chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Condition aggravated, Crohn's disease, Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a 58 year old female pharmacist referring to herself. The patient's concurrent conditions included breast cancer and Crohn's disease. The patient also had unspecified "problems" with REMICADE (manufactured by Janssen) and her concomitant therapies included FEMHRT. On unknown dates, "3 or 4 years ago", the patient was vaccinated with 3 dose series of RECOMBIVAX HB (dose, route of administration, lot number and expiration date were not provided) for prophylaxis. On approximately 08-SEP-2017 (reported as "3 weeks ago), the patient experienced recurrence of unspecified symptoms of her pre-existing Crohn's disease; therefore, the patient went to her physician, where she was prescribed azathioprine and prednisone (manufacturer unknown) as treatment for these symptoms, she was additionally performed a bloodwork drawn including hepatitis B titers at this visit, which showed that she was negative for immunity to hepatitis B. At the reporting time, the patient had not recovered from the symptoms of her pre-existing Crohn's disease and the outcome of negative for immunity to hepatitis B was unknown. The causality assessment between RECOMBIVAX HB and the events was not reported. Upon internal review recurrence of unspecified symptoms of the patient's of Crohn's disease was considered to be medically significant.
Age: 73.0
Sex: F
Vaccine: PPV, FLUA3, HEPA, PPV
Symptoms: Diarrhoea, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 73 year old female patient reporting on herself. There was no information about the patient's concurrent conditions, medical history, drug reactions/allergies or concomitant medication. On 29-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 29-SEP-2017, the patient experienced swelling, tenderness and heat (feeling hot) about 4 inches below the injection site. There was no swelling or anything at the injection site. On 30-SEP-2017, the patient developed a fever and nausea and on the next day, reported as on 01-OCT-2017, the patient developed diarrhea. On an unspecified date in 2017, the patient did not longer experience swelling, tenderness and heat where it first appeared (resolved), but "it was itchy" and the swelling, tenderness and heat was appearing below her elbow on the same arm. At the reporting time, the fever, nausea and diarrhea were "almost gone" (resolving).The patient sought medical attention and spoke with her doctor on the phone. The outcome of the events prutitus, swelling, tenderness and heat below her elbow was reported as not resolved. The reporter did not assess the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Age: 73.0
Sex: F
Vaccine: PPV, FLUA3, HEPA, PPV
Symptoms: Nausea, Peripheral swelling, Pyrexia, Skin warm, Tenderness
Clinical narrative: Information has been received from a 73 year old female patient reporting on herself. There was no information about the patient's concurrent conditions, medical history, drug reactions/allergies or concomitant medication. On 29-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 29-SEP-2017, the patient experienced swelling, tenderness and heat (feeling hot) about 4 inches below the injection site. There was no swelling or anything at the injection site. On 30-SEP-2017, the patient developed a fever and nausea and on the next day, reported as on 01-OCT-2017, the patient developed diarrhea. On an unspecified date in 2017, the patient did not longer experience swelling, tenderness and heat where it first appeared (resolved), but "it was itchy" and the swelling, tenderness and heat was appearing below her elbow on the same arm. At the reporting time, the fever, nausea and diarrhea were "almost gone" (resolving).The patient sought medical attention and spoke with her doctor on the phone. The outcome of the events prutitus, swelling, tenderness and heat below her elbow was reported as not resolved. The reporter did not assess the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Age: 73.0
Sex: F
Vaccine: PPV, FLUA3, HEPA, PPV
Symptoms: Diarrhoea, Feeling hot, Nausea, Peripheral swelling, Pruritus
Clinical narrative: Information has been received from a 73 year old female patient reporting on herself. There was no information about the patient's concurrent conditions, medical history, drug reactions/allergies or concomitant medication. On 29-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 29-SEP-2017, the patient experienced swelling, tenderness and heat (feeling hot) about 4 inches below the injection site. There was no swelling or anything at the injection site. On 30-SEP-2017, the patient developed a fever and nausea and on the next day, reported as on 01-OCT-2017, the patient developed diarrhea. On an unspecified date in 2017, the patient did not longer experience swelling, tenderness and heat where it first appeared (resolved), but "it was itchy" and the swelling, tenderness and heat was appearing below her elbow on the same arm. At the reporting time, the fever, nausea and diarrhea were "almost gone" (resolving).The patient sought medical attention and spoke with her doctor on the phone. The outcome of the events prutitus, swelling, tenderness and heat below her elbow was reported as not resolved. The reporter did not assess the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Age: 73.0
Sex: F
Vaccine: PPV, FLUA3, HEPA, PPV
Symptoms: Pyrexia, Tenderness
Clinical narrative: Information has been received from a 73 year old female patient reporting on herself. There was no information about the patient's concurrent conditions, medical history, drug reactions/allergies or concomitant medication. On 29-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 29-SEP-2017, the patient experienced swelling, tenderness and heat (feeling hot) about 4 inches below the injection site. There was no swelling or anything at the injection site. On 30-SEP-2017, the patient developed a fever and nausea and on the next day, reported as on 01-OCT-2017, the patient developed diarrhea. On an unspecified date in 2017, the patient did not longer experience swelling, tenderness and heat where it first appeared (resolved), but "it was itchy" and the swelling, tenderness and heat was appearing below her elbow on the same arm. At the reporting time, the fever, nausea and diarrhea were "almost gone" (resolving).The patient sought medical attention and spoke with her doctor on the phone. The outcome of the events prutitus, swelling, tenderness and heat below her elbow was reported as not resolved. The reporter did not assess the causal relationship between the events and therapy with PNEUMOVAX 23 were not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 03-OCT-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 03-FEB-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-SEP-2016, the patient was treated by a physician in a physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 29-SEP-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ 1 dose orally, lot number lot M043836 and expiration date 17-JUN-2018 (strength and frequency were not reported) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 degree Farenheth to 77 degree Farenheith, time frame of 12 hours and no previous temperature excursion. Digital Data logger was involved.; Sender's Comments: US-009507513-1710USA001900: US-009507513-1710USA001901:
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist reporting on a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history, drug reactions/allergies or concomitant medication. On 01-OCT-2017, the patient received an expired dose of PNEUMOVAX 23 lot # L019836, expiry date 24-MAR-2017, for prevention of pneumonia (anatomical location, route of administration, lot number and expiration date were not reported). On 01-OCT-2017, the patient experienced redness around injection site. It was reported that the patient did not seek medical attention; no treatment was given for the adverse event and it was unknown by the reporter if lab diagnostics/studies were performed. The outcome of the event injection site erythema and its causal with PNEUMOVAX 23 were not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On 02-OCT-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ 1 dose orally, lot number lot M043836 and expiration date 17-JUN-2018 (strength and frequency were not reported) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit, time frame of 12 hours and no previous temperature excursion. Digital Data logger was involved. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1710USA001900: US-009507513-1710USA001694.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Balance disorder, Cardiovascular examination, Chest pain, Dysarthria, Facial paralysis
Clinical narrative: 9/8/17-pt called office complaining of tingling in arms and body, feeling achy and not well. 9/10/17-to ER-stroke workup negative-had (L) facial droop->dx=Bell's Palsy. 9/12/17-return to ER for chest pain and slurred speech-cardiac and pulmonary embolus workup negative so sent home. 9/14/17-presented to PCP office-balance off/fell, slurred speech, facial droop so sent back to hospital who admitted-dx eventually was Guillain-Barre syndrome.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fall, Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test normal, Malaise
Clinical narrative: 9/8/17-pt called office complaining of tingling in arms and body, feeling achy and not well. 9/10/17-to ER-stroke workup negative-had (L) facial droop->dx=Bell's Palsy. 9/12/17-return to ER for chest pain and slurred speech-cardiac and pulmonary embolus workup negative so sent home. 9/14/17-presented to PCP office-balance off/fell, slurred speech, facial droop so sent back to hospital who admitted-dx eventually was Guillain-Barre syndrome.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Paraesthesia
Clinical narrative: 9/8/17-pt called office complaining of tingling in arms and body, feeling achy and not well. 9/10/17-to ER-stroke workup negative-had (L) facial droop->dx=Bell's Palsy. 9/12/17-return to ER for chest pain and slurred speech-cardiac and pulmonary embolus workup negative so sent home. 9/14/17-presented to PCP office-balance off/fell, slurred speech, facial droop so sent back to hospital who admitted-dx eventually was Guillain-Barre syndrome.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site irritation, Pyrexia
Clinical narrative: Patient had injection site redness and irritation and began running a fever. He followed up with his transplant physician and they diagnosed the immunized arm as having cellulitus  and prescribed an antibiotic.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: Syncope, dizziness, nausea.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Throat irritation
Clinical narrative: Elevated heart rate, SOB, chest tightness, itchy throat.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dysphagia, Pharyngeal oedema, Pruritus, Rash
Clinical narrative: Rash on neck with itching and burning, throat swelling with difficulty swallowing, taken to ER given EPIPEN and other meds, reaction subsided, monitored for 3 hours in ER.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Joint range of motion decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: 9/29/17- I began noticing pain in my left shoulder. Later that afternoon, the pain became worse radiating to my hand, arm, and left collarbone. I have had a terrible time sleeping since 9/29/17 with constant pain in my left arm, especially the collarbone. I have been brought to tears several times. I visited a Urgent Clinic due to the pain. I have been using ICYHOT, Ibuprofen, ice packs, and pharmacy brand pain relieving patches. I am still having trouble with range of motion and putting my clothes on without pain. I am unable to lift my child at this time.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Tearfulness, Weight bearing difficulty
Clinical narrative: 9/29/17- I began noticing pain in my left shoulder. Later that afternoon, the pain became worse radiating to my hand, arm, and left collarbone. I have had a terrible time sleeping since 9/29/17 with constant pain in my left arm, especially the collarbone. I have been brought to tears several times. I visited a Urgent Clinic due to the pain. I have been using ICYHOT, Ibuprofen, ice packs, and pharmacy brand pain relieving patches. I am still having trouble with range of motion and putting my clothes on without pain. I am unable to lift my child at this time.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hypoaesthesia, Limb discomfort, Muscle spasms, Muscular weakness
Clinical narrative: Left arm heaviness with numbness and b/l hand cramps; developed weakness of b/l hands, generalized headache.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: 10/05/2017 Patient called the Health Department to report that one hour after receiving vaccination, she started to itch, and then she broke out in hives. After vaccination, and before the hives she had consumed Cheese, watermelon and two chocolates. She went to Medical Center and received IV Benadryl. She went home with a prescription for a steriod. Patient was instructed by the ER Doctor to see an Allergist.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chest pain, Wheezing
Clinical narrative: Patient experienced chest pain and tightness as well as wheezing within one hour after receiving her flu shot. She was taken to the ER to rule out all other causes such as a heart attack and pulmonary embolism, which were all ruled. Patient already had several allergies listed, and she was given the preservative free version of FLUVIRIN.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered at inappropriate site, Erythema, Exposure during pregnancy, Induration, Nodule
Clinical narrative: I am currently 30 weeks pregnant (EDD 12/12/17) and received Tdap in my OBGYN's office 1.5 days ago. Of note, my previous Tdap was July 2014. Reaction started with small nodule/induration and then progressed in size to now 1.5 by 1.5 inches. Area is red, raised, warm, and indurated. I have a slight fever. Injection was lower than normal, so is possible that it was administered subcutaneously rather than intramuscularly as intended.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm, Swelling
Clinical narrative: I am currently 30 weeks pregnant (EDD 12/12/17) and received Tdap in my OBGYN's office 1.5 days ago. Of note, my previous Tdap was July 2014. Reaction started with small nodule/induration and then progressed in size to now 1.5 by 1.5 inches. Area is red, raised, warm, and indurated. I have a slight fever. Injection was lower than normal, so is possible that it was administered subcutaneously rather than intramuscularly as intended.
Age: 1.25
Sex: F
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: Fever 102.9.
Age: 18.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Bed rest, Pyrexia, Upper-airway cough syndrome
Clinical narrative: Patient presented in clinic with fever and post nasal drainage. TYLENOL and bed rest was recommended.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Right arm erythema.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Cold sweat, Dizziness, Hypoaesthesia, Pallor, Rash erythematous
Clinical narrative: 20 min after receiving vaccine, R upper extremity from elbow to hand developed numbness. Nasal rash was noted by co-worker 50 minutes after receiving vaccine, was initially dart red and slowly fading in color but remains red today. At 2:30 pm yesterday, he developed lightheadedness, was clammy and looked pale. He drank a bottle of water and rested x 1 hour. Lightheadedness, clamminess and numbness of right upper extremity slowly improved and resolved when patient woke up this morning at 0530. Nasal rash persists but much less red. No meds taken.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Blood sodium decreased, Developmental regression, Gastrointestinal disorder, Growth failure, Pulmonary function test decreased
Clinical narrative: Could not keep sodium levels up, gastrointestinal problems, throwing up every feed, kidney function diminished, regression, slow growth, lung function diminished, uncontrollable seizures starting immediately after.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Renal impairment, Seizure, Vomiting
Clinical narrative: Could not keep sodium levels up, gastrointestinal problems, throwing up every feed, kidney function diminished, regression, slow growth, lung function diminished, uncontrollable seizures starting immediately after.
Age: 24.0
Sex: M
Vaccine: UNK
Symptoms: Ear discomfort, Feeling abnormal
Clinical narrative: Within two days of getting the shot my ears were bothering me enough almost to the point I was going to call in sick. I thought I had an ear infection. It was an extreme fullness and felt horrible and lasted for a week or two until I felt worse and eventually got better.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Fall, Feeling abnormal, Head injury, Unresponsive to stimuli
Clinical narrative: When the patient stood up shortly after getting the vaccine, he slumped against the chair, and then fell on the floor, hitting his head. After a short moment, he became responsive and was able to answer questions. His head had a red mark, but no cuts. He answered questions lucidly and reported no symptoms other than a slight fogginess that cleared after a few moments. 911 was called, and EMS came to check on him. They did not feel that a visit to the emergency room was necessary. The mother then took him home. I have tried calling for a follow-up, but have not been able to reach them yet.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess, Injection site abscess, Rash pustular, Skin warm, Wound treatment
Clinical narrative: 9/19/2017- Tdap Injection administered. 9/28/2017-Noticed an abscess at injection site on left arm, notified Nursing Supervisor, Nurse Practitioner, Supervisor. Nursing Supervisor notified Medical Director of incident and asked if CNP could treat me. This was approved and I was given KEFLEX 500mg 1 tablet, four times a day x 10 days. 10/3/2017- while meeting with a client I noticed the abscess begin to drain. I notified Primary Med. nurse and CNP who instructed me to come back to be seen. Nursing Supervisor, Nurse Practitioner assessed the area, irrigated the area with normal saline, and applied triple antibiotic and dressing. I was instructed to go to emergency room if symptoms worsened. 10/4/2017- Nursing supervisor and Primary Med. nurse assessed area and noticed that site was looking better but the fluid had moved to another pocket in my arm. Nursing Supervisor informed my supervisor of this and I was sent home. 10/5/2017- Nurse Practitioner and Nursing Supervisor inspected area to check drainage. Site is looking better no redness and no longer hot. Drainage is clear, noticed puss still in areas. CNP advised me to go see PCP today. Primary med. nurse scheduled appointment for today. I notified supervisor who will notify HR.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Condition aggravated, Injection site reaction, Myosclerosis, Oral herpes
Clinical narrative: This spontaneous report was received from a 61 year old female patient, concerning herself. The patient's concurrent conditions were not reported; however, she did not have any drug reactions or allergies, and was not taking any concomitant medications. The patient's medical history included common cold sores. On 26-SEP-2017, the patient was vaccinated with a single dose of ZOSTAVAX in the left arm for prevention of shingles (dose, lot number and expiration date were not reported). On 28-SEP-2017, 2 days after getting the vaccine, the patient developed a cold sore (oral herpes). Additionally, on the same date, she experienced joint pain (arthralgia) and muscle hardness (myosclerosis) near the injection site. The patient did not seek for medical attention and no intervention to prevent serious criteria was performed. The outcome of oral herpes, arthralgia and myosclerosis was not reported. The reporter's causality assessment between all aforementioned events and ZOSTAVAX was not provided. Upon internal review myosclerosis, was considered to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Thyroid disorder
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On an unknown date in 2016 (reported as "about a year ago"), the patient was vaccinated in her thigh with a dose of PNEUMOVAX 23 lot # K007262, expiration date 25-NOV-2015 (dose and route of administration were not provided), for prevention of pneumococcal disease. At the time of the report, she needed a needle biopsy of the thyroid for an unspecified reason (onset date was not reported). The outcome of the event was unknown. The relatedness between the vaccine and the unspecified event was not provided.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Loss of personal independence in daily activities, Mobility decreased, Muscle tightness, Nausea
Clinical narrative: Severe 10/10 pain, unable to remove clothing, muscle tightness in arm, immobile, nausea, chills - have since subsided with the aid of Tylenol, will continue to monitor.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Severe 10/10 pain, unable to remove clothing, muscle tightness in arm, immobile, nausea, chills - have since subsided with the aid of Tylenol, will continue to monitor.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Employee seen on 10/5/2017, from Varicella injection on 10/3/2017 to complete a two shot series since Varicella titer was negative, in Hospital with right upper arm swollen from elbow to mid bicep on under side and lateral side of right arm. Area was reddened with dark red center and light red on outer edges. Area of swelling was notably warm to the touch. Employee sent to Employee Health but would not see due to no insurance. Employee was referred to Urgent Care for follow up evaluation and treatment.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: C/O redness, swelling and warmth at site of his varicella injection. C/O achy at site and itchy. Denies tenderness. Denies difficulty breathing or swallowing. Start hydrocortisone for itching BID and warm compresses TID. Assured local reaction that should resolve on own. Advised to return to clinic if site increases in size, warmth, redness, drainage, pain or develops fever.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: C/O redness, swelling and warmth at site of his varicella injection. C/O achy at site and itchy. Denies tenderness. Denies difficulty breathing or swallowing. Start hydrocortisone for itching BID and warm compresses TID. Assured local reaction that should resolve on own. Advised to return to clinic if site increases in size, warmth, redness, drainage, pain or develops fever.
Age: 51.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Abdominal discomfort, Pain, Pruritus generalised
Clinical narrative: Approximately 1 hour after receiving vaccines, patient complained of generalized itching (no observed rash), abdominal discomfort and body ache.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Blood glucose normal, Blood potassium increased, Dizziness, Erythema
Clinical narrative: Client returned to clinic about one hour after injection stating she did not feel well with complaints of dizziness and a faint feeling. She also stated she was having left arm pain originating at the injection site. Both arms were urticaric with a pruritus developing on her chest. She reports the arm pain @ 6/10. She presented alert and oriented & somewhat anxious. Her lips were pink and did not present with signs of respiratory distress. Once seated her vital signs were monitored and found to be in normal limits. T-97.4 HR 60 RR 16 BP 100/60. Since she is pre-diabetic an Accucheck was done and was 94. After about 20 minutes of rest and reassurance she stated she was feeling better. Some of the arm redness was clearing up. She said she would call her family doctor once she got back to her office & she was at this point thinking of driving home to rest. She was Ibuprofen 200mg po for the arm pain. She has a history of dizziness and feeling lightheaded and she said that her MD has been working her up possible immune issues. She said that last month her K was elevated and that she was anemic but could not say what her HCT actually was. The client states that she has never had a reaction to the flu shot before.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Malaise, Pain in extremity, Pruritus, Urticaria
Clinical narrative: Client returned to clinic about one hour after injection stating she did not feel well with complaints of dizziness and a faint feeling. She also stated she was having left arm pain originating at the injection site. Both arms were urticaric with a pruritus developing on her chest. She reports the arm pain @ 6/10. She presented alert and oriented & somewhat anxious. Her lips were pink and did not present with signs of respiratory distress. Once seated her vital signs were monitored and found to be in normal limits. T-97.4 HR 60 RR 16 BP 100/60. Since she is pre-diabetic an Accucheck was done and was 94. After about 20 minutes of rest and reassurance she stated she was feeling better. Some of the arm redness was clearing up. She said she would call her family doctor once she got back to her office & she was at this point thinking of driving home to rest. She was Ibuprofen 200mg po for the arm pain. She has a history of dizziness and feeling lightheaded and she said that her MD has been working her up possible immune issues. She said that last month her K was elevated and that she was anemic but could not say what her HCT actually was. The client states that she has never had a reaction to the flu shot before.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema
Clinical narrative: Patient came back with antibiotic for KEFLEX 250 four times daily for 7 days due to cellulitis on her arm. Dr drew a circle around to monitor and pt seems to be doing ok.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt. left arm was red, swollen and warm touch, but never ran a fever. Pt. was put on Cephalexin 10.5.17.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Shot given before noon, and by 8 pm patient said her face had a bad rash that itched. She took a Benadryl and was fine in 24 hours.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dyspnoea, Rash pruritic
Clinical narrative: Itchy rash, chest tightness, SOB.
Age: 31.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth, Insomnia
Clinical narrative: Vaccine Reaction; Warmth, swelling, raised red welts on arm around injection sites; Nausea,  dry heaving;  Hasn't eaten anything; Difficulty sleeping; Never had reaction to any immunizations before;  Malaise;  Took tylenol, hasn't taken anything else.
Age: 31.0
Sex: F
Vaccine: FLU4, HEPA, PPV
Symptoms: Malaise, Nausea, Retching
Clinical narrative: Vaccine Reaction; Warmth, swelling, raised red welts on arm around injection sites; Nausea,  dry heaving;  Hasn't eaten anything; Difficulty sleeping; Never had reaction to any immunizations before;  Malaise;  Took tylenol, hasn't taken anything else.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Full blood count, Headache, Injection site erythema, Injection site pain
Clinical narrative: The patient developed a headache, nausea, vomiting, chills, tenderness and redness at site of injection over an 18x10 cm area, and orthostasis. Doctor will treat with Keflex and Prednisone. Will also check cbc.
Age: 46.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Nausea, Vomiting
Clinical narrative: The patient developed a headache, nausea, vomiting, chills, tenderness and redness at site of injection over an 18x10 cm area, and orthostasis. Doctor will treat with Keflex and Prednisone. Will also check cbc.
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Ear discomfort, Hyperhidrosis, Nasal congestion, Nausea, Throat irritation
Clinical narrative: After 10min of administering the vaccine she started feeling nausea and sweating, later she felt itchy throat and funny ears and slightly stuffy nose.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site nodule, Injection site swelling
Clinical narrative: Patient reported bleeding from the site at the time of the injection, and reported 0 pain. She said she felt a knot at the injection site, and a bump developed over the next few days. She also had a large bruise at the injection site. the bruise was approx. 3.5" by 1.5" on Thursday, October 5 (5 days after administration).
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Eyelid oedema, Rash erythematous, Rash generalised, Swelling face
Clinical narrative: Developed whole body red rash at 4:00 PM, advised to give BENADRYL which helped rash. Next morning woke up with swollen eyelids and face, went to ER, given prednisone and BENADRYL.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Expired product administered, Hypoaesthesia, Paraesthesia, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to 64-year-old female patient with codeine allergy. The patient's concomitant medication included unspecified antidepressant and unspecified medications to treat unspecified thyroid condition, high cholesterol and hypertension. On 16-SEP-2017 the patient was vaccinated with an improperly stored and expired dose of ZOSTAVAX (lot L007222, expiration date: 03-JUN-2016, dose and route of administration were not provided) reconstituted with properly stored sterile diluent (MRK) (lot #, expiration date, dose and route of administration were not provided) both for shingles prevention. Reporter stated that ZOSTAVAX was stored between 15° Fahrenheit degrees to 46° Fahrenheit degrees for "more than a year" prior to administration. The digital data logger was not used. In an approximately September 2017 the patient experienced "tingling and redness on her unspecified arm and numbness of her head. On an unknown date, in September 2017, the patient sought medical attention by seeing the physician but it was unknown, if she received any treatment for the events. The patient did not recovered from the events of tingling and redness on her unspecified arm and numbness of her head. The relatedness between the events of tingling and redness on her unspecified arm and numbness of her head and ZOSTAVAX and sterile diluent (MRK) was not reported.
Age: 73.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies were not reported. On an unknown date, reported as "at least a year ago", the patient was vaccinated with PREVNAR 13. On 24-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N012127, expiration date 20-JAN-2019, 0.5 ml, intramuscularly for prophylaxis. Her concomitant therapies included levothyroxine sodium (manufacturer unknown), losartan potassium (manufacturer unknown), pravastatin and sucralfate. On 24-SEP-2017, reported as "right away after receiving with PNEUMOVAX 23", the patient experienced pain 3 inches below the injection site. On 25-SEP-2017, the patient woke up with swelling and redness 3 inches below the injection site of the PNEUMOVAX 23 that went also down the arm. The patient sought medical attention and contacted the pharmacy. No lab diagnostic studies were performed for the patient and no treatment was given for the events. The outcome of injection site pain, injection site erythema and injection site swelling were reported as not recovered/not resolved. Relatedness between the events and PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative and refers to a female patient of age between 60 and 64. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In September 2017, 7 to 10 days prior to the report, the patient was vaccinated with a dose of ZOSTAVAX (route of administration, lot number and expiration date were not reported). 4 days after the vaccination, in September 2017, the patient visited the physician's office with soreness, swelling and pain at the injection site. There was no treatment given for the events. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from social media via other and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry date and dosing details were not reported) for prophylaxis. Later, on an unknown date, the patient died and the cause of death was unknown. It was unknown if an autopsy was performed. It was reported that, 63 reports on GARDASIL lot recalled, including one death (product quality issue). And the reports in vax from same lot given after recall. Causality assessment was not provided. Upon internal review, death was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death.
Age: 12.0
Sex: M
Vaccine: FLUX, HPV9, MNQ
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 year old male patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 02-OCT-2017, the patient was inadvertently vaccinated with GARDASIL 9 lot number N009801, expiration date 20-NOV-2019; dose 1, subcutaneous (drug use via unapproved administration route) for prophylaxis. No adverse events reported.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Pharyngeal abscess
Clinical narrative: This is a spontaneous report from a contactable physician, reporting for himself. A male patient of an unspecified age and race/ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced redness at injection site (shoulder) and abscess in the throat. The events were non-serious. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 25-year-old male patient received TRUMENBA (Batch/lot S26985, exp. 31Jan2019), via an unspecified route of administration on an unspecified date at 0.5 ml single  for immunisation. The patient medical history and concomitant medications were not reported. 7 days post injection with meningococcal group b rlp2086 , the patient experienced left facial weakness. He presented to hospital ER and diagnosed with Bells Palsy. Outcome of the event was unknown.
Sex: M
Vaccine: PNC13, TTOX
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist communicated to a sales representative. A male patient in his 50's received on an unspecified date (reported as several months before the report) PREVNAR 13 intramuscular, at single dose, for prevention of pneumococcal pneumonia (immunization) and tetanus vaccine (trade name unknown), for immunization. Both vaccines were administered in the same arm. Medical history included bone marrow transplant. The patient was immunocompromised. Concomitant medications were not reported. On an unknown date the patient developed an injection site reaction with a large lump and swelling of the arm at the injection site. The events resolved within one week, on an unknown date. His experience was not painful. He was going to receive other injections or products on that day, but he did not due to his experience after he received PREVNAR 13 injection.
Age: 41.0
Sex: F
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 41-year-old female patient received PREVNAR 13 via an unspecified route of administration single dose at left arm on 25Sep2017 10:00 for immunization, at the doctor's office. Medical history included ongoing asthma for 20 plus years. No family relevant medical history. There were no concomitant medications. No history of previous immunization. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient was reporting the way the vaccine was injected. The vaccine was not injected in the back of her arm, but up high near shoulder bone on 25Sep2017 at 10:00. Immediately she had soreness and muscle pain for seven days. Felt like she was hit with a baseball bat. She also did not witness the Nurse assistant shake the vial before administration. The events muscle pain at injection site and soreness at injection site were recovered on an unknown date in 2017. No event required a visit to Emergency Room or Physician Office. The Doctor was not aware of events. No investigations performed. No treatments received. No relevant tests performed.
Age: 57.0
Sex: M
Vaccine: YF
Symptoms: Chills, Fatigue, Feeling cold, Feeling hot, Impaired work ability
Clinical narrative: I spoke with patient today. He states that he had YF vaccine on 9-28-17. On the evening of 10-03-17 while watching TV he felt very fatigued and went to bed early. He later woke up with shivers and feeling cold as if he had a fever. This was better in about 30 minutes and he took TYLENOL which is made him feel much better. He took off of work 10-04-17 due to malaise and still not feeling well. Today he is feeling much better but has intermittent aches and feeling warm on and off. I highly encouraged him to see his doctor. He stated that he did not feel bad enough to see a doctor. I again encouraged him to get checked out by his doctor.  He said that he would see if he could get in today since he is traveling soon. He was very thankful for the discussion and advice.
Age: 57.0
Sex: M
Vaccine: YF
Symptoms: Malaise, Pain
Clinical narrative: I spoke with patient today. He states that he had YF vaccine on 9-28-17. On the evening of 10-03-17 while watching TV he felt very fatigued and went to bed early. He later woke up with shivers and feeling cold as if he had a fever. This was better in about 30 minutes and he took TYLENOL which is made him feel much better. He took off of work 10-04-17 due to malaise and still not feeling well. Today he is feeling much better but has intermittent aches and feeling warm on and off. I highly encouraged him to see his doctor. He stated that he did not feel bad enough to see a doctor. I again encouraged him to get checked out by his doctor.  He said that he would see if he could get in today since he is traveling soon. He was very thankful for the discussion and advice.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: VIS version date 10/06/2009 .... within 12 hours the injection area was red, within 24 hours the red area doubled in size and started to itch. within 48 hours the area was swollen and the skin was hard to the touch and sore. Went to walk-in treatment center and was told it is an allergic reation and was given steriods. One shot in office and a Medrol Dosepak to start the next day.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: VIS version date 10/06/2009 .... within 12 hours the injection area was red, within 24 hours the red area doubled in size and started to itch. within 48 hours the area was swollen and the skin was hard to the touch and sore. Went to walk-in treatment center and was told it is an allergic reation and was given steriods. One shot in office and a Medrol Dosepak to start the next day.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Nodule, Peripheral swelling, Pruritus
Clinical narrative: Grandmother states child had swelling with a red knot and itching in arm of vaccination. Grandmother states it started the night of when the vaccine was given and had started to get worse. She reported to nurse at Health department two days later on 10/04/2017 at approximately 4:00pm. Nurse instructed to go to clinic. Grandmother states she had made an appointment for 10/05/2017 and would take to emergency if needed.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Employee's left arm is red, warm to touch and tender about 1 hour after vaccine and still red, tender 10/5/2017.
Age: 28.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Fever to 102 degrees F, arm redness, swelling: pain.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Blood glucose, Blood lead, Haemoglobin, Metabolic function test, Seizure
Clinical narrative: Patient had a seizure within 5-10 minutes of receiving vaccines.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: After receiving the vaccine the patient reported to provider that they had hives.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site pain
Clinical narrative: Patient reports pain and tenderness with palpation at site of injection. Onset 8/30/17 and continuing through 10/05/2017.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swollen and bright red around injection site (about 4 inch diameter across). site is warm to the touch.  patient first noticed when adverse event when she woke up the morning of 10/3/17 and symptoms have persisted.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Computerised tomogram normal, Diplopia, Eye movement disorder, Headache, Injected limb mobility decreased
Clinical narrative: VACCINATION WAS GIVEN ON WEDNESDAY (9/27) AND THAT AFTERNOON PT SAID HER LEFT ARM WAS EXTREMELY SORE. BY THURSDAY (9/28) THE SORENESS WAS IN THE UPPER SHOULDER, BY FRIDAY (9/29) THE SORENESS WAS UP ON HER NECK AND SHE COULDN'T LIFT HER ARM. SATURDAY (9/30) THE PAIN WAS ACROSS THE BACK OF HER HEAD AND SHE HAD DOUBLE VISION. TREATED WITH IBUPROFEN AND TYLENOL (IBUPROFEN WORKED BETTER).
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Neck pain, Pain in extremity, Transient ischaemic attack
Clinical narrative: VACCINATION WAS GIVEN ON WEDNESDAY (9/27) AND THAT AFTERNOON PT SAID HER LEFT ARM WAS EXTREMELY SORE. BY THURSDAY (9/28) THE SORENESS WAS IN THE UPPER SHOULDER, BY FRIDAY (9/29) THE SORENESS WAS UP ON HER NECK AND SHE COULDN'T LIFT HER ARM. SATURDAY (9/30) THE PAIN WAS ACROSS THE BACK OF HER HEAD AND SHE HAD DOUBLE VISION. TREATED WITH IBUPROFEN AND TYLENOL (IBUPROFEN WORKED BETTER).
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Patient reported to doctor that she had fainted after shot. Nothing else is known.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Blood test, Dizziness, Hypersensitivity, Nausea, Pain
Clinical narrative: Vaccine given at onsite workplace clinic at 8:50 am. 20 minutes after vaccination patient reports becoming dizzy. 30 minutes after vaccination he became very nauseous and had 2 episodes of dry heaving. He went home from work around 10:10 am and reported increasing dizziness and nausea at this time as well has body aches and feeling "feverish." By 2 pm he reported vomiting 4-5 times. He reported having a 100 degree F fever and took some TYLENOL. Later in evening he went to the ER because he could not stop vomiting and was in severe pain all over and was hypersensitive to physical stimulus. He was given fluids and antiemetics and had bloodwork done. Was given prescription for ZOFRAN and was sent home. The next day he reported he was feeling a bit better because the ZOFRAN was decreasing his nausea and he was less achy than before but he still is running a temp of 99-100.