred to a 36-year-old male patient. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies was provided. On 03-OCT-2017, the patient was vaccinated with GARDASIL via intradermal route (lot# M014929, expiration date: 27-MAY-2017; dose and anatomical location were not reported) instead of the recommended intramuscular route. No adverse effects were reported. No product quality complaint was involved.
Age: 4.0
Sex: U
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assisstant refers to a 4 year old patient. Information on medical history, past drugs, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, at 15:45, the patient was vaccinated with second dose of VAQTA (lot # N005796, Exp date: 26-MAY-2018) dose 1, 1 DF, intramuscularly in the left arm for prophylaxis. Other suspect therapies included PROQUAD, (lot#N013270, Exp date: 25-OCT-2018) 1 DF, into left arm subcutaneously for prophylaxis on the same day. Also the patient was vaccinated with fifth dose of DIPHTHERIA TOXOID (+) PERTUSSIS VACCINE (UNSPECIFIED) (+) TETANUS TOXO, (05102AA) 1 DF, into right arm, intramuscularly for prophylaxis on the same day and on an unknown date, fourth dose of POLIOVIRUS VACCINE INACTIVATED (UNSPECIFIED), (N1G41) 1 DF, was administered into right arm, intramuscularly for prophylaxis. On 02-AUG-2017, at 08:45 am, the patient experienced incorrect product storage. No adverse symptoms or reactions were reported. This case is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA005166: US-009507513-1708USA005167: US-009507513-1708USA005169: US-009507513-1708USA005170: US-009507513-1708USA005168: US-009507513-1708USA001493.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Rash
Clinical narrative: Pateint developed rash approximately 24 hours after vaccine on back and side (bra strap area). No reaction at injection site or area. This was reported to pharmacy several days later in search of remedy to help rash.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: Aches, pains, chills, fever (102), dizziness, weakness, headache. This began about 4 hours after receiving the Flu Vaccine. Still not fully recovered. So far, 24 hours of sleeping, aspirin and no food.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersomnia, Pain, Pyrexia
Clinical narrative: Aches, pains, chills, fever (102), dizziness, weakness, headache. This began about 4 hours after receiving the Flu Vaccine. Still not fully recovered. So far, 24 hours of sleeping, aspirin and no food.
Age: 31.0
Sex: F
Vaccine: PNC13
Symptoms: Chest discomfort, Neck pain
Clinical narrative: I received the vaccine on 10/11/17 around 9 am and at 7 am on 10/12/17 I woke with a tightness in my chest and a sore neck. Pain of 5/6 on scale of 1-10.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: 24 hours post shot, muscle aches, fever, chills, nausea, vomiting, headache. 48 hours post shot still mild muscle aches and headache.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: 24 hours post shot, muscle aches, fever, chills, nausea, vomiting, headache. 48 hours post shot still mild muscle aches and headache.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Hypertension, Influenza like illness, Injection site induration, Injection site pruritus
Clinical narrative: Patient called and notified pharmacy at 9:00 am on 10/12/17 about an adverse event she attributed to the PNEUMOVAX 23 vaccine. She described flushing, fever, high blood pressure and general flu like symptoms the night before 10/11/17. She also had arm pain and itchiness/hardness at the injection site. The patient stated that some of the symptoms had resolved by morning 10/12/17  but  arm pain was still present. I advised the patient to use tylenol or ibuprofen and a cold compress at the injection site. At the time of this report she was unsure of seeking medical treatment. I will follow up with her in the afternoon.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient called and notified pharmacy at 9:00 am on 10/12/17 about an adverse event she attributed to the PNEUMOVAX 23 vaccine. She described flushing, fever, high blood pressure and general flu like symptoms the night before 10/11/17. She also had arm pain and itchiness/hardness at the injection site. The patient stated that some of the symptoms had resolved by morning 10/12/17  but  arm pain was still present. I advised the patient to use tylenol or ibuprofen and a cold compress at the injection site. At the time of this report she was unsure of seeking medical treatment. I will follow up with her in the afternoon.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Fatigue, Herpes zoster, Musculoskeletal chest pain
Clinical narrative: Began having severe pain on left side of rib cage and left side of lower back on Saturday, Oct. 7th in AM. Woke up on Sunday morning, Oct. 8 around 5:50 AM to find raised bumps across the left front side of my torso above navel. Later the same day raised bumps appeared on left side of back and in the small of my back. Still lots of joint pain and extremely tired. Called Dr.'s office on Tuesday morning on Oct. 10 and was seen by Dr. At approximately 12:15 PM Dr. confirmed shingles outbreak. Was immediately started on Anti-viral, Valaciclovir HCL 1 gram TID, no pain meds prescribed as per my request.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Began having severe pain on left side of rib cage and left side of lower back on Saturday, Oct. 7th in AM. Woke up on Sunday morning, Oct. 8 around 5:50 AM to find raised bumps across the left front side of my torso above navel. Later the same day raised bumps appeared on left side of back and in the small of my back. Still lots of joint pain and extremely tired. Called Dr.'s office on Tuesday morning on Oct. 10 and was seen by Dr. At approximately 12:15 PM Dr. confirmed shingles outbreak. Was immediately started on Anti-viral, Valaciclovir HCL 1 gram TID, no pain meds prescribed as per my request.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Arthralgia, Chills, Gait disturbance, Headache
Clinical narrative: I experienced severe muscle and joint pain, headache, chills and stomach cramps the evening of October 11, approximately 32 hours after receiving the flu vaccination on October 10 at 8:30 AM. The symptoms started with stomach cramping and progressed into the severe muscle and joint pain, headache and chills shortly after. I had difficulty moving and especially walking as it impacted my knees and legs badly. This lasted for about 6 hours. I contemplated visiting a local urgent care center or emergency room, but I was able to sleep and felt a little better in the morning.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Myalgia
Clinical narrative: I experienced severe muscle and joint pain, headache, chills and stomach cramps the evening of October 11, approximately 32 hours after receiving the flu vaccination on October 10 at 8:30 AM. The symptoms started with stomach cramping and progressed into the severe muscle and joint pain, headache and chills shortly after. I had difficulty moving and especially walking as it impacted my knees and legs badly. This lasted for about 6 hours. I contemplated visiting a local urgent care center or emergency room, but I was able to sleep and felt a little better in the morning.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, warm to touch, itchy at injection site. Employee was seen by pcp and treated with prednisone.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: SWELLING, REDNESS, FEVER.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: There was no adverse event. Patient received sub-optimal dosing in error (less than 0.5ml). This occurred due to leftover fluid in a needle tip that was changed out for a new needle tip without pharmacist aware of loss of fluid. Patient to be re-vaccinated with correct dosage.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Cardiac function test normal, Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram normal
Clinical narrative: Patient with a history of WPW S/P ablation. Developed chest pain and shortness of breath approximately 30 minutes after vaccination that persisted into the next day. Was evaluated in ED and had cardiac evaluation that was negative.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Fibrin D dimer normal, Full blood count normal
Clinical narrative: Patient with a history of WPW S/P ablation. Developed chest pain and shortness of breath approximately 30 minutes after vaccination that persisted into the next day. Was evaluated in ED and had cardiac evaluation that was negative.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site induration, Injection site reaction
Clinical narrative: Localized redness and firmness at the injection site, measuring 3 inches in circumference, afebrile, feels well.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Chills, Flushing, Myalgia
Clinical narrative: PT HAD CHILLS, MUSCLE ACHES AND FLUSHING STARTING ON 10/8/17, SYMPTOMS WORSEN UNTIL 10/11/17. ON 10/12/17 PT IS STARTING TO FEEL BETTER AND WILL START TO TAKE MORE FLUID, INCREASE SLEEP AND TAKE TYLENOL AS NEEDED.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Pyrexia, Skin warm
Clinical narrative: Rash at site of injection and feverish arm; patient also had fever of 102.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Mobility decreased, Pyrexia
Clinical narrative: Fever, sick and could not get out of bed.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Dysstasia, Hyperhidrosis, Palpitations
Clinical narrative: Heart racing, dizziness, weak, sweats, not able to stand.
Sex: F
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives in a infant female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received the 1st dose of FLULAVAL QUADRIVALENT .5 ml. On an unknown date, less than an hour after receiving FLULAVAL QUADRIVALENT, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were unknown. It was unknown if the reporter considered the hives and rash to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient was reporter's granddaughter. The reporter did not want to provide demographics. The reporter did not know the name of patient's physician.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Exposure via eye contact, Eye irrigation, Eye pain, Immediate post-injection reaction, Syringe issue
Clinical narrative: This case was reported by a nurse and described the occurrence of ocular stinging in a 37-year-old female patient who received ENGERIX B (batch number 53P39, expiry date 12th February 2020). On an unknown date, the patient received ENGERIX B. On 2nd October 2017, immediately after receiving ENGERIX B, the patient experienced ocular stinging and inadvertent exposure to vaccine. On an unknown date, the outcome of the ocular stinging and inadvertent exposure to vaccine. On an unknown date, the outcome of the ocular stinging and inadvertent exposure to vaccine were unknown. It was unknown if the reporter considered the ocular stinging to be related to ENGERIX B. Additional details were reported as follows: The age at vaccination was not applicable for this report. While administering ENGERIX-B, the needle cracked and the vaccine squirted out of the syringe. The vaccine went into the nurse's eye, which led to inadvertent exposure to vaccine. The nurse had stinging in her eye for which she flushed her eye as treatment. This case was linked to case US2017GSK152218, reported by same reporter.
Age: 54.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Asthenia, Contusion, Erythema, Injection site erythema, Injection site nodule
Clinical narrative: This 54 year old patient presents for Arm pain and IZ. Onset: 4 days ago. Duration: 4 days. Severity level is 9. Location: bilateral shoulder. The pain is burning and deep. Context: there is no injury. The pain is aggravated by touch. The pain is relieved by massage. Associated symptoms include bruising, swelling, weakness and itching and red. Pertinent negatives include tingling in the arms. Addition information: Pt state received TdaP and flu on Monday and since then arms have developed knot and is irritating. Pt just received flu and TDaP in each arm. Both had reaction. Pt has had these vaccines in the past without allergic reaction. Now mild erythema and pruritus. Pt has not try taking BENADRYL or putting cream over site of injection. Denies fever or shortness of breath. IZ.
Age: 54.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site pain, Injection site pruritus, Pain, Paraesthesia, Pruritus
Clinical narrative: This 54 year old patient presents for Arm pain and IZ. Onset: 4 days ago. Duration: 4 days. Severity level is 9. Location: bilateral shoulder. The pain is burning and deep. Context: there is no injury. The pain is aggravated by touch. The pain is relieved by massage. Associated symptoms include bruising, swelling, weakness and itching and red. Pertinent negatives include tingling in the arms. Addition information: Pt state received TdaP and flu on Monday and since then arms have developed knot and is irritating. Pt just received flu and TDaP in each arm. Both had reaction. Pt has had these vaccines in the past without allergic reaction. Now mild erythema and pruritus. Pt has not try taking BENADRYL or putting cream over site of injection. Denies fever or shortness of breath. IZ.
Age: 54.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Skin irritation, Swelling
Clinical narrative: This 54 year old patient presents for Arm pain and IZ. Onset: 4 days ago. Duration: 4 days. Severity level is 9. Location: bilateral shoulder. The pain is burning and deep. Context: there is no injury. The pain is aggravated by touch. The pain is relieved by massage. Associated symptoms include bruising, swelling, weakness and itching and red. Pertinent negatives include tingling in the arms. Addition information: Pt state received TdaP and flu on Monday and since then arms have developed knot and is irritating. Pt just received flu and TDaP in each arm. Both had reaction. Pt has had these vaccines in the past without allergic reaction. Now mild erythema and pruritus. Pt has not try taking BENADRYL or putting cream over site of injection. Denies fever or shortness of breath. IZ.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Dizziness, Electrocardiogram, Nausea, Seizure
Clinical narrative: Patient appeared to have a seizure, felt dizzy, nauseous and vomited. Was made comfortable, head kept upright. 911 was called. Pt assessed by 911 staff Blood sugar was low, advised to see physician for follow up.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient appeared to have a seizure, felt dizzy, nauseous and vomited. Was made comfortable, head kept upright. 911 was called. Pt assessed by 911 staff Blood sugar was low, advised to see physician for follow up.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Peripheral swelling, Sensory loss
Clinical narrative: Patient returned to pharmacy on 10/12/17 stating on the evening of 10/11/17 she began to have pain in Left hand and swelling. Reports loss of feeling and pain today with visual swelling.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site turned red and swelling, was hot to touch. As of Monday AM, 10/9/17, redness going away - no longer hot and swelling has gone down.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling
Clinical narrative: Swelling to (L) axilla, (L) neck and small round moveable area to (L) neck after flu vacc. to (L) arm on 10/10/17.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Cold sweat, Hypoaesthesia, Nausea
Clinical narrative: About 15 minutes after vaccines were given, pt felt nauseous, felt clammy to the touch, had cold sweats and face felt numb. Symptoms improved slowly and totally resolved in 90 minutes.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMRV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Irritability, Poor quality sleep
Clinical narrative: He has not had any fevers. He has been more fussy than usual and has slept poorly every night since the shots. Last night the parents noticed red bumps on his left thigh. He is otherwise well.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No symptoms.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Parents noticed redness and swelling at injection site 10-12 hours after vaccine administration. Area warm to touch. Elevated temp. of 100. Swelling increased x2 days to double the size of pt arm. Area of swelling extending from shoulder to below elbow. Area warm to touch.