chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Severe pain at injection site for over 3 weeks. Swelling and very hot at injection site for 2 days with mottled red and white skin around the area. Discoloration, green/blue at injection site for 3 weeks. General malaise and joint discomfort. Difficulty raising arm.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Livedo reticularis, Malaise, Musculoskeletal discomfort
Clinical narrative: Severe pain at injection site for over 3 weeks. Swelling and very hot at injection site for 2 days with mottled red and white skin around the area. Discoloration, green/blue at injection site for 3 weeks. General malaise and joint discomfort. Difficulty raising arm.
Age: 20.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Vision blurred
Clinical narrative: At 4pm in afternoon I was informed that patient felt light-headed and had blurred vision at work. He was taken to the hospital by ambulance where he is currently being evaluated.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Night sweats, Pain
Clinical narrative: Patient was administered the vaccine on 8/27 and by the end of the day experinced soreness. She was awaken at night with sweats and then later developed chills, fever, and the arm is swollen and red about 4 finger lengths. The red area appears to be at the lower end of the left deltoid.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient was administered the vaccine on 8/27 and by the end of the day experinced soreness. She was awaken at night with sweats and then later developed chills, fever, and the arm is swollen and red about 4 finger lengths. The red area appears to be at the lower end of the left deltoid.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Headache, Injection site erythema, Injection site induration
Clinical narrative: Patient was administered the vaccine on 8/27 and by the end of the day experinced soreness. She was awaken at night with sweats and then later developed chills, fever, and the arm is swollen and red about 4 finger lengths. The red area appears to be at the lower end of the left deltoid.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site warmth, Pyrexia, Tremor
Clinical narrative: Patient was administered the vaccine on 8/27 and by the end of the day experinced soreness. She was awaken at night with sweats and then later developed chills, fever, and the arm is swollen and red about 4 finger lengths. The red area appears to be at the lower end of the left deltoid.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: PATIENT CAME IN FOR F/U MEDICAL APPOINTMENT AND COMPLAINED OF LT ARM STILL BEING SORE FROM INJECTION GIVEN 4/9/18 AT VISIT ON 8/28/18. HE ALSO STATES THAT IT HURTS TO EXTEND ELBOW. THE SPOT OF INJECTION IS SORE, THOUGH IS IMPROVING SIGHTLY. HE DOES NOT FEEL WEAK. HEAT IN SHOWER MAKES IT FEEL BETTER. HE WAS INSTRUCTED TO CONTINUE HEAT, DOESN'T' WANT TO DO HOT COMPRESSES. ADVISED TO OBSERVE FOR NOW GIVEN NORMAL STRENGTH AND MUSCLE BULK.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Anxiety, Arthralgia, Computerised tomogram, Dizziness, Dyspnoea
Clinical narrative: The patient went horseback riding after the vaccine. When she got home about 3 hours after the vaccine.  She started feeling bad with extreme anxiety, dizziness, trouble breathing, joint pain, vomiting. She went to Medical center and was given IV fluids and nausea medicine.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Electrocardiogram, Feeling abnormal, Laboratory test, Nausea, Vomiting
Clinical narrative: The patient went horseback riding after the vaccine. When she got home about 3 hours after the vaccine.  She started feeling bad with extreme anxiety, dizziness, trouble breathing, joint pain, vomiting. She went to Medical center and was given IV fluids and nausea medicine.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Back pain
Clinical narrative: Client was heard by pharmacy staff in the aisles requesting help. The client was hunched over at shelves with excrutiating lower back pain. Pharmacy staff got a chair for her to sit in while we waited for 911 ambulance to arrive. EMT were able to transfer patient to gurney and patient was taken to local area hospital. We did here from family that hospital did not believe the pain was associated with vaccine but was unsure of cause the pain was subsiding by midafternoon from last report, will followup with patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling abnormal, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Headache in back of head, behind ears I & on both sides of temples. Upset stomach, just feeling cloudy. I had a very hard time sleeping because of the headache. I actually wrap my head with a bandanna to stop the throbbing. The injection site (upper right arm) was swollen and red. My arm hurt on underside of injection site. I had to leave work early two days in a row.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Headache in back of head, behind ears I & on both sides of temples. Upset stomach, just feeling cloudy. I had a very hard time sleeping because of the headache. I actually wrap my head with a bandanna to stop the throbbing. The injection site (upper right arm) was swollen and red. My arm hurt on underside of injection site. I had to leave work early two days in a row.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Chills, 99.5F, Aching all over, Tiredness. Soreness to touch in left arm continued until 08-29-2018. Took One Acetaminophen 500 mg every 4 hours from 4:00 PM 08-25-18 until 4:00 AM 08-26-2018.
Age: 79.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Chills, 99.5F, Aching all over, Tiredness. Soreness to touch in left arm continued until 08-29-2018. Took One Acetaminophen 500 mg every 4 hours from 4:00 PM 08-25-18 until 4:00 AM 08-26-2018.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Cellulitis, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Patient called the store on 8/30/2018, 3 days after the administration of SHINGRIX, said she experiences redness and swelling around the injection site, she also feels fatigue and weakness. She contacted her doctor office and they advised her that the site of injection was probably too low on her arm, and that she might have cellulitis. They wrote the Rx for KEFLEX and instructed her to take it if the area of swelling and redness keep getting bigger.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hypersensitivity, Peripheral swelling
Clinical narrative: Allergic reaction in the left arm with slight swelling and redness pt advice to take TYLENOL or Ibuprofen OTC. DR PRESCRIBED antibiotic AUGMENTIN.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Patient states she had a rash and red below the injection site, not at the injection site, but lower on her arm.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Lip pruritus, Lip swelling, Pruritus generalised
Clinical narrative: Patient called pharmacy to report swollen lip, itchy lips, and itching on body after receiving flu  vaccine today.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itchiness of the injected site.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Cough, Crying, Culture urine negative, Emotional distress, Gait disturbance
Clinical narrative: Mom became concerned of immediate irritability, crying, not as consolable as usual, then later fever to Tmax 104.4 on the day of vaccination. The second day after vaccines, pt developed a runny nose, and a mild cough which resolved by the 2nd day. There were no sick contacts known. They used TYLENOL and MOTRIN to help with fever. There was also a time (not sure when) pt had a refusal to walk. Mom waited until the 3rd day of fever and irritability to present to the office. Pt was also putting her hands in her m Pt had a fever work up was done by a colleague, which was negative (tested for RSV, Influenza, and urine culture). She was told it may be a viral illness and sent home. On day 5 after the vaccine pt developed a rash that was generalized, but remained with daily fevers all >101. Finally on day 9 the fevers are trending down to 100 range. Rash is bumpy and remains present. Mood is better.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Immediate post-injection reaction, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Irritability
Clinical narrative: Mom became concerned of immediate irritability, crying, not as consolable as usual, then later fever to Tmax 104.4 on the day of vaccination. The second day after vaccines, pt developed a runny nose, and a mild cough which resolved by the 2nd day. There were no sick contacts known. They used TYLENOL and MOTRIN to help with fever. There was also a time (not sure when) pt had a refusal to walk. Mom waited until the 3rd day of fever and irritability to present to the office. Pt was also putting her hands in her m Pt had a fever work up was done by a colleague, which was negative (tested for RSV, Influenza, and urine culture). She was told it may be a viral illness and sent home. On day 5 after the vaccine pt developed a rash that was generalized, but remained with daily fevers all >101. Finally on day 9 the fevers are trending down to 100 range. Rash is bumpy and remains present. Mood is better.
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, MMR
Symptoms: Pyrexia, Rash generalised, Respiratory syncytial virus test negative, Rhinorrhoea
Clinical narrative: Mom became concerned of immediate irritability, crying, not as consolable as usual, then later fever to Tmax 104.4 on the day of vaccination. The second day after vaccines, pt developed a runny nose, and a mild cough which resolved by the 2nd day. There were no sick contacts known. They used TYLENOL and MOTRIN to help with fever. There was also a time (not sure when) pt had a refusal to walk. Mom waited until the 3rd day of fever and irritability to present to the office. Pt was also putting her hands in her m Pt had a fever work up was done by a colleague, which was negative (tested for RSV, Influenza, and urine culture). She was told it may be a viral illness and sent home. On day 5 after the vaccine pt developed a rash that was generalized, but remained with daily fevers all >101. Finally on day 9 the fevers are trending down to 100 range. Rash is bumpy and remains present. Mood is better.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Hunger, Injection site erythema, Myalgia
Clinical narrative: After I received the shot and left the doctors office I had a sore arm (Nurse said there may be sore arm and side effect) Throughout the day I had a headache and muscle pain. Felt like I had an empty stomach. I had redness on arm where I received the shot (left arm). On the evening of the shot I had a fever, shivers, and arm was very sore, and redness. Fever and shivering lasted for most of the night. The 2nd day I was tired most of the day and I slept most of the day, had soreness and redness sin arm. Did not feel like doing much of anything. Third day I felt much better but still had soreness and redness in arm. 4th day I still have redness and much less soreness in arm. I did call my doctor on day 2 to let them know of the adverse effect I had after the shot and throughout the day  and overnight.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: After I received the shot and left the doctors office I had a sore arm (Nurse said there may be sore arm and side effect) Throughout the day I had a headache and muscle pain. Felt like I had an empty stomach. I had redness on arm where I received the shot (left arm). On the evening of the shot I had a fever, shivers, and arm was very sore, and redness. Fever and shivering lasted for most of the night. The 2nd day I was tired most of the day and I slept most of the day, had soreness and redness sin arm. Did not feel like doing much of anything. Third day I felt much better but still had soreness and redness in arm. 4th day I still have redness and much less soreness in arm. I did call my doctor on day 2 to let them know of the adverse effect I had after the shot and throughout the day  and overnight.
Age: 2.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pallor, Rash erythematous, Rash generalised, Rash maculo-papular
Clinical narrative: Patient was alert cooperative and breathing comfortably multiple blanching, non-tender erythematous maculopapular lesions all over the face, neck, behind the ears, trunk and extremities. No enlarged tonsils. Regular heart rate rhythm no murmurs.
Age: 1.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Measles post vaccine
Clinical narrative: Vaccine induced measles infection.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Malaise, Pain in extremity
Clinical narrative: Received SHINGRIX #2 in left deltoid 8/28/18. That night developed fever, ill feeling/arm pain. Today noted hard/red/warmth at site and rash on neck/chest. Treated with KEFLEX for cellulitis 8/30/18 at inj site.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Received SHINGRIX #2 in left deltoid 8/28/18. That night developed fever, ill feeling/arm pain. Today noted hard/red/warmth at site and rash on neck/chest. Treated with KEFLEX for cellulitis 8/30/18 at inj site.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Pain, Pyrexia
Clinical narrative: Painful, fevered, red.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: Pt. previously received 2 month vaccine on 4/24/18 and 4 month vaccines on 6/25/18. Website recommendations showed pt. only received 2 month vaccines. 4 month vaccines were given again on 8/27/18. So pt. received an extra dose of PEDVAXHIB and ROTARIX. No adverse reactions noted.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash macular, Vaccination site cellulitis, Vaccination site erythema
Clinical narrative: Rash developed on anterior (L) thigh. Presented to a walk in clinic. Note states "blotchy red rash with erythema centered at vaccination site about 6 cm." Diagnosed with cellulitis, prescribed clindamycin 7 mg 3 times daily x 5 days. Improved with antibiotic.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm where vaccine was given was swollen and red and slightly warm to the touch. Pt said it was sore and difficult to move. She could also feel the soreness up her right neck.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Neck pain
Clinical narrative: Right arm where vaccine was given was swollen and red and slightly warm to the touch. Pt said it was sore and difficult to move. She could also feel the soreness up her right neck.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Loss of control of legs, Muscular weakness
Clinical narrative: Red, swollen arm at injection site - hot to touch, size of baseball. Jaw pain. Muscle weakness/legs gave out in church. Fever/achy. TRMT: Took IBU, used ice pack, went to doctor.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in jaw, Pyrexia
Clinical narrative: Red, swollen arm at injection site - hot to touch, size of baseball. Jaw pain. Muscle weakness/legs gave out in church. Fever/achy. TRMT: Took IBU, used ice pack, went to doctor.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Swelling
Clinical narrative: Patient reports swelling at the injection site and a small bump and swelling below the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site urticaria, Rash, Urticaria
Clinical narrative: Urticaria rash - face, chest, injection site RT, no resp abnormalities.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Influenza like illness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever, flu like symptoms, body aches, arm where vaccine administrated red and swollen.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 8th June 2018 with no adverse effects). On 13th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was recovered/resolved. It was unknown if the reporter considered the muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extreme muscle soreness for several days afterwards. The effects subsided and disappeared. The reporter reported the adverse events to regulatory authority. The reporter asked if it was common for the second vaccine dose to have more severe side effects than the first dose and also, if there any test to determine if the vaccinations have been successful.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 8th June 2018 with no adverse effects). On 13th August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was recovered/resolved. It was unknown if the reporter considered the muscle soreness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extreme muscle soreness for several days afterwards. The effects subsided and disappeared. The reporter reported the adverse events to regulatory authority. The reporter asked if it was common for the second vaccine dose to have more severe side effects than the first dose and also, if there any test to determine if the vaccinations have been successful.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acoustic stimulation tests abnormal, Cold sweat, Computerised tomogram head abnormal, Deafness unilateral, Diarrhoea
Clinical narrative: 12 hr later pt experienced diarrhea followed by nausea, vomiting-vomiting lasted all day-led to feeling dizzy and pressure, went to ER and diagnosed with sinus infection, next day PCP gave MUCINEX. Pt reports hearing loss in (L) ear.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dysstasia, Inner ear disorder, Labyrinthitis, Sinusitis, Vomiting
Clinical narrative: 12 hr later pt experienced diarrhea followed by nausea, vomiting-vomiting lasted all day-led to feeling dizzy and pressure, went to ER and diagnosed with sinus infection, next day PCP gave MUCINEX. Pt reports hearing loss in (L) ear.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Computerised tomogram head abnormal, Deafness unilateral, Diarrhoea, Discomfort, Dizziness
Clinical narrative: 12 hr later pt experienced diarrhea followed by nausea, vomiting-vomiting lasted all day-led to feeling dizzy and pressure, went to ER and diagnosed with sinus infection, next day PCP gave MUCINEX. Pt reports hearing loss in (L) ear.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Nausea, Sinusitis, Vomiting
Clinical narrative: 12 hr later pt experienced diarrhea followed by nausea, vomiting-vomiting lasted all day-led to feeling dizzy and pressure, went to ER and diagnosed with sinus infection, next day PCP gave MUCINEX. Pt reports hearing loss in (L) ear.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acoustic stimulation tests, Computerised tomogram, Deafness unilateral, Nausea, Vertigo
Clinical narrative: 12 hr later pt experienced diarrhea followed by nausea, vomiting-vomiting lasted all day-led to feeling dizzy and pressure, went to ER and diagnosed with sinus infection, next day PCP gave MUCINEX. Pt reports hearing loss in (L) ear.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On 21st July 2018, 61 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported for self that she had experienced an episode of shingles, 2 months after receiving the SHINGRIX vaccine and still had the outbreak 1 month later at the time of reporting.
Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Headache, Body Aches, Nauseous and Chills.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Pt  developed a fever 08/14/18 of 39C/102.2F. Pt. complained of left arm pain measured area of redness 8x5 cm wide. Pt states no fever since last night. Exam: Alert  well appearing. Left upper arm with erythematous patch, approximately 2x3in. Soft, mildly tender. No active drainage. No streaking.  Left arm FROM.
Sex: F
Vaccine: HPV9
Symptoms: Injection site irritation, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 18-JUL-2018, the patient was vaccinated with first dose of GARDASIL 9, (dose, lot # and expiration date were not reported) for prophylaxis. On 18-JUL-2018, immediately after receiving the GARDASIL 9, the patient experienced injection site reaction: swelling, irritation and itching at the injection site. The patient was treated with ice in the office. The outcome of the events was unknown (also reported as ''it sounded like the patient was okay when she left that day but it could not be confirmed if she recovered and what date she recovered so outcome was unknown''). The causality assessment between therapy with GARDASIL 9 and the events was not reported.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a 15-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-AUG-2018, the patient was vaccinated with an adult dose of VAQTA, strength: 50/1.0 U/ml, lot # N020503, expiration date 04-SEP-2018, for prophylaxis, instead of a pediatric dose. No adverse effect was reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age (pharmacist's mother). Patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose, lot# and expiration date were not reported), intramuscularly for the prevention of pneumococcal disease. On an unknown date, the patient experienced injection site swelling and redness greater than expected. She did not seek medical attention. No treatment was given. The outcome of injection site swelling and redness was reported as recovered on an unknown date. The relatedness between the injection site swelling and redness and PNEUMOVAX 23 was not reported.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 4 month old female patient. On 06-AUG-2018 the patient was vaccinated with improperly stored ROTATEQ dose 1, oral for prophylaxis (product storage error).  Other suspect therapies included PREVNAR 13 and PENTACEL. No adverse event reported.; Sender's Comments: US-009507513-1808USA007069: US-009507513-1808USA003706:
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, Somnolence
Clinical narrative: This spontaneous report has been received from a physician regarding an 11 year old  twin patient (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). After receiving the vaccine GARDASIL 9, the patient experienced sleepiness, described as "sleeping off and on for a whole day". The reporter did not assess the causal relationship between therapy with GARDASIL 9 and the event. The next day after vaccination, on an unknown date, the patient recovered from the event. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA010075:
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 42-year-old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not reported. On 16-AUG-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # N019838 with expiration date: 16-FEB-2019), intravenously (dose and frequency were not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a patient of unknown age and gender. The patient's concurrent, historical conditions, concomitant medications and drug reactions or allergies were not provided. On 20-AUG-2018, the patient was vaccinated with VARIVAX lot # N023957 and expiration date on 01-SEP-2019 (dosage, route of administration and anatomical location were not reported) and PROQUAD lot # R004439 and expiration date on 12-AUG-2019 (dosage, route of administration, and anatomical location were not reported); both administered for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions and allergies were not provided. The office manager reported that, on 22-AUG-2018, the patient received a dose of improperly stored VARIVAX, subcutaneously, for prophylaxis (dose number, frequency and anatomical location of vaccination were not provided; lot number R008394, expiration date 20-MAR-2020). The reporter also mentioned that the vaccine was reconstituted with a properly stored sterile diluent. No adverse effects were reported. The VARIVAX dose was exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46 °F (22.1 F) for a time frame of 2 hours and 30 minutes, which was detected by the Digital Data Logger. No previous temperature excursion was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant (CMS) referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 28-AUG-2018, the patient was inadvertently vaccinated with an expired dose of M-M-R II lot # M034857 expired on 27-JUL-2018, for prophylaxis (dose, frequency and route of administration were not reported). Concomitant therapies included sterile diluent. No adverse effects were reported.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Pneumonia bacterial
Clinical narrative: This initial spontaneous report was received from a pharmacist and also a 44 year old female patient. Concurrent conditions included bipolar disorder, high blood pressure, and diabetes.  Concomitant medications included aspirin and unspecified diabetes, bipolar, and high blood pressure medication. She had no drug reactions/allergies. On 08-DEC-2015, the patient was vaccinated with PNEUMOVAX 23 at a pharmacy to prevent pneumonia (lot # K009874; expiration 19-MAR-2016). The patient reported that she started coming down with symptoms on 25-AUG-2018 and went to an urgent care facility on 26-AUG-2018 where a chest x-ray determined that she had bacterial pneumonia. The pharmacist stated that the patent called the pharmacy on 29-AUG-2018 to inform that she was diagnosed with pneumonia. She was treated with antibiotics and TYLENOL. The pharmacist reported that the patient was currently taking an unspecified antibiotic regimen for the pneumonia. The patient was recovering from the bacterial pneumonia at the time of the report. Causality was not specifically reported. The patient requested compensation for pain and suffering due to pneumonia after being vaccinated with PNEUMOVAX 23. Upon internal review, bacterial pneumonia was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist reported for herself via Pfizer sales representative. This female patient (who is a pharmacist) of an unspecified age received 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 experienced swelling all the way up her arm on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: Patient reports getting a sinus infection and needing to taking antibiotics because she was only getting worse upon just trying to take acetaminophen and Mucinex.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Abdominal distension, Adenovirus test, Escherichia test negative, Flatulence, Giardia test negative
Clinical narrative: 8/22/18 Patient in office started vomiting after every feeding few hours after vaccines. Decreased urine output, no fever. Sent to ER for lab and x-ray. ZOFRAN given for vomiting. 8/23/18 Patient brought in for follow up doing much better no stools but lots of gas. Eating well vomited once at night given ZOFRAN did well. 8/24/18 Per mother, patient started vomiting again, given ZOFRAN, no vomiting since.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Helicobacter test negative, Laboratory test abnormal, Norovirus test, Polymerase chain reaction, Rotavirus test positive
Clinical narrative: 8/22/18 Patient in office started vomiting after every feeding few hours after vaccines. Decreased urine output, no fever. Sent to ER for lab and x-ray. ZOFRAN given for vomiting. 8/23/18 Patient brought in for follow up doing much better no stools but lots of gas. Eating well vomited once at night given ZOFRAN did well. 8/24/18 Per mother, patient started vomiting again, given ZOFRAN, no vomiting since.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Salmonella test negative, Urine output decreased, Viral test negative, Vomiting, X-ray gastrointestinal tract abnormal
Clinical narrative: 8/22/18 Patient in office started vomiting after every feeding few hours after vaccines. Decreased urine output, no fever. Sent to ER for lab and x-ray. ZOFRAN given for vomiting. 8/23/18 Patient brought in for follow up doing much better no stools but lots of gas. Eating well vomited once at night given ZOFRAN did well. 8/24/18 Per mother, patient started vomiting again, given ZOFRAN, no vomiting since.
Age: 0.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Yersinia test negative
Clinical narrative: 8/22/18 Patient in office started vomiting after every feeding few hours after vaccines. Decreased urine output, no fever. Sent to ER for lab and x-ray. ZOFRAN given for vomiting. 8/23/18 Patient brought in for follow up doing much better no stools but lots of gas. Eating well vomited once at night given ZOFRAN did well. 8/24/18 Per mother, patient started vomiting again, given ZOFRAN, no vomiting since.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Pain, Viral test negative
Clinical narrative: 8/13/18 awoke 8/13/18 with complaints temp 99.6 and neck pain. No other complaints following administration of N/V - Advised not typical 4D following immunization to F/U with MD to be seen same day. 8/27/18 - LM for parent to call for F/U. 8/30/18 - mother stated - Patient ended up with body aches also - all symptoms lasted 4D and resolved with ADVIL.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Erythema, Fatigue, Joint range of motion decreased, Peripheral swelling
Clinical narrative: Swelling, redness (L) arm and forearm, decreased range in motion, poor appetite, fatigue, color in the area, scab formation noted. Results in treatment: MEDROL dose pack.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Scab, Skin discolouration
Clinical narrative: Swelling, redness (L) arm and forearm, decreased range in motion, poor appetite, fatigue, color in the area, scab formation noted. Results in treatment: MEDROL dose pack.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Pain
Clinical narrative: Numbness in the area of the ulnar nerve. Numbness resolved 24 hrs after vaccination. Still C/O pain.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Induration, Skin discolouration
Clinical narrative: Large induration with central pink, no drainage.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paranasal sinus discomfort, Rash, Rash papular
Clinical narrative: Patient indeed did have a rash across her chest which she says is new in onset, shortly after getting the vaccine. Site itself was normal. Rash extended from top/between breasts up to her neck. Rash was fine, papular, and erythematous. No excoriations, no pus or bleeding. Did not itch, not painful. No fever or chills. Is reporting some sinus pressure, no headache. Unsure if the head symptoms are related- she does have bouts of sinsitis annually.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Arm soreness by 6 PM, headache by 12 AM during sleep, next morning by 6:30 AM fatigue, stomach cramps, continued headache, arm pain when moving arm, body aches. Second and third days some symptoms slightly better but still lingering. Fourth day nausea, vomited once, shivers, unable to sleep due to aches and restlessness.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Restlessness, Vomiting
Clinical narrative: Arm soreness by 6 PM, headache by 12 AM during sleep, next morning by 6:30 AM fatigue, stomach cramps, continued headache, arm pain when moving arm, body aches. Second and third days some symptoms slightly better but still lingering. Fourth day nausea, vomited once, shivers, unable to sleep due to aches and restlessness.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Malaise
Clinical narrative: Arm soreness and 3 red areas at injection site. Lasted 5 days. Fatigue lasted 4 days. Fever x 1 day. Malaise x 4 days.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 22-AUG-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # L041205, expiration date 20-OCT-2017 (dose and route of administration were not provided) for prophylaxis. It was reported that this was not supported as per the stability memo. No adverse effects were reported.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Musculoskeletal stiffness, Oropharyngeal pain, Pain in extremity, Paraesthesia
Clinical narrative: 2 Days after - low grade fever, malaise, sore throat; 3 days later tingling Right foot, 4th day tingling in left foot started. 1 week later - tingling in right hand then next day noted in left hand; also noted hands stiff and painful. Tingling/pain in Feet and Hands continue with increase pain in evening and from overuse.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Repetitive strain injury
Clinical narrative: 2 Days after - low grade fever, malaise, sore throat; 3 days later tingling Right foot, 4th day tingling in left foot started. 1 week later - tingling in right hand then next day noted in left hand; also noted hands stiff and painful. Tingling/pain in Feet and Hands continue with increase pain in evening and from overuse.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Two days after immunization she awoke with symptoms of dizziness, mild nausea and low grade headache.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Insomnia, Pain, Pain in extremity
Clinical narrative: Arm pain and soreness at site of vaccine about an hour after it was received. Sleeplessness during the night after receiving the shot. The next morning I felt achy, had a slight fever and had a mild headache. The site of the vaccine is red, very sore and 2 inches in diameter. It also continues into the second day. I took one ibuprofen to ease the symptoms. That has helped with all but the site soreness and redness.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Arm pain and soreness at site of vaccine about an hour after it was received. Sleeplessness during the night after receiving the shot. The next morning I felt achy, had a slight fever and had a mild headache. The site of the vaccine is red, very sore and 2 inches in diameter. It also continues into the second day. I took one ibuprofen to ease the symptoms. That has helped with all but the site soreness and redness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain, Peripheral swelling
Clinical narrative: Sore, swollen arm and flu-like symptoms - no fever.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient given expired vaccine. Vaccine Expired on 08/15/2018 and immunization given on 08/21/2018. Patients mother was called and notified, patient will be coming in 1 month to get revaccinated.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Rash, Skin warm, Swelling
Clinical narrative: Rash about the size of two human hands. Swelling. Heat. Very painful. Patient reported on 8/25/18.
Age: 59.0
Sex: F
Vaccine: PNC13
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given vaccine to soon. Received in July 2018 and not to receive until November 2018.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Bacterial test positive, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Dysarthria, Dyspnoea
Clinical narrative: Aa 64yrs Male who presented to emergency department with shortness of breath. Of note HPI taken from record and report as patient unable to participate as intubated and sedated. On 8/9 the patient developed gradually worsening shortness of breath with increased work of breathing associated with slurred speech, nausea, and vomiting. Of note the patient's son reports that the patient started not feeling well after his shingles vaccination on 8/9. In the emergency department the patient was hypoxic requiring intubation. CXR and CT scan notes RML and RLL pneumonia. Empiric antibiotics and IVF given. He was admitted to CICU for close monitoring and further management.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Endotracheal intubation, Hypoxia, Intensive care, Malaise, Nausea
Clinical narrative: Aa 64yrs Male who presented to emergency department with shortness of breath. Of note HPI taken from record and report as patient unable to participate as intubated and sedated. On 8/9 the patient developed gradually worsening shortness of breath with increased work of breathing associated with slurred speech, nausea, and vomiting. Of note the patient's son reports that the patient started not feeling well after his shingles vaccination on 8/9. In the emergency department the patient was hypoxic requiring intubation. CXR and CT scan notes RML and RLL pneumonia. Empiric antibiotics and IVF given. He was admitted to CICU for close monitoring and further management.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pneumonia, Vomiting
Clinical narrative: Aa 64yrs Male who presented to emergency department with shortness of breath. Of note HPI taken from record and report as patient unable to participate as intubated and sedated. On 8/9 the patient developed gradually worsening shortness of breath with increased work of breathing associated with slurred speech, nausea, and vomiting. Of note the patient's son reports that the patient started not feeling well after his shingles vaccination on 8/9. In the emergency department the patient was hypoxic requiring intubation. CXR and CT scan notes RML and RLL pneumonia. Empiric antibiotics and IVF given. He was admitted to CICU for close monitoring and further management.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (100.8), chills, body aches/pain.
Age: 1.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site warmth, Irritability
Clinical narrative: Patient became fussy after administration of vaccine and developed a red, hot area on his upper left thigh where the vaccine had been administered.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Very sore arm. Fever, chills and major headache.
Age: 1.42
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash, Swelling face
Clinical narrative: Mild facial swelling and rash 2 hours after vaccine. Rash self resolved.
Age: 1.08
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Seen 8/30/18 for Shingles of Left Arm. Started on Acyclovir due to severity and seen again on 8/31/18 for pain. Has clustered vesicles all down forearm and onto hand consistent with Zoster.  Sister also noted to have Varicella type lesion on trunk for last 5 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Addison's disease, Adrenal disorder, Condition aggravated, Hypotension
Clinical narrative: Patient experience low blood pressure 2 days after 2nd shingrix vaccination; visited emergency room until stabilized. No inference made as to SHINGRIX being the cause, and probably related to patient's adrenal gland issues, Addison's disease. Patient has experience several episodes of low bp  prior to vaccination with SHINGRIX.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt was accessed in clinic for pain in arm and swelling. No actions were taken since pain can be treated with TYLENOL or ADVIL and swelling will go down, pt is aware to contact the clinic or go to the ED if arm gets worse. PCP is aware of the event.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Nausea, Pain
Clinical narrative: Patient developed a fever, body aches, nausea the evening of vaccination administration. These symptoms resolved after two days. Patient also developed redness, hardness, and soreness at site of injection that has gotten better but not yet completely resolved.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3, PPV
Symptoms: Pyrexia
Clinical narrative: Patient developed a fever, body aches, nausea the evening of vaccination administration. These symptoms resolved after two days. Patient also developed redness, hardness, and soreness at site of injection that has gotten better but not yet completely resolved.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Dizziness, Headache, Injection site pain, Injection site swelling
Clinical narrative: Dizzy, weak, fevers, arm painful top to wrist, needle entry hot - painful, swollen. Fever 99.4, lower range was upper 98's. Weekend, no car or driver. Too weak to go to clinic. Headaches. TYLENOL helped, migraine med helped fever and headaches, rested slept. Lasted 4 days approx.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Migraine, Pain in extremity, Pyrexia
Clinical narrative: Dizzy, weak, fevers, arm painful top to wrist, needle entry hot - painful, swollen. Fever 99.4, lower range was upper 98's. Weekend, no car or driver. Too weak to go to clinic. Headaches. TYLENOL helped, migraine med helped fever and headaches, rested slept. Lasted 4 days approx.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, Hypoaesthesia
Clinical narrative: Numbness to bilateral feet and hands. Nurse admin tdap on 8/27/18 with expiation date 8/25/17. Upon discovery per MD direction admin 2nd tdap on 8/29/18 with expiration date 10/01/20.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Patient presented to pharmacy with mildly swelling, redness, and mild heat in arm. Patient presented to pharmacy about 36 hours after immunization. Patient claimed there had been some pain (throbbing). Upon presentation, pharmacist gave patient acetaminophen, cold compress, antihistamine. Requested patient to return to pharmacy if symptoms didn't resolve in next 2 days or got worse. Patient said after cold compress, the site felt better. Picture taken at time presented to pharmacy. Patient received the PNEUMOVAX on front of right deltoid, and flu about 1 plus inches behind that on more rear side of deltoid.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Irritability, Urticaria
Clinical narrative: Healthy 12 month old well visit, received schedule 12 month vaccine of varicella with diluent on 08/29/2018 without incident. Mom called office and states child woke up with "hives" all over his body and was cranky. Pt seen in office that am and appears well other than the hives. Was treated with BENADRYL.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Peripheral swelling, Syncope
Clinical narrative: Left arm swelling, overall feeling sick and fainted.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Child received KINRIX in left thigh on 29 AUG 2018. Mom reports that site hurt the following day and by the end of the day, child's thigh was swollen and red and warm to touch. No fever or change in activity per Mom. Today, 2 days after immunization, left thigh very swollen and remains red and warm to touch though no define area of induration. No fever and child remains active. No availability in clinic for patient to be seen by provider so sent to Urgent Care for evaluation.