chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a 22 year old patient of unknown gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 15-SEP-2017 the patient was vaccinated with an expired dose of GARDASIL 9 with lot number L007560 and expiration date on 15-JUN-2017, for prophylaxis (dose, dose number and route of administration were not provided). No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA009964: US-009507513-1709USA010096.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M005732, expiration date 19-OCT-2017)  (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 15 minutes. Also there was previous temperature excursion from 32 Fahrenheit (°F) degrees to 35 Fahrenheit (°F) degrees for 19 hours and 30 minutes and from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 1 hour and 45 minutes. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA009372: US-009507513-1709USA010095:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA (lot # N003194, expiration date 28-OCT-2017) (dose and route were not reported). The vaccine was exposed from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 15 minutes. Also there was previous temperature excursion from 32 Fahrenheit (°F) degrees to 35 Fahrenheit (°F) degrees for 19 hours and 30 minutes and from 47 Fahrenheit (°F) degrees to 77 Fahrenheit (°F) degrees for 1 hour and 45 minutes. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA010094: US-009507513-1709USA009372.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of M-M-RII (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. It was reported that M-M-RII was reconstituted with properly sterile diluent (MERCK). The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA009964: US-009507513-1709USA010092.
Age: 14.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product name confusion
Clinical narrative: This spontaneous report as received from a pharmacy student and refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Pharmacy student reported that multiple unspecified pediatric patients received adult doses of VAQTA 25/0.5, lot#N016805, expiry date: 04-SEP-2018 (dosing details, anatomical location and route were unknown) and multiple unspecified adult patients received pediatric doses of VAQTA injection 25/0.5, (N014945, 31-AUG-2018), (Captured in MARRS 1708USA003180). All doses were administered on unspecified dates. Pharmacy student reported that product confusion was the cause of error. No adverse effects were reported. No product quality compliant (PQC) was present. Outcome of events was unknown. Follow-up information was received from the supervisor (other) on 14-SEP-2017 concerning a 14 year old patient. On 17-JUL-2017, the patient was vaccinated with the adult dose of VAQTA as opposed to the pediatric dose because of product confusion. This is one of the several reports received from the same reporter. Patient demographics, product details, event, reporter and narrative were updated. Sender's Comments: US-009507513-1708USA003180: US-009507513-1708USA003849: US-009507513-1708USA003180.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Product name confusion
Clinical narrative: This spontaneous report as received from a pharmacy student and refers to a patient of unknown age and gender. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. Pharmacy student reported that multiple unspecified pediatric patients received adult doses of VAQTA 25/0.5, lot#N016805, expiry date: 04-SEP-2018 (dosing details, anatomical location and route were unknown) and multiple unspecified adult patients received pediatric doses of VAQTA injection 25/0.5, (lot#N014945, expiry date:31-AUG-2018), (Captured in MARRS 1708USA003180). All doses were administered on unspecified dates. Pharmacy student reported that product confusion was the cause of error. No adverse effects were reported. No product quality compliant (PQC) was present. Follow-up information was received from the supervisor (other) on 14-SEP-2017 concerning an 11 year old patient. On 17-JUL-2017, the patient was vaccinated with the adult dose of VAQTA as opposed to the pediatric dose because of product confusion. This is one of the several reports received from the same reporter. Patient demographics, product details, event, reporter and narrative were updated. Sender's Comments: US-009507513-1708USA003180: US-009507513-1708USA003849: US-009507513-1709USA010238.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, and adult patient was vaccinated with a dose of PROQUAD (dose, route of administration, lot#, expiration date were not reported) for prophylaxis. The vaccine was reconstituted with a sterile diluent (lot# and expiration date were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a female patient of unknown age who refers to herself. The patient had no pertinent medical history and drug reactions or allergies. She was not administered any concomitant medications. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot#, expiration date were not reported) to prevent shingles. On 20-SEP-2017, the patient experienced redness at the site of injection (also reported as insertion). The patient did not seek medical attention. The outcome of the event was unknown. The relatedness between the event and the suspect drug was not reported.
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, Product packaging confusion
Clinical narrative: This spontaneous report was received from a pharmacist, who reported that M-M-R II injection and sterile diluent supplied with it could be potentially confused since they are in extremely similar packaging as "the cartons differ only by one stripe" (product packaging confusion and circumstance or information capable of leading to medication error). It was also stated that at the time of reporting no patients were involved with the potential product confusion yet. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Back pain, Depressed level of consciousness, Disorientation, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the son (patient's mother). An 18-year-old male patient received TRUMENBA, via an unspecified route of administration at single dose in the right arm on 02Sep2017 10:45 for immunisation. Medical history included ear infection when he was child. Concomitant medications were not reported. The patient previously took MENACTRA in 2010 and in 2015 (at the age of 16 years), meningococcal vaccine on unknown date and TRUMENBA on 19Sep2016 and experienced peripheral swelling, vaccination site warmth, pain. On 02Sep2017, the patient experienced almost passed out/ he has passed out, had a fever/ was burning with fever/ basal thermometer that went up to 101°F, terrible back pain/ back pain and whole body ached, body aches/ back pain and whole body ached, dizziness/ he was dizzy, he felt like he was going to vomit, he was disoriented, he looked terrible, he looked exhausted, all with outcome of recovered. He did not look good, looking pale on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of fever included acetaminophen. The events were described as follows: That night 02Sep2017, she thought he was reading, when she went up to check on him, he had passed out, was burning up with fever. Only could find a basal thermometer that went up to 101°F, his temperature could have been higher. Was given acetaminophen. He was disoriented, he looked terrible, had back pain and whole body ached. When he tried to go to bathroom, he was dizzy and almost passed out and felt like he was going to vomit, but he did not lose consciousness. Had vaccine in the morning, unknown if he was feeling well at dinner. He had just went to college, he looked exhausted. She had read on (Online) that she should take him to emergency room. She had called doctor an hour later, by that time his fever had gone down to 99°F. He was ok the next day, fever had gone. Still did not look good, looking pale. First couple of days he was not a 100%. Unknown date when he fully recovered from adverse events.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain, Pallor, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for the son (patient's mother). An 18-year-old male patient received TRUMENBA, via an unspecified route of administration at single dose in the right arm on 02Sep2017 10:45 for immunisation. Medical history included ear infection when he was child. Concomitant medications were not reported. The patient previously took MENACTRA in 2010 and in 2015 (at the age of 16 years), meningococcal vaccine on unknown date and TRUMENBA on 19Sep2016 and experienced peripheral swelling, vaccination site warmth, pain. On 02Sep2017, the patient experienced almost passed out/ he has passed out, had a fever/ was burning with fever/ basal thermometer that went up to 101°F, terrible back pain/ back pain and whole body ached, body aches/ back pain and whole body ached, dizziness/ he was dizzy, he felt like he was going to vomit, he was disoriented, he looked terrible, he looked exhausted, all with outcome of recovered. He did not look good, looking pale on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of fever included acetaminophen. The events were described as follows: That night 02Sep2017, she thought he was reading, when she went up to check on him, he had passed out, was burning up with fever. Only could find a basal thermometer that went up to 101°F, his temperature could have been higher. Was given acetaminophen. He was disoriented, he looked terrible, had back pain and whole body ached. When he tried to go to bathroom, he was dizzy and almost passed out and felt like he was going to vomit, but he did not lose consciousness. Had vaccine in the morning, unknown if he was feeling well at dinner. He had just went to college, he looked exhausted. She had read on (Online) that she should take him to emergency room. She had called doctor an hour later, by that time his fever had gone down to 99°F. He was ok the next day, fever had gone. Still did not look good, looking pale. First couple of days he was not a 100%. Unknown date when he fully recovered from adverse events.
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Rash
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program, received from a non-contactable male consumer reporting for himself. A male patient of an unspecified age and ethnicity started to receive PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient had a bad rash on an unspecified date with outcome of unknown. The patient thought it was an allergic reaction. Consumer wanted to know if another medication would also give him the same side effects. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician. A 21-year-old female patient of an unspecified ethnicity received the first dosage of TRUMENBA, via an unspecified route of administration on an unspecified date to an unspecified date at single dose for immunisation. The medical history and concomitant medications were not reported. The patient experienced a very swollen arm after the first dose on an unspecified date with outcome of unknown.
Age: 8.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Hypoaesthesia, Pain, Sleep disorder
Clinical narrative: This is a spontaneous report from a contactable pharmacist, received via a Pfizer sales representative. A male patient in his 70s of an unspecified ethnicity received PREVNAR 13 in a Pharmacy/Drugstore, intramuscular on 11Sep2017 at 0.5 ml, single as pneumonia vaccine. The patient's medical history and concomitant medications were not reported. The patient received a shot at a Doctor's office on Monday, 11SEP2017 in the morning. The pharmacist thinks it was a flu shot. Then the doctor gave the patient a prescription for pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) the same day. The patient went into the pharmacy that afternoon on 11SEP2017 to receive the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The pharmacist administered pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). Then the patient came back to the pharmacy on Friday of unspecified date in Sep2017, and reported that on the night he received the injection, 11Sep2017, he had so much pain he could not sleep and it had progressed to numbness. It was clarified that, the pain went away and the patient was alarmed since he started having numbness in the arm (Sep2017). The pharmacist instructed the patient to apply a cold compress and consult his physician if it does not get better. The outcome of the event pain was recovered on an unspecified date. The outcome of other events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Pain in extremity, Pruritus, Skin warm
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13 (NDC number: 0005-1971-02, Lot number: 195216 and Expiration date: Apr2018), via an unspecified route of administration in the arm on 12Sep2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist told the patient that her arm was going to get tender because at some point in her life she might have had pneumonia and made antibodies. On an unspecified date the patient arm did get sore and then got better. Then it came back and got a little bit hot and a little bit sore, it was also reported that it felt itchy. These had been completely resolved. It was also reported that on an unspecified date, there was red erythema around the injection site. Everything had been good and then it broke out in the red erythema and other symptoms. The outcome of the event red erythema around the injection site was unknown. The outcome of other reported events was recovered on 16Sep2017.
Age: 60.0
Sex: M
Vaccine: FLU4, PPV, TD
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Patient said his left arm swelled up, was hot to the touch, was red in color. He also had a fever for 3 days and felt aching in his legs. After 3 days he was beginning to feel better but his arm was still swollen, hot to the touch, and red in color.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Erythema, Lethargy, Mobility decreased, Pain
Clinical narrative: Red, swollen arm and low grade fever (99.7) with pain on 9/20/17 at noon. By 3:30 pm, she had a fever of 101.7, was lethargic and couldn't lift arm. Was given 1 1/2 tsp children's ibuprofen and continued to have 101.7 fever; she was still lethargic but also became somewhat giddy and "out of it." Before bedtime she developed hives around the injection site and was given a dose of Benadryl. Overnight, her fever spiked and went over 102. She was dizzy and needed help getting to the bathroom, complained of pain in her red, incredibly swollen arm. As of 9/21, she still has arm pain and the redness has extended to her elbow. She was seen by a doctor in the Urgent Care, who recorded her symptoms. She also has a scratch near the injection site that we are monitoring for infection.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Scratch
Clinical narrative: Red, swollen arm and low grade fever (99.7) with pain on 9/20/17 at noon. By 3:30 pm, she had a fever of 101.7, was lethargic and couldn't lift arm. Was given 1 1/2 tsp children's ibuprofen and continued to have 101.7 fever; she was still lethargic but also became somewhat giddy and "out of it." Before bedtime she developed hives around the injection site and was given a dose of Benadryl. Overnight, her fever spiked and went over 102. She was dizzy and needed help getting to the bathroom, complained of pain in her red, incredibly swollen arm. As of 9/21, she still has arm pain and the redness has extended to her elbow. She was seen by a doctor in the Urgent Care, who recorded her symptoms. She also has a scratch near the injection site that we are monitoring for infection.
Age: 16.0
Sex: M
Vaccine: MENB, VARCEL
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Around 20 hours  after vaccination appeared  (erythema and rash with pruritus on trunk and upper extremities ), TX : Benadryl one tablet every 12 hours.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Vomiting and slight fever the next day (9/20). Redness adjacent to vaccine site, raised, warm, and tender on 9/21.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Vomiting and slight fever the next day (9/20). Redness adjacent to vaccine site, raised, warm, and tender on 9/21.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Erythema, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Tuesday, September 19, 2017 3:43pm patient immediately felt woozy, dizzy, lightheaded and sat in the waiting room before being able to leave the pediatrician's office. Her throat felt tight and her head began to hurt. Her arms and legs hurt. By the time she drove herself home she was feeling very tired and went to sleep. 9:00 pm patient was running a low grade fever, complaining of a headache, that her arms and legs hurt, and of a very sore throat so I gave her TYLENOL, a cup of tea with honey, and a bottle of water to keep by her bed. Wednesday, September 20, 2017 6:30 am patient didn't go to school. She was feeling dizzy, nauseous, and still complaining of headache, arm and leg pain, sore and tight throat, vision changes, felt feverish all day. 3:00 pm She became very dizzy trying to shower and move around the house. She called her grandmother to come over to help her when she couldn't get a hold of me at work. Grandma is a nurse so she pushed fluids and stayed with patient until I got home. 8:30 pm A rash broke out on patient's inner right thigh. The skin was very red and there were dark purplish marks, a fine red rash and a section that was raised a bit more than the rest. I gave her 18ml of children's BENADRYL. Within an hour she was back asleep for the night. Thursday, September 21, 2017 patient didn't go to school. Still feverish and the same complaints. So I called to get an appointment with the pediatrician.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of personal independence in daily activities, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Tuesday, September 19, 2017 3:43pm patient immediately felt woozy, dizzy, lightheaded and sat in the waiting room before being able to leave the pediatrician's office. Her throat felt tight and her head began to hurt. Her arms and legs hurt. By the time she drove herself home she was feeling very tired and went to sleep. 9:00 pm patient was running a low grade fever, complaining of a headache, that her arms and legs hurt, and of a very sore throat so I gave her TYLENOL, a cup of tea with honey, and a bottle of water to keep by her bed. Wednesday, September 20, 2017 6:30 am patient didn't go to school. She was feeling dizzy, nauseous, and still complaining of headache, arm and leg pain, sore and tight throat, vision changes, felt feverish all day. 3:00 pm She became very dizzy trying to shower and move around the house. She called her grandmother to come over to help her when she couldn't get a hold of me at work. Grandma is a nurse so she pushed fluids and stayed with patient until I got home. 8:30 pm A rash broke out on patient's inner right thigh. The skin was very red and there were dark purplish marks, a fine red rash and a section that was raised a bit more than the rest. I gave her 18ml of children's BENADRYL. Within an hour she was back asleep for the night. Thursday, September 21, 2017 patient didn't go to school. Still feverish and the same complaints. So I called to get an appointment with the pediatrician.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rash, Rash erythematous, Skin discolouration, Somnolence, Swelling
Clinical narrative: Tuesday, September 19, 2017 3:43pm patient immediately felt woozy, dizzy, lightheaded and sat in the waiting room before being able to leave the pediatrician's office. Her throat felt tight and her head began to hurt. Her arms and legs hurt. By the time she drove herself home she was feeling very tired and went to sleep. 9:00 pm patient was running a low grade fever, complaining of a headache, that her arms and legs hurt, and of a very sore throat so I gave her TYLENOL, a cup of tea with honey, and a bottle of water to keep by her bed. Wednesday, September 20, 2017 6:30 am patient didn't go to school. She was feeling dizzy, nauseous, and still complaining of headache, arm and leg pain, sore and tight throat, vision changes, felt feverish all day. 3:00 pm She became very dizzy trying to shower and move around the house. She called her grandmother to come over to help her when she couldn't get a hold of me at work. Grandma is a nurse so she pushed fluids and stayed with patient until I got home. 8:30 pm A rash broke out on patient's inner right thigh. The skin was very red and there were dark purplish marks, a fine red rash and a section that was raised a bit more than the rest. I gave her 18ml of children's BENADRYL. Within an hour she was back asleep for the night. Thursday, September 21, 2017 patient didn't go to school. Still feverish and the same complaints. So I called to get an appointment with the pediatrician.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Throat tightness, Visual impairment
Clinical narrative: Tuesday, September 19, 2017 3:43pm patient immediately felt woozy, dizzy, lightheaded and sat in the waiting room before being able to leave the pediatrician's office. Her throat felt tight and her head began to hurt. Her arms and legs hurt. By the time she drove herself home she was feeling very tired and went to sleep. 9:00 pm patient was running a low grade fever, complaining of a headache, that her arms and legs hurt, and of a very sore throat so I gave her TYLENOL, a cup of tea with honey, and a bottle of water to keep by her bed. Wednesday, September 20, 2017 6:30 am patient didn't go to school. She was feeling dizzy, nauseous, and still complaining of headache, arm and leg pain, sore and tight throat, vision changes, felt feverish all day. 3:00 pm She became very dizzy trying to shower and move around the house. She called her grandmother to come over to help her when she couldn't get a hold of me at work. Grandma is a nurse so she pushed fluids and stayed with patient until I got home. 8:30 pm A rash broke out on patient's inner right thigh. The skin was very red and there were dark purplish marks, a fine red rash and a section that was raised a bit more than the rest. I gave her 18ml of children's BENADRYL. Within an hour she was back asleep for the night. Thursday, September 21, 2017 patient didn't go to school. Still feverish and the same complaints. So I called to get an appointment with the pediatrician.
Age: 43.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Vaccination complication
Clinical narrative: Patient came into clinic on 9/07/17 and stated she had a mild reaction to the vaccines she received on 6/15/17. She received MMR and Varicella on that date. She stated that when she got home, she had a rash on her face. That was the only symptom, no breathing difficulty, tongue swelling, no lips swelling. She stated the rash went away on its own and it was not a cause for concern for her but she wanted to let me know. I advised the patient, next time she has symptoms and she is having breathing difficulty to call 911.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient experienced 5inch circumferenced raised red circular rash on left tricep. Patient reports noticing the rash a day after Zoster immunization. Rash is located at typical site of subcutaneous injection. Patient reports no itching or discomfort. Patient was referred to PCP. Recommended to apply ice pack to rash and use of Benadryl as needed.
Age: 78.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Patient's left arm was red and swollen around the vaccine site as well as around the circumference of the arm in that area. Patient saw doctor on Thursday, 9/21/17 and was given an antibiotic (amoxicillin 500 mg 1 BIDx10d) since the doctor thought it was an infection from the shot. I spoke with patient at the pharmacy when she came to pick the antibiotic.
Age: 23.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Gaze palsy, Generalised tonic-clonic seizure, Joint hyperextension, Muscle tightness, Musculoskeletal stiffness
Clinical narrative: Pt was having tonic type of seizure, which are stiffening or tightening of all muscle groups; the head or eyes turned inward, right arm stretched out.
Age: 23.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Posture abnormal
Clinical narrative: Pt was having tonic type of seizure, which are stiffening or tightening of all muscle groups; the head or eyes turned inward, right arm stretched out.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: HEADACHE/POLYMYALGIA/POLYARTHRALGIA.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 4pper right arm red and itchy not at injection site. Reaction site is lower than injection site >50 mm wide and >50mm length.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Laceration
Clinical narrative: Pt came in on 9-21-2017 to report a problem with her vaccine. She had shoulder pain at the site of the injection. She went to her doctor and he said she had a lacerated shoulder.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Chills, Headache, Neck pain, Pain
Clinical narrative: Patient states had reaction to vaccination: Chills, Aches, Neck pain, balance issues, headache; Patient took acetaminophen and went to bed. Felt better the next day.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest X-ray normal, Dizziness, Fatigue, Full blood count abnormal, Headache
Clinical narrative: C/o HA, dizziness, tinnitus, fatigue that began 30 minutes after receiving the flu vaccine. By 9/20/17 symptoms have mostly resolved, only fatigue and tinnitus remain.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Metabolic function test normal, Nuclear magnetic resonance imaging brain normal, Tinnitus, Troponin normal
Clinical narrative: C/o HA, dizziness, tinnitus, fatigue that began 30 minutes after receiving the flu vaccine. By 9/20/17 symptoms have mostly resolved, only fatigue and tinnitus remain.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Patient came in with redness and what seems to be a rash on the upper arm where she received the injection site. It is raised up at the injection site and warmer than usual, so I advised her to put ice pack for a bit and take TYLENOL for the pain. If the rash spreads, advised her to see the doctor today. Will follow up with patient tomorrow.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reports abnormal swelling warmth and redness at injection site, described as greater than 2 inches.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Pruritus, Swelling, Swelling face, Urticaria
Clinical narrative: Pt presented with c/o one day scalp itching then woke up this morning with hives all over her body. Pt stated she felt her lips and face were slightly more swollen and she had a lot of itching and felt swollen behind her ears. Did not report any fever, abd pain, n/v., difficulty breathing, or SOB.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red circular rash approximately 2 inches across about one-half to one inch below injection site and warm to touch.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Night of vaccination had fever to 102.0. Vomited after dinner and x 3 on 9/20/2017. Afebrile 9/21/2017.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient alleges she received her vaccine in the bursa/rotator cuff area, resulting in a possible small tear and pain. She is unable to lift her arm without assistance of her other hand.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an Immunization Coordinator and 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, the patients were vaccinated with improperly stored doses of PROQUAD therapy type rHA (recombinant human albumin) with lot # M014304, expiration date 22-SEP-2017 and lot# M040141, expiration date 06-JAN-2018 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluents (lot# and expiration date were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9.5 degrees Fahrenheit for 36 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009125.
Age: 28.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Redness/swelling from shoulder to elbow seen. Warm to touch and slight itching.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth, Pain
Clinical narrative: Shortly after immunization, she reports that she experienced severe pain. In the same day, she noticed her skin started to turn red and feel hot to touch around the area of the shot. She came in to the pharmacy today to show me. Her left arm is red from the shoulder down to her elbow and about 4 inches in width.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Patient said she noticed the reaction this morning (9/21/17), she said it is red, swollen and itchy. She showed me the rash and it looks about the size of 2-3 quarters, and it is on the back of her right arm at the site of the zoster injection. When asked if she's taken anything for it yet she said no. When suggested she could take some Benadryl for it, she said she can't take it yet because she has work today and Benadryl makes her too sleepy.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Dehydration, Diarrhoea, Gastroenteritis, Nausea, Tachycardia
Clinical narrative: Nausea R11.0: Pt with nausea, vomiting, and diarrhea beginning around 7pm on 20 September 2017. Tachycardic from dehydration so given 1L bolus NS. Given Zofran 4mg ODT X1 from ED as well as 4 day supply r for nausea. Spoke with Allergy/Immunologist about case and given that this pt has had this vaccine before and tolerated well, as well as no cutaneous findings, does not recommend to stop giving the anthrax vaccine at this time. Likely a gastroenteritis. Pt given return precautions. -zofran 4mg ODT X4 days -zofran 4mg X1 from in ED -1L NS.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Nausea R11.0: Pt with nausea, vomiting, and diarrhea beginning around 7pm on 20 September 2017. Tachycardic from dehydration so given 1L bolus NS. Given Zofran 4mg ODT X1 from ED as well as 4 day supply r for nausea. Spoke with Allergy/Immunologist about case and given that this pt has had this vaccine before and tolerated well, as well as no cutaneous findings, does not recommend to stop giving the anthrax vaccine at this time. Likely a gastroenteritis. Pt given return precautions. -zofran 4mg ODT X4 days -zofran 4mg X1 from in ED -1L NS.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Exfoliative rash, Feeling hot, Rash, Rash papular
Clinical narrative: She started having symptoms later the same day she got the flu vaccine. Says she was feeling really warm inside and broke out in a rash all over her trunk area. Mom states the next morning the rash had spread all over; from her neck down to her mid thigh area. Dr examined her on 9/19/17, she had an extensive scaly papular rash with a Christmas tree like appearance pointing towards midline.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Fever onset (101 F) on Sunday (09/17/17) around 18:00. Low grade fever (100 F) all day Monday followed by mild rash all over the body on Tuesday.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Injection site pruritus, Joint swelling, Pain
Clinical narrative: Patient experienced itching from the top of the immunized arm to the elbow. She had a large bump on the inside of her elbow that she said was hard and painful.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Pruritus, Skin warm
Clinical narrative: Tired, and arm red and itchy. Arm also warm to touch. Dr was contacted and pt was encouraged to see him and has an appointment with him this afternoon.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash papular
Clinical narrative: PAPULAR RASH AND ITCHING TO BILAT ARMS, TORSO.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abdominal pain, Confusional state, Flushing, Vomiting
Clinical narrative: Approximately 15 minutes after immunizations child vomited multiple times in hallway, he was moved to a room - no respiratory distress but flushed and said "tummy hurt". Mother reports he was very confused and may have passed out or become unresponsive. BP 99/62. BENADRYL and MOTRIN given - child observed - no respiratory distress - left at approx. 10:40 AM BP 99/56, P 85, T - 96.8. Spoke with mom on 9/20/17 stated child was fine and that he felt better after he ate lunch on 9/19/17.
Age: 12.0
Sex: M
Vaccine: FLUA3
Symptoms: Headache
Clinical narrative: Patient complained of headache.  Mother advised to give Patient ibuprofen and monitor patient activity.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired driving ability, Pain in extremity
Clinical narrative: Pt complained of pain in the injection arm and had a hard time driving.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Described as tired and achy for 2 days and then arm was still sore after that.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dry throat
Clinical narrative: The patient reported feeling light headed/dizziness 5-10 minutes after the immunization. I then checked the patients blood pressure and it was 155/88. I continually monitored the patient. When I asked the patient if they were any problems breathing or swelling in the throat o face, the patient reported their throat felt dry. I monitored the patient several more times, and the patients blood pressure normalized to 138/74. I asked the patient how they where feeling over the course of several minutes and she reported she felt better/fine. I next gave the patient a bottle of water. She left the pharmacy and store soon after since she said she felt fine. I called and check on the patient at 3:15 pm the same day, and the patient reported feeling fine - no other issues to report.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site reaction, Rash macular
Clinical narrative: Patient reports she experienced a firm red macular rash surrounding the injection site about 6 days after the inoculation. She denies pruritus at the site but endorses, the rash. Patient followed up with her PCP. I am unaware as to if the provider reported the reaction.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Balance disorder, Feeling abnormal, Loss of consciousness, Pallor, Presyncope
Clinical narrative: Patient was brought back to room after nearly fainting in lobby at checkout. She reported to mom that everything went black and she didn't feel good. Mom noticed she was wobbly and caught her as she was unsteady on her feet. Reported she was pale and white. Also felt warm on forehead. Nurse confirmed pallor. When I saw her she did seem more pale than during our visit. She was alert and awake. She had normal vital signs and a normal exam. She was given juice and cookies and observed for approximately 20 minutes. Her color improved and mom reports she looked better. She was discharged home with return precautions. I spoke to mom today who said she didn't feel quite herself yet.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Patient was brought back to room after nearly fainting in lobby at checkout. She reported to mom that everything went black and she didn't feel good. Mom noticed she was wobbly and caught her as she was unsteady on her feet. Reported she was pale and white. Also felt warm on forehead. Nurse confirmed pallor. When I saw her she did seem more pale than during our visit. She was alert and awake. She had normal vital signs and a normal exam. She was given juice and cookies and observed for approximately 20 minutes. Her color improved and mom reports she looked better. She was discharged home with return precautions. I spoke to mom today who said she didn't feel quite herself yet.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient reports a red swollen area (approximately 3 in diameter) around injection site that appeared the morning after the injection.
Age: 92.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Hyperhidrosis, Malaise
Clinical narrative: Patient states she started feeling very sick two days after getting both vaccines together. She has had the flu shot by itself and never had a problem before. This time she got the chills and was sweating a lot to the point she would wake up soaked in sweat. She is convinced it was due to getting both vaccines together. She is better now but came into the pharmacy to report the symptoms and to double check that there was no interaction from taking both at the same time.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse reaction.
Age: 9.0
Sex: F
Vaccine: FLUA3
Symptoms: Administration site pain, Administration site swelling
Clinical narrative: Swelling and soreness at the admission site. Mother advised to apply a cold compress, give child ibuprofen and monitor activity.
Age: 20.0
Sex: F
Vaccine: FLUA3
Symptoms: Exposure during pregnancy
Clinical narrative: LMP 6-14-17; EDD 3-11-18. Patient was approximately 15 weeks 2 days gestation at time of vaccine administration.
Age: 20.0
Sex: M
Vaccine: TYP, YF
Symptoms: Full blood count normal, Headache, Influenza virus test negative, Pain, Photophobia
Clinical narrative: Received a call today from NP at pediatric office. Patient was seen last night (9-20-17) for c/o fever (101.8F), headache, body aches, light sensitivity, and thirst. She tested for strep, flu, and did a urine dip, all negative. He had Yellow Fever vaccine and Typhoid Vi 9-14-17.  She told me that he is on STELARA. He had an injection 12 weeks ago and yesterday (9-20-17) he did not tell his dermatologist that he had YF vaccine 9-14-17 (STELARA was not on his medication list on his intake form). After discussion, NP stated that she will consult ID MD. I discussed case with our medical director. He attempted to call patient then spoke to NP.
Age: 20.0
Sex: M
Vaccine: TYP, YF
Symptoms: Pyrexia, Streptococcus test negative, Thirst, Urine analysis normal
Clinical narrative: Received a call today from NP at pediatric office. Patient was seen last night (9-20-17) for c/o fever (101.8F), headache, body aches, light sensitivity, and thirst. She tested for strep, flu, and did a urine dip, all negative. He had Yellow Fever vaccine and Typhoid Vi 9-14-17.  She told me that he is on STELARA. He had an injection 12 weeks ago and yesterday (9-20-17) he did not tell his dermatologist that he had YF vaccine 9-14-17 (STELARA was not on his medication list on his intake form). After discussion, NP stated that she will consult ID MD. I discussed case with our medical director. He attempted to call patient then spoke to NP.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Peripheral swelling, Skin warm
Clinical narrative: Arm very swollen and hot to touch. Each day swelling gets a tad bit bigger. Complaints of pain in that area.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated on 9-8-17 that arm swelled up softball size at injection site and was warm and painful to touch. Day after that 9-9-17 swelling went down and warmth and pain went away.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Evening of the same day of the vaccine administration- began itching and hives all over body. Took over the counter Benadryl PO X2 doses over the next 12 hours and in the morning symptoms were gone. Never had a vaccine reaction prior and receives the flu vaccine annually.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Incorrect route of drug administration, Pain, Pain in extremity, Skin warm
Clinical narrative: A medical assistant was administered a flu shot in the posterolateral aspect of her right upper arm.  It was apparently given in the subcutaneous tissue as opposed to intramuscularly. The following day she noted a 6 cm area of erythema, warmth and tenderness of the arm. She has pain when moving the arm and when sleeping on her right side. She tried ibuprofen and ice with minimal improvement in her discomfort. She continues to work without restrictions.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Tenderness
Clinical narrative: A medical assistant was administered a flu shot in the posterolateral aspect of her right upper arm.  It was apparently given in the subcutaneous tissue as opposed to intramuscularly. The following day she noted a 6 cm area of erythema, warmth and tenderness of the arm. She has pain when moving the arm and when sleeping on her right side. She tried ibuprofen and ice with minimal improvement in her discomfort. She continues to work without restrictions.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Audiogram abnormal, Deafness unilateral, Tinnitus
Clinical narrative: He states that on the evening of the injection he had ringing of his right ear associated with hearing loss in the right ear. The symptoms resolved over the next 2 days.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Swelling
Clinical narrative: Patient reported "puffiness" and some local soreness.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Induration, Rash generalised, Rash macular, Skin warm, Tenderness
Clinical narrative: LEFT ARM HAD LARGE INDURATION APPROXIMETLY 9.5CM WARM AND PAINFUL TO TOUCH. MEMBER REPORTS SEVERAL RED BLOTCHES ALL OVER HER BODY.
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Chills, Mobility decreased, Muscle tightness, Muscular weakness
Clinical narrative: Symptom onset approximately 4 hours after immunization. Unable to lift arm past should height without pain. Vomiting and chills lasting 24 hours. Vomited approximately 6 times. Lower back pain, tightness, and muscle weakness.
Age: 23.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain, Vomiting
Clinical narrative: Symptom onset approximately 4 hours after immunization. Unable to lift arm past should height without pain. Vomiting and chills lasting 24 hours. Vomited approximately 6 times. Lower back pain, tightness, and muscle weakness.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: Influenza was given below the acromion process resulting in pain with ROM, numbness/tingling.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Crying, Discomfort, Erythema, Headache
Clinical narrative: Her syptoms started at dinnertime with a feeling of lethargy and pain in arm, which progressed to severe pain,especially in arm, back and legs, a stif neck and arm, and headache. The pain was so severe that she was sobbing and needed to take some oxycodone. The severe pain lasted most of the night, and started to diminish in the morning. However when she called me at 4pm today she was still uncomfortable, lethargic and her arm is swollen and bright pink. She feels like she is definitely improving.